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 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. (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. (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, 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 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 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. (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 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 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. (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 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 Each of the Company and the Company Subsidiaries holds, and is operating in material compliance with, such Company Permits 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”) required for the conduct of its business as currently conducted (collectively, the “Regulatory Permits”). Each of the Company and the Company Subsidiaries has fulfilled and performed all of its material obligations with respect to the Regulatory Permits, and no event has occurred which would allow, with or without notice or lapse of time, revocation or termination thereof or would result in any other material impairment of the rights of the holder of any Regulatory Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not have a Company Material Adverse Effect. Except to the extent disclosed on Section 3.28(a) of the Company Disclosure Schedule, each of the Company and the Company Subsidiaries has operated and currently is in compliance in all material respects with applicable statutes and implementing regulations administered or enforced by the FDA or any other Regulatory Authority, except where the failure to so comply would not have a Company Material Adverse Effect. (b) Since January 1, 2005, all of Company’s and the Company Subsidiaries’ Pharmaceutical Products that are subject to the jurisdiction of the FDA or other Regulatory Authorities in other jurisdictions are being manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed 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 the “CROs”) have obtained Company Subsidiaries in compliance in all Governmental Approvals required by material respects with all applicable requirements under any Governmental EntityRegulatory Permit or Laws, including applicable statutes and implementing regulations administered or enforced by the FDAFDA or other Regulatory Authority, including those relating to investigational use, premarket approval and applications or abbreviated applications to market a new Pharmaceutical Product. Since January 1, 2005, all material applications, submissions, information and data utilized by the Company or the Company’s Subsidiaries as the basis for, or submitted by or, 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 knowledge of the Company, on behalf of the Company or the Company’s Subsidiaries in connection with, any CROand all requests for a Regulatory Permit relating to the Company or any Company Subsidiary, and its respective business and Pharmaceutical Products, when submitted to the FDA or other Regulatory Authority, were true and correct in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Regulatory Authority. (c) Since January 1, 2005, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary have been, and if still pending are being, conducted in material compliance with all applicable Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except to the extent disclosed on Section 3.28(c) of the Company Disclosure Schedule, since January 1, 2005, no clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary 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, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary 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 ongoing clinical investigation conducted by or, to the knowledge of the Company, on behalf of the Company or any Company Subsidiary. (d) Except as set forth in Section 3.28(d) of the Company Disclosure Schedule, since January 1, 2005, neither the Company nor any Company Subsidiary has had any Pharmaceutical Product or manufacturing site (whether Company-owned or that of a contract manufacturer for Pharmaceutical Products) subject to a Regulatory Authority (including FDA) shutdown or import or export prohibition, nor received any communication from any Governmental Entity regardingFDA Form 483 or other Regulatory Authority written notice of material inspectional observations, any such Governmental Approvals“warning letters,” “untitled letters” or written requests to make material changes, any failure in each case as it applies to materially comply with applicable Laws the Pharmaceutical Products or any term of the Company’s manufacturing processes or requirement procedures that if not complied with would have a Company Material Adverse Effect. (e) To the knowledge of the Company, Section 3.28(e) of the Company Disclosure Schedule sets forth a list of all recalls, field notifications, market withdrawals or replacements, written warnings, “dear doctor” letters, investigator notices, safety alerts, post-approval “serious adverse event” reports or other material written notice of action relating to an alleged lack of safety or regulatory compliance of the Pharmaceutical Products issued by the Company and/or any such Governmental ApprovalCompany Subsidiary since January 1, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval2005 (“Safety Notices”). To the Knowledge Company’s knowledge, and except as disclosed in any item reference in Section 3.28(e) of the CompanyCompany Disclosure Schedule, there are no facts or circumstances that are would be reasonably likely to adversely affect any such Governmental Approvals. The Company, and result in (A) a material Safety Notice with respect to the Knowledge Pharmaceutical Products, or (B) a material change in the labeling of any of the Pharmaceutical Products. (f) Since January 1, 2005, all manufacturing operations conducted by or, to the knowledge of the Company, for 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 benefit 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 Company or any Company Subsidiary 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, includingincluding the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 for Pharmaceutical Products sold in the United States, but and the respective counterparts thereof promulgated by Regulatory Authorities in countries outside the United States, except where the failure to so comply would not limited to the FDCAhave a Company Material Adverse Effect. (g) Since January 1, good clinical practice requirements2005, 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 neither the Company, nor any CROCompany Subsidiary, 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, 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 or any other Regulatory Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities”, or similar policies, set forth in any applicable Laws. Neither Since January 1, 2005, none of the Company, northe Company Subsidiaries or, to Knowledge the knowledge of the Company, any of its officers, CROs, agents their respective officers or clinical investigators is the subject key employees has been convicted of any pending crime or threatened investigation by the FDA pursuant engaged in any conduct that has resulted, or would reasonably be expected to its Fraudresult, Untrue Statements of Material Factsin debarment under applicable Law, Briberyincluding, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment are pending, and Illegal Gratuities Final Policy the Company has not received written notice that any such claims, actions, proceedings or by investigations are threatened against the Company, the Company Subsidiaries, or any other Governmental Entity pursuant to any similar applicable Lawof their respective officers or key employees. (ivh) Each of the Company and the Company Subsidiaries, and to the knowledge of the Company its respective directors, officers, employees, and agents (while acting in such capacity) is, and at all times has been, in material compliance with all health care Laws applicable to the Company or any Company Subsidiary or by which any or their respective properties, businesses, products or other assets is bound or affected, including, to the extent applicable, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Medicare Program (Title XVIII of the Social Security Act), the Medicaid Program (Title XIX of the Social Security Act), the regulations promulgated pursuant to such Laws, requirements of the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, requirements of Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) state pharmaceutical assistance programs and regulations under such Laws (collectively, “Health Care Laws”). Since January 1, 2005, none of the Company or any Company Subsidiary has received any written notification, correspondence or any other written or communication from any Governmental Authority, including, without limitation, the FDA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of Inspector General, of potential or actual material non-compliance by, or liability of, the Company or any Company Subsidiary, under any Health Care Laws. (i) None of the CompanyCompany or any Company Subsidiary is a party to any corporate integrity agreements, the Sellers monitoring agreements, consent decrees, settlement orders, or the CROsother similar written agreements, nor in each case, entered into with or imposed by any of their respective officersRegulatory Authority, directorsother than any such agreement, employees, shareholders, consultants, agents, clinical investigators decree or Affiliates order that 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, previously disclosed 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 CROsOther Filing.

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. (a) Company and each of its Subsidiaries have obtained all authorizations, consents, licenses, permits (temporary or otherwise), orders, approvals, waivers, franchises and other rights ("Governmental Permits") of Governmental Entities (i) The pursuant to which Company or any of its Subsidiaries currently operates or holds any interest in any of its properties or (ii) that is required for the operation of Company's or any of its Subsidiaries' business or the holding of any such interest, and all of such Governmental Permits are in full force and effect, except where the failure to obtain or have any such Governmental Permits could not reasonably be expected to have a Material Adverse Effect on Company. There are no circumstances of which Company is aware which indicate that any such Governmental Permits may be revoked or not renewed or withdrawn or amended, in whole or in part (except in each case to an immaterial or beneficial extent). Schedule 2.18(a) sets forth a true and complete list of ---------------- all Governmental Permits held by Company or any of its Affiliates andSubsidiaries. (b) Company and its Subsidiaries have complied, and are in compliance, in all material respects with all applicable federal, state, local and self-regulatory laws, statutes, licensing requirements, rules, and regulations. Each of Company and its Subsidiaries has, and is in compliance in all material respects with, all Governmental Permits necessary to conduct their businesses, including, but not limited to, Governmental Permits of the OTS, the contract research organizations engaged to perform clinical trials on behalf FDIC, the SEC, the NASD, the NASD Regulation, Inc., the Nasdaq Stock Market, or any state or foreign securities or prosecutorial authority. Neither Company nor any of its Subsidiaries has received any notice from any Governmental Entity (i) asserting that Company or any of its Subsidiaries is not in compliance with any of the Company statutes, regulations, or ordinances that such Governmental Entity enforces or (ii) restricting or disqualifying their activities (except for restrictions generally imposed by law, rule, regulation or administrative policy on banking organizations generally). After giving effect to the “CROs”) have obtained Merger, all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct Permits of the Business Surviving Corporation and all such Governmental Approvals are its Subsidiaries shall continue to be valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor effect to the Knowledge same extent as they presently are for Company and its Subsidiaries, except for any conditions or restrictions imposed on Parent, Company or a Subsidiary in approvals issued by a Governmental Entity in connection with the Merger. There is no order issued, investigation or proceeding pending or (to Company's knowledge) threatened, or notice served, with respect to any violation of the Companyany law, any CROstatute, has received any communication from ordinance, order, writ, decree, rule, or regulation issued by any Governmental Entity regardingapplicable to either Company or any of its Subsidiaries or any of their respective directors, officers or employees. (c) Neither Company nor any of its Subsidiaries is a party or subject to, any such Governmental Approvalsagreement, any failure to materially comply with applicable Laws consent decree or any term order, or requirement of any such Governmental Approvalother understanding or arrangement with, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification directive of any such Governmental Approval. To the Knowledge of the CompanyEntity which imposes any material restrictions on, there are no facts or circumstances that are reasonably likely to adversely affect otherwise affects in any such Governmental Approvals. The Companymaterial respect, 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 Businessbusiness of Company or any of its Subsidiaries. All such filingsSchedule 2.18(c) ---------------- sets forth all compliance or enforcement proceedings or, representationsto the knowledge of Company, 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 investigations or submissions. (ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Companyinquiries convened, and all manufacturing operationsfines, 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”) sanctions and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Company, nor measures imposed by 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 actbody against, made any statement concerning or failed relating 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 officersSubsidiaries, CROsor any of their current respective directors, agents officers or clinical investigators employees. (d) Each of Company and its Subsidiaries, to the extent required to so register (the "Broker-Dealers"), is duly registered as a broker-dealer with the subject SEC and under all applicable state, federal, foreign or related laws and, to the extent required, is a member of the NASD and a member of SIPC. None of the Broker-Dealers has exceeded in any pending material respect the business activities enumerated in any membership agreements or threatened investigation by other limitations imposed in connection with its registrations, forms (including Form BDs and reports filed with the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy NASD or by any other Governmental Entity pursuant to any similar applicable LawEntity. The information contained in such registrations, forms and reports was true and complete in all material respects as of the date of the filing thereof with the SEC. Each such registration is in full force and effect on the date hereof. (ive) None Each of Company and its Subsidiaries, to the extent required to so register (the "Advisers"), is duly registered as an investment adviser under the Investment Advisers Act of 1940, as amended (the "Advisers Act"), and under all state, federal and foreign investment adviser or related laws pursuant to which it is required to be so registered. The information contained in forms and reports filed by any Advisors (including Form ADVs) was or will be true and complete in all material respects as 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 time of the FDCAfiling thereof with the SEC. 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 Each such registration is in compliance with all applicable Laws, contracts to which full force and effect on 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 CROsdate hereof.

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 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. 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 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. (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. (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. (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 Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Each of the Company (the “CROs”) have obtained and its Subsidiaries has filed and will file all Governmental Approvals required by any Governmental Entity, including the FDA, material documents and reports relating to permit the conduct each of the Business Company and all such Governmental Approvals are valid and its Subsidiaries required to be filed with the FRB, the FDIC (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 case of any Subsidiary 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 Companyif applicable), 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, CDFI 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, having jurisdiction over its business or any other Governmental Entity is considering of its assets or properties (each a “Regulatory Authority”). All such action reports conform or communication. (iii) Neither will conform in all material respects with the Companyapplicable requirements promulgated by such Regulatory Authorities and as of their respective dates, nor, to the Knowledge of the Company such documents and reports did not and will not contain 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 to the FDA stated therein or other Governmental Entity or (c) committed any other act, made any statement or failed necessary to make any statementthe statements therein, 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 light of the Companycircumstances under which they were made, not misleading. (b) Except as may otherwise be set forth on Schedule 4.9(b) of the Company Disclosure Schedule, neither the Company 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. Subsidiaries (ivi) 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 notis, directly or indirectly, used party or subject to any employeeorder, agentdecree, agreement, memorandum of understanding or similar arrangement with, or independent contractor who has been (i) debarred bya commitment letter or similar submission to, or is the subject of debarment proceedings byextraordinary supervisory letter from, any Governmental Entity Regulatory Authority or (ii) convicted pursuant has been advised by, or has any knowledge of facts which are reasonably expected to Section 306 give rise to an advisory notice by, any Regulatory Authority that such Regulatory Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any order, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission. Except as set forth on Schedule 4.9(b) of the FDCA. (v) The Company’s andCompany Disclosure Schedule, with respect all compliance or corrective action relating 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 any of useits Subsidiaries required by Regulatory Authorities having jurisdiction over the Company or any of its Subsidiaries has been taken. The Each of the Company and the CROs each maintain policies its Subsidiaries has paid all assessments made or imposed by 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 required to have been no security breaches relating to, or violations of heretofore paid to 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 Authority. PALOALTO 66463 v1 (2K) -25-

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) Online and each of its subsidiaries have obtained each federal, state, county, local or foreign governmental consent, license, permit, grant, or other authorization of a Governmental Entity (i) The Companypursuant to which Online or any of its subsidiaries currently operates or holds any interest in any of its properties or (ii) that is required for the operation or conduct of Online's or any of its subsidiaries' business or the holding of any such interest ((i) and (ii) herein collectively called "Online Authorizations"), and all of such Online Authorizations are in full force and effect and there are no circumstances which indicate that any of such Online Authorizations may not be renewed or withdrawn or amended, in whole or in part, except where the failure to obtain or have any of such Online Authorizations could not reasonably be expected to have a Material Adverse Effect on Online. (b) Online and its Affiliates andsubsidiaries have complied, and are in compliance, in all material respects with all applicable federal, state, local and self-regulatory laws, statutes, licensing requirements, rules, and regulations. Each of Online and its subsidiaries has, and is in compliance in all material respects with, all material Governmental Permits necessary to conduct their businesses, including, but not limited to, Governmental Permits of the SEC, the contract research organizations engaged NASD, the NASD Regulation, Inc., The Nasdaq Stock Market, any state or foreign securities or prosecutorial authority or any other Governmental Entity required to perform clinical trials on behalf operate their respective businesses and maintain their respective assets. Each of the Company (the “CROs”) have Online and its subsidiaries has obtained all material Governmental Approvals required by Permits of any Governmental Entity, including the FDA, to permit the conduct of the Business and all Governmental Entities required for the carrying on of its business and the maintenance of its assets and such material Governmental Approvals Permits are valid and in full force and effect, and there are no circumstances of which Online is aware which indicate that any of such material Governmental Approval has been or is being Permits may be revoked or challengednot renewed or withdrawn or (except to an immaterial or beneficial extent) amended, in whole or in part. SCHEDULE 3.18 to the Online Disclosure Schedule sets forth a true and complete list of all Governmental Permits held by Online or any of its subsidiaries or any of their respective employees (including all registered personnel). Neither the Company, Online nor to the Knowledge any of the Company, any CRO, its subsidiaries has received any communication notice from any Governmental Entity regarding(i) asserting that Online or any of its Subsidiaries is not in compliance in any material respect with any of the statutes, regulations, or ordinances that such Governmental Entity enforces or (ii) threatening to revoke cancel or not renew any Permit or (iii) restricting or disqualifying their activities. After giving effect to the Merger all Governmental Permits of the Online Surviving Corporation and its subsidiaries shall continue to be valid and in full force and effect to the same extent as they presently are for Online and its subsidiaries. There is no order issued, investigation or proceeding pending or (to Online's knowledge) threatened, or notice served which remains outstanding or unresolved, with respect to any material violation of any law, statute, ordinance, order, writ, decree, rule, or regulation issued by any Governmental Entity applicable to either Online or any of its subsidiaries or any of their respective directors, officers, employees or agents. (c) Neither Online nor any of its subsidiaries is a party or subject to, any such Governmental Approvalsagreement, any failure to materially comply with applicable Laws consent decree or any term order, or requirement of any such Governmental Approvalother understanding or arrangement with, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification directive of any such Governmental Approval. To Entity which imposes any material restrictions on, or otherwise affects in any material respect, the Knowledge conduct of the Companybusiness of Online or any of its subsidiaries. SCHEDULE 3.18 of the Online Disclosure Schedule sets forth all compliance or enforcement proceedings or, there are no facts to the knowledge of Online, examinations, inspections, investigations or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Companyinquiries convened, and all fines, sanctions and other measures imposed by any Governmental Entity or body against, concerning or relating to Online, any of its subsidiaries, any of their respective predecessor entities, or any of their respective directors, officers, employees or agents. (d) Each of Online and its subsidiaries, to the Knowledge extent required to so register (the "Online Broker-Dealers"), is duly registered as a broker-dealer with the SEC and under all applicable state, federal, foreign or related laws and is a member of the Company, NASD and a member of SIPC and the CROs, have Municipal Securities Rulemaking Board. Online has delivered or made available to Omega a true and complete copy of Online's currently effective Form BD as filed with the applicable Governmental EntitiesNASD, including the FDAa copy of any restriction agreement, its NASD membership agreement, and all Government Permits, including, all filingscurrently effective SEC, representations, declarations, listingsNASD, and state registrations. Online has also made available to Omega all prior Form BD's filed with the NASD and any state, as well as any state registration filings submitted on state specific forms. Online has also made available to Omega all correspondence between Online and any Governmental Entity, including the SEC, NASD and all applicable state regulators, within the last five years, and will provide Omega such forms and reports as are filed from and after the date hereof and prior to the Closing. None of the Online Broker-Dealers has exceeded in any material respect the business activities enumerated in any applicable restriction or submissions membership agreements or other limitations imposed in connection with its registrations, forms (including Form BDs) and reports filed with the NASD or any other Governmental Entity. The information contained in such registrations, forms and reports was or will be true and complete in all material respects as of the date hereof and, except as indicated on a subsequent registration form or report filed before the Closing, will continue to be true and complete in all material respects. Each such registration is in full force and effect, except where the failure to be so would not have a Material Adverse Effect on Online. (e) None of Online or any of its subsidiaries is required to be registered as an investment adviser under the FDCA Advisers Act or under any state, federal and foreign investment adviser or related laws. (f) None of Online, its subsidiaries or their respective operations are required to be registered as an investment company under the Public Health Service Investment Company Act of 19441940, 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. (iig) All nonclinical Schedule 3.18(g) of the Online Disclosure Schedule sets forth a list of all bank, brokerage and clinical investigations conducted or sponsored proprietary trading accounts maintained by or on behalf of the CompanyOnline, and all manufacturing operations, both with respect the persons authorized as signatories 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 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 communicationconduct transactions relating thereto. (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 CompanyExcept as would not reasonably be expected to have, its Affiliates andindividually or in the aggregate, the contract research organizations engaged to perform clinical trials on behalf a Company Material Adverse Effect, each of the Company and its Subsidiaries holds or is in the process of acquiring (A) all authorizations under the U.S. Food, Drug, and Cosmetic Act of 1938 (the “CROsFDCA”), and the applicable regulations of the U.S. Food and Drug Administration (the “FDA”) have obtained promulgated thereunder, (B) all authorizations under the U.S. Federal Insecticide, Fungicide and Rodenticide Act of 1910 (the “FIFRA”), the U.S. Food Quality Protection Act of 1996 (the “FQPA”) and the applicable regulations of the U.S. Environmental Protection Agency (the “EPA”) promulgated thereunder and (C) authorizations of the FDA, U.S. Department of Agriculture (“USDA”) and any other applicable Governmental Approvals required by Entity that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Company Products (any such Governmental Entity, including a “Company Regulatory Agency”), in each case, that is necessary for the FDA, to permit the conduct lawful operation of the Business and businesses of the Company or any of its Subsidiaries as currently conducted (the “Company Regulatory Permits”). Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Governmental Approvals Company Regulatory Permits are valid and in full force and effect, 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 Company and its Subsidiaries 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 in compliance with the applicable Governmental Entities, including the FDA, terms of 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 submissionsCompany Regulatory Permits. (iib) All nonclinical and clinical investigations conducted Except as would not reasonably be expected to have, individually or sponsored by or on behalf of in the Companyaggregate, and all manufacturing operationsa Company Material Adverse Effect, 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 each 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 Subsidiaries is in compliance with all regulations and requirements of the FDA, USDA, EPA and other Company Regulatory Agencies, including any applicable LawsGood Manufacturing Practices, contracts Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or repackaging requirements, laboratory controls, storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to which have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, all Company Products have been produced, distributed, labeled, marketed and sold, and all raw materials and ingredients in such products have been procured, in compliance in all material respects with all Applicable Laws governing the procurement, production, distribution, labeling and sale of such products, raw materials or ingredients. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, there have been no recalls, withdrawals or suspensions with respect to any Company Products produced, distributed, labeled, marketed or sold by the Company or CRO any of its Subsidiaries. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries has received any written notice of or otherwise 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 aware of, any data Company Regulatory Agency untitled letters, warning letters, notices of warning or information used by the Company orwithholding, suspension or withdrawal of inspection, seizure, criminal referral or other similar federal, state or private enforcement actions with respect to such Company Products. Except as would not reasonably be expected to have, individually or in the Productaggregate, a Company Material Adverse Effect, since January 1, 2019, neither the CROsCompany nor any of its Subsidiaries is subject (or has been subject) to any adverse inspection finding, recall, investigation, penalty assessment, audit or other compliance or enforcement action by the FDA, USDA, EPA and other Company Regulatory Agencies. (c) Neither the Company nor any of its Subsidiaries is party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency, except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.

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 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. (a) The Company and each of the Company Subsidiaries possesses all material Regulatory Authorizations from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Entities relating to the Company’s and each of the Company Subsidiaries’ product candidates (“Company Products”) or that are necessary for the Company or any of the Company Subsidiaries to conduct its business in all material respects as presently conducted. Except as would not reasonably be expected to be material to the businesses of 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 (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 Regulatory Authorizations are valid and in full force and effect, (ii) the Company and each of the Company Subsidiaries has fulfilled and performed all of its obligations with respect to such Regulatory Authorizations, and (iii) 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 to (1) the Knowledge Company and each of the CompanyCompany Subsidiaries has filed, any CROmaintained or furnished to FDA or other applicable Governmental Entities all required documents, has received any communication from any Governmental Entity regardingcorrespondences, any filings, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all reportable adverse event/experience reports) and (2) all such Governmental Approvals, any failure to materially comply submissions were complete and accurate and in compliance with applicable Laws Law when filed (or were corrected or completed in a subsequent filing). (b) All preclinical and clinical investigations conducted or sponsored by the Company or any term or requirement of any such Governmental Approvalthe Company Subsidiaries have been conducted in material compliance with applicable Law, or any revocationrules and regulations, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approvalincluding Good Clinical Practices. To the Knowledge of the Company, there are have been no facts serious 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 unanticipated adverse effects associated 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 Company Products during clinical trials that have not been reported 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 Entities as required by applicable Laws. Neither the FDA nor any other Governmental Entity performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company or any of the Company 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 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 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. Neither the Company nor any of the Company Subsidiaries has received any written notifications from any institutional review board, ethics committee or safety monitoring committee responsible for review, oversight, or regarding approval of any clinical trial involving a Company Product raising any material noncompliance of such studies issues that require or tests would require the termination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any, clinical trials proposed or currently conducted by, or on behalf of, the Company or any of the ProductCompany Subsidiaries, and and, to Knowledge of the Company, no such action has been threatened. With respect to each Company there is no reason to believe that any institution, institutional review boardProduct, the FDA, Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company or any other of the Company Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of the Company Subsidiaries and the applicable Governmental Entity is considering such action or communicationEntities, including the FDA. (iiic) Neither the Company, nor, to To the Knowledge of the Company, neither the Company nor any of the CROs, Company Subsidiaries has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity, (bii) failed to disclose a material fact required to be disclosed to the FDA or any 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 PolicyPolicy that is set forth in 56 Fed. Reg. 46191 (September 10, 1991). Neither the Company, nor, to Knowledge Company nor any of the Company, any of its officers, CROs, agents or clinical investigators Company Subsidiaries 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 or by any other Governmental Entity pursuant of the Company Subsidiaries nor, to the Knowledge of the Company, any officers, employees or agents of the Company or any of the Company 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 applicable Law or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (ivd) None Except as would not reasonably be expected to have a Company Material Adverse Effect, the Company and each of the Company Subsidiaries is and since January 1, 2020, has been in compliance with the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”) and applicable rules and regulations implementing the FDCA. Neither the Company nor any of the Company Subsidiaries is subject to any enforcement, regulatory or administrative proceedings regarding compliance with such Laws and, 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. (e) To the extent required by applicable Law, or is subject to debarment or conviction, pursuant to Section 306 the Knowledge of the FDCA. In Company, all manufacturing operations conducted for the course benefit 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 any Company Product used in human clinical trials have been conducted in accordance with GMP Regulations, except where the Product), failure to comply would not reasonably be expected to be material to the business of the Company. The Company has notnot engaged in activities that are, directly or indirectlyas applicable, used any employee, agentprohibited under, or independent contractor who has been (i) debarred cause for false claim liability, civil penalties, or mandatory or permissive exclusion from, Medicare, Medicaid or any other applicable Governmental Entity health care program. The Company is not a party to, or bound by, any Judgments, prosecution agreements, monitoring agreements or is the subject of debarment proceedings similar agreements with, or imposed by, any Governmental Entity or (ii) convicted pursuant to Section 306 of the FDCAEntity. (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) There is no civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against Company, and, to the Company’s Knowledge, the Company has no liability (whether actual or contingent) for failure to comply with the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. §301 et. seq., and all applicable regulations promulgated by the United States Food and Drug Administration (“FDA”) (collectively, “FDA Law and Regulation”) or any law or regulation of a comparable foreign regulatory or Governmental Authority. There has not been any material violation of any FDA Law and Regulation or any law or regulation of a comparable foreign regulatory or Governmental Authority by the Company in its product development efforts, submissions, record keeping and reports to FDA or a comparable Governmental Authority that could reasonably be expected to require or lead to investigation, corrective action or enforcement, regulatory or administrative action. (b) Each of the product candidates of the Company is being, and at all times has been, developed, tested, manufactured, labeled, promoted and stored, as applicable, in material compliance with FDA Law and Regulation and requirements of comparable foreign regulatory and Governmental Authorities. (c) The Companyclinical trials, its Affiliates andstudies and other preclinical tests conducted by the Company were, and if still pending, are, being conducted in all material respects in accordance with all experimental protocols, informed consents, procedures and controls of the contract research organizations engaged to perform Company and applicable FDA and foreign requirements including, but not limited to, good clinical trials practices, good laboratory practices, and FDA Law and Regulation including the protection of human subjects. The Company has not received any written notice from the FDA or any other regulatory or Governmental Authority requiring the termination or suspension or material modification of any animal study, preclinical study or clinical trial conducted by or on behalf of the Company. (d) With respect to all third party manufacturers and suppliers of key raw materials used by the Company (each a “Third Party Manufacturer”), the “CROs”Company has applied Supplier Evaluation and Controls comparable to those contemplated by 21 CFR 820 and ISO 13485 to seek to verify that all Third Party Manufacturers and to its Knowledge, each such Third Party Manufacturer (A) have obtained has complied and is complying, in each case in all Governmental Approvals required by any Governmental Entitymaterial respects, with all Laws, including the FDA, FD&C Act and any similar state or foreign Laws; and (B) has all material permits to permit the conduct of the Business perform its obligations as a Third Party Manufacturer and all such Governmental Approvals permits 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. . (e) 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 in connection 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 formationbusiness, conducted in material compliance with applicable Lawsno director, includingofficer, 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 employee 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 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 has: made 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 other Governmental Entity, (b) Authority; failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity Authority; or (c) committed any other an act, made any statement a statement, or failed to make any statement, a statement that (in any such case) establishes a reasonable would reasonably be expected to provide the basis for a Governmental Entity to allege a violation of an applicable Law, including without limitation, for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyGratuities,” as set forth in 56 Fed.Reg. 46191 (September 10, 1991). (f) Neither the CompanyCompany nor any director or officer of the Company is debarred or otherwise excluded from or restricted in any manner from participation in, norany government program or, to the Knowledge of the Company, any of its officers, CROs, agents or clinical investigators is the subject convicted of any pending crime or threatened investigation engaged in any conduct for which debarment is mandated or permitted by the FDA pursuant to its Fraud21 U.S.C. § 335a, Untrue Statements or convicted of Material Facts, Bribery, and Illegal Gratuities Final Policy any crime or by engaged in any other Governmental Entity pursuant to conduct for which such person could be excluded from participating in any similar applicable Lawfederal health care programs. (ivg) None The Company has complied with all applicable security and privacy standards regarding protected health information under HIPAA or any foreign equivalent and applicable privacy laws. (h) To the extent applicable, the Company has submitted to the FDA and all comparable foreign regulatory or Governmental Authorities for and received approval of all material registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations (the “FD&C Act Permits”) necessary to conduct the business of the Company as currently conducted. The Company is in material compliance with all such FD&C Act Permits. To the Knowledge of the Company, the Sellers no suspension, revocation, cancellation 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 withdrawal of the FDCA. In the course of the discoveryFD&C Act Permits is threatened and there is no basis for believing that such FD&C Act Permits will not be renewable upon expiration or will be suspended, research and any other development of the Product (including in the conduct of any non-clinical researchrevoked, safety and toxicology studies cancelled, modified 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 FDCAwithdrawn. (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 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 or submissions, including but not limited to adverse event reports and investigational new drug (“IND”) 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 Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissionssubmissions remain outstanding. (iib) All Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, 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, Company are being, and being or have been since the Company’s formation, conducted in material compliance with applicable LawsLaws and guidances, including, but not limited to the FDCA, good clinical practice : (i) Good Clinical Practices requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act ; (ii) applicable International Council for Harmonisation of 1996, Public Law 104-191 Technical Requirements for Pharmaceuticals for Human Use (“HIPAAICH”) guidelines, (iii) approved clinical protocols and other legal requirements informed consents, and (iv) 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 any institution, institutional review board, correspondence to the FDA, or any other Governmental Entity Company 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 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 communicationhave a Material Adverse Effect. (iiic) Neither To the Company’s knowledge, nor, to the Knowledge of neither the Company nor any of entity acting on the CROs, Company’s behalf 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 Companydate of this Agreement, neither the Company nor, to Knowledge of the Company’s knowledge, any of its officers, CROs, agents or clinical investigators entity acting on the Company’s behalf 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 nor, to the knowledge of the Company, any officers, employees, agents or by clinical investigators of the Company or any other Governmental Entity pursuant entity or individual acting on the Company’s behalf 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 applicable Law or (b) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (ivd) None of the CompanyExcept as, the Sellers individually 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 would not reasonably be expected to the Product)have a Material Adverse Effect, the Company has notis in compliance and since January 1, directly or indirectly2020, 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 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)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Federal Food, Drug and Cosmetic Act (“FDCA”) or Public Health Service Act (“PHS Act”) and the regulations and guidances issued pursuant to the FDCA and PHS Act; (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 thereto; (iv) Laws which are cause for exclusion from any federal health care program; and (v) 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 the Company. The Company is not subject to any enforcement, regulatory or Legal Proceeding against or affecting the Company relating to or arising under the FDCA, PHS Act, the Anti- Kickback Statute, or similar Laws, and no such enforcement, regulatory or Legal Proceeding has been threatened, including by the issuance of a warning letter, untitled letter, or Form 483, or similar notice of potential violations of healthcare laws. (e) To the extent required by applicable Laws, contracts to which all manufacturing operations conducted for the benefit 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 any product candidate being used in human clinical trials have been conducted in accordance with GMP Regulations, except where the Productfailure to comply would not, individually or in the CROsaggregate, reasonably be expected to have a Material Adverse Effect.

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. (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 Company, its Affiliates andExcept as described in the Registration Statement and the Prospectus, the contract research organizations engaged to perform preclinical and clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required studies conducted by any Governmental Entity, including the FDAor, 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 knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, the “Studies”), were, and if still pending are, being conducted in all material respects in accordance with all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”). The Company has no knowledge of any CROother studies not described in the Registration Statement and the Prospectus, has the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus. The Company and its subsidiaries are, and since May 1, 2018, have operated in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities and all other applicable federal, state or foreign health care laws and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export, or disposal of any product candidates under development by the Company or any of its subsidiaries (collectively, the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its subsidiaries, to the knowledge of the Company, have received any communication written notices, correspondence or other communications from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws the Regulatory Authorities or any term other governmental agency requiring or requirement threatening the termination or suspension of any such Governmental ApprovalStudies, or any revocationand, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To to the Knowledge knowledge of the Company, there are no facts reasonable grounds for the same. Except as would not, whether singly or circumstances in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries has received any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that are reasonably likely to adversely affect it is in violation of any such Governmental Approvals. The CompanyHealth Care Laws, and and, to the Knowledge knowledge of the Company, the CROsno such claim, have filed with the applicable Governmental Entitiesaction, including the FDAsuit, all filingsproceeding, representationshearing, declarationsenforcement, listingsinvestigation, and registrations, as well as all reports arbitration 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 action has 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 informationthreatened. 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, its subsidiaries 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 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 ’s or the CROs, nor any of their respective its subsidiaries’ officers, directors, employees, shareholderscontractors or agents is a party to any corporate integrity agreements, consultantsdeferred prosecution agreements, agentsmonitoring agreements, clinical investigators consent decrees, settlement orders, or Affiliates similar agreements with or imposed by any Regulatory Authority with respect to Health Care Laws. Neither the Company, any of its subsidiaries nor, to the knowledge of the Company, any of the Company’s or its subsidiaries’ employees, officers, directors, contractors or agents has been excluded, suspended or debarred from participation in any U.S. federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) or convicted, human clinical research or is subject to debarment a governmental inquiry, investigation, proceeding or convictionother similar action that would reasonably be expected to result in such debarment, 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 suspension 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 FDCAexclusion. (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 possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Bodies relating to the Company’s and each of its Subsidiaries’ products and product candidates (“Company 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 a Material Adverse Effect, (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 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, but not limited to the FDCAregulations and guidances, 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, clinical studies proposed or currently conducted by, or on behalf of, the Company or any other Governmental Entity is considering 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 and reasonably available to 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, in each case with respect to any clinical studies proposed or currently conducted by, or on behalf of, the Company or any of its Subsidiaries. (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 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 As of the Companydate of this Agreement, neither the Company nor any of its officers, CROs, agents or clinical investigators Subsidiaries 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 or by any other Governmental Entity pursuant of its Subsidiaries nor, to any similar applicable Law. (iv) None the knowledge of the Company, the Sellers or the CROs, nor any of their respective officers, directors, employees, shareholders, consultants, agents, agents or clinical investigators of the Company or Affiliates any of its Subsidiaries 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 research, safety and toxicology studies crime or clinical trials with respect engaged in any conduct that would reasonably be expected to the Product)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 has notand each of its Subsidiaries is and since January 1, directly or indirectly2019, 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 healthcare laws applicable Lawsto the operation of its business as currently conducted, contracts 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.); (ii) the Federal Food, Drug and Cosmetics Act (“FDCA”); (iii) the Health Insurance Portability and Accountability Act of 1996 and the Health Information and Technology for Economic and Clinical Health Act (collectively “HIPAA”); (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) Legal Requirements relating to which 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 CRO any of its Subsidiaries. Neither the Company nor any of its Subsidiaries is boundsubject to any enforcement, privacy policies and terms of use. The Company and the CROs each maintain policies and procedures regulatory or administrative proceedings regarding data security and privacy and maintains administrative, technical and physical safeguards that are commercially reasonable compliance with healthcare laws and, in to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. To the knowledge of the Company, neither the Company nor 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 its Subsidiaries has had any unauthorized access of, any data use or information disclosure of “protected health information” (as such term is used by under HIPAA) that would constitute a security incident or breach that would require the Company orto provide notice under HIPAA. (e) To the extent required by applicable Legal Requirements, all manufacturing operations conducted for the benefit of the Company with respect to any Company Product used in human clinical trials have been conducted in accordance with GMP Regulations, except where the Product, the CROsfailure to comply would not reasonably be expected to have a Material Adverse Effect.

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. (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. (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. (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf Except as is set forth in Section 4.12 of the Company Disclosure Letter: (a) Except as would not reasonably be expected to have a Material Adverse Effect, the “CROs”) have obtained Company and the Company Subsidiary are in compliance in all respects with all healthcare laws applicable to the operation of their respective businesses as currently conducted. Neither the Company nor the Company Subsidiary has received any written notice from the FDA or any other Governmental Approvals required by Body alleging noncompliance with any Governmental Entity, including such provision of Law. Neither the FDA, Company nor the Company Subsidiary is subject to permit any Legal Proceedings relating to or arising under the conduct of the Business and all such Governmental Approvals are valid and in full force and effectFDCA or similar Laws, and no such Governmental Approval Legal Proceeding has been or is being revoked or challenged. Neither threatened. (b) The Company and 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, Company Subsidiary have filed with the applicable FDA or any other Governmental Entities, including the FDA, Body all required filings, representations, declarations, listings, and notices, registrations, as well as all reports and submissions, except where the failure to make any filings, declarations, listings, notices, registrations, reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amendeddoes not have, and their implementing regulationswould not reasonably be expected to have, as well as adverse event reports and all other submitted data relating to individually or in the Product required to be filed or submitted to permit the conduct of the Businessaggregate, a Material Adverse Effect. All such filings, representations, declarations, listings, notices, registrations, reports and submissions were in material compliance with applicable Laws when filed, remain in full force and effect, and no material deficiencies have been asserted in writing by any applicable Governmental Entity Body with respect to any such filings, representations, declarations, listinglistings, notices, registrations, reports or and submissions. (iic) All To the Knowledge of the Company, except as set forth in documents made available to Parent or its Representatives prior to the date of this Agreement, all nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, Company and all manufacturing operations, both with respect to the Product, Company Subsidiary are being, and have been since the Company’s formation, being conducted in material compliance with applicable Laws, includingincluding Good Laboratory Practices, but not limited to the FDCAGood Clinical Practices, good clinical practice requirementsand 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 guidance restricting the use and disclosure of individually identifiable health information. Neither the Company, Company nor any CRO, the Company Subsidiary has received any written notice, correspondence or other communication notice from any institution, institutional review board, the FDA, FDA or any other Governmental Entity Body with respect to any completed, ongoing clinical trial or planned non-clinical trial or nonclinical studies test requiring or tests sponsored 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 with any applicable Laws with respect thereto. Neither the Company nor the Company Subsidiary is the subject of such studies or tests of any pending or, to the Product, and to Knowledge of the Company there is no reason to believe that any institutionCompany, institutional review boardthreatened, investigation by the FDA, FDA or any other Governmental Entity is considering such action or communicationBody. (iiid) Neither the Company, the Company Subsidiary 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, 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 research, safety and toxicology studies crime or clinical trials with respect engaged in any conduct that would reasonably be expected to the Product), the Company has not, directly result in (A) debarment under 21 U.S.C. Section 335a 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 similar Law or (iiB) convicted pursuant to exclusion under 42 U.S.C. Section 306 of the FDCA1320a-7 or any similar Law. (ve) The Company’s and, with respect to the ProductNotwithstanding any other provision of this Agreement, the CROs’, use representations and dissemination warranties contained in this Section 4.12 constitute the sole and exclusive representations and warranties 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 Company Subsidiary relating to FDA matters 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, FDCA 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 CROssimilar Laws.

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 (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 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, 21 U.S.C. § 335a or any unauthorized access ofsimilar Law, any data or information used by the Company or, with respect to the Product, the CROs.(B) excluded from participation in federal health care programs under 42 U.S.C.

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 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 CompanyBioTE Companies have obtained all Permits that are necessary for the development, its Affiliates andtesting, the contract research organizations engaged to perform clinical trials on behalf manufacturing, packaging, labeling, distribution, promotion, storage, sale, marketing, import or export of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental EntityProducts as presently conducted, including the FDA, to permit the conduct and each of the Business and all such Governmental Approvals are Permits is valid and in full force and effect. There is no Proceeding pending, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CROthreatened, has received any communication from any Governmental Entity regardingthat would result in the termination, revocation, suspension or the imposition of a restriction on any such Governmental ApprovalsPermit or the imposition of any fine, any failure to materially comply with applicable Laws penalty or any term or requirement other sanction for the violation of any such Governmental ApprovalPermit. (b) Since January 1, or any revocation2016, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge all of the CompanyCompany Products are being and have been manufactured, there are no facts or circumstances that are reasonably likely to adversely affect processed, developed, packaged, labeled, promoted, marketed, sold, stored, tested, distributed, imported and exported in material compliance with all applicable requirements under any such Governmental Approvals. The Companyapplicable Law, including all Regulatory 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 to the Knowledge reporting of the Company, the CROs, corrections and removals. (c) The BioTE Companies have timely filed with the applicable regulatory authorities (including, without limitation, the FDA or any other Governmental Entities, including Entity 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 Regulatory 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 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 or was corrected in or supplemented by a subsequent filing, both with respect and (ii) any material and legally necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the Product, are being, and have been since applicable Governmental Entity. (d) Except as set forth in Section 3.20(d) of the Company’s formationDisclosure Letter, 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, no BioTE Company has received any written notice, correspondence or other communication from notification of 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, norpending or, to the Knowledge of the Company, threatened (i) Proceeding or Order alleging potential or actual non-compliance with any Permits or Regulatory Laws; or (ii) non-ordinary course audit, inspection or investigation by any Governmental Entity. (e) No Company Product has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing and, to the Knowledge of the Company, 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 any BioTE Company. (f) Except as set forth in Section 3.20(f) of the Company’s Disclosure Letter, no BioTE Company has received or been subject to any action, notice, warning, administrative proceeding, review, or investigation by a Governmental Entity, including any FDA Form 483, FDA warning letter or untitled letter or any similar notice, that (i) alleged or asserted that a BioTE Company violated any applicable Regulatory Laws, (ii) commenced, or threatened to initiate, any Proceeding or Order to withdraw a premarket clearance or investigational device exemption of any Company Product or product candidate, (iii) commenced, or threatened to initiate, any Proceeding or Order to enjoin manufacture or distribution of any Company Product or product candidate; or (iv) commenced, or threatened to initiate any action, suit, claim, investigation, proceeding or order to change the labeling or classification of any Company Product or product candidate. (g) To the Knowledge of the Company, none of the BioTE Companies nor any of the CROstheir respective officers, directors, employees, or agents has (ai) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity, (bii) failed to disclose a material fact required to be disclosed to the FDA or any 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 any applicable Law and/or Regulatory Law, including without limitation, for . None of the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, BioTE Companies nor, to the Knowledge of the Company, any of its their respective officers, CROsdirectors, employees, 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 Entity pursuant to any similar applicable Regulatory Law. (ivh) None 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 each BioTE Company is and 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 operated 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 all material respects in compliance with all applicable Contracts of any BioTE Company and all applicable Health Care Laws relating to the BioTE Companies’ respective business during the last six (6) years. No BioTE Company has been notified in writing during the last six (6) years of any violation or alleged violation of any Health Care Laws, contracts except as disclosed in Section 3.20(f) of the Company’s Disclosure Letter. (i) Each of the BioTE Companies is in possession of all Permits of all Governmental Entities material to which the Company conduct of such BioTE Company’s business as presently conducted. A complete list of all such Permits is set forth in Section 3.20(i) of the Company’s Disclosure Letter. Except as set forth in Section 3.20(i) of the Company’s Disclosure Letter, all Permits required to be set forth on Section 3.20(i) of the Company’s Disclosure Letter are in full force and effect in all material respects and no such Permit will be subject to material loss or CRO is boundlimitation or obligation to re-apply, privacy policies and terms as a result of usethe consummation of the transactions contemplated by this Agreement. The Company and No event has occurred that, with or without notice or lapse of time or both, would reasonably be expected to result in the CROs each maintain policies and procedures regarding data security and privacy and maintains administrativerevocation, technical and physical safeguards that are commercially reasonable andsuspension, lapse or limitation of any Permit set forth in Section 3.20(i) of the Company’s Disclosure Letter. (j) None of the BioTE Companies have, directly or indirectly: (i) offered, paid or received, or made arrangements to offer, pay or receive, any remuneration, in cash or in kind, to any eventpast, present or potential customers or providers, past or present suppliers, patients, contractors or third-party payors in compliance order to obtain business or payments from such Persons that would reasonably be expected to subject any BioTE Company to any material damage or penalty in any civil, criminal or governmental litigation or proceeding, (ii) given or agreed to give, or has knowledge that there has been made or that there is any agreement or other arrangement to make, any improper, noncompliant or illegal gift or gratuitous payment of any kind, nature or description (whether in money, property or services) to any customer or potential customer, patient or potential patient, supplier or potential supplier, contractor, third-party payor or any other Person, other than in connection with all applicable Laws promotional or entertainment expenses in the ordinary and contracts. There have lawful conduct of business; (iii) made or agreed to make, or has knowledge that there has been no security breaches relating made or that there is any agreement or other arrangement to make, any contribution, payment or gift of funds or property to, or violations of any security policy regarding, or any unauthorized access for the private use of, any data Governmental Entity where either the contribution, payment or information gift is or was illegal under applicable Laws under which such payment, contribution or gift was made; (iv) established or maintained any unrecorded fund or asset for any purpose or made any false or artificial entries on any of its books or records for any reason in material violation of Health Care Laws; (v) made, or agreed to make, or has Knowledge that there has been made or that there is any agreement or other arrangement to make, any payment to any Person with the intention or understanding that any part of such payment would be used for any unlawful purpose other than any legitimate business purpose as described in the documents supporting such payment; or (vi) paid, offered to pay, accepted or offered to accept any illegal remuneration for any referral in violation of the Health Care Laws. Except as set forth in Section 3.20(j) of the Company’s Disclosure Letter, none of the BioTE Companies are a party to any Contract (including any joint venture or consulting agreement) with any physician, health care facility, hospital, or other licensed health care professional or other Person who is in a position to make or influence referrals to or otherwise generate business for any BioTE Company to provide services, lease space, lease equipment or engage in any other venture or activity. (k) Each of the BioTE Companies maintains compliance protocols, including policies and procedures, designed to promote compliance with applicable Laws including without limitation the Health Care Laws, compliance driven culture and ethical standards, to improve the quality and performance of operations, and to detect, prevent, and address violations of legal or ethical standards applicable to the operations of the BioTE Companies (the “Compliance Program”). Each of the BioTE Companies have taken all actions necessary to comply in all material respects with all requirements of the Compliance Program. None of the BioTE Companies (i) is a party to a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General; (ii) has reporting obligations pursuant to any settlement agreement entered into with any Governmental Entity; (iii) has been the subject of any federal or state governmental reimbursement program investigation conducted by any federal or state enforcement agency other than audits conducted in the ordinary course of business; (iv) has been a defendant in any unsealed qui tam/False Claims Act litigation; and/or (v) has been served with or received any search warrant, subpoena, civil investigation demand or contact letter from any federal or state enforcement agency related to its respective participation in any federal or state governmental reimbursement program. (l) None of the BioTE Companies receives any reimbursement from any health insurer, whether a private or governmental payor, for the Company Product or services of any BioTE Company. The BioTE Companies receive payments from providers for the Company Products and services provided by the Company orBioTE Companies at fair market value, with respect and to the ProductKnowledge of the Company, these payments are not billed to any health insurer, whether a private or governmental payor, or otherwise passed along in any way to any private or government payor. No BioTE Company bills or participates in any way in any reimbursement program, including federal, state, local, and private health insurance programs. (m) None of the BioTE Companies nor any officer, employee, contractor, or agent of any BioTE Company, has (i) been convicted or sanctioned of any crime or engaged in any conduct for which debarment is mandated or authorized by 21 U.S.C. § 335a or excluded pursuant to 42 U.S.C. § 1320a-7, nor has any such Person been so debarred, (ii) been convicted or sanctioned of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under 42 U.S.C. § 1320a-7, nor has any such Person been excluded from participation in such programs, (iii) been convicted of or charged or threatened in writing with prosecution or is under an investigation or subject to any enforcement action by a Governmental Entity, including the Center for Medicare and Medicaid Services, the CROsU.S. Department of Health and Human Services Officer of Inspector General, Office for Civil Rights and the U.S. Department of Justice, or assessed any Civil Monetary Penalty, for any violation of a Health Care Law or any Law applicable to a federal or state government health care reimbursement program, and/or (iv) been subject to reporting obligations pursuant to a deferred prosecution agreement, consent decree, settlement, integrity agreement, corrective action plan, or other similar obligations, Order, or agreement with any Governmental Entity. (n) The Company is not subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and does not receive any “Protected Health Information” (as defined by HIPAA) from any entity that is a covered entity or business associate under HIPAA.

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). (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 Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf each of the Company (the “CROs”) have obtained and its Subsidiaries hold all Governmental Approvals material Permits required by any Governmental Entityto own, including the FDAlease, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effectmaintain, operate, and no such Governmental Approval has been or is being revoked or challengedconduct its business as currently conducted. Neither Since January 1, 2019, neither the Company, Company nor to the Knowledge any of the Company, any CRO, its Subsidiaries has received any communication written notice from any Governmental Entity regarding, Authority regarding (a) any such Governmental Approvals, any actual or possible material violation of or material failure by the Company to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, Permit or (b) any actual or possible revocation, withdrawal, suspension, cancellation, material limitationtermination, termination or material modification of any such Governmental Approval. To Permit. (b) Except as has not had and would not reasonably be expected to have, individually or in the Knowledge of the Companyaggregate, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of a Material Adverse Effect on the Company, the CROs, have Company or its applicable Subsidiary has filed with the applicable Governmental Entities, regulatory authorities (including the FDA, FDA or any other Governmental Authority) 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 or submissions, including but not limited to adverse event reports and registrations and reports required to be filed with xxxxxxxxxxxxxx.xxx, and all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws Applicable Law when filedfiled (or were corrected or supplemented by a subsequent submission) and since January 1, and no material 2019, the Company has not received written notice of any deficiencies have been asserted in writing by any applicable Governmental Entity Authority with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (iic) All nonclinical Except as has not had and clinical investigations conducted would not reasonably be expected to have, individually or sponsored by or in the aggregate, a Material Adverse Effect on behalf of the Company, the Company’s and all manufacturing operationsits Subsidiaries’ products and product candidates, both with respect to including the Product, are beingbeing and since January 1, and 2019, have been since the Company’s formationbeen, conducted in material compliance with applicable Lawsresearched, includingdeveloped, but not limited to the FDCAtested, good clinical practice requirementsstudied, good laboratory practice requirementsmanufactured, GMPprocessed, ICH principles and Health Insurance Portability and Accountability Act of 1996packaged, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually identifiable health information. Neither the Companystored, nor any CROsupplied, has received any written noticelicensed, correspondence imported, exported, distributed, labeled, advertised, promoted, marketed, commercialized, sold or other communication from any institutiondisposed, institutional review boardas applicable, 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 its Subsidiaries in compliance with the FDCA and other applicable Healthcare Laws. As of the date of this Agreement, since January 1, 2019, none of the Company or any of its Subsidiaries has received any written notices or other written communication from the FDA or any other Governmental Authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests, . (d) The Company has provided or regarding material noncompliance made available to Parent prior to the date hereof complete and correct copies of such studies or tests of the Product, and each IND filed with respect to Knowledge any product candidate of the Company there is no reason to believe that currently being developed by the Company, including any institutionmaterial supplements and amendments thereto, institutional review boardin each case, as of the FDA, or any other Governmental Entity is considering such action or communicationdate hereof. (iiie) Neither Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, nor, to the Knowledge of none the Company or 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 EntityAuthority, (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, including with respect to scientific data or information, that (in any such case) establishes at the time such 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 Fraudfraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final PolicyPolicy or for any Governmental Authority to invoke any similar policy or law. Neither the Company, nor, to Knowledge As of the Companydate of this Agreement, none of the Company or any of its officers, CROs, agents or clinical investigators Subsidiaries is the subject of any pending or or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraudfraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Entity pursuant to any similar applicable Law. (iv) Policy. None of the Company, the Sellers or the CROs, nor any of their respective its Subsidiaries, or any directors, officers, directors, employees, shareholdersor, consultantsto the knowledge of the Company, agents, agents or clinical investigators of the Company or Affiliates any of its Subsidiaries, has been excluded, 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 law or (b) exclusion under 42 U.S.C. Section 1320a 7 or any similar law. (f) Except as has not had and would not reasonably be expected to have, individually 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 a Material Adverse Effect on the Product)Company, 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 its Subsidiaries are in 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 Lawsto the operation of their respective businesses as currently conducted, contracts 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)) and the civil False Claims Act (31 U.S.C. Section 3729 et seq.); (ii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act; and (iii) laws which are cause for debarment, suspension or exclusion from any federal health care program. The Company has not received written notice of any enforcement, regulatory or administrative action or proceeding that is pending, and, to which the knowledge of the Company, no such enforcement, regulatory or administrative action or proceeding has been threatened in writing, against the Company or CRO any of its Subsidiaries under the FDCA, the Public Health Service Act (42 U.S.C. § 256b), the Anti-Kickback Statute or other Healthcare Laws, other than any such proceeding that would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect on the Company. Neither the Company or any of its Subsidiaries is bounda party to or has any ongoing reporting obligations pursuant to, privacy policies any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction, or similar agreements with or imposed by a Governmental Authority. (g) Except as has not had and terms of use. The would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, the Company and its Subsidiaries, and to the CROs knowledge of the Company, each maintain policies Development Partner, hold all Governmental Authorizations from the FDA and procedures regarding data security and privacy and maintains administrative, technical and physical safeguards all other Governmental Authorities that are commercially reasonable andrequired for the conduct of the Company’s and its Subsidiaries’ businesses as currently conducted, and all such Governmental Authorizations are (i) in any eventfull force and effect, (ii) validly registered and on file with applicable Governmental Authorities, if any, and (iii) in compliance with all applicable Laws formal filing and contractsmaintenance requirements and, to the knowledge of the Company, the consummation of the transactions contemplated by this Agreement, in and of themselves, would not cause the revocation or cancellation of any such Governmental Authorization held by the Company and its Subsidiaries. There Since January 1, 2019, the Company and its Subsidiaries have not received written notice of any pending or threatened claims, actions, suits or other proceedings in law or in equity, or investigations, relating to the suspension, modification, revocation, or cancellation in each case before or by any Governmental Authority with respect to any such Governmental Authorization. (h) Since January 1, 2019, there have been no security breaches recalls, field notifications, market withdrawals or replacements, “dear doctor” letters, investigator notices, IND safety reports, serious adverse event reports or other notices of action relating to, to a safety concern or violations alleged lack of regulatory compliance of any security policy regardingproduct or product candidate, or any unauthorized access of, any data or information used by the Company or, with respect to including the Product, of the CROsCompany or any of its Subsidiaries. (i) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, the Company, its Subsidiaries and, to the Knowledge of the Company, all Development Partners in connection with any product or product candidate of the Company or any of its Subsidiaries, have implemented compliance programs that conform to and ensure material compliance with applicable Healthcare Laws and industry standards. (j) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, no Person has filed against the Company or any of its Subsidiaries any action relating to the Company or any of its Subsidiaries under any applicable federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (k) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, there are no claims, actions or proceedings pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries, in each case, alleging that the Company or any of its Subsidiaries has any liability (whether in negligence, breach of warranty, strict liability, failure to warn or otherwise) arising out of or relating to any claimed injury or damage to individuals or property as a result of the claimed ownership, possession, exposure to or use of any product or product candidate, including the Product, of the Company or any of its Subsidiaries.