Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures of (i) The Company, its Affiliates and, the following contract research organizations engaged to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each 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 its Subsidiaries has timely all such Governmental Approvals are valid and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses in full force and submissionseffect, 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 similar documents, together with any amendments submitted data relating to the Product required to be made with respect thereto, that filed or submitted to permit the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures conduct of the following to be true as would not be reasonably expected to beBusiness. All such filings, individually or representations, declarations, listings, registrations, reports and submissions were in the aggregatematerial compliance with applicable Laws when filed, and no material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception deficiencies have been asserted in writing by the Company or any of its Subsidiaries 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 documents described in the first sentence of this Section 3.21Company, and as 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 their respective dates1996, 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 documents complied in all studies or tests, or regarding material respects with all requirements noncompliance of applicable Law such studies or tests of the Product, and did not contain 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 omit fraudulent statement to state the FDA or any Governmental Entity, (b) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order 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 statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company, nor, to Knowledge of the circumstances under which they were madeCompany, not misleadingany 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. Except for such failures to be in compliance as would not reasonably be expected to beIn the course of the discovery, individually or research and any other development of the Product (including in the aggregateconduct of any non-clinical research, material safety and toxicology studies or clinical trials with respect to the Company and its Subsidiaries taken as a wholeProduct), 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 its Subsidiaries are dissemination of any personally-identifiable information or Protected Health Information (as defined under HIPAA) concerning individuals is in compliance with all formal written Governmental Authority directives 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 formal written undertakings made 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 its Subsidiaries or, with respect to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental AuthorityProduct, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectthe CROs.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the (a) The Company and each of its Subsidiaries taken as a wholepossesses all material approvals, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reportsauthorizations, schedulescertificates, formsregistrations, Permit applications or renewalslicenses, examination responses and submissionsexemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (“EMA”) and all other similar documents, together with any amendments required to be made with respect thereto, applicable Governmental Bodies that the Company or any of its Subsidiary was Subsidiaries are required to file since January 1, 2017 possess relating to the date products and product candidates sponsored, manufactured, studied, marketed or sold by or on behalf of this Agreement, with the Company or any Governmental Authority and timely paid of its Subsidiaries (“Company Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all fees and assessments due and payable in connection therewithmaterial respects as presently conducted. Except for such failures of the following to be true as would not reasonably be reasonably expected to behave a Material Adverse Effect, individually (i) all such Regulatory Authorizations are (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 event has occurred which allows, or in the aggregateafter notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to be material to the Company, (1) the Company and each of its Subsidiaries taken has filed, maintained or furnished to FDA or other applicable Governmental Bodies all required filings, 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 compliance with applicable Legal Requirements when filed (or were corrected or completed in a subsequent filing). (b) Except as would not reasonably be expected to have a wholeMaterial Adverse Effect, there is no unresolved violation all preclinical and clinical investigations sponsored by the Company or exception any of its Subsidiaries are being conducted in material compliance with applicable Legal Requirements, rules and regulations, including Good Clinical Practices. Neither the FDA nor any other Governmental 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 ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. Neither the Company nor any 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 termination, 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 of its Subsidiaries, and, to knowledge of the documents described 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 first sentence possession of the Company or any of its Subsidiaries and all material written correspondence that exists as of the date of this Section 3.21Agreement between the Company or any of its Subsidiaries and the applicable Governmental Bodies. (c) To the knowledge of the Company, and as neither the Company nor any of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any its Subsidiaries has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any Governmental Body or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. As of the circumstances date of this Agreement, neither the Company nor any of its Subsidiaries has been notified that it is the subject of any pending 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. Neither the Company, any of its Subsidiaries or any of its officers or employees nor, to the knowledge of the Company, any agents or clinical investigators of the 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 which they were made, not misleading. 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 for such failures to be in compliance as would not reasonably be expected to behave a Material Adverse Effect, the Company 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 its Subsidiaries has been notified that it is subject to any enforcement, regulatory or administrative proceedings regarding compliance with healthcare laws and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. Neither the Company nor any of its Subsidiaries has had any unauthorized use or disclosure of Protected Health Information (as such term is used under HIPAA) 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, material 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 Company jurisdiction of the FDA are, and its Subsidiaries taken as a wholesince January 1, 2019 have been, formulated, manufactured, tested, packaged, and distributed in compliance in all material respects with all applicable requirements under the FDCA. Since January 1, 2019, all manufacturing operations conducted by or for the benefit of the Company and 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 Subsidiaries are 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 compliance with all formal written Governmental Authority directives and with all formal written undertakings made by respect of the Company or its Subsidiaries 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 otherwise received by the Company from any source, 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 any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectProduct.

Regulatory Matters. Except for such failures of (a) The Company and the following to be true as Company Subsidiaries have not been established and would not be reasonably expected to be, individually or in the aggregate, material administer compliance programs (including written compliance policies) applicable to the Company and its the Company Subsidiaries taken (i) to assist the Company, the 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 Company Subsidiaries or their businesses and (ii) to provide compliance policies governing activities and requirements applicable to medical device companies (including pre-clinical and clinical testing, product design and development, product testing, product manufacturing, product labeling, product storage, pre-market clearance and approval, marketing, advertising and promotion, product sales and distribution, medical device recall and reporting regulations, and record keeping). (b) Except as a whole, each set forth in Part 3.18(b) of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reportsDisclosure Schedule, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there each Company Subsidiary is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with all requirements 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 applicable Law 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 did not contain statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any untrue statement and all requests for authorizations, approvals, certificates, waivers, certifications, clearances, exemptions, notifications, consents, orders, registrations, licenses or permits of a 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 fact respects and in conformance with Legal Requirements as of the date of submission and any updates, changes, corrections or omit modification to state a material fact such applications, submissions, information and data which were or are necessary or required to be stated therein filed, maintained, or necessary furnished to the FDA or other Governmental Entities have been timely filed, maintained, or furnished and were true, complete and correct in order to make the statements therein, all material respects and in light conformance with Legal Requirements as of the circumstances under which they were made, not misleadingdate of submission. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to The labeling claims made by the Company and its the Company Subsidiaries taken as a wholefor 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) The activities, products and facilities of the Company and the Company Subsidiaries, as well as, to the Company’s knowledge, its Subsidiaries suppliers, distributors, contractors and other intermediaries, are in compliance with all formal written applicable requirements of CLIA, the FDCA and implementing FDA regulations, including the registration, listing, labeling and manufacturing requirements of 21 C.F.R. Parts 807, 809 and 820, all to the 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 Authority directives 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 Company’s and the Company Subsidiaries’ products and all Medical Device Reports, in each case, filed with the FDA within the last five years. The Company has delivered to Parent true, complete and correct copies of all formal written undertakings made warning letters, untitled letters, notices of inspectional observations (Form FDA 483s), or similar notices, or other correspondence relating to the Company’s and the 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, since January 1, 2003, no exemptions, clearances or approvals for the Company and the Company Subsidiaries’ products have been subjected to reevaluation or suspension of sale by the FDA and no products manufactured, marketed or sold by the Company or its any Company Subsidiary have been recalled or subject 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 product sold or proposed to be sold by the Company or a Company Subsidiary. To the Company’s knowledge, there are no facts which are reasonably likely to 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 any the jurisdiction of the FDA or comparable Governmental Authority including any Entity are being manufactured, labeled, stored, tested, distributed, and marketed in material compliance with all applicable requirements and implementing regulations thereunder. (f) Except as set forth in Part 3.18(f) of the Company Disclosure Schedule, all pre-clinical trials and clinical trials conducted by or on behalf of the Company and the Company Subsidiaries have been, and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all directives applicable Legal Requirements relating thereto, including the FDCA and undertakings arising from its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56 and 812. (g) Neither the most recent examination by such Governmental AuthorityCompany, and have satisfactorily addressed in all material respects all matters requiring attentionthe Company Subsidiaries, if any. None nor, to the knowledge of such directivesthe Company, undertakings and actionsany of their collective officers, individually employees or collectivelyagents has committed any act, has had made any statement, or failed to make any statement, that would be reasonably expected to have provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (h) Neither the Company, the Company Material Adverse EffectSubsidiaries, nor, to the knowledge of the Company, any of their collective officers, employees or agents 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 against the Company, the Company Subsidiaries, or, to the knowledge of the Company, any of their collective officers, employees or agents. (i) Except as disclosed on Part 3.18(i) of the Company Disclosure Schedule, there are no investigations, audits, actions or other proceedings pending with respect to a violation by the Company or any Company Subsidiary of any Legal Requirement that reasonably would be expected to result in administrative, civil, or criminal liability, and there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an investigation, audit, action or other proceeding. (j) The Company and each of the Company Subsidiaries is in material compliance with all applicable FDA import and export requirements, including import-for-export requirements, export notifications or authorizations and record keeping requirements.

Regulatory Matters. (i) Except 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, Health Canada or any other Governmental Authority, for the conduct of their Business as currently conducted, to permit any manufacturing, distribution, sales, testing, marketing or research and development activities of such failures Loan Party to date (the “Activities to Date”) with respect to each Product; (B) all such Material Licenses are in full force and effect 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 following to be true as have not been rights of the holder of any Material License; (C) each Loan Party in compliance in all respects with all terms and would not be reasonably expected to beconditions of each Material License, individually or in the aggregate, material and with all Applicable Laws and requirements pertaining to the Company Activities to Date with respect to each 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, processed, packed, held for distribution or from which and its Subsidiaries taken as a wholeinto 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, each of the Company including, without limitation plant registrations. (ii) All applications, notifications, submissions, information, claims, reports and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsstatistics, and other similar documentsdata and conclusions derived therefrom, together utilized as the basis for or submitted in connection with any amendments required to be made with respect theretoand all requests for a Material License from the FDA, that the Company Health Canada, or its Subsidiary was required to file since January 1, 2017 other Governmental Authority relating to the date Loan Parties or the Business or Products, when submitted to the FDA, Health Canada, United States Department of this Agreement, with any Agriculture or other Governmental Authority were true, complete and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied correct in all material respects as of the date of submission and any necessary or required 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) Except as set out in Schedule 7.1(kk), each Product that is subject to the Applicable 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 requirements 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 applicable Law and did not contain the Products. (iv) None of the Loan Parties nor, to the knowledge of the Borrower, any officer, employee, contractor or agent of the Loan Parties has ever made an untrue statement of a material fact or omit fraudulent statement to state a Regulatory Authority or failed to disclose a material fact required to be stated therein disclosed to a Regulatory Authority, or necessary in order committed any act, made any statement, or failed to make the statements thereinany statement, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as that would not reasonably be expected to beprovide a basis for the FDA to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Health Canada or other Governmental Authority directives and with all formal written undertakings made by the Company to invoke any similar policy or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectlaw.

Regulatory Matters. Except for such failures (i) The execution and delivery of this Agreement by the Company, the performance of the following 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 rules 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 true conducted; and (ii) neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any such 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 have not been and would not be reasonably expected to bea whole; (c) To the Company's knowledge, individually neither the Company nor any Subsidiary is in violation of, or in default under, the Communications Act, as amended by the Telecom Act of 1996, the rules or regulations of the FCC, or the rules or regulations of any of the State Commissions, the effect of which, singly or in the aggregate, material to the would have a Material Adverse Effect on Company and its the Subsidiaries taken as a whole, each ; and (d) (i) no decree or order of the Company and its Subsidiaries has timely and accurately filed FCC or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that of the State Commissions is outstanding against the Company or its the Subsidiary was required to file since January 1, 2017 and (ii) to the date Company's knowledge, no formal litigation, proceeding, inquiry or investigation has been commenced or threatened, and no formal notice of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by order to show cause has been issued, against the Company or any of its Subsidiaries with respect to the Subsidiary before the FCC or any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectState Commissions.

Regulatory Matters. Except for (a) The Company 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, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports. All such failures filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and no deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) To the knowledge of the following Company, except as set forth in documents either delivered or made available to be true as have not been and would not be reasonably expected to be, individually Parent or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 Parent’s Representatives prior to the date of this Agreement, with any Governmental Authority all preclinical and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception clinical investigations sponsored by the Company have been and are being conducted in material compliance with applicable Legal Requirements, rules, regulations and guidances, including Good Clinical Practices requirements and federal and state laws, rules, regulations and guidances restricting the use and disclosure of individually identifiable health information. The Company has not received any written notices or other correspondence from the FDA or any of its Subsidiaries other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring or recommending the termination, suspension or material modification of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did studies or tests. (c) The Company has not contain any to its knowledge (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA and (iii) committed any other act, made any statement or necessary in order failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. The Company is not the subject of any pending 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. Neither the Company nor, to the knowledge of the circumstances Company, any of its officers, employees, agents or clinical investigators 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 which they were made, not misleading. 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 for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as have a wholeMaterial Adverse Effect, the Company and its Subsidiaries are is in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authorityhas, and have satisfactorily addressed since January 1, 2010, been in compliance, in each case, in all material respects with all matters requiring attentionhealthcare laws applicable to the operation of its business as currently conducted, if anyincluding (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 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 thereto, (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) 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. None of The Company is not subject to any enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under the FDCA, the Anti-Kickback Statute, or similar Legal Requirements, and no such directivesenforcement, undertakings and actions, individually regulatory or collectively, administrative proceeding has had or would reasonably expected to have a Company Material Adverse Effectbeen threatened.

Regulatory Matters. Except for such failures (a) The Acquired Corporations and, to the knowledge of the following Company, the Collaboration Partners (with respect to be true the Company Products) have obtained all material clearances, authorizations, licenses, registrations and other Governmental Authorizations required by any foreign or domestic Governmental Body (including the FDA and EMA) to permit the conduct of its business as currently conducted and all such Governmental Authorizations are valid, and in full force and effect. To the knowledge of the Company, none of the Governmental Authorizations have been or are being revoked or challenged, except where such revocation or challenge does not been and would not be reasonably expected to benot, individually or in the aggregate, material be likely to have a Material Adverse Effect. The Acquired Corporations and, to the knowledge of the Company, the Collaboration Partners (with respect to the Company Products) have filed with the applicable regulatory authorities (including the FDA and its Subsidiaries taken as a wholeEMA or any other Governmental Body performing functions similar to those performed by the FDA) all required filings, each representations, declarations, listings, registrations, reports or submissions, including adverse event reports and all other submitted data relating to the Company Products. All such filings, representations, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and no deficiencies which are material in the aggregate have been asserted by any applicable Governmental Body with respect to any such filings, representations, declarations, listing, registrations, reports or submissions. (b) To the knowledge of the Company and its Subsidiaries has timely and accurately filed Company, except as set forth in documents either delivered or provided all regulatory reports, schedules, forms, Permit applications otherwise made available to Parent or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 Parent’s Representatives prior to the date of this Agreement, the business of the Acquired Corporations and all preclinical and clinical investigations sponsored by the Acquired Corporations and, to the Company’s knowledge, its Collaboration Partners (with respect to the Company Products), and all manufacturing operations with respect to the Company Products, are being conducted in material compliance with applicable Legal Requirements, rules, regulations, directives and guidances, including, Good Clinical Practice requirements, Good Laboratory Practice requirements, Good Manufacturing Practice requirements, ICH requirements, and federal and state laws, rules, regulations and guidances restricting the use and disclosure of individually identifiable health information with respect to manufacturing, clinical research and development, and future potential marketing and sale of the Company Products. The Acquired Corporations have not, and to the Company’s knowledge, none of its Collaboration Partners (with respect to the Company Products) has, received since December 31, 2008 any material written notices or other material correspondence from the FDA, EMA or any other foreign, federal, state or local Governmental Body 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 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, to the knowledge of the Company, threatened actions or proceedings by the FDA, EMA or any other Governmental Body which would prohibit or impede 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. (c) None of the Acquired Corporations or, to the knowledge of the Company, any Collaboration Partner (with respect to any Company Product) has (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any Governmental Authority Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA or other Governmental Body or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and timely paid all fees and assessments due and payable in connection therewithIllegal Gratuities Final Policy or for any other Governmental Body to invoke a similar remedy. Except for such failures None of the following Acquired Corporations is the subject of any pending or, to be true 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 Body pursuant to any similar Legal Requirement. (d) Except as would not reasonably be reasonably expected to behave a Material Adverse Effect, individually or in each of the aggregateAcquired Corporations, material 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 Subsidiaries taken 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, Collaboration Pharmaceutical Products are being developed, labeled, stored, tested and distributed in material compliance with all applicable requirements under all applicable Legal Requirements, 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 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 whole, there is no unresolved violation result of any action by the FDA or exception any other similar foreign Governmental Body by the Company or any of its Subsidiaries or, to the knowledge of the Company, any 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 investigation, audit, suit, claim, action or proceeding with respect to any of action to withdraw or delay approval of, place restrictions on the documents described in production, dosing, clinical use or testing, or sales or marketing of, or request the first sentence of this Section 3.21recall, and as of their respective datessuspension or discontinuation of, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectProduct.

Regulatory Matters. Except for (a) The Company is a “holding company,” as such failures term is defined in PUHCA. Certain subsidiaries of the following 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 “Regulated Operating Subsidiaries”). (b) All filings required to be true 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 been made, as applicable, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements pertaining thereto, including all rates, tariffs and related documents, and all such filings complied, as of their respective dates, with all applicable requirements of applicable statutes and the rules and regulations thereunder, except for filings the failure of which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and the rules and regulations thereunder do not been have and would not reasonably be reasonably expected to behave, individually or in the aggregate, material to a Material Adverse Effect on the Company and its Subsidiaries taken as a whole, each Company. (c) Each of the Company and Regulated Operating Subsidiaries is legally entitled to provide services in all areas (i) where it currently provides service to its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionscustomers, and (ii) as identified in their respective tariffs, service agreements and other similar documentsContracts with its customers, together with any amendments required except for failures to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to beso entitled that, individually or in the aggregate, material 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 its 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 taken as (other than those rate filings or other material proceedings of a wholegeneral 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 any of the Regulated Operating Subsidiaries operates) filed with respect to, there is no unresolved violation or exception applicable to, the services provided by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21Regulated Operating Subsidiaries, and as all agreements to provide service on non-tariff terms (and complete and correct copies of their respective datesall 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 the terms and conditions of valid and effective tariffs or valid and enforceable agreements for non-tariff charges and are not subject to refund, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except except for such failures to be in compliance as would not reasonably be expected to behave made such charges or charged such fees that, individually or in the aggregate, material to the Company have not had and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would not reasonably be expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures There is no legal or governmental proceeding to which the Company or any Company Subsidiary is a party or of which any property or assets of the following to be true as have not been and would not be reasonably expected to beCompany or any subsidiary is the subject, individually including any proceeding before any Governmental Authorities which singularly or in the aggregate, material if determined adversely to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21Company Subsidiary, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not could reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect; and to the best of the Company’s knowledge, no such proceedings are threatened or contemplated by Governmental Authorities or threatened by others. The Company and each Company Subsidiary are in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business, or any other federal, state or 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 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 modification of any of its preclinical studies or clinical trials.

Regulatory Matters. (a) Except for such failures of the following to be true as have not been and would not reasonably be reasonably expected to beexpected, individually or in the aggregate, material to the Company and its Subsidiaries taken as have a wholeMaterial Adverse Effect, each of Acquired Company has filed with the Company and its Subsidiaries has timely and accurately filed applicable regulatory authorities (including the FDA or provided any other Governmental Body performing functions similar to those performed by the FDA) all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications registrations, reports or renewals, examination responses and submissions, and other similar documents, together with any amendments required including but not limited to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewithadverse event reports. Except for such failures of the following to be true as would not reasonably be reasonably expected to beexpected, individually or in the aggregate, to have a Material Adverse Effect, all such filings, declarations, listings, registrations, reports or submissions were in material to the Company compliance with applicable Laws when filed (or were corrected or supplemented by a subsequent submission) and, and its Subsidiaries taken as a whole, there is no unresolved violation or exception deficiencies have been asserted by the Company or any of its Subsidiaries applicable Governmental Body with respect to any of the documents described in the first sentence of this Section 3.21such filings, and as of their respective datesdeclarations, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact listing, registrations, reports or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. submissions. (b) Except for such failures to be in compliance as would not reasonably be expected to beexpected, individually or in the aggregate, material to have a Material Adverse Effect, to the Knowledge of the Company, all preclinical and clinical investigations sponsored by an Acquired Company are being conducted in compliance with applicable Laws. As of the Agreement Date, no Acquired Company has received any written notices or other written correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory 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. (c) Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, no Acquired Company has (i) made an untrue statement of a material fact statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and its Subsidiaries taken as a wholeIllegal Gratuities Final Policy. As of the Agreement Date, the Company is not the subject of any pending or, to the Knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and its Subsidiaries Illegal Gratuities Final Policy. Neither any of the Acquired Companies nor, to the Knowledge of the Company, any officers, employees, agents or clinical investigators of any 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 Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (d) Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Acquired Companies are in compliance and, since January 1, 2019, have been in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by healthcare Laws applicable to the Company or operation of its Subsidiaries to any Governmental Authority business as currently conducted, including (i) any and all directives applicable federal, state and undertakings arising 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, 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 most recent examination by such Governmental AuthorityAgreement Date, to the Knowledge of the Company no enforcement, regulatory or administrative proceeding is pending, and have satisfactorily addressed no such enforcement, regulatory or administrative proceeding has been threatened in all material respects all matters requiring attentionwriting, if any. None of against the Company under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Anti-Kickback Statute or similar Laws, other than any such directives, undertakings and actionsproceeding that would not reasonably be expected, individually or collectivelyin the aggregate, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for (a) Since January 1, 2016, the Acquired Companies have filed, maintained or furnished with the applicable regulatory authorities (including the FDA, European Medicines Agency (“EMA”) or any other Governmental Body performing functions similar to 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 failures other Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and 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 compliance with applicable Legal Requirements in all material respects when filed, and no material deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports, submissions, applications, amendments, modifications, notices and other 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. (b) To the knowledge of the following Company, except as set forth in documents either delivered or made available to be true as Parent, all preclinical and clinical investigations sponsored or conducted by or on behalf of the Acquired Companies have not been 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, applicable research protocols, corrective action plans, and federal and state laws, rules, regulations and binding guidances relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Since January 1, 2016, except as has not had, or would not reasonably be reasonably expected to behave, individually or in the aggregate, material a Material Adverse Effect, no clinical trial sponsored or conducted by or on behalf of any Acquired Company has been terminated, delayed or suspended prior to completion for safety or other non-business reasons, and neither the FDA, the EMA nor any other Specified Governmental Body, clinical investigator or contract research organization that has participated or is 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 Company and its Subsidiaries taken as a whole, each knowledge of the Company and its Subsidiaries has timely and accurately filed Company, threatened to initiate, any action to place a clinical hold order on, or provided all regulatory reportsotherwise terminate, schedulesmaterially delay or suspend, formsany proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of any Acquired Company, Permit applications or renewals, examination responses and submissions, and other similar documents, together alleged any violation of any Health Care Law in connection with any amendments such clinical trial. The Company periodically reviews clinical trial sites participating in any Acquired Company-sponsored trial for compliance with all applicable Health Care Laws. (c) Since December 31, 2014, to the knowledge of the Company, no Acquired Company or officer, employee, agent or clinical investigator thereof has (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any other Specified Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA, Centers for Medicare and Medicaid Services or any other Specified Governmental Body or (iii) committed any other act, made with respect theretoany statement or failed to make any statement, that (in any such case) establishes a reasonable basis 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. No Acquired Company is the subject of any pending or, to the knowledge of the Company, threatened in writing investigation or other action by the FDA pursuant to its Subsidiary was required to file since Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Governmental Body in any similar investigation or other action. Since January 1, 2017 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 the date of this Agreementresult 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 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 any Governmental Authority all Health Care Laws. Since January 1, 2016, except as has not had, and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not reasonably be reasonably expected to behave, individually or in the aggregate, material 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 its Subsidiaries taken as a whole, there is no unresolved violation not pending any allegation that any operation or exception by activity of any Acquired Company relating to such the Company Company’s business or any Product is in violation of its Subsidiaries with respect to any Health Care Law or other applicable Legal Requirement and (iii) as of the documents described in the first sentence date of this Section 3.21Agreement, 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 as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to behave, individually or in the aggregate, material 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 Company’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, 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 Subsidiaries taken as a whole, the Company and its Subsidiaries are business in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects with all matters requiring attentionapplicable Legal Requirements, if anyclinical 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. None L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of such directivesthe foregoing (the “Health Care Data Requirements”). The Company has implemented in all material respects any confidentiality, undertakings security and actionsother 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, individually no Acquired Company has suffered any accidental, unauthorized, or collectivelyunlawful 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 had 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 the notification requirements of 45 C.F.R. Part 164, Subpart D, and, as of the date hereof, no information security or privacy breach event has occurred that would reasonably expected to have a Company Material Adverse Effectrequire notification under any comparable Legal Requirements.

Regulatory Matters. Except for such failures of (a) To the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeCompany’s knowledge, each of its clinical trials 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 FDA and comparable foreign Governmental Bodies (including the TGA). No investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and its Subsidiaries neither the FDA nor any applicable foreign Governmental Body has timely and accurately filed commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or provided all regulatory otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or in which the Company has participated with respect to any Company Product. (b) All material reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments claims and notices required to be made with respect theretofiled, that the Company maintained, or its Subsidiary was required to file since January 1, 2017 furnished to the date of this Agreement, with any Governmental Authority FDA and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception TGA by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21have been so filed, maintained or furnished. All such reports, documents, claims, and as of their respective dates, such documents complied 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 all requirements respect to such filing. (c) Neither the Company nor any of its Subsidiaries have received any written notices from the FDA or TGA alleging or asserting material noncompliance with any applicable Law and did not contain any untrue statement of a material fact Legal Requirements or omit to state a material fact required to be stated therein Governmental Authorizations issued by the FDA or necessary in order to make TGA. (d) To the statements therein, in light knowledge of the circumstances under Company, the manufacture of Company Products is being conducted in material compliance with “good manufacturing practices” as defined by the FDA. (e) Neither the Company nor its Subsidiaries has been convicted of any crime or engaged in any conduct which they were madecould result in debarment or disqualification by the FDA or any drug regulatory agency, not misleading. Except for such failures and there are no proceedings pending or, to be in compliance as would not the knowledge of the Company, threatened that reasonably might be expected to be, individually result in criminal liability or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made debarment or disqualification by the Company FDA or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectdrug regulatory agency.

Regulatory Matters. Except for such failures of the following to be true as have not been The Company, its directors, officers and would not be reasonably expected to beemployees, individually or in the aggregateand, material to the Company Company’s knowledge, its agents, affiliates and its Subsidiaries taken as a wholerepresentatives, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsare, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or at all times: (i) have operated and currently operate its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable business in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the FDA and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company’s product candidates; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting material non-compliance with (A) any Health Care Laws or (B) or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact Regulatory Authorizations required to be stated therein or necessary conduct its business as currently conducted as described in order to make the statements thereinGeneral Disclosure Package and the Prospectus and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in light any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities alleging that any product operation or activity is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that any of the circumstances under which they Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that, to the knowledge of the Company, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were madematerially 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 agreements with or imposed by any Applicable Regulatory Authority; and (viii) has not misleading. Except for such failures been excluded, suspended or debarred from participation in any government health care program or human clinical research or, to be in compliance as would not the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to beresult in debarment, individually suspension, or in exclusion. The term “Health Care Laws” means Title XVIII of the aggregateSocial Security Act, material 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the Company and its Subsidiaries taken health care fraud criminal provisions under HIPAA, 42 U.S.C. §§ 1320d et seq.; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made amended by the Company or its Subsidiaries to any Governmental Authority including any Health Information Technology for Economic and all directives and undertakings arising from Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the most recent examination by such Governmental AuthorityFederal Food, Drug, and have satisfactorily addressed in all material respects all matters requiring attentionCosmetic Act, if any. None of 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such directiveslaws; and any similar federal, undertakings state and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectlocal laws and regulations.

Regulatory Matters. Except 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 (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Registration Statement, the General Disclosure Package and the Prospectus requires such licensing, except for such failures of jurisdictions in which the following failure to be true as have not been and so licensed would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to result in a Material Adverse Effect. Except as described in the Company Registration Statement, the General Disclosure Package and its Subsidiaries taken as a wholethe Prospectus, each of the Company and its Subsidiaries subsidiaries has timely all other necessary authorizations, approvals, orders, consents, certificates, licenses, permits, registrations and accurately filed 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 of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or provided all regulatory reports, schedules, forms, Permit applications qualifications or renewals, examination responses and submissions, and other similar documents, together with any amendments required their failure to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority in full force and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as effect would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to result in a Material Adverse Effect. None of the Company or its subsidiaries has received any notification from any insurance 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 its Subsidiaries taken the Prospectus, except for any such notification received where the failure to 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 a wholeotherwise described in the Registration Statement, there is the General Disclosure Package and the Prospectus, no unresolved violation insurance regulatory authority has issued any order or exception decree impairing, restricting or prohibiting the payment of dividends by the Company or any of its Subsidiaries with respect to any of the documents subsidiaries. Except as otherwise described in the first sentence Registration Statement, the General Disclosure Package and the Prospectus, none of this Section 3.21the Company or its subsidiaries is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. Each of the Company and as of their respective datesits subsidiaries has filed all statutory financial returns, such reports, documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact other information required to be stated therein or necessary in order filed pursuant to make the statements therein, in light applicable Insurance Laws of the circumstances under which they were madeUnited States and the various states thereof, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beexcept where the failure, individually or in the aggregate, material to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Effect, and each of the Company and its Subsidiaries taken subsidiaries maintains its books and records in accordance with, and is otherwise in compliance with, all applicable Insurance Laws, except where the failure to so maintain its books and records or be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Except as a wholedisclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its Subsidiaries are subsidiaries have made no material change in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authoritytheir insurance reserving practices since December 31, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect2022.

Regulatory Matters. Except for (a) Since January 1, 2019, each Acquired Company has filed, maintained or furnished with the applicable regulatory authorities (including the FDA, European Medicines Agency (“EMA”) or any other Governmental Body performing functions similar to 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 failures other Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and 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 compliance with applicable Legal Requirements, including all applicable Health Care Laws in all material respects when filed, and no material deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports, submissions, applications, amendments, modifications, notices and other documents. Since January 1, 2019, any updates, changes, corrections or modifications 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. (b) All preclinical and clinical investigations sponsored or conducted by or on behalf of any Acquired Company or, to the knowledge of the following Company, by any Acquired Company’s research, development, collaboration or similar partners with respect to be true any Product Candidates of any Acquired Company while acting in such capacity (each such party a “Collaboration Partner”), have been since January 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, applicable research protocols and federal and state laws, rules, regulations and binding guidances relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Since January 1, 2019, except as have has not been had, and would not reasonably be reasonably expected to behave, individually or in the aggregate, material a Material Adverse Effect, no clinical trial sponsored or conducted by or on behalf of any Acquired Company or by any Collaboration Partner has been terminated, delayed or suspended prior to completion for safety or other non-business reasons, and neither the FDA, the EMA nor any other Specified Governmental Body, clinical investigator or contract research organization that has participated or is 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 Company and its Subsidiaries taken as a whole, each 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 and its Subsidiaries has timely and accurately filed or provided all regulatory reportsby any Collaboration Partner, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together alleged any violation of any Health Care Law in connection with any amendments such clinical trial. The Acquired Companies or an agent on their behalf periodically reviews clinical trial sites participating in any Acquired Company-sponsored trial for compliance with all applicable Health Care Laws. (c) Since January 1, 2019, no Acquired Company nor, to the knowledge of the Company, any Company Associate, employee, agent, clinical investigator or Collaboration Partner has (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any other Specified Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA, Centers for Medicare and Medicaid Services or any other Specified Governmental Body or (iii) committed any other act, made with respect theretoany statement or failed to make any statement, that (in any such case) establishes a reasonable basis 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. No Acquired Company nor, to the knowledge of the Company, any Collaboration Partner, is the subject of any pending or, to the knowledge of the Company, threatened in writing investigation or other action by the FDA pursuant to its Subsidiary was required Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Governmental Body in any similar investigation or other action. Since January 1, 2019, no Acquired Company nor any Company Associate or clinical investigator of any Product Candidates or, to file 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, 2017 to the date of this Agreement2019, have been, developed, tested, labeled, manufactured, and stored, as applicable, in all material respects with any Governmental Authority all Health Care Laws. Since January 1, 2019, except as has not had, and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not reasonably be reasonably expected to behave, individually or in the aggregate, material 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 its Subsidiaries taken as a wholeno such enforcement, regulatory or administrative proceeding has been threatened in writing, (ii) no Acquired Company nor, to the knowledge of the 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 knowledge of the Company, there is no unresolved violation not pending any allegation that any operation or exception by the activity of any Acquired Company or any of its Subsidiaries with respect 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 documents described in the first sentence date of this Section 3.21Agreement, 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 as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to behave, individually or in the aggregate, material 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 Subsidiaries taken Collaboration Partners have prepared, submitted and implemented timely responses and, as a wholeapplicable, 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 and 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 Subsidiaries are business in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects with all matters requiring attentionapplicable Legal Requirements, if anyclinical 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. None L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of such directivesthe foregoing (the “Health Care Data Requirements”). Each Acquired Company has implemented in all material respects any confidentiality, undertakings security and actionsother measures required by the Health Care Data Requirements. Each Acquired Company is, individually and has at all times since January 1, 2019, been 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, since January 1, 2019, no Acquired Company has suffered any accidental, unauthorized, or collectivelyunlawful 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 had 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 the notification requirements of 45 C.F.R. Part 164, Subpart D, and, as of the date hereof, no information security or privacy breach event has occurred that would reasonably expected to have a Company Material Adverse Effectrequire notification under any comparable Legal Requirements.

Regulatory Matters. Except for (a) The Acquired Corporations have filed, maintained or furnished with the applicable regulatory authorities (including the FDA, European Medicines Agency (“EMA”) or any other Governmental Body performing functions similar to those performed by the FDA or 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 or biological products (such failures other Governmental Bodies collectively, the “Specified Governmental Bodies”) all required material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and 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 Legal Requirements when filed, and no deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports, submissions, applications, amendments, modifications, notices or other 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. (b) 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 by or on behalf of the following to be true as Acquired Corporations have not been 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, applicable research protocols, corrective action plans, and federal and state laws, rules, regulations and binding guidances relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Since January 1, 2016, except as has not had or would not reasonably be reasonably expected to behave, individually or in the aggregate, material a Material Adverse Effect, no clinical or pre-clinical trial sponsored or conducted by or on behalf of any Acquired Corporation has been terminated, delayed or suspended prior to completion for safety or other non-business reasons, and neither the FDA, EMA or any other Specified Governmental Body, clinical investigator or contract research organization that has participated in or is 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 and its Subsidiaries taken as Company’s knowledge, threatened to initiate any action to place a wholeclinical hold order on, each 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 the Company and its Subsidiaries has timely and accurately filed any Acquired Corporation, or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together alleged any violation of applicable Health Care Laws in connection with any amendments such clinical or pre-clinical trial. The Company periodically reviews clinical trial sites participating in any Acquired Corporation-sponsored trial for compliance with applicable Health Care Laws. (c) No Acquired Corporation or officer thereof or to the Company’s knowledge, no employee, agent or clinical investigator thereof has (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any other Specified Governmental Body; (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA, or any other Specified Governmental Body or (iii) committed any other act, made with respect theretoany statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the Company FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or its Subsidiary was required for the EMA or any other Specified Governmental Body to file since January 1, 2017 to invoke any similar policy. As of the date of this Agreement, with no Acquired Corporation is the subject of any pending 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 Authority and timely paid all fees and assessments due and payable in connection therewithBody under any similar policy. Except for such failures Since January 1, 2016, no Acquired Corporation or officer thereof nor to the knowledge of the following Company, any employee, agent or clinical investigator thereof has been disqualified, suspended, debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to be true 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 reasonably expected to behave 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) the FDCA and the regulations promulgated thereunder; (ii) 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 thereto; and (iv) Legal Requirements the violation of which is cause for exclusion from any federal health care program. (e) The Products are being, and since January 1, 2016 have been, developed, tested, labeled, manufactured, stored, imported and exported, as 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, material 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 Legal Requirement, 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 the Company and its Subsidiaries taken as a wholeCompany’s knowledge, there is no unresolved violation not pending any allegation that any operation or exception by activity of any Acquired Corporation relating to the Company business of the Acquired Corporations or any Product is in violation of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21Health Care Law or other applicable Legal Requirement, and (iii) no Acquired Corporation has received any FDA Form-483 or other notices of violations, inspectional observations, warning letters, untitled letters or other written administrative, regulatory or enforcement notice from any Specified Governmental Body. (f) Since January 1, 2016, except as of their respective dateshas not had, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to behave, individually or in the aggregate, material to a Material Adverse Effect: (i) no investigational new drug application or similar document filed by or on behalf of the Company and its Subsidiaries taken as a wholeAcquired Corporations with the FDA, the Company and its Subsidiaries are in compliance with all formal written EMA or any other Specified Governmental Authority directives and with all formal written undertakings made by the Company Body has been placed on clinical hold or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authorityotherwise limited, terminated, or suspended, and have satisfactorily addressed (ii) no Acquired Corporation has received any written notice from a Specified Governmental Body that any Product cannot be developed, tested, labeled, manufactured, stored, marketed, promoted or distributed substantially in all material respects all matters requiring attentionthe manner presently performed or contemplated by an Acquired Corporation. (g) Except as has not had, if any. None of such directives, undertakings and actionswould not reasonably be expected to have, individually or collectivelyin the aggregate, has had or would reasonably expected to have a Company Material Adverse Effect, each Acquired Corporation 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 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.

Regulatory Matters. (a) The Acquired Companies have filed, maintained or furnished with the applicable regulatory authorities (including the FDA 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, declarations, listings, registrations, 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 Legal Requirements when filed, and no deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports, submissions or other documents. (b) Except as would not reasonably be expected to have a Material Adverse Effect, all preclinical and clinical investigations sponsored or conducted by the Acquired Companies or, to the Company’s knowledge, for such failures investigations conducted on behalf of any of the following to be true as Acquired Companies have not been and are being conducted in material compliance with all applicable Legal Requirements and guidances, including Good Clinical Practices requirements, applicable research protocols, corrective action plans, and guidances relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Since January 1, 2016, except as has not had, or would not reasonably be reasonably expected to behave, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect., no clinical trial sponsored or conducted by or on behalf of any Acquired Company has been terminated, delayed or suspended prior to completion for safety or other non-business reasons, and no Specified Governmental Body, clinical investigator or contract research organization that has participated or is 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

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since (a) Since January 1, 2017 2012, the Company has filed, or caused its Subsidiaries to the date of this Agreementfile, with the FDA or any other Governmental Authority and timely paid performing functions similar to those performed by the FDA, all fees and assessments due and payable in connection therewithrequired filings, declarations, listings, registrations, reports or submissions, including adverse event reports. Except for such failures To the Knowledge of the following to be true as would not be reasonably expected to beCompany, individually all such filings, declarations, listings, registrations, reports or submissions were in the aggregatematerial compliance with applicable Laws when filed, material to and the Company has not received any communication from any such applicable Governmental Authority asserting deficiencies with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) To the Knowledge of the Company, all preclinical and its Subsidiaries taken as a whole, there is no unresolved violation clinical investigations sponsored by the Company with respect to products or exception product candidates currently in development by the Company or any of its Subsidiaries are being conducted in material compliance with all applicable Laws including the FDCA and its implementing regulations and applicable experimental protocols, informed consents, procedures, controls, guidance and industry standards, including good manufacturing practice, good laboratory practice, and good clinical practice, requirements and industry standards of oversight of clinical sites including monitors, and Laws and guidance restricting the use, disclosure and protection of individually identifiable health information. None of the Company or its Subsidiaries has received any notices or other correspondence from the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or any institutional review board or ethics committee with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. To the Knowledge of the documents described in Company, neither the first sentence FDA nor any other applicable Governmental Authority nor any clinical investigator that has participated or is participating in, or institutional review board or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of this Section 3.21the Company 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 as of their respective datesnotices required to be filed, such documents complied maintained, or furnished to the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or drug regulatory agency by the Company or its Subsidiaries have been so filed, maintained or furnished and were complete and correct in all material respects with 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 requirements 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 any of applicable Law and did not contain any its Subsidiaries has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary any other Governmental Authority performing functions similar to those performed by the FDA. To the Knowledge of the Company, none of the Company or any of its Subsidiaries is the subject of any pending or threatened investigation by the FDA or any Governmental Authority performing functions similar to those performed by the FDA to take enforcement action against the Company or any of its Subsidiaries including the termination or suspension of any clearance, authorization, license or registration. (f) The Company and its Subsidiaries is in order to make compliance and has, during the statements thereinpast three years, been in compliance, in light 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 circumstances 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, none of their respective employees or other persons engaged to perform clinical services by the Company or any of its Subsidiaries have ever been while performing services for the Company or such Subsidiary, (i) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a (a) and (b)) (“Debarred”), (ii) convicted of a crime for which they were made, not misleading. Except a person can be Debarred or (iii) indicted for such failures to a crime or otherwise engaged in conduct for which a person can be Debarred or engaged in compliance as any conduct that would not reasonably be expected to beresult in Debarment under applicable Law. To the Knowledge of the Company, individually none of the matters listed in sub-parts (i), (ii), or in (iii) herein has been threatened, against the aggregateCompany, material to its Subsidiaries or any of its officers, employees or agents. (i) Set forth on Section 4.24(i) of the Company and its Subsidiaries taken Disclosure Schedule is a list of all new drug applications that, as a wholeof the date of this Agreement, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by intends to submit to the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from FDA within 90 days following the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None date of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectthis Agreement.

Regulatory Matters. (a) Except for such failures of the following to be true as have not been and would not be reasonably expected to beset forth on Schedule 4.10(a), individually or in the aggregatesince January 1, material to the Company and its Subsidiaries taken as a whole2019, each of the Company 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 Subsidiaries has timely implementing regulations, California’s Safe Drinking Water and accurately filed or provided all regulatory reportsToxic Enforcement Act of 1986 (“Proposition 65”) and its implementing regulations, schedules, forms, Permit applications or renewals, examination responses the California Safe Cosmetics Program (“CSCP”) and submissionsits implementing regulations, and all other similar documentslaws regarding developing, together with any amendments required importing, exporting, formulating, testing, manufacturing, storing, labeling, advertising, marketing, distributing or promoting the Products including (i) good manufacturing practice requirements, (ii) labeling requirements, (iii) requirements pertaining to be made with respect theretothe truth, accuracy, and substantiation of claims used in labeling and advertising, and (iv) requirements regarding complaint handling and adverse event reporting. To the Seller’s Knowledge, there are no allegations that the Company or its Subsidiary was required to file since January 1Seller, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any respective products, are in violation of the documents described 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 first sentence FDCA and relevant regulations. (b) Seller is in possession of this Section 3.21all required marketing authorizations required by the FDCA and FDA’s implementing regulations, and including any marketing authorizations required as a result of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement modifications to the design or performance of a material fact Product, to its labeling or omit packaging or to state its indications for use, after initially receiving marketing authorization from FDA, except where such a material fact required to be stated therein or necessary in order to make the statements therein, in light lack of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as possession would not reasonably be expected to be, individually or in the aggregate, be material to the Company 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 Subsidiaries taken as 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 of its Affiliates, has been the subject of a wholelegal, administrative, enforcement, or other adverse action initiated by FDA or another Governmental Authority where it was alleged that Seller or any of its Affiliates violated the FDA, and to the Knowledge of Seller, neither the FDA nor any other Governmental Authority will or is considering such an action, in each case with respect to the Purchased Assets, the Company Products or the Business. (e) The Products have been designed, manufactured, packaged, labeled, processed, and its Subsidiaries are distributed in material compliance with all formal written applicable Governmental Authority directives and with all formal written undertakings made by requirements, including FDA good manufacturing practice requirements, such as cGMP and/or QSR. (f) Since January 1, 2019, neither Seller nor any of its Affiliates has initiated any recall, product correction, or taken any other field action, including but not limited to market withdrawal, relative to any Product. (g) Neither Seller nor its Affiliates or any manufacturers of the Company Products or its Subsidiaries to of the raw materials for the Products, have received any Form FDA 483 observations, warning letters, notice of violation letters, untitled letters or other communications from any Governmental Authority including regarding violations or potential violations of Laws related to the Products that would reasonably be expected to adversely impact the manufacture, distribution, or the marketing of the Products. Neither Seller nor any of its Affiliates has received any written notice from any Governmental 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 form of enforcement action. (h) Neither Seller nor any of its Affiliates has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to initiate an investigation or enforcement action pursuant to its Compliance Policy Guide Section 120.100 “Fraud, Untrue Statements of Material Facts, Bribery and all directives Illegal Gratuities” and undertakings arising from any amendments thereto. (i) Neither Seller nor, to the most recent examination by such Governmental AuthorityKnowledge of Seller any of its Affiliates or its or their officers, and have satisfactorily addressed in all material respects all matters requiring attentionkey employees, if any. None of such directives, undertakings and actions, individually or collectivelyagents, has had been convicted of any crime, subjected to civil monetary penalties, or engaged in any conduct that would reasonably expected be likely to have a Company Material Adverse Effectresult in prosecution or imposition of civil monetary penalties under the FDCA or FDA implementing regulations.

Regulatory Matters. (a) Except for such failures as set out in Schedule 4.1(iii)(a), BNI 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 Public Health Service Act (“PHSA”) and the regulations of the following Food and Drug Administration (“FDA”) promulgated thereunder and similar applicable foreign Legal Requirements, including those relating to be true as have not been investigational use, good manufacturing practices, good clinical practices, good laboratory practices, registration and would not be reasonably expected to belisting, individually or in the aggregaterecord keeping, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsadverse event reporting, and submission of other similar documents, together with any amendments required reports. The required licenses and authorizations are current and in full force and effect and include all necessary and relevant regulatory filings and governmental registrations made by or issued to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company BNI or any of its Subsidiaries 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 any applicable foreign regulatory authority to permit the operation of the intended use by BNI and the Affiliates as presently conducted and all such licenses, permits and registrations are included in the Specified Authorizations. Neither BNI nor any of its Affiliates have received any communication from any Governmental Entity threatening to withdraw or suspend any such license, permit, or registration. BNI or its Affiliates have filed with the applicable regulatory authorities all required filings, declarations, listings, registrations, reports or submissions, including adverse event reports. All relevant filings, declarations, listings, registrations, reports or submissions were in compliance with all applicable Legal Requirements when filed, and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listing, registrations, reports or submissions. (c) Neither BNI nor any of its Affiliates nor, to the Knowledge of BNI, any of the documents described officers, key employees, agents or clinical investigators acting for BNI or any of its Affiliates has 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 first sentence FDCA, the PHSA, FDA regulations promulgated thereunder, or similar applicable foreign Legal Requirements. (d) Neither BNI nor any of this Section 3.21its Affiliates nor, to the Knowledge of BNI, any of the officers, key employees, agents or clinical investigators acting for BNI or its Affiliates, has committed any act, made any statement or failed to make any statement or commit any act that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and as Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Additionally, neither BNI or its Affiliates, nor to the Knowledge of their respective datesBNI, such documents complied any officer, employee or agent of BNI or its Affiliates has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar state Legal Requirement; or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state Legal Requirement. (e) To 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 all requirements of healthcare Legal Requirements to the extent applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light operation of the circumstances under which they were madeintended use and the sale of BNI Products, not misleading. Except for such failures to be in compliance as would not reasonably be expected to becurrently conducted, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives federal, state and undertakings 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. Neither BNI nor any Affiliate is subject to any enforcement, regulatory or administrative proceedings against or affecting BNI relating to or arising from under the most recent examination by such Governmental AuthorityFDCA or similar Legal Requirement, and have satisfactorily addressed in all material respects all matters requiring attentionto the Knowledge of BNI no such enforcement, if any. None of such directives, undertakings and actions, individually regulatory or collectively, administrative proceeding has had or would reasonably expected to have a Company Material Adverse Effectbeen threatened.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each (a) All of the Company Products are being and its Subsidiaries have been manufactured, processed, developed, packaged, labeled, promoted, marketed, sold, stored, tested, distributed, imported and exported in material compliance with all applicable requirements under any applicable Law, including all Laws 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. (b) The Company has timely and accurately filed with the applicable regulatory authorities (including, without limitation, the FDA or provided any other Governmental Authority performing functions similar to those performed by the FDA) all regulatory material filings, documents, declarations, listings, registrations, reports, schedulesstatements, formsamendments, Permit applications supplements or renewals, examination responses and submissions, and other similar documentsincluding but not limited to adverse event reports, together with any amendments required to be made 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 respect theretoapplicable Laws when filed, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with and no material deficiencies have been asserted by any applicable Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any such filings, documents, declarations, listing, registrations, reports, statements, amendments, supplements or submissions. To the knowledge of the documents described in the first sentence of this Section 3.21Company, (i) each such filing was true and as of their respective dates, such documents complied correct in all material respects as of the date of submission, 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 applicable Governmental Authority. (c) Except as set forth on Schedule 4.07(c) of the Company Disclosure Schedule, the Company has not received any notification of any pending or, to the knowledge of the Company, threatened (i) action, suit, claim, investigation, proceeding or order alleging potential or actual non-compliance with all requirements 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, (ii) commenced, or threatened to initiate, any action, suit, claim, investigation, 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 action, suit, claim, investigation, 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. (f) Neither the Company nor, to the knowledge of the 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 Laws 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 and did not contain 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 (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any other Governmental Authority or (iii) 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 Authority to allege a violation of any applicable Law, including without limitation, for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company nor, to the knowledge of the circumstances under which they were madeCompany, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beany of its officers, individually employees, or in agents is the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made subject of any pending or threatened investigation by the Company FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or its Subsidiaries by any other Government Entity pursuant to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectsimilar Law.

Regulatory Matters. Except (a) The Company 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, declarations, listings, notices, requests for Governmental Authorizations, registrations, reports or submissions, including but not limited to adverse event reports. All such failures filings, declarations, listings, notices, requests for Governmental Authorizations, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, remain in full force and effect, and no deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, notices, requests for Governmental Authorizations, listing, registrations, reports or submissions. (b) To the knowledge of the following Company, except as set forth in documents either delivered or made available to be true as have not been and would not be reasonably expected to be, individually Parent or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 Parent’s Representatives prior to the date of this Agreement, with any Governmental Authority all nonclinical and timely paid all fees and assessments due and payable in connection therewith. Except for such failures clinical investigations sponsored by or on behalf of the following Company have been and are being conducted in material compliance with applicable Legal Requirements, rules, regulations and guidances, including Good Laboratory Practices, Good Clinical Practices, and federal and state laws, rules, regulations and guidances restricting the use and disclosure of individually identifiable health information. The Company has not received any written notice or other correspondence from the FDA or any other Governmental Body performing functions similar to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception those performed by the Company or any of its Subsidiaries FDA with respect to any ongoing clinical trial or nonclinical study or test requiring or recommending the termination, suspension or material modification of such studies or tests, or otherwise alleging noncompliance with any applicable Legal Requirements with respect thereto. (c) To the documents described in Company’s knowledge, the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did Company has not contain any (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any Governmental Body, or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. As of the circumstances date of this Agreement, the Company is not the subject of any pending 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. Neither the Company nor, to the knowledge of the Company, any of its officers, employees, agents or clinical investigators 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 which they were made, not misleading. 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 for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as have a wholeMaterial Adverse Effect, the Company and its Subsidiaries are is in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authorityhas, and have satisfactorily addressed since January 1, 2015, been in compliance, in each case, in all material respects with all matters requiring attentionhealthcare laws applicable to the operation of its business as currently conducted, if anyincluding (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. None 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 similar Legal Requirements, and no such directivesenforcement, undertakings regulatory or administrative proceeding has been threatened. (e) Prior to the date of this Agreement, the Company has delivered to Parent all material data and actionsother material information known to the Company with respect to the products under development by the Company, individually including the safety or collectively, has had or would reasonably expected to have a Company Material Adverse Effectefficacy thereof.

Regulatory Matters. Except for such failures of (i) First Mutual and its Subsidiaries have duly filed with the following appropriate regulatory authorities in substantially correct form the monthly, quarterly and annual reports required to be true as have filed under applicable laws and regulations, and such reports were in all material respects complete and accurate and in compliance with the requirements of applicable laws and regulations, and First Mutual has previously delivered or made available to Washington Federal accurate and complete copies of all such reports. In connection with the most recent examination of First Mutual and its Subsidiaries by the appropriate regulatory authorities, neither First Mutual nor any of its Subsidiaries was required to correct or change any action, procedure or proceeding which First Mutual believes in good faith has not been and would now corrected or changed, other than corrections or changes which, if not be reasonably expected to bemade, either individually or in the aggregate, material would not have a Material Adverse Effect on First Mutual. To the knowledge of First Mutual, since its last regulatory examination of Community Reinvestment Act compliance, FMB has not received any complaints as to the Company and Community Reinvestment Act compliance. (ii) Except as Previously Disclosed, neither First Mutual nor any of its Subsidiaries taken as nor any of their respective properties is a wholeparty to or is subject to any order, each decree, directive, agreement, memorandum of the Company and its Subsidiaries understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company First Mutual or any of its Subsidiaries with respect to adopted any of policies procedures or board resolutions at the documents described in the first sentence of this Section 3.21request or suggestion of, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleadingGovernmental Authority. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company First Mutual and its Subsidiaries taken as a whole, the Company and have paid all assessments made or imposed by any Governmental Authority. (iii) Neither First Mutual nor any of its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries has been advised by, nor does it have any knowledge of facts which could give rise to an advisory notice by, any Governmental Authority including any and all directives and undertakings arising from the most recent examination by that such Governmental AuthorityAuthority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, and have satisfactorily addressed in all material respects all matters requiring attentiondecree, if any. None directive, agreement, memorandum of such directivesunderstanding, undertakings and actionscommitment letter, individually supervisory letter or collectively, has had or would reasonably expected to have a Company Material Adverse Effectsimilar submission.

Regulatory Matters. (i) Since January 1, 2021, the Company Group has filed with the applicable regulatory authorities (including the FDA or any other Governmental Entity performing functions similar to those performed by the FDA) all required material filings, 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 deficiencies that have been asserted by any applicable Governmental Entity with respect to any such filings, declarations, listing, registrations, reports or submissions remain outstanding. (ii) Except for such failures of the following to be true as have not been and would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to the have a Company Material Adverse Effect, all nonclinical and its Subsidiaries taken as a whole, each clinical investigations sponsored by or on behalf of the Company Group are, to the knowledge of the Company, being or have been conducted in material compliance with applicable Laws and its Subsidiaries has timely guidance, including (A) Good Clinical Practices requirements, (B) applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, (C) approved clinical protocols and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses informed consents and submissions, (D) applicable Laws restricting the use and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to disclosure of individually identifiable health information. As of the date of this Agreement, with neither the FDA nor any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA has sent any written notices or other correspondence to any member of the following Company Group with respect to be true as would not be reasonably expected to beany ongoing clinical or nonclinical studies or tests requiring the termination, suspension or material modification of such studies or tests, which modification, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect. (iii) To the Company’s knowledge, since January 1, 2021, neither the members of the Company Group nor any Representative acting on any member of the Company Group’s behalf has (A) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws, (B) failed to disclose a material fact required to be disclosed to the FDA 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 the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or for any Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws to invoke an equivalent policy. As of the date of this Agreement, none of any member of the Company Group nor, to the Company’s knowledge, any entity or other Representative acting on any member of the Company Group’s behalf is the subject of any pending 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 Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws on the basis of an equivalent Policy. (iv) Neither the Company nor, to the knowledge of the Company, any executive officers, employees, agents or clinical investigators of the Company Group or any entity or individual acting on the Company’s behalf has been (A) debarred under 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 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 any Governmental Entity or (E) convicted of, charged with, investigated for or engaged in any conduct that would reasonably be expected to 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 Company 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) Except as, individually or in the aggregate, would not reasonably be expected to have a Company Material Adverse Effect, the Company Group is in compliance and since January 1, 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, all manufacturing operations conducted for the benefit of any member of the Company 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 failure to so comply would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the The Company and its Subsidiaries taken as a wholesubsidiaries, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reportstheir respective directors, schedulesofficers and employees, formsand, Permit applications or renewalsto the Company’s knowledge, examination responses its and submissionstheir respective agents, affiliates and representatives, are, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or at all times: (i) have operated and currently operate its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable business in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the FDA, the Department of Health and Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company's product candidates or any product manufactured or distributed by the Company; (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting 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 such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact Regulatory Authorizations required to be stated therein or necessary conduct its business as currently conducted and such Regulatory Authorizations are valid and in order to make full force and effect and neither the statements thereinCompany nor any of its subsidiaries are in violation, in light any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities alleging that any product operation or activity is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) has not received notice that any of the circumstances under which they Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were made, materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); (vii) is not misleading. Except for such failures a party to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries have any ongoing reporting obligations pursuant to any Governmental Authority including corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Applicable Regulatory Authority; and all directives and undertakings arising (viii) has not been excluded, suspended or debarred from the most recent examination by such Governmental Authority, and have satisfactorily addressed participation in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.any government health care program or

Regulatory Matters. Except for (a) Since January 1, 2018, the Company has filed, maintained or furnished with the applicable regulatory authorities (including the FDA, European Medicines Agency (“EMA”) or any other Governmental Body performing functions similar to 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 failures other Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required material filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and 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 compliance with applicable Legal Requirements, including all applicable Health Care Laws in all material respects when filed, and no material deficiencies have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports, submissions, applications, amendments, modifications, notices and other documents. Any updates, changes, corrections or modifications 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. (b) All preclinical and clinical investigations sponsored or conducted by or on behalf of the following Company or, to be true as the knowledge of the Company, by any of the Company’s research, development, collaboration or similar partners with respect to any Product Candidates of the Company while acting in such capacity (each such party a “Collaboration Partner”), have not been 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, applicable research protocols and federal and state laws, rules, regulations and binding guidances relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. Since January 1, 2018, except as has not had, or would not reasonably be reasonably expected to behave, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeMaterial Adverse Effect, each no clinical trial sponsored or conducted by or on behalf of the Company and its Subsidiaries or by any Collaboration Partner has timely and accurately filed been terminated, delayed or provided all regulatory reports, schedules, forms, Permit applications suspended prior to completion for safety or renewals, examination responses and submissionsother non-business reasons, and neither the FDA, the EMA nor any other similar documentsSpecified Governmental Body, together clinical investigator or contract research organization that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted or sponsored by or on behalf of the 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 the Company or by any Collaboration Partner, or alleged any violation of any Health Care Law in connection with any amendments such clinical trial. The Company or an agent on its behalf periodically reviews clinical trial sites participating in any Company-sponsored trial for compliance with all applicable Health Care Laws. (c) Since January 1, 2018, neither the Company nor, to the knowledge of the Company any Company Associate, employee, agent, clinical investigator or Collaboration Partner has (i) made an untrue statement of a material fact or fraudulent statement to the FDA, EMA or any other Specified Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, EMA, Centers for Medicare and Medicaid Services or any other Specified Governmental Body or (iii) committed any other act, made with respect theretoany statement or failed to make any statement, that (in any such case) establishes a reasonable basis 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 the knowledge of the Company, any Collaboration Partner, is the subject of any pending or, to the knowledge of the Company, threatened in writing investigation or other action by the FDA pursuant to its Subsidiary was required Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by the EMA or any other Governmental Body in any similar 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 file the knowledge of the Company, any Collaboration Partner of the 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. (d) The Product Candidates are being, and since January 1, 2017 to the date of this Agreement2018, have been, developed, tested, labeled, manufactured, and stored, as applicable, in all material respects with any Governmental Authority all Health Care Laws. Since January 1, 2018, except as has not had, and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not reasonably be reasonably expected to behave, individually or in the aggregate, material a Material Adverse Effect (i) the Company and, to the Company knowledge of the Company, any Collaboration Partner, are and its Subsidiaries taken as a wholehave not been subject to any enforcement, there is no unresolved violation regulatory or exception by administrative proceedings against or affecting the Company or any of its Subsidiaries with respect 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) neither the Company nor, to the knowledge of the documents described 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 knowledge of the Company, there is not pending any allegation that any operation or activity of the Company or any Collaboration Partner relating to the 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 first sentence date of this Section 3.21Agreement, the Company has not 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, 2018, except as has not had, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to behave, individually or in the aggregate, material a Material Adverse Effect (i) no investigational new drug application or similar document filed by or on behalf of the Company with the FDA, EMA or any other Specified Governmental Body has, to the Company knowledge of the Company, been terminated or suspended, and its Subsidiaries taken as a whole, (ii) neither the Company and its Subsidiaries are 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 compliance with all formal written Governmental Authority directives and with all formal written undertakings made 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 Subsidiaries 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) material corrective and preventive actions relating to the Product Candidates or the Company’s business. (g) The Company has not submitted any claim for payment to any Governmental Authority 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 and all directives and undertakings arising from anti-kickback Legal Requirement, including the most recent examination by such Governmental AuthorityU.S. Federal Xxxx-Xxxxxxxx Xxxxxxx, and have satisfactorily addressed 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 matters requiring attentionapplicable Legal Requirements, if anyclinical 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. None L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of such directivesthe foregoing (the “Health Care Data Requirements”). The Company has implemented in all material respects any confidentiality, undertakings security and actionsother 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, individually the Company has not suffered any accidental, unauthorized, or collectivelyunlawful 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 had 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 the Company that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D, and, as of the date hereof, no information security or privacy breach event has occurred that would reasonably expected to have a Company Material Adverse Effectrequire notification under any comparable Legal Requirements.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since (a) Since January 1, 2017 2012, the Company has filed, or caused its Subsidiaries to the date of this Agreementfile, with the FDA or any other Governmental Authority and timely paid performing functions similar to those performed by the FDA, all fees and assessments due and payable in connection therewithrequired filings, declarations, listings, registrations, reports or submissions, including adverse event reports. Except for such failures To the Knowledge of the following to be true as would not be reasonably expected to beCompany, individually all such filings, declarations, listings, registrations, reports or submissions were in the aggregatematerial compliance with applicable Laws when filed, material to and the Company has not received any communication from any such applicable Governmental Authority asserting deficiencies with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) To the Knowledge of the Company, all preclinical and its Subsidiaries taken as a whole, there is no unresolved violation clinical investigations sponsored by the Company with respect to products or exception product candidates currently in development by the Company or any of its Subsidiaries are being conducted in material compliance with all applicable Laws including the FDCA and its implementing regulations and applicable experimental protocols, informed consents, procedures, controls, guidance and industry standards, including good manufacturing practice, good laboratory practice, and good clinical practice, requirements and industry standards of oversight of clinical sites including monitors, and Laws and guidance restricting the use, disclosure and protection of individually identifiable health information. None of the Company or its Subsidiaries has received any notices or other correspondence from the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or any institutional review board or ethics committee with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. To the Knowledge of the documents described in Company, neither the first sentence FDA nor any other applicable Governmental Authority nor any clinical investigator that has participated or is participating in, or institutional review board or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of this Section 3.21the Company 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 as of their respective datesnotices required to be filed, such documents complied maintained, or furnished to the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or drug regulatory agency by the Company or its Subsidiaries have been so filed, maintained or furnished and were complete and correct in all material respects with 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 requirements 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 any of applicable Law and did not contain any its Subsidiaries has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary any other Governmental Authority performing functions similar to those performed by the FDA. To the Knowledge of the Company, none of the Company or any of its Subsidiaries is the subject of any pending or threatened investigation by the FDA or any Governmental Authority performing functions similar to those performed by the FDA to take enforcement action against the Company or any of its Subsidiaries including the termination or suspension of any clearance, authorization, license or registration. (f) The Company and its Subsidiaries is in order to make compliance and has, during the statements thereinpast three years, been in compliance, in light 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 circumstances 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, none of their respective employees or other persons engaged to perform clinical services by the Company or any of its Subsidiaries have ever been while performing services for the Company or such Subsidiary, (i) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a (a) and (b)) (“Debarred”), (ii) convicted of a crime for which they were made, not misleading. Except a person can be Debarred or (iii) indicted for such failures to a crime or otherwise engaged in conduct for which a person can be Debarred or engaged in compliance as any conduct that would not reasonably be expected to beresult in Debarment under applicable Law. To the Knowledge of the Company, individually none of the matters listed in sub-parts (i), (ii), or in (iii) herein has been threatened, against the aggregateCompany, material to its Subsidiaries or any of its officers, employees or agents. (i) Set forth on Section 3.24(i) of the Company and its Subsidiaries taken Disclosure Schedule is a list of all new drug applications that, as a wholeof the date of this Agreement, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by intends to submit to the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from FDA within 90 days following the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None date of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectthis Agreement.

Regulatory Matters. Except for such failures (a) Section 4.16(a) of the following Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to be Parent, true and complete copies of, all Regulatory Authorizations from the FDA and Health Canada and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company or any Company Subsidiary relating to the Company Products, facilities and/or that are otherwise necessary to conduct the Company’s business as presently conducted. All such Regulatory Authorizations are (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiaries have not been fulfilled and performed all of their material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be reasonably expected to beto, individually or in the aggregate, result in a material liability to the Company and its the Company Subsidiaries (taken as a whole), each (x) the Company and the Company Subsidiaries have filed, maintained or furnished with the applicable Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other information (collectively, the “Health Care Submissions”) and (y) all such Health Care Submissions were complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). There has been no Proceeding pending, or to the knowledge of the Company, threatened, with respect to any Health Care Submission. (b) Since January 1, 2019, (i) the Company and the Company Subsidiaries have been in material compliance with all applicable Health Laws that affect the business, Company Products, properties, assets and activities of the Company and its Subsidiaries the Company Subsidiaries, (ii) as of the Agreement Date, neither the Company nor any Company Subsidiary has timely and accurately filed received any written notice or provided all regulatory reportsother written communication from any Regulatory Authority (A) withdrawing or placing any clinical studies of the Company Products on “clinical hold” or requiring the termination, schedulessuspension, formsmaterial modification, Permit applications evaluation, or renewalsinvestigation of any non-clinical, examination responses and submissionspre-clinical studies or clinical trials, clinical investigations, performance evaluation trials, and other similar documents, together with any amendments required to be made with respect thereto, that the Company investigations or its Subsidiary was required to file since January 1, 2017 to the date evaluations of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material related to the Company Products or facilities or (B) alleging any material violation of any Health Law and its Subsidiaries taken as a whole(iii) there have been no investigations, there is no unresolved violation suits, claims, actions or exception by proceedings pending, or to the knowledge of the Company, threatened against the Company or any of its Subsidiaries Company Subsidiary with respect to any of the documents described Company Products or facilities or alleging any violation by the Company or any Company Subsidiary or the Company Products or facilities of any such Health Law. (c) Since January 1, 2019, all non-clinical studies, pre-clinical studies, clinical trials, clinical investigations, performance evaluation trials, and other investigations or evaluations conducted or being conducted with respect to the Company Products by or at the direction of the Company have been and are currently being conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Health Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the 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. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, neither the Company nor any Company Subsidiary has received any written notifications or other written communications from any 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 termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any clinical studies proposed or currently conducted by, or on behalf of, the Company and, to knowledge of the Company, no such action has been threatened against the Company or any Company Subsidiary. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data and all material written correspondence that exists as of the Agreement Date between the Company and the applicable Regulatory Authorities, in each case in the first sentence possession of this Section 3.21the Company as of the Agreement Date. (d) Since January 1, 2019, all manufacture of the Company Products, including any clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in material compliance with the applicable specifications and as requirements of Good Manufacturing Practices and Health Laws. As of the Agreement Date, neither the Company nor, to the knowledge of the Company, any person acting on its behalf has, with respect to any Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material change to any Company Product or any of the Company’s or any Company Subsidiary’s manufacturing or clinical trial processes or procedures or any similar written correspondence from any Regulatory Authority in respect of the Company or the Company Subsidiary or their manufacturing or clinical trial operations alleging or asserting noncompliance with any applicable Health Law or Regulatory Authorization and, to the knowledge of the Company, no Regulatory Authority is considering such action. (e) None of the Company nor any of the Company Subsidiaries or any of their respective datesofficers or employees, such documents complied in all material respects with all requirements nor, to the knowledge of applicable Law and did not contain the Company, agents or any clinical investigator acting for the Company has (i) made an untrue statement of a material fact or omit fraudulent statement to state any Regulatory Authority or any other Governmental Entity, (ii) failed to disclose a material fact required to be stated therein disclosed to any Regulatory Authority or necessary in order any other Governmental Entity or (iii) committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the statements thereintime such disclosure was made or failure to disclose occurred, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beprovide a basis for the FDA to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or in for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the aggregate, material communication or submission of false information to any applicable Regulatory Authority or Governmental Entity. None of the Company nor any of the Company Subsidiaries (nor has any other Person to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by extent giving rise to liability for the Company or its Subsidiaries any Company Subsidiary) has committed or engaged in any fraud or falsification or forgery of any research or development data, report, studies or publications of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority or any other Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if anyEntity. None of such directivesthe Company, undertakings and actionsany Company Subsidiary or any of their respective officers or employees, individually nor, to the knowledge of the Company, agents or collectivelyany clinical investigator acting for the Company, is currently or has had been convicted of any crime or engaged in any conduct that has resulted in, or would reasonably be expected to result in, debarment from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 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 Company 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 pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, threatened against the Company or the Company Subsidiary, nor have any such proceedings been pending at any time. The Company has made available to Parent all material information about serious adverse events (as such term is defined in 21 C.F.R. 312.32) in the possession of the Company as of the Agreement Date relating to any Company Product that is or has been manufactured, tested, distributed, or held or marketed by or on behalf of the Company or any of its licensors or licensees. The Company has filed all annual and periodic reports, amendments and safety reports required for any Company Product required to be made to any Regulatory Authority. (g) The Company and any Company Subsidiary is not a Company Material Adverse Effectparty to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Regulatory Authority or any other Governmental Entity.

Regulatory Matters. (a) Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries Acquired Corporation, taken as a whole, the Company Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA or otherwise having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, storage, marketing, promotion, sale, commercialization, shipment, import, export or distribution of pharmaceutical products (such Governmental Bodies, collectively, the “Specified Governmental Bodies”)) all required filings, permits, claims, responses, declarations, listings, registrations, reports or submissions, including adverse event reports. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Acquired Corporations, taken as a whole, all such filings, permits, claims, responses, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed (or were corrected or supplemented by a subsequent submission) and, and its Subsidiaries no deficiencies have been asserted by any Specified Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, all preclinical and clinical investigations sponsored by the Acquired Corporations are being conducted in compliance with all formal applicable clinical protocols, informed consents and Laws, including Good Clinical Practices requirements (preclinical and clinical), Good Manufacturing Practices and pharmacovigilance. As of the Agreement Date, the Acquired Corporations have not received any written notices or other correspondence from the FDA or any other Specified Governmental Authority directives Body with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. (c) To the Knowledge of the Company, no Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statement to any Specified Governmental Body, (ii) failed to disclose a material fact required to be disclosed to any Specified Governmental Body or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis the FDA or any other Specified Governmental Body to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy (or similar rule, regulation or policy). Except as has not had or would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, no Acquired Corporation is the subject of any pending or, to the Knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. None of the Acquired Corporations nor, to the Knowledge of the Company, any officers, employees, agents or clinical investigators of the Acquired Corporations 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 Law or (b) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, each Acquired Corporation is in compliance and, since January 1, 2017, has been in compliance with all formal written undertakings made by healthcare laws applicable to the Company or operation of its Subsidiaries to any Governmental Authority business as currently conducted, including (i) any and all directives applicable federal, state and undertakings arising from local fraud and abuse laws, including the most recent examination by federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7(b)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.) and the regulations promulgated pursuant to such Governmental Authoritystatutes; (ii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and have satisfactorily addressed the regulations promulgated pursuant thereto; (iii) Laws which are cause for exclusion from any federal health care program; and (iv) 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 material respects all matters requiring attentionof the foregoing, if anyby an Acquired Corporation. None No enforcement, regulatory or administrative proceeding is pending, or, to the Knowledge of the Company, no such directivesenforcement, undertakings regulatory or administrative proceeding has been threatened, against any Acquired Corporation under the Federal Drug and actionsCosmetics Act, the Anti-Kickback Statute, or similar Laws other than any such proceeding that would not reasonably be expected to have, individually or collectivelyin the aggregate, a Material Adverse Effect. (e) As of the Agreement Date, the Product (or to the Knowledge of the Company any component thereof) has not been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No Legal Proceeding is pending seeking the recall, withdrawal, suspension or seizure of the Product is pending or, to the Knowledge of the Company, threatened against any of the Acquired Corporations. (f) To the Knowledge of the Company, there has been (i) no adverse event reportable to the FDA or other Specified Governmental Body with respect to the safety or efficacy of the Product or (ii) no scientific or technical fact or circumstance that, in the case of clauses (i) or (ii) has had or would reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse Effect.

Regulatory Matters. Except for such failures of (i) Since January 1, 2013, SVBank has timely and duly filed with or furnished to the following appropriate Governmental Authorities in substantially the correct form the monthly, quarterly and annual reports, documents, filings, statements and submissions, together with any amendments thereto, required to be true filed or furnished by it under applicable laws and regulations, has paid all fees and assessments due in connection therewith, and such reports, documents, filings, statements and submissions, together with any amendments thereto, and were in all material respects complete and accurate. There are no unresolved violations set forth in any such report, documents, filings, statements and submissions, or any amendments thereto relating to any examinations or inspections by any Governmental Authority of SVBank. Except as have Previously Disclosed, in connection with the most recent examination of SVBank by the appropriate Governmental Authorities, SVBank was not required to correct or change any action, procedure or proceeding which SVBank believes in good faith has not been and would now corrected or changed, other than corrections or changes which, if not be reasonably expected to bemade, either individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as have a whole, there is no unresolved violation or exception by the Company or Material Adverse Effect on SVBank. (ii) Neither SVBank nor any of its Subsidiaries properties is a party to or is subject to any order, decree, directive, agreement, memorandum of understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor has SVBank adopted any policies, procedures or board resolutions at the request or suggestion of, any Governmental Authority. SVBank has paid all assessments made or imposed by any Governmental Authority. (iii) Except as Previously Disclosed, no Governmental Authority has initiated since December 31, 2013, or has pending any proceeding, enforcement action or, to the knowledge of SVBank, investigation or inquiry into the business, operations, policies, practices or disclosures of SVBank (other than normal examinations conducted by a Governmental Authority in the ordinary course of the business of SVBank), or, to the knowledge of SVBank, threatened any of the foregoing. (iv) The most recent regulatory rating given to SVBank as to compliance with the Community Reinvestment Act is “Satisfactory.” Since the last regulatory examination of SVBank with respect to Community Reinvestment Act compliance, SVBank has not received any of complaints as to Community Reinvestment Act compliance. (v) SVBank satisfies the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit conditions necessary to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances qualify for an 18-month examination cycle under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect12 CFR § 337.12(b).

Regulatory Matters. (a) Except for such failures Licenses the absence of the following to be true as have not been and which would not be reasonably expected to benot, individually or in the aggregate, material to have a Company Material Adverse Effect, the Company and its Subsidiaries taken have obtained all Communications Licenses necessary (i) to conduct their businesses as presently conducted and (ii) to place, keep or otherwise locate the Network in or on public property owned or otherwise held by a wholemunicipality or other Government Authority. (b) Each Communications License granted to the Company or any of its Subsidiaries is valid and in full force and effect and has not been suspended, revoked, cancelled or adversely modified, except where the failure thereof to be in full force and effect, or the suspension, revocation, cancellation or modification thereof, would not, individually or in the aggregate, have a Company Material Adverse Effect. No Communications License granted to the Company or any of its Subsidiaries is subject to (A) any conditions or requirements that have not been imposed generally upon licenses in the same service, unless such conditions or requirements are set forth on the face of the applicable authorization or would not have, individually or in the aggregate, a Company Material Adverse Effect, (B) any pending proceeding by or before a Governmental Authority to suspend, revoke or cancel such Communications License, or any judicial review of a decision by a Governmental Authority with respect thereto, unless such pending proceeding or judicial review would not, individually or in the aggregate, have a Company Material Adverse Effect. To the Knowledge of the Company, there has not been any event, condition or circumstance that would preclude any Communications License granted to the Company or any of its Subsidiaries from being renewed in the ordinary course (to the extent that such Communications License is renewable by its terms), except where the failure thereof to be renewed would not be material to the business of the Company. (c) Since January 1, 2015, the holder of each Communications License granted to the Company or any of its Subsidiaries has been in compliance with such Communications License and has fulfilled and performed all of its obligations with respect thereto and the Communications Laws, including (x) all reports, notifications and applications required under any applicable Communications Law and (y) the payment of all regulatory fees, assessments and contributions, except (A) for exemptions, waivers or similar concessions or allowances under the Communications Laws, and (B) where such failure of such licensee to be in compliance, fulfill or perform its obligations or pay such fees or contributions would not, individually or in the aggregate, have a Company Material Adverse Effect. (d) Section 3.28(d) of the Company Disclosure Letter contains a correct and complete list of all Communications Licenses granted to the Company or any of its Subsidiaries, together with the name of the entity holding such Communications License. (e) Without limiting the foregoing or Section 3.18, since January 1, 2015, the Company and its Subsidiaries have filed all required Universal Service Fund reports and all such filings were, when made, true, correct and complete and in accordance with existing precedent of the relevant Governmental Authority. At the Closing, the Company and its Subsidiaries shall have paid all federal and state Universal Service Contributions billed by Fund Administrators and due and payable prior to the Closing Date. At the Closing, the Company and its Subsidiaries shall have filed all forms that were due on or prior to the Closing Date, and retained all supporting documentation, necessary for the Fund Administrators to calculate its Universal Service Contributions. Where such forms are not due to be filed until after the Closing Date, the Company and its Subsidiaries shall also have compiled and retained all documentation needed to file any forms necessary for the Fund Administrators to calculate Universal Service Contributions for the period prior to the Closing Date. Except as would not have a Company Material Adverse Effect, (i) since January 1, 2017, none of the Company and its Subsidiaries has timely and accurately filed been the subject of any enforcement, Action, fine, penalty or provided all regulatory reportsinterest related to Universal Service Subsidies or Universal Service Contributions and, schedulesto the Knowledge of the Company, formsno such enforcement, Permit applications Action, fine, penalty or renewalsinterests is threatened, (ii) there is no audit, examination responses and submissions, and other or similar documents, together with any amendments required to be made proceeding currently in progress or pending with respect thereto, that the Company to Universal Service Subsidies or its Subsidiary was required to file since January 1, 2017 to the date Universal Service Contributions of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by and (iii) none of the Company or any of its Subsidiaries with respect has received any written or, to any the Knowledge of the documents described in Company, other notice indicating any intent to open an audit (or other review) or request for information related to Universal Service Subsidies or Universal Service Contributions from any Fund Administrator or other Governmental Authority. (f) Without limiting the first sentence of this Section 3.21foregoing, and as of their respective datessince January 1, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole2017, the Company and its Subsidiaries are have been in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects with (i) the FCC’s requirements for receipt of CAF-ICC, Connect America Fund Broadband Loop Support (“CAF-BLS”), Universal Service High Cost Loop (“USF HCL”), Alternative Connect America Model I (“A-CAM”), Revised Alternative Connect America Model I (“Revised A-CAM I”) and Alternative Connect America Model II (“A-CAM II”) funding including but not limited to meeting all matters requiring attentionbroadband deployment milestones applicable to the Company and its Subsidiaries, if any. None (ii) the requirements for receipt of such directivesfunding from the Alabama Transition Service Fund and Alabama Broadband Accessibility Fund, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect(iii) the requirements for receipt of funding from the Maine Universal Service Fund.

Regulatory Matters. Except for such failures (a) Section 3.16(a) of the following Company Disclosure Letter sets forth a true and complete list, as of the date of this Agreement, and the Company has made available to be Parent true and complete copies of, all Regulatory Authorizations from the FDA, EMA and all other applicable Regulatory Authorities held by the Company or the Company Subsidiary relating to the Company Products and/or necessary to conduct its business as presently conducted. All such Regulatory Authorizations are (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiary have not been fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be reasonably expected to beto, individually or in the aggregate, material to have a Company Material Adverse Effect, (x) the Company and its Subsidiaries taken as the Company Subsidiary have filed, maintained or furnished with the applicable Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other information (collectively, the “Health Care Submissions”) with the FDA, EMA and all other applicable Regulatory Authorities and (y) all such Health Care Submissions were complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed in a wholesubsequent filing). (b) (i) The Company and the Company Subsidiary are in material compliance with all applicable Health Laws that affect the business, each Company Products, properties, assets and activities of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reportsCompany, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to (ii) as of the date of this Agreement, with neither the Company nor the Company Subsidiary has received any Governmental written notice or other communication from any Regulatory Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures (A) withdrawing or placing any clinical studies of the following Company Products on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Company Products or (B) alleging any material violation of any Health Law and (iii) there are no investigations, suits, claims, actions or proceedings pending, or to be true as would not be reasonably expected the knowledge of the Company, threatened against the Company or the Company Subsidiary with respect to be, individually any of the Company Products or in alleging any violation by the aggregate, material Company or the Company Subsidiary or the Company Products of any such Health Law. (c) All pre-clinical studies and clinical trials conducted or being conducted with respect to the Company Products by or at the direction of the Company have been and are being conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Laws, including the FDCA and its Subsidiaries taken applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the 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. The Company (or its agents, e.g., the applicable contract research organization(s)) has provided all notices to and obtained all consents from Persons relating to the Company Products necessary to conduct its business as presently conducted and as required in order for Company to undertake the actions set forth in this Agreement, including the transfer of all data and associated rights to the data to Parent as set forth in this Agreement, and that such transfer is in compliance with applicable Laws, including all applicable Health Laws. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. Neither the Company nor the Company Subsidiary has received any written notifications or other written communications from any 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 termination or suspension or investigation, or place a wholeclinical hold order on or otherwise delay or materially restrict any clinical studies proposed or currently conducted by, there or on behalf of, the Company, or in which the Company or the Company Subsidiary has participated and, to knowledge of the Company, no such action has been threatened against the Company or the Company Subsidiary. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company and all material written correspondence that exists as of the date of this Agreement between the Company and the applicable Regulatory Authorities. (d) All manufacture of the Company Products, including any clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in all material respects in compliance with the applicable specifications and requirements of Good Manufacturing Practices and applicable Law. Neither the Company nor, to the knowledge of the Company, any person acting on its behalf has, with respect to any Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any change to any Company Product or any of the Company’s or the Company Subsidiary’s processes or procedures, or any similar correspondence from any Regulatory Authority in respect of the Company or the Company Subsidiary or their business operations alleging or asserting noncompliance with any applicable Law, permit or any such requests or requirements of a Regulatory Authority and, to the knowledge of the Company, no Regulatory Authority is no unresolved violation or exception by considering such action. (e) None of the Company or any of its Subsidiaries with respect respective officers, employees or agents, or, to any the knowledge of the documents described in Company, any clinical investigator acting for the first sentence of this Section 3.21Company, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any has (i) made an untrue statement of a material fact or omit fraudulent statement to state a material fact required to be stated therein any Regulatory Authority or necessary in order to make any other Governmental Entity, including the statements therein, in light of the circumstances under which they were made, not misleading. Except Centers for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company Medicare and its Subsidiaries taken as a wholeMedicaid Services, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None U.S. Department of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.Health and

Regulatory Matters. Except for such failures of the following to be true as have not been (a) The Company and would not be reasonably expected to be, individually or in the aggregate, material to the Company Subsidiaries have obtained, and are in material compliance with, all clearances, consents, certificates, authorizations, licenses, permits, approvals, waivers, variances, filings, accreditations, exemptions and registrations required under applicable Laws by any Governmental Body to permit the conduct of its Subsidiaries taken business as currently conducted (each, a whole“Company Permit”), each and all such Company Permits are identified on Section 3.9(a) of the Company Disclosure Schedule and its Subsidiaries are valid and in full force and effect. No Governmental Body has timely provided any written or, to Knowledge of the Company, oral notice that it intends to limit, suspend, revoke, withdraw, cancel or modify any such Company Permit. The Company and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents have complied in all material respects with all of the applicable requirements of any applicable Law Governmental Body and did not contain under applicable Laws, including making all required filings, declarations, listings, registrations, notifications, certifications, reports or submissions, including adverse event reports. All such filings, declarations, listings, registrations, notifications, certifications, reports or submissions were in compliance with applicable Laws when filed, and no deficiencies have been asserted by any applicable Governmental Body with respect to any Company Permit or filings, declarations, listing, registrations, notifications, certifications, reports, submissions, or other matters and, to the Knowledge of the Company, there are no facts that would reasonably give rise to an assertion of such a deficiency. (b) Neither the Company nor any Company Subsidiary has (i) made an untrue statement of a material fact or omit fraudulent statement to state any other Governmental Body or (ii) failed to disclose a material fact required to be stated therein or necessary in order disclosed to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the any other Governmental Body. (c) The Company and its Company Subsidiaries taken as a whole, the Company and its Subsidiaries are have at all times complied in compliance all material respects with all formal written Governmental Authority directives applicable Laws (and with all formal written undertakings made their own rules, policies and procedures) relating to rights of publicity, privacy, data protection, and the collection, use, storage and disposal of personal information collected, used, or held for use by the Company or its Subsidiaries to any Governmental Authority a Company Subsidiary in the conduct of their businesses, including any registration requirements. No claim, action or proceeding has been asserted or, to the Knowledge of the Company, threatened alleging a violation of any Person’s rights of publicity or privacy or personal information or data rights and all directives and undertakings arising from the most recent examination consummation of the transactions contemplated hereby will not breach or otherwise cause any violation of any Laws or rule, policy, or procedure related to rights of publicity, privacy, data protection, information security, or the collection, use, storage or disposal of personal information collected, used, or held for use by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually the Company or collectively, has had or would reasonably expected to have a Company Material Adverse EffectSubsidiary in the conduct of their businesses.

Regulatory Matters. Except for such failures of the following (a) Seres has made available to be true as have not been and would not be reasonably expected to be, individually NHSc all material Regulatory Documentation owned or in the aggregate, material possessed by Seres regarding or related to the Company Collaboration Products, including, any minutes of meetings (including by teleconference) with Regulatory Authorities and its Subsidiaries taken as a wholeany material correspondence with Regulatory Authorities, each any notice of the Company and its Subsidiaries inspection, inspection report, warning letter, deficiency letter or similar communication. Seres has timely and accurately filed prepared, maintained or provided retained all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments material Regulatory Documentation relating to Collaboration Products that is required to be made maintained or reported pursuant to Regulatory Authorities and such items have been prepared in accordance with the applicable requirements of GLP and GCP, as applicable, to the extent required, and applicable Law, and to Seres’ Knowledge, such Regulatory Documentation does not contain any materially false or misleading statements. (b) Neither Seres nor any of its Affiliates has received, with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this AgreementCollaboration Products, with any oral or written communication (including any warning letter, untitled letter, or similar notices) from any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeand, there is no unresolved violation action pending or, to Seres’ Knowledge, threatened (including any prosecution, injunction, seizure, civil fine, suspension or exception by recall), in each case alleging that with respect to the Company Collaboration Products in the Field, Seres or any of its Subsidiaries Affiliates is not currently materially in compliance with any and all applicable Laws implemented by such Governmental Authority. Neither Seres nor any of its Affiliates has received any written notice from any Governmental Authority claiming that the research, development, manufacture, use, offer for sale, sale, or import of the Collaboration Products in the Field is not in material compliance with all applicable Laws and permits; and (c) To Seres’ Knowledge, none of Seres, any of its Affiliates, or any of their respective officers, employees or agents has made, with respect to any of the documents described in the first sentence of this Section 3.21Collaboration Products, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any an untrue statement of a material fact to any Governmental Authority or omit failed to state disclose a material fact required to be stated therein or necessary in order disclosed to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures (a) The Seller or the Acquired Subsidiaries have all licenses, permits, certificates, franchises, consents, waivers, registrations or other regulatory authorizations from the appropriate Governmental Authority in each applicable jurisdiction required to provide the telecommunications network services and operate the Network Facilities or otherwise provide telecommunication services as presently conducted by the Business (the "Communications Licenses"). All of the following to be true as have Communications Licenses are set forth in Section 3.10(a) of the Disclosure Schedule. (b) Each of the Communications Licenses was duly issued, is valid and in full force and effect, has not been suspended, canceled, revoked or modified in any adverse manner, and would not be reasonably expected to beis validly held, individually or free and clear of all Encumbrances and, in the aggregateeach case, material to the Company and its Subsidiaries taken as a whole, each Knowledge of the Company Seller and its Subsidiaries has timely upon the grant of the Telecom Approvals, shall remain so immediately following the consummation of the transactions contemplated by this Agreement and accurately filed or provided all regulatory reportsthe Ancillary Agreements. Except as set forth on Section 3.10(b) of the Disclosure Schedule, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures Knowledge of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeSeller, there is no unresolved circumstance, Law, event or other reason that exists or is likely to exist that would prevent the granting of the Telecom Approvals or the transfer of the Communications Licenses. (c) Except as set forth in Section 3.10(c) of the Disclosure Schedule, each holder of a Communications License (i) has operated in all material respects in compliance with all terms thereof including all systems build-out requirements, and (ii) is in all material respects in compliance with, and the conduct of its business has been and is in all material respects in compliance with, the applicable Law, and has filed all registrations, statements, documents and reports and paid all fees required by all applicable Law, in each case, relating to the Communications Licenses and any other applicable Law. There is no pending or, to the Knowledge of the Seller, threatened action by or before any Governmental Authority to revoke, cancel, suspend, modify or refuse to renew any of the Communications Licenses, there is not now issued, outstanding or, to the Knowledge of the Seller, threatened, any notice by any Governmental Authority of any violation or exception complaint, or any application, complaint, or proceeding (other than applications, proceedings, or complaints that generally affect the Seller's industry as a whole) relating to the business or operations of the Seller or any Acquired Subsidiary. To the Knowledge of the Seller, no Person has asserted in writing to a Governmental Authority that a material Communications License should be modified or revoked, or that the Seller or any Acquired Subsidiary is not in material compliance with any Communications License. (d) To the Knowledge of the Seller, no event has occurred which would permit the revocation or termination of any of the Communications Licenses or the imposition of any restriction thereon, or that would prevent any of the Communications Licenses from being renewed on a routine basis or in the ordinary course. (e) To the Knowledge of the Seller, Section 3.10(e) of the Disclosure Schedule sets forth a complete list of all Telecom Approvals required by Seller in connection with the Company consummation of the transactions contemplated by this Agreement and the Ancillary Agreements. Assuming the receipt of the Telecom Approvals, to the Knowledge of the Seller, none of the execution, delivery or performance of this Agreement or any of its Subsidiaries with respect to any the other Ancillary Agreements by the Seller, nor the consummation by Seller of the documents described transactions contemplated hereby or thereby, will result in any revocation, cancellation, suspension or modification of any Communications Licenses or give rise to the first sentence right of this Section 3.21any Governmental Authority to take any such action or to fail to renew any Communications License. (f) No Acquired Subsidiary has (i) a security clearance issued by any Governmental Authority or (ii) a request for a new or upgraded security clearance in process with any Governmental Authority. (g) In addition to the Communications Licenses, the Seller and each Acquired Subsidiary holds and is in compliance with all other material licenses, franchise permits, consents, registrations, certificates, and other governmental or regulatory permits, authorizations or approvals required for the operation of the business as presently conducted and for the ownership, lease or operation of their respective datesthe Seller's and the Acquired Subsidiaries' properties (collectively, "Other Licenses"). All of such documents complied Other Licenses are valid and in full force and effect and, to the Knowledge of the Seller, upon grant of any Regulatory Approvals applicable to the Other Licenses, shall remain so immediately following the consummation of the transactions contemplated by this Agreement and the other Ancillary Agreements, and the Seller and the Acquired Subsidiaries have duly performed and are in compliance in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light their respective obligations under such Other Licenses. Except as set forth on Section 3.10(g) of the Disclosure Schedule, to the Knowledge of the Seller, there is no circumstance, Law, event or other reason that exists or is likely to exist that would prevent the granting of the Regulatory Approvals or the transfer of the Other Licenses. To the Knowledge of the Seller, no Person has alleged any violation or failure to comply by the Seller or any Acquired Subsidiary, with any Other License, no suspension, cancellation or termination of any such Other License is threatened, and no event has occurred or circumstances under which they were madeexist that may (with or without notice or lapse of time) constitute or result directly or indirectly in a violation of or failure to comply with any term or requirement of any such Other License, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or result directly or indirectly in the aggregaterevocation, material to the Company and its Subsidiaries taken as a wholewithdrawal, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company suspension, cancellation or its Subsidiaries to termination of, or any Governmental Authority including modification to, any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectOther License.

Regulatory Matters. Except for such failures (i) Neither NSD nor any of its Subsidiaries nor any of their respective properties is a party to or is subject to any order, decree, agreement, memorandum of understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, any Bank Regulatory Authority or any federal or state governmental agency or authority charged with the following to be true as have not been and would not be reasonably expected to besupervision or regulation of issuers of securities or the supervision or regulation of it (collectively, individually or in the aggregate, material to the Company "NSD Regulatory Authorities"). NSD and its Subsidiaries taken as a whole, each have paid all assessments made or imposed by any NSD Regulatory Authority. (ii) Neither NSD nor any of the Company and its Subsidiaries has been advised by, nor does it have any knowledge of facts that could give rise to an advisory notice by, any NSD Regulatory Authority that such NSD Regulatory Authority is contemplating issuing or requesting, or is considering the appropriateness of issuing or requesting, any such order, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission. (iii) NSD and each of its Subsidiaries have timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses registrations and submissions, and other similar documentsstatements, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was they were required to file since January 1, 2017 2001 with (A) the Federal Reserve Board, (B) the FDIC, (C) the Department or (D) any other state regulatory authority and (E) the SEC, and all other reports and statements required to the date of this Agreementbe filed by them since January 1, with any Governmental Authority 2001, and timely have paid all fees and assessments due and payable in connection therewith. Except for such failures as set forth in Schedule 5.03(i) of the following NSD Disclosure Schedule and except for normal examinations conducted by Bank Regulatory Authorities, (A) no Bank Regulatory Authority has initiated or has pending any proceeding or, to be true as would the knowledge of NSD, investigation into the business or operations of NSD or any of its Subsidiaries since January 1, 2001, except where such proceedings or investigation are not be reasonably expected likely to behave, either individually or in the aggregate, material to the Company a NSD Material Adverse Effect, and its Subsidiaries taken as a whole, (B) there is no unresolved violation violation, criticism or exception by the Company or any of its Subsidiaries Bank Regulatory Authority with respect to any the business, operations, policies or procedures of the documents described in the first sentence of this Section 3.21NSD or NorthSide Bank since January 1, and as of their respective dates2001 that are reasonably likely to have, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, either individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company NSD Material Adverse Effect.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since (a) Since January 1, 2017 2012, the Company has filed, or caused its Subsidiaries to the date of this Agreementfile, with the FDA or any other Governmental Authority and timely paid performing functions similar to those performed by the FDA, all fees and assessments due and payable in connection therewithrequired filings, declarations, listings, registrations, reports or submissions, including adverse event reports. Except for such failures To the Knowledge of the following to be true as would not be reasonably expected to beCompany, individually all such filings, declarations, listings, registrations, reports or submissions were in the aggregatematerial compliance with applicable Laws when filed, material to and the Company has not received any communication from any such applicable Governmental Authority asserting deficiencies with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) To the Knowledge of the Company, all preclinical and its Subsidiaries taken as a whole, there is no unresolved violation clinical investigations sponsored by the Company with respect to products or exception product candidates currently in development by the Company or any of its Subsidiaries are being conducted in material compliance with all applicable Laws including the FDCA and its implementing regulations and applicable experimental protocols, informed consents, procedures, controls, guidance and industry standards, including good manufacturing practice, good laboratory practice, and good clinical practice, requirements and industry standards of oversight of clinical sites including monitors, and Laws and guidance restricting the use, disclosure and protection of individually identifiable health information. None of the Company or its Subsidiaries has received any notices or other correspondence from the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or any institutional review board or ethics committee with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. To the Knowledge of the documents described in Company, neither the first sentence FDA nor any other applicable Governmental Authority nor any clinical investigator that has participated or is participating in, or institutional review board or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of this Section 3.21the Company 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 as of their respective datesnotices required to be filed, such documents complied maintained, or furnished to the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or drug regulatory agency by the Company or its Subsidiaries have been so filed, maintained or furnished and were complete and correct in all material respects with 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 requirements 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 any of applicable Law and did not contain any its Subsidiaries has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority performing functions similar to those performed by the FDA or (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary any other Governmental Authority performing functions similar to those performed by the FDA. To the Knowledge of the Company, none of the Company or any of its Subsidiaries is the subject of any pending or threatened investigation by the FDA or any Governmental Authority performing functions similar to those performed by the FDA to take enforcement action against the Company or any of its Subsidiaries including the termination or suspension of any clearance, authorization, license or registration. (f) The Company and its Subsidiaries is in order to make compliance and has, during the statements thereinpast three years, been in compliance, in light 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 circumstances 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, none of their respective employees or other persons engaged to perform clinical services by the Company or any of its Subsidiaries have ever been while performing services for the Company or such Subsidiary, (i) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a (a) and (b)) ("Debarred"), (ii) convicted of a crime for which they were made, not misleading. Except a person can be Debarred or (iii) indicted for such failures to a crime or otherwise engaged in conduct for which a person can be Debarred or engaged in compliance as any conduct that would not reasonably be expected to beresult in Debarment under applicable Law. To the Knowledge of the Company, individually none of the matters listed in sub-parts (i), (ii), or in (iii) herein has been threatened, against the aggregateCompany, material to its Subsidiaries or any of its officers, employees or agents. (i) Set forth on Section 3.24(i) of the Company and its Subsidiaries taken Disclosure Schedule is a list of all new drug applications that, as a wholeof the date of this Agreement, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by intends to submit to the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from FDA within 90 days following the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None date of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectthis Agreement.

Regulatory Matters. (a) Except for such failures of the following to be true as have not been and would not reasonably be reasonably expected to beexpected, individually or in the aggregate, to be material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed with the applicable regulatory authorities (including the FDA or provided 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 regulatory reportsmaterial required filings, schedulespermits, formsclaims, Permit applications responses, declarations, listings, registrations, reports or renewals, examination responses and submissions, and other similar documents, together with any amendments required including but not limited to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewithadverse event reports. Except for such failures of the following to be true as would not reasonably be reasonably expected to beexpected, individually or in the aggregate, to be material to the Company and its Subsidiaries taken as a whole, there is all such filings, permits, claims, responses, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed and no unresolved violation or exception deficiencies have been asserted by the Company or any of its Subsidiaries Specified Governmental Body with respect to any such filings, permits, claims, responses, declarations, listing, registrations, reports or submissions. (b) Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, all preclinical and clinical investigations sponsored by the Company are being conducted in compliance with all applicable clinical protocols and informed consent and other Laws, including Good Clinical Practices requirements (preclinical and clinical), Good Manufacturing Practices and pharmacovigilance. As of the documents described in Agreement Date, the first sentence Company has not received any written notices or other correspondence from the FDA or any other Specified Governmental Body with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did studies or tests. (c) The Company has not contain any (i) made an untrue statement of a material fact or omit fraudulent statement to state any Specified Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to any Specified Governmental Body or necessary in order (iii) committed any other act, made any statement or failed to make any statement that (in any such case) establishes a reasonable basis for the statements thereinFDA or for any other Specified Governmental Body to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy (or similar Law or policy). The Company is not the subject of any pending 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. Neither the Company nor any officers of the circumstances Company (or, to the Knowledge of the Company, any other employees, agents or clinical investigators of the Company) 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 which they were made, 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. (d) Except as has not misleading. Except for such failures to be in compliance had and as would not reasonably be expected to behave, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeMaterial Adverse Effect, the Company and its Subsidiaries are is in compliance and, since January 1, 2020, has been in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by healthcare laws applicable to the Company or operation of its Subsidiaries to any Governmental Authority including business as currently conducted, including: (i) any and all directives applicable federal, state and undertakings arising 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; (iii) Laws which are cause for exclusion from any federal health care program; and (iv) Laws relating to the most recent examination 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. No enforcement, regulatory or administrative proceeding is pending, or, to the Company’s Knowledge, no such Governmental Authorityenforcement, regulatory or administrative proceeding has been threatened in writing, against the Company under the Federal Food, Drug, and have satisfactorily addressed in all material respects all matters requiring attentionCosmetic Act (21 U.S.C. Section 301, if anyet seq.), the Anti-Kickback Statute or similar Laws. (e) The Company Product (or, to the Knowledge of the Company, any component thereof) has not been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). None No Legal Proceeding (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of the Company Product is pending or, to the Knowledge of the Company, threatened against the Company, nor has any such directivesLegal Proceeding been pending at any time. (f) To the Knowledge of the Company, undertakings and actions, individually there has been (i) no adverse event reportable to the FDA or collectively, other Specified Governmental Body with respect to the safety or efficacy of the Company Product or (ii) no scientific or technical fact or circumstance that has had or would reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse EffectEffect on the scientific, therapeutic or commercial viability of the Company Product in light of the particular stage of development of the Company Product and taking into account all relevant facts and circumstances at the time such facts or circumstances arose, including medical and clinical considerations, the regulatory environment and competitive market conditions.

Regulatory Matters. Except (a) The Company and the Included Subsidiaries hold all licenses, franchises, certificates, consents, permits, qualifications and authorizations (including, without limitation, FCC Licenses, and licenses, authorizations and certificates of public convenience and necessity from applicable state and local authorities) from all governmental authorities necessary for such failures the lawful conduct of the following to be true as have not been and would not be reasonably expected to beCompany's business (collectively, the "Licenses"), other than the Licenses the lack of which, individually or in the aggregate, material has not had and would not reasonably be expected to have a Material Adverse Effect on the Company Group. Schedule 3.23 sets forth each certificate of convenience and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that necessity obtained by the Company or its Subsidiary was required the Included Subsidiaries from any state public utilities commission. To the Sellers' Knowledge, no event has occurred or fact exists with respect to the Licenses (other than the requirement to file since January 1applications for renewal and obtain renewals in the ordinary course) which permits, 2017 to the date or after notice or lapse of this Agreementtime or both would permit, with revocation or termination of any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true Licenses or would result in any other impairment of the rights of the holder of any of the Licenses or which might limit the operation of the Cellular Telephone System as it is now conducted, except for revocations, limitations or terminations which, individually or in the aggregate have not had and would not reasonably be reasonably expected to behave a Material Adverse Effect on the Company Group. The Company and the Included Subsidiaries have performed their respective obligations under such Licenses with such exceptions which, individually or in the aggregate, material to the Company have not had and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to behave a Material Adverse Effect on the Company Group. The FCC actions granting the FCC Licenses, individually together with all underlying construction permits have not been reversed, stayed, enjoined, annulled or suspended, and there is not pending or, to the Knowledge of Sellers, threatened, any application, petition, objection or other pleading with the FCC or other governmental entity which challenges or questions the validity of or any rights of the holder under any License, except for such reversals, stays, injunctions, annulments, suspensions, applications, petitions, objections or other pleadings, which have not had and would not reasonably be expected to have a Material Adverse Effect on the Company Group. (b) Except as set forth in Schedule 3.23, all of the aggregate, material to cell sites and microwave paths of the Company and its the Included Subsidiaries taken as in respect of which a whole, filing with the Company FCC was required have been constructed and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed currently operated in all material respects all matters requiring attentionas represented to the FCC in currently effective filings, if any. None of and, with such directives, undertakings exceptions which have not had and actions, individually or collectively, has had or would not reasonably be expected to have a Company Material Adverse EffectEffect on the Company Group, modifications to such cell sites and microwave paths have been preceded by the submission to the FCC of all required filings.

Regulatory Matters. Except (a) There is no civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for such failures 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 following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to product candidates of the Company is being, and its Subsidiaries taken at all times has been, developed, tested, manufactured, labeled, promoted and stored, as a wholeapplicable, each in material compliance with FDA Law and Regulation and requirements of comparable foreign regulatory and Governmental Authorities. (c) The clinical trials, studies 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 Company and its Subsidiaries has timely applicable FDA and accurately filed or provided all regulatory reportsforeign requirements including, schedulesbut not limited to, formsgood clinical practices, Permit applications or renewals, examination responses and submissionsgood 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 similar documents, together with any amendments required to be made with respect thereto, that the Company regulatory or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures requiring the termination or suspension or material modification of any animal study, preclinical study or clinical trial conducted by or on behalf of the following Company. (d) With respect to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company all third party manufacturers and its Subsidiaries taken as a whole, there is no unresolved violation or exception suppliers of key raw materials used by the Company or any of (each a “Third Party Manufacturer”), the 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 Subsidiaries with respect to any of the documents described Knowledge, each such Third Party Manufacturer (A) has complied and is complying, in the first sentence of this Section 3.21, and as of their respective dates, such documents complied each case in all material respects respects, with all requirements Laws, including the FD&C Act and any similar state or foreign Laws; and (B) has all material permits to perform its obligations as a Third Party Manufacturer and all such permits are in full force and effect. (e) To the Knowledge of applicable Law the Company, and did not contain in connection with the Company's business, no director, officer, employee or agent of the Company has: made any untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority; failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any other Governmental Authority; or committed an act, made a statement, or failed to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as a statement that would not reasonably be expected to beprovide the basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed.Reg. 46191 (September 10, 1991). (f) Neither the Company nor any director or officer of the Company is debarred or otherwise excluded from or restricted in the aggregateany manner from participation in, material any government program or, to the Knowledge of the Company, convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a, or convicted of any crime or engaged in any conduct for which such person could be excluded from participating in any federal health care programs. (g) The Company has complied with all applicable security and its Subsidiaries taken as a wholeprivacy 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 its Subsidiaries are 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 formal written Governmental Authority directives such FD&C Act Permits. To the Knowledge of the Company, no suspension, revocation, cancellation or withdrawal of the FD&C Act Permits is threatened and with all formal written undertakings made by the Company there is no basis for believing that such FD&C Act Permits will not be renewable upon expiration or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authoritywill be suspended, and have satisfactorily addressed in all material respects all matters requiring attentionrevoked, if any. None of such directivescancelled, undertakings and actions, individually modified or collectively, has had or would reasonably expected to have a Company Material Adverse Effectwithdrawn.

Regulatory Matters. (a) Except for such failures as disclosed in the Disclosure Schedule, the Group Companies have obtained any and all Approvals from applicable Governmental Authorities and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to the Founders’ investment in the Group Companies, and with respect to the Group Companies and their operations. Except as disclosed in the Disclosure Schedule, the Schools have obtained any and all Approvals from applicable Governmental Authorities and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to their establishments and operations. All filings and registrations with applicable Governmental Authorities required with respect to the Group Companies and the Schools have been duly completed in accordance with applicable Law. No Group Company has received any letter or notice from any applicable Governmental Authorities notifying it of the following revocation of any Approval issued to be true as have not it or any Schools or the need for compliance or remedial actions with respect to the activities carried out directly or indirectly by any Group Company or any School. Each Group Company and each School has been conducting its business activities within the permitted scope of business or is otherwise operating its Businesses in full compliance with all relevant Laws and would Governmental Orders, including providing products and/or services with all requisite licenses, permits and approvals granted by the competent Governmental Authorities. Neither any Founder nor any Group Company has reason to believe that any authorization of any Governmental Authority, license or permit required for the conduct of any part of its Business and/or for the operation of any School which is subject to periodic renewal will not be reasonably expected granted or renewed by the relevant Governmental Authorities. (b) Each holder of any Equity Securities of the Company or any Sellers (each, a “Company Security Holder”), who is a Domestic Resident and subject to beany of the registration or reporting requirements of Circular 37 or any other applicable SAFE rules and regulations (collectively, individually the “SAFE Rules and Regulations”), has complied with such reporting and/or registration requirements under the SAFE Rules and Regulations. Neither the Warrantors nor any of the Company Security Holders has received any oral or in written inquiries, notifications, orders or any other forms of official correspondence from SAFE or any of its local branches with respect to any actual or alleged non-compliance with the aggregate, material to SAFE Rules and Regulations and the Company and the Company Security Holders have made all oral or written filings, registrations, reporting or any other communications required by SAFE or any of its Subsidiaries taken local branches. Each Group Company has obtained all certificates, approvals, permits, licenses, registration receipts and any similar authority necessary under the PRC Law to conduct foreign exchange transactions as a wholenow being conducted by it. (c) Lebai has obtained any and all Approvals from applicable Governmental Authorities and has fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to its franchising agreements entered into with any and all franchisees for Firstleap Education and the relevant businesses conducted thereunder. Lebai has not violated any of such franchising agreements in any material aspect and, to the best knowledge of the Warrantors, each of the Company training centres of Lebai is duly established under PRC Law and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together been operating in full compliance with any amendments required to be made with respect thereto, that PRC Law. To the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures best knowledge of the following to be true as would not be reasonably expected to beWarrantors, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any each of the documents described franchised schools and training centers of Beijing Company (the “Franchised Schools”) is duly established and operated in accordance with the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in People’s Republic of China on the aggregate, material to the Company Promotion of Privately-run Schools («中华人民共和国民办教育促进法» ) and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectrelevant regulations.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each (a) All of the Company Products are being and its Subsidiaries have been manufactured, processed, developed, packaged, labeled, promoted, marketed, sold, stored, tested, distributed, imported and exported in material compliance with all applicable requirements under any applicable Law. (b) The Company has timely and accurately filed or provided with the applicable Governmental Authorities all regulatory material filings, documents, declarations, listings, registrations, reports, schedulesstatements, formsamendments, Permit applications supplements or renewals, examination responses and submissions, and other similar documentsincluding but not limited to adverse event reports, together with any amendments required to be made filed by it under applicable Law. All such filings, documents, declarations, listings, registrations, reports, statements, amendments, supplements or submissions were in material compliance with respect theretoapplicable Laws when filed, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with and no material deficiencies have been asserted by any applicable Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21such filings, documents, declarations, listing, registrations, reports, statements, amendments, supplements or submissions. Each such filing was true and as of their respective dates, such documents complied correct in all material respects as of the date of submission, or was corrected in or supplemented by a subsequent filing, and any material and legally necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Authority. (c) Except as set forth on Schedule 4.07(c) of the Company Disclosure Schedules, the Company has not received any notification of any pending or, to the knowledge of the Company, threatened (i) action, suit, claim, investigation, proceeding or order alleging potential or actual non-compliance with all requirements 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 that (i) alleged or asserted that the Company violated any applicable Laws, (ii) commenced, or threatened to initiate, any action, suit, claim, investigation, 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 action, suit, claim, investigation, 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. (f) Neither the Company nor, to the knowledge of the 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 Laws 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 and did not contain 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 (i) made an untrue statement of a material fact or omit fraudulent statement to state any Governmental Authority, (ii) failed to disclose a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries disclosed to any Governmental Authority including or (iii) committed any and all directives and undertakings arising from other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for a Governmental Authority to allege a violation of any applicable Law. Neither the most recent examination Company nor, to the knowledge of the Company, any of its officers, employees, or agents is the subject of any pending or threatened investigation by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected any Government Entity pursuant to have a Company Material Adverse Effectany similar Law.

Regulatory Matters. Except for (a) The Acquired Corporations have obtained all clearances, authorizations, licenses, registrations and other Governmental Authorizations required by any foreign or domestic Governmental Body (including, the FDA, EMA and BfArM) to permit the conduct of its business as currently conducted and all such failures Governmental Authorizations are valid, and in full force and effect. To the knowledge of the following to be true as Company, none of the Governmental Authorizations have been or are being revoked or challenged, except where such revocation or challenge does not been and would not be reasonably expected to benot, individually or in the aggregate, material be likely to have a Material Adverse Effect. The Acquired Corporations have filed with the applicable regulatory authorities (including, the FDA, BfArM or any other Governmental Body performing functions similar to those performed by the FDA) all required filings, representations, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports relating to the Company Products. All such filings, representations, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and its Subsidiaries taken as a wholeno deficiencies which are material in the aggregate have been asserted by any applicable Governmental Body with respect to any such filings, each representations, declarations, listing, registrations, reports or submissions. (b) To the knowledge of the Company and its Subsidiaries has timely and accurately filed Company, except as set forth in documents either delivered or provided all regulatory reports, schedules, forms, Permit applications otherwise made available to Parent or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company Parent’s Representatives on or its Subsidiary was required to file since January 1, 2017 prior to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures the business of the following Acquired Corporations and all preclinical and clinical investigations sponsored by the Acquired Corporations are being conducted in material compliance with applicable Legal Requirements, rules, regulations, directives and guidances, including, Good Clinical Practice requirements, Good Laboratory Practice requirements, Good Manufacturing Practice requirements, ICH requirements, and federal and state laws, rules, regulations and guidances restricting the use and disclosure of individually identifiable health information with respect to be true as would not be reasonably expected to bemanufacturing, individually or in the aggregateclinical research and development, material to and future potential marketing and sale of the Company and its Subsidiaries taken as a wholeProducts. The Acquired Corporations have not received since May 2006 any material written notices or other material correspondence from the FDA, there is no unresolved violation EMA, BfArM or exception any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the Company or any of its Subsidiaries 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 that have not been disclosed or made available to Parent or its Representatives on or prior to the date of this Agreement. (i) Other than in Germany, there are no pending or, to the knowledge of the documents described Company, threatened actions or proceedings by the FDA, EMA, BfArM or any other Governmental Body and (ii) in Germany, to the knowledge of the Company, there are no pending or threatened actions or proceedings by the FDA, EMA, BfArM or any other Governmental Body, which in the first sentence case of this Section 3.21either (i) or (ii) would prohibit or impede 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 as oversight of their respective datesmarketing and sales practices or limit in any material respect the ability of any Acquired Corporation to develop, such documents complied in all material respects with all requirements manufacture, market or sell any of applicable Law and did not contain any the Company Products. (c) To the knowledge of the Company, none of the Acquired Corporations has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA, EMA, BfArM or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA, EMA, BfArM or necessary in order other Governmental Body, (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or for any other Governmental Body to invoke a similar remedy. (i) Other than in light Germany, none of the circumstances under which they were madeAcquired Corporations is the subject of any pending or, not misleading. to the Company’s knowledge, threatened investigation and (ii) in Germany, to the Company’s knowledge, none of the Acquired Corporations is the subject of any pending or threatened investigation in the case of either (i) or (ii) by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Body pursuant to any similar Legal Requirement. (d) Except for such failures to be in compliance as would not reasonably be expected to behave a Material Adverse Effect, individually or each of the Acquired Corporations is in compliance and has, for the aggregatepast three years, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are been in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by healthcare Legal Requirements applicable to the Company or operation of its Subsidiaries to any Governmental Authority including business as currently conducted, including, (i) any and all directives federal, state and undertakings 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 currently subject to any enforcement, regulatory or administrative proceedings against or affecting any Company Product relating to or arising from under the most recent examination by FDCA, PHSA or similar Legal Requirements, and, to the Company’s knowledge, no such Governmental Authorityenforcement, regulatory or administrative proceeding has been threatened. (e) The Acquired Corporations have maintained their material regulatory communications, filings and have satisfactorily addressed submissions in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would in a manner reasonably expected to have a Company Material Adverse Effectin accordance with industry standards.

Regulatory Matters. Except for such failures (a) Target has obtained all clearances, authorizations, licenses and registrations required by any foreign or domestic Governmental Authority (including, without limitation, Health Canada and the FDA, if applicable) to permit the conduct of its business as currently conducted. Target has filed with the following applicable regulatory authorities (including, without limitation, Health Canada, the FDA or any other applicable Governmental Authority performing functions similar to be true as have not been and would not be reasonably expected to bethose performed by Health Canada or the FDA) all materially required filings, individually declarations, listings, registrations, reports or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, including but not limited to adverse event reports. All such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed (or were corrected or supplemented by a subsequent submission), and other similar documents, together with no material deficiencies have been asserted by any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any applicable Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) All products labeled, distributed, marketed, stored, sold, imported by or on behalf of Target that are subject to the documents described in jurisdiction of Health Canada, the first sentence of this Section 3.21FDA or any other applicable Governmental Authority performing functions similar to those performed by Health Canada or the FDA have been and are being labeled, distributed, marketed, stored, sold, and imported, as of their respective datesapplicable, such documents complied in all material respects in compliance with all requirements Health Canada Laws, any comparable Laws enforced by any other comparable Governmental Authority that has jurisdiction over the operations of Target, or any other applicable Law Law, including those regarding labeling, advertising, record-keeping, and did adverse event reporting. Target has not contain any (i) made an untrue statement of a material fact or omit fraudulent statement to state Health Canada or any comparable Governmental Authority, (ii) failed to disclose a material fact required to be stated therein disclosed to Health Canada or necessary in order any comparable Governmental Authority, or (iii) committed any other act, made any statement or failed to make any statement that (in any such case) establishes a reasonable basis for Health Canada to invoke its fraud, untrue statements of material facts, bribery, and illegal gratuities policy. Target is not the statements thereinsubject of any pending or, in light to the knowledge of Seller, threatened investigation by Health Canada. (c) To the circumstances under which they were madeknowledge of Seller, not misleading. Except for such failures to be in compliance as would not reasonably be expected to bethere are no currently existing facts that will (i) cause the withdrawal or recall, individually or require suspension or additional approvals or clearances, of any product currently sold by Target, (ii) require a change in the aggregatemanufacturing, marketing classification, labeling or intended use of any such product, or (iii) require the termination or suspension of marketing of any such product. No product has been recalled or subject to a field safety notification (whether voluntarily or otherwise) or other similar safety notification or safety alert from Health Canada or any other Governmental Authority that has jurisdiction over the operations of Target; and (ii) Target has not received written notice (whether completed or pending) of any proceeding seeking recall, suspension or seizure of any product. (d) Target is in material to the Company compliance and its Subsidiaries taken as a whole, the Company and its Subsidiaries are at all times has been in material compliance with all formal written Governmental Authority directives and with all formal written undertakings made by Laws applicable to the Company or operation of its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authoritybusiness. (e) Target has not been, and none of its officers, directors, or employees have satisfactorily addressed in all material respects all matters requiring attentionever been, if any. None (i) debarred, suspended, or excluded from participation under a federal health care program and/or under the provisions of such directivesthe Generic Drug Enforcement Act of 1992, undertakings 21 U.S.C. §335a (a) and actions(b), individually or collectively(ii) convicted of a crime for which a person can be debarred, has had suspended, or would reasonably expected to have a Company Material Adverse Effectexcluded.

Regulatory Matters. Except for such failures (a) Section 4.16(a) of the following Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to be Parent true and complete copies of, all Authorizations from the FDA and any other applicable Regulatory Authorities held by the Company and 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 filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience and 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 respects with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). As of the Agreement Date, no material deficiencies have been asserted by any applicable Regulatory Authority to the Company with respect to any Health Care Submission. The Company has a complete documentary record of submissions, correspondence, contacts, and consultations with the applicable Regulatory Authorities except as has not been been, and would not reasonably be reasonably expected to be, individually or in the aggregate, material to the result in a Company and its Subsidiaries taken Material Adverse Effect. (b) Except as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsnot had, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not reasonably be reasonably expected to beresult in, individually or in the aggregate, material to a Company Material Adverse Effect, since December 16, 2019, the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company Subsidiaries are, and since December 16, 2019 have been, in compliance with all applicable Health Laws. Neither the Company, nor any Company Subsidiary has received any written notices or other correspondence from any Governmental Entity, Regulatory Authority, or any institutional review board or ethics committee alleging any violation of its Subsidiaries with respect to any Health Law or otherwise indicating an investigation into a potential violation of the documents described 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 the first sentence of this Section 3.21, and as of their respective dates, such documents complied 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 Law regulations that relate to the proper conduct of clinical studies and did 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, ethics committee or safety monitoring committee raising any material issues with respect to any ongoing clinical or pre-clinical studies or trials threatening the initiation of any action to place a clinical hold order on any such studies or trials, or otherwise requiring the delay, termination, suspension or material modification of such studies or trials in each case, solely with respect to Product Candidates. (d) Neither the Company 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 contain 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 Company’s or any Company Subsidiary’s processes or procedures. Since December 16, 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. (f) The Company and Company Subsidiaries have not (i) made an untrue statement of a material fact or omit fraudulent statement to state any Regulatory Authority, (ii) failed to disclose a material fact required to be stated therein disclosed to any Regulatory Authority or necessary in order (iii) committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the statements thereintime such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), 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, any Company Subsidiary and, to the Knowledge of the Company, any of their respective officers, employees or agents, is or has been (i) debarred under 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 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) holding a meeting with any such party, or (iii) making a regulatory decision or taking a regulatory action with respect to a Product Candidate in each case (i), (ii), and (iii) to the extent such delay, individually or in the aggregate, may have a material impact on the development program for any Product Candidate. (k) 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 light 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 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 FDA or any other Regulatory Authority by or on behalf of the circumstances under which they were madeCompany or any Company Subsidiary, 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 records of material 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 misleading. Except for such failures to be in compliance as been, and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries Company, taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures of the following to be true as have not been The studies, tests and would not be reasonably expected to be, individually preclinical or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package and its Subsidiaries has timely the Prospectus (the “Company Studies and accurately filed or provided Trials”) were and, if still pending, are being, conducted in all regulatory reportsmaterial respects in accordance with experimental protocols, schedulesprocedures and controls pursuant to, formswhere applicable, Permit applications or renewals, examination responses accepted professional medical and submissionsscientific standards, and all applicable federal, state or foreign laws, rules, orders and regulations, including all rules and regulations of the FDA or any federal, state, local or foreign governmental body exercising comparable authority; the descriptions of the results of the Company Studies and Trials contained or incorporated by reference in the Registration Statement, the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other similar documentsstudies or trials not described in the Registration Statement, together the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; and the Company has not received any amendments required notices or correspondence with the FDA or any federal, state, local or foreign governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be made with respect thereto, that obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception disclosing patient information received by the Company or any of its Subsidiaries in connection with respect to any of the documents described in Company Studies and Trials, the first sentence of this Section 3.21, and as of their respective dates, such documents Company has complied in all material respects with all requirements applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of applicable Law 1996 and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements thereinrules and regulations thereunder. To the Company’s Knowledge, in light none of the circumstances under which they were madeCompany Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or any federal, not misleadingstate, local or foreign governmental body exercising comparable authority to have engaged in scientific misconduct. Except for such failures to be To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects with all matters requiring attentionapplicable statutes, if any. None rules, regulations and policies of such directivesthe FDA or any federal, undertakings and actionsstate, individually local or collectively, has had or would reasonably expected foreign governmental body exercising comparable authority to have a that of the FDA to which the Company Material Adverse Effectis subject.

Regulatory Matters. (a) Except for such failures as set forth on Section 3.17(a) of the following Company Disclosure Letter, and except with respect to be true Permits required under applicable Environmental Laws (as have not been to which certain representations and would not be reasonably expected warranties are made pursuant to beSection 3.12), individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed hold all Permits issued by the FCC or provided all the state public service or public utility commissions or other similar state regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsbodies (“State PSCs”), and all other similar documentsmaterial regulatory Permits, together with any amendments required including franchises, ordinances and other agreements granting access to be made with respect theretopublic rights of way, that the Company issued or its Subsidiary was required granted to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of the Company Subsidiaries by a Governmental Entity (the “Company Licenses”) that are required for the Company and each of the Company Subsidiaries to conduct its Subsidiaries business, as presently conducted in all material respects. (b) Each Company License is in full force and effect and has not been suspended, revoked, cancelled or adversely modified. No Company License is subject to (i) any conditions or requirements that have not been imposed generally upon licenses in the same service, unless such conditions or requirements are set forth on the face of the applicable authorization, or (ii) any pending proceeding by or before any Governmental Entity, including the FCC or State PSCs to suspend, revoke or cancel such Company License, or any judicial review of a decision by any Governmental Entity, including the FCC or State PSCs with respect to any thereto. To the knowledge of the documents described Company, there has not been any event, condition or circumstance that would preclude any Company License from being renewed in the first sentence ordinary course (to the extent that such Company License is renewable by its terms). (c) The licensee of this Section 3.21, and as of their respective dates, such documents complied each Company License is in compliance in all material respects with such Company License and has fulfilled and performed all of its material obligations with respect thereto, including all reports, notifications and applications required by any Law, including the Communications Act of 1934 (the “Communications Act”) or the rules, regulations, written policies and orders of the FCC (together with the Communications Act, the “FCC Rules”) or similar state telecommunications laws (the “State Telecommunications Laws”) and the rules, regulations, written policies and Orders of State PSCs (collectively with the State Telecommunications Laws, the, “PSC Rules”), and the payment of all regulatory fees and contributions, except as permitted by applicable exemptions, waivers or similar concessions or allowances. Without limiting the foregoing, the licensee of each Company License is in material compliance with the applicable requirements of the Federal and state Universal Service Fund programs, the Federal Telecommunications Relay Service programs, the Federal North American Numbering Plan Administration program, the Federal Local Number Portability Administration program (collectively, the “USF Programs”), the Communications Assistance to Law Enforcement Act (“CALEA”), and the FCC’s regulations concerning treatment and protection of Customer Proprietary Network Information (“CPNI”). All reports and other submissions required in connection with the USF Programs, CALEA, CPNI regulations, including contribution remittances, have been timely filed in materially true, correct and complete form. To the knowledge of the Company and the Company Subsidiaries, there are no pending or threatened investigations, inquiries, audits, examinations or other proceedings in connection with the performance of the Company and the Company Subsidiaries of their USF Programs, CALEA and CPNI obligations. (d) Except as set forth in Section 3.17(d) of the Company Disclosure Letter, neither the Company nor any Company Subsidiary has (i) implemented, or been alleged or found to have implemented, an unauthorized change of an end user’s carrier (“Slamming”) or (ii) placed or been alleged or found to have placed an unauthorized charge on customer billing (“Cramming”). (e) Except as set forth in Section 3.17(e) of the Company Disclosure Letter, the Company and all Company Subsidiaries have timely complied with any compensation, restoration, reimbursement, reporting, or other obligations arising in connection with public and private right-of-way access and pole attachment agreements. (f) Except as set forth in Section 3.17(f) of the Company Disclosure Letter, the Company and all Company Subsidiaries have timely submitted all required international traffic and circuit status reports in materially true, correct and complete form. (g) Except as set forth in Section 3.17(g) of the Company Disclosure Letter, the licensee of each Company License is in material compliance with the applicable Law requirements of federal and did not contain state network outage reporting (“NOR”) requirements. All reports and other submissions required in connection with federal and state NOR requirements have been timely filed in materially true, correct and complete form. To the knowledge of the Company and the Company Subsidiaries, there are no pending or threatened investigations, inquiries, audits, examinations or other proceedings in connection with the performance of the Company and the Company Subsidiaries of their NOR requirements. (h) Except as set forth in Section 3.17(h) of the Company Disclosure Letter, the Company or a wholly owned Subsidiary of the Company directly or indirectly owns all of the Equity Interests and controls all of the voting power and decision-making authority of each licensee of the Company Licenses. No Company License, Order or other agreement, obtained from, issued by or concluded with any untrue statement State PSC would impose restrictions on the ability of a material fact or omit to state a material fact required to be stated therein or necessary in order any Company Subsidiary to make payments, dividends or other distributions to the statements thereinCompany or any Company Subsidiary that limits, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as or would not reasonably be expected to belimit, individually or in the aggregate, material to cash funding and management alternatives of the Company and its Subsidiaries taken as on a whole, the Company and its Subsidiaries are consolidated basis in compliance with all formal written Governmental Authority directives and with all formal written undertakings made a manner disproportionate to restrictions applied by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectother State PSCs.

Regulatory Matters. Except for such failures of (a) The Acquired Corporations have filed with the following applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to be true those performed by the FDA) all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports, except as have would not been have, and would not reasonably be reasonably expected to behave, individually or in the aggregate, a Material Adverse Effect. All such filings, declarations, listings, registrations, reports or submissions were in material to the Company and its Subsidiaries taken compliance with applicable Legal Requirements when filed, and, as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, no deficiencies have been asserted in writing by any applicable Governmental Body to the Company with respect to any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true filings, declarations, listing, registrations, reports or submissions, except as would not have, and would not reasonably be reasonably expected to behave, individually or in the aggregate, material a Material Adverse Effect. (b) Except as has not had, and would not reasonably be expected to have, individually or in the Company aggregate, a Material Adverse Effect, all preclinical and its Subsidiaries taken as a whole, there is no unresolved violation clinical studies or exception tests sponsored by the Company Acquired Corporations since January 1, 2014 have been conducted in material compliance with applicable Legal Requirements, rules, regulations and guidances, including Good Clinical Practices requirements and federal and state laws, rules, regulations and guidances restricting the use and disclosure of individually identifiable health information. Since January 1, 2014 and through the date of this Agreement, the Acquired Corporations have not received any written notices or other correspondence from the FDA or any of its Subsidiaries other foreign, federal, state or local governmental or regulatory 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. (c) To the documents described in the first sentence of this Section 3.21Company’s knowledge, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any no Acquired Corporation has (i) made an untrue statement of a material fact or omit fraudulent statement to the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, except, in light of the circumstances under which they were madeeach case, as would not misleading. Except for such failures to be in compliance as have, and would not reasonably be expected to behave, individually or in the aggregate, material a Material Adverse Effect. As of the date of this Agreement, no Acquired Corporation is the subject of any pending or, to the Company Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and its Subsidiaries taken Illegal Gratuities Final Policy. None of the Acquired Corporations nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators of the Acquired Corporations 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, except, in each case, as would not have, and would not reasonably be expected to have, individually or in the aggregate, a wholeMaterial Adverse Effect. (d) Except as has not had, and would not reasonably be expected to have, individually or in the Company and its Subsidiaries are aggregate, a Material Adverse Effect, each Acquired Corporation is in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authorityand, and have satisfactorily addressed since January 1, 2014, has been in compliance, in each case, in all material respects with all matters requiring attentionhealthcare laws applicable to the operation of its business as currently conducted, if anyincluding (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 FDCA, (iii) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant thereto; (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) 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 an Acquired Corporation. None No Acquired Corporation, nor its officers, employees, representatives or agents (in each case, acting in the capacity of an employee or representative of any Acquired Corporation), is subject to any enforcement, regulatory or administrative proceedings against or affecting the Acquired Corporation relating to or arising under the FDCA, the Anti-Kickback Statute, or similar Legal Requirements, and, to the Company’s knowledge, as of the date of this Agreement, no such directivesenforcement, undertakings regulatory or administrative proceeding has been threatened in writing, except, in each case, as would not have, and actionswould not reasonably be expected to have, individually or collectivelyin the aggregate, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures (a) Section 4.14(a) of the following Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to be Parent true and complete copies of, all Regulatory Authorizations from the FDA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company relating to the Company Products. Except as have not been and would not reasonably be reasonably expected to beto, individually or in the aggregate, material to result in a Company Material Adverse Effect, (x) the Company and its Subsidiaries taken as a wholehas filed, each of maintained or furnished with the Company and its Subsidiaries has timely and accurately filed or provided applicable Regulatory Authorities all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other similar documentsinformation (collectively, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority “Health Care Submissions”) and timely paid (y) all fees such Health Care Submissions were complete and assessments due accurate and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). (b) (i) Since December 31, 2021, the Company and its subsidiaries have been in material compliance with all applicable Health Laws that affect the business, Company Products, properties, assets and activities of the Company or its subsidiaries; (ii) 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 (iii) there are no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company or its subsidiaries with respect to the Company Products or alleging any violation by the Company, its subsidiaries or the Company Products of any such Health Law. (c) Since December 31, 2021, to the Company’s knowledge, 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, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, neither the Company nor its subsidiaries have outstanding written notifications or other written communications from any 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 termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any 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 clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in material compliance with the applicable specifications and requirements of applicable Health Laws. As of the Agreement Date, neither the Company nor, to the 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 to the Company or its business operations alleging or asserting noncompliance with any applicable Law and did not contain 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 (i) made an untrue statement of a material fact or omit fraudulent statement to state any Regulatory Authority or any other Governmental Entity, (ii) failed to disclose a material fact required to be stated therein disclosed to any Regulatory Authority or necessary in order any other Governmental Entity or (iii) committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the statements thereintime such disclosure was made or failure to disclose occurred, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beprovide a basis for the FDA to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or in for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company communication or its Subsidiaries 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, report, studies or publications of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority including or any and all directives and undertakings arising from the most recent examination by such other Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if anyEntity. None of such directivesthe Company, undertakings and actionsits subsidiaries, individually or, to the knowledge of the Company, its officers, employees, or collectivelyany clinical investigator acting for the Company, is currently or has had been convicted of any crime that has resulted in, or would reasonably be expected to have result in, debarment pursuant to 21 U.S.C. Section 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 Company 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 pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, 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. (g) Neither the Company nor its subsidiaries are a Company Material Adverse Effectparty to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Regulatory Authority or any other Governmental Entity.

Regulatory Matters. Except for such failures of (a) The Acquired Corporations have filed with the following applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to be true as have not been and would not be reasonably expected to bethose performed by the FDA) all required material filings, individually declarations, listings, registrations, reports or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, including but not limited to adverse event reports. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and other similar documents, together with no deficiencies have been asserted by any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any applicable Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries Body with respect to any such filings, declarations, listing, registrations, reports or submissions. (b) Except as would not reasonably be expected to have a Material Adverse Effect, all preclinical and clinical investigations sponsored by the Acquired Corporations, including those in which any or all obligations under the Federal Food, Drug, and Cosmetic Act (“FDCA”) have been transferred to a third party, are being conducted in material compliance with applicable Legal Requirements, rules, regulations and guidance documents, including Good Laboratory Practices and Good Clinical Practices requirements, and federal and state laws, rules, regulations and guidance documents restricting the use and disclosure of individually identifiable health information. (c) There has not been any material violation of the documents described FDCA and the FDA’s regulations or any law or regulation of any other applicable regulatory authority by the Acquired Corporations in connection with their product development, investigation or manufacturing efforts, the preparation or evaluation of submissions, or record keeping and reports to the FDA or any other applicable regulatory authority that could reasonably be expected to require or lead to an investigation, corrective action, enforcement or regulatory or administrative action. The Acquired Corporations have not received any warning letters, untitled letters, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other material correspondence or notices from the FDA or any other applicable regulatory authority relating to deficiencies in the first sentence of this Section 3.21development, investigation, and manufacture of products or non-compliance with the FDCA and FDA’s regulations or the laws and regulations of any other applicable regulatory authority, including correspondence regarding the termination, suspension or material delay or modification of any ongoing clinical or pre-clinical studies or tests. Except as stated in Part 3.11 of their respective datesthe Disclosure Schedule, such documents complied in all material respects the Acquired Corporations have not received any correspondence from third parties alleging non-compliance with all requirements of applicable Law the FDCA and did not contain any FDA’s regulations. (d) To the Company’s knowledge, no Acquired Corporation has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.Material

Regulatory Matters. Except for such failures (a) Section 4.14(a) of the following Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to be Parent true and complete copies of, all Regulatory Authorizations from the FDA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company relating to a Company Product. Except as have not been and would not reasonably be reasonably expected to beto, individually or in the aggregate, result in a material liability to the Company and its Subsidiaries taken as a wholeCompany, each of (i) the Company and its Subsidiaries has timely and accurately filed filed, maintained or provided furnished with the applicable Regulatory Authorities all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other similar documentsinformation (collectively, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority “Health Care Submissions”) and timely paid (ii) all fees such Health Care Submissions were complete and assessments due accurate and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). (b) Since April 3, 2019, (i) the Company has been in material compliance with all applicable Health Laws that affect the business, Company Product, properties, assets and activities of the Company, (ii) as of the Agreement Date, the Company has not received any written notice or other written communication from any Regulatory Authority alleging any material violation of any Health Law and (iii) there are no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened in writing against the Company with respect to a Company Product or alleging any violation by the Company or a Company Product of any such Health Law. (c) Since April 3, 2019, to the knowledge of the Company, all pre-clinical studies and clinical trials conducted with respect to a 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, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, 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. Since April 3, 2019, no clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, the Company has no outstanding written notifications or other written communications from any 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 termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any 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 April 3, 2019, to the knowledge of the Company, all manufacture of a Company Product, including any clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in material compliance with the applicable specifications and requirements of applicable Health Laws. As of the Agreement Date, neither the Company nor, to the knowledge of the Company, any person acting on its behalf has, with respect to a Company Product, (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 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 material noncompliance with any applicable Law and did not contain or Regulatory Authorization and, to the knowledge of the Company, 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 (i) made an untrue statement of a material fact or omit fraudulent statement to state any Regulatory Authority or any other Governmental Entity, (ii) failed to disclose a material fact required to be stated therein disclosed to any Regulatory Authority or necessary in order any other Governmental Entity or (iii) committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the statements thereintime such disclosure was made or failure to disclose occurred, would provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in light 56 Fed. 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 communication or submission of the circumstances under which they were madefalse 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, not misleading. Except for such failures report, studies or publications of any document or statement voluntarily submitted or required to be in compliance as would not reasonably be expected submitted to be, individually any Regulatory Authority or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written any other Governmental Authority directives and with all formal written undertakings made by Entity. None of the Company or any of its Subsidiaries officers, employees or agents or, to the knowledge of the Company, any Governmental Authority including clinical investigator acting for the Company, is currently or has been convicted of any and all directives and undertakings arising crime or engaged in any conduct that has resulted in debarment from the most recent examination by such Governmental Authority, and have satisfactorily addressed participation in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected any program related to have a Company Material Adverse Effect.pharmaceutical products pursuant to 21 U.S.

Regulatory Matters. Except for as otherwise disclosed in the General Disclosure Package or the Prospectus, neither the Company nor any of its subsidiaries is subject or is party to, or has received any notice or advice that any of them may become subject or party to any investigation with respect to, any corrective, suspension or cease-and-desist order, agreement, consent agreement, memorandum of understanding or other regulatory enforcement action, proceeding or order with or by, or is a party to any commitment letter or similar undertaking to, or is subject to any directive by, or has been a recipient of any supervisory letter from, or has adopted any board resolutions at the request of, any agency, court or other governmental body, domestic or foreign (each, a “Governmental Entity”), that currently relates to or restricts in any material respect the conduct of their business or that in any manner relates to their capital adequacy, credit policies or management (each, a “Regulatory Agreement”), nor has the Company or any of its subsidiaries been advised by any Governmental Entity that it is considering issuing or requesting any such failures Regulatory Agreement. There is no unresolved violation, criticism or exception by any Governmental Entity with respect to any report or statement relating to any examinations of the following to Company or any of its subsidiaries which might reasonably be true as have not been and would not be reasonably expected to beresult in a Material Adverse Effect. The deposit accounts of the Bank are insured by the Federal Deposit Insurance Corporation (the “FDIC”) to the legal maximum, and the Bank has paid all premiums and assessments required by the FDIC and the regulations promulgated by the FDIC, and no proceeding for the termination or revocation of such insurance is pending or, to the Company’s knowledge, threatened. No actions, consents, or approvals of, registrations or filings with, notices to, or other actions by the FDIC or the Board of Governors of the Federal Reserve System (the “Federal Reserve”) or any state bank regulatory authority acting under applicable laws (collectively, the “Approvals”), is or will be required in connection with this Agreement and the transactions contemplated hereby, except those Approvals that already have been received and are in full force and effect. The Bank has complied with all applicable rules and regulations of the FDIC, the Federal Reserve and any applicable state bank regulatory authority, except for violations that, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or result in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures of (A) The Company and the following to be true as Company Subsidiaries have not been established and would not be reasonably expected to be, individually or in the aggregate, material administer compliance programs (including written compliance policies) applicable to the Company and its the Company Subsidiaries taken (i) to assist the Company, the 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 Company Subsidiaries or their businesses and (ii) to provide compliance policies governing activities and requirements applicable to medical device companies (including pre-clinical and clinical testing, product design and development, product testing, product manufacturing, product labeling, product storage, pre- market clearance and approval, marketing, advertising and promotion, product sales and distribution, medical device recall and reporting regulations, and record keeping). (B) Except as a whole, each set forth in Part 3.18(b) of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reportsDisclosure Schedule, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there each Company Subsidiary is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with all requirements 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 applicable Law 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 did not contain statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any untrue statement and all requests for authorizations, approvals, certificates, waivers, certifications, clearances, exemptions, notifications, consents, orders, registrations, licenses or permits of a 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 fact respects and in conformance with Legal Requirements as of the date of submission and any updates, changes, corrections or omit modification to state a material fact such applications, submissions, information and data which were or are necessary or required to be stated therein filed, maintained, or necessary furnished to the FDA or other Governmental Entities have been timely filed, maintained, or furnished and were true, complete and correct in order to make the statements therein, all material respects and in light conformance with Legal Requirements as of the circumstances under which they were made, not misleadingdate of submission. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to The labeling claims made by the Company and its the Company Subsidiaries taken as a wholefor 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) The activities, products and facilities of the Company and the Company Subsidiaries, as well as, to the Company's knowledge, its Subsidiaries suppliers, distributors, contractors and other intermediaries, are in compliance with all formal written applicable requirements of CLIA, the FDCA and implementing FDA regulations, including the registration, listing, labeling and manufacturing requirements of 21 C.F.R. Parts 807, 809 and 820, all to the 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 Authority directives 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 Company's and the Company Subsidiaries' products and all Medical Device Reports, in each case, filed with the FDA within the last five years. The Company has delivered to Parent true, complete and correct copies of all formal written undertakings made warning letters, untitled letters, notices of inspectional observations (Form FDA 483s), or similar notices, or other correspondence relating to the Company's and the 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, since January 1, 2003, no exemptions, clearances or approvals for the Company and the Company Subsidiaries' products have been subjected to reevaluation or suspension of sale by the FDA and no products manufactured, marketed or sold by the Company or its any Company Subsidiary have been recalled or subject 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 product sold or proposed to be sold by the Company or a Company Subsidiary. To the Company's knowledge, there are no facts which are reasonably likely to 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 any the jurisdiction of the FDA or comparable Governmental Authority including any Entity are being manufactured, labeled, stored, tested, distributed, and marketed in material compliance with all applicable requirements and implementing regulations thereunder. (F) Except as set forth in Part 3.18(f) of the Company Disclosure Schedule, all pre-clinical trials and clinical trials conducted by or on behalf of the Company and the Company Subsidiaries have been, and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all directives applicable Legal Requirements relating thereto, including the FDCA and undertakings arising from its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56 and 812. (G) Neither the most recent examination by such Governmental AuthorityCompany, and have satisfactorily addressed in all material respects all matters requiring attentionthe Company Subsidiaries, if any. None nor, to the knowledge of such directivesthe Company, undertakings and actionsany of their collective officers, individually employees or collectivelyagents has committed any act, has had made any statement, or failed to make any statement, that would be reasonably expected to have provide a basis for the FDA to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities," set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (H) Neither the Company, the Company Material Adverse EffectSubsidiaries, nor, to the knowledge of the Company, any of their collective officers, employees or agents 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 against the Company, the Company Subsidiaries, or, to the knowledge of the Company, any of their collective officers, employees or agents. (I) Except as disclosed on Part 3.18(i) of the Company Disclosure Schedule, there are no investigations, audits, actions or other proceedings pending with respect to a violation by the Company or any Company Subsidiary of any Legal Requirement that reasonably would be expected to result in administrative, civil, or criminal liability, and there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an investigation, audit, action or other proceeding. (J) The Company and each of the Company Subsidiaries is in material compliance with all applicable FDA import and export requirements, including import-for-export requirements, export notifications or authorizations and record keeping requirements.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each (i) Each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reportsLicenses necessary to conduct its business as presently conducted, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid including all fees and assessments due and payable in connection therewith. Except for such failures Licenses of the following 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 be true conduct its business as would not be reasonably expected to bepresently conducted (collectively, the “Regulatory Licenses”), except those Licenses the absence of which, individually or in the aggregateaggregate with other such absences, material 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 taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be has operated in compliance as would not reasonably be expected with applicable Laws administered or enforced by Regulatory Authorities, except where the failure so to becomply, individually or in the aggregateaggregate with other such failures, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would not reasonably expected 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, 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 FDA from time to time), except for noncompliances that, individually or in the aggregate, are not reasonably likely to have a Company Material Adverse Effect. With respect to the Key Product, IDX-21459 and Samatasvir, no clinical trial conducted by or, to the Knowledge of 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 of their employees or clinical investigators engaged by the Company or its Subsidiaries have been convicted of any crime or engaged in any conduct that in any such case has resulted, or is reasonably likely to result, in debarment under 21 U.S.C. Section 335a. (iv) The Company has made available to Parent 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 related supplements, amendments and annual reports.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or described in the aggregatePrivate Placement Memorandum, material to the Company and its Subsidiaries taken as a whole, each of the Company its subsidiaries: (i) is and its Subsidiaries at all times has timely and accurately filed been in material compliance with all statutes, rules or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 regulations applicable to the date ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually product manufactured or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception distributed by the Company or such subsidiary (“Applicable Laws”); (ii) has not received any notice of its Subsidiaries adverse finding, warning letter, untitled letter or other correspondence or notice from the SFDA or any other Regulatory Agency alleging or asserting noncompliance with respect 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 has no knowledge that any such Regulatory Agency or 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 of 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 the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied 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 requirements of applicable Law material respects any Applicable Laws, and did not contain any untrue statement of a all pending or to the Company’s knowledge threatened legal or governmental proceedings relating to such Applicable Laws that are material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, Company’s business in light of the circumstances applicable disclosure requirements under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect1934 Act.

Regulatory Matters. Except (a) Uniti and its Subsidiaries possess, and since the Applicable Date have possessed all material Governmental Authorizations required under Applicable Law for such failures the ownership, lease, operation, use or maintenance of communications facilities and their business as currently conducted, including all Uniti Communications Licenses and Governmental Authorizations issued by a Governmental Franchising Authority. ‎Section 4.16(a)(i) of the following to be true Uniti Disclosure Schedule sets forth a true, correct and complete list and description of each Uniti Communications License, including the (i) description of authorization, (ii) docket, case or similar designation, (iii) certificate number, if any, (iv) date of issuance, and (v) if applicable, the current term thereof. Except as have not been and set forth in ‎Section 4.16(a)(ii) of the Uniti Disclosure Schedule or as would not reasonably be reasonably expected to behave, individually or in the aggregate, material to a Uniti Material Adverse Effect, since the Company Applicable Date, Uniti and its Subsidiaries taken as a whole(i) are and have been in material compliance with all Uniti Communications Licenses, each Governmental Authorizations, and the Communications Laws, (ii) have not received any written notification or communication from any Governmental Authority asserting that Uniti or one of its Subsidiaries is or was not in compliance with any Uniti Communications License, Governmental Authorization, or Communications Law and (iii) have not been threatened in writing of the Company suspension, revocation, cancellation or modification of any Uniti Communications License. Uniti and its Subsidiaries has timely and accurately have filed or provided all regulatory reportsnecessary applications to renew or, schedulesif applicable, formsreplace such Uniti Communications Licenses, Permit applications or renewals, examination responses and submissions, and other similar documents, together with except for any amendments required to be made with respect thereto, that the Company or its Subsidiary was required such failure to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to bethat, individually or in the aggregate, material would not reasonably be expected to have a Uniti Material Adverse Effect. None of such Uniti Communications Licenses will be subject to revocation, suspension, modification, cancellation, rescission, non-renewal or termination as a result of the Company execution and delivery of this Agreement or the consummation of the Transactions, except as would not, individually or in the aggregate, reasonably be expected to have a Uniti Material Adverse Effect. (b) Without limiting the foregoing, except as would not, individually or in the aggregate, reasonably be expected to have a Uniti Material Adverse Effect, since the Applicable Date, Uniti and its Subsidiaries taken as a wholehave filed all required Universal Service Fund reports and all such filings were, there is no unresolved violation or exception by the Company or any of its Subsidiaries when made, true, correct and complete and in accordance with respect to any existing precedent of the documents described relevant Governmental Authority. Except as set forth in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light ‎Section 4.16(b) of the circumstances under which they were made, not misleading. Except for such failures to be in compliance Uniti Disclosure Schedule or as would not reasonably be expected to behave, individually or in the aggregate, material to a Uniti Material Adverse Effect, (i) since the Company and its Subsidiaries taken as a wholeApplicable Date, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company none of Uniti or its Subsidiaries has been the subject of any enforcement, Proceeding, fine, penalty or interest related to Universal Service Subsidies or Universal Service Contributions and, to the Knowledge of Uniti and its Subsidiaries, no such enforcement, Proceeding, fine, penalty or interests is threatened, (ii) to the Knowledge of Uniti and its Subsidiaries, there is no audit, examination, investigation or similar Proceeding currently in progress or pending with respect to Universal Service Subsidies or Universal Service Contributions of Uniti or its Subsidiaries and (iii) none of Uniti or its Subsidiaries has received any Governmental Authority including written or, to the Knowledge of Uniti and its Subsidiaries, other notice indicating any and all directives and undertakings arising intent to open an audit (or other review) or request for information related to Universal Service Subsidies or Universal Service Contributions from the most recent examination by such any Fund Administrator or other Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. (a) Except as set forth on Schedule 3.16(a), since December 31, 2012 through the date hereof, the Group Companies have not received any FDA Form 483, warning letter, untitled letter, or other similar correspondence or written notice from the FDA or any similar foreign Governmental Entity alleging or asserting noncompliance with any Permits or applicable Laws. (b) The Company has filed with the FDA and any similar foreign Governmental Entity all required material filings, declarations, listings, registrations, reports or submissions, including any adverse event reports. All such material filings, declarations, listings, registrations, reports or submissions were correct and complete, in each case, in all material respects, and in material compliance with applicable Laws when filed, and no deficiencies have been asserted by any applicable Governmental Entity with respect to any such filings, declarations, listing, registrations, reports or submissions, except for such failures (i) additional information that the FDA has requested in connection with the submissions set forth on Schedule 3.16(b), and (ii) similar requests for additional information that the FDA has made in connection with any of the following Company’s new drug applications, abbreviated new drug applications, supplements to be true as have not been and would not be reasonably expected to bean approved new drug application or abbreviated new drug application, individually or postmarketing commitments or requirements, in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, case that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority has addressed and timely paid all fees and assessments due and payable in connection therewith. resolved. (c) Except for such failures of the following to be true as would not be reasonably expected to behave a Material Adverse Effect and, individually except as set forth on Schedule 3.16(c), the Group Companies have not initiated or in the aggregateconducted any recall, material market withdrawal, safety alert, warning, or other action relating to an alleged defect or lack of safety or efficacy of any product and, to the Company and its Subsidiaries taken as a wholeCompany’s knowledge, there is are no unresolved violation or exception by the Company or facts which would cause any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21such action. (d) The Group Companies have not, and as to the Company’s knowledge, none of their respective datesofficers, such documents complied in all material respects with all requirements of applicable Law and did not contain employees, agents, or clinical investigators has made or caused to be made any untrue statement of a material fact or omit fraudulent statement to state the FDA, failed to disclose a material fact required to be stated therein disclosed to the FDA, or necessary committed any other act that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy set forth in order the FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09) and the Group Companies are not the subject of any pending or, to make the statements thereinCompany’s knowledge, in light threatened investigation by the FDA pursuant to such policy. (e) None of the circumstances under which they were madeGroup Companies and, not misleading. Except for such failures to be the Company’s knowledge, their officers, employees, agents, or clinical investigators has been suspended or debarred or convicted of any crime or engaged in compliance as any conduct that would not reasonably be expected to be, individually result in debarment under 21 U.S.C. Section 335a or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company any similar Law or its Subsidiaries to exclusion under 42 U.S.C. Section 1320a-7 or any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectsimilar Law.

Regulatory Matters. Except The SBC Companies and their Subsidiaries hold all licenses, franchises, certificates, consents, Permits, qualifications and authorizations (including, without limitation, licenses granted by the FCC ("FCC Licenses"), and licenses, authorizations and certificates of public convenience and necessity from applicable state and local authorities) from all Governmental Entities required under Utilities Laws ("Licenses") necessary for such failures the lawful conduct of the following to be true as have not been and would not be reasonably expected to beSBC Business, other than Licenses the lack of which, individually or in the aggregate, material to the Company have not had and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected likely to behave a Material Adverse Effect on the SBC Companies. Schedule 3.1(n) of the SBC Disclosure Letter sets forth each License obtained by SBC or any of its Subsidiaries as of the date hereof and which is, or in the absence of a violation thereof, would be in full force and effect with respect to the SBC Business (the "SBC Companies' Licenses"). To the Knowledge of SBC, no event has occurred or fact exists with respect to the SBC Companies' Licenses (other than the requirement to file in the future applications for renewal and obtain renewals in the ordinary course) which permits, or after notice or lapse of time or both would permit, revocation, non-renewal or termination of any of such licenses or would result in any other impairment of the rights of the holder of any of such licenses or which would be reasonably likely to limit the operation of the SBC Companies' and their Subsidiaries' businesses as they are currently conducted, except for revocations, limitations, non- renewals or other terminations which, individually or in the aggregate, material have not had and would not be reasonably likely to have a Material Adverse Effect on the Company SBC Companies. The SBC Companies and its their Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of have performed their respective dates, obligations under the SBC Companies' Licenses with such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beexceptions which, individually or in the aggregate, material have not had and would not be reasonably likely to have a Material Adverse Effect on the SBC Companies. The FCC actions granting the SBC Companies' Licenses, together with all underlying construction permits, have not been reversed, stayed, enjoined, annulled or suspended, and there is not pending or, to the Company Knowledge of SBC, threatened, any application, petition, objection or other pleading with the FCC or other Governmental Entity which challenges or questions the validity of or any rights of the holder under any of the SBC Companies' Licenses, except for such reversals, stays, injunctions, annulments, suspensions, applications, petitions, objections or other pleadings, which have not had and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actionswould not, individually or collectivelyin the aggregate, has had or would be reasonably expected likely to have a Company Material Adverse EffectEffect on the SBC Companies.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each (a) All of the Company Products are being and its Subsidiaries have been manufactured, processed, developed, packaged, labeled, promoted, marketed, sold, stored, tested, distributed, imported and exported in material compliance with all applicable requirements under any applicable Law, including all Laws 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. (b) The Company has timely and accurately filed with the applicable regulatory authorities (including, without limitation, the FDA or provided any other Governmental Authority performing functions similar to those performed by the FDA) all regulatory material submissions, documents, declarations, listings, registrations, reports, schedulesstatements, formsamendments, Permit applications supplements or renewals, examination responses and submissions, and other similar documentsincluding but not limited to adverse event reports, together with any amendments required to be made filed 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 submissions, documents, declarations, listings, registrations, reports, statements, amendments, supplements or submissions were in material compliance with respect theretoapplicable Laws when filed, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with and no material deficiencies have been asserted by any applicable Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any such filings, documents, declarations, listing, registrations, reports, statements, amendments, supplements or submissions. To the knowledge of the documents described in the first sentence of this Section 3.21Company, (i) each such filing was true and as of their respective dates, such documents complied correct in all material respects as of the date of submission, 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 applicable Governmental Authority. (c) Except as set forth on Schedule 4.07(c) of the Company Disclosure Schedule, the Company has not received any notification of any pending or, to the knowledge of the Company, threatened (i) action, suit, claim, investigation, proceeding or order alleging potential or actual non-compliance with all requirements 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, subject to an import alert, 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, import alert, 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, (ii) commenced, or threatened to initiate, any action, suit, claim, investigation, 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 action, suit, claim, investigation, 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. (f) Neither the Company nor, to the knowledge of the 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 Laws 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 and did not contain 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 any of its officers, employees or agents has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any other Governmental Authority or (iii) 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 Authority to allege a violation of any applicable Law, including without limitation, for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company nor, to the knowledge of the circumstances under which they were madeCompany, not misleading. Except for such failures any of its officers, employees, or agents is the subject of any pending or threatened investigation by the FDA pursuant to be in compliance as would not reasonably be expected to beits Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written by any other Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries pursuant to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectsimilar Law.

Regulatory Matters. Except for such failures of (i) Since January 1, 2014, DELTA and its Subsidiaries have duly filed with the following appropriate regulatory authorities in substantially correct form the monthly, quarterly and annual reports required to be true filed under applicable laws and regulations, and such reports were in all material respects complete and accurate and in compliance with the requirements of applicable laws and regulations, and DELTA has previously delivered or made available to F&M accurate and complete copies of all such reports, other than the confidential portions of all such reports. Except as have set forth in Section 5.03(i)(i) of DELTA’s Disclosure Schedule, in connection with the most recent examination of DELTA and its Subsidiaries by the appropriate regulatory authorities, neither DELTA nor any of its Subsidiaries was required to correct or change any action, procedure or proceeding which DELTA believes in good faith has not been and would now corrected or changed, other than corrections or changes which, if not be reasonably expected to bemade, either individually or in the aggregate, material to the Company would not have a Material Adverse Effect on DELTA. (ii) Except as set forth in Section 5.03(i)(ii) of DELTA’s Disclosure Schedule and its Subsidiaries taken as a wholeexcept for orders, each decrees, directives, agreements, memorandums of the Company and its Subsidiaries has timely and accurately filed understanding or provided all regulatory reports, schedules, forms, Permit applications similar arrangements with or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with from any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material applicable to the Company and banking industry in general, neither DELTA nor any of its Subsidiaries taken as nor any of their respective properties is a wholeparty to or is subject to any order, there is no unresolved violation decree, directive, agreement, memorandum of understanding or exception by the Company similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor has DELTA or any of its Subsidiaries adopted any policies, procedures or board resolutions at the request or suggestion of, any Governmental Authority. DELTA and its Subsidiaries have paid all assessments made or imposed by any Governmental Authority. (iii) Except for orders, decrees, directives, agreements, memorandums of understanding commitment letters, supervisory letters or similar submission with or from any Governmental Authority applicable to the banking industry in general, neither DELTA nor any of its Subsidiaries has been advised by, nor does it have any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, decree, directive, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission or any request for the adoption of any policy, procedure or board resolution. (iv) (A) Except as set forth in Section 5.03(i)(iv) of DELTA’s Disclosure Schedule, no Governmental Authority has initiated since December 31, 2013 or has pending any proceeding, enforcement action or, to the Knowledge of DELTA, investigation or inquiry into the business, operations, policies, practices or disclosures of DELTA or any of its Subsidiaries (other than normal examinations conducted by a Governmental Authority in the ordinary course of the business of DELTA and its Subsidiaries), or, to the Knowledge of DELTA, threatened any of the foregoing, and (B) there is no unresolved violation, criticism, comment or exception by any Governmental Authority with respect to any report or statement relating to any examinations or inspections of the documents described in the first sentence DELTA or any of this Section 3.21, and its Subsidiaries. (v) The most recent regulatory rating given to DELTA Bank as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and the Community Reinvestment Act is “satisfactory.” To the Knowledge of DELTA, since the last regulatory examination of DELTA Bank with all formal written undertakings made by the Company or its Subsidiaries respect to Community Reinvestment Act compliance, DELTA Bank has not received any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected complaints as to have a Company Material Adverse EffectCommunity Reinvestment Act compliance.

Regulatory Matters. Except (a) There is no civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for such failures 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 following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to product candidates of the Company is being, and its Subsidiaries taken at all times has been, developed, tested, manufactured, labeled, promoted and stored, as a wholeapplicable, each in material compliance with FDA Law and Regulation and requirements of comparable foreign regulatory and Governmental Authorities. (c) The clinical trials, studies 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 Company and its Subsidiaries has timely applicable FDA and accurately filed or provided all regulatory reportsforeign requirements including, schedulesbut not limited to, formsgood clinical practices, Permit applications or renewals, examination responses and submissionsgood 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 similar documents, together with any amendments required to be made with respect thereto, that the Company regulatory or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures requiring the termination or suspension or material modification of any animal study, preclinical study or clinical trial conducted by or on behalf of the following Company. (d) With respect to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company all third party manufacturers and its Subsidiaries taken as a whole, there is no unresolved violation or exception suppliers of key raw materials used by the Company or any of (each a “Third Party Manufacturer”), the 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 Subsidiaries with respect to any of the documents described Knowledge, each such Third Party Manufacturer (A) has complied and is complying, in the first sentence of this Section 3.21, and as of their respective dates, such documents complied each case in all material respects respects, with all requirements Laws, including the FD&C Act and any similar state or foreign Laws; and (B) has all material permits to perform its obligations as a Third Party Manufacturer and all such permits are in full force and effect. (e) To the Knowledge of applicable Law the Company, and did not contain in connection with the Company’s business, no director, officer, employee or agent of the Company has: made any untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority; failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any other Governmental Authority; or committed an act, made a statement, or failed to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as a statement that would not reasonably be expected to beprovide the basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed.Reg. 46191 (September 10, 1991). (f) Neither the Company nor any director or officer of the Company is debarred or otherwise excluded from or restricted in the aggregateany manner from participation in, material any government program or, to the Knowledge of the Company, convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a, or convicted of any crime or engaged in any conduct for which such person could be excluded from participating in any federal health care programs. (g) The Company has complied with all applicable security and its Subsidiaries taken as a wholeprivacy 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 its Subsidiaries are 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 formal written Governmental Authority directives such FD&C Act Permits. To the Knowledge of the Company, no suspension, revocation, cancellation or withdrawal of the FD&C Act Permits is threatened and with all formal written undertakings made by the Company there is no basis for believing that such FD&C Act Permits will not be renewable upon expiration or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authoritywill be suspended, and have satisfactorily addressed in all material respects all matters requiring attentionrevoked, if any. None of such directivescancelled, undertakings and actions, individually modified or collectively, has had or would reasonably expected to have a Company Material Adverse Effectwithdrawn.

Regulatory Matters. (a) The Company 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, 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 deficiencies that have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions remain outstanding. (b) Except for such failures of the following to be true as have not been and would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to the Company have a Material Adverse Effect, all nonclinical and its Subsidiaries taken as a whole, each clinical investigations sponsored by or on behalf of the Company are being or have been conducted in material compliance with applicable Laws and its Subsidiaries has timely guidances, including: (i) Good Clinical Practices requirements; (ii) applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) guidelines, (iii) approved clinical protocols and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsinformed consents, and other similar documents, together with any amendments required to be made with respect thereto, that (iv) applicable Laws restricting the Company or its Subsidiary was required to file since January 1, 2017 to use and disclosure of individually identifiable health information. As of the date of this Agreement, neither the FDA nor any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company with respect to any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for ongoing clinical or nonclinical studies or tests requiring the termination, suspension or material modification of such failures of the following to be true as would not be reasonably expected to bestudies or tests, which modification, individually or in the aggregate, material would reasonably be expected to have a Material Adverse Effect. (c) To the Company’s knowledge, neither the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by nor any entity acting on the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any Company’s behalf has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. As of the circumstances under which they were madedate of this Agreement, not misleadingneither the Company nor, to the Company’s knowledge, any entity acting on the Company’s behalf is the subject of any pending 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. Except for such failures Neither the Company nor, to be the knowledge of the Company, any officers, employees, agents or clinical investigators of the Company or any entity or individual acting on the Company’s behalf has been suspended or debarred or convicted of any crime or engaged in compliance as any conduct that would not reasonably be expected to beresult 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. (d) Except as, individually or in the aggregate, material would not reasonably be expected to the Company and its Subsidiaries taken as have a wholeMaterial Adverse Effect, the Company is in compliance and its Subsidiaries are since January 1, 2020, has been in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by healthcare laws applicable to the Company or operation of its Subsidiaries to any Governmental Authority business as currently conducted, including (i) any and all directives federal, state and undertakings arising from local fraud and abuse laws, including the most recent examination by 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 Governmental Authoritystatutes; (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, all manufacturing operations conducted for the benefit of the Company with respect to any product candidate being used in human clinical trials have satisfactorily addressed been conducted in all material respects all matters requiring attentionaccordance with GMP Regulations, if any. None of such directives, undertakings and actionsexcept where the failure to comply would not, individually or collectivelyin the aggregate, has had or would reasonably be expected to have a Company Material Adverse Effect.

Regulatory Matters. (a) Except for such failures of the following to be true as have not been and would not be reasonably expected to benot, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries taken as a wholeCompany, each of the Company and its Subsidiaries has timely and accurately filed with the applicable regulatory authorities (including the FDA or provided any other Governmental Body performing functions similar to those performed by the FDA) all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications registrations, reports or renewals, examination responses and submissions, and other similar documents, together with any amendments required including but not limited to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewithadverse event reports. Except for such failures of the following to be true as would not be reasonably expected to benot, individually or in the aggregate, reasonably be expected to be material to the Company Company, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Laws when filed (or were corrected or supplemented by a subsequent submission) and, and its Subsidiaries taken as a whole, there is no unresolved violation or exception deficiencies have been asserted by the Company or any of its Subsidiaries applicable Governmental Body with respect to any of the documents described in the first sentence of this Section 3.21such filings, and as of their respective datesdeclarations, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact listing, registrations, reports or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. submissions. (b) Except for such failures to be in compliance as would not reasonably be expected to benot, individually or in the aggregate, reasonably be expected to be material to the Company, the Company’s products and product candidates, including the Product, are being and have been, researched, developed, tested, studied, manufactured, stored, supplied, licensed or imported, as applicable, by or on behalf of the Company and its Subsidiaries taken as a wholein compliance with applicable Healthcare Laws. As of the Agreement Date, the Company has not received any written notices or other written communication from the FDA or any other Governmental Body 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. (c) The Company has provided or made available to Parent, as of the date hereof, complete and correct copies of each IND filed with respect to any product candidate of the Company currently being developed by the Company, including any material supplements and amendments thereto. (d) Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company has not (i) made an untrue statement of a material fact statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) 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) at the time such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for the FDA to invoke its Subsidiaries Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy or for any Governmental Body to invoke any similar policy or Law. As of the Agreement Date, the Company is not the subject of any pending or, to the Company’s Knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy. Neither the Company nor, to the Knowledge of the Company, any officers, employees, agents or clinical investigators of the Company 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 Law or (b) exclusion under 42 U.S.C. Section 1320a 7 or any similar Law. (e) The Company has made available to Parent true, correct and complete copies of (i) all material clinical data available as of the date hereof with respect to the Product and, to the extent in the possession of the Company through the date hereof and (ii) all material correspondence of the Company with, and research, pre-clinical, clinical and other applicable material reports filed with or submitted to, Governmental Bodies (and all summaries of such correspondence or reports to the extent available) with respect to the Product through the date hereof. (f) Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company is in compliance 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 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 exclusion from any federal health care program. As of the Agreement Date, no enforcement, regulatory or administrative proceeding is pending, or, to the Company’s Knowledge, no such enforcement, regulatory or administrative proceeding has been threatened in writing, against the Company under the FDCA, the Anti-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. (g) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Company, (x) the Company and, to the Knowledge of the Company, each partner, third-party service provider or third party which pursuant to a Contract with the Company co-develops, or otherwise has a license or other right to research develop, manufacture, supply, test, or import any Company product or product candidate, hold all Governmental Authorizations from the FDA and all other Governmental Bodies that are required for the conduct of the Company’s business as currently conducted, and (y) all such Governmental Authorizations are (i) in full force and effect, (ii) validly registered and on file with applicable Governmental Bodies, if any, and (iii) in compliance with all formal written Governmental Authority directives filing and with all formal written undertakings made by maintenance requirements. The consummation of the Company Transactions, in and of themselves, would not cause the revocation or its Subsidiaries to cancellation of any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectAuthorization.

Regulatory Matters. (a) The Company 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, declarations, listings, registrations, reports 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 Legal Requirements when filed, and no deficiencies that have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions remain outstanding. (b) Except for such failures of the following to be true as have not been and would not reasonably be reasonably expected to behave a Material Adverse Effect, individually or in the aggregate, material to all preclinical and clinical investigations sponsored by the Company are being conducted in material compliance with applicable Legal Requirements, rules, regulations and its Subsidiaries taken as a wholeguidances, each including Good Clinical Practices requirements and federal and state laws, rules, regulations and guidances restricting the use and disclosure of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to individually identifiable health information. As of the date of this Agreement, with neither the FDA nor any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the following to be true as would not be reasonably expected to be, individually FDA has sent any written notices or in the aggregate, material other correspondence to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. (c) To, the documents described in Company’s knowledge, the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did Company has not contain any (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. As of the circumstances date of this Agreement, the Company is not the subject of any pending 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. Neither the Company nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators of the Company 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 which they were made, not misleading. 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 for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as have a wholeMaterial Adverse Effect, the Company is in compliance and its Subsidiaries are since January 1, 2018, has been in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by healthcare laws applicable to the Company or operation of its Subsidiaries to any Governmental Authority business as currently conducted, including (i) any and all directives federal, state and undertakings arising from local fraud and abuse laws, including the most recent examination by 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 Governmental Authoritystatutes; (ii) the Federal Food, Drug and Cosmetics Act (“FDCA”), (iii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and have satisfactorily addressed in all material respects all matters requiring attentionthe regulations promulgated pursuant thereto; (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) Legal Requirements relating to the billing or submission of claims, if any. None collection of such directivesaccounts receivable, undertakings and actionsunderwriting the cost of, individually or collectively, has had provision of management or would reasonably expected to have a Company Material Adverse Effect.administrative

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company (a) NRx and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionsAffiliates have complied, and other similar documentsare now complying, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements applicable Laws applicable to NRx’s or its Affiliates’ (as applicable) ownership or use and of the Transferred Assets and Product. NRx has delivered or will deliver on or prior to the Closing Date to Relief, solely with respect to the Product, copies of any written material reports in NRx’s and its Affiliates’ possession and control as of or before the Closing Date of inspectional observations, establishment inspection reports, untitled letters, warning letters and any other material documents received by NRx or any of its Affiliates from a Governmental Authority relating exclusively to the Product, in each case that arise from a lack of compliance, in any material respect, with any applicable Laws. All CMC data, stability reports, manufacturing batch records and CMC related regulatory filings have, or as of the Closing Date, shall have been placed in the data room. (b) NRx and its Affiliates have not, and, to NRx’s Knowledge, NRx’s current and former employees, officers, directors, or Affiliates have not made, in each case solely with respect to the Product, any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy. In relation to the Product, NRx and its Affiliates are not the subject of any pending or, to NRx’s Knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy. To NRx’s Knowledge, there are no FDA commitments with respect to the Product and the Transferred Assets. (c) NRx and its Affiliates are not subject to any pending or, to NRx’s Knowledge, threatened enforcement, regulatory or administrative proceedings against NRx or any of its Affiliates with respect to any alleged or actual violation by NRx or its Affiliates of any applicable Law and did not contain any untrue statement or other requirement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority relating to the Product, including under the FDCA. NRx has no Knowledge of any existing facts in any jurisdiction that would lead to any future enforcement, regulatory, or administrative actions that would have a Material Adverse Effect on the Product, the Transferred Assets, or the Transactions. (d) NRx and all directives and undertakings arising its Affiliates have not been debarred or suspended under 21 U.S.C. §335(a) or (b), are not the subject of a conviction described in Section 306 of the FDCA, have not been excluded from the most recent examination by such Governmental Authoritya federal health care program, debarred from federal contracting, convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, and have satisfactorily addressed are not subject to any similar sanction of other Regulatory Authorities outside of the United States (“Debarred/Excluded”) and, to NRx’s Knowledge, none of the NRx Representatives (while employed by NRx) involved in the use of the Product has been Debarred/Excluded. (e) NRx has made available to Relief copies of all material respects all matters requiring attentioninformation and data in NRx’s and its Affiliates’ possession or control as of the Execution Date, if any. None or the Closing Date, as applicable, specifically and exclusively relating to the safety of such directivesthe Product, undertakings including written summaries in NRx’s and actions, individually its Affiliates’ possession or collectively, has had control of complaints and notices of alleged Product defects or would reasonably expected to have a Company Material Adverse Effectadverse reactions resulting from administration of the Product.

Regulatory Matters. Except (a) The Company and the Company Subsidiaries hold, and since January 1, 2022 have held, such Regulatory Authorizations required for such failures the conduct of their business as presently or, during that time period, conducted, including those necessary to permit the design, development, pre-clinical and clinical testing, manufacturing, distribution and promotion of the following Company Product, as applicable, in the jurisdictions where it currently conducts such activities with respect to be true as have not been and the Company Product, except to the extent where failure to hold such Regulatory Authorizations would not be reasonably expected to benot, individually or in the aggregate, be reasonably expected to result in a material liability to the Company and its the Company Subsidiaries (taken as a whole, each of ). Except as would not reasonably be expected to result in a material liability to the Company and its the Company Subsidiaries has timely (taken as a whole), (i) the Company and accurately filed the Company Subsidiaries have filed, maintained or provided furnished with the applicable Regulatory Authorities all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other similar documentsrequired information (collectively, together the “Health Care Submissions”) and (ii) all such Health Care Submissions were complete and accurate and in compliance with any amendments required applicable Health Laws when filed (or were corrected or completed in a subsequent filing). (b) Except as would not reasonably be expected to be made with respect thereto, that result in a material liability to the Company or its Subsidiary was required to file and the Company Subsidiaries (taken as a whole), since January 1, 2017 2022, (i) the Company, the Company Subsidiaries and, to the Company’s knowledge, any other Person that has performed or is performing any material research, development, manufacturing, distribution or other services or activities on behalf of the Company or any Company Subsidiary with respect to a Company Product, in each case, to the extent acting in such capacity (each, a “Collaboration Partner”) are, and have been, in compliance with all Health Laws applicable to the Company, the Company Subsidiaries and the Company Product and (ii) neither the Company, either Company Subsidiary nor any Collaboration Partner (only with respect to a Company Product) has received any written notice or other communication from any Regulatory Authority alleging any violation of any Health Law. (c) Except as would not reasonably be expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2022, all pre-clinical studies and clinical trials conducted or being conducted with respect to the Company Product by, on behalf of, or at the direction of the Company have been and are being conducted in compliance with the required experimental protocols, procedures and controls, and all applicable Health Laws, including the FDCA and its applicable implementing regulations, including all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects required by the FDA. As of the date of this the Agreement, with no clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Governmental Authority and timely paid all fees and assessments due and payable in connection therewithRegulatory Authority. Except for such failures of the following to be true as would not reasonably be reasonably expected to behave, individually or in the aggregate, a material and adverse effect on the Company and the Company Subsidiaries (taken as a whole), neither the Company nor either Company Subsidiary has received any written notifications or other communications from any Regulatory Authority that requires or would require the termination or suspension or investigation, or place a clinical hold order on or otherwise delay or restrict any clinical studies currently conducted by, or on behalf of, the Company, or in which the Company or either Company Subsidiary has participated and, to knowledge of the Company, no such action has been threatened in writing against the Company or either Company Subsidiary. (d) Except as would not reasonably be expected to result in a material liability to the Company and its the Company Subsidiaries (taken as a whole), there is no unresolved violation or exception since January 1, 2022, the Company, the Company Subsidiaries and, to the Company’s knowledge, any other Collaboration Partner are, and have been, in compliance with applicable Health Laws, including the FDCA and applicable regulations and Good Manufacturing Practices and other standards required by the FDA. As of the Agreement Date, neither the Company nor, to the knowledge of the Company, any manufacturing site that assists in the manufacturing of the Company Product or any material Company Product components (whether Company-owned or operated or that of its Subsidiaries a Collaboration Partner) has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export detention, refusal or prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of the documents described in the first sentence of this Section 3.21inspectional observations, adverse findings, “warning letters,” “untitled letters” or similar written notice alleging or asserting material noncompliance with any applicable Health Law, and as to the Company’s knowledge, no such action or proceeding is pending or threatened. (e) No Company, Company Subsidiary nor any of their respective datesemployees, such documents complied officers, or directors nor, to the Company’s knowledge, any Collaboration Partner have been debarred, delisted or similarly punished under any Law, including any Health Law, by any Governmental Entity or Regulatory Authority or convicted of a crime for which debarment is mandated or permitted by 21 U.S.C. § 355a, and the Company does not employ, or to the Company’s knowledge, contract with any individuals who are disqualified pursuant to 21 C.F.R § 312.70 or § 812.119. There have been no allegations or investigations against the Company, Company Subsidiary, any employee or the Company’s knowledge, any contractor, that could result in all exclusion, debarment or disqualification. Additionally, and only to the extent applicable, none of the Company, any Company Subsidiary nor their respective directors, officers, employees or to the Company’s knowledge, Collaboration Partners has been restricted in any material respects respect, suspended, excluded or threated with all requirements exclusion from, participation in any federal or state health care program under any applicable Health Law. (f) No Company nor any Company Subsidiary currently is nor has been since January 1, 2022: (i) assessed a civil monetary penalty under any Health Law, (ii) party to a corporate integrity agreement with any Governmental Entity or Regulatory Authority, or (iii) subject to a deferred prosecution agreement, non-prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement, in each case, entered into with or imposed by any Governmental Entity or Regulatory Authority, or order of a Governmental Entity or Regulatory Authority mandating or prohibiting future or past activities in connection with the Company’s noncompliance with applicable Law Health Laws. (g) The Company and did the Company Subsidiaries have not contain any (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Entity, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any Governmental Entity, or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case), at the statements thereintime such disclosure or statement was made or failure to make occurred, in light establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the circumstances under which they were madeCompany nor any Company Subsidiary is, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beor has since January 1, individually or in 2022 been, the aggregatesubject of any pending or, material to the Company and its Subsidiaries taken as a wholeCompany’s knowledge, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made threatened, investigation by the Company or FDA pursuant to its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental AuthorityFraud, Untrue Statements of Material Facts, Bribery, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectIllegal Gratuities Final Policy.

Regulatory Matters. Except for such failures of the following to be true as have not been and would not be reasonably expected to be(a) To VBI’s knowledge, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all (i) any regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments filings required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority VBI Products have been complete and timely paid all fees correct and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational products have been and are being conducted by VBI according to all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) VBI has disclosed to the Purchasers all such regulatory filings and all material communications between representatives of VBI and any such regulatory agency. (b) VBI and, to VBI’s knowledge, VBI’s agents, are in compliance in all material respects with all applicable statutes, rules and regulations of the United States Food and Drug Administration (the “FDA”), the Department of Health (Canada) (the “DOH”) or similar federal, state, provincial or local governmental authority (together with the FDA and DOH, the “Regulatory Authorities”) with respect to the design, manufacture, packaging, sale, labeling, storage, testing, distribution or marketing of any VBI Products. VBI has all the necessary and requisite permits, approvals, clearances, registrations, licenses or the like from the Regulatory Authorities to conduct its business as it is currently, and currently proposed to be, conducted. VBI is in compliance in all material respects with all applicable registration and listing requirements set forth in the Federal Food, Drug & Cosmetic Act (the “Act”), 21 U.S.C. § 360, and all similar applicable laws, including the Food and Drugs Act (R.S., 1985, c.F-27) in Canada. VBI adheres in all material respects to applicable regulations in the manufacture of Company Products, including applicable Law provisions of the FDA’s Quality System regulation as set forth in Title 21 of the Code of Federal Regulations. (c) VBI has not received from the Regulatory Authorities any notice of adverse findings, FDA Form 483 inspectional observations, notices of violations, Warning Letters, criminal proceeding notices under Section 305 of the Act, or other similar communication from the Regulatory Authorities. There have been no seizures conducted or, to VBI’s knowledge, threatened by the Regulatory Authorities, and did no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration or safety alerts conducted, requested or, to VBI’s knowledge, threatened by the Regulatory Authorities, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration or safety alerts have been conducted, requested or, to VBI’s knowledge, threatened by the Regulatory Authorities relating to VBI Products. VBI has not contain received any written notification that remains unresolved from the FDA or other Regulatory Authorities indicating that any Company Product is misbranded or adulterated as defined in the Act or the rules and regulations promulgated thereunder. (d) Neither VBI nor any officer, employee or, to VBI’s knowledge, agent of VBI has made an untrue statement of a material fact or omit fraudulent statements to state the FDA or other authorities, failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order other authorities, or committed an act, made a statement, or failed to make a statement that, at the statements therein, in light of the circumstances under which they were time such disclosure was made, not misleading. Except for such failures to be in compliance as would not could reasonably be expected to beprovide a basis for the FDA or other authority to invoke its policy respecting Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (e) VBI has not received any written notice that the FDA or other authorities has commenced, or, to VBI’s knowledge, threatened, to initiate any action to withdraw its approval or clearance of or requested the recall of any VBI Products or commenced or, to VBI’s knowledge, overtly threatened to initiate, any action to enjoin production at any facility of VBI. (f) The clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by VBI or in the aggregatewhich VBI’s Products or product candidates under development have participated, material to the Company were and its Subsidiaries taken as a wholeif still pending, the Company are being conducted in accordance with standard medical and its Subsidiaries are scientific research procedures. VBI has operated within, and currently is in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects with, all matters applicable laws as well as the rules and regulations of the FDA including but not limited to those rules and regulations governing studies for which an investigational new drug application has been filed in accordance with 21 C.F.R. Part 312 and other authorities regarding its clinical studies. VBI has not received any notices or other correspondence from the FDA or other authorities requiring attentionthe termination or suspension of any clinical, if any. None preclinical, safety or other studies or tests used to support regulatory clearance of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectVBI’s Products.

Regulatory Matters. Except for such failures of the following to be true as (a) The Company and its Subsidiaries have not been established and would not be reasonably expected to be, individually administer one or in the aggregate, material more compliance programs (including a written compliance policy) applicable to the Company and its Subsidiaries taken as a whole(i) to assist the Company and its Subsidiaries and the directors, each officers and employees of the Company and its Subsidiaries has timely in complying with applicable Legal Requirements (including those administered by the FDA or comparable Governmental Authority) applicable to the Company, its Subsidiaries or their respective businesses and accurately filed or provided all regulatory reports(ii) to provide compliance policies and training to appropriate persons governing applicable areas for medical device companies (including pre-clinical and clinical testing, schedulesproduct design and development, formsproduct testing, Permit applications or renewalsproduct manufacturing, examination responses product labeling, product storage, pre-market clearance and submissionsapproval, advertising and other similar documentspromotion, together with any amendments required to be made with respect theretoproduct sales and distribution, that medical device recall and reporting regulations and record keeping). (b) Except as disclosed in the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeSEC Reports, the Company and its Subsidiaries are in compliance in all material respects with the provisions of all formal written Legal Requirements of applicable Governmental Authority directives Authorities relating to the regulation of the Company’s and its Subsidiaries’ products, including the FDC Act, the PHS Act, and all rules and regulations promulgated thereunder, except for instances of noncompliance that have not had and reasonably would not be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as disclosed in the Company SEC Reports, with respect to the marketing of products by the Company or any of its Subsidiaries, all formal written undertakings applications, submissions, information, claims and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for authorizations, approvals, certificates, waivers, certifications, clearances, exemptions, notifications, consents, orders, registrations, listings, licenses or permits of any applicable Governmental Authority, including the FDA and the USDA, relating to the Company, its Subsidiaries, their respective businesses and products, when submitted to the applicable Governmental Authority, were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the applicable Governmental Authority. All product claims made by the Company or its Subsidiaries with respect to any Governmental Authority including any the Company’s or its Subsidiaries’ products are valid, supported by proper research, design, testing, analysis and all directives disclosure, and undertakings arising from are permitted by applicable Legal Requirements administered by the most recent examination by such FDA, USDA or comparable non-U.S. Governmental Authority, except for such failures as have not had and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actionsreasonably would not be expected to have, individually or collectivelyin the aggregate, has had or would reasonably expected to have a Company Material Adverse Effect. (c) The Company’s and its Subsidiaries’ activities and relevant facilities, as well as, to the Knowledge of the Company, its suppliers, distributors and other intermediaries, are in compliance with all applicable Legal Requirements of any U.S. Governmental Authority that govern the marketing of products by the Company or any of its Subsidiaries, including the FDC Act and the PHS Act and all implementing regulations thereunder, including the registration, listing, labeling, reporting and manufacturing requirements of 21 C.F.R. Parts 803, 806, 807, 809, 812, 814 and 820, all to the extent applicable to in vitro diagnostic devices and accessories, and comparable Legal Requirements of any applicable non-U.S. Governmental Authority of Brazil, Japan, Canada, the United Kingdom, Germany, France or comparable European Union directives, and to the Knowledge of the Company, any other non-U.S. jurisdictions, except for noncompliance that has not had and reasonably would not be expected to have, individually or in the aggregate, a material adverse effect on the Company or applicable Subsidiary of the Company. Except as disclosed in the Company SEC Reports, neither the Company nor any of its Subsidiaries is subject to any obligation arising under any consent decree, consent agreement, or warning letter issued by or entered into with the FDA or other notice, response or commitment made to the FDA or any comparable Governmental Authority. The Company has disclosed to the Purchaser any warning letters, untitled (or “notice of violation”) letters, or similar notices, or other correspondence relating to the Company’s or any of its Subsidiaries’ compliance status under applicable Legal Requirements of any Governmental Authority that govern the marketing of products by the Company or any of its Subsidiaries within the last two (2) years. (d) All products being manufactured, distributed, or developed by the Company or any of its Subsidiaries that are subject to the jurisdiction of the FDA or any comparable non-U.S. Governmental Authority are being manufactured, labeled, stored, tested, distributed, and marketed in compliance with all applicable Legal Requirements of any Governmental Authority that govern the marketing of products by the Company or any of its Subsidiaries, except for instances of noncompliance that have not had and reasonably would not be expected to have, individually or in the aggregate, a Material Adverse Effect. (e) There are no clinical trials or studies being conducted by or on behalf of the Company or any of its Subsidiaries. Except as disclosed in the Company SEC Reports, all pre-clinical trials and clinical trials conducted by or on behalf of the Company or any of its Subsidiaries have been, and are being conducted in material compliance with the applicable Legal Requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54 and 56 and, where applicable, the Declaration of Helsinki, except for instances of noncompliance that have not had and reasonably would not be expected to have, individually or in the aggregate, a Material Adverse Effect. (f) Except as disclosed in the Company SEC Reports, to the Knowledge of the Company, neither the Company nor any of its Subsidiaries, nor their respective officers, employees or agents has committed any act, made any statement, or failed to make any statement, that would be reasonably expected to provide a basis for the FDA to withdraw product approval or clearance or to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or provide a basis for a U.S. Governmental Authority to bring an action against the Company or any of its Subsidiaries for a violation of 18 U.S.C. Section 1001 or any other comparable Legal Requirement of any applicable Governmental Authority for making false statements to the FDA.. (g) Except as disclosed in the Company SEC Reports, neither the Company nor any Subsidiary of the Company has been convicted of any crime or engaged in any conduct that could result in a debarment under 21 U.S.C. Section 335a, 48 C.F.R. Subpart 9.4, or under any similar Legal Requirement, or under any exclusion from participation in general health care programs of the United States pursuant to 42 U.S.C. Section 1320a-7. (h) Except as disclosed in the Company SEC Reports filed prior to the date hereof, there are no proceedings pending with respect to a violation by the Company or any of its Subsidiaries of the FDC Act or the PHS Act or their implementing regulations, the Controlled Substance Act or any other similar legislation or regulation promulgated by any other Governmental Authority that reasonably would be expected to result in criminal liability. (i) With respect to the year ended December 31, 2005, sales by the Company and its Subsidiaries with respect to Contracts with the U.S. Government did not exceed $3 million. To the Knowledge of the Company, the Company and its Subsidiaries are in material compliance with the terms and conditions of such Contracts with the U.S. Government and applicable Legal Requirements with respect to such Contracts.

Regulatory Matters. Except for such failures The Company is in compliance with all statutes, rules or regulations of the following FDA, the DEA, the EMA, the MHRA and other comparable governmental agencies engaged in the regulation of pharmaceutical drugs applicable to be true as have not been and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company except where noncompliance would not be reasonably expected to benot, individually singularly or in the aggregate, material to the Company have a Material Adverse Effect. The nonclinical studies and its Subsidiaries taken as a whole, each clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and its Subsidiaries has timely Trials”) were and, if still pending, are being, conducted in all material respects with all applicable federal, state and accurately filed or provided all regulatory reportsforeign laws, schedulesrules, forms, Permit applications or renewals, examination responses orders and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that 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 its Subsidiary was required trials not described in the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to file since January 1in the Prospectus; and the Company has not received any written notices or correspondence from the FDA, 2017 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 any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeCompany’s knowledge, there is are no unresolved violation reasonable grounds for the same. In using or exception disclosing patient information received by the Company or any of its Subsidiaries in connection with respect to any of the documents described in Company Studies and Trials, the first sentence of this Section 3.21, and as of their respective dates, such documents Company has complied in all material respects with all requirements federal, state, local or foreign applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of applicable Law 1996 and did not contain the rules and regulations thereunder (“HIPAA”). Neither the Company, nor its subsidiaries or any untrue statement of a material fact their respective directors, officers, employees or, to the Company’s knowledge, agents is or omit since January 1, 2015 has been debarred, suspended or excluded or, to state a material fact required to be stated therein or necessary in order to make the statements therein, in light knowledge of the circumstances under which they were madeCompany, not misleading. Except for such failures to be engaged in compliance as any conduct that would not reasonably be expected to beresult in a debarment, individually suspension or in exclusion from any federal or state government health care program or human clinical research. To the aggregateCompany’s knowledge, material to none of the Company Studies and its Subsidiaries taken Trials involved any investigator, as such term is defined in Title 21, Section 50.3 of the U.S. Code of Federal Regulations, who has been disqualified as a wholeclinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, the Company manufacturing facilities and operations of its Subsidiaries suppliers are operated in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects with all matters requiring attentionapplicable statutes, if any. None rules and regulations of such directivesthe FDA, undertakings and actionsthe DEA, individually the EMA, the MHRA or collectively, has had or would reasonably expected comparable regulatory agencies outside of the United States to have a which the Company Material Adverse Effectis subject.

Regulatory Matters. Except for such failures of (a) For the following to be true as have not been and would not be reasonably expected to belast seven (7) years, individually or in the aggregate, material to the Company Group Members have obtained all clearances, authorizations, licenses and its Subsidiaries taken as a wholeregistrations required by any foreign or domestic Governmental Authorities (including, each of without limitation, the FDA and EMA) to permit the Company Group Members to conduct their business as currently conducted. The Company Group Members have filed with the applicable regulatory authorities (including, without limitation, the FDA, the EMA or any other Governmental Authority performing functions similar to those performed by the FDA and its Subsidiaries has timely and accurately filed EMA) all material filings, notices, responses to notices, supplemental applications, declarations, listings, registrations, reports or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments including but not limited to adverse event reports required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 filed prior to the date of this AgreementAgreement Date. All such filings, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to bedeclarations, individually listings, registrations, reports or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21submissions are, and as of their respective dateswere since filing (or were corrected in or supplemented by a subsequent filing), such documents complied in compliance in all material respects with Applicable Laws and all requirements formal filing and maintenance requirements, and no material deficiencies have been asserted by any applicable Governmental Authority with respect to any such filings, declarations, listing, registrations, reports or submissions that have not been cured. (b) For the last seven (7) years, all preclinical studies, and Clinical Trials and investigations sponsored or conducted by the Company Group Members have been, and are being, conducted in material compliance with Applicable Laws, and the rules and regulations of any applicable Law Governmental Authority, including, as applicable, Good Laboratory Practices and did Good Clinical Practices requirements, and federal and state, national and supranational Applicable Laws, rules, regulations and guidance restricting the use, transfer and disclosure of individually identifiable health information and human subject or patient clinical biological samples. The Company Group Members have not contain received any written notices or other correspondence from any institutional review board, ethics committee, safety monitoring committee or the FDA or any other supranational, foreign, federal, state or local governmental or Regulatory Authority performing functions similar to those performed by the FDA with respect to any ongoing Clinical Trials or preclinical studies or tests requiring the termination, suspension or material modification of such studies or tests, and to the Company’s knowledge, no such action has been threatened. (c) The Company Group Members have not received any written notice from any Regulatory Authority withdrawing or placing any Investigational New Drug application or equivalent application in other countries related to any Company Product or Service, on “clinical hold” or requiring the termination or suspension or investigation of any preclinical studies or Clinical Trials conducted or sponsored by the Company Group, and to the Company’s knowledge there are no pending actions by any Regulatory Authority against or affecting the Company Group with respect to any Company Product or Service or relating to or arising under any Applicable Laws relating to government health care programs, private health care plans or the privacy and confidentiality of patient health information. The Company Group Members have made available to Buyer complete and correct copies of all material serious adverse event reports, non-clinical expedited safety reports and periodic adverse event reports, and all material Regulatory Authority communications and documents submitted by the Company Group Members to or received by the Company Group Members from the FDA, the European Commission, the EMA or any other Regulatory Authority, including any material meeting minutes, scientific advice, inspection reports, warning letters and similar documents, relating to the Company Group, the conduct of the business of the Company Group or any Company Product or Service. (d) For the last seven (7) years, the Company Group Members have not, and to the Company’s knowledge, no Company Representative has, (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any other Governmental Authority, (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes, or would have established at the statements thereintime such statement was made, a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy or any Governmental Authority to invoke any similar Applicable Law. To the Company’s knowledge, the Company Group Members are not the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy or any Governmental Authority to invoke any similar Applicable Law. (e) The Company Group Members are in light compliance and have been in compliance in all material respects with all Healthcare Laws applicable to the operation of its business as currently conducted. The Company Group Members are not subject to any enforcement, regulatory or administrative proceedings against or affecting the Company Group relating to or arising under the FDCA or similar Applicable Law, and no such enforcement, regulatory or administrative proceeding has been threatened in writing. (f) The Company Group Members have never been and none of the circumstances Company Representatives (while employed or engaged by the Company Group) has ever been, (i) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a) or equivalent foreign law, (ii) convicted of a crime for which they were madea person can be debarred or (iii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred or excluded from participating in any U.S. federal health care programs or any equivalent foreign law. (g) Any manufacture of a Company Product or Service used in any Clinical Trials conducted or sponsored by or on behalf of the Company Group Members have been conducted in material compliance with the applicable requirements of current Good Manufacturing Practices and all other Applicable Laws. (h) Except as disclosed on Section 3.13(h) of the Company Disclosure Schedule, there has not misleading. Except for occurred (A) any adverse event(s) in a nonclinical study or Clinical Trial or any other setting that are deemed by the study director or investigator in such failures nonclinical study or Clinical Trial to be at least possibly related to the Company Product or Service, or (B) the failure of any Clinical Trial for the Company Product or Service to achieve one or more of its primary endpoints in compliance as would not reasonably be expected any material respect, or (C) any failure of the Company Group or any Third Party service provider acting on behalf of a Company Group Member to beadhere to the requirements under the FDCA, the regulations and guidance documents of the FDA promulgated thereunder, the equivalent Applicable Laws and guidance of the EU, or the EU member states, or any other equivalent foreign authority or any Governmental Permit (including the failure to possess or maintain the validity of any Governmental Permit), (x) relating to the investigational use and clinical trials of the Company Product or Service or (y) with respect to the making of untrue or fraudulent statements, the failure to disclose information, or any failure to adhere to clinical protocols or informed consent requirements, which, individually or in the aggregateaggregate as to (A), material (B) and (C) above would at the time of such of such adverse event or failure, as applicable, reasonably be expected to prevent or materially delay the filing of or require the withdrawal, suspension or termination of an Investigational New Drug application in the United States or equivalent application in other countries covering the Company and its Subsidiaries taken as a wholeProduct or Service, or prevent or materially delay the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company Product or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising Service from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectobtaining Approval.

Regulatory Matters. (a) The Company and each Company Subsidiary possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (including all investigational new drug applications (as defined in 21 C.F.R. § 312.20 et seq., establishment registrations (as defined in 21 C.F.R. § 207), and product listings (as defined in 21 C.F.R. § 207), all supplements or amendments thereto, and all comparable approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents provided for in other applicable Laws) (“Regulatory Authorizations”) from the United States Food and Drug Administration (the “FDA”) and all other applicable Regulatory Authorities relating to any Product or that are necessary for the Company or any Company Subsidiary to conduct its business in all material respects as presently conducted. (i) All such Regulatory Authorizations are materially (A) in full force and effect, (B) validly registered and on file with applicable Regulatory Authorities and (C) in compliance with all formal filing and maintenance requirements and (ii) the Company and each Company Subsidiary has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except for such failures of the following as would not reasonably be expected to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the business of the Company and its Subsidiaries the Company Subsidiaries, taken as a whole, each of (1) the Company and its Subsidiaries each Company Subsidiary has timely and accurately filed filed, maintained or provided furnished to the FDA or other applicable Governmental Bodies or other applicable Regulatory Authorities all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and other similar documentsresponses to notices, together with any amendments required to be made with respect theretoapplications and supplemental applications, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority reports (including all adverse event/experience reports) and timely paid (2) all fees such submissions were complete and assessments due accurate and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with applicable Laws when filed (or were corrected or completed in a subsequent filing). (i) The Company and each Company Subsidiary has never marketed, sold, distributed, promoted or advertised any pharmaceutical products (including the Products) and (ii) the Company and each Company Subsidiary is, and since January 1, 2020 has been, in material compliance with applicable Laws, including the FDCA and its implementing regulations, relating to the development, testing, manufacturing, holding, marketing, selling, distributing, labeling, promoting, advertising, importing or exporting of pharmaceutical products, in each case as applicable, including without limitation, (i) requirements for obtaining Regulatory Authorizations, (ii) requirements for establishment registration and product listing; (iii) payment of all application and program fees invoiced for the Products, (iv) label and labeling requirements and (v) applicable promotion and advertising requirements. (c) All non-clinical studies and clinical investigations, preclinical studies or tests sponsored or conducted by or on behalf of the Company or any Company Subsidiary are being conducted in material compliance with applicable Law Laws, including Good Laboratory Practices, Good Clinical Practices, the FDCA, and did not contain all other Laws regarding developing, testing, labeling, manufacturing, storage, marketing, promotion, sale, commercialization, safety, quality, shipment, import, export, or distribution of the products of the Company. None of the FDA, any other Regulatory Authority, or any institutional review board has sent any written notices or other correspondence with respect to any proposed, ongoing or completed clinical, preclinical or non-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. With respect to each Product, the Company has made available to Parent complete and accurate copies of all material clinical, preclinical and nonclinical data in the possession of and reasonably available to the Company or any Company Subsidiary and all material written correspondence that exists as of the date of this Agreement between the Company and any of its Subsidiaries and the FDA or any other Regulatory Authority performing functions similar to those performed by the FDA. (d) Neither the Company nor any Company Subsidiary nor, to the knowledge of the Company, any officers, employees or agents of the Company or any Company Subsidiary, has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any other Regulatory Authority, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. As of the circumstances date of this Agreement, neither the Company nor any Company Subsidiary is the subject of any pending 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. Neither the Company nor any Company Subsidiary nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators of the Company or any Company Subsidiary 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 which they were made, not misleading. 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. (e) Except for such failures to be in compliance as would not reasonably be expected to bebe material to the business of the Company and the Company Subsidiaries, individually taken as a whole, (i) the Company, each Company Subsidiary and any contractor or other Person acting on their behalf is obtaining and since January 1, 2020, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the aggregateCompany’s ongoing clinical studies; (ii) in using or disclosing patient information received by the Company in connection with the Company’s ongoing clinical studies, the Company, each Company Subsidiary and any contractor or other Person acting on their behalf have complied with all Laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996, the FDCA and the rules and regulations thereunder. (f) To the extent required by applicable Laws, all manufacturing operations conducted with respect to any Product used in human clinical trials have been conducted in material accordance with the FDCA, Laws, and Good Manufacturing Practices. (g) Since January 1, 2021, no Product has been recalled, withdrawn, suspended or discontinued. (h) Since January 1, 2021, no preclinical studies sponsored or conducted by or on behalf of the Company for the purpose of supporting a regulatory filing have had any material adverse safety findings that the Company would reasonably expect to have a material adverse impact on clinical studies, and all material preclinical toxicology reports or preclinical toxicology studies conducted by or on behalf of the Company for the purpose of supporting a regulatory filing have been disclosed to the FDA and all other applicable Regulatory Authorities to the extent required by applicable Laws. (i) The Company and each Company Subsidiary is, and since January 1, 2021 has been, in material compliance with all applicable Healthcare Laws. Neither the Company nor any Company Subsidiary is subject to any enforcement, regulatory or administrative proceedings regarding alleged non-compliance with any Healthcare Laws and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. (j) The Company and the Company Subsidiaries have adopted and maintain a compliance program that is intended to assist the Company and the Company Subsidiaries to be in material compliance with all Law, standards and guidelines relevant to its business, including all Healthcare Laws, and includes each of the following elements: (i) a code of conduct and other applicable policies and procedures; (ii) training on the code of conduct, policies and procedures for all employees; (iii) an auditing and monitoring function; (iv) an anonymous reporting process for potential violations of Law or the compliance program; (v) designation of a compliance officer; and (vi) a mechanism for ensuring the effectiveness of the compliance program. None of the Company and its Subsidiaries taken as a wholeor, to the Company and knowledge of the Company, any of its Subsidiaries are in officers, directors, employees, contractors or agents has materially violated any such compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectprogram.

Regulatory Matters. Except (a) The Acquired Companies have filed with the applicable regulatory authorities (including the Food and Drug Administration (the “FDA”) or any other Governmental Body performing functions similar to those performed by the FDA in any jurisdiction) all required material filings, 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 Legal Requirements when filed, and no deficiencies that have been asserted by any applicable Governmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions remain outstanding. (b) All nonclinical and clinical investigations sponsored by or on behalf of the Acquired Companies have been conducted and are being conducted in material compliance with applicable Legal Requirements and guidances, including good clinical practices requirements and applicable Legal Requirements restricting the use and disclosure of individually identifiable health information. As of the date of this Agreement, neither the FDA, nor any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA, nor any institutional review board or independent ethics committee, has sent any written notices or other correspondence to any Acquired Company or an investigator with respect to any clinical or nonclinical studies or tests sponsored by or on behalf of any Acquired Company alleging or asserting material noncompliance with any applicable Legal Requirements or Governmental Authorizations with respect to any such study or test, or recommending or requiring the termination, suspension or material modification of such studies or tests, which modification would reasonably be expected to have a Material Adverse Effect. (c) All animal studies or other preclinical tests performed in connection with or as the basis for any regulatory approval or clearance required for a product or product candidate of the Acquired Companies either (i) have been conducted in accordance, in all material respects, with applicable Good Laboratory Practice requirements contained in 21 C.F.R. Part 58 (“GLPs”) or (ii) involved experimental research techniques that could not be performed by a registered GLP testing laboratory (with appropriate notice being given to the FDA) and have employed in all material respects the procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to those being developed by the Acquired Companies. (d) None of the Acquired Companies or any officer, director or managing employee of the Acquired Companies or, to the knowledge of the Company and to the extent relating to any product or product candidate of the Acquired Companies, any Collaboration Partner (i) has made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Body, (ii) has failed to disclose a material fact required to be disclosed to the FDA or any Governmental Body, (iii) has committed any other act, made any statement or failed to make any statement, that (in any such failures case) establishes a reasonable basis for the FDA or any other Governmental Body to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or any similar policy, (iv) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act, codified at Title 00, Xxxxxxx 0, xx xxx Xxxxxx Xxxxxx Code, or (v) is currently listed on the United States General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs. As of the date of this Agreement, no Acquired Company is the subject of any pending or, to the Company’s knowledge, threatened investigation in writing by the FDA or any other Governmental Body pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or any similar policy. None of the Acquired Companies or any officers or employees of any Acquired Company or, to the knowledge of the Company, any agents or clinical investigators of the Acquired Companies has been suspended or debarred or charged with 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. (e) Each Acquired Company is and, to the knowledge of the Company and to the extent relating to any product or product candidate of the Acquired Companies, each Collaboration Partner is, in material compliance and since January 1, 2020, has been in material compliance with all healthcare laws to the extent 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”), (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) the Public Health Service Act (“PHSA”); and (v) Legal Requirements which are cause for exclusion from any federal health care program. The Acquired Companies are not and have not been subject to and, to the knowledge of the Company and to the extent relating to any product or product candidate of the Acquired Companies, no Collaboration Partner is or has been subject to, any civil or criminal enforcement, regulatory or administrative proceedings against or affecting the Acquired Companies relating to or arising under the FDCA, the Anti-Kickback Statute, or similar Legal Requirements, and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened in writing. None of the Acquired Companies or any officers or employees of any Acquired Company or, to the knowledge of the Company, no agent or clinical investigator of the Acquired Companies, is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order or similar agreement with or imposed by any Governmental Body. (f) All manufacturing operations conducted for the benefit of the Acquired Companies with respect to any product candidate being used in human clinical trials have been conducted in all material respects in accordance with all applicable Legal Requirements including GMP. No manufacturing site that has conducted or is conducting manufacturing operations of product candidates for the benefit of the Acquired Companies is or has been, with respect to such product candidates being used in human clinical trials, subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Body. None of the Acquired Companies or, to the knowledge of the Company, any contract manufacturer for a product candidate manufactured for the benefit of the Acquired Companies that has been or is being used in human clinical trials, has, with respect to such product candidate, received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to its products, manufacturing processes or procedures, or (v) other similar correspondence or written notice from the FDA or any other Governmental Body alleging or asserting material noncompliance with any applicable Legal Requirements or Governmental Authorizations. To the knowledge of the Company, no event has occurred which would reasonably be expected to lead to any material claim, suit, proceeding, investigation, enforcement, inspection or other action by any Governmental Body or any FDA Form 483, warning letter, untitled letter or request or requirement to make changes to such product candidates or the manner in which such product candidates are manufactured, distributed, or marketed. (g) The Company has made available to Parent and Parent’s Representatives true, and correct copies of the following materials in the possession of the Acquired Companies as of the date of this Agreement: (i) Investigational New Drug Applications; (ii) all material correspondence to be true or from the FDA and any other Governmental Body, and all other documents concerning material communications to or from the FDA and any other Governmental Body, in each case held by the Acquired Companies or any of their Collaboration Partners concerning (A) any product or product candidate of the Acquired Companies, (B) the compliance of the Acquired Companies and their Collaboration Partners with applicable Legal Requirements regarding any product or product candidate of the Acquired Companies, and (C) the likelihood or timing of, or requirements for, regulatory approval of any product or product candidate of the Acquired Companies; (iii) nonclinical, clinical and other data contained in or relied upon in any of the foregoing; and (iv) all material information concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of any product or product candidate of the Acquired Companies. (h) Each Acquired Company holds and has, since January 1, 2020, held all material Governmental Authorizations and has submitted notices to the applicable regulatory authorities, including all authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, necessary for the lawful operation of such Acquired Company’s business as is currently conducted or has been conducted, and all such Governmental Authorizations are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any such Governmental Authorization. Each Acquired Company is in compliance in all material respects with the terms of all such Governmental Authorizations. Since January 1, 2020, the Acquired Companies have not received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body alleging that any operation or activity of any Acquired Company is in material violation of any law that applies to such a Governmental Authorization. (i) As of the date of this Agreement, the Company has no knowledge of (i) any adverse events that should have been and reported but were not yet reported to FDA or other Governmental Body or institutional review board or independent ethics committee with respect to the safety or efficacy of any product or product candidate of the Acquired Companies, (ii) any scientific or technical fact or circumstance in existence as of the date of this Agreement that has had or would not reasonably be reasonably expected to behave, individually or in the aggregate, a material adverse effect on the scientific, therapeutic or commercial viability of any product or product candidate of the Acquired Companies in light of the particular stage of development of the product or product candidate of the Acquired Companies and taking into account all relevant facts and circumstances in existence as of the date of this Agreement at the time such facts or circumstances arose, including medical and clinical considerations, the regulatory environment and competitive market conditions, or (iii) any circumstance in existence as of the date of this Agreement that would reasonably be expected to lead to any refusal by any Governmental Body to accept or approve any filing, application or request for regulatory approval of the Company and its Subsidiaries taken as a whole, each products or product candidates of the Acquired Companies in the United States or any other applicable jurisdiction. (j) Part 3.13(j) of the Company Disclosure Schedule sets forth a true and its Subsidiaries has timely complete list of all drug and accurately filed biologic products that are being researched or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that under development by the Company or its Subsidiary was required to file since January 1, 2017 to Acquired Companies as of the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable . All such products are in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with all applicable requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make under the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeFDCA, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any PHSA and all directives comparable state or foreign laws, including all requirements relating to research, development, manufacture, storing, testing, record-keeping, reporting, import, export, labeling, marketing, promotion, advertising, and undertakings arising distributing. The Acquired Companies have not received any written notice or other written communication from the most recent examination by such FDA or any other Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None Body alleging any violation of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectrequirements.

Regulatory Matters. (i) Since January 1, 2021, the Company Group has filed with the applicable regulatory authorities (including the FDA or any other Governmental Entity performing functions similar to those performed by the FDA) all required material filings, 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 deficiencies that have been asserted by any applicable Governmental Entity with respect to any such filings, declarations, listing, registrations, reports or submissions remain outstanding. (ii) Except for such failures of the following to be true as have not been and would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to the have a Company Material Adverse Effect, all nonclinical and its Subsidiaries taken as a whole, each clinical investigations sponsored by or on behalf of the Company Group are, to the knowledge of the Company, being or have been conducted in material compliance with applicable Laws and its Subsidiaries has timely guidance, including (A) Good Clinical Practices requirements, (B) applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, (C) approved clinical protocols and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses informed consents and submissions, (D) applicable Laws restricting the use and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to disclosure of individually identifiable health information. As of the date of this Agreement, with neither the FDA nor any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA has sent any written notices or other correspondence to any member of the following Company Group with respect to be true as would not be reasonably expected to beany ongoing clinical or nonclinical studies or tests requiring the termination, suspension or material modification of such studies or tests, which modification, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect. (iii) To the Company’s knowledge, since January 1, 2021, neither the members of the Company Group nor any Representative acting on any member of the Company Group’s behalf has (A) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws, (B) failed to disclose a material fact required to be disclosed to the FDA 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 the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or for any Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws to invoke an equivalent policy. As of the date of this Agreement, none of any member of the Company Group nor, to the Company’s knowledge, any entity or other Representative acting on any member of the Company Group’s behalf is the subject of any pending 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 Governmental Entity having applicable jurisdiction over the Company Group under applicable Healthcare Laws on the basis of an equivalent Policy. (iv) Neither the Company nor, to the knowledge of the Company, any executive officers, employees, agents or clinical investigators of the Company Group or any entity or individual acting on the Company’s behalf has been (A) debarred under 21 U.S.C. § 335a or any similar Law, (B) excluded from participation in federal health care programs under 42 U.S.C.

Regulatory Matters. Except for such failures (a) The operations of the following Company (inclusive of the Products, services, and advertising and promotional materials) are, and have been at all times, in compliance with all applicable Healthcare Laws. The Products are, and have, been manufactured, researched and developed by, or on behalf of, the Company in compliance with all applicable Healthcare Laws. The Company has obtained all applicable approvals, authorizations, licenses, registrations, and Permits required by the FDA and any other Governmental Authority responsible for the oversight and enforcement with respect to be true Healthcare Laws, including to permit any manufacturing, labeling, storing, testing, research and development of each Product as have not been previously conducted or currently being conducted by or on behalf of the Company. Section 2.20(a) of the Disclosure Schedule sets forth a complete and would not be reasonably expected accurate list of (i) all licenses, certifications, orders, clearances, exemptions, authorizations, and approvals granted or pending with the FDA or any other Governmental Authority to beresearch, individually develop, or market any Product used in the aggregateconduct of the Business; (ii) each clinical trial protocol submitted by the Company to the FDA or any other Governmental Authority; (iii) all other filings or submissions made by the Company pursuant to the Federal Food, Drug, and Cosmetic Act, as amended (“FD&C Act”) and its respective implementing orders and regulations, or any similar Applicable Law; and (iv) any material to correspondence between the Company and its Subsidiaries taken as the FDA or any other Governmental Authority concerning the Company or a whole, Product. The Company has delivered to Buyer each of the items described in (i)-(iv) above. (b) The Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with not received any amendments required to be made with respect thereto, notice that the Company FDA or its Subsidiary was required any other Governmental Authority responsible for oversight or enforcement of any Healthcare Law, or any institutional review board (or similar body responsible for oversight of human subjects research) or institutional animal care and use committees (or similar body responsible for oversight of animal research), has initiated, or threatened to file since January 1initiate, 2017 any action, suit, proceeding or order to restrict or suspend, nonclinical research on or clinical study of any Product, or to recall, suspend or otherwise restrict the manufacture of any Product, or in which the Governmental Authority alleges or asserts a failure to comply, with applicable Healthcare Laws. 39881135.1 ACTIVE/118012393.3 (c) There are no lawsuits, actions, arbitrations, proceedings, charges, complaints or, to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures Knowledge of the following to be true as would not be reasonably expected to beCompany, individually investigations pending, or in the aggregate, material to the Company and its Subsidiaries taken as a wholeKnowledge of the Company, there is no unresolved violation or exception by the Company or any of its Subsidiaries threatened, with respect to any alleged violation by the Company, any of its Affiliates, or to the Knowledge of the documents described in Company, any of its subcontractors, partners or collaborators of the first sentence of this Section 3.21FD&C Act or any other Healthcare Law, and as the Company, its Affiliates, and to the Knowledge of their respective datesthe Company, its subcontractors, partners and collaborators are not party to or subject to, nor is any Product subject to, any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar Contracts with or imposed by any Governmental Authority related to any Healthcare Law, and no such documents complied Contract is currently pending or, to the Knowledge of the Company, threatened. The Company is not a defendant or named party in all material respects any unsealed qui tam/False Claims Act litigation. The Company is not resubmitting or planning to resubmit to the government any data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Act of 1992, or the Medicare Part D Coverage Gap Discount Program, or refunding any monies owed due to a resubmission. (d) Neither the Company, nor to the Knowledge of the Company, any Person engaged by the Company for contract research, contract manufacturing, consulting, other collaboration services, partners or collaborators with all requirements of applicable Law and did not contain respect to any Product has made an untrue statement of a material fact or omit a fraudulent statement to state the FDA or any Governmental Authority responsible for enforcement or oversight with respect to Healthcare Laws, or failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order to make other such Governmental Authority that, at the statements therein, in light of the circumstances under which they were time such disclosure was made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beprovide a basis for the FDA to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991), or for any other Governmental Authority to invoke a similar policy. (e) Neither the Company nor any of its current or former members, officers, partners, or employees, nor to the Knowledge of the Company, contractors or agents have been or are currently suspended, excluded or debarred from any federal contracting or healthcare programs, or threatened with or currently subject to an investigation or proceeding that could result in suspension, exclusion or debarment under state or federal statutes or regulations, or assessed or threatened with assessment of civil monetary penalties. Neither the Company nor any of its current or former members, officers, partners, employees, nor to the Knowledge of the Company, contractors or agents have been convicted of any crime or engaged in any conduct that has previously caused or would reasonably be expected to result in (i) disqualification or debarment under 21 U.S.C. Sections 335 or any similar law, rule or regulation of any other Governmental Authorities, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any Governmental Authorities. (f) All pre-clinical studies and clinical trials conducted or being conducted with respect to any Product or the Business by or, to the Knowledge of the Company, at the direction of the Company have been and are being conducted in material compliance with all Applicable Law, including (i) standard medical and scientific research procedures and all Healthcare Laws, as applicable, including 21 C.F.R. Parts 11, 50, 54, 56, 58 and 312 and comparable foreign Laws; (ii) the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects (including “Informed Consent” as such term is defined under Applicable Law in the jurisdictions where clinical trials were or are being conducted); and (iii) Applicable Law governing the privacy of patient medical records and other personal information and data. The Company has not received any notifications 39881135.1 ACTIVE/118012393.3 or other communications from any institutional review board (IRB), ethics committee, safety monitoring committee or Governmental Authority raising any issues in any jurisdiction requiring the termination or suspension or investigation of any clinical studies conducted by, or on behalf of, the Company, or in which the aggregateCompany has participated and, material to the Company Knowledge of the Company, no such action has been threatened and its Subsidiaries taken as a wholethere is nothing that would warrant any such action. Complete and correct copies of all material Regulatory Materials, including scientific and clinical data of the Company with respect to all Products or the Business, have been made available to Buyer. Such Regulatory Materials are complete and its Subsidiaries are correct in all material respects and have been maintained in compliance with all formal written filing and maintenance requirements. The Company has made available to Buyer complete and correct copies of all serious adverse event reports, periodic adverse event reports, non-clinical expedited safety reports, and all other Governmental Authority directives communications, documents and with all formal written undertakings made other information submitted by the Company to or its Subsidiaries to received by the Company from any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, including inspection reports, warning letters and similar documents, relating to the Company, the conduct of the Business, or any Product. (g) There have satisfactorily addressed been no (i) FDA Form 483 inspection observations, (ii) establishment inspection reports, (iii) warning, untitled or action letters, (iv) orders, (v) enforcement actions or (vi) other documents or actions that assert lack of compliance in any material respect with any applicable Law, in all such cases, relating to, arising out of or in connection with the Business or any Product. There has not been, nor, to the Knowledge of the Company, is there currently under consideration by the Company, its partners, collaborators or any Governmental Authority, any recall, market withdrawal, safety alert, “Dear Doctor” letter, public health notification or other safety communication in respect of any Product. (h) If applicable, the manufacture of the Products are being conducted in compliance with current good manufacturing practices, as defined by the FDA, including, as applicable, the FDA’s Current Good Manufacturing Practices set forth in 21 C.F.R. Parts 210 and 211 and any successor legislation or regulations, and comparable foreign Laws. (i) The Company owns or has the right to use and access (including the right to make copies of) all material respects information and data generated in all matters requiring attentiondevelopment activities and all nonclinical, if any. None toxicology and other studies, and clinical studies and trials (together with data sets associated with such studies) with respect to the Products, in each case, undertaken by or on behalf of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse EffectCompany.

Regulatory Matters. (a) The Company and each of its Subsidiaries possesses all 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 as presently conducted. All such Regulatory Authorizations are (i) in full force and effect, (ii) validly registered and on file with applicable Governmental Bodies, and (iii) in compliance with all formal filing and maintenance requirements. The Company and each of its Subsidiaries has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except for such failures of the following as would not reasonably be expected to be true as have not been and would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeCompany, each of (x) the Company and each of its Subsidiaries has timely and accurately filed filed, maintained or provided furnished to FDA or other applicable Governmental Bodies all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and other similar documentsresponses to notices, together applications and supplemental applications, reports (including all adverse event/experience reports) and (y) all such submissions were complete and accurate and in compliance with any amendments required to be made with respect thereto, that applicable Legal Requirements when filed (or were corrected or completed in a subsequent filing). (b) All preclinical and clinical investigations sponsored by the Company or its Subsidiary was required to file since January 1, 2017 to the date any of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a wholeare being, there is no unresolved violation and have been, conducted in material compliance with applicable Legal Requirements, rules, regulations and guidances, including Good Clinical Practices. Neither the FDA nor any other Governmental Body performing functions similar to those performed by the FDA has sent any written notices or exception by other correspondence to the Company or any of its Subsidiaries with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. Neither the Company nor any of its Subsidiaries has received any written notifications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Governmental Body in any jurisdiction that requires or would require the termination or suspension or investigation, or seeking place a clinical hold order on or otherwise delay or materially restrict any clinical studies proposed or currently conducted by, or Table of Contents on behalf of, the Company or any of its Subsidiaries, or in which the Company or any of its Subsidiaries has participated and, to knowledge of the documents described 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 first sentence possession of the Company or any of its Subsidiaries and all material written correspondence that exists as of the date of this Section 3.21, Agreement between the Company or any of its Subsidiaries and as the applicable Governmental Bodies. (c) Neither the Company nor any of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any its Subsidiaries has (i) made an untrue statement of a material fact or omit fraudulent statement to state the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary in order any Governmental Body or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the statements thereinFDA to invoke its Fraud, in light Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or similar policy of a Governmental Body. As of the circumstances date of this Agreement, neither the Company nor any of its Subsidiaries is the subject of any pending 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. Neither the Company or any of its Subsidiaries nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators of the 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) The Company and each of its Subsidiaries is and since January 1, 2018, has been in material compliance with all contractual commitments relating to the privacy and security of Protected Health Information and all healthcare laws applicable to the operation of its business, 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 Cosmetics Act (“FDCA”), (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 (collectively “HIPAA”); (iv) Legal Requirements which they were madeare cause for exclusion from any federal health care program; and (v) Legal Requirements relating to the billing or submission of claims, not misleadingcollection 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. Except Neither the Company nor any of its Subsidiaries is subject to any enforcement, regulatory or administrative proceedings regarding compliance with healthcare laws and no such enforcement, regulatory or administrative proceeding has been threatened. Neither the Company nor any of its Subsidiaries has or had any unauthorized use or disclosure of Protected Health Information that would constitute a security incident or breach that would require the Company to provide notice under any healthcare laws. (e) To the extent required by applicable Legal Requirements, all manufacturing operations conducted for such failures the benefit of the Company with respect to be any Company Product used in compliance as human clinical trials have been conducted in accordance with GMP Regulations, except where the failure to comply would not reasonably be expected to be, individually or in have a Table of Contents material impact on the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by Company. Neither the Company or any of its Subsidiaries, nor, to the knowledge of the Company, any person acting on its or any of its Subsidiaries’ behalf has, with respect to any Company Product, (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 change to any Company Product or any of the Company’s or any of its Subsidiaries’ processes or procedures, or any similar correspondence from any Governmental Body in respect of the Company, any of its Subsidiaries or their respective business operations alleging or asserting noncompliance with any applicable Legal Requirements or Regulatory Authorizations and, to any the knowledge of the Company, no Governmental Authority including any and all directives and undertakings arising from the most recent examination by Body is considering such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectaction.

Regulatory Matters. Except for such failures (a) Section 4.14 (a) of the following Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to be Parent true and complete copies of, all Regulatory Authorizations from the FDA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company relating to the Company Product. Except as have not been and would not reasonably be reasonably expected to beto, individually or in the aggregate, result in a material liability to the Company and its Subsidiaries taken as a wholeCompany, each of (x) the Company and its Subsidiaries has timely and accurately filed filed, maintained or provided furnished with the applicable Regulatory Authorities all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other similar documentsinformation (collectively, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority “Health Care Submissions”) and timely paid (y) all fees such Health Care Submissions were complete and assessments due accurate and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied 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 that affect the business, Company Product, properties, assets and 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 (iii) there are no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company with respect to the Company Product or alleging any violation by the Company or the Company Product of any such Health Law. (c) Since December 23, 2021, to the Company’s knowledge, 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, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, 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. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, the Company has no outstanding written notifications or other written communications from any 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 termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any 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 clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in material compliance with the applicable specifications and requirements of applicable Health Laws. As of the Agreement Date, neither the Company nor, to the 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 and did not contain or Regulatory Authorization and, to the knowledge of the Company, 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 (i) made an untrue statement of a material fact or omit fraudulent statement to state any Regulatory Authority or any other Governmental Entity, (ii) failed to disclose a material fact required to be stated therein disclosed to any Regulatory Authority or necessary in order any other Governmental Entity or (iii) committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the statements thereintime such disclosure was made or failure to disclose occurred, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beprovide a basis for the FDA to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. 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 communication or submission of false information to any applicable Regulatory Authority or Governmental Entity. The Company has not committed or engaged in the aggregateany fraud or falsification or forgery of any research or development data, material report, studies or publications of any document or statement voluntarily submitted or required to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written be submitted to any Regulatory Authority or any other Governmental Authority directives and with all formal written undertakings made by Entity. None of the Company or any of its Subsidiaries officers, employees or agents or, to the knowledge of the Company, any Governmental Authority including clinical investigator acting for the Company, is currently or has been convicted of any and all directives and undertakings arising from the most recent examination by such Governmental Authoritycrime or engaged in any conduct that has resulted in, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably be expected to have a Company Material Adverse Effect.result in, debarment from participation in any program related to pharmaceutical products pursuant to 21 U.S.

Regulatory Matters. Except for such failures (a) Section 3.11(a) of the following Stockholder’s Disclosure Schedule sets forth a complete and accurate list of (i) the Products that any Group Company (x) sells, distributes, markets or manufactures, or (y) for which any Group Company holds or has applied for any Governmental Authorization pertaining to marketing or manufacturing, and (ii) all Governmental Authorizations previously granted to any Group Company by, or for which applications are pending before, any Governmental Authority to develop, manufacture, import, export, market, distribute or sell any of the Products or to own or operate any of its assets or to operate its business as currently conducted. None of those Governmental Authorizations will cease to be true valid or effective by reason of the consummation of the transactions provided for in this Agreement. (b) Except as set forth in Section 3.11(b) of the Stockholder’s Disclosure Schedule, since September 1, 2010, there has been no material Product Event, and to the knowledge of the Stockholder there are no facts that would be reasonably likely to result in a Product Event, or a material change in the labeling of any Product, in order to avoid a specific concern that could result in a Product Event. (c) Except as set forth on Section 3.11(c) of the Stockholder’s Disclosure Schedule, none of the Group Companies has knowingly made any false statements on, or material omissions from, any applications, approvals, reports or other submissions to any Governmental Authority, or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to any Governmental Authorization of any Products. (d) Except as set forth on Section 3.11(d) of the Stockholder’s Disclosure Schedule, (i) no Group Company has breached any representation or warranty, express or implied, given in respect of any product previously sold by any of them, (ii) all products previously marketed, distributed, sold or exported by any Group Company complied in all respects with all applicable product specifications and requirements and with the terms of all applicable Governmental Authorizations, except for any inconsistencies between labeling and packaging and the applicable Governmental Authorization that (x) have not been and would not reasonably be reasonably expected to be, individually or result in the aggregate, material to the any adverse effect on a Group Company and its Subsidiaries taken as a whole, each of the Company (y) have not and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissionswould not reasonably be expected to result in injury to consumers, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, (iii) there is no unresolved violation or exception by the Company or design defect in any of its Subsidiaries with respect to any Product. (e) Each of the documents described in Group Companies has taken all reasonable measures, directly or indirectly, to ensure the first sentence confidentiality, privacy and security of this Section 3.21employee, patient, customer financial and other confidential information, and as each of their respective dates, such documents complied them has conducted its business in compliance in all material respects with all requirements applicable Laws and all of applicable Law its policies and did not contain any untrue statement procedures governing privacy, data protection and the protection of a material fact or omit personal information (including with respect to state a material fact required to be stated therein or necessary in order to make the statements thereinemployees, in light patients, customers and other individuals). The rights of the circumstances under which they were made, Group Companies to use and disclose such information will not misleading. Except for such failures to be adversely affected in compliance as would not reasonably be expected to be, individually or in the aggregate, any material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made respect by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from consummation of the most recent examination transactions contemplated by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectthis Agreement.

Regulatory Matters. Except for such failures During the 12-month period immediately preceding the date hereof, except as described in the SEC Documents, the Company and each of its Subsidiaries: (A) is and at all times has been to the following Company’s knowledge in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to be true Company and each of its Subsidiaries (“Applicable Laws”), except as have not been and would not be reasonably expected to benot, 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 (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and are not in violation of any term of any such material Authorizations; (D) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority 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 Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge that any such Governmental Authority 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 Applicable Laws or material Authorizations and that all such reports, 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). During the 12-month period immediately preceding the date hereof, to the Company Company’s knowledge, the studies, tests and its Subsidiaries taken as a whole, each preclinical and clinical 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 its Subsidiaries has timely controls pursuant to accepted professional scientific standards and accurately filed or provided all regulatory reportsApplicable Laws, schedulesincluding, formswithout limitation, Permit applications or renewalsthe United States Federal Food, examination responses Drug and submissionsCosmetic Act and the laws, rules and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures regulations of the following to be true as would not be reasonably expected to beTherapeutic Products Directorate, individually 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 aggregateSEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, material to tests and trials; the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by descriptions in the Company or any of its Subsidiaries with respect to any SEC Documents of the documents described in the first sentence results of this Section 3.21, and as of their respective dates, such documents complied clinical trials are consistent in all material respects with all requirements of applicable Law such results and did not contain any untrue statement of a material fact to the Company’s knowledge there are no other studies or omit other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to SEC Documents; and the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written has not received any notices or correspondence from any Governmental Authority directives and with all formal written undertakings made requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or its Subsidiaries Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to any Governmental Authority including any review, from time to time, the progress and all directives results of the studies, tests and undertakings arising from preclinical and clinical trials and, based upon (i) the most recent examination information provided to the Company by the third parties conducting such Governmental Authoritystudies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and have satisfactorily addressed (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions in the SEC Document of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectrespects.

Regulatory Matters. Except for such failures (a) All of the following products of the Company and its Subsidiaries that are subject to the jurisdiction of the United States Food and Drug Administration (the “FDA”) or other similar Governmental Authorities (“Regulated Products”) in other jurisdictions are being, and since January 1, 2021 have been, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, detailed and distributed by or on behalf of the Company and its Subsidiaries in compliance with Laws and Judgments applicable to the Company and its Subsidiaries, except where the failure to be true as have not been and in such compliance would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to have a Material Adverse Effect. All such Regulated Products have been and are being marketed, commercialized, and labeled solely for research use only purposes, consistent with FDA’s guidance document, Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only (Nov. 25, 2013). None of the Regulated Products have been marketed, commercialized, or labeled for clinical investigative use, diagnostic use, or any other clinical use. (b) The Company and its Subsidiaries taken as have not been restrained by a wholeGovernmental Authority or other Person in their ability to conduct or have conducted the manufacturing, each operation, storage, distribution, marketing, pricing, sale, promotion, advertising, warehousing, packaging, labeling, handling, shipping, and/or nonclinical, clinical, or other testing of the Company and its Subsidiaries products. (c) As required under applicable Law or pursuant to an authorization, the Company has timely and accurately filed maintained, filed, or provided furnished to the FDA or other similar Governmental Authority all regulatory material filings, documents, claims, reports, schedules, forms, Permit applications or renewals, examination responses and submissionsnotices, and other similar documentssubmissions (collectively “Reports”), together with any amendments required to be made with respect theretomaintained, that the Company filed, or its Subsidiary was required furnished to file since January 1, 2017 to the date of this Agreement, with any such Governmental Authority on a timely basis, and, at the time of maintenance, filing, or furnishing all such Reports were complete and timely paid accurate in all fees and assessments due and payable in connection therewith. material respects, or were subsequently updated, changed, corrected, or modified. (d) Except for such failures of the following to be true as would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to have a Material Adverse Effect, since January 1, 2021, (i) neither the Company nor, with respect to the products and services of the Company, any Person providing services to the Company has received any written notice, including any warning letter, untitled letter, cyber letter, reprimand, regulatory letter, FDA Form-483, Establishment Inspection Report, adverse inspectional findings, notice of an integrity re-view, notice of an investigation, request for corrective or remedial action, notice of other ad-verse finding, or notice of deficiency or violation, or similar communication from the FDA or any other Governmental Authority alleging that the Company, its operations, or the Company products and its Subsidiaries taken as a whole, services are in violation of any applicable Law; and (ii) there is no unresolved violation Action pending or, to the Knowledge of the Company, threatened by the FDA or exception by any other similar Governmental Authority (including, without limitation, foreign regulators, notified bodies, and state regulators with authority over medical product manufacturing, marketing, distribution, sale, or dispensing), in each case relating to any products of the Company or any of its Subsidiaries with respect to or the facilities at which such products are designed, manufactured, packaged, stored, or initially distributed. (e) To the Knowledge of the Company, since January 1, 2021, no director, officer, employee or agent of the Company or any of its Subsidiaries has, in connection with the documents described in business of the first sentence Company or any of this Section 3.21its Subsidiaries, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain (i) made any untrue statement of a material fact or omit fraudulent statement to state the FDA or any other similar Governmental Authority or in any documents or records required to be maintained under any FDA or other similar Governmental Authority requirements or regulations; or (ii) failed to disclose a material fact required to be stated therein disclosed to the FDA or necessary any other similar Governmental Authority or in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures any documents or records required to be in compliance as would not reasonably be expected to be, individually maintained under any FDA or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written other similar Governmental Authority directives and with all formal written undertakings made by the Company requirements or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effectregulations.

Regulatory Matters. Except for such failures (a) Section 4.14(a) of the following Company Disclosure Letter sets forth a true and complete list, as of the Agreement Date, and the Company has made available to be Parent true and complete copies of, all Regulatory Authorizations from the FDA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company relating to the Company Products. Except as have not been and would not reasonably be reasonably expected to beto, individually or in the aggregate, material to result in a Company Material Adverse Effect, (x) the Company and its Subsidiaries taken as a wholehas filed, each of maintained or furnished with the Company and its Subsidiaries has timely and accurately filed or provided applicable Regulatory Authorities all regulatory reportsrequired filings, schedulesdeclarations, formslistings, Permit applications or renewalsregistrations, examination responses and submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other similar documentsinformation (collectively, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority “Health Care Submissions”) and timely paid (y) all fees such Health Care Submissions were complete and assessments due accurate and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied 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 that affect the business, Company Products, properties, assets and activities of the Company or its subsidiaries; (ii) 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 (iii) there are no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company or its subsidiaries with respect to the Company Products or alleging any violation by the Company, its subsidiaries or the Company Products of any such Health Law. (c) Since December 31, 2021, to the Company’s knowledge, 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, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, neither the Company nor its subsidiaries have outstanding written notifications or other written communications from any 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 termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any 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 clinical supplies used in any clinical trials, by or on behalf of the Company has been conducted in material compliance with the applicable specifications and requirements of applicable Health Laws. As of the Agreement Date, neither the Company nor, to the 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 to the Company or its business operations alleging or asserting noncompliance with any applicable Law and did not contain 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 (i) made an untrue statement of a material fact or omit fraudulent statement to state any Regulatory Authority or any other Governmental Entity, (ii) failed to disclose a material fact required to be stated therein disclosed to any Regulatory Authority or necessary in order any other Governmental Entity or (iii) committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the statements thereintime such disclosure was made or failure to disclose occurred, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to beprovide a basis for the FDA to invoke its policy respecting “Fraud, individually Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or in for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company communication or its Subsidiaries 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, report, studies or publications of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority including or any and all directives and undertakings arising from the most recent examination by such other Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if anyEntity. None of such directivesthe Company, undertakings and actionsits subsidiaries, individually or, to the knowledge of the Company, its officers, employees, or collectivelyany clinical investigator acting for the Company, is currently or has had been convicted of any crime that has resulted in, or would reasonably be expected to have result in, debarment pursuant to 21 U.S.C. Section 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 Company 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 pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, 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. (g) Neither the Company nor its subsidiaries are a Company Material Adverse Effectparty to any corporate integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any Regulatory Authority or any other Governmental Entity.

Regulatory Matters. (a) Except for such failures of the following to be true as have has not been had and would not reasonably be reasonably expected to behave, individually or in the aggregate, material to a Material Adverse Effect on the Company and its Subsidiaries taken as a wholeCompany, each of the Company and its Subsidiaries has timely and accurately filed or provided hold all regulatory reportsmaterial Permits required to own, scheduleslease, formsmaintain, Permit applications or renewals, examination responses and submissionsoperate, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or conduct its Subsidiary was required to file since business as currently conducted. Since January 1, 2017 to 2019, neither the date Company nor any of this Agreement, with its Subsidiaries has received any written notice from any Governmental Authority regarding (a) any actual or possible material violation of or material failure by the Company to comply with any term or requirement of any Permit or (b) any actual or possible revocation, withdrawal, suspension, cancellation, termination, or modification of any Permit. (b) Except as has not had and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not reasonably be reasonably expected to behave, individually or in the aggregate, material to a Material Adverse Effect on the Company, the Company or its applicable Subsidiary has filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority) all required filings, 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 compliance with Applicable Law when filed (or were corrected or supplemented by a subsequent submission) and since January 1, 2019, the Company has not received written notice of any deficiencies asserted by any applicable Governmental Authority with respect to any such filings, declarations, listing, registrations, reports or submissions. (c) 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’s and its Subsidiaries’ products and product candidates, including the Product, are being and since January 1, 2019, have been, researched, developed, tested, studied, manufactured, processed, packaged, stored, supplied, licensed, imported, exported, distributed, labeled, advertised, promoted, marketed, commercialized, sold or disposed, as applicable, by or on behalf of the Company or its Subsidiaries taken as a wholein compliance with the FDCA and other applicable Healthcare Laws. As of the date of this Agreement, there is no unresolved violation or exception by 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 made available to Parent prior to the date hereof complete and correct copies of each IND filed with respect to any product candidate of the documents described Company currently being developed by the Company, including any material supplements and amendments thereto, in the first sentence of this Section 3.21each case, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law the date hereof. (e) Except as has not had and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to behave, individually or in the aggregate, a Material Adverse Effect on the Company, none the Company or any of its Subsidiaries has (i) made an untrue statement of a material fact to the FDA or any Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) 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) at the time such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for the FDA to invoke its fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy or for any Governmental Authority to invoke any similar policy or law. As of the date of this Agreement, none of the Company and or any of its Subsidiaries taken is the subject of any pending or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy. None of the Company, any of its Subsidiaries, or any directors, officers, employees, or, to the knowledge of the Company, agents or clinical investigators of the Company or any of its Subsidiaries, has been excluded, 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 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 in the aggregate, a wholeMaterial Adverse Effect on the Company, the Company and its Subsidiaries are in compliance and, since January 1, 2019, have been in compliance with all Healthcare Laws applicable to the operation of their respective businesses as currently conducted, including (i) any and all applicable federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7(b)) 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 the knowledge of the Company, no such enforcement, regulatory or administrative action or proceeding has been threatened in writing, against the Company or 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 a party to or has any ongoing reporting obligations pursuant to, 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 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 knowledge of the Company, each Development Partner, hold all Governmental Authorizations from the FDA and all other Governmental Authorities that are required for the conduct of the Company’s and its Subsidiaries’ businesses as currently conducted, and all such Governmental Authorizations are (i) in full force and effect, (ii) validly registered and on file with applicable Governmental Authorities, if any, and (iii) in compliance with all formal written filing and maintenance 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 Authority directives and with all formal written undertakings made Authorization held by the Company or and its Subsidiaries. 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 including with respect to any and all directives and undertakings arising from the most recent examination by such Governmental AuthorityAuthorization. (h) Since January 1, 2019, there have been no 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 a safety concern or alleged lack of regulatory compliance of any product or product candidate, including the Product, of the Company or any of its Subsidiaries. (i) Except as has not had and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actionswould not reasonably be expected to have, individually or collectivelyin 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 or and would not reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse EffectEffect 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.

Regulatory Matters. Except (a) To the Company’s knowledge, the manufacturing, processing, distribution, labeling and storage of pre-clinical and clinical trial supplies performed by or on behalf of the Company are in compliance in all material respects with all laws, rules and regulations administered or issued by the FDA and any other Governmental Authority responsible for regulating the Product Candidate. (b) To the Company’s knowledge, all clinical investigations conducted or sponsored by the Company are being conducted in material compliance with all applicable experimental protocols, laws, rules and regulations, including the Good Clinical Practice requirements relating to informed consent and institutional review boards designed to ensure the protection of the rights and welfare of human subjects as set forth in 21 C.F.R. parts 50, 54, 56, 58 and 312, as well as federal and state laws, rules and regulations restricting the use and disclosure of individually identifiable health information. (c) The Company has made available to Parent all material information in its possession or control with respect to the safety or efficacy of the Product Candidate. The Company is not to its knowledge in possession of information that would reasonably be expected to lead to the denial by the FDA of an application for regulatory approval pursuant to the Company’s current development plans for the Product Candidate as provided to Parent. (d) The Company (i) has not received any FDA Form 483, notice of adverse finding, warning letters or other written correspondence or notice from FDA or any other Governmental Authority alleging or asserting noncompliance with any Applicable Laws; (ii) has no knowledge or reason to believe that the FDA or any other such Governmental Authority is considering such action described in subsection (i) above; (iii) has no knowledge of any actual or threatened prosecution, injunction, seizure, civil fine, suspension, recall or other enforcement action or proceeding by the FDA or other Governmental Authority alleging that the Company is not currently in compliance with applicable laws, regulations or orders; and (iv) has no knowledge that any such Governmental Authority is considering such action described in subsection (iii) above; in each of (i) through (iv) above, except for such failures of the following to be true actions as have not been and would not be reasonably expected to benot, individually or in the aggregate, material reasonably be expected to have a Material Adverse Effect. None of the Company and its Subsidiaries taken as a wholeCompany’s officers, each employees or Affiliates is or has been the subject of any of the foregoing pending or threatened actions or proceedings. (e) To the Company’s knowledge, no data generated by or on behalf of the Company is the subject of any regulatory action, either pending or threatened, by the FDA relating to the truthfulness of such data. (f) The Company is not the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue, Material Facts, Bribery and Illegal Gratuities Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (g) Neither the Company nor any of its Subsidiaries has timely and accurately filed officers, employees or provided all regulatory reportsagents knowingly committed any act, schedulesmade any statement or failed to make any statement that would reasonably be expected to provide the basis for the FDA to invoke its Fraud, formsUntrue, Permit applications or renewalsMaterial Facts, examination responses and submissionsBribery, and Illegal Gratuities Final Policy. (h) Neither the Company nor any of its officers, employees or agents has received any notice that the FDA or any other similar documentsGovernmental Authority has initiated, together or threatened in writing to initiate, suspend or terminate any Investigational New Drug Application sponsored by the Company, or to recall, suspend or otherwise restrict the manufacture of any pharmaceutical product of the Company. (i) To the Company’s knowledge, all animal studies and other preclinical tests performed in connection with or as the basis for any amendments regulatory approval required for the Product Candidate either (x) have been or are being conducted in accordance, in all material respects, with applicable Good Laboratory Practice requirements contained in 21 C.F.R. Part 58, (y) were or are pilot safety studies or (z) involved or involve experimental research techniques that are not generally performed by registered GLP testing laboratories and have employed or employ procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to be made those being developed by the Company. (j) There are no proceedings pending with respect thereto, that to a violation by the Company of the FDCA, FDA regulations adopted thereunder or its Subsidiary was required to file since January 1any other legislation or regulation promulgated by any other Governmental Authority, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except except for such failures of the following to be true proceedings as would not be reasonably expected to benot, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries with respect to any of the documents described in the first sentence of this Section 3.21, and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.

Regulatory Matters. Except for such failures (i) Since January 1, 2014, F&M and each of its Subsidiaries has duly filed with the following appropriate Governmental Authority in substantially correct form the monthly, quarterly and annual reports required to be true as have filed under applicable laws and regulations, and such reports were in all material respects complete and accurate and in compliance with the requirements of applicable laws and regulations. In connection with the most recent examination of F&M and each of its Subsidiaries by the appropriate regulatory authorities, neither F&M nor any of its Subsidiaries was required to correct or change any action, procedure or proceeding which F&M believes in good faith has not now been and would corrected or changed, other than corrections or changes which, if not be reasonably expected to bemade, either individually or in the aggregate, material would not have a Material Adverse Effect on F&M. To the Knowledge of F&M, since F&M Bank’s last regulatory examination of Community Reinvestment Act compliance, F&M Bank has not received any complaints as to Community Reinvestment Act compliance. (ii) Neither F&M nor any of its Subsidiaries nor any of any of their respective properties is a party to or is subject to any order, decree, directive, agreement, memorandum of understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor, excluding those applicable to the Company and its Subsidiaries taken as a wholebanking industry generally, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company F&M or any of its Subsidiaries adopted any policies, procedures or board resolutions at the request or suggestion of, any Governmental Authority. F&M and its Subsidiaries have paid all assessments made or imposed by any Governmental Authority. (iii) Neither F&M nor any its Subsidiaries has been advised by, and does not have any Knowledge of facts which would reasonably be expected to give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, decree, directive, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission or, excluding those applicable to the banking industry generally, any request for the adoption of any policy, procedure or board resolution. (iv) (A) No Governmental Authority has initiated since December 31, 2013 or has pending any proceeding, enforcement action or, to F&M’s Knowledge, investigation or inquiry into the business, operations, policies, practices or disclosures of F&M or any of its Subsidiaries (other than normal examinations conducted by a Governmental Authority in the ordinary course of the business of F&M or the applicable Subsidiary), or, to F&M’s Knowledge, threatened any of the foregoing, and (B) there is no unresolved violation, criticism, comment or exception by any Governmental Authority with respect to any report or statement relating to any examinations or inspections of the documents described F&M or its Subsidiaries, except in the first sentence of this Section 3.21each case in subparagraphs (A) and (B), and as of their respective dates, such documents complied in all material respects with all requirements of applicable Law and that did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. Except for such failures to be in compliance as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect. (v) F&M and F&M Bank are and will be at the Effective Time, after giving effect to the Merger and Transactions contemplated by the Agreement, “well-capitalized” (as that term is defined at 12 CFR §225.2(r) or the relevant regulation of its primary federal bank regulator) and the rating of F&M Bank under the CRA is no less than “satisfactory.” Neither F&M nor F&M Bank has received any notification from a Governmental Authority that their status as “well-capitalized” or “satisfactory” for CRA purposes will change within one year, nor does F&M have Knowledge of any conditions or circumstances that would result in a CRA rating of less than “satisfactory” or material criticism from regulators with respect to discriminatory lending practices.

Regulatory Matters. Except for such failures (a) With respect to the Product: (i) (A) the Vendor, its Affiliates and Subco have obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by the applicable Governmental Authorities, including, without limitation, the CE Mxxx, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the following to be true as have not been and would not be reasonably expected to be, individually or Product in the aggregate, material to the Company and its Subsidiaries taken as a whole, each of the Company and its Subsidiaries has timely and accurately filed or provided all regulatory reports, schedules, forms, Permit applications or renewals, examination responses and submissions, and other similar documents, together with any amendments required to be made with respect thereto, that the Company or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for jurisdictions where it currently conducts such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception by the Company or any of its Subsidiaries activities with respect to any of the documents described Product (collectively, the “Regulatory Approvals”), (B) the Vendor, its Affiliates and Subco are in the first sentence of this Section 3.21, and as of their respective dates, such documents complied compliance in all material respects with all terms and conditions of each Regulatory Approval, (C) the Vendor, its Affiliates and Subco are in compliance in all material respects with all applicable Laws regarding registration, license and certification for each jurisdiction at which the Product is labeled, sold, or distributed, and (D) to the extent that the Product has been exported, it has only been exported in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Vendor, its Affiliates and Subco have been and are being conducted in all material respects in compliance with applicable Laws relating to quality systems in each country where compliance is required; (iii) all non-clinical laboratory studies of the Product sponsored by the Vendor, its Affiliates and/or Subco used or intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance with the applicable Laws, including Health Care Laws; and (iv) the Vendor, its Affiliates and Subco are in compliance in all material respects with all applicable reporting requirements for all Regulatory Approvals or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in each country where compliance is required. (b) The Vendor, its Affiliates and Subco are in compliance in all material respects with all applicable Governmental Authority (in each country where compliance is required) and similar provincial, state and local Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Product. Section 3.29(b) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Product. Set forth on Section 3.29(b) of the Disclosure Schedule are complaint review and analysis reports of the Vendor, its Affiliates and Subco with respect to the Business through the date hereof, including information regarding complaints, categorized by root cause analysis of closed complaints, which reports are correct in all material respects. (c) Except as set forth in Section 3.29(c) of the Disclosure Schedule, none of the Vendor, its Affiliates or Subco have received any written notice or other written communication from any Governmental Authority: (i) contesting the approval of, the uses of or the labeling and promotion of the Product; or (ii) otherwise alleging any violation of any Laws by the Vendor, its Affiliates or Subco with respect to the use, sale or manufacture of the Product. (d) Except as disclosed in Section 3.29(d) of the Disclosure Schedule, there have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or, to the Knowledge of the Vendor, threatened) by any Governmental Authority with respect to the Product, including any facilities where the Product is produced, processed, packaged or stored and none of the Vendor, its Affiliates or Subco have within the last three (3) years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of the Product. (e) All filings with and submissions to any Governmental Authority made by the Vendor, its Affiliates and/or Subco with regard to the Product, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update, and such filings, submissions and updates comply with all regulations of such Governmental Authorities in all material respects. (f) None of the Vendor, its Affiliates nor Subco is the subject, officially or otherwise, of any pending or, to the Knowledge of the Vendor, threatened investigation by any Governmental Authority pursuant to any anti-bribery Law and did not contain related to the Business, the Purchased Assets, or the Product. None of the Vendor, its Affiliates nor, to the Knowledge of the Vendor, any officer, employee or agent of the Vendor or its Affilites, has (A) made an untrue statement of a material fact or omit fraudulent statement to state any Governmental Authority, (B) failed to disclose a material fact required to be stated therein disclosed to any Governmental Authority, or necessary in order (C) committed an act, made a statement, or failed to make a statement that, at the statements therein, in light of the circumstances under which they were time such disclosure was made, not misleading. Except for such failures to be in compliance as that would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as provide a whole, the Company and its Subsidiaries are in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to basis for any Governmental Authority including to invoke its policy related to such Laws, in each case, related to the Business, the Purchased Assets, or the Product. (g) None of the Vendor, its Affiliates or Subco, or, to the Knowledge of the Vendor, any and all directives and undertakings arising from officer, employee or agent of the most recent examination Vendor, its Affiliates or Subco, has been convicted of any crime or engaged in any conduct for which debarment is mandated by such Governmental Authority, and have satisfactorily addressed in all material respects all matters requiring attention, if anyapplicable Law or authorized by applicable Law with respect to the Business. None of such directivesthe Vendor, undertakings and actionsits Affiliates or Subco, individually or, to the Knowledge of the Vendor, any officer, employee or collectivelyagent of the Vendor, its Affiliates or Subco, has had been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in any aspect of the Business under applicable Law. (h) None of the Vendor, its Affiliates or Subco has received any written notice that any Governmental Authority has (a) commenced, or threatened to initiate, any action to withdraw its approval or request the recall of the Product, or (b) commenced, or threatened to initiate, any action to enjoin production of the Product. (i) The Vendor and its Affiliates with respect to the Business are and at all times have been in material compliance with: (i) the provisions of applicable Laws relating to investigational use, premarket clearance or marketing approval (or exemptions thereto) to market a product, good manufacturing practices, labeling, advertising, record keeping, filing of reports and security; (ii) the applicable provisions relating to the privacy and security of individually identifiable health information, and all regulations thereunder; (iii) any applicable antikickback Laws; and (iv) health care fraud Laws. Since January 1, 2011, none of the Vendor or its Affiliates has received any written notice or other communication from any Governmental Authority regarding any actual or possible violation of, or failure to comply with, any legal requirement set forth in this Section 3.29(i) with respect to the Business. (j) No Employee has been excluded from participation in any health care program or, to the Knowledge of the Vendor, committed any offense that would reasonably expected to have be the basis for such exclusion in a Company Material Adverse Effecthealth care program.

Regulatory Matters. Except for such failures of the following to be true as have not been The studies, tests and would not be reasonably expected to be, individually preclinical or in the aggregate, material to the Company and its Subsidiaries taken as a whole, each clinical trials conducted by or on behalf of the Company or any of its Subsidiaries, or to the Company’s Knowledge by third parties, to support approval for commercialization of the Company’s product candidates or that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional medical and scientific standards, and all applicable federal, state or foreign laws, rules, orders and regulations and all rules and regulations of the FDA or any foreign, state or local governmental body exercising comparable authority, including current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement and the Prospectus; and neither the Company nor any of its Subsidiaries has timely received any notices or correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and accurately filed Trials that termination, suspension or provided all regulatory reportsmaterial modification would reasonably be expected to have a Material Adverse Effect and, schedulesto the Company’s Knowledge, formsthere are no reasonable grounds for the same. The Company and each of its Subsidiaries, Permit applications if any, has obtained (or renewals, examination responses and submissions, and other similar documents, together with any amendments required caused to be made with respect thereto, that obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or its Subsidiary was required to file since January 1, 2017 to the date of this Agreement, with any Governmental Authority and timely paid all fees and assessments due and payable in connection therewith. Except for such failures of the following to be true as would not be reasonably expected to be, individually or in the aggregate, material to the Company and its Subsidiaries taken as a whole, there is no unresolved violation or exception disclosing patient information received by the Company or any of its Subsidiaries in connection with respect to any the Company Studies and Trials, the Company and each of the documents described in the first sentence of this Section 3.21its Subsidiaries, and as of their respective datesif any, such documents have complied in all material respects with all requirements applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of applicable Law 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make Clinical Health Act (the statements therein“HITECH Act”) (42 U.S.C. Section 17921 et seq.), in light of and the circumstances under which they were maderules and regulations thereunder, not misleading. Except for such failures to be in compliance as except where noncompliance would not reasonably be expected to benot, individually singularly or in the aggregate, material have a Material Adverse Effect. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA, or any foreign, state or local governmental body exercising comparable authority, to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of the Company and its Subsidiaries taken as a wholeSubsidiaries’ suppliers are operated in compliance in all respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company and its Subsidiaries are is subject, except where noncompliance would not, singularly or in compliance with all formal written Governmental Authority directives and with all formal written undertakings made by the Company or its Subsidiaries to any Governmental Authority including any and all directives and undertakings arising from the most recent examination by such Governmental Authorityaggregate, and have satisfactorily addressed in all material respects all matters requiring attention, if any. None of such directives, undertakings and actions, individually or collectively, has had or would reasonably expected to have a Company Material Adverse Effect.