Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The CompanyExcept for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Affiliates andSubsidiaries taken as a whole, the contract research organizations engaged to perform clinical trials on behalf each of the Company (the “CROs”) have obtained and its Subsidiaries has timely and accurately filed or provided all Governmental Approvals required by any Governmental Entityregulatory reports, including the FDAschedules, to permit the conduct of the Business forms, Permit applications or renewals, examination responses and all such Governmental Approvals are valid and in full force and effectsubmissions, and no such Governmental Approval has been or is being revoked or challenged. Neither the Companyother similar documents, nor to the Knowledge of the Company, together with any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product amendments required to be filed made with respect thereto, that the Company or submitted its Subsidiary was required to permit file since January 1, 2017 to the conduct date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the Business. All such filingsfollowing to be true as would not be reasonably expected to be, representationsindividually or in the aggregate, declarationsmaterial to the Company and its Subsidiaries taken as a whole, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and there is no material deficiencies have been asserted in writing unresolved violation or exception by the Company or any applicable Governmental Entity of its Subsidiaries with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Companydocuments described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all manufacturing operations, both material respects with respect to the Product, are being, all requirements of applicable Law and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but did not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor contain any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement omit to the FDA or any Governmental Entity, (b) failed to disclose state a material fact required to be disclosed stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes Company and its Subsidiaries taken as a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product)whole, the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is its Subsidiaries are in compliance with all applicable Laws, contracts to which formal written Governmental Authority directives and with all formal written undertakings made by the Company or CRO is boundits Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, privacy policies and terms have satisfactorily addressed in all material respects all matters requiring attention, if any. None of use. The such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsMaterial Adverse Effect.

Regulatory Matters. (a) The Company and the Company Subsidiaries have established and administer compliance programs (including written compliance policies) applicable to the Company and the Company Subsidiaries (i) The to assist the Company, its Affiliates andthe Company Subsidiaries and their respective directors, officers and employees in complying with all Legal Requirements and guidelines (including those administered by the FDA) applicable to the Company, the contract research organizations engaged Company Subsidiaries or their businesses and (ii) to perform provide compliance policies governing activities and requirements applicable to medical device companies (including pre-clinical trials on behalf and clinical testing, product design and development, product testing, product manufacturing, product labeling, product storage, pre-market clearance and approval, marketing, advertising and promotion, product sales and distribution, medical device recall and reporting regulations, and record keeping). (b) Except as set forth in Part 3.18(b) of the Company Disclosure Schedule, the Company and each Company Subsidiary is in compliance in all material respects with all Legal Requirements applicable to the Company’s products and activities, including product design, development, testing, manufacture, marketing, distribution, labeling, storage and transport, in all jurisdictions in which such acts or any of them occur or are reasonably likely to occur or such products or any of them are likely to be sold or used (including any FDA Laws). All applications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the “CROs”basis for or submitted in connection with any and all requests for authorizations, approvals, certificates, waivers, certifications, clearances, exemptions, notifications, consents, orders, registrations, licenses or permits of the FDA or comparable Governmental Entities relating to the Company, the Company Subsidiaries, their businesses and their products were, when submitted to the FDA or other Governmental Entities, true, complete and correct in all material respects and in conformance with Legal Requirements as of the date of submission and any updates, changes, corrections or modification to such applications, submissions, information and data which were or are necessary or required to be filed, maintained, or furnished to the FDA or other Governmental Entities have been timely filed, maintained, or furnished and were true, complete and correct in all material respects and in conformance with Legal Requirements as of the date of submission. The labeling claims made by the Company and the Company Subsidiaries for each of their products are consistent with the scope of regulatory clearance, exemption or approval for each product in each jurisdiction where it is marketed in all material respects, and supported by proper research design, testing, analysis and disclosure that conforms with Legal Requirements. (c) have obtained The activities, products and facilities of the Company and the Company Subsidiaries, as well as, to the Company’s knowledge, its suppliers, distributors, contractors and other intermediaries, are in compliance with all Governmental Approvals required by any Governmental Entityapplicable requirements of CLIA, the FDCA and implementing FDA regulations, including the FDAregistration, listing, labeling and manufacturing requirements of 21 C.F.R. Parts 807, 809 and 820, all to permit the conduct extent applicable to the Company’s products and services. The Company and each Company Subsidiary is not subject to any obligation arising under any consent decree, consent agreement, or warning letter issued by or entered into with the FDA or any other Governmental Entity or other notice, response or commitment made to the FDA or any other Governmental Entity. The Company has delivered to Parent true, correct and complete copies of all customer complaints relating to the Business Company’s and the Company Subsidiaries’ products and all such Governmental Approvals are valid Medical Device Reports, in each case, filed with the FDA within the last five years. The Company has delivered to Parent true, complete and in full force and effectcorrect copies of all warning letters, and no such Governmental Approval has been untitled letters, notices of inspectional observations (Form FDA 483s), or is being revoked similar notices, or challenged. Neither other correspondence relating to the Company, nor to ’s and the Knowledge Company Subsidiaries’ products and its compliance with Legal Requirements from the FDA and any other Governmental Entity and all of the Company’s responses thereto within the last five years. (d) Except as set forth in Part 3.18(d) of the Company Disclosure Schedule, any CROsince January 1, has received any communication from any Governmental Entity regarding2003, any such Governmental Approvalsno exemptions, any failure clearances or approvals for the Company and the Company Subsidiaries’ products have been subjected to materially comply with applicable Laws reevaluation or suspension of sale by the FDA and no products manufactured, marketed or sold by the Company or any term Company Subsidiary have been recalled or requirement of any such Governmental Approvalsubject to a field notification, field correction or safety alert (whether voluntarily or otherwise) and no proceedings have occurred (whether completed or pending) seeking to recall, reclassify, re-label, suspend, or seize any revocation, withdrawal, suspension, cancellation, material limitation, termination product sold or material modification of any such Governmental Approvalproposed to be sold by the Company or a Company Subsidiary. To the Knowledge of the Company’s knowledge, there are no facts or circumstances that which are reasonably likely to adversely affect cause: (A) the recall, suspension, field notification, field correction, reclassification, re-labeling or safety alert of any product sold or intended to be sold by the Company or any Company Subsidiary; (B) a change in the marketing classification or a material change in labeling of any such products; or (C) a termination or suspension of marketing of any such products. (e) All products being manufactured, distributed, or developed by the Company and the Company Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Approvals. The CompanyEntity are being manufactured, labeled, stored, tested, distributed, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were marketed in material compliance with all applicable Laws when filed, requirements and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsimplementing regulations thereunder. (iif) All nonclinical Except as set forth in Part 3.18(f) of the Company Disclosure Schedule, all pre-clinical trials and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or trials conducted by or on behalf of the Company requiring and the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the ProductCompany Subsidiaries have been, and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to Knowledge of accepted professional scientific standards and all applicable Legal Requirements relating thereto, including the Company there is no reason to believe that any institutionFDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, institutional review board54, the FDA, or any other Governmental Entity is considering such action or communication56 and 812. (iiig) Neither the Company, the Company Subsidiaries, nor, to the Knowledge knowledge of the Company Company, any of the CROstheir collective officers, employees or agents has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement statement, or failed to make any statement, that (in any such case) establishes would be reasonably expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (h) Neither the Company, the Company Subsidiaries, nor, to Knowledge the knowledge of the Company, any of its their collective officers, CROs, employees or agents or clinical investigators is the subject has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under 21 U.S.C. Section 335a or under any similar Legal Requirement. No claims, actions, proceedings or investigations that could reasonably be expected to result in such a material debarment or exclusion are pending or threatened investigation by against the FDA pursuant Company, the Company Subsidiaries, or, to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None the knowledge of the Company, the Sellers or the CROs, nor any of their respective collective officers, directors, employees, shareholders, consultants, employees or agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 . (i) Except as disclosed on Part 3.18(i) of the FDCA. In the course of the discoveryCompany Disclosure Schedule, research and any there are no investigations, audits, actions or other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials proceedings pending with respect to the Product), a violation by the Company has notor any Company Subsidiary of any Legal Requirement that reasonably would be expected to result in administrative, directly or indirectly, used any employee, agentcivil, or independent contractor who has been (i) debarred bycriminal liability, and there are no facts or is the subject of debarment proceedings bycircumstances existing that would reasonably be expected to serve as a basis for such an investigation, any Governmental Entity audit, action or (ii) convicted pursuant to Section 306 of the FDCAother proceeding. (vj) The Company’s and, with respect to Company and each of the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals Company Subsidiaries is in material compliance with all applicable LawsFDA import and export requirements, contracts to which the Company including import-for-export requirements, export notifications or CRO is bound, privacy policies authorizations and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsrecord keeping requirements.

Regulatory Matters. (i) The CompanyExcept as set forth on Schedule 7.1(kk) and (i) each Loan Party has obtained and holds in its name all Material Licenses required by the FDA, its Affiliates andHealth Canada or any other Governmental Authority, for the contract conduct of their Business as currently conducted, to permit any manufacturing, distribution, sales, testing, marketing or research organizations engaged and development activities of such Loan Party to perform clinical trials on behalf of the Company date (the “CROsActivities to Date”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, with respect to permit the conduct of the Business and each Product; (B) all such Governmental Approvals Material Licenses are valid and in full force and effecteffect 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 License; (C) each Loan Party in compliance in all respects with all terms and conditions of each Material License, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor with all Applicable Laws and requirements pertaining to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure Activities to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Date with respect to any such filingseach Product; (D) each Loan Party is in compliance with all Applicable Laws regarding registration or notification for the site at which the Products are manufactured, representationsprocessed, declarationspacked, listingheld for distribution or from which and into which they are distributed; (ii) all manufacturing operations performed by or on behalf of each Loan Party are in compliance with current good manufacturing practice requirements and Applicable Laws and Material Licenses; and (iii) each Loan Party is in compliance with all reporting requirements for all Material Licenses, including, without limitation plant registrations, reports or submissions. (ii) All nonclinical applications, notifications, submissions, information, claims, reports and clinical investigations conducted or sponsored by or on behalf of the Companystatistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication requests for a Material License from any institution, institutional review board, the FDA, Health Canada, or any other Governmental Entity with respect Authority relating to any completedthe Loan Parties or the Business or Products, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and when submitted to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, Health Canada, United States Department of Agriculture or any other Governmental Entity is considering such action Authority were true, complete and correct in all material respects as of the date of submission and any necessary or communicationrequired updates, changes, corrections or modification have been submitted to the FDA, Health Canada, or other Governmental Authority. The claims for the Products are valid and supported by proper research, design, testing, analysis and disclosure. (iii) Neither Except as set out in Schedule 7.1(kk), each Product that is subject to the CompanyApplicable Laws promulgated by a Regulatory Authority, is manufactured, packaged, labelled, imported, exported, stored, distributed, sold (whether or not for consideration), advertised and marketed in compliance with all such Applicable Laws, (except for immaterial non-compliance) as well as all material terms and conditions imposed in any Licenses and permits issued in respect of the Products. (iv) None of the Loan Parties nor, to the Knowledge knowledge of the Company Borrower, any officer, employee, contractor or agent of the CROs, Loan Parties has (a) ever made an untrue statement of a material fact or fraudulent statement to the FDA a Regulatory Authority or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA a Regulatory Authority, or other Governmental Entity or (c) committed any other act, made any statement statement, or failed to make any statement, that (in any such case) establishes would reasonably be expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” set forth in 56 Fed. Neither the CompanyReg. 46191 (September 10, nor, to Knowledge of the Company, any of its officers, CROs, agents 1991) or clinical investigators is the subject of any pending Health Canada or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant Authority to invoke any similar applicable Lawpolicy or law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf execution and delivery of the Company (the “CROs”) have obtained all Governmental Approvals required this Agreement by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge performance of the Company's obligations hereunder, and the consummation of the transactions contemplated hereby and thereby, do not violate (1) the Communications Act of 1934 (the "COMMUNICATIONS ACT") or interpreted as of this date, (2) the Telecommunications Act of 1996 (the "TELECOM ACT OF 1996") or interpreted as of this date, (3) any CROrules or regulations of the Federal Communications Commission (the "FCC") applicable to the Company or the Subsidiary or interpreted as of this date, or (4) any rules or regulations of the California Public Utilities Commission, New York Public Service Commission, Massachusetts Department of Public Utilities, Washington Utilities and Transportation Commission, Illinois Commerce Commission or the Oregon Public Utilities Commission (the "STATE COMMISSIONS") or interpreted as of this date, and (ii) no authorization of or filing with the FCC or any of the State Commissions is necessary for the execution and delivery of this Agreement by the Company and consummation of the transactions contemplated hereby in accordance with the terms hereof; (i) The Company and each Subsidiary in all material respects (1) have made all reports and filings, and paid all fees, required by the FCC and any of the State Commissions; and (2) have all certificates, orders, permits, licenses, authorizations, consents and approvals of and from, and have made all filings and registrations with, the FCC and any of the State Commissions necessary to own, lease, license and use their properties and assets and to conduct their businesses as presently conducted and as proposed to be conducted; and (ii) neither the Company nor any Subsidiary has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure notice of proceedings relating to materially comply with applicable Laws the revocation or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. certificates, orders, permits, licenses, authorizations, consents or approvals, or the qualification or rejection of any such filing or registration, the effect of which would have a Material Adverse Effect on the Company and the Subsidiaries taken as a whole; (c) To the Knowledge of Company's knowledge, neither the CompanyCompany nor any Subsidiary is in violation of, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Companyin default under, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrationsCommunications Act, as well as all reports or submissions required under amended by the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Telecom Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure rules or regulations of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAFCC, or any other Governmental Entity with respect to any completed, ongoing the rules or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf regulations of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROsState Commissions, has (a) made an untrue statement the effect of which, singly or in the aggregate, would have a material fact or fraudulent statement to Material Adverse Effect on Company and the FDA or any Governmental Entity, (b) failed to disclose Subsidiaries taken as a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law.whole; and (ivd) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, no decree or order of the FCC or any of the State Commissions is outstanding against the subject of debarment proceedings by, any Governmental Entity Company or the Subsidiary and (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the ProductCompany's knowledge, the CROs’no formal litigation, use proceeding, inquiry or investigation has been commenced or threatened, and dissemination no formal notice of any personally-identifiable information violation or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Lawsorder to show cause has been issued, contracts to which against the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, Subsidiary before the FCC or any unauthorized access of, any data or information used by of the Company or, with respect to the Product, the CROsState Commissions.

Regulatory Matters. (ia) The CompanyCompany and each of its Subsidiaries possesses all material approvals, its Affiliates andauthorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”), the contract research organizations engaged European Medicines Agency (“EMA”) and all other applicable Governmental Bodies that the Company or any of its Subsidiaries are required to perform clinical trials possess relating to the products and product candidates sponsored, manufactured, studied, marketed or sold by or on behalf of the Company or any of its Subsidiaries (the “CROsCompany Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all material respects as presently conducted. Except as would not reasonably be expected to have obtained all Governmental Approvals required by any Governmental Entitya Material Adverse Effect, including the FDA, to permit the conduct of the Business and (i) all such Governmental Approvals Regulatory Authorizations are valid and (A) in full force and effect, (B) validly registered and on file with applicable Governmental Bodies and (C) in compliance with all formal filing and maintenance requirements and (ii) the Company and each of its Subsidiaries has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no such Governmental Approval event has been occurred which allows, or is being revoked after notice or challengedlapse of time would allow, revocation or termination thereof. Neither Except as would not reasonably be expected to be material to the Company, nor (1) the Company and each of its Subsidiaries has filed, maintained or furnished to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws FDA or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the other applicable Governmental Entities, including the FDA, Bodies all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and (2) all such submissions were complete and accurate and in material compliance with applicable Laws Legal Requirements when filed, and no material deficiencies have been asserted filed (or were corrected or completed in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsa subsequent filing). (iib) All nonclinical Except as would not reasonably be expected to have a Material Adverse Effect, all preclinical and clinical investigations conducted or sponsored by the Company or on behalf any of the Company, and all manufacturing operations, both with respect to the Product, its Subsidiaries are being, and have been since the Company’s formation, being conducted in material compliance with applicable LawsLegal Requirements, includingrules and regulations, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health informationincluding Good Clinical Practices. Neither the Company, FDA nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity Body performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company or any of its Subsidiaries with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of . Neither the Company there is no reason to believe that nor any institution, of its Subsidiaries has received any written notifications from any institutional review board, ethics committee or safety monitoring committee raising any material issues that require or would require the FDAtermination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any other Governmental Entity is considering clinical studies proposed or currently conducted by, or on behalf of, the Company or any of its Subsidiaries, and, to knowledge of the Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company or communicationany of its Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of its Subsidiaries and the applicable Governmental Bodies. (iiic) Neither To the knowledge of the Company, nor, to the Knowledge of neither the Company nor any of the CROs, its Subsidiaries has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA or other any Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge As of the Companydate of this Agreement, neither the Company nor any of its officers, CROs, agents or clinical investigators Subsidiaries has been notified that it is the subject of any pending or or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy Policy. Neither the Company, any of its Subsidiaries or by any other Governmental Entity pursuant of its officers or employees nor, to any similar applicable Law. (iv) None the knowledge of the Company, any agents or clinical investigators of the Sellers Company or any of its Subsidiaries has been suspended or debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (d) Except as would not reasonably be expected to have a Material Adverse Effect, the CROsCompany and each of its Subsidiaries is and since January 1, 2019, has been in compliance with all healthcare laws applicable to the operation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), and the civil False Claims Act (31 U.S.C. § 3729 et seq.); (ii) the Federal Food, Drug and Cosmetics Act (“FDCA”); (iii) the Public Health Service Act; (iv) the Controlled Substances Act; (v) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010; (vi) the Physician Payment Sunshine Act; (vii) the Veterans Health Care Act of 1992; (viii) Drug Supply Chain Security Act; (ix) the Health Insurance Portability and Accountability Act of 1996 and the Health Information and Technology for Economic and Clinical Health Act (collectively “HIPAA”); (x) Legal Requirements which are cause for exclusion from any federal health care program; and (xi) Legal Requirements relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by the Company or any of its Subsidiaries. Neither the Company nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates its Subsidiaries has been debarred or convicted, or notified that it is subject to debarment any enforcement, regulatory or convictionadministrative proceedings regarding compliance with healthcare laws and, pursuant to Section 306 the knowledge of the FDCACompany, no such enforcement, regulatory or administrative proceeding has been threatened. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), Neither the Company nor any of its Subsidiaries has not, directly had any unauthorized use or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject disclosure of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined such term is used under HIPAA) concerning individuals is that would constitute a security incident or breach that would require the Company to provide notice under HIPAA. Neither the Company nor any of its Subsidiaries (i) has retained an overpayment received from, or failed to refund any amount due to, any Third Party Payor in violation of any healthcare law or contract, except where such action could not, either individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; nor (ii) has received written notice of, or has knowledge of, any overpayment or refunds due to any Third Party Payor, except where such overpayment or refund could not, either individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (e) All Company Products that are subject to the jurisdiction of the FDA are, and since January 1, 2019 have been, formulated, manufactured, tested, packaged, and distributed in compliance in all material respects with all applicable Lawsrequirements under the FDCA. Since January 1, contracts 2019, all manufacturing operations conducted by or for the benefit of the Company have been conducted in accordance with GMP Regulations in all material respects. Since January 1, 2019, neither the Company nor, to the knowledge of the Company, any person acting on its behalf has (i) been subject to a Governmental Body shutdown or import or export prohibition or (ii) received any FDA Form 483 or similar notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material change to any product or any of the Company’s processes or procedures, or any similar written correspondence from any Governmental Body in respect of the Company or its business operations alleging or asserting material noncompliance with any applicable Legal Requirements or Regulatory Authorizations and, to the knowledge of the Company, no Governmental Body is considering such action. (f) Since January 1, 2019, no Company Product has been, recalled, withdrawn or suspended (whether voluntarily or otherwise) or, to the Company’s knowledge, has been adulterated or misbranded. No proceedings (whether complete or pending) seeking the recall, withdrawal, suspension or seizure of any such Company Product or Regulatory Authorizations are pending or, to the knowledge of the Company, threatened against the Company, nor have any such proceedings been pending at any time since January 1, 2019. The Company has made available to Parent or Parent’s Representatives all material information in the possession of the Company (or to which the Company has access) about adverse events obtained or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used otherwise received by the Company orfrom any source, with respect in the United States or outside of the United States, including information derived from clinical investigations, surveillance studies or registries, reports in the scientific literature and unpublished scientific papers relating to the any Company Product, the CROs.

Regulatory Matters. (i) The Company, its Affiliates and, There is no legal or governmental proceeding to which the contract research organizations engaged to perform clinical trials on behalf Company or any Company Subsidiary is a party or of which any property or assets of the Company (or any subsidiary is the “CROs”) have obtained all Governmental Approvals required by subject, including any proceeding before any Governmental EntityAuthorities which singularly or in the aggregate, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor if determined adversely to the Knowledge Company or any Company Subsidiary, could reasonably be expected to have a Company Material Adverse Effect; and to the best of the Company’s knowledge, any CRO, has received any communication from any no such proceedings are threatened or contemplated by Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws Authorities or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvalsthreatened by others. The CompanyCompany and each Company Subsidiary are in compliance with all applicable federal, state, local and to the Knowledge of the Companyforeign laws, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports orders and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAdecrees governing its business, or any other Governmental Entity with respect to any completedfederal, ongoing state or planned foreign agencies or bodies engaged in the regulation of biopharmaceuticals, except where noncompliance would not, singularly or in the aggregate, have a Company Material Adverse Effect. All preclinical studies and clinical or nonclinical studies or tests sponsored or trials, conducted by or on behalf of the Company and any Company Subsidiary are being and have been conducted by the Company or any Company Subsidiary, or to the Company’s knowledge, by third parties, in compliance with all applicable protocols, standard medical and scientific research procedures, and federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance as could not reasonably be expected to have, singularly or in the aggregate, a Company Material Adverse Effect. Each description of the results of studies is accurate and complete in all material respects and fairly presents the data derived from such studies or trials. The Company is not aware of any other preclinical studies or clinical trials, the results of which reasonably call into question the results; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension, material modification or clinical hold of any preclinical studies or clinical trials conducted by or on behalf of the Company. Neither the Company nor its subsidiaries, nor any of its or their respective officers, employees or directors, nor any of its or their respective agents or clinical investigators, has been excluded, suspended, disqualified or debarred from participation, for example, in any U.S. federal health care program or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, disqualification, suspension, or exclusion, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. § 335a or comparable foreign law. The Company and the Company Subsidiaries have made all filings and obtained all approvals, including approvals to conduct preclinical studies and clinical trials, as may be required any Government Authorities to conduct such studies or trials; and the Company and the Company Subsidiaries have not received any notice of, or correspondence from, any Governmental Authorities requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology preclinical studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAtrials. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. The Company and its subsidiaries, and its and their respective directors, officers and employees, and, to the Company’s knowledge, its and their respective agents, affiliates and representatives, are, and at all times: (i) The Company, have operated and currently operate its Affiliates andbusiness in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the FDA, the contract research organizations engaged Department of Health and Human Services (“HHS”) and any comparable foreign or other regulatory authority to perform clinical trials on behalf which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company Company's product candidates or any product manufactured or distributed by the Company; (the “CROs”ii) have obtained all Governmental Approvals has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any Governmental Entity, including the FDA, such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to permit the conduct of the Business its business as currently conducted and all such Governmental Approvals Regulatory Authorizations are valid and in full force and effecteffect and neither the Company nor any of its subsidiaries are in violation, and no such Governmental Approval has been or is being revoked or challenged. Neither the Companyin any material respect, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities alleging that any product operation or activity is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities is considering any such Governmental Approval. To the Knowledge claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that any of the CompanyApplicable Regulatory Authorities has taken, there are is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no facts or circumstances knowledge that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity Applicable Regulatory Authorities is considering such action action; (vi) has filed, obtained, maintained or communication. (iii) Neither the Companysubmitted all material reports, nordocuments, to the Knowledge of the Company any of the CROsforms, has (a) made an untrue statement of a material fact notices, applications, records, claims, submissions and supplements or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact amendments as required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); (vii) is not a party to or have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar applicable Law. agreements with or imposed by any Applicable Regulatory Authority; and (ivviii) None of the Companyhas not been excluded, the Sellers suspended or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, from participation in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company government health care program or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The To the Company’s knowledge, each of its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of or pre-clinical studies were (or, if still pending, are being), conducted in accordance all material respects with applicable protocols, procedures and controls and all applicable Legal Requirements administered by the Company FDA and comparable foreign Governmental Bodies (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challengedTGA). Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have No investigational new drug application filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the CompanyCompany with the FDA has been terminated or suspended by the FDA, and all manufacturing operationsneither the FDA nor any applicable foreign Governmental Body has commenced, both with respect or, to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act knowledge of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor threatened to initiate, any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAaction to place a clinical hold order on, or otherwise terminate or suspend, any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or trial conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of in which the Company there is no reason has participated with respect to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationCompany Product. (iiib) All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA and TGA by the Company or any of its Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no material liability exists with respect to such filing. (c) Neither the Company, nor, to the Knowledge of the Company nor any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to its Subsidiaries have received any written notices from the FDA or TGA alleging or asserting material noncompliance with any applicable Legal Requirements or Governmental Entity, (b) failed to disclose a material fact required to be disclosed to Authorizations issued by the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable LawTGA. (ivd) None To the knowledge of the Company, the Sellers or manufacture of Company Products is being conducted in material compliance with “good manufacturing practices” as defined by the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAFDA. (ve) The Company’s andNeither the Company nor its Subsidiaries has been convicted of any crime or engaged in any conduct which could result in debarment or disqualification by the FDA or any drug regulatory agency, with respect and there are no proceedings pending or, to the Productknowledge of the Company, threatened that reasonably might be expected to result in criminal liability or debarment or disqualification by the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, FDA or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsdrug regulatory agency.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf All of the Company (the “CROs”) Products are being and have obtained been manufactured, processed, developed, packaged, labeled, promoted, marketed, sold, stored, tested, distributed, imported and exported in material compliance with all Governmental Approvals required by applicable requirements under any Governmental Entityapplicable Law, including the FDAall Laws regarding non-clinical testing, to permit the conduct of the Business clinical research, establishment registration, drug and all such Governmental Approvals are valid and in full force and effectdevice listing, good manufacturing practices, record-keeping, adverse event reporting, and no such Governmental Approval reporting of corrections and removals. (b) The Company has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have timely filed with the applicable regulatory authorities (including, without limitation, the FDA or any other Governmental Entities, including Authority performing functions similar to those performed by the FDA, ) all material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representationsdocuments, declarations, listings, registrations, reports reports, statements, amendments, supplements or submissions, including but not limited to adverse event reports, required to be filed by it under applicable Law, including all Laws and/or those regarding non-clinical testing, clinical research, establishment registration, drug and device listing, good manufacturing practices, record-keeping, adverse event reporting, and reporting of corrections and removals. All such filings, documents, declarations, listings, registrations, reports, statements, amendments, supplements or submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Authority with respect to any such filings, representationsdocuments, declarations, listing, registrations, reports reports, statements, amendments, supplements or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf . To the knowledge of the Company, (i) each such filing was true and correct in all manufacturing operationsmaterial respects as of the date of submission, both with respect or was corrected in or supplemented by a subsequent filing, and (ii) any material and legally necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the Productapplicable Governmental Authority. (c) Except as set forth on Schedule 4.07(c) of the Company Disclosure Schedule, are beingthe Company has not received any notification of any pending or, and have been since to the knowledge of the Company’s formation, conducted in material threatened (i) action, suit, claim, investigation, proceeding or order alleging potential or actual non-compliance with any Company Permits or Laws; or (ii) non-ordinary course audit, inspection or investigation by any Governmental Authority. (d) No Company Product has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing and there are no facts or circumstances reasonably likely to cause the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such Company Product are pending or, to the knowledge of the Company, threatened against the Company. (e) The Company has not received or been subject to any action, notice, warning, administrative proceeding, review, or investigation by a Governmental Authority, including any FDA Form 483, FDA warning letter or untitled letter or any similar notice, that (i) alleged or asserted that the Company violated any applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”ii) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAcommenced, or threatened to initiate, any other Governmental Entity with respect action, suit, claim, investigation, proceeding or order to withdraw a premarket clearance or investigational device exemption of any completedCompany Product or product candidate, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests(iii) commenced, or regarding material noncompliance threatened to initiate, any action, suit, claim, investigation, proceeding or order to enjoin manufacture or distribution of such studies any Company Product or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDAproduct candidate; or (iv) commenced, or threatened to initiate any other Governmental Entity is considering such action action, suit, claim, investigation, proceeding or communicationorder to change the labeling or classification of any Company Product or product candidate. (iiif) Neither the Company, Company nor, to the Knowledge knowledge of the Company Company, any of its officers, employees or agents (i) is or has been debarred under 21 USC § 335a or excluded pursuant to 42 U.S.C. § 1320a-7, or equivalent actions under the CROsLaws in any jurisdiction, (ii) has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 USC § 335a or exclusion pursuant to 42 U.S.C. § 1320a-7 or equivalent actions under the Laws in any jurisdiction, or (iii) has been convicted of, charged with or investigated for any violation of Law related to fraud, theft, embezzlement, breach of fiduciary duty, financial misconduct, controlled substances or obstruction of an investigation. (g) To the knowledge of the Company, Neither the Company nor, to the knowledge of the Company, any of its officers, employees or agents has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental EntityAuthority, (bii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity Authority or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity Authority to allege a violation of an any applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, Company nor, to Knowledge the knowledge of the Company, any of its officers, CROsemployees, or agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Government Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The CompanySince January 1, its Affiliates and2012, the contract research organizations engaged Company has filed, or caused its Subsidiaries to perform clinical trials on behalf of file, with the Company (the “CROs”) have obtained all FDA or any other Governmental Approvals required Authority performing functions similar to those performed by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effectrequired filings, and no such Governmental Approval has been declarations, listings, registrations, reports or is being revoked or challenged. Neither the Companysubmissions, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approvalincluding adverse event reports. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and or submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by the Company has not received any communication from any such applicable Governmental Entity Authority asserting deficiencies with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical and clinical investigations conducted or sponsored by or on behalf To the Knowledge of the Company, all preclinical and all manufacturing operations, both clinical investigations sponsored by the Company with respect to products or product candidates currently in development by the Product, Company or any of its Subsidiaries are being, and have been since the Company’s formation, being conducted in material compliance with all applicable LawsLaws including the FDCA and its implementing regulations and applicable experimental protocols, includinginformed consents, but not limited to the FDCAprocedures, controls, guidance and industry standards, including good clinical practice requirementsmanufacturing practice, good laboratory practice requirementspractice, GMPand good clinical practice, ICH principles requirements and Health Insurance Portability industry standards of oversight of clinical sites including monitors, and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) Laws and other legal requirements guidance restricting the use use, disclosure and disclosure protection of individually identifiable health information. Neither None of the Company, nor any CRO, Company or its Subsidiaries has received any written notice, correspondence notices or other communication correspondence from any institution, institutional review board, the FDA, FDA or any other Governmental Entity Authority performing functions similar to those performed by the FDA or any institutional review board or ethics committee with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of . To the Product, and to Knowledge of the Company there Company, neither the FDA nor any other applicable Governmental Authority nor any clinical investigator that has participated or is no reason to believe that any institutionparticipating in, or institutional review boardboard or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the FDACompany or its Subsidiaries has commenced or threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) All reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any other Governmental Entity is considering such action Authority performing functions similar to those performed by the FDA or communicationdrug regulatory agency by the Company or its Subsidiaries have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). (d) As of the date of this Agreement, the Company has made available to Parent (i) complete and correct copies of each investigational new drug application and each similar state or foreign regulatory filing made on behalf of the Company or its Subsidiaries, including all supplements and amendments thereto, (ii) all material correspondence sent to and received from the FDA and similar state and foreign Governmental Authorities by the Company or its Subsidiaries and (iii) all existing written records relating to all material discussions and all meetings between the Company or its Subsidiaries and the FDA or similar foreign regulatory or Governmental Authorities. (e) Neither the Company, nor, to the Knowledge of the Company nor any of the CROs, its Subsidiaries has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity, Authority performing functions similar to those performed by the FDA or (bii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity or (c) committed any other act, made any statement or failed Authority performing functions similar to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for those performed by the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyFDA. Neither To the Company, nor, to Knowledge of the Company, none of the Company or any of its officers, CROs, agents or clinical investigators Subsidiaries is the subject of any pending or threatened investigation by the FDA pursuant or any Governmental Authority performing functions similar to those performed by the FDA to take enforcement action against the Company or any of its FraudSubsidiaries including the termination or suspension of any clearance, Untrue Statements of Material Factsauthorization, Bribery, and Illegal Gratuities Final Policy license or by any other Governmental Entity pursuant to any similar applicable Lawregistration. (ivf) The Company and its Subsidiaries is in compliance and has, during the past three years, been in compliance, in each case, in all material respects with all healthcare Laws applicable to the operation of its business as currently conducted, including: (i) any and all federal, state and local fraud and abuse Laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Clinical Laboratory Improvement Amendments of 1988; and (iii) requirements of Law relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by the Company and its Subsidiaries. None of the Company or any of its Subsidiaries is subject to any currently pending enforcement, regulatory or administrative proceedings against or affecting the Company or any of its Subsidiaries relating to or arising under the FDCA or similar Law, and to the Knowledge of the Company no such enforcement, regulatory or administrative proceeding has been threatened. (g) None of the Company or any of its Subsidiaries is enrolled as a supplier or provider under Medicare, Medicaid, or any other governmental health care program or third party payment program or a party to any participation agreement for payment by any such a health care program and third party payment program. (h) None of the Company or any of its Subsidiaries has been, and to the Knowledge of the Company, the Sellers or the CROs, nor any none of their respective officers, directors, employees, shareholders, consultants, agents, employees or other persons engaged to perform clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), services by the Company has notor any of its Subsidiaries have ever been while performing services for the Company or such Subsidiary, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by(under the provisions of the Generic Drug Enforcement Act of 1992, or is the subject of debarment proceedings by21 U.S.C. §335a (a) and (b)) (“Debarred”), any Governmental Entity or (ii) convicted pursuant of a crime for which a person can be Debarred or (iii) indicted for a crime or otherwise engaged in conduct for which a person can be Debarred or engaged in any conduct that would reasonably be expected to Section 306 result in Debarment under applicable Law. To the Knowledge of the FDCACompany, none of the matters listed in sub-parts (i), (ii), or (iii) herein has been threatened, against the Company, its Subsidiaries or any of its officers, employees or agents. (vi) The Company’s andSet forth on Section 4.24(i) of the Company Disclosure Schedule is a list of all new drug applications that, with respect as of the date of this Agreement, the Company intends to submit to the Product, FDA within 90 days following the CROs’, use and dissemination date of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsthis Agreement.

Regulatory Matters. (ia) The CompanyExcept as set out in Schedule 4.1(iii)(a), its Affiliates andBNI Product are being or have been developed, manufactured, tested, packaged, distributed, and sold in substantial compliance with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FDCA”), the contract research organizations engaged to perform clinical trials on behalf Public Health Service Act (“PHSA”) and the regulations of the Company Food and Drug Administration (the “CROsFDA”) have obtained all Governmental Approvals required by any Governmental Entitypromulgated thereunder and similar applicable foreign Legal Requirements, including the FDAthose relating to investigational use, to permit the conduct good manufacturing practices, good clinical practices, good laboratory practices, registration and listing, record keeping, adverse event reporting, and submission of the Business other required reports. The required licenses and all such Governmental Approvals authorizations are valid current and in full force and effecteffect and include all necessary and relevant regulatory filings and governmental registrations made by or issued to BNI or any of its Affiliates that relate specifically to BNI Products. BNI has made available to Q Bio true and complete copies of all governmental correspondence (including copies of official notices, citations or decisions) in the files of BNI or its Affiliates relating to the Specified Authorizations. (b) Except as set out in Schedule 4.1(iii)(b), BNI or its Affiliates have obtained all necessary licenses, permits and registrations required by FDA, any other applicable Governmental Entity, and no any applicable foreign regulatory authority to permit the operation of the intended use by BNI and the Affiliates as presently conducted and all such Governmental Approval has been or is being revoked or challengedlicenses, permits and registrations are included in the Specified Authorizations. Neither the Company, BNI nor to the Knowledge any of the Company, any CRO, has its Affiliates have received any communication from any Governmental Entity regarding, threatening to withdraw or suspend any such Governmental Approvalslicense, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approvalpermit, or any revocation, withdrawal, suspension, cancellation, material limitation, termination registration. BNI or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, its Affiliates have filed with the applicable Governmental Entities, including the FDA, regulatory authorities all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and or submissions, including adverse event reports. All relevant filings, declarations, listings, registrations, reports or submissions were in material compliance with all applicable Laws Legal Requirements when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity regulatory authority with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iic) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, BNI nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, its Affiliates nor, to the Knowledge of the Company BNI, any of the CROsofficers, key employees, agents or clinical investigators acting for BNI or any of its Affiliates has (a) made an untrue statement of a material fact or fraudulent statement to the received any communication from FDA or any other Governmental Entity, including without limitation any warning letter or untitled letter that alleges or suggests that the intended use is not in compliance with any applicable requirements under the FDCA, the PHSA, FDA regulations promulgated thereunder, or similar applicable foreign Legal Requirements. (bd) failed to disclose a material fact required to be disclosed Neither BNI nor any of its Affiliates nor, to the FDA Knowledge of BNI, any of the officers, key employees, agents or other Governmental Entity clinical investigators acting for BNI or (c) its Affiliates, has committed any other act, made any statement or failed to make any statement, statement or commit any act that (in any such case) establishes would reasonably be expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities” set forth in 56 Fed. Neither Reg. 46191 (September 10, 1991) and any amendments thereto. Additionally, neither BNI or its Affiliates, nor to the Company, nor, to Knowledge of the CompanyBNI, any officer, employee or agent of BNI or its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred convicted of any crime or convictedengaged in any conduct that would reasonably be expected to result, or is subject to debarment or convictionhas resulted, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, debarment under 21 U.S.C. Section 335a or is the subject of debarment proceedings by, any Governmental Entity similar state Legal Requirement; or (ii) convicted pursuant to exclusion under 42 U.S.C. Section 306 of the FDCA1320a-7 or any similar state Legal Requirement. (ve) The Company’s andTo the Knowledge of BNI, there are no investigations, suits, claims, actions or proceedings against or affecting BNI or any Affiliate relating to BNI Assets, including those relating to or arising under applicable Legal Requirements relating to government health care programs, private health care plans, or the privacy and confidentiality of patient health information. (f) BNI and the Affiliates are in compliance in all material respects with respect all healthcare Legal Requirements to the Productextent applicable to the operation of the intended use and the sale of BNI Products, as currently conducted, including any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information civil False Claims Act (as defined under HIPAA31 U.S.C. § 3729 et seq.) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies regulations promulgated pursuant to such statutes. Neither BNI nor any Affiliate is subject to any enforcement, regulatory or administrative proceedings against or affecting BNI relating to or arising under the FDCA or similar Legal Requirement, and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the ProductKnowledge of BNI no such enforcement, the CROsregulatory or administrative proceeding has been threatened.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA, ) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and or submissions, including but not limited to adverse event reports. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws Legal Requirements when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical and clinical investigations conducted or sponsored by or on behalf To the knowledge of the Company, and all manufacturing operations, both with respect except as set forth in documents either delivered or made available to Parent or Parent’s Representatives prior to the Productdate of this Agreement, are being, all preclinical and clinical investigations sponsored by the Company have been since the Company’s formation, and are being conducted in material compliance with applicable LawsLegal Requirements, includingrules, but not limited to the FDCAregulations and guidances, good clinical practice requirementsincluding Good Clinical Practices requirements and federal and state laws, good laboratory practice requirementsrules, GMP, ICH principles regulations and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements guidances restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, The Company has not received any written notice, correspondence notices or other communication correspondence from any institution, institutional review board, the FDA, FDA or any other Governmental Entity foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored requiring or conducted by or on behalf of the Company requiring recommending the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iiic) Neither the Company, nor, The Company has not to the Knowledge of the Company any of the CROs, has its knowledge (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or and (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators The Company is not the subject of any pending or or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant Policy. Neither the Company nor, to any similar applicable Law. (iv) None the knowledge of the Company, the Sellers or the CROs, nor any of their respective its officers, directors, employees, shareholders, consultants, agents, agents or clinical investigators or Affiliates has been suspended or debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct convicted of any non-clinical researchcrime or engaged in any conduct that would reasonably be expected to result in (a) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (d) Except as would not reasonably be expected to have a Material Adverse Effect, safety the Company is in compliance and toxicology studies or clinical trials has, since January 1, 2010, been in compliance, in each case, in all material respects with respect all healthcare laws applicable to the Productoperation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been civil False Claims Act (i31 U.S.C. § 3729 et seq.) debarred by, or is and the subject of debarment proceedings by, any Governmental Entity or regulations promulgated pursuant to such statutes; (ii) convicted the Clinical Laboratory Improvement Amendments of 1988; and (iii) the Health Insurance Portability and Accountability Act of 1996 (“HIPPA”), the Health Information and Technology for Economic and Clinical Health Act (“HITECH”), and the regulations promulgated pursuant to Section 306 of the FDCA. thereto, (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) The Company’s and, with respect requirements of law relating to the Productbilling or submission of claims, collection of accounts receivable, underwriting the CROs’cost of, use or provision of management or administrative services in connection with, any and dissemination all of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Lawsthe foregoing, contracts to which by the Company or CRO is bound, privacy policies and terms of useCompany. The Company and is not subject to any enforcement, regulatory or administrative proceedings against or affecting the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativeCompany relating to or arising under the FDCA, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating tothe Anti-Kickback Statute, or violations of any security policy regardingsimilar Legal Requirements, and no such enforcement, regulatory or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsadministrative proceeding has been threatened.

Regulatory Matters. (ia) The CompanySince January 1, its Affiliates and2016, the contract research organizations engaged to perform clinical trials on behalf of Acquired Companies have filed, maintained or furnished with the Company applicable regulatory authorities (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws European Medicines Agency (“EMA”) or any term or requirement of any such other Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely Body performing functions similar to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including those performed by the FDA, EMA or otherwise having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products (such other Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports reports, submissions, applications, amendments, modifications, notices and submissions other documents, including but not limited to adverse event reports. All such material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and other documents filed or submitted after January 1, 2016: (i) have been made available to Parent and (ii) were in material compliance with applicable Laws Legal Requirements in all material respects when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports reports, submissions, applications, amendments, modifications, notices and other documents. Any updates, changes, corrections or submissionsmodifications to such materials required under applicable Legal Requirements have been submitted in compliance with such Legal Requirements in all material respects. (iib) All nonclinical To the knowledge of the Company, except as set forth in documents either delivered or made available to Parent, all preclinical and clinical investigations sponsored or conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and Acquired Companies have been since the Company’s formation, and are being conducted in material compliance with all applicable Legal Requirements, rules, regulations and binding guidances, including Good Clinical Practices requirements, other Health Care Laws, includingapplicable research protocols, but not limited corrective action plans, and federal and state laws, rules, regulations and binding guidances relating to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Neither the CompanySince January 1, nor any CRO2016, except as has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAnot had, or any other Governmental Entity with respect would not reasonably be expected to any completedhave, ongoing individually or planned in the aggregate, a Material Adverse Effect, no clinical or nonclinical studies or tests trial sponsored or conducted by or on behalf of the any Acquired Company requiring the terminationhas been terminated, suspension delayed or material modification of such studies suspended prior to completion for safety or tests, or regarding material noncompliance of such studies or tests of the Productother non-business reasons, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, neither the FDA, or the EMA nor any other Specified Governmental Entity Body, clinical investigator or contract research organization that has participated or is considering participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted or sponsored by or on behalf of any Acquired Company has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any Acquired Company, or alleged any violation of any Health Care Law in connection with any such action or communicationclinical trial. The Company periodically reviews clinical trial sites participating in any Acquired Company-sponsored trial for compliance with all applicable Health Care Laws. (iiic) Neither Since December 31, 2014, to the knowledge of the Company, norno Acquired Company or officer, to the Knowledge of the Company any of the CROsemployee, agent or clinical investigator thereof has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA FDA, EMA or any other Specified Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA FDA, EMA, Centers for Medicare and Medicaid Services or any other Specified Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy or for the EMA or any other Specified Governmental Body to invoke any similar policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators No Acquired Company is the subject of any pending or, to the knowledge of the Company, threatened in writing investigation or threatened investigation other action by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Governmental Entity pursuant to Body in any similar applicable Lawinvestigation or other action. Since January 1, 2016, no Acquired Company, or any Company Associate or clinical investigator of any Acquired Company has been suspended, debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (ivd) None The Products are being, and since December 31, 2014 have been, developed, tested, labeled, manufactured, stored, imported, exported, marketed, promoted and distributed, as applicable, in all material respects with all Health Care Laws. Since January 1, 2016, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect (i) no Acquired Company is subject to any enforcement, regulatory or administrative proceedings against or affecting such Acquired Company relating to or arising under any Health Care Law or other applicable Legal Requirement, and no such enforcement, regulatory or administrative proceeding has been threatened to the knowledge of the Company, (ii) no Acquired Company has received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other Legal Proceeding, and there is not pending any allegation that any operation or activity of any Acquired Company relating to such the Sellers Company’s business or any Product is in violation of any Health Care Law or other applicable Legal Requirement and (iii) as of the date of this Agreement, no Acquired Company has received any FDA Forms 483 or other Specified Governmental Body notices of violations, inspectional observations, “warning letters,” “untitled letters” or other similar written administrative, regulatory or enforcement notice. (e) Since January 1, 2016, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect (i) no investigational new drug application or similar document filed by or on behalf of the Acquired Companies with the FDA, EMA or any other Specified Governmental Body has, to the knowledge of the Company, been terminated or suspended, and (ii) no Acquired Company has received any written notice from a Governmental Body that any Product cannot be developed, tested, labeled, manufactured, stored, marketed, promoted or distributed substantially in the manner presently performed or contemplated by an Acquired Company. (f) Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each Acquired Company has prepared, submitted and implemented timely responses and, as applicable, any corrective action plans required to be prepared and submitted in response to all (i) internal or third-party audits, inspections, investigations or examinations of the Products or the CROsCompany’s business; (ii) adverse event reports; (iii) material patient complaints; (iv) medical incident reports relating to the Products; and (v) material corrective and preventive actions. (g) No Acquired Company has submitted any claim for payment to any government healthcare program in connection with any referrals related to any Product, nor or engaged in any other conduct, that violated in any material respect any applicable self-referral Legal Requirement, including the U.S. Federal Ethics in Patient Referrals Act, 42 U.S.C. §1395nn (known as the “Xxxxx Law”), any anti-kickback Legal Requirement, any false claims Legal Requirement, or any other applicable similar state or non-U.S. Legal Requirement. (h) The Company has operated its business in compliance in all material respects with all applicable Legal Requirements, clinical trial protocols, and contractual or other requirements relating to medical records and medical information privacy that regulate or limit the maintenance, use, disclosure or transmission of medical records, clinical trial data, patient information or other personal information made available to or collected by the Company in connection with the operation of the Company’s business, including the Standards for Privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164 (subparts A and E), the Security Standards at 45 C.F.R. Parts 160 and 164 (subparts A and C), the Standards for Electronic Transactions and Code Sets at 45 C.F.R. Parts 160 and 162 promulgated under the U.S. Health Insurance Portability and Accountability Act of 1996, as amended by the U.S. Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPAA”), the U.S. Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of their respective officersthe foregoing (the “Health Care Data Requirements”). The Company has implemented in all material respects any confidentiality, directorssecurity and other measures required by the Health Care Data Requirements. Each Acquired Company is and has at all times been in compliance in all material respects with the applicable privacy and security requirements of HIPAA and HITECH in conducting the Company’s business. As of the date hereof, employeesno Acquired Company has suffered any accidental, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convictedunauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, personal data or suffered a security breach in relation to any other data which it holds. As of the date hereof, no material breach has occurred with respect to any unsecured Protected Health Information, as that term is defined in 45 C.F.R. §160.103, maintained by or for any Acquired Company that is subject to debarment or convictionthe notification requirements of 45 C.F.R. Part 164, pursuant to Section 306 Subpart D, and, as of the FDCA. In the course of the discoverydate hereof, research and no information security or privacy breach event has occurred that would require notification under any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAcomparable Legal Requirements. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The CompanyAcquired Companies have filed, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been maintained or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed furnished with the applicable Governmental Entities, regulatory authorities (including the FDAFDA or any other Governmental Body performing functions similar to those performed by the FDA or otherwise having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products (such Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports reports, submissions and other documents, including but not limited to adverse event reports. Since January 1, 2016, all such filings, declarations, listings, registrations, reports, submissions and other documents were in material compliance with applicable Laws Legal Requirements when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports reports, submissions or submissionsother documents. (iib) All nonclinical Except as would not reasonably be expected to have a Material Adverse Effect, all preclinical and clinical investigations sponsored or conducted or sponsored by or the Acquired Companies or, to the Company’s knowledge, for investigations conducted on behalf of any of the Company, and all manufacturing operations, both with respect to the Product, are being, and Acquired Companies have been since the Company’s formation, and are being conducted in material compliance with all applicable LawsLegal Requirements and guidances, including, but not limited to the FDCA, good clinical practice including Good Clinical Practices requirements, good laboratory practice requirementsapplicable research protocols, GMPcorrective action plans, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal guidances relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Neither the CompanySince January 1, nor any CRO2016, except as has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAnot had, or any other Governmental Entity with respect would not reasonably be expected to any completedhave, ongoing individually or planned in the aggregate, a Material Adverse Effect, no clinical or nonclinical studies or tests trial sponsored or conducted by or on behalf of the any Acquired Company requiring the terminationhas been terminated, suspension delayed or material modification of such studies suspended prior to completion for safety or testsother non-business reasons, and no Specified Governmental Body, clinical investigator or contract research organization that has participated or is participating in, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review boardboard that has or has had jurisdiction over, the FDA, a clinical trial conducted or any other Governmental Entity is considering such action sponsored by or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject on behalf of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Acquired Company has notcommenced, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The CompanyAcquired Corporations have filed, its Affiliates and, maintained or furnished with the contract research organizations engaged to perform clinical trials on behalf of the Company applicable regulatory authorities (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws European Medicines Agency (“EMA”) or any term other Governmental Body performing functions similar to those performed by the FDA or requirement of any such Governmental ApprovalEMA, or any revocationotherwise having jurisdiction over the safety, withdrawalefficacy, suspensionapproval, cancellationdevelopment, material limitationtesting, termination labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or material modification distribution of any pharmaceutical or biological products (such other Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the CompanyBodies collectively, the CROs, have filed with the applicable “Specified Governmental Entities, including the FDA, Bodies”) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports reports, submissions, applications, amendments, modifications, notices and submissions other documents, including adverse event reports. All such material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and other documents were in material compliance with applicable Laws Legal Requirements when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports reports, submissions, applications, amendments, modifications, notices or submissionsother documents. Any updates, changes, corrections or modifications to such materials required under applicable Legal Requirements have been submitted in compliance with such Legal Requirements in all material respects. (iib) All nonclinical Since January 1, 2016, except as set forth in documents either delivered or made available to Parent or Parent’s Representatives prior to the date of this Agreement, all preclinical and clinical investigations sponsored or conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and Acquired Corporations have been since the Company’s formation, and are being conducted in material compliance with all applicable Legal Requirements, rules, regulations and binding guidances, including Good Clinical Practices, Good Laboratory Practices, other Health Care Laws, includingapplicable research protocols, but not limited corrective action plans, and federal and state laws, rules, regulations and binding guidances relating to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Neither Since January 1, 2016, except as has not had or would not reasonably be expected to have, individually or in the Companyaggregate, nor any CROa Material Adverse Effect, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned no clinical or nonclinical studies or tests pre-clinical trial sponsored or conducted by or on behalf of the Company requiring the terminationany Acquired Corporation has been terminated, suspension delayed or material modification of such studies suspended prior to completion for safety or tests, or regarding material noncompliance of such studies or tests of the Productother non-business reasons, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, neither the FDA, EMA or any other Specified Governmental Entity Body, clinical investigator or contract research organization that has participated in or is considering participating in, or institutional review board or data safety monitoring board that has or has had jurisdiction over, a clinical or pre-clinical trial conducted or sponsored by or on behalf of any Acquired Corporation has commenced or, to the Company’s knowledge, threatened to initiate any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend any proposed or ongoing clinical or pre-clinical trial conducted or proposed to be conducted by or on behalf of any Acquired Corporation, or alleged any violation of applicable Health Care Laws in connection with any such action clinical or communicationpre-clinical trial. The Company periodically reviews clinical trial sites participating in any Acquired Corporation-sponsored trial for compliance with applicable Health Care Laws. (iiic) Neither No Acquired Corporation or officer thereof or to the Company’s knowledge, norno employee, to the Knowledge of the Company any of the CROs, agent or clinical investigator thereof has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA FDA, EMA or any other Specified Governmental Entity, Body; (bii) failed to disclose a material fact required to be disclosed to the FDA FDA, EMA, or any other Specified Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or for the EMA or any other Specified Governmental Body to invoke any similar policy. Neither the Company, nor, to Knowledge As of the Companydate of this Agreement, any of its officers, CROs, agents or clinical investigators no Acquired Corporation is the subject of any pending or or, to the Company’s knowledge, threatened investigation or other action by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Specified Governmental Entity pursuant to Body under any similar applicable Law. (iv) None policy. Since January 1, 2016, no Acquired Corporation or officer thereof nor to the knowledge of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, agent or independent contractor who clinical investigator thereof has been disqualified, suspended, debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement or (C) disqualification as a clinical investigator under 21 CFR 312.70 or any similar Legal Requirement. (d) Except as would not reasonably be expected to have a Material Adverse Effect, each Acquired Corporation is in compliance and has, since January 1, 2016, been in compliance, in each case, in all material respects with all Legal Requirements applicable to the operation of its business as currently conducted, including (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or FDCA and the regulations promulgated thereunder; (ii) convicted the Clinical Laboratory Improvement Amendments of 1988; (iii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant to Section 306 thereto; and (iv) Legal Requirements the violation of the FDCAwhich is cause for exclusion from any federal health care program. (ve) The Company’s andProducts are being, with respect to the Productand since January 1, the CROs’2016 have been, use developed, tested, labeled, manufactured, stored, imported and dissemination of any personally-identifiable information or Protected Health Information (exported, as defined under HIPAA) concerning individuals is applicable, in all material respects in compliance with all Health Care Laws. Since January 1, 2016, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect: (i) no Acquired Corporation is subject to any enforcement, regulatory or administrative proceedings against or affecting such Acquired Corporation relating to or arising under any Health Care Law or other applicable LawsLegal Requirement, contracts and no such enforcement, regulatory or administrative proceeding has been threatened, (ii) no Acquired Corporation has received notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other Legal Proceeding, and, to which the Company Company’s knowledge, there is not pending any allegation that any operation or CRO activity of any Acquired Corporation relating to the business of the Acquired Corporations or any Product is boundin violation of any Health Care Law or other applicable Legal Requirement, privacy policies and terms (iii) no Acquired Corporation has received any FDA Form-483 or other notices of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains violations, inspectional observations, warning letters, untitled letters or other written administrative, technical regulatory or enforcement notice from any Specified Governmental Body. (f) Since January 1, 2016, except as has not had, and physical safeguards would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect: (i) no investigational new drug application or similar document filed by or on behalf of the Acquired Corporations with the FDA, EMA or any other Specified Governmental Body has been placed on clinical hold or otherwise limited, terminated, or suspended, and (ii) no Acquired Corporation has received any written notice from a Specified Governmental Body that are commercially reasonable any Product cannot be developed, tested, labeled, manufactured, stored, marketed, promoted or distributed substantially in the manner presently performed or contemplated by an Acquired Corporation. (g) Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each Acquired Corporation has prepared, submitted and implemented timely responses and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access ofas applicable, any data corrective action plans required to be prepared and submitted in response to all (i) internal or information used by third-party audits, inspections, investigations or examinations of the Company or, with respect Products or such Acquired Corporation’s business; (ii) adverse event reports; (iii) material patient complaints; (iv) medical incident reports relating to the Products; and (v) material corrective and preventive actions. (h) No Acquired Corporation has submitted any claim for payment to any government healthcare program in connection with any referrals related to any Product, the CROs.

Regulatory Matters. (ia) The CompanySince January 1, its Affiliates and2019, each Acquired Company has filed, maintained or furnished with the contract research organizations engaged to perform clinical trials on behalf of the Company applicable regulatory authorities (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws European Medicines Agency (“EMA”) or any term or requirement of any such other Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely Body performing functions similar to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including those performed by the FDA, EMA or otherwise having jurisdiction over the pricing, reimbursement, safety, efficacy, approval, development, testing, labeling, manufacture, or storage of pharmaceutical products (such other Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports reports, submissions, applications, amendments, modifications, notices and submissions other documents, including but not limited to adverse event reports. All such material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and other documents filed or submitted after January 1, 2019: (i) have been made available to Parent and (ii) were in material compliance with applicable Legal Requirements, including all applicable Health Care Laws in all material respects when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports reports, submissions, applications, amendments, modifications, notices and other documents. Since January 1, 2019, any updates, changes, corrections or submissionsmodifications to such materials required under applicable Legal Requirements, including all applicable Health Care Laws, have been submitted in compliance with such Legal Requirements in all material respects. (iib) All nonclinical preclinical and clinical investigations sponsored or conducted or sponsored by or on behalf of any Acquired Company or, to the knowledge of the Company, and all manufacturing operationsby any Acquired Company’s research, both development, collaboration or similar partners with respect to the Productany Product Candidates of any Acquired Company while acting in such capacity (each such party a “Collaboration Partner”), are being, and have been since the Company’s formationJanuary 1, 2019, and are being, conducted in material compliance with all applicable Legal Requirements, rules, regulations and binding guidances, including Good Clinical Practices requirements, other Health Care Laws, includingapplicable research protocols and federal and state laws, but not limited rules, regulations and binding guidances relating to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Neither Since January 1, 2019, except as has not had, and would not reasonably be expected to have, individually or in the Companyaggregate, nor any CROa Material Adverse Effect, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned no clinical or nonclinical studies or tests trial sponsored or conducted by or on behalf of the any Acquired Company requiring the terminationor by any Collaboration Partner has been terminated, suspension delayed or material modification of such studies suspended prior to completion for safety or tests, or regarding material noncompliance of such studies or tests of the Productother non-business reasons, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, neither the FDA, or the EMA nor any other Specified Governmental Entity Body, clinical investigator or contract research organization that has participated or is considering participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted or sponsored by or on behalf of any Acquired Company or by any Collaboration Partner has commenced, or, to the knowledge of the Company, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any Acquired Company or by any Collaboration Partner, or alleged any violation of any Health Care Law in connection with any such action clinical trial. The Acquired Companies or communicationan agent on their behalf periodically reviews clinical trial sites participating in any Acquired Company-sponsored trial for compliance with all applicable Health Care Laws. (iiic) Neither the CompanySince January 1, 2019, no Acquired Company nor, to the Knowledge knowledge of the Company, any Company any of the CROsAssociate, employee, agent, clinical investigator or Collaboration Partner has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA FDA, EMA or any other Specified Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA FDA, EMA, Centers for Medicare and Medicaid Services or any other Specified Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy or for the EMA or any other Specified Governmental Body to invoke any similar policy. Neither the Company, No Acquired Company nor, to Knowledge the knowledge of the Company, any of its officersCollaboration Partner, CROs, agents or clinical investigators is the subject of any pending or, to the knowledge of the Company, threatened in writing investigation or threatened investigation other action by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Governmental Entity pursuant to Body in any similar applicable Law. (iv) None investigation or other action. Since January 1, 2019, no Acquired Company nor any Company Associate or clinical investigator of any Product Candidates or, to the knowledge of the Company, any Collaboration Partner has been suspended, debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (d) The Product Candidates are being, and since January 1, 2019, have been, developed, tested, labeled, manufactured, and stored, as applicable, in all material respects with all Health Care Laws. Since January 1, 2019, except as has not had, and would not reasonably be expected to have, individually or in the Sellers aggregate, a Material Adverse Effect (i) each Acquired Company and, to the knowledge of the Company, each Collaboration Partner, are not and have not been subject to any enforcement, regulatory or administrative proceedings against or affecting any Acquired Company or any Product Candidate relating to or arising under any Health Care Law or other applicable Legal Requirement, and no such enforcement, regulatory or administrative proceeding has been threatened in writing, (ii) no Acquired Company nor, to the CROsknowledge of the Company, nor any Collaboration Partner, has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other Legal Proceeding, and to the knowledge of the Company, there is not pending any allegation that any operation or activity of any Acquired Company or any Collaboration Partner relating to any Acquired Company’s business or any Product Candidate is in violation of any Health Care Law or other applicable Legal Requirement and (iii) as of the date of this Agreement, no Acquired Company has received any FDA Forms 483 or other Specified Governmental Body notices of violations, inspectional observations, “warning letters,” “untitled letters” or other similar written administrative, regulatory or enforcement notice. (e) Since January 1, 2019, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect: (i) no investigational new drug application or similar document filed by or on behalf of any Acquired Company with the FDA, EMA or any other Specified Governmental Body has, to the knowledge of the Company, been terminated or suspended, and (ii) no Acquired Company nor, to the knowledge of the Company, any Collaboration Partner, has received any written notice from a Governmental Body that any Product Candidate cannot be developed, tested, labeled, manufactured or stored, substantially in the manner presently performed or contemplated by any Acquired Company or any Collaboration Partner. (f) Since January 1, 2019, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each Acquired Company and, to the knowledge of the Company, its Collaboration Partners have prepared, submitted and implemented timely responses and, as applicable, any corrective action plans required to be prepared and submitted in response to all (i) internal or third-party audits, inspections, investigations or examinations of the Product Candidates and each Acquired Company’s business; (ii) adverse event reports relating to the Product Candidates; (iii) material patient complaints relating to the Product Candidates; (iv) medical incident reports relating to the Product Candidates; and (v) material corrective and preventive actions relating to the Product Candidates and each Acquired Company’s business. (g) Since January 1, 2019, no Acquired Company has submitted any claim for payment to any government healthcare program in connection with any referrals related to any Product Candidate, or engaged in any other conduct, that violated in any material respect any applicable self-referral Legal Requirement, including the U.S. Federal Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn (known as the Sxxxx Law), any anti-kickback Legal Requirement, including the U.S. Federal Axxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x, any false claims Legal Requirement, including the U.S. Federal False Claims Act, 31 U.S.C. § 3729 et seq., or any other applicable similar state or non-U.S. Legal Requirement. (h) Since January 1, 2019, each Acquired Company has operated its business in compliance in all material respects with all applicable Legal Requirements, clinical trial protocols, and contractual or other requirements relating to medical records and medical information privacy that regulate or limit the maintenance, use, disclosure or transmission of medical records, clinical trial data, patient information or other personal information made available to or collected by the Acquired Companies in connection with the operation of the Acquired Companies’ businesses, including the Standards for Privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164 (subparts A and E), the Security Standards at 45 C.F.R. Parts 160 and 164 (subparts A and C), the Standards for Electronic Transactions and Code Sets at 45 C.F.R. Parts 160 and 162 promulgated under the U.S. Health Insurance Portability and Accountability Act of 1996, as amended by the U.S. Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPAA”), the U.S. Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of their respective officersthe foregoing (the “Health Care Data Requirements”). Each Acquired Company has implemented in all material respects any confidentiality, directorssecurity and other measures required by the Health Care Data Requirements. Each Acquired Company is, employeesand has at all times since January 1, shareholders2019, consultantsbeen in compliance in all material respects with the applicable privacy and security requirements of HIPAA and HITECH in conducting the Acquired Companies’ businesses. As of the date hereof, agentssince January 1, clinical investigators or Affiliates 2019, no Acquired Company has been debarred or convictedsuffered any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, personal data or suffered a security breach in relation to any other data which it holds. As of the date hereof, since January 1, 2019, no material breach has occurred with respect to any unsecured Protected Health Information, as that term is defined in 45 C.F.R. §160.103, maintained by or for any Acquired Company that is subject to debarment or convictionthe notification requirements of 45 C.F.R. Part 164, pursuant to Section 306 Subpart D, and, as of the FDCA. In the course of the discoverydate hereof, research and no information security or privacy breach event has occurred that would require notification under any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAcomparable Legal Requirements. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The CompanySince January 1, its Affiliates and2021, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval Group has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, regulatory authorities (including the FDA or any other Governmental Entity performing functions similar to those performed by the FDA, ) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports and investigational new drug safety reports. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws when filed, and no material deficiencies that have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionssubmissions remain outstanding. (ii) All Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, all nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company Group are, to the knowledge of the Company, and all manufacturing operations, both with respect to the Product, are being, and being or have been since the Company’s formation, conducted in material compliance with applicable LawsLaws and guidance, including, but not limited to the FDCA, good clinical practice including (A) Good Clinical Practices requirements, good laboratory practice requirements(B) applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, GMP, ICH principles (C) approved clinical protocols and Health Insurance Portability informed consents and Accountability Act of 1996, Public Law 104-191 (“HIPAA”D) and other legal requirements applicable Laws restricting the use and disclosure of individually identifiable health information. Neither As of the Companydate of this Agreement, neither the FDA nor any CROother foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA has received sent any written notice, correspondence notices or other communication from correspondence to any institution, institutional review board, member of the FDA, or any other Governmental Entity Company Group with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, which modification, individually or regarding material noncompliance of such studies or tests of in the Productaggregate, and would reasonably be expected to Knowledge of the have a Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationMaterial Adverse Effect. (iii) Neither To the Company’s knowledge, norsince January 1, to 2021, neither the Knowledge members of the Company Group nor any Representative acting on any member of the CROs, Company Group’s behalf has (aA) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityEntity having applicable jurisdiction over the Company Group under applicable Healthcare Laws, (bB) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (cC) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy or for any Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws to invoke an equivalent policy. Neither As of the Companydate of this Agreement, none of any member of the Company Group nor, to Knowledge the Company’s knowledge, any entity or other Representative acting on any member of the Company, any of its officers, CROs, agents or clinical investigators Company Group’s behalf is the subject of any pending or or, to the Company’s knowledge, threatened investigation in writing by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar having applicable Lawjurisdiction over the Company Group under applicable Healthcare Laws on the basis of an equivalent Policy. (iv) None Neither the Company nor, to the knowledge of the Company, the Sellers or the CROs, nor any of their respective executive officers, directors, employees, shareholders, consultants, agents, agents or clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In Company Group or any entity or individual acting on the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who Company’s behalf has been (iA) debarred byunder 21 U.S.C. § 335a or any similar Law, (B) excluded from participation in federal health care programs under 42 U.S.C. §§ 1320a-7, 1320a-7a or is the subject any similar Law, (C) disqualified by any Governmental Entity, (D) suspended or otherwise determined to be or identified as ineligible to participate in any health care contracting program of debarment proceedings by, any Governmental Entity or (iiE) convicted pursuant of, charged with, investigated for or engaged in any conduct that would reasonably be expected to Section 306 result in such debarment, exclusion, disqualification, suspension, or ineligibility. No debarment, exclusion or disqualification proceedings or investigations are pending or, to the Company’s knowledge, threatened against the Company or any officer, director, consultant, employee, manager or agent acting for or on behalf of the FDCACompany Group. No Legal Proceedings are pending or, to the Company’s knowledge, threatened that would reasonably be expected to result in criminal liability, debarment, disqualification, or exclusion by any Governmental Entity. (v) The Company’s andExcept as, with respect individually or in the aggregate, would not reasonably be expected to the Producthave a Company Material Adverse Effect, the CROs’Company Group is in compliance and since January 1, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is 2021, has been in compliance with all Healthcare Laws to the extent applicable to the operation of its business as currently conducted. The Company is not subject to any enforcement, regulatory or Legal Proceeding against or affecting the Company relating to or arising under any Healthcare Law, and no such enforcement, regulatory or Legal Proceeding has been threatened, including by the issuance of a warning letter, untitled letter, Form 483 or similar notice of potential violations of Healthcare Laws. To the extent required by applicable Laws, contracts to which all manufacturing operations conducted for the benefit of any member of the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, Group with respect to any product or product candidate being used in human clinical trials have been conducted in accordance with GMP Regulations, except where the Productfailure to so comply would not, individually or in the CROsaggregate, reasonably be expected to have a Company Material Adverse Effect.

Regulatory Matters. (i) The Company, First Mutual and its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) Subsidiaries have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have duly filed with the applicable Governmental Entitiesappropriate regulatory authorities in substantially correct form the monthly, including the FDA, all filings, representations, declarations, listings, quarterly and registrations, as well as all annual reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All under applicable laws and regulations, and such filings, representations, declarations, listings, registrations, reports and submissions were in all material respects complete and accurate and in compliance with the requirements of applicable Laws when filedlaws and regulations, and no material deficiencies First Mutual has previously delivered or made available to Washington Federal accurate and complete copies of all such reports. In connection with the most recent examination of First Mutual and its Subsidiaries by the appropriate regulatory authorities, neither First Mutual nor any of its Subsidiaries was required to correct or change any action, procedure or proceeding which First Mutual believes in good faith has not been now corrected or changed, other than corrections or changes which, if not made, either individually or in the aggregate, would not have been asserted in writing by a Material Adverse Effect on First Mutual. To the knowledge of First Mutual, since its last regulatory examination of Community Reinvestment Act compliance, FMB has not received any applicable Governmental Entity with respect complaints as to any such filings, representations, declarations, listing, registrations, reports or submissionsCommunity Reinvestment Act compliance. (ii) All nonclinical and clinical investigations conducted Except as Previously Disclosed, neither First Mutual nor any of its Subsidiaries nor any of their respective properties is a party to or sponsored by is subject to any order, decree, directive, agreement, memorandum of understanding or on behalf of the Companysimilar arrangement with, and all manufacturing operationsor a commitment letter or similar submission to, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Companyor extraordinary supervisory letter from, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, First Mutual or any other of its Subsidiaries adopted any policies procedures or board resolutions at the request or suggestion of, any Governmental Entity with respect to Authority. First Mutual and its Subsidiaries have paid all assessments made or imposed by any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationAuthority. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, First Mutual nor any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROsSubsidiaries has been advised by, nor does it have any knowledge of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject facts which could give rise to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings an advisory notice by, any Governmental Entity Authority that such Governmental Authority is contemplating issuing or requesting (iior is considering the appropriateness of issuing or requesting) convicted pursuant to Section 306 any such order, decree, directive, agreement, memorandum of the FDCAunderstanding, commitment letter, supervisory letter or similar submission. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Each of the Company and its subsidiaries is duly licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (the collectively, “CROsInsurance Laws”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit of each jurisdiction in which the conduct of its existing business as described in the Business Registration Statement, the General Disclosure Package and the Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, each of the Company and its subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Registration Statement, the General Disclosure Package and the Prospectus and all such Governmental Approvals of the foregoing are valid and in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and no such Governmental Approval has been effect would not, individually or is being revoked or challengedin the aggregate, reasonably be expected to result in a Material Adverse Effect. Neither the Company, nor to the Knowledge None of the Company, any CRO, Company or its subsidiaries has received any communication notification from any Governmental Entity regardinginsurance regulatory authority or other governmental authority in the United States or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its subsidiaries to conduct its existing business as described in the Registration Statement, the General Disclosure Package and the Prospectus, except for any such Governmental Approvals, any notification received where the failure to materially comply with applicable Laws obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Except as otherwise described in the Registration Statement, the General Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or decree impairing, restricting or prohibiting the payment of dividends by the Company or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approvalits subsidiaries. To Except as otherwise described in the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the CompanyRegistration Statement, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA General Disclosure Package and the Public Health Service Act of 1944Prospectus, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf none of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there its subsidiaries is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None outstanding order or is a party to any written agreement, consent agreement or memorandum of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convictedunderstanding with, or is subject to debarment any order or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred directive by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination a recipient of any personally-identifiable information supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or Protected Health Information (as defined under HIPAA) concerning individuals is that in compliance with all applicable Lawsany manner relates to its capital adequacy, contracts to which its management or its business, nor has the Company or CRO any subsidiary been advised by any regulatory authority that it is boundconsidering issuing or requesting any such agreement, privacy policies and terms order or letter. Each of use. The the Company and its subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the CROs applicable Insurance Laws of the United States and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Effect, and each maintain policies of the Company and procedures regarding data security its subsidiaries maintains its books and privacy records in accordance with, and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, is otherwise in compliance with with, all applicable Laws Insurance Laws, except where the failure to so maintain its books and contractsrecords or be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. There have been no security breaches relating toExcept as disclosed in the Registration Statement, or violations of any security policy regardingthe General Disclosure Package and the Prospectus, or any unauthorized access of, any data or information used by the Company orand its subsidiaries have made no material change in their insurance reserving practices since December 31, with respect to the Product, the CROs2022.

Regulatory Matters. (a) Except as set forth on Schedule 4.10(a), since January 1, 2019, each of the Products have been designed, manufactured, packaged, labeled, stored, tested, distributed, imported, exported, and otherwise marketed and promoted in material compliance with all applicable requirements under the FDCA, and implementing regulations of the FDA, the FTC, or any similar governmental entity, the FTCA and its implementing regulations, California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”) and its implementing regulations, the California Safe Cosmetics Program (“CSCP”) and its implementing regulations, and all other laws regarding developing, importing, exporting, formulating, testing, manufacturing, storing, labeling, advertising, marketing, distributing or promoting the Products including (i) The Companygood manufacturing practice requirements, its Affiliates and(ii) labeling requirements, (iii) requirements pertaining to the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entitytruth, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effectaccuracy, and no such Governmental Approval has been or is being revoked or challenged. Neither the Companysubstantiation of claims used in labeling and advertising, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approvaland (iv) requirements regarding complaint handling and adverse event reporting. To the Knowledge of the CompanySeller’s Knowledge, there are no facts allegations that the Seller, or circumstances that any of its respective products, are in violation of the FDCA, Proposition 65, CSCP, or any other applicable Laws, ordinances, regulations, consent decrees, court orders, or rules pertaining to the operations or products of Seller. The Products are not misbranded or adulterated as defined in the FDCA and relevant regulations. (b) Seller is in possession of all required marketing authorizations required by the FDCA and FDA’s implementing regulations, including any marketing authorizations required as a result of any modifications to the design or performance of a Product, to its labeling or packaging or to its indications for use, after initially receiving marketing authorization from FDA, except where such a lack of such possession would not reasonably likely be expected to be material to the Business. (c) Since January 1, 2019, there have not been and are not now any investigations, adverse third party allegations or actions, claims, proceedings, demands, complaints, hearings, demand letters, warning letters, untitled letters, or requests for information pending or in effect against Seller for failure to comply with any Health Law or consumer protection Law (including but not limited to false advertising laws), including any pending or threatened (in writing) action against Seller or any of its Affiliates, officers or employees, in any court or by or before any Governmental Authority, with respect to the Products, or Seller’s obligations set forth herein, including any which may adversely affect Seller’s ability to perform its obligations under this Agreement. (d) Since January 1, 2019, neither Seller nor any such of its Affiliates, has been the subject of a legal, administrative, enforcement, or other adverse action initiated by FDA or another Governmental Approvals. The CompanyAuthority where it was alleged that Seller or any of its Affiliates violated the FDA, and to the Knowledge of Seller, neither the CompanyFDA nor any other Governmental Authority will or is considering such an action, in each case with respect to the Purchased Assets, the CROsProducts or the Business. (e) The Products have been designed, have filed with the applicable Governmental Entitiesmanufactured, including the FDApackaged, all filingslabeled, representations, declarations, listingsprocessed, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were distributed in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any all applicable Governmental Entity with respect to any Authority requirements, including FDA good manufacturing practice requirements, such filings, representations, declarations, listing, registrations, reports or submissionsas cGMP and/or QSR. (iif) All nonclinical and clinical investigations conducted Since January 1, 2019, neither Seller nor any of its Affiliates has initiated any recall, product correction, or sponsored by or on behalf of the Companytaken any other field action, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, including but not limited to market withdrawal, relative to any Product. (g) Neither Seller nor its Affiliates or any manufacturers of the FDCAProducts or of the raw materials for the Products, good clinical practice requirementshave received any Form FDA 483 observations, good laboratory practice requirementswarning letters, GMPnotice of violation letters, ICH principles and Health Insurance Portability and Accountability Act untitled letters or other communications from any Governmental Authority regarding violations or potential violations of 1996Laws related to the Products that would reasonably be expected to adversely impact the manufacture, Public Law 104-191 (“HIPAA”) and other legal requirements restricting distribution, or the use and disclosure marketing of individually identifiable health informationthe Products. Neither the Company, Seller nor any CRO, of its Affiliates has received any written notice, correspondence or other communication notice from any institution, institutional review board, the FDAGovernmental Authority that it has commenced, or threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on, or request the recall of the Products, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the Products or distribution of the Products or to initiate any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf form of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationenforcement action. (iiih) Neither the Company, nor, to the Knowledge of the Company Seller nor any of the CROs, its Affiliates has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, statement that (in any such case) establishes would reasonably be expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke initiate an investigation or enforcement action pursuant to its Compliance Policy Guide Section 120.100 “Fraud, Untrue Statements of Material Facts, Bribery, Bribery and Illegal Gratuities Final Policy. Gratuities” and any amendments thereto. (i) Neither the Company, Seller nor, to the Knowledge of the Company, Seller any of its Affiliates or its or their officers, CROskey employees, agents or clinical investigators is the subject agents, has been convicted of any pending or threatened investigation by the FDA pursuant crime, subjected to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convictedcivil monetary penalties, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, engaged in any event, conduct that would reasonably be likely to result in compliance with all applicable Laws and contracts. There have been no security breaches relating to, prosecution or violations imposition of any security policy regarding, civil monetary penalties under the FDCA or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsFDA implementing regulations.

Regulatory Matters. (ia) The CompanyExcept as would not reasonably be expected, its Affiliates and, individually or in the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDAaggregate, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effecthave a Material Adverse Effect, and no such Governmental Approval each Acquired Company has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA, ) all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and or submissions, including but not limited to adverse event reports. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws when filedfiled (or were corrected or supplemented by a subsequent submission) and, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical and clinical investigations conducted Except as would not reasonably be expected, individually or sponsored by or on behalf in the aggregate, to have a Material Adverse Effect, to the Knowledge of the Company, all preclinical and all manufacturing operations, both with respect to the Product, clinical investigations sponsored by an Acquired Company are being, and have been since the Company’s formation, being conducted in material compliance with applicable Laws. As of the Agreement Date, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, no Acquired Company has received any written notice, correspondence notices or other communication written correspondence from any institution, institutional review board, the FDA, FDA or any other Governmental Entity foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iiic) Neither Except as would not reasonably be expected, individually or in the Company, noraggregate, to the Knowledge of the have a Material Adverse Effect, no Acquired Company any of the CROs, has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither As of the CompanyAgreement Date, northe Company is not the subject of any pending or, to the Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy Policy. Neither any of the Acquired Companies nor, to the Knowledge of the Company, any officers, employees, agents or by clinical investigators of any other Governmental Entity pursuant of the Acquired Companies have been suspended or debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar applicable Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (ivd) None of Except as would not reasonably be expected, individually or in the Companyaggregate, to have a Material Adverse Effect, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including Acquired Companies are in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s compliance and, with respect to the Productsince January 1, the CROs’2019, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is have been in compliance with all healthcare Laws applicable to the operation of its business as currently conducted, including (i) any and all applicable federal, state and local fraud and abuse Laws, contracts including the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7(b)) and the civil False Claims Act (31 U.S.C. Section 3729 et seq.); (ii) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information and Technology for Economic and Clinical Health Act; (iii) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); and (iv) Laws that are cause for exclusion from any federal health care program. As of the Agreement Date, to which the Knowledge of the Company no enforcement, regulatory or CRO administrative proceeding is boundpending, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativeno such enforcement, technical and physical safeguards that are commercially reasonable andregulatory or administrative proceeding has been threatened in writing, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by against the Company orunder the Federal Food, with respect to the ProductDrug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the CROsAnti-Kickback Statute or similar Laws, other than any such proceeding that would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Regulatory Matters. (ia) The CompanySince January 1, its Affiliates and2018, the contract research organizations engaged to perform clinical trials on behalf of Company has filed, maintained or furnished with the Company applicable regulatory authorities (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws European Medicines Agency (“EMA”) or any term or requirement of any such other Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely Body performing functions similar to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including those performed by the FDA, EMA or otherwise having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, or storage of pharmaceutical products (such other Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports reports, submissions, applications, amendments, modifications, notices and submissions other documents, including but not limited to adverse event reports. All such material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and other documents filed or submitted after January 1, 2018: (i) have been made available to Parent and (ii) were in material compliance with applicable Legal Requirements, including all applicable Health Care Laws in all material respects when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports reports, submissions, applications, amendments, modifications, notices and other documents. Any updates, changes, corrections or submissionsmodifications to such materials required under applicable Legal Requirements, including all applicable Health Care Laws, have been submitted in compliance with such Legal Requirements in all material respects. (iib) All nonclinical preclinical and clinical investigations sponsored or conducted or sponsored by or on behalf of the Company or, to the knowledge of the Company, and all manufacturing operationsby any of the Company’s research, both development, collaboration or similar partners with respect to any Product Candidates of the ProductCompany while acting in such capacity (each such party a “Collaboration Partner”), are being, and have been since the Company’s formation, and are being conducted in material compliance with all applicable Legal Requirements, rules, regulations and binding guidances, including Good Clinical Practices requirements, other Health Care Laws, includingapplicable research protocols and federal and state laws, but not limited rules, regulations and binding guidances relating to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Neither the CompanySince January 1, nor any CRO2018, except as has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAnot had, or any other Governmental Entity with respect would not reasonably be expected to any completedhave, ongoing individually or planned in the aggregate, a Material Adverse Effect, no clinical or nonclinical studies or tests trial sponsored or conducted by or on behalf of the Company requiring or by any Collaboration Partner has been terminated, delayed or suspended prior to completion for safety or other non-business reasons, and neither the terminationFDA, suspension the EMA nor any other Specified Governmental Body, clinical investigator or material modification of such studies contract research organization that has participated or testsis participating in, or regarding material noncompliance of such studies institutional review board that has or tests of the Producthas had jurisdiction over, and to Knowledge a clinical trial conducted or sponsored by or on behalf of the Company there is no reason or by any Collaboration Partner has commenced, or, to believe that the knowledge of the Company, threatened in writing to initiate, any institution, institutional review board, the FDAaction to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any other Governmental Entity is considering proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company or by any Collaboration Partner, or alleged any violation of any Health Care Law in connection with any such action clinical trial. The Company or communicationan agent on its behalf periodically reviews clinical trial sites participating in any Company-sponsored trial for compliance with all applicable Health Care Laws. (iiic) Neither Since January 1, 2018, neither the Company, Company nor, to the Knowledge knowledge of the Company any of the CROsCompany Associate, employee, agent, clinical investigator or Collaboration Partner has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA FDA, EMA or any other Specified Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA FDA, EMA, Centers for Medicare and Medicaid Services or any other Specified Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy or for the EMA or any other Specified Governmental Body to invoke any similar policy. Neither the Company, Company nor, to Knowledge the knowledge of the Company, any of its officersCollaboration Partner, CROs, agents or clinical investigators is the subject of any pending or, to the knowledge of the Company, threatened in writing investigation or threatened investigation other action by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Governmental Entity pursuant to Body in any similar applicable Law. (iv) None investigation or other action. Since January 1, 2018, neither the Company nor any Company Associate or clinical investigator of any Product Candidates of the Company or, to the knowledge of the Company, any Collaboration Partner of the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates Company has been suspended, debarred or convictedconvicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (d) The Product Candidates are being, and since January 1, 2018, have been, developed, tested, labeled, manufactured, and stored, as applicable, in all material respects with all Health Care Laws. Since January 1, 2018, except as has not had, and would not reasonably be expected to have, individually or is in the aggregate, a Material Adverse Effect (i) the Company and, to the knowledge of the Company, any Collaboration Partner, are and have not been subject to debarment any enforcement, regulatory or convictionadministrative proceedings against or affecting the Company or any Product Candidate relating to or arising under any Health Care Law or other applicable Legal Requirement, pursuant and no such enforcement, regulatory or administrative proceeding has been threatened in writing, (ii) neither the Company nor, to Section 306 the knowledge of the FDCA. In Company, any Collaboration Partner, has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other Legal Proceeding, and to the course knowledge of the discoveryCompany, research and there is not pending any other development allegation that any operation or activity of the Company or any Collaboration Partner relating to the Company’s business or any Product (including Candidate is in the conduct violation of any non-clinical research, safety Health Care Law or other applicable Legal Requirement and toxicology studies or clinical trials with respect to (iii) as of the Product)date of this Agreement, the Company has notnot received any FDA Forms 483 or other Specified Governmental Body notices of violations, directly inspectional observations, “warning letters,” “untitled letters” or indirectlyother similar written administrative, used any employeeregulatory or enforcement notice. (e) Since January 1, agent2018, except as has not had, and would not reasonably be expected to have, individually or independent contractor who has been in the aggregate, a Material Adverse Effect (i) debarred byno investigational new drug application or similar document filed by or on behalf of the Company with the FDA, EMA or is any other Specified Governmental Body has, to the subject knowledge of debarment proceedings bythe Company, any Governmental Entity been terminated or suspended, and (ii) convicted pursuant neither the Company nor, to Section 306 the knowledge of the FDCACompany, any Collaboration Partner, has received any written notice from a Governmental Body that any Product Candidate cannot be developed, tested, labeled, manufactured or stored, substantially in the manner presently performed or contemplated by the Company or any Collaboration Partner. (f) Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the Company and, to the knowledge of the Company, its Collaboration Partners have prepared, submitted and implemented timely responses and, as applicable, any corrective action plans required to be prepared and submitted in response to all (i) internal or third-party audits, inspections, investigations or examinations of the Product Candidates or the Company’s business; (ii) adverse event reports relating to the Product Candidates; (iii) material patient complaints relating to the Product Candidates; (iv) medical incident reports relating to the Product Candidates; and (v) The material corrective and preventive actions relating to the Product Candidates or the Company’s andbusiness. (g) The Company has not submitted any claim for payment to any government healthcare program in connection with any referrals related to any Product Candidate, or engaged in any other conduct, that violated in any material respect any applicable self-referral Legal Requirement, including the U.S. Federal Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn (known as the Xxxxx Law), any anti-kickback Legal Requirement, including the U.S. Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x, any false claims Legal Requirement, including the U.S. Federal False Claims Act, 31 U.S.C. § 3729 et seq., or any other applicable similar state or non-U.S. Legal Requirement. (h) The Company has operated its business in compliance in all material respects with all applicable Legal Requirements, clinical trial protocols, and contractual or other requirements relating to medical records and medical information privacy that regulate or limit the maintenance, use, disclosure or transmission of medical records, clinical trial data, patient information or other personal information made available to or collected by the Company in connection with the operation of the Company’s business, including the Standards for Privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164 (subparts A and E), the Security Standards at 45 C.F.R. Parts 160 and 164 (subparts A and C), the Standards for Electronic Transactions and Code Sets at 45 C.F.R. Parts 160 and 162 promulgated under the U.S. Health Insurance Portability and Accountability Act of 1996, as amended by the U.S. Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPAA”), the U.S. Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of the foregoing (the “Health Care Data Requirements”). The Company has implemented in all material respects any confidentiality, security and other measures required by the Health Care Data Requirements. The Company is and has at all times been in compliance in all material respects with the applicable privacy and security requirements of HIPAA and HITECH in conducting the Company’s business. As of the date hereof, the Company has not suffered any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, personal data or suffered a security breach in relation to any other data which it holds. As of the date hereof, no material breach has occurred with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or unsecured Protected Health Information (Information, as that term is defined under HIPAA) concerning individuals is in compliance with all applicable Laws45 C.F.R. §160.103, contracts to which maintained by or for the Company or CRO that is boundsubject to the notification requirements of 45 C.F.R. Part 164, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativeSubpart D, technical and physical safeguards that are commercially reasonable and, in as of the date hereof, no information security or privacy breach event has occurred that would require notification under any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROscomparable Legal Requirements.

Regulatory Matters. (ia) The CompanySince January 1, its Affiliates and2012, the contract research organizations engaged Company has filed, or caused its Subsidiaries to perform clinical trials on behalf of file, with the Company (the “CROs”) have obtained all FDA or any other Governmental Approvals required Authority performing functions similar to those performed by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effectrequired filings, and no such Governmental Approval has been declarations, listings, registrations, reports or is being revoked or challenged. Neither the Companysubmissions, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approvalincluding adverse event reports. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and or submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by the Company has not received any communication from any such applicable Governmental Entity Authority asserting deficiencies with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical and clinical investigations conducted or sponsored by or on behalf To the Knowledge of the Company, all preclinical and all manufacturing operations, both clinical investigations sponsored by the Company with respect to products or product candidates currently in development by the Product, Company or any of its Subsidiaries are being, and have been since the Company’s formation, being conducted in material compliance with all applicable LawsLaws including the FDCA and its implementing regulations and applicable experimental protocols, includinginformed consents, but not limited to the FDCAprocedures, controls, guidance and industry standards, including good clinical practice requirementsmanufacturing practice, good laboratory practice requirementspractice, GMPand good clinical practice, ICH principles requirements and Health Insurance Portability industry standards of oversight of clinical sites including monitors, and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) Laws and other legal requirements guidance restricting the use use, disclosure and disclosure protection of individually identifiable health information. Neither None of the Company, nor any CRO, Company or its Subsidiaries has received any written notice, correspondence notices or other communication correspondence from any institution, institutional review board, the FDA, FDA or any other Governmental Entity Authority performing functions similar to those performed by the FDA or any institutional review board or ethics committee with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of . To the Product, and to Knowledge of the Company there Company, neither the FDA nor any other applicable Governmental Authority nor any clinical investigator that has participated or is no reason to believe that any institutionparticipating in, or institutional review boardboard or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the FDACompany or its Subsidiaries has commenced or threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) All reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any other Governmental Entity is considering such action Authority performing functions similar to those performed by the FDA or communicationdrug regulatory agency by the Company or its Subsidiaries have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). (d) As of the date of this Agreement, the Company has made available to Parent (i) complete and correct copies of each investigational new drug application and each similar state or foreign regulatory filing made on behalf of the Company or its Subsidiaries, including all supplements and amendments thereto, (ii) all material correspondence sent to and received from the FDA and similar state and foreign Governmental Authorities by the Company or its Subsidiaries and (iii) all existing written records relating to all material discussions and all meetings between the Company or its Subsidiaries and the FDA or similar foreign regulatory or Governmental Authorities. (e) Neither the Company, nor, to the Knowledge of the Company nor any of the CROs, its Subsidiaries has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity, Authority performing functions similar to those performed by the FDA or (bii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity or (c) committed any other act, made any statement or failed Authority performing functions similar to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for those performed by the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyFDA. Neither To the Company, nor, to Knowledge of the Company, none of the Company or any of its officers, CROs, agents or clinical investigators Subsidiaries is the subject of any pending or threatened investigation by the FDA pursuant or any Governmental Authority performing functions similar to those performed by the FDA to take enforcement action against the Company or any of its FraudSubsidiaries including the termination or suspension of any clearance, Untrue Statements of Material Factsauthorization, Bribery, and Illegal Gratuities Final Policy license or by any other Governmental Entity pursuant to any similar applicable Lawregistration. (ivf) The Company and its Subsidiaries is in compliance and has, during the past three years, been in compliance, in each case, in all material respects with all healthcare Laws applicable to the operation of its business as currently conducted, including: (i) any and all federal, state and local fraud and abuse Laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Clinical Laboratory Improvement Amendments of 1988; and (iii) requirements of Law relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by the Company and its Subsidiaries. None of the Company or any of its Subsidiaries is subject to any currently pending enforcement, regulatory or administrative proceedings against or affecting the Company or any of its Subsidiaries relating to or arising under the FDCA or similar Law, and to the Knowledge of the Company no such enforcement, regulatory or administrative proceeding has been threatened. (g) None of the Company or any of its Subsidiaries is enrolled as a supplier or provider under Medicare, Medicaid, or any other governmental health care program or third party payment program or a party to any participation agreement for payment by any such a health care program and third party payment program. (h) None of the Company or any of its Subsidiaries has been, and to the Knowledge of the Company, the Sellers or the CROs, nor any none of their respective officers, directors, employees, shareholders, consultants, agents, employees or other persons engaged to perform clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), services by the Company has notor any of its Subsidiaries have ever been while performing services for the Company or such Subsidiary, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by(under the provisions of the Generic Drug Enforcement Act of 1992, or is the subject of debarment proceedings by21 U.S.C. §335a (a) and (b)) (“Debarred”), any Governmental Entity or (ii) convicted pursuant of a crime for which a person can be Debarred or (iii) indicted for a crime or otherwise engaged in conduct for which a person can be Debarred or engaged in any conduct that would reasonably be expected to Section 306 result in Debarment under applicable Law. To the Knowledge of the FDCACompany, none of the matters listed in sub-parts (i), (ii), or (iii) herein has been threatened, against the Company, its Subsidiaries or any of its officers, employees or agents. (vi) The Company’s andSet forth on Section 3.24(i) of the Company Disclosure Schedule is a list of all new drug applications that, with respect as of the date of this Agreement, the Company intends to submit to the Product, FDA within 90 days following the CROs’, use and dissemination date of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsthis Agreement.

Regulatory Matters. (ia) The Acquired Corporations and, to the knowledge of the Company, its Affiliates and, the contract research organizations engaged Collaboration Partners (with respect to perform clinical trials on behalf of the Company (the “CROs”Products) have obtained all material clearances, authorizations, licenses, registrations and other Governmental Approvals Authorizations required by any foreign or domestic Governmental Entity, Body (including the FDA, FDA and EMA) to permit the conduct of the Business its business as currently conducted and all such Governmental Approvals Authorizations are valid valid, and in full force and effect. To the knowledge of the Company, and no such none of the Governmental Approval has Authorizations have been or is are being revoked or challenged, except where such revocation or challenge does not and would not, individually or in the aggregate, be likely to have a Material Adverse Effect. Neither the CompanyThe Acquired Corporations and, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge knowledge of the Company, the CROs, Collaboration Partners (with respect to the Company Products) have filed with the applicable Governmental Entities, regulatory authorities (including the FDA and EMA or any other Governmental Body performing functions similar to those performed by the FDA, ) all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944submissions, as amended, and their implementing regulations, as well as including adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the BusinessCompany Products. All such filings, representations, declarations, listings, registrations, reports and or submissions were in material compliance with applicable Laws Legal Requirements when filed, and no deficiencies which are material deficiencies in the aggregate have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical and clinical investigations conducted or sponsored by or on behalf To the knowledge of the Company, except as set forth in documents either delivered or otherwise made available to Parent or Parent’s Representatives prior to the date of this Agreement, the business of the Acquired Corporations and all manufacturing operationspreclinical and clinical investigations sponsored by the Acquired Corporations and, both to the Company’s knowledge, its Collaboration Partners (with respect to the ProductCompany Products), and all manufacturing operations with respect to the Company Products, are being, and have been since the Company’s formation, being conducted in material compliance with applicable LawsLegal Requirements, rules, regulations, directives and guidances, including, but not limited to the FDCA, good clinical practice Good Clinical Practice requirements, good laboratory practice Good Laboratory Practice requirements, GMPGood Manufacturing Practice requirements, ICH principles requirements, and Health Insurance Portability federal and Accountability Act of 1996state laws, Public Law 104-191 (“HIPAA”) rules, regulations and other legal requirements guidances restricting the use and disclosure of individually identifiable health informationinformation with respect to manufacturing, clinical research and development, and future potential marketing and sale of the Company Products. Neither The Acquired Corporations have not, and to the Company’s knowledge, nor none of its Collaboration Partners (with respect to the Company Products) has, received since December 31, 2008 any CRO, has received any material written notice, correspondence notices or other communication material correspondence from any institution, institutional review board, the FDA, EMA or any other foreign, federal, state or local Governmental Entity Body performing functions similar to those performed by the FDA with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or teststests that have not been disclosed or made available to Parent or its Representatives on or prior to the date of this Agreement. There are no pending or, or regarding material noncompliance of such studies or tests to the knowledge of the ProductCompany, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, threatened actions or proceedings by the FDA, EMA or any other Governmental Entity is considering such action Body which would prohibit or communicationimpede the potential future commercial sale of any Company Product. To the knowledge of the Company, there are no Company Contracts, including settlements with Governmental Bodies, which would reasonably be expected to impose obligations for independent review and oversight of marketing and sales practices or limit in any material respect the ability of any Acquired Corporation or Collaboration Partner (with respect to any Company Product) to develop, manufacture, market or sell any of the Company Products. (iiic) Neither None of the Acquired Corporations or, to the knowledge of the Company, nor, any Collaboration Partner (with respect to the Knowledge of the any Company any of the CROs, Product) has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA FDA, EMA or any Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA FDA, EMA or other Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy or for any other Governmental Body to invoke a similar remedy. Neither the Company, nor, to Knowledge None of the Company, any of its officers, CROs, agents or clinical investigators Acquired Corporations is the subject of any pending or or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity Body pursuant to any similar applicable LawLegal Requirement. (ivd) Except as would not reasonably be expected to have a Material Adverse Effect, each of the Acquired Corporations, and to the Company’s knowledge, each of its Collaboration Partners (with respect to the Company Products) is in compliance and has, for the past three years, been in compliance with all healthcare Legal Requirements applicable to the operation of its business as currently conducted, including, (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes and any foreign equivalents; (ii) the Clinical Laboratory Improvement Amendments of 1988 and any foreign equivalents; and (iii) Legal Requirements relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by the Company. None of the Acquired Corporations is, and to the Company’s knowledge, none of the Collaboration Partners (with respect to the Company Products) is currently subject to any enforcement, regulatory or administrative proceedings against or affecting any Company Product relating to or arising under the FDCA, PHSA or similar Legal Requirements, and, to the Company’s knowledge, no such enforcement, regulatory or administrative proceeding has been threatened. (e) All Pharmaceutical Products, and to the knowledge of the Company, the Sellers or the CROsCollaboration Pharmaceutical Products are being developed, nor any of their respective officerslabeled, directorsstored, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research tested and any other development of the Product (including distributed in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in material compliance with all applicable Lawsrequirements under all applicable Legal Requirements, contracts including the FDCA, the PHSA, their implementing regulations, and all federal, state, local and foreign regulatory requirements of any Governmental Body, including those relating to which investigational use, premarket clearance and applications or abbreviated applications to market a new Product. (f) No Company Product has been recalled, suspended, discontinued or the subject of a refusal to file, clinical hold, deficiency or similar action letter (including any correspondence questioning data integrity) as a result of any action by the FDA or any other similar foreign Governmental Body by the Company or CRO is boundany of its Subsidiaries or, privacy policies and terms to the knowledge of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativeCompany, technical and physical safeguards that are commercially reasonable andany Collaboration Partner, in the United States or outside of the United States. (g) To the knowledge of the Company, there are no facts, circumstances or conditions that would reasonably be expected to form the basis for any eventinvestigation, in compliance audit, suit, claim, action or proceeding with all applicable Laws and contracts. There have been no security breaches relating torespect to any action to withdraw or delay approval of, place restrictions on the production, dosing, clinical use or testing, or violations of any security policy regardingsales or marketing of, or any unauthorized access request the recall, suspension or discontinuation of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The Company, its Affiliates directors, officers and employees, and, to the contract research organizations engaged to perform clinical trials on behalf Company’s knowledge, its agents, affiliates and representatives, are, and at all times: (i) have operated and currently operate its business in compliance in all material respects with applicable provisions of the Company Health Care Laws (as defined below) of the FDA and any comparable foreign or other regulatory authority to which they are subject (collectively, the “CROsApplicable Regulatory Authorities”) have obtained all Governmental Approvals applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any Governmental Entity, including such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted as described in the FDA, to permit General Disclosure Package and the conduct of the Business Prospectus and all such Governmental Approvals Regulatory Authorizations are valid and in full force and effecteffect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities alleging that any product operation or activity is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities is considering any such Governmental Approval claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has been not received notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is being revoked considering such action; (vi) has filed, obtained, maintained or challenged. Neither the Companysubmitted all material reports, nor documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that, to the Knowledge knowledge of the Company, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); (vii) is not a party to or have any CROongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and (viii) has received not been excluded, suspended or debarred from participation in any communication from any Governmental Entity regardinggovernment health care program or human clinical research or, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge knowledge of the Company, there are no facts is subject to a governmental inquiry, investigation, proceeding, or circumstances other similar action that are could reasonably likely be expected to adversely affect any such Governmental Approvalsresult in debarment, suspension, or exclusion. The Companyterm “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA, 42 U.S.C. §§ 1320d et seq.; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the Federal Food, Drug, and to the Knowledge of the CompanyCosmetic Act, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and 21 U.S.C. §§ 301 et seq.; the Public Health Service Act of 1944Act, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to 42 U.S.C. §§ 201 et seq.; the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA regulations promulgated pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, such laws; and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Lawfederal, state and local laws and regulations. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The CompanyCompany has filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA) all required material filings, its Affiliates anddeclarations, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all listings, notices, requests for Governmental Approvals required by any Governmental EntityAuthorizations, registrations, reports or submissions, including the FDAbut not limited to adverse event reports. All such filings, to permit the conduct of the Business and all such declarations, listings, notices, requests for Governmental Approvals are valid and Authorizations, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, remain in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representationsdeclarations, declarationsnotices, requests for Governmental Authorizations, listing, registrations, reports or submissions. (iib) All To the knowledge of the Company, except as set forth in documents either delivered or made available to Parent or Parent’s Representatives prior to the date of this Agreement, all nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and Company have been since the Company’s formation, and are being conducted in material compliance with applicable LawsLegal Requirements, includingrules, but not limited to the FDCAregulations and guidances, good clinical practice requirementsincluding Good Laboratory Practices, good laboratory practice requirementsGood Clinical Practices, GMPand federal and state laws, ICH principles rules, regulations and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements guidances restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, The Company has not received any written notice, correspondence notice or other communication correspondence from any institution, institutional review board, the FDA, FDA or any other Governmental Entity Body performing functions similar to those performed by the FDA with respect to any completed, ongoing or planned clinical trial or nonclinical studies study or tests sponsored test requiring or conducted by or on behalf of the Company requiring recommending the termination, suspension or material modification of such studies or tests, or regarding material otherwise alleging noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that with any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationapplicable Legal Requirements with respect thereto. (iiic) Neither To the Company’s knowledge, nor, to the Knowledge of the Company any of the CROs, has not (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA or other any Governmental Entity Body, or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge As of the Companydate of this Agreement, any of its officers, CROs, agents or clinical investigators the Company is not the subject of any pending or threatened or, to the Company’s knowledge, threatened, investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant Policy. Neither the Company nor, to any similar applicable Law. (iv) None the knowledge of the Company, the Sellers or the CROs, nor any of their respective its officers, directors, employees, shareholders, consultants, agents, agents or clinical investigators or Affiliates has been suspended or debarred or convictedconvicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (d) Except as would not reasonably be expected to have a Material Adverse Effect, the Company is in compliance and has, since January 1, 2015, been in compliance, in each case, in all material respects with all healthcare laws applicable to the operation of its business as currently conducted, including (i) the FDCA and the regulations promulgated thereunder; (ii) the PHSA and the regulations promulgated thereunder; (iii) the Clinical Laboratory Improvement Amendments of 1988; (iv) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant thereto, and (v) Legal Requirements, the violation of which are cause for exclusion from any federal health care program. The Company has not received any written notice from FDA or any other Governmental Body alleging noncompliance with any such provision of Legal Requirements in any material respect. The Company is not subject to any enforcement, regulatory or administrative proceedings relating to or arising under the FDCA, the PHSA, or is subject similar Legal Requirements, and no such enforcement, regulatory or administrative proceeding has been threatened. (e) Prior to debarment or convictionthe date of this Agreement, pursuant the Company has delivered to Section 306 of Parent all material data and other material information known to the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials Company with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined products under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used development by the Company orCompany, with respect to including the Product, the CROssafety or efficacy thereof.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Company is a “holding company,” as such term is defined in PUHCA. Certain subsidiaries of the Company qualify as an “electric utility company” within the meaning of PUHCA, as a “public utility” under the FPA subject to regulation by FERC, as a “public utility” or “utility” subject to the Public Utility Regulatory Act of Texas, or as a “public utility” or “utility” subject to the Public Utility Act of New Mexico (hereinafter the “CROsRegulated Operating Subsidiaries”). (b) All filings required to be made by the Company or any of the Regulated Operating Subsidiaries since January 1, 2018, with FERC under the FPA or the PUHCA, the Department of Energy and any applicable state utility commissions, as the case may be, have obtained all Governmental Approvals required by any Governmental Entitybeen made, as applicable, including the FDAall forms, to permit the conduct of the Business statements, reports, agreements and all documents, exhibits, amendments and supplements pertaining thereto, including all rates, tariffs and related documents, and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrationsfilings complied, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s anddates, with respect all applicable requirements of applicable statutes and the rules and regulations thereunder, except for filings the failure of which to make or the Product, the CROs’, use and dissemination failure of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is which to make in compliance with all applicable Lawsrequirements of applicable statutes and the rules and regulations thereunder do not have and would not reasonably be expected to have, contracts individually or in the aggregate, a Material Adverse Effect on the Company. (c) Each of the Regulated Operating Subsidiaries is legally entitled to provide services in all areas (i) where it currently provides service to its customers, and (ii) as identified in their respective tariffs, service agreements and other Contracts with its customers, except for failures to be so entitled that, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect on the Company. (d) Section 3.19(d) of the Company Disclosure Schedule sets forth, as of the date of this Agreement, (i) all rate filings pending as of the date of this Agreement related to the Company or any of the Regulated Operating Subsidiaries before the FERC and any state energy regulatory body and each other material proceeding pending as of the date of this Agreement before the FERC or any state energy regulatory body relating to the Company or any of the Regulated Operating Subsidiaries (other than those rate filings or other material proceedings of a general or industry-wide nature that also affect other entities engaged in a business similar to that of the Company or any of the Regulated Operating Subsidiaries) and (ii) all tariffs (other than tariffs applicable to utilities generally in any jurisdiction in which the Company or CRO is bound, privacy policies and terms any of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance Regulated Operating Subsidiaries operates) filed with all applicable Laws and contracts. There have been no security breaches relating respect to, or violations of any security policy regardingapplicable to, or any unauthorized access of, any data or information used the services provided by the Company oror any of the Regulated Operating Subsidiaries, and all agreements to provide service on non-tariff terms (and complete and correct copies of all such tariffs and agreements have been provided to Parent). All charges that have been made for service and all related fees have been charged in accordance with respect the terms and conditions of valid and effective tariffs or valid and enforceable agreements for non-tariff charges and are not subject to refund, except for failures to have made such charges or charged such fees that, individually or in the Productaggregate, the CROshave not had and would not reasonably be expected to have a Material Adverse Effect.

Regulatory Matters. (i) The Each of the Company and its Subsidiaries has all Licenses necessary to conduct its business as presently conducted, including all such Licenses of the United States Food and Drug Administration (“FDA”) or any other applicable U.S. or foreign drug regulatory authority (collectively with the FDA, “Regulatory Authorities”) necessary to conduct its business as presently conducted (collectively, the “Regulatory Licenses”), except those Licenses the absence of which, individually or in the aggregate with other such absences, are not reasonably likely to have a Company Material Adverse Effect and are not reasonably likely to prevent, materially delay or materially impair the consummation of the transactions contemplated hereby. There has not occurred any revocation or termination of any Regulatory License, or any impairment of the rights of the Company or its Subsidiaries under any Regulatory License, except for any such revocation, termination or impairment that, individually or in the aggregate with other such revocations, terminations and impairments, are not reasonably likely to have a Company Material Adverse Effect. Each of the Company and its Subsidiaries has operated in compliance with applicable Laws administered or enforced by Regulatory Authorities, except where the failure so to comply, individually or in the aggregate with other such failures, are not reasonably likely to have a Company Material Adverse Effect. (ii) With respect to the Key Product, IDX-21459 and Samatasvir, all preclinical studies and clinical trials (and the drug products, including placebos, used in such clinical trials), and other studies and tests conducted by or, to the Knowledge of the Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company or its Subsidiaries have been, and if still pending are being, conducted in compliance with all applicable Laws (including those pertaining to clinical trial registrations, and adverse event reporting, Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312, all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, and 56, and Good Manufacturing Practice contained in 21 C.F.R. 210 and 211 and applicable guidance published by the “CROs”) FDA from time to time), except for noncompliances that, individually or in the aggregate, are not reasonably likely to have obtained all Governmental Approvals required a Company Material Adverse Effect. With respect to the Key Product, IDX-21459 and Samatasvir, no clinical trial conducted by any Governmental Entity, including the FDAor, to permit the conduct Knowledge of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, on behalf of the Company or its Subsidiaries, has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Regulatory Authority has commenced, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on any ongoing clinical investigation conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries. (iii) Neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any CRO, has received of their employees or clinical investigators engaged by the Company or its Subsidiaries have been convicted of any communication from crime or engaged in any Governmental Entity regarding, conduct that in any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approvalcase has resulted, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are is reasonably likely to adversely affect any such Governmental Approvals. The Companyresult, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required in debarment under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions21 U.S.C. Section 335a. (iiiv) All nonclinical The Company has made available to Parent complete and clinical investigations conducted correct copies of each Investigational New Drug Application and each similar state or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or foreign regulatory filing made on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Lawits Subsidiaries, including without limitationall related supplements, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, amendments and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Lawannual reports. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. Except as described in the Private Placement Memorandum, the Company and each of its subsidiaries: (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained is and at all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval times has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with all statutes, rules or regulations applicable Laws when filedto the ownership, and no material deficiencies have been asserted in writing testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by any applicable Governmental Entity with respect to any the Company or such filings, representations, declarations, listing, registrations, reports or submissions. subsidiary (“Applicable Laws”); (ii) All nonclinical has not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the SFDA or any other Regulatory Agency alleging or asserting noncompliance with any Applicable Laws or any Governmental Licenses; (iii) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Regulatory Agency or third party alleging that any product operation or activity is in violation of any Applicable Laws or Government Licenses and clinical investigations conducted has no knowledge that any such Regulatory Agency or sponsored third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (iv) has not received notice that any Regulatory Agency has taken, is taking or intends to take action to materially limit, suspend, materially modify or revoke any Government Licenses and has no knowledge that any such Regulatory Agency is considering such action; and (v) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Government Licenses and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on behalf of the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The statements in the Private Placement Memorandum, or incorporated by reference into the Private Placement Memorandum from the Company’s Form 10-K for the period ended December 31, 2007, under the captions “Risk Factors—There could be changes in government regulations toward the pharmaceutical and nutraceutical industries that may adversely affect our business,” “Risk Factors—Our business may be affected by unexpected changes in regulatory requirements in the jurisdictions in which we operate,” “Risk Factors—Our international operations require us to comply with a number of U.S. and international regulations,” “Risk Factors—We may be unable to secure the government licenses that are necessary for us to engage in the sale of analgesic pharmaceuticals,” “Risk Factors—Some of our TCM products and technologies potentially could be restricted from foreign ownership” and “Business—Regulation of Our Industry” (collectively, the “Regulatory Sections”) fairly present in all material respects any Applicable Laws, and all manufacturing operations, both with respect pending or to the Product, are being, and have been since the Company’s formation, conducted in knowledge threatened legal or governmental proceedings relating to such Applicable Laws that are material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf ’s business in light of the Company requiring applicable disclosure requirements under the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication1934 Act. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The CompanySeres has made available to NHSc all material Regulatory Documentation owned or possessed by Seres regarding or related to the Collaboration Products, including, any minutes of meetings (including by teleconference) with Regulatory Authorities and any material correspondence with Regulatory Authorities, any notice of inspection, inspection report, warning letter, deficiency letter or similar communication. Seres has prepared, maintained or retained all material Regulatory Documentation relating to Collaboration Products that is required to be maintained or reported pursuant to Regulatory Authorities and such items have been prepared in accordance with the applicable requirements of GLP and GCP, as applicable, to the extent required, and applicable Law, and to Seres’ Knowledge, such Regulatory Documentation does not contain any materially false or misleading statements. (b) Neither Seres nor any of its Affiliates has received, with respect to the Collaboration Products, any oral or written communication (including any warning letter, untitled letter, or similar notices) from any Governmental Authority and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDAthere is no action pending or, to permit Seres’ Knowledge, threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that with respect to the conduct Collaboration Products in the Field, Seres or any of the Business its Affiliates is not currently materially in compliance with any and all applicable Laws implemented by such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challengedAuthority. Neither the Company, Seres nor to the Knowledge any of the Company, any CRO, its Affiliates has received any communication written notice from any Governmental Entity regardingAuthority claiming that the research, any such Governmental Approvalsdevelopment, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approvalmanufacture, use, offer for sale, sale, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge import of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to Collaboration Products in the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were Field is not in material compliance with all applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions.permits; and (iic) All nonclinical and clinical investigations conducted To Seres’ Knowledge, none of Seres, any of its Affiliates, or sponsored by any of their respective officers, employees or on behalf of the Companyagents has made, and all manufacturing operations, both with respect to the ProductCollaboration Products, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) Authority or failed to disclose a material fact required to be disclosed to the FDA or other such Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable LawAuthority. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The CompanySeller or the Acquired Subsidiaries have all licenses, its Affiliates andpermits, certificates, franchises, consents, waivers, registrations or other regulatory authorizations from the contract research organizations engaged appropriate Governmental Authority in each applicable jurisdiction required to perform clinical trials on behalf provide the telecommunications network services and operate the Network Facilities or otherwise provide telecommunication services as presently conducted by the Business (the "Communications Licenses"). All of the Company (the “CROs”Communications Licenses are set forth in Section 3.10(a) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are Disclosure Schedule. (b) Each of the Communications Licenses was duly issued, is valid and in full force and effect, and no such Governmental Approval has not been or is being suspended, canceled, revoked or challenged. Neither the Companymodified in any adverse manner, nor and is validly held, free and clear of all Encumbrances and, in each case, to the Knowledge of the CompanySeller and upon the grant of the Telecom Approvals, shall remain so immediately following the consummation of the transactions contemplated by this Agreement and the Ancillary Agreements. Except as set forth on Section 3.10(b) of the Disclosure Schedule, to the Knowledge of the Seller, there is no circumstance, Law, event or other reason that exists or is likely to exist that would prevent the granting of the Telecom Approvals or the transfer of the Communications Licenses. (c) Except as set forth in Section 3.10(c) of the Disclosure Schedule, each holder of a Communications License (i) has operated in all material respects in compliance with all terms thereof including all systems build-out requirements, and (ii) is in all material respects in compliance with, and the conduct of its business has been and is in all material respects in compliance with, the applicable Law, and has filed all registrations, statements, documents and reports and paid all fees required by all applicable Law, in each case, relating to the Communications Licenses and any other applicable Law. There is no pending or, to the Knowledge of the Seller, threatened action by or before any Governmental Authority to revoke, cancel, suspend, modify or refuse to renew any of the Communications Licenses, there is not now issued, outstanding or, to the Knowledge of the Seller, threatened, any CRO, has received any communication from notice by any Governmental Entity regardingAuthority of any violation or complaint, or any application, complaint, or proceeding (other than applications, proceedings, or complaints that generally affect the Seller's industry as a whole) relating to the business or operations of the Seller or any Acquired Subsidiary. To the Knowledge of the Seller, no Person has asserted in writing to a Governmental Authority that a material Communications License should be modified or revoked, or that the Seller or any Acquired Subsidiary is not in material compliance with any Communications License. (d) To the Knowledge of the Seller, no event has occurred which would permit the revocation or termination of any of the Communications Licenses or the imposition of any restriction thereon, or that would prevent any of the Communications Licenses from being renewed on a routine basis or in the ordinary course. (e) To the Knowledge of the Seller, Section 3.10(e) of the Disclosure Schedule sets forth a complete list of all Telecom Approvals required by Seller in connection with the consummation of the transactions contemplated by this Agreement and the Ancillary Agreements. Assuming the receipt of the Telecom Approvals, to the Knowledge of the Seller, none of the execution, delivery or performance of this Agreement or any of the other Ancillary Agreements by the Seller, nor the consummation by Seller of the transactions contemplated hereby or thereby, will result in any revocation, cancellation, suspension or modification of any Communications Licenses or give rise to the right of any Governmental Authority to take any such action or to fail to renew any Communications License. (f) No Acquired Subsidiary has (i) a security clearance issued by any Governmental ApprovalsAuthority or (ii) a request for a new or upgraded security clearance in process with any Governmental Authority. (g) In addition to the Communications Licenses, the Seller and each Acquired Subsidiary holds and is in compliance with all other material licenses, franchise permits, consents, registrations, certificates, and other governmental or regulatory permits, authorizations or approvals required for the operation of the business as presently conducted and for the ownership, lease or operation of the Seller's and the Acquired Subsidiaries' properties (collectively, "Other Licenses"). All of such Other Licenses are valid and in full force and effect and, to the Knowledge of the Seller, upon grant of any Regulatory Approvals applicable to the Other Licenses, shall remain so immediately following the consummation of the transactions contemplated by this Agreement and the other Ancillary Agreements, and the Seller and the Acquired Subsidiaries have duly performed and are in compliance in all material respects with all of their respective obligations under such Other Licenses. Except as set forth on Section 3.10(g) of the Disclosure Schedule, to the Knowledge of the Seller, there is no circumstance, Law, event or other reason that exists or is likely to exist that would prevent the granting of the Regulatory Approvals or the transfer of the Other Licenses. To the Knowledge of the Seller, no Person has alleged any violation or failure to materially comply by the Seller or any Acquired Subsidiary, with any Other License, no suspension, cancellation or termination of any such Other License is threatened, and no event has occurred or circumstances exist that may (with or without notice or lapse of time) constitute or result directly or indirectly in a violation of or failure to comply with applicable Laws or any term or requirement of any such Governmental ApprovalOther License, or any result directly or indirectly in the revocation, withdrawal, suspension, cancellation, material limitation, cancellation or termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDAof, or any other Governmental Entity with respect to any completedmodification to, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable LawOther License. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The CompanyCompany is in compliance with all statutes, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf rules or regulations of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct DEA, the EMA, the MHRA and other comparable governmental agencies engaged in the regulation of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor pharmaceutical drugs applicable to the Knowledge of the Companyownership, any CROtesting, has received any communication from any Governmental Entity regardingdevelopment, any such Governmental Approvalsmanufacture, any failure to materially comply with applicable Laws packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or any term or requirement disposal of any such Governmental Approvalproduct under development, manufactured or any revocationdistributed by the Company except where noncompliance would not, withdrawalsingularly or in the aggregate, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvalshave a Material Adverse Effect. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical studies and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Prospectus; and the Company has not received any written notices or correspondence from the FDA, the DEA, the EMA, the MHRA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of such studies any Company Studies and Trials that termination, suspension or tests, or regarding material noncompliance of such studies or tests of the Product, and modification would reasonably be expected to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, norhave a Material Adverse Effect and, to the Knowledge of Company’s knowledge, there are no reasonable grounds for the same. In using or disclosing patient information received by the Company any of in connection with the CROsCompany Studies and Trials, the Company has (a) made an untrue statement of a complied in all material fact respects with all federal, state, local or fraudulent statement to the FDA foreign applicable laws and regulatory rules or any Governmental Entityrequirements, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other actincluding, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements Health Insurance Portability and Accountability Act of Material Facts, Bribery, 1996 and Illegal Gratuities Final Policythe rules and regulations thereunder (“HIPAA”). Neither the Company, nornor its subsidiaries or any of their respective directors, officers, employees or, to Knowledge the Company’s knowledge, agents is or since January 1, 2015 has been debarred, suspended or excluded or, to the knowledge of the Company, engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion from any federal or state government health care program or human clinical research. To the Company’s knowledge, none of its officersthe Company Studies and Trials involved any investigator, CROsas such term is defined in Title 21, agents Section 50.3 of the U.S. Code of Federal Regulations, who has been disqualified as a clinical investigator or clinical investigators is the subject of any pending or threatened investigation has been found by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of have engaged in scientific misconduct. To the Company’s knowledge, the Sellers or the CROs, nor any manufacturing facilities and operations of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is its suppliers are operated in compliance in all material respects with all applicable Lawsstatutes, contracts rules and regulations of the FDA, the DEA, the EMA, the MHRA or comparable regulatory agencies outside of the United States to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROssubject.

Regulatory Matters. (ia) The Company, its Affiliates and, Key Holders and the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) Group Companies have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Approvals from applicable Governmental Approvals are valid Authorities and in full force have fulfilled any and effect, all filings and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply registration requirements with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both Authorities necessary with respect to the Product, are beingFounders and their investment in the Group Companies, and with respect to the Group Companies and their operations. The Schools have obtained any and all Approvals from applicable Governmental Authorities and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to their establishment and operations. All filings and registrations with applicable Governmental Authorities required with respect to the Group Companies, the Founders and the Schools have been since the Company’s formation, conducted duly completed in material compliance accordance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health informationLaw. Neither the Company, any Founder nor any CRO, Group Company has received any written notice, correspondence letter or other communication notice from any institution, institutional review board, applicable Governmental Authorities notifying it of the FDA, revocation of any Approval issued to it or any other Governmental Entity Schools or the need for compliance or remedial actions with respect to the activities carried out directly or indirectly by any completedFounder or any Group Company or any School. Each Group Company and each School has been conducting its business activities within the permitted scope of business or is otherwise operating its Businesses in full compliance with all relevant Laws and Governmental Orders, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted including providing products and/or services with all requisite licenses, permits and approvals granted by or on behalf of the competent Governmental Authorities. Neither any Founder nor any Group Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no has reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge authorization of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityAuthority, (b) failed to disclose a material fact license or permit required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical researchpart of its Business and/or for the operation of any School which is subject to periodic renewal will not be granted or renewed by the relevant Governmental Authorities. (b) Each holder of any Equity Securities of the Company (each, safety a “Company Security Holder”), who is a Domestic Resident and toxicology studies subject to any of the registration or clinical trials reporting requirements of Circular 75 or any other applicable SAFE rules and regulations (collectively, the “SAFE Rules and Regulations”), has complied with such reporting and/or registration requirements under the SAFE Rules and Regulations. Neither the Warrantors nor any of the Company Security Holders has received any oral or written inquiries, notifications, orders or any other forms of official correspondence from SAFE or any of its local branches with respect to any actual or alleged non-compliance with the Product), SAFE Rules and Regulations and the Company and the Company Security Holders have made all oral or written filings, registrations, reporting or any other communications required by SAFE or any of its local branches. Each Group Company has notobtained all certificates, directly or indirectlyapprovals, used permits, licenses, registration receipts and any employee, agent, or independent contractor who has been (i) debarred by, or is similar authority necessary under the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant PRC Law to Section 306 of the FDCAconduct foreign exchange transactions as now being conducted by it. (vc) The Company’s and, Beijing Company has obtained any and all Approvals from applicable Governmental Authorities and has fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to its franchising agreements entered into with any and all franchisees for Firstleap Education and the Productrelevant businesses conducted thereunder. The Beijing Company has not violated any of such franchising agreements in any material aspect and, to the CROs’best knowledge of the Warrantors, use each of the training centres of Beijing Company is duly established under PRC Law and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is has been operating in full compliance with all applicable LawsPRC Law. To the best knowledge of the Warrantors, contracts to which each of the franchised schools and training centres of Beijing Company or CRO (the “Franchised Schools”) is bound, privacy policies duly established and terms operated in accordance with the Law of use. The Company the People’s Republic of China on the Promotion of Privately-run Schools (《中华人民共和国民办教育促进法》) and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsrelevant regulations.

Regulatory Matters. (a) The Company and its Subsidiaries have established and administer one or more compliance programs (including a written compliance policy) applicable to the Company and its Subsidiaries (i) The to assist the Company and its Subsidiaries and the directors, officers and employees of the Company and its Subsidiaries in complying with applicable Legal Requirements (including those administered by the FDA or comparable Governmental Authority) applicable to the Company, its Affiliates andSubsidiaries or their respective businesses and (ii) to provide compliance policies and training to appropriate persons governing applicable areas for medical device companies (including pre-clinical and clinical testing, product design and development, product testing, product manufacturing, product labeling, product storage, pre-market clearance and approval, advertising and promotion, product sales and distribution, medical device recall and reporting regulations and record keeping). (b) Except as disclosed in the Company SEC Reports, the contract research organizations engaged Company and its Subsidiaries are in compliance in all material respects with the provisions of all Legal Requirements of applicable Governmental Authorities relating to perform clinical trials on behalf the regulation of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental EntityCompany’s and its Subsidiaries’ products, including the FDAFDC Act, to permit the conduct of the Business PHS Act, and all such rules and regulations promulgated thereunder, except for instances of noncompliance that have not had and reasonably would not be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as disclosed in the Company SEC Reports, with respect to the marketing of products by the Company or any of its Subsidiaries, all applications, submissions, information, claims and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for authorizations, approvals, certificates, waivers, certifications, clearances, exemptions, notifications, consents, orders, registrations, listings, licenses or permits of any applicable Governmental Approvals are valid Authority, including the FDA and in full force and effectthe USDA, and no such Governmental Approval has been or is being revoked or challenged. Neither relating to the Company, nor its Subsidiaries, their respective businesses and products, when submitted to the applicable 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 applications, submissions, information and data have been submitted to the applicable Governmental Authority. All product claims made by the Company or its Subsidiaries with respect to the Company’s or its Subsidiaries’ products are valid, supported by proper research, design, testing, analysis and disclosure, and are permitted by applicable Legal Requirements administered by the FDA, USDA or comparable non-U.S. Governmental Authority, except for such failures as have not had and reasonably would not be expected to have, individually or in the aggregate, a Material Adverse Effect. (c) The Company’s and its Subsidiaries’ activities and relevant facilities, as well as, to the Knowledge of the Company, its suppliers, distributors and other intermediaries, are in compliance with all applicable Legal Requirements of any CRO, has received any communication from any U.S. Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws Authority that govern the marketing of products by the Company or any term or requirement of its Subsidiaries, including the FDC Act and the PHS Act and all implementing regulations thereunder, including the registration, listing, labeling, reporting and manufacturing requirements of 21 C.F.R. Parts 803, 806, 807, 809, 812, 814 and 820, all to the extent applicable to in vitro diagnostic devices and accessories, and comparable Legal Requirements of any such applicable non-U.S. Governmental ApprovalAuthority of Brazil, Japan, Canada, the United Kingdom, Germany, France or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Companycomparable European Union directives, and to the Knowledge of the Company, any other non-U.S. jurisdictions, except for noncompliance that has not had and reasonably would not be expected to have, individually or in the CROsaggregate, have filed a material adverse effect on the Company or applicable Subsidiary of the Company. Except as disclosed in the Company SEC Reports, neither the Company nor any of its Subsidiaries is subject to any obligation arising under any consent decree, consent agreement, or warning letter issued by or entered into with the applicable FDA or other notice, response or commitment made to the FDA or any comparable Governmental EntitiesAuthority. The Company has disclosed to the Purchaser any warning letters, including the FDAuntitled (or “notice of violation”) letters, all filingsor similar notices, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data correspondence relating to the Product required to be filed Company’s or submitted to permit any of its Subsidiaries’ compliance status under applicable Legal Requirements of any Governmental Authority that govern the conduct marketing of products by the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by Company or any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsof its Subsidiaries within the last two (2) years. (iid) All nonclinical and clinical investigations conducted products being manufactured, distributed, or sponsored developed by the Company or on behalf any of its Subsidiaries that are subject to the jurisdiction of the CompanyFDA or any comparable non-U.S. Governmental Authority are being manufactured, labeled, stored, tested, distributed, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted marketed in material compliance with all applicable Laws, including, but not limited to Legal Requirements of any Governmental Authority that govern the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act marketing of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting products by the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, Company or any other Governmental Entity with respect of its Subsidiaries, except for instances of noncompliance that have not had and reasonably would not be expected to any completedhave, ongoing individually or planned in the aggregate, a Material Adverse Effect. (e) There are no clinical trials or nonclinical studies or tests sponsored or being conducted by or on behalf of the Company requiring or any of its Subsidiaries. Except as disclosed in the terminationCompany SEC Reports, suspension all pre-clinical trials and clinical trials conducted by or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge on behalf of the Company there is no reason or any of its Subsidiaries have been, and are being conducted in material compliance with the applicable Legal Requirements relating to believe that any institutionprotection of human subjects contained in 21 C.F.R. Parts 50, institutional review board54 and 56 and, where applicable, the FDADeclaration of Helsinki, except for instances of noncompliance that have not had and reasonably would not be expected to have, individually or any other Governmental Entity is considering such action or communicationin the aggregate, a Material Adverse Effect. (iiif) Neither Except as disclosed in the Company, norCompany SEC Reports, to the Knowledge of the Company, neither the Company nor any of the CROsits Subsidiaries, nor their respective officers, employees or agents has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement statement, or failed to make any statement, that (in any such case) establishes would be reasonably expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to withdraw product approval or clearance or to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” set forth in 56 Fed. Neither Reg. 46191 (September 10, 1991) and any amendments thereto, or provide a basis for a U.S. Governmental Authority to bring an action against the CompanyCompany or any of its Subsidiaries for a violation of 18 U.S.C. Section 1001 or any other comparable Legal Requirement of any applicable Governmental Authority for making false statements to the FDA.. (g) Except as disclosed in the Company SEC Reports, norneither the Company nor any Subsidiary of the Company has been convicted of any crime or engaged in any conduct that could result in a debarment under 21 U.S.C. Section 335a, 48 C.F.R. Subpart 9.4, or under any similar Legal Requirement, or under any exclusion from participation in general health care programs of the United States pursuant to 42 U.S.C. Section 1320a-7. (h) Except as disclosed in the Company SEC Reports filed prior to the date hereof, there are no proceedings pending with respect to a violation by the Company or any of its Subsidiaries of the FDC Act or the PHS Act or their implementing regulations, the Controlled Substance Act or any other similar legislation or regulation promulgated by any other Governmental Authority that reasonably would be expected to result in criminal liability. (i) With respect to the year ended December 31, 2005, sales by the Company and its Subsidiaries with respect to Contracts with the U.S. Government did not exceed $3 million. To the Knowledge of the Company, any the Company and its Subsidiaries are in material compliance with the terms and conditions of its officers, CROs, agents or clinical investigators is such Contracts with the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, U.S. Government and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials Legal Requirements with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAsuch Contracts. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (a) Each of the Corporation and the Purchaser agrees to use (and the Corporation agrees to cause each of the Banks to use) diligent efforts in good faith, at its own expense, to obtain any Required Approvals necessary for the Closing on terms consistent with the terms set forth in this (i) The Companypromptly submit, to each applicable Governmental Authority, completed notices, requests and applications required from such party, as applicable, for each Required Approval, and (ii) promptly provide to the other party copies of the public portions of all such notices, requests and applications as they are filed with each Governmental Authority. Each party agrees to use (and the Corporation agrees to cause each of the Banks to use) diligent efforts in good faith, at its Affiliates andown expense, to assist and support the other party’s efforts to obtain each Required Approval. In connection with the foregoing, the contract research organizations engaged Purchaser agrees to perform clinical trials on behalf (i) if required by the Federal Reserve, submit to standard passivity and anti-association commitments as of the Company date of this Agreement, and (the “CROs”ii) have obtained all Governmental Approvals if required by the FDIC, submit to the provisions applicable to investors provided for in the FDIC’s Final Statement of Policy on Qualifications for Failed Bank Acquisitions, as interpreted and applied as of the date of this Agreement. Notwithstanding anything herein to the contrary, the Purchaser shall not be required to (x) agree to or suffer to exist any condition, limitation, restriction or requirement that would be, individually or in the aggregate, reasonably likely to result in a Burdensome Condition or (y) take any action that would result in the Purchaser or any of its affiliates or associates being deemed in control of the Corporation or the Banks for purposes of the BHC Act or any applicable state banking law or the cross-guaranty liability provisions of the Federal Deposit Insurance Act or otherwise being regulated as a bank holding company within the meaning of the BHC Act. Notwithstanding anything herein to the contrary, the Purchaser shall not be required to furnish the Corporation with any (1) sensitive personal biographical or personal financial information of any of the directors, officers, employees, managers or partners of the Purchaser or any of its affiliates or (2) proprietary and non-public information related to the organizational terms of, or investors in, the Purchaser or its affiliates. To the extent consistent with applicable law, the Corporation shall promptly furnish to the Purchaser copies of all written communications received by the Corporation or the Banks from, or delivered by the Corporation or the Banks to, any Governmental EntityAuthority in connection with the transactions contemplated by this Agreement. (b) In the event that the Purchaser in its sole discretion determines to acquire or to establish its authority to acquire shares of any class of securities other than pursuant to this Agreement whose acquisition is or may be subject to one or more regulatory approvals (including without limitation non-objections), including the FDAPurchaser may, but is not obligated, to permit seek any such approvals, in which event the conduct of Corporation agrees that it will (and will cause the Business Banks to) use diligent efforts in good faith, at its own expense, to assist and all such Governmental Approvals are valid and in full force and effectsupport the Purchaser’s efforts to obtain, and no such Governmental Approval has been or is being revoked or challenged. Neither neither Corporation nor the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regardingBanks shall oppose, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsapprovals. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The CompanyExcept as otherwise disclosed in the General Disclosure Package or the Prospectus, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of neither the Company nor any of its subsidiaries is subject or is party to, or has received any notice or advice that any of them may become subject or party to any investigation with respect to, any corrective, suspension or cease-and-desist order, agreement, consent agreement, memorandum of understanding or other regulatory enforcement action, proceeding or order with or by, or is a party to any commitment letter or similar undertaking to, or is subject to any directive by, or has adopted any board resolutions at the request of, any agency, court or other governmental body, domestic or foreign (each, a “Governmental Entity”), that currently relates to or restricts in any material respect the conduct of their business or that in any manner relates to their capital adequacy, credit policies or management (each, a “CROsRegulatory Agreement”) have obtained all Governmental Approvals required ), nor has the Company or any of its subsidiaries been advised by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been Entity that it is considering issuing or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, requesting any such Governmental ApprovalsRegulatory Agreement. There is no unresolved violation, any failure to materially comply with applicable Laws criticism or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing exception by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports report or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf statement relating to any examinations of the CompanyCompany or any of its subsidiaries which might reasonably be expected to result in a Material Adverse Effect. The deposit accounts of WashingtonFirst Bank, a Virginia state-chartered bank (the “Bank”) are insured by the Federal Deposit Insurance Corporation (the “FDIC”) to the legal maximum, and the Bank has paid all manufacturing operations, both with respect to premiums and assessments required by the Product, are beingFDIC and the regulations promulgated by the FDIC, and have been since no proceeding for the termination or revocation of such insurance is pending or, to the Company’s formationknowledge, conducted in material compliance with applicable Lawsthreatened. No actions, includingconsents, but not limited to or approvals of, registrations or filings with, notices to, or other actions by the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act FDIC or the Board of 1996, Public Law 104-191 Governors of the Federal Reserve System (the “HIPAAFederal Reserve”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor or any CRO, has received any written notice, correspondence or other communication from any institution, institutional review boardstate bank regulatory authority acting under applicable laws (collectively, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product“Approvals”), is or will be required in connection with this Agreement and the Company transactions contemplated hereby, except those Approvals that already have been received and are in full force and effect. The Bank has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance complied with all applicable Laws, contracts to which rules and regulations of the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the ProductFDIC, the CROsFederal Reserve and any applicable state bank regulatory authority, except for violations that, singly or in the aggregate, would not result in a Material Adverse Effect.

Regulatory Matters. (ia) The Company, its Affiliates andExcept as disclosed in the Disclosure Schedule, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) Group Companies have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Approvals from applicable Governmental Approvals are valid Authorities and in full force have fulfilled any and effect, all filings and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply registration requirements with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both Authorities necessary with respect to the Product, are beingFounders’ investment in the Group Companies, and with respect to the Group Companies and their operations. Except as disclosed in the Disclosure Schedule, the Schools have obtained any and all Approvals from applicable Governmental Authorities and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to their establishments and operations. All filings and registrations with applicable Governmental Authorities required with respect to the Group Companies and the Schools have been since the Company’s formation, conducted duly completed in material compliance accordance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health informationLaw. Neither the Company, nor any CRO, No Group Company has received any written notice, correspondence letter or other communication notice from any institution, institutional review board, applicable Governmental Authorities notifying it of the FDA, revocation of any Approval issued to it or any other Governmental Entity Schools or the need for compliance or remedial actions with respect to the activities carried out directly or indirectly by any completedGroup Company or any School. Each Group Company and each School has been conducting its business activities within the permitted scope of business or is otherwise operating its Businesses in full compliance with all relevant Laws and Governmental Orders, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted including providing products and/or services with all requisite licenses, permits and approvals granted by or on behalf of the competent Governmental Authorities. Neither any Founder nor any Group Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no has reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge authorization of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityAuthority, (b) failed to disclose a material fact license or permit required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical researchpart of its Business and/or for the operation of any School which is subject to periodic renewal will not be granted or renewed by the relevant Governmental Authorities. (b) Each holder of any Equity Securities of the Company or any Sellers (each, safety a “Company Security Holder”), who is a Domestic Resident and toxicology studies subject to any of the registration or clinical trials reporting requirements of Circular 37 or any other applicable SAFE rules and regulations (collectively, the “SAFE Rules and Regulations”), has complied with such reporting and/or registration requirements under the SAFE Rules and Regulations. Neither the Warrantors nor any of the Company Security Holders has received any oral or written inquiries, notifications, orders or any other forms of official correspondence from SAFE or any of its local branches with respect to any actual or alleged non-compliance with the Product), SAFE Rules and Regulations and the Company and the Company Security Holders have made all oral or written filings, registrations, reporting or any other communications required by SAFE or any of its local branches. Each Group Company has notobtained all certificates, directly or indirectlyapprovals, used permits, licenses, registration receipts and any employee, agent, or independent contractor who has been (i) debarred by, or is similar authority necessary under the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant PRC Law to Section 306 of the FDCAconduct foreign exchange transactions as now being conducted by it. (vc) The Company’s and, Lebai has obtained any and all Approvals from applicable Governmental Authorities and has fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to its franchising agreements entered into with any and all franchisees for Firstleap Education and the Productrelevant businesses conducted thereunder. Lebai has not violated any of such franchising agreements in any material aspect and, to the CROs’best knowledge of the Warrantors, use each of the training centres of Lebai is duly established under PRC Law and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is has been operating in full compliance with all applicable LawsPRC Law. To the best knowledge of the Warrantors, contracts to which each of the franchised schools and training centers of Beijing Company or CRO (the “Franchised Schools”) is bound, privacy policies duly established and terms operated in accordance with the Law of use. The Company the People’s Republic of China on the Promotion of Privately-run Schools («中华人民共和国民办教育促进法» ) and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsrelevant regulations.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Section 4.14(a) of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental EntityDisclosure Letter sets forth a true and complete list, including the FDA, to permit the conduct as of the Business Agreement Date, and the Company has made available to Parent true and complete copies of, all Regulatory Authorizations from the FDA and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company, nor Company relating to the Knowledge of Company Products. Except as would not reasonably be expected to, individually or in the Companyaggregate, any CROresult in a Company Material Adverse Effect, (x) the Company has received any communication from any Governmental Entity regardingfiled, any such Governmental Approvals, any failure to materially comply with applicable Laws maintained or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed furnished with the applicable Governmental Entities, including the FDA, Regulatory Authorities all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and submissions other information (collectively, the “Health Care Submissions”) and (y) all such Health Care Submissions were complete and accurate and in compliance in all material respects with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). (b) (i) Since December 31, 2021, the Company and its subsidiaries have been in material compliance with all applicable Health Laws when filedthat affect the business, Company Products, properties, assets and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports activities of the Company or submissions. its subsidiaries; (ii) All nonclinical as of the Agreement Date, neither the Company nor its subsidiaries have received any written notice or other communication from any Regulatory Authority alleging any material violation of any Health Law; and clinical investigations conducted (iii) there are no investigations, suits, claims, actions or sponsored by proceedings pending, or on behalf to the knowledge of the Company, and all manufacturing operations, both threatened against the Company or its subsidiaries with respect to the ProductCompany Products or alleging any violation by the Company, are beingits subsidiaries or the Company Products of any such Health Law. (c) Since December 31, and have been since 2021, to the Company’s formationknowledge, all pre-clinical studies and clinical trials conducted with respect to the Company Products by or at the direction of the Company have been conducted in material compliance with applicable experimental protocols, procedures and controls, and all applicable Laws, includingincluding the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, but not limited 54, 56, 58 and 312, and any other applicable regulations that relate to the FDCAproper conduct of clinical studies and requirements relating to the protection of human subjects. No clinical trial conducted by or, good clinical practice requirementson behalf of, good laboratory practice requirementsthe Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting neither the use and disclosure of individually identifiable health information. Neither the Company, Company nor any CRO, has received any its subsidiaries have outstanding written notice, correspondence notifications or other communication written communications from any institution, institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction, that requires or would require the FDAtermination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any other Governmental Entity with respect clinical studies in which the Company or its subsidiaries have participated and, to the knowledge of the Company, no such action has been threatened against the Company or its subsidiaries. (d) Since December 31, 2021, to the Company’s knowledge, all manufacture of the Company Product, including any completedclinical supplies used in any clinical trials, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring has been conducted in material compliance with the termination, suspension or material modification applicable specifications and requirements of such studies or tests, or regarding material noncompliance of such studies or tests applicable Health Laws. As of the ProductAgreement Date, and to Knowledge of neither the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge knowledge of the Company, any person acting on its behalf has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material change to the Company Product or any of the CROsCompany’s processes or procedures or any similar correspondence from any Regulatory Authority in respect to the Company or its business operations alleging or asserting noncompliance with any applicable Law or Regulatory Authorization. (e) None of the Company, its subsidiaries, or, to the knowledge of the Company, its officers, employees, or any clinical investigator acting for the Company has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA any Regulatory Authority or any other Governmental Entity, (bii) failed to disclose a material fact required to be disclosed to the FDA any Regulatory Authority or any other Governmental Entity or (ciii) committed any other an act, made any statement a statement, or failed to make any a statement, that (in including with respect to any scientific data or information, that, at the time such case) establishes disclosure was made or failure to disclose occurred, would reasonably be expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” set forth in 56 Fed. Neither Reg. 46191 (September 10, 1991), and any amendments thereto, or for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the Company, nor, communication or submission of false information to Knowledge of the Company, any of its officers, CROs, agents applicable Regulatory Authority or clinical investigators is the subject Governmental Entity. The Company has not committed or engaged in any fraud or falsification or forgery of any pending research or threatened investigation by the FDA pursuant development data, report, studies or publications of any document or statement voluntarily submitted or required to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy be submitted to any Regulatory Authority or by any other Governmental Entity pursuant to any similar applicable Law. (iv) Entity. None of the Company, its subsidiaries, or, to the Sellers or knowledge of the CROsCompany, nor any of their respective its officers, directors, employees, shareholdersor any clinical investigator acting for the Company, consultants, agents, clinical investigators is currently or Affiliates has been debarred or convictedconvicted of any crime that has resulted in, or is subject would reasonably be expected to result in, debarment or conviction, pursuant to 21 U.S.C. Section 306 335a (a) or (b) or exclusion from participation in any federal health care program pursuant to 42 U.S.C. Section 1320a-7. (f) No Company Product that is or has been manufactured, tested, distributed, held or marketed by or on behalf of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has notbeen recalled, directly withdrawn or indirectlysuspended (whether voluntarily or otherwise) or, used any employeeto the Company’s knowledge, agent, or independent contractor who has been adulterated or misbranded. No Proceedings (iwhether complete or pending) debarred byseeking the recall, withdrawal, suspension or is seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 knowledge of the FDCACompany, threatened against the Company. The Company has filed all annual and periodic reports, amendments and safety reports required for the Company Product required to be made to any Regulatory Authority. (vg) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which Neither the Company or CRO is boundnor its subsidiaries are a party to any corporate integrity agreement, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativemonitoring agreement, technical and physical safeguards that are commercially reasonable andconsent decree, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating tosettlement order, or violations of similar agreement with or imposed by any security policy regarding, Regulatory Authority or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsother Governmental Entity.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, Acquired Corporations have filed with the applicable Governmental Entities, regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA, ) all required material filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and or submissions, including but not limited to adverse event reports. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws Legal Requirements when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical Except as would not reasonably be expected to have a Material Adverse Effect, all preclinical and clinical investigations conducted or sponsored by the Acquired Corporations, including those in which any or on behalf of all obligations under the CompanyFederal Food, Drug, and all manufacturing operations, both with respect Cosmetic Act (“FDCA”) have been transferred to the Producta third party, are being, and have been since the Company’s formation, being conducted in material compliance with applicable LawsLegal Requirements, includingrules, but not limited to the FDCAregulations and guidance documents, good clinical practice including Good Laboratory Practices and Good Clinical Practices requirements, good laboratory practice requirementsand federal and state laws, GMPrules, ICH principles regulations and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements guidance documents restricting the use and disclosure of individually identifiable health information. Neither . (c) There has not been any material violation of the CompanyFDCA and the FDA’s regulations or any law or regulation of any other applicable regulatory authority by the Acquired Corporations in connection with their product development, nor any CRO, has received any written notice, correspondence investigation or other communication from any institution, institutional review boardmanufacturing efforts, the FDApreparation or evaluation of submissions, or record keeping and reports to the FDA or any other Governmental Entity applicable regulatory authority that could reasonably be expected to require or lead to an investigation, corrective action, enforcement or regulatory or administrative action. The Acquired Corporations have not received any warning letters, untitled letters, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other material correspondence or notices from the FDA or any other applicable regulatory authority relating to deficiencies in the development, investigation, and manufacture of products or non-compliance with respect to the FDCA and FDA’s regulations or the laws and regulations of any completedother applicable regulatory authority, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring including correspondence regarding the termination, suspension or material delay or modification of such any ongoing clinical or pre-clinical studies or tests, or regarding material noncompliance of such studies or tests . Except as stated in Part 3.11 of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review boardDisclosure Schedule, the Acquired Corporations have not received any correspondence from third parties alleging non-compliance with the FDCA and FDA, or any other Governmental Entity is considering such action or communication’s regulations. (iiid) Neither To the Company’s knowledge, nor, to the Knowledge of the Company any of the CROs, no Acquired Corporation has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.Material

Regulatory Matters. (i) The CompanySince January 1, its Affiliates and2013, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business SVBank has timely and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been duly filed with or is being revoked or challenged. Neither the Company, nor furnished to the Knowledge of appropriate Governmental Authorities in substantially the Companycorrect form the monthly, any CROquarterly and annual reports, has received any communication from any Governmental Entity regardingdocuments, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representationsstatements and submissions, declarationstogether with any amendments thereto, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All furnished by it under applicable laws and regulations, has paid all fees and assessments due in connection therewith, and such reports, documents, filings, representationsstatements and submissions, declarationstogether with any amendments thereto, listings, registrations, reports and submissions were in all material compliance with applicable Laws when filedrespects complete and accurate. There are no unresolved violations set forth in any such report, documents, filings, statements and no material deficiencies have been asserted in writing submissions, or any amendments thereto relating to any examinations or inspections by any applicable Governmental Entity Authority of SVBank. Except as Previously Disclosed, in connection with respect the most recent examination of SVBank by the appropriate Governmental Authorities, SVBank was not required to correct or change any such filingsaction, representationsprocedure or proceeding which SVBank believes in good faith has not been now corrected or changed, declarationsother than corrections or changes which, listingif not made, registrationseither individually or in the aggregate, reports or submissionswould not have a Material Adverse Effect on SVBank. (ii) All nonclinical and clinical investigations conducted Neither SVBank nor any of its properties is a party to or sponsored by is subject to any order, decree, directive, agreement, memorandum of understanding or on behalf of the Companysimilar arrangement with, and all manufacturing operationsor a commitment letter or similar submission to, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Companyor extraordinary supervisory letter from, nor has SVBank adopted any CROpolicies, procedures or board resolutions at the request or suggestion of, any Governmental Authority. SVBank has received paid all assessments made or imposed by any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationAuthority. (iii) Neither the CompanyExcept as Previously Disclosed, norno Governmental Authority has initiated since December 31, 2013, or has pending any proceeding, enforcement action or, to the Knowledge knowledge of SVBank, investigation or inquiry into the business, operations, policies, practices or disclosures of SVBank (other than normal examinations conducted by a Governmental Authority in the ordinary course of the Company business of SVBank), or, to the knowledge of SVBank, threatened any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Lawforegoing. (iv) None The most recent regulatory rating given to SVBank as to compliance with the Community Reinvestment Act is “Satisfactory.” Since the last regulatory examination of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials SVBank with respect to the Product)Community Reinvestment Act compliance, the Company SVBank has not, directly or indirectly, used not received any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant complaints as to Section 306 of the FDCACommunity Reinvestment Act compliance. (v) The Company’s and, with respect SVBank satisfies the conditions necessary to the Product, the CROs’, use and dissemination of any personallyqualify for an 18-identifiable information or Protected Health Information (as defined month examination cycle under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs12 CFR § 337.12(b).

Regulatory Matters. (i) The CompanyDuring the 12-month period immediately preceding the date hereof, its Affiliates andexcept as described in the SEC Documents, the contract research organizations engaged Company and each of its Subsidiaries: (A) is and at all times has been to perform clinical trials on behalf the Company’s knowledge in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and each of its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (the “CROsGovernmental Authority”) have obtained all Governmental Approvals alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any Governmental Entity, including the FDA, to permit the conduct of the Business such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and all such Governmental Approvals material Authorizations are valid and in full force and effecteffect and are not in violation of any term of any such material Authorizations; (D) have not received notice of any claim, and no such Governmental Approval has been action, suit, proceeding, hearing, enforcement, investigation, arbitration or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication other action from any Governmental Entity regardingAuthority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental ApprovalsAuthority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received notice that any failure Governmental Authority has taken, is taking or intends to materially comply with applicable Laws take action to limit, suspend, modify or revoke any term or requirement of Authorizations and the Company has no knowledge that any such Governmental ApprovalAuthority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any revocation, withdrawal, suspension, cancellation, material limitation, termination Applicable Laws or material modification of any Authorizations and that all such Governmental Approvalreports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). To During the Knowledge of 12-month period immediately preceding the Companydate hereof, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review boardknowledge, the FDAstudies, or any other Governmental Entity with respect to any completed, ongoing or planned tests and preclinical and clinical or nonclinical studies or tests sponsored or trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of such studies any studies, tests or tests, preclinical or regarding material noncompliance of such studies clinical trials conducted by or tests of the Product, and to Knowledge on behalf of the Company there is no reason or its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to believe that any institutionreview, institutional review boardfrom time to time, the FDAprogress and results of the studies, or any other Governmental Entity is considering tests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such action or communication. (iii) Neither studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company, nor, to the Knowledge ’s review of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Briberyinformation, and Illegal Gratuities Final Policy. Neither (ii) the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product)’s actual knowledge, the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is reasonably believes that the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 descriptions in the SEC Document of the FDCAresults of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (i) The CompanyNeither NSD nor any of its Subsidiaries nor any of their respective properties is a party to or is subject to any order, its Affiliates anddecree, agreement, memorandum of understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, any Bank Regulatory Authority or any federal or state governmental agency or authority charged with the supervision or regulation of issuers of securities or the supervision or regulation of it (collectively, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) "NSD Regulatory Authorities"). NSD and its Subsidiaries have obtained paid all Governmental Approvals required assessments made or imposed by any Governmental Entity, including the FDA, to permit the conduct NSD Regulatory Authority. (ii) Neither NSD nor any of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval its Subsidiaries has been advised by, nor does it have any knowledge of facts that could give rise to an advisory notice by, any NSD Regulatory Authority that such NSD Regulatory Authority is contemplating issuing or requesting, or is being revoked considering the appropriateness of issuing or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regardingrequesting, any such Governmental Approvalsorder, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission. (iii) NSD and each of its Subsidiaries have timely filed all reports, registrations and statements, together with any failure amendments required to materially comply be made with applicable Laws respect thereto, that they were required to file since January 1, 2001 with (A) the Federal Reserve Board, (B) the FDIC, (C) the Department or (D) any other state regulatory authority and (E) the SEC, and all other reports and statements required to be filed by them since January 1, 2001, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Schedule 5.03(i) of the NSD Disclosure Schedule and except for normal examinations conducted by Bank Regulatory Authorities, (A) no Bank Regulatory Authority has initiated or has pending any proceeding or, to the knowledge of NSD, investigation into the business or operations of NSD or any term of its Subsidiaries since January 1, 2001, except where such proceedings or requirement investigation are not reasonably likely to have, either individually or in the aggregate, a NSD Material Adverse Effect, and (B) there is no unresolved violation, criticism or exception by any Bank Regulatory Authority with respect to the business, operations, policies or procedures of any such Governmental ApprovalNSD or NorthSide Bank since January 1, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances 2001 that are reasonably likely to adversely affect any such Governmental Approvals. The Companyhave, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports either individually or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical researchaggregate, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAa NSD Material Adverse Effect. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Section 4.16(a) of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental EntityDisclosure Letter sets forth a true and complete list, including the FDA, to permit the conduct as of the Business and all such Governmental Approvals are valid and in full force and effectAgreement Date, and no such Governmental Approval the Company has been or is being revoked or challenged. Neither the Company, nor made available to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, Parent true and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDAcomplete copies of, all filings, representations, declarations, listings, Authorizations from the FDA and registrations, as well as all reports or submissions required under any other applicable Regulatory Authorities held by the FDCA Company and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data each Company Subsidiary relating to the Product Candidates and/or necessary to conduct the Company’s business as presently conducted. The Company and the Company Subsidiaries have filed, maintained or furnished, in all material respects, with the applicable Regulatory Authorities all required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience and submissions safety reports) and other information, including all CSAs (collectively, the “Health Care Submissions”), and all such Health Care Submissions were complete and accurate and in compliance in all material compliance respects with applicable Health Laws when filedfiled (or were corrected or completed in a subsequent filing). As of the Agreement Date, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Regulatory Authority to the Company with respect to any such filingsHealth Care Submission. The Company has a complete documentary record of submissions, representationscorrespondence, declarationscontacts, listingand consultations with the applicable Regulatory Authorities except as has not been, registrationsand would not reasonably be expected to be, reports individually or submissionsin the aggregate, result in a Company Material Adverse Effect. (iib) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the CompanyExcept as has not had, and all manufacturing operationswould not reasonably be expected to result in, both with respect to individually or in the Productaggregate, are beinga Company Material Adverse Effect, since December 16, 2019, the Company and the Company Subsidiaries are, and since December 16, 2019 have been since the Company’s formationbeen, conducted in material compliance with all applicable Health Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, Company Subsidiary has received any written notice, correspondence notices or other communication correspondence from any institutionGovernmental Entity, Regulatory Authority, or any institutional review board or ethics committee alleging any violation of any Health Law or otherwise indicating an investigation into a potential violation of any Health Law. (c) The Product Candidates are being, and, since December 16, 2019, have been, developed, studied, tested, manufactured, labeled, distributed and stored in compliance in all material respects with all applicable Health Laws, and all pre-clinical studies and clinical trials conducted or being conducted with respect to the Product Candidates by or at the direction of the Company have been, since December 16, 2019, and are being conducted in compliance in all material respects with the required experimental protocols, procedures and controls, and all applicable Health Laws, all applicable requirements of Good Laboratory Practices, Good Documentation Practices, and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws, including applicable Health Laws, governing the privacy of patient medical records and other personal information and data. As of the Agreement Date, no clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. Neither the Company, nor any Company Subsidiary, nor, to the Knowledge of the Company any other third party involved in the research, development, and study of any Product Candidate has received any written notifications or other communications from any applicable Regulatory Authority, institutional review board, the FDA, ethics committee or safety monitoring committee raising any other Governmental Entity material issues with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored trials threatening the initiation of any action to place a clinical hold order on any such studies or conducted by trials, or on behalf of the Company otherwise requiring the delay, termination, suspension or material modification of such studies or teststrials in each case, or regarding material noncompliance of such studies or tests of the Product, and solely with respect to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationProduct Candidates. (iiid) Neither the CompanyCompany nor any Company Subsidiary has, nor, to the Knowledge of the Company, has any of their respective officers, employees, representatives or agents (in each case, acting in the capacity of an employee, representative or agent of the Company or any Company Subsidiary) engaged in any conduct that is not compliant in any material respect with applicable Health Laws relating to the integrity of data generated or used in any clinical trials or other studies related to the development, use, handling, safety, efficacy, reliability or manufacturing of any Product Candidate. (e) Since December 16, 2019, all development and manufacture of the Product Candidates, including any components thereof and any clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in compliance in all material respects with the applicable specifications and requirements of Good Manufacturing Practices and Health Laws. As of the Agreement Date, neither the Company, nor any Company Subsidiary, nor, to the Knowledge of the Company, any officer, director employee, representative, agent, or other person acting on behalf of the Company or any Company Subsidiary has, with respect to any Product Candidate, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any Form FDA 483, or other Regulatory Authority written notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material change to any Product Candidate or any of the CROsCompany’s or any Company Subsidiary’s processes or procedures. Since December 16, has 2019, the Company and Company Subsidiaries have instituted and maintain policies and procedures reasonably designed to ensure the integrity of data generated in manufacturing all Product Candidates and reasonably designed to encourage employees to report any compliance issues related thereto. (af) The Company and Company Subsidiaries have not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental EntityRegulatory Authority, (bii) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity any Regulatory Authority or (ciii) committed any other an act, made any statement a statement, or failed to make any a statement, that (in including with respect to any scientific data or information, that, at the time such case) establishes disclosure was made or failure to disclose occurred, would reasonably be expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” set forth in 56 Fed. Neither Reg. 46191 (September 10, 1991), and any amendments thereto, or for any applicable Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the communication or submission of false information to any such Regulatory Authority or Governmental Entity. (g) None of the Company, norany Company Subsidiary and, to the Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, employees or agents, clinical investigators is or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred byunder 21 U.S.C. § 335a or any similar applicable Law; (ii) excluded under 42 U.S.C. §§ 1320a-7 or 1320a-7a or any similar applicable Law, including without limitation persons identified on the HHS/OIG List of Excluded Individuals/Entities; (iii) suspended or otherwise declared ineligible for U.S. and non-U.S. federal, state, provincial or other healthcare program participation, including without limitation persons identified on the General Services Administration’s System for Award Management; (iv) convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment, exclusion, or suspension under (i), (ii), or (iii); (v) declared ineligible for the awards of contracts by any U.S. or non-U.S. federal, state, provincial or other agency; (vi) disqualified as a clinical investigator by the FDA or other Regulatory Authority; or (vii) convicted of any offense related to any U.S. and non-U.S. federal, state, provincial or other healthcare program. (h) The Company has made available to Parent all information about adverse events (as such term is defined or described in 21 C.F.R. 312.32) and all other material safety information in the possession or control of the Company as of the Agreement Date relating to any Product Candidate that is or has been manufactured, tested, distributed, held or marketed by or on behalf of the Company or any of its licensors or licensees. (i) Neither the Company nor any Company Subsidiary are party to or have any ongoing reporting obligations pursuant to or under any order by any Regulatory Authority or Governmental Entity (including, for the avoidance of doubt, any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order or other similar agreements) and, to the Knowledge of the Company, no such order is currently contemplated, proposed or pending. Neither the Company, nor any Company Subsidiary, nor, to the Knowledge of the Company, any of their officers, employees, representatives or agents (in each case, acting in the capacity of an officer, employee, representative or agent of the Company or any Company Subsidiary) are subject of debarment proceedings by, to any investigation by any Governmental Entity or Regulatory Authority or enforcement, regulatory or administrative proceeding relating to or arising under any other Health Law and, to the Knowledge of the Company, no such investigation or enforcement, regulatory or administrative proceeding has been threatened. (j) Neither the Company, nor any Company Subsidiary, nor, to the Knowledge of the Company, any third party involved in the research, development, and study of any Product Candidate has received any notices or other written correspondence from the FDA or any other Regulatory Authority that the COVID-19 pandemic has delayed or may delay the timeline for (i) providing guidance, feedback, information, or responses to any such party, (ii) convicted pursuant holding a meeting with any such party, or (iii) making a regulatory decision or taking a regulatory action with respect to Section 306 of a Product Candidate in each case (i), (ii), and (iii) to the FDCAextent such delay, individually or in the aggregate, may have a material impact on the development program for any Product Candidate. (vk) Neither the Company, nor any Company Subsidiary, nor to the Knowledge of the Company any third party involved in the research, development, and study of any Product Candidate has become aware of any effects of the COVID-19 pandemic (i) on a clinical trial or a clinical or non-clinical study of any Product Candidate or (ii) on the manufacturing of any Product Candidate or its key components or the availability of key materials for such manufacturing, in each case, that, individually or in the aggregate, may have a material impact on the development program for that Product Candidate. For the avoidance of doubt, such effects may include but are not limited to delays or pauses in study initiation, study site activation, or study subject enrollment; delayed or missed study drug dosing, study assessments, or follow-up visits; other unplanned protocol deviations; disruptions in the supply of study drug; reports of adverse events that are or may be related to symptoms of COVID-19; study subject discontinuation; and delays in or the inability to monitor study sites or perform database lock, in each case, that, individually or in the aggregate, may have a material impact on the development program for such Product Candidate. (l) The Company’s and, with respect Company has made available to Parent complete and accurate copies of (i) each material CSA and all material correspondence relating to such CSAs or any other Health Care Submissions relating to any Product Candidate submitted to the Product, the CROs’, use and dissemination FDA or any other Regulatory Authority by or on behalf of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is boundany Company Subsidiary, privacy policies including any material supplements or amendments thereto; (ii) all clinical study reports relating to any Product Candidate; (iii) all written material correspondence to or from any Regulatory Authority, including meeting minutes and terms records of usematerial contacts, in each case since December 16, 2019, relating to any Product Candidate; (iv) all documents in the possession of the Company related to inspections by any Regulatory Authority, in each case relating to any Product Candidate; (v) all material information relating to adverse drug experiences, events or reactions or other safety information obtained or otherwise received by the Company relating to any Product Candidate; and (vi) all material manufacturing and analytical reports and non-clinical study reports relating to any Product Candidate. The Company has a complete documentary record of all documents described in clauses (i)-(vi) of this section, except as have not been, and would not reasonably be expected to be, individually or in the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativeaggregate, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect material to the ProductCompany, the CROstaken as a whole.

Regulatory Matters. (i) The Companystudies, its Affiliates and, the contract research organizations engaged to perform tests and preclinical or clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company or any of its Subsidiaries, or to the Company’s Knowledge by third parties, to support approval for commercialization of the Company’s product candidates or that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional medical and scientific standards, and all applicable federal, state or foreign laws, rules, orders and regulations and all rules and regulations of the FDA or any foreign, state or local governmental body exercising comparable authority, including current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement and the Prospectus; and neither the Company nor any of its Subsidiaries has received any notices or correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of such studies any Company Studies and Trials that termination, suspension or testsmaterial modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company and each of its Subsidiaries, if any, has obtained (or regarding material noncompliance caused to be obtained) informed consent by or on behalf of such studies each human subject who participated in the Company Studies and Trials. In using or tests disclosing patient information received by the Company or any of its Subsidiaries in connection with the ProductCompany Studies and Trials, the Company and each of its Subsidiaries, if any, have complied in all respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”) (42 U.S.C. Section 17921 et seq.), and to Knowledge the rules and regulations thereunder, except where noncompliance would not, singularly or in the aggregate, have a Material Adverse Effect. To the Company’s Knowledge, none of the Company there is no reason to believe that Studies and Trials involved any institution, institutional review board, investigator who has been disqualified as a clinical investigator or has been found by the FDA, or any other Governmental Entity is considering such action foreign, state or communication. (iii) Neither local governmental body exercising comparable authority, to have engaged in scientific misconduct. To the Company’s Knowledge, nor, to the Knowledge manufacturing facilities and operations of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke and its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is Subsidiaries’ suppliers are operated in compliance in all respects with all applicable Lawsstatutes, contracts rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject, except where noncompliance would not, singularly or CRO is boundin the aggregate, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsa Material Adverse Effect.

Regulatory Matters. (ia) The CompanyCompany and the Included Subsidiaries hold all licenses, its Affiliates andfranchises, certificates, consents, permits, qualifications and authorizations (including, without limitation, FCC Licenses, and licenses, authorizations and certificates of public convenience and necessity from applicable state and local authorities) from all governmental authorities necessary for the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the lawful conduct of the Business and all such Governmental Approvals are valid and Company's business (collectively, the "Licenses"), other than the Licenses the lack of which, individually or in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CROaggregate, has received any communication not had and would not reasonably be expected to have a Material Adverse Effect on the Company Group. Schedule 3.23 sets forth each certificate of convenience and necessity obtained by the Company or the Included Subsidiaries from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approvalstate public utilities commission. To the Knowledge of the CompanySellers' Knowledge, there are no facts event has occurred or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both fact exists with respect to the ProductLicenses (other than the requirement to file applications for renewal and obtain renewals in the ordinary course) which permits, are beingor after notice or lapse of time or both would permit, revocation or termination of any of the Licenses or would result in any other impairment of the rights of the holder of any of the Licenses or which might limit the operation of the Cellular Telephone System as it is now conducted, except for revocations, limitations or terminations which, individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect on the Company Group. The Company and the Included Subsidiaries have performed their respective obligations under such Licenses with such exceptions which, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect on the Company Group. The FCC actions granting the FCC Licenses, together with all underlying construction permits have not been reversed, stayed, enjoined, annulled or suspended, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nornot pending or, to the Knowledge of Sellers, threatened, any application, petition, objection or other pleading with the FCC or other governmental entity which challenges or questions the validity of or any rights of the holder under any License, except for such reversals, stays, injunctions, annulments, suspensions, applications, petitions, objections or other pleadings, which have not had and would not reasonably be expected to have a Material Adverse Effect on the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, Group. (b) failed to disclose Except as set forth in Schedule 3.23, all of the cell sites and microwave paths of the Company and the Included Subsidiaries in respect of which a filing with the FCC was required have been constructed and are currently operated in all material fact required to be disclosed respects as represented to the FDA or other Governmental Entity or (c) committed any other actFCC in currently effective filings, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect such exceptions which have not had and would not reasonably be expected to have a Material Adverse Effect on the Company Group, modifications to such cell sites and microwave paths have been preceded by the submission to the Product, the CROs’, use and dissemination FCC of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsrequired filings.

Regulatory Matters. (ia) The CompanyAll of the products of the Company and its Subsidiaries that are subject to the jurisdiction of the United States Food and Drug Administration (the “FDA”) or other similar Governmental Authorities (“Regulated Products”) in other jurisdictions are being, its Affiliates andand since January 1, the contract research organizations engaged to perform clinical trials 2021 have been, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed by or on behalf of the Company and its Subsidiaries in compliance with Laws and Judgments applicable to the Company and its Subsidiaries, except where the failure to be in such compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. All such Regulated Products have been and are being marketed, commercialized, and labeled solely for research use only purposes, consistent with FDA’s guidance document, Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only (the “CROs”) have obtained all Governmental Approvals required by any Governmental EntityNov. 25, including the FDA, to permit the conduct 2013). None of the Business Regulated Products have been marketed, commercialized, or labeled for clinical investigative use, diagnostic use, or any other clinical use. (b) The Company and its Subsidiaries have not been restrained by a Governmental Authority or other Person in their ability to conduct or have conducted the manufacturing, operation, storage, distribution, marketing, pricing, sale, promotion, advertising, warehousing, packaging, labeling, handling, shipping, and/or nonclinical, clinical, or other testing of the Company products. (c) As required under applicable Law or pursuant to an authorization, the Company has maintained, filed, or furnished to the FDA or other similar Governmental Authority all material filings, documents, claims, reports, notices, and other submissions (collectively “Reports”), required to be maintained, filed, or furnished to such Governmental Authority on a timely basis, and, at the time of maintenance, filing, or furnishing all such Governmental Approvals are valid Reports were complete and accurate in full force all material respects, or were subsequently updated, changed, corrected, or modified. (d) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2021, (i) neither the Company nor, with respect to the products and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither services of the Company, nor any Person providing services to the Company has received any written notice, including any warning letter, untitled letter, cyber letter, reprimand, regulatory letter, FDA Form-483, Establishment Inspection Report, adverse inspectional findings, notice of an integrity re-view, notice of an investigation, request for corrective or remedial action, notice of other ad-verse finding, or notice of deficiency or violation, or similar communication from the FDA or any other Governmental Authority alleging that the Company, its operations, or the Company products and services are in violation of any applicable Law; and (ii) there is no Action pending or, to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws threatened by the FDA or any term or requirement of any such other similar Governmental ApprovalAuthority (including, without limitation, foreign regulators, notified bodies, and state regulators with authority over medical product manufacturing, marketing, distribution, sale, or dispensing), in each case relating to any revocationproducts of the Company or any of its Subsidiaries or the facilities at which such products are designed, withdrawalmanufactured, suspensionpackaged, cancellationstored, material limitation, termination or material modification of any such Governmental Approval. initially distributed. (e) To the Knowledge of the Company, there are since January 1, 2021, no facts director, officer, employee or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf agent of the Company requiring or any of its Subsidiaries has, in connection with the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge business of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. of its Subsidiaries, (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (ai) made an any untrue statement of a material fact or fraudulent statement to the FDA or any other similar Governmental Entity, Authority or in any documents or records required to be maintained under any FDA or other similar Governmental Authority requirements or regulations; or (bii) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement similar Governmental Authority or failed to make any statement, that (in any such case) establishes a reasonable basis for a documents or records required to be maintained under any FDA or other similar Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents Authority requirements or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Lawregulations. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The Companyoperations of the Company (inclusive of the Products, its Affiliates andservices, and advertising and promotional materials) are, and have been at all times, in compliance with all applicable Healthcare Laws. The Products are, and have, been manufactured, researched and developed by, or on behalf of, the contract Company in compliance with all applicable Healthcare Laws. The Company has obtained all applicable approvals, authorizations, licenses, registrations, and Permits required by the FDA and any other Governmental Authority responsible for the oversight and enforcement with respect to Healthcare Laws, including to permit any manufacturing, labeling, storing, testing, research organizations engaged to perform clinical trials and development of each Product as previously conducted or currently being conducted by or on behalf of the Company Company. Section 2.20(a) of the Disclosure Schedule sets forth a complete and accurate list of (i) all licenses, certifications, orders, clearances, exemptions, authorizations, and approvals granted or pending with the “CROs”) have obtained all FDA or any other Governmental Approvals required by Authority to research, develop, or market any Governmental Entity, including the FDA, to permit Product used in the conduct of the Business Business; (ii) each clinical trial protocol submitted by the Company to the FDA or any other Governmental Authority; (iii) all other filings or submissions made by the Company pursuant to the Federal Food, Drug, and all such Cosmetic Act, as amended (“FD&C Act”) and its respective implementing orders and regulations, or any similar Applicable Law; and (iv) any material correspondence between the Company and the FDA or any other Governmental Approvals Authority concerning the Company or a Product. The Company has delivered to Buyer each of the items described in (i)-(iv) above. (b) The Company has not received any notice that the FDA or any other Governmental Authority responsible for oversight or enforcement of any Healthcare Law, or any institutional review board (or similar body responsible for oversight of human subjects research) or institutional animal care and use committees (or similar body responsible for oversight of animal research), has initiated, or threatened to initiate, any action, suit, proceeding or order to restrict or suspend, nonclinical research on or clinical study of any Product, or to recall, suspend or otherwise restrict the manufacture of any Product, or in which the Governmental Authority alleges or asserts a failure to comply, with applicable Healthcare Laws. 39881135.1 ACTIVE/118012393.3 (c) There are valid no lawsuits, actions, arbitrations, proceedings, charges, complaints or, to the Knowledge of the Company, investigations pending, or to the Knowledge of the Company, threatened, with respect to any alleged violation by the Company, any of its Affiliates, or to the Knowledge of the Company, any of its subcontractors, partners or collaborators of the FD&C Act or any other Healthcare Law, and in full force the Company, its Affiliates, and effectto the Knowledge of the Company, its subcontractors, partners and collaborators are not party to or subject to, nor is any Product subject to, any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar Contracts with or imposed by any Governmental Authority related to any Healthcare Law, and no such Governmental Approval has been Contract is currently pending or, to the Knowledge of the Company, threatened. The Company is not a defendant or named party in any unsealed qui tam/False Claims Act litigation. The Company is being revoked not resubmitting or challenged. planning to resubmit to the government any data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Act of 1992, or the Medicare Part D Coverage Gap Discount Program, or refunding any monies owed due to a resubmission. (d) Neither the Company, nor to the Knowledge of the Company, any CROPerson engaged by the Company for contract research, has received any communication from any Governmental Entity regardingcontract manufacturing, any such Governmental Approvalsconsulting, any failure to materially comply with applicable Laws other collaboration services, partners or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity collaborators with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, Product has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or a fraudulent statement to the FDA or any Governmental EntityAuthority responsible for enforcement or oversight with respect to Healthcare Laws, (b) or failed to disclose a material fact required to be disclosed to the FDA or other such Governmental Entity or (c) committed any other actAuthority that, made any statement or failed at the time such disclosure was made, would reasonably be expected to make any statement, that (in any such case) establishes provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991), or for any other Governmental Authority to invoke a similar policy. (e) Neither the CompanyCompany nor any of its current or former members, norofficers, partners, or employees, nor to the Knowledge of the Company, contractors or agents have been or are currently suspended, excluded or debarred from any federal contracting or healthcare programs, or threatened with or currently subject to an investigation or proceeding that could result in suspension, exclusion or debarment under state or federal statutes or regulations, or assessed or threatened with assessment of civil monetary penalties. Neither the Company nor any of its current or former members, officers, CROspartners, agents or clinical investigators is employees, nor to the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None Knowledge of the Company, the Sellers contractors or agents have been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment under 21 U.S.C. Sections 335 or any similar law, rule or regulation of any other Governmental Authorities, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any Governmental Authorities. (f) All pre-clinical studies and clinical trials conducted or being conducted with respect to any Product or the CROsBusiness by or, nor to the Knowledge of the Company, at the direction of the Company have been and are being conducted in material compliance with all Applicable Law, including (i) standard medical and scientific research procedures and all Healthcare Laws, as applicable, including 21 C.F.R. Parts 11, 50, 54, 56, 58 and 312 and comparable foreign Laws; (ii) the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects (including “Informed Consent” as such term is defined under Applicable Law in the jurisdictions where clinical trials were or are being conducted); and (iii) Applicable Law governing the privacy of patient medical records and other personal information and data. The Company has not received any notifications 39881135.1 ACTIVE/118012393.3 or other communications from any institutional review board (IRB), ethics committee, safety monitoring committee or Governmental Authority raising any issues in any jurisdiction requiring the termination or suspension or investigation of their respective officersany clinical studies conducted by, directorsor on behalf of, employeesthe Company, shareholdersor in which the Company has participated and, consultantsto the Knowledge of the Company, agents, clinical investigators or Affiliates no such action has been debarred or convictedthreatened and there is nothing that would warrant any such action. Complete and correct copies of all material Regulatory Materials, or is subject to debarment or conviction, pursuant to Section 306 including scientific and clinical data of the FDCACompany with respect to all Products or the Business, have been made available to Buyer. In Such Regulatory Materials are complete and correct in all material respects and have been maintained in compliance with all formal filing and maintenance requirements. The Company has made available to Buyer complete and correct copies of all serious adverse event reports, periodic adverse event reports, non-clinical expedited safety reports, and all other Governmental Authority communications, documents and other information submitted by the course of Company to or received by the discoveryCompany from any Governmental Authority, research including inspection reports, warning letters and any other development of similar documents, relating to the Product (including in Company, the conduct of the Business, or any non-clinical researchProduct. (g) There have been no (i) FDA Form 483 inspection observations, (ii) establishment inspection reports, (iii) warning, untitled or action letters, (iv) orders, (v) enforcement actions or (vi) other documents or actions that assert lack of compliance in any material respect with any applicable Law, in all such cases, relating to, arising out of or in connection with the Business or any Product. There has not been, nor, to the Knowledge of the Company, is there currently under consideration by the Company, its partners, collaborators or any Governmental Authority, any recall, market withdrawal, safety alert, “Dear Doctor” letter, public health notification or other safety communication in respect of any Product. (h) If applicable, the manufacture of the Products are being conducted in compliance with current good manufacturing practices, as defined by the FDA, including, as applicable, the FDA’s Current Good Manufacturing Practices set forth in 21 C.F.R. Parts 210 and 211 and any successor legislation or regulations, and comparable foreign Laws. (i) The Company owns or has the right to use and access (including the right to make copies of) all material information and data generated in all development activities and all nonclinical, toxicology and other studies, and clinical studies or clinical and trials (together with data sets associated with such studies) with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable andProducts, in any eventeach case, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, undertaken by or violations on behalf of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsCompany.

Regulatory Matters. (ia) The CompanyExcept as would not reasonably be expected to be, its Affiliates andindividually or in the aggregate, material to the Acquired Corporation, taken as a whole, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, Acquired Corporations have filed with the applicable Governmental Entities, regulatory authorities (including the FDAFDA or any other Governmental Body performing functions similar to those performed by the FDA or otherwise having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products (such Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required filings, representationspermits, declarationsclaims, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representationsresponses, declarations, listings, registrations, reports and or submissions, including adverse event reports. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Acquired Corporations, taken as a whole, all such filings, permits, claims, responses, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws when filedfiled (or were corrected or supplemented by a subsequent submission) and, and no material deficiencies have been asserted in writing by any applicable Specified Governmental Entity Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iib) All nonclinical Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, all preclinical and clinical investigations conducted or sponsored by or on behalf the Acquired Corporations are being conducted in compliance with all applicable clinical protocols, informed consents and Laws, including Good Clinical Practices requirements (preclinical and clinical), Good Manufacturing Practices and pharmacovigilance. As of the CompanyAgreement Date, and all manufacturing operations, both with respect to the Product, are being, and Acquired Corporations have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence notices or other communication correspondence from any institution, institutional review board, the FDA, FDA or any other Specified Governmental Entity Body with respect to any completed, ongoing or planned clinical or nonclinical pre-clinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iiic) Neither the Company, nor, to To the Knowledge of the Company any of the CROsCompany, no Acquired Corporation has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any Specified Governmental EntityBody, (bii) failed to disclose a material fact required to be disclosed to the FDA or other any Specified Governmental Entity Body or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA or any other Specified Governmental Body to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy (or similar rule, regulation or policy). Neither Except as has not had or would not reasonably be expected to have, individually or in the Companyaggregate, nora Material Adverse Effect, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators no Acquired Corporation is the subject of any pending or or, to the Knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy Policy. None of the Acquired Corporations nor, to the Knowledge of the Company, any officers, employees, agents or by clinical investigators of the Acquired Corporations has been suspended or debarred or convicted of any other Governmental Entity pursuant crime or engaged in any conduct that would reasonably be expected to result in (a) debarment under 21 U.S.C. Section 335a or any similar applicable Law or (b) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each Acquired Corporation is in compliance and, since January 1, 2017, has been in compliance with all healthcare laws applicable to the operation of its business as currently conducted, including (i) any and all applicable federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7(b)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant thereto; (iii) Laws which are cause for exclusion from any federal health care program; and (iv) None Laws relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by an Acquired Corporation. No enforcement, regulatory or administrative proceeding is pending, or, to the Knowledge of the Company, the Sellers no such enforcement, regulatory or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates administrative proceeding has been debarred or convictedthreatened, against any Acquired Corporation under the Federal Drug and Cosmetics Act, the Anti-Kickback Statute, or is subject similar Laws other than any such proceeding that would not reasonably be expected to debarment have, individually or convictionin the aggregate, pursuant to Section 306 a Material Adverse Effect. (e) As of the FDCA. In Agreement Date, the course Product (or to the Knowledge of the discoveryCompany any component thereof) has not been recalled, research and any other development withdrawn, suspended or discontinued (whether voluntarily or otherwise). No Legal Proceeding is pending seeking the recall, withdrawal, suspension or seizure of the Product (including in the conduct of any non-clinical researchis pending or, safety and toxicology studies or clinical trials with respect to the Product)Knowledge of the Company, threatened against any of the Company has notAcquired Corporations. (f) To the Knowledge of the Company, directly or indirectly, used any employee, agent, or independent contractor who there has been (i) debarred by, no adverse event reportable to the FDA or is other Specified Governmental Body with respect to the subject safety or efficacy of debarment proceedings by, any Governmental Entity the Product or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information no scientific or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company technical fact or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable andcircumstance that, in any eventthe case of clauses (i) or (ii) has had or would reasonably be expected to have, individually or in compliance with all applicable Laws and contracts. There have been no security breaches relating tothe aggregate, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROsa Material Adverse Effect.

Regulatory Matters. The SBC Companies and their Subsidiaries hold all licenses, franchises, certificates, consents, Permits, qualifications and authorizations (iincluding, without limitation, licenses granted by the FCC ("FCC Licenses"), and licenses, authorizations and certificates of public convenience and necessity from applicable state and local authorities) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained from all Governmental Approvals Entities required by any Governmental Entity, including under Utilities Laws ("Licenses") necessary for the FDA, to permit the lawful conduct of the Business SBC Business, other than Licenses the lack of which, individually or in the aggregate, have not had and all such Governmental Approvals are valid would not be reasonably likely to have a Material Adverse Effect on the SBC Companies. Schedule 3.1(n) of the SBC Disclosure Letter sets forth each License obtained by SBC or any of its Subsidiaries as of the date hereof and which is, or in the absence of a violation thereof, would be in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor effect with respect to the Knowledge of SBC Business (the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval"SBC Companies' Licenses"). To the Knowledge of the CompanySBC, there are no facts event has occurred or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both fact exists with respect to the ProductSBC Companies' Licenses (other than the requirement to file in the future applications for renewal and obtain renewals in the ordinary course) which permits, or after notice or lapse of time or both would permit, revocation, non-renewal or termination of any of such licenses or would result in any other impairment of the rights of the holder of any of such licenses or which would be reasonably likely to limit the operation of the SBC Companies' and their Subsidiaries' businesses as they are beingcurrently conducted, except for revocations, limitations, non- renewals or other terminations which, individually or in the aggregate, have not had and would not be reasonably likely to have a Material Adverse Effect on the SBC Companies. The SBC Companies and their Subsidiaries have performed their respective obligations under the SBC Companies' Licenses with such exceptions which, individually or in the aggregate, have not had and would not be reasonably likely to have a Material Adverse Effect on the SBC Companies. The FCC actions granting the SBC Companies' Licenses, together with all underlying construction permits, have not been reversed, stayed, enjoined, annulled or suspended, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nornot pending or, to the Knowledge of SBC, threatened, any application, petition, objection or other pleading with the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA FCC or other Governmental Entity which challenges or (c) committed questions the validity of or any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge rights of the Company, holder under any of its officersthe SBC Companies' Licenses, CROsexcept for such reversals, agents stays, injunctions, annulments, suspensions, applications, petitions, objections or clinical investigators is the subject of any pending other pleadings, which have not had and would not, individually or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical researchaggregate, safety and toxicology studies or clinical trials with respect be reasonably likely to have a Material Adverse Effect on the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCASBC Companies. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (a) The Company and each of its Subsidiaries have all material permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to conduct the research, development (clinical or otherwise), manufacture, or commercialization of the Company product candidate STS101 or otherwise the Company’s and each of the Subsidiary’s business as currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries (the “Company Permits”). The Company has timely submitted all renewal applications, reports, forms, registrations and documents required to be filed and paid all fees and assessments in connection with the Company Permits and has not received any written notice from a Governmental Entity alleging that it has failed to hold any Company Permit. The Company is in compliance with the rules and regulations of the Governmental Entity issuing such Company Permit. (b) The Company Permits are in full force and effect, except for any failures to be in full force and effect that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries. The Company and each of its Subsidiaries is in compliance under such Company Permits, except for such failures to comply that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole. (c) Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, since January 1, 2021, the Company and each of its Subsidiaries: (i) The is and at all times has been in compliance, with the Health Care Laws; (ii) has not received any written notice or correspondence from any Governmental Entity alleging or asserting any noncompliance with any Company Permit or Health Care Law; and (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Company Permit and, to the Knowledge of the Company, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that such Governmental Entity is considering such action. Neither the Company nor any of its Affiliates andSubsidiaries has been subject to any adverse inspection, finding, penalty assessment or other Legal Proceeding or investigation or non-routine audit by any Governmental Entity, nor are there any non-routine internal investigations or inquiries currently being conducted by the contract research organizations engaged to perform clinical trials on behalf compliance program of the Company that would reasonably be expected to be materially adverse to the Company. (the “CROs”d) have obtained all Governmental Approvals All applications, filings, reports, documents, claims, submissions and notices required by to be filed, maintained, or furnished to any Governmental Entity, including the FDA, by the Company or its Subsidiaries have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports with regard to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challengedany Company products. Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, nor threatened investigation regarding the Company or its products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), or otherwise. Since January 1, 2021, none of the Company, any of its Subsidiaries, or, to the Knowledge of the Company, any CROofficer, has received any communication from any Governmental Entity regardingemployee, any such Governmental Approvals, any failure to materially comply with applicable Laws agent or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf distributor of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, its Subsidiaries has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity Entity, or (c) committed any other an act, made any a statement or failed to make any statementa statement that, that (in any at the time such case) establishes disclosure was made, would reasonably be expected to provide a reasonable basis for a the FDA or any other Governmental Entity to allege a violation of an applicable Law, including without limitation, for invoke the FDA to invoke its FraudFraud Policy or any similar policy. Since January 1, Untrue Statements 2021, none of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, norany of its Subsidiaries, or, to the Knowledge of the Company, any officer, employee, agent or distributor of the Company or any of its Subsidiaries, has been convicted of any crime for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law. No claims, actions, proceedings or investigation that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, CROs, agents employees or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Lawagents. (ive) None Neither the Company nor any of the Company Subsidiaries is or has at any time been a party to any corporate integrity agreement, judgment, order, deferred prosecution agreement, monitoring agreement, consent decree or settlement agreement that (i) requires the payment of money by the Company or any Company Subsidiary to a Governmental Entity, (ii) requires any recoupment of money of the Company or any Company Subsidiary by any Governmental Entity or (iii) prohibits or limits any activity currently conducted by such Person under any Health Care Law. Neither the Company nor any of the Company Subsidiaries is a defendant or named party in any current or pending qui tam or False Claims Act litigation. (f) Neither the Company, the Company Subsidiaries, any of their respective directors or officers, employees, nor, to the Knowledge of the Company, the Sellers independent contractors or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates (i) has been debarred or convictedis currently debarred, excluded, or suspended from contracting with the federal or state government or from participating in any payment program, including Federal Health Care Programs, (ii) is currently subject to debarment or convictionhas been threatened with, an investigation or proceeding that could reasonably be expected to result in such debarment, exclusion or suspension, or (iii) has been assessed or threatened with assessment of civil monetary penalties pursuant to Section 306 of the FDCA. In the course of the discovery, research 42 C.F.R. Part 1003. (g) The Company and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has notSubsidiaries have never, directly or indirectly, used conducted or coordinated research that have been conducted, or supported with any federal funds or grants. Each of the Company and the Company Subsidiaries, as applicable, maintains in compliance all records required to be maintained under FDA and Research Laws, and/or are necessary to document research subjects’ consent/authorization to participate in research conducted or coordinated by the Company or any Company Subsidiary. All financial relationships between the Company, a Company Subsidiary, or officer, employee, or agent thereof, on the one hand, and any: (i) sponsor, funder, or supporter of research or clinical trials conducted by the Company, a Company Subsidiary, or any employee, agent, agent or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity affiliate thereof; or (ii) convicted pharmaceutical or device company, distributor, wholesaler, or any officer, employee, representative, agent, of affiliate thereof (including but not limited to pharmaceutical representatives and sales employees, contract research organizations, site management organizations or similar Persons) are in compliance with the FDA and Research Laws. No officer, employee or agent of a member of the Company (or any Company Subsidiary) (including any physician investigator engaged by such Person) has been, or has been threatened in writing to be: (a) debarred under FDA proceedings under 21 U.S.C. § 335a; (b) disqualified under FDA investigator disqualification proceedings; (c) subject to FDA’s Application Integrity Policy; or (d) subject to any enforcement proceeding arising from false statements to FDA pursuant to Section 306 of the FDCA18 U.S.C. § 1001. (vh) The Company’s andExcept for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of the Company or any of its Subsidiaries including with respect to the ProductCompany product candidate STS101 are being conducted or have been conducted in accordance with experimental protocols, the CROs’, use procedures and dissemination of any personally-identifiable information controls pursuant to accepted professional and scientific standards for products or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts product candidates comparable to which those being developed by the Company or CRO is bound, privacy policies its Subsidiaries and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws laws and contractsregulations and (ii) since January 1, 2021, neither the Company nor any of its Subsidiaries has received any written notices or correspondence from a Governmental Entity or any institutional review board or comparable authority requiring the termination, clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries. There have been no security breaches recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating toto an alleged lack of safety, efficacy, or violations regulatory compliance of any security policy regardingCompany product, or any unauthorized access ofseizures ordered or adverse regulatory actions taken (or, any data or information used to the Knowledge of the Company, threatened) by the Company or, FDA or any other Governmental Entity with respect to any of the ProductCompany products or any facilities where any such products are tested, the CROsproduced, processed, packaged or stored.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of Company and the Company (the “CROs”) Subsidiaries have obtained obtained, and are in material compliance with, all Governmental Approvals clearances, consents, certificates, authorizations, licenses, permits, approvals, waivers, variances, filings, accreditations, exemptions and registrations required under applicable Laws by any Governmental Entity, including the FDA, Body to permit the conduct of the Business its business as currently conducted (each, a “Company Permit”), and all such Governmental Approvals Company Permits are identified on Section 3.9(a) of the Company Disclosure Schedule and are valid and in full force and effect. No Governmental Body has provided any written or, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CROoral notice that it intends to limit, has received any communication from any Governmental Entity regardingsuspend, revoke, withdraw, cancel or modify any such Company Permit. The Company and the Company Subsidiaries have complied in all material respects with all of the applicable requirements of any applicable Governmental ApprovalsBody and under applicable Laws, any failure to materially comply including making all required filings, declarations, listings, registrations, notifications, certifications, reports or submissions, including adverse event reports. All such filings, declarations, listings, registrations, notifications, certifications, reports or submissions were in compliance with applicable Laws when filed, and no deficiencies have been asserted by any applicable Governmental Body with respect to any Company Permit or any term or requirement of any such Governmental Approvalfilings, declarations, listing, registrations, notifications, certifications, reports, submissions, or any revocationother matters and, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To to the Knowledge of the Company, there are no facts or circumstances that are would reasonably likely give rise to adversely affect any an assertion of such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsa deficiency. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iiib) Neither the Company, nor, to the Knowledge of the Company nor any of the CROs, Company Subsidiary has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA any other Governmental Body or any Governmental Entity, (bii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity or Body. (c) committed any other actThe Company and its Company Subsidiaries have at all times complied in all material respects with all applicable Laws (and their own rules, made any statement policies and procedures) relating to rights of publicity, privacy, data protection, and the collection, use, storage and disposal of personal information collected, used, or failed to make any statement, that (held for use by the Company or a Company Subsidiary in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation the conduct of an applicable Lawtheir businesses, including without limitationany registration requirements. No claim, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, noraction or proceeding has been asserted or, to the Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject threatened alleging a violation of any pending Person’s rights of publicity or threatened investigation privacy or personal information or data rights and the consummation of the transactions contemplated hereby will not breach or otherwise cause any violation of any Laws or rule, policy, or procedure related to rights of publicity, privacy, data protection, information security, or the collection, use, storage or disposal of personal information collected, used, or held for use by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy Company or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including a Company Subsidiary in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAtheir businesses. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (ia) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Section 4.14 (a) of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental EntityDisclosure Letter sets forth a true and complete list, including the FDA, to permit the conduct as of the Business Agreement Date, and the Company has made available to Parent true and complete copies of, all Regulatory Authorizations from the FDA and all such Governmental Approvals are valid and material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company relating to the Company Product. Except as would not reasonably be expected to, individually or in full force and effectthe aggregate, and no such Governmental Approval has been or is being revoked or challenged. Neither result in a material liability to the Company, nor to (x) the Knowledge of the CompanyCompany has filed, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws maintained or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed furnished with the applicable Governmental Entities, including the FDA, Regulatory Authorities all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and submissions other information (collectively, the “Health Care Submissions”) and (y) all such Health Care Submissions were complete and accurate and in compliance in all material respects with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). (b) Since December 23, 2021, (i) the Company has been in material compliance with all applicable Health Laws when filedthat affect the business, Company Product, properties, assets and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf activities of the Company, (ii) as of the Agreement Date, the Company has not received any written notice or other communication from any Regulatory Authority alleging any material violation of any Health Law and all manufacturing operations(iii) there are no investigations, both suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company with respect to the ProductCompany Product or alleging any violation by the Company or the Company Product of any such Health Law. (c) Since December 23, are being2021, and have been since to the Company’s formationknowledge, all pre-clinical studies and clinical trials conducted with respect to the Company Product by or at the direction of the Company have been conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Laws, includingincluding the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, but not limited 54, 56, 58 and 312, and any other applicable regulations that relate to the FDCAproper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws, good clinical practice requirementsincluding applicable Health Laws, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act governing the privacy of 1996, Public Law 104-191 (“HIPAA”) patient medical records and other legal requirements restricting personal information and data. No clinical trial conducted by or, on behalf of, the use and disclosure Company has been terminated or suspended by any Regulatory Authority. As of individually identifiable health information. Neither the CompanyAgreement Date, nor any CRO, the Company has received any no outstanding written notice, correspondence notifications or other communication written communications from any institution, institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction that requires or would require the FDAtermination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any other Governmental Entity with respect clinical studies in which the Company has participated and, to the knowledge of the Company, no such action has been threatened against the Company. (d) Since December 23, 2021, to the Company’s knowledge, all manufacture of the Company Product, including any completedclinical supplies used in any clinical trials, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring has been conducted in material compliance with the termination, suspension or material modification applicable specifications and requirements of such studies or tests, or regarding material noncompliance of such studies or tests applicable Health Laws. As of the ProductAgreement Date, and to Knowledge of neither the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge knowledge of the Company, any person acting on its behalf has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material change to the Company Product or any of the Company’s processes or procedures or any similar correspondence from any Regulatory Authority in respect of the Company or its business operations alleging or asserting noncompliance with any applicable Law or Regulatory Authorization and, to the knowledge of the CROsCompany, no Regulatory Authority is considering such action. (e) None of the Company or its officers or employees, or, to the knowledge of the Company, any clinical investigator acting for the Company has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA any Regulatory Authority or any other Governmental Entity, (bii) failed to disclose a material fact required to be disclosed to the FDA any Regulatory Authority or any other Governmental Entity or (ciii) committed any other an act, made any statement a statement, or failed to make any a statement, that (in including with respect to any scientific data or information, that, at the time such case) establishes disclosure was made or failure to disclose occurred, would reasonably be expected to provide a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” set forth in 56 Fed. Neither Reg. 46191 (September 10, 1991), and any amendments thereto, or for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the Companycommunication or submission of false information to any applicable Regulatory Authority or Governmental Entity. The Company has not committed or engaged in any fraud or falsification or forgery of any research or development data, norreport, studies or publications of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority or any other Governmental Entity. None of the Company or any of its officers, employees or agents or, to Knowledge the knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of investigator acting for the Company, the Sellers is currently or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred convicted of any crime or convictedengaged in any conduct that has resulted in, or is subject would reasonably be expected to result in, debarment or conviction, from participation in any program related to pharmaceutical products pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.21 U.S.

Regulatory Matters. (a) Section 3.11(a) of the Stockholder’s Disclosure Schedule sets forth a complete and accurate list of (i) The Companythe Products that any Group Company (x) sells, its Affiliates anddistributes, the contract research organizations engaged markets or manufactures, or (y) for which any Group Company holds or has applied for any Governmental Authorization pertaining to perform clinical trials on behalf marketing or manufacturing, and (ii) all Governmental Authorizations previously granted to any Group Company by, or for which applications are pending before, any Governmental Authority to develop, manufacture, import, export, market, distribute or sell any of the Company (the “CROs”) have obtained all Products or to own or operate any of its assets or to operate its business as currently conducted. None of those Governmental Approvals required Authorizations will cease to be valid or effective by any Governmental Entity, including the FDA, to permit the conduct reason of the Business and all such Governmental Approvals are valid and consummation of the transactions provided for in full force and effectthis Agreement. (b) Except as set forth in Section 3.11(b) of the Stockholder’s Disclosure Schedule, since September 1, 2010, there has been no material Product Event, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, Stockholder there are no facts or circumstances that are would be reasonably likely to adversely affect result in a Product Event, or a material change in the labeling of any such Governmental Approvals. The CompanyProduct, and in order to the Knowledge avoid a specific concern that could result in a Product Event. (c) Except as set forth on Section 3.11(c) of the CompanyStockholder’s Disclosure Schedule, none of the CROsGroup Companies has knowingly made any false statements on, have filed or material omissions from, any applications, approvals, reports or other submissions to any Governmental Authority, or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to any Governmental Authorization of any Products. (d) Except as set forth on Section 3.11(d) of the Stockholder’s Disclosure Schedule, (i) no Group Company has breached any representation or warranty, express or implied, given in respect of any product previously sold by any of them, (ii) all products previously marketed, distributed, sold or exported by any Group Company complied in all respects with all applicable product specifications and requirements and with the terms of all applicable Governmental Authorizations, except for any inconsistencies between labeling and packaging and the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listingsAuthorization that (x) have not and would not reasonably be expected to result in any adverse effect on a Group Company and (y) have not and would not reasonably be expected to result in injury to consumers, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were (iii) there is no design defect in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsProduct. (iie) All nonclinical and clinical investigations conducted or sponsored by or on behalf Each of the Company, and Group Companies has taken all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor any CRO, has received any written notice, correspondence or other communication from any institution, institutional review board, the FDA, or any other Governmental Entity with respect to any completed, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring the termination, suspension or material modification of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge of the Company any of the CROs, has (a) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be disclosed to the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has notmeasures, directly or indirectly, used any to ensure the confidentiality, privacy and security of employee, agentpatient, or independent contractor who customer financial and other confidential information, and each of them has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is conducted its business in compliance with in all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance material respects with all applicable Laws and contracts. There have been no security breaches relating toall of its policies and procedures governing privacy, or violations data protection and the protection of any security policy regarding, or any unauthorized access of, any data or personal information used by the Company or, (including with respect to employees, patients, customers and other individuals). The rights of the Product, Group Companies to use and disclose such information will not be adversely affected in any material respect by the CROsconsummation of the transactions contemplated by this Agreement.

Regulatory Matters. (a) Section 3.16(a) of the Company Disclosure Letter sets forth a true and complete list, as of the date of this Agreement, and the Company has made available to Parent true and complete copies of, all Regulatory Authorizations from the FDA, EMA and all other applicable Regulatory Authorities held by the Company or the Company Subsidiary relating to the Company Products and/or necessary to conduct its business as presently conducted. All such Regulatory Authorizations are (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiary have fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no such Governmental Approval event has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approvaloccurred which allows, or any revocationafter notice or lapse of time would allow, withdrawalrevocation or termination thereof. Except as would not reasonably be expected to, suspension, cancellation, material limitation, termination individually or material modification of any such Governmental Approval. To in the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROsaggregate, have filed a Company Material Adverse Effect, (x) the Company and the Company Subsidiary have filed, maintained or furnished with the applicable Governmental Entities, including the FDA, Regulatory Authorities all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and submissions other information (collectively, the “Health Care Submissions”) with the FDA, EMA and all other applicable Regulatory Authorities and (y) all such Health Care Submissions were complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). (b) (i) The Company and the Company Subsidiary are in material compliance with all applicable Health Laws when filedthat affect the business, Company Products, properties, assets and activities of the Company, (ii) as of the date of this Agreement, neither the Company nor the Company Subsidiary has received any written notice or other communication from any Regulatory Authority (A) withdrawing or placing any clinical studies of the Company Products on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Company Products or (B) alleging any material violation of any Health Law and (iii) there are no material deficiencies have been asserted in writing by any applicable Governmental Entity investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company or the Company Subsidiary with respect to any of the Company Products or alleging any violation by the Company or the Company Subsidiary or the Company Products of any such filings, representations, declarations, listing, registrations, reports or submissionsHealth Law. (iic) All nonclinical pre-clinical studies and clinical investigations trials conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both being conducted with respect to the Product, are being, and Company Products by or at the direction of the Company have been since the Company’s formation, and are being conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Laws, includingincluding the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, but not limited 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the FDCAproper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws, good clinical practice requirementsincluding applicable Health Laws, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act governing the privacy of 1996, Public Law 104-191 (“HIPAA”) patient medical records and other legal requirements restricting personal information and data. The Company (or its agents, e.g., the use applicable contract research organization(s)) has provided all notices to and disclosure obtained all consents from Persons relating to the Company Products necessary to conduct its business as presently conducted and as required in order for Company to undertake the actions set forth in this Agreement, including the transfer of individually identifiable health informationall data and associated rights to the data to Parent as set forth in this Agreement, and that such transfer is in compliance with applicable Laws, including all applicable Health Laws. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. Neither the Company, Company nor any CRO, the Company Subsidiary has received any written notice, correspondence notifications or other communication written communications from any institution, institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction that requires or would require the FDAtermination or suspension or investigation, or place a clinical hold order on or otherwise delay or materially restrict any other Governmental Entity with clinical studies proposed or currently conducted by, or on behalf of, the Company, or in which the Company or the Company Subsidiary has participated and, to knowledge of the Company, no such action has been threatened against the Company or the Company Subsidiary. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company and all material written correspondence that exists as of the date of this Agreement between the Company and the applicable Regulatory Authorities. (d) All manufacture of the Company Products, including any completedclinical supplies used in any clinical trials, ongoing or planned clinical or nonclinical studies or tests sponsored or conducted by or on behalf of the Company requiring has been conducted in all material respects in compliance with the termination, suspension or material modification applicable specifications and requirements of such studies or tests, or regarding material noncompliance of such studies or tests of the Product, Good Manufacturing Practices and to Knowledge of applicable Law. Neither the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communication. (iii) Neither the Company, nor, to the Knowledge knowledge of the Company, any person acting on its behalf has, with respect to any Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any change to any Company Product or any of the Company’s or the Company Subsidiary’s processes or procedures, or any similar correspondence from any Regulatory Authority in respect of the Company or the Company Subsidiary or their business operations alleging or asserting noncompliance with any applicable Law, permit or any such requests or requirements of a Regulatory Authority and, to the knowledge of the Company, no Regulatory Authority is considering such action. (e) None of the Company or any of its respective officers, employees or agents, or, to the CROsknowledge of the Company, any clinical investigator acting for the Company, has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA any Regulatory Authority or any other Governmental Entity, (b) failed to disclose a material fact required to be disclosed to including the FDA or other Governmental Entity or (c) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis Centers for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, Medicare and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) None of the CompanyMedicaid Services, the Sellers or the CROs, nor any U.S. Department of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s Health and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.

Regulatory Matters. (a) The Company and the Company Subsidiaries hold, and since January 1, 2022 have held, such Regulatory Authorizations required for the conduct of their business as presently or, during that time period, conducted, including those necessary to permit the design, development, pre-clinical and clinical testing, manufacturing, distribution and promotion of the Company Product, as applicable, in the jurisdictions where it currently conducts such activities with respect to the Company Product, except to the extent where failure to hold such Regulatory Authorizations would not, individually or in the aggregate, be reasonably expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole). Except as would not reasonably be expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole), (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (and the “CROs”) Company Subsidiaries have obtained all Governmental Approvals required by any Governmental Entityfiled, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been maintained or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed furnished with the applicable Governmental Entities, including the FDA, Regulatory Authorities all required filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and submissions other required information (collectively, the “Health Care Submissions”) and (ii) all such Health Care Submissions were complete and accurate and in material compliance with applicable Health Laws when filed, and no material deficiencies have been asserted filed (or were corrected or completed in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissionsa subsequent filing). (iib) All nonclinical Except as would not reasonably be expected to result in a material liability to the Company and clinical investigations conducted the Company Subsidiaries (taken as a whole), since January 1, 2022, (i) the Company, the Company Subsidiaries and, to the Company’s knowledge, any other Person that has performed or sponsored by is performing any material research, development, manufacturing, distribution or other services or activities on behalf of the Company, and all manufacturing operations, both Company or any Company Subsidiary with respect to the a Company Product, are beingin each case, to the extent acting in such capacity (each, a “Collaboration Partner”) are, and have been since the Company’s formationbeen, conducted in material compliance with all Health Laws applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, the Company Subsidiaries and the Company Product and (ii) neither the Company, either Company Subsidiary nor any CRO, Collaboration Partner (only with respect to a Company Product) has received any written notice, correspondence notice or other communication from any institutionRegulatory Authority alleging any violation of any Health Law. (c) Except as would not reasonably be expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole), institutional review boardsince January 1, the FDA2022, all pre-clinical studies and clinical trials conducted or any other Governmental Entity being conducted with respect to the Company Product by, on behalf of, or at the direction of the Company have been and are being conducted in compliance with the required experimental protocols, procedures and controls, and all applicable Health Laws, including the FDCA and its applicable implementing regulations, including all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any completedother applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects required by the FDA. As of the date of the Agreement, ongoing or planned no clinical or nonclinical studies or tests sponsored or trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. Except as would not reasonably be expected to have, individually or in the aggregate, a material and adverse effect on the Company and the Company Subsidiaries (taken as a whole), neither the Company nor either Company Subsidiary has received any written notifications or other communications from any Regulatory Authority that requires or would require the termination or suspension or investigation, or place a clinical hold order on or otherwise delay or restrict any clinical studies currently conducted by, or on behalf of, the Company, or in which the Company or either Company Subsidiary has participated and, to knowledge of the Company requiring the terminationCompany, suspension or material modification of no such studies or tests, or regarding material noncompliance of such studies or tests of the Product, and to Knowledge of action has been threatened in writing against the Company there is no reason to believe that any institution, institutional review board, the FDA, or any other Governmental Entity is considering such action or communicationeither Company Subsidiary. (iiid) Neither Except as would not reasonably be expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2022, the Company, the Company Subsidiaries and, to the Company’s knowledge, any other Collaboration Partner are, and have been, in compliance with applicable Health Laws, including the FDCA and applicable regulations and Good Manufacturing Practices and other standards required by the FDA. As of the Agreement Date, neither the Company nor, to the Knowledge knowledge of the Company, any manufacturing site that assists in the manufacturing of the Company Product or material Company Product components (whether Company-owned or operated or that of a Collaboration Partner) has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export detention, refusal or prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, adverse findings, “warning letters,” “untitled letters” or similar written notice alleging or asserting material noncompliance with any applicable Health Law, and to the Company’s knowledge, no such action or proceeding is pending or threatened. (e) No Company, Company Subsidiary nor any of their respective employees, officers, or directors nor, to the CROsCompany’s knowledge, any Collaboration Partner have been debarred, delisted or similarly punished under any Law, including any Health Law, by any Governmental Entity or Regulatory Authority or convicted of a crime for which debarment is mandated or permitted by 21 U.S.C. § 355a, and the Company does not employ, or to the Company’s knowledge, contract with any individuals who are disqualified pursuant to 21 C.F.R § 312.70 or § 812.119. There have been no allegations or investigations against the Company, Company Subsidiary, any employee or the Company’s knowledge, any contractor, that could result in exclusion, debarment or disqualification. Additionally, and only to the extent applicable, none of the Company, any Company Subsidiary nor their respective directors, officers, employees or to the Company’s knowledge, Collaboration Partners has been restricted in any material respect, suspended, excluded or threated with exclusion from, participation in any federal or state health care program under any applicable Health Law. (af) No Company nor any Company Subsidiary currently is nor has been since January 1, 2022: (i) assessed a civil monetary penalty under any Health Law, (ii) party to a corporate integrity agreement with any Governmental Entity or Regulatory Authority, or (iii) subject to a deferred prosecution agreement, non-prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement, in each case, entered into with or imposed by any Governmental Entity or Regulatory Authority, or order of a Governmental Entity or Regulatory Authority mandating or prohibiting future or past activities in connection with the Company’s noncompliance with applicable Health Laws. (g) The Company and the Company Subsidiaries have not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (bii) failed to disclose a material fact required to be disclosed to the FDA or other any Governmental Entity Entity, or (ciii) committed any other act, made any statement or failed to make any statement, that (in any such case) ), at the time such disclosure or statement was made or failure to make occurred, establishes a reasonable basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the CompanyCompany nor any Company Subsidiary is, noror has since January 1, to Knowledge of the Company2022 been, any of its officers, CROs, agents or clinical investigators is the subject of any pending or threatened or, to the Company’s knowledge, threatened, investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable LawPolicy. (iv) None of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, clinical investigators or Affiliates has been debarred or convicted, or is subject to debarment or conviction, pursuant to Section 306 of the FDCA. In the course of the discovery, research and any other development of the Product (including in the conduct of any non-clinical research, safety and toxicology studies or clinical trials with respect to the Product), the Company has not, directly or indirectly, used any employee, agent, or independent contractor who has been (i) debarred by, or is the subject of debarment proceedings by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCA. (v) The Company’s and, with respect to the Product, the CROs’, use and dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all applicable Laws, contracts to which the Company or CRO is bound, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable and, in any event, in compliance with all applicable Laws and contracts. There have been no security breaches relating to, or violations of any security policy regarding, or any unauthorized access of, any data or information used by the Company or, with respect to the Product, the CROs.