Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a Material Adverse Effect, none whole): (A) the Company and its Subsidiaries hold all Licenses under the Healthcare Laws (as defined below) that are necessary for the lawful operation of the Borrowers business of the Company and its Subsidiaries in each jurisdiction in which the Company or any Subsidiary thereof of its Subsidiaries operates, including the FDCA (including Section 510(k) thereof), and all Licenses of any applicable Governmental Entity that has regulatory authority over the testing, development, design, quality, identity, safety, efficacy, manufacturing, labeling, marketing, distribution, commercialization, sale, pricing, import or export of the products sold by the Company (“Company Products” and any such Governmental Entity, a “Regulatory Agency”), necessary for the lawful operation of the business of the Company or its Subsidiaries in each jurisdiction in which the Company or any of its Subsidiaries operates (the “Regulatory Permits”); (B) all such Regulatory Permits are valid and in full force and effect; and (C) the Company and its Subsidiaries are in compliance with the terms of all Regulatory Permits. There is no Proceeding to which the Company is subject pending or, to the Knowledge of the Company, threatened in writing that would result in the termination, revocation, suspension or the imposition of a restriction on any such Regulatory Permit or the imposition of any fine, penalty or other sanction for violation of any applicable Healthcare Lawsuch Regulatory Permit, in each case, except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole). (cii) No Borrower Except 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 business of the Company and its Subsidiaries is being conducted in compliance with: (A) the FDCA (including all applicable registration and listing requirements set forth in Section 510 of the FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (B) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010; (C) federal Medicare and Medicaid statutes and related state or local statutes; (D) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), ▇▇▇▇▇ Law (42 U.S.C. § 1395nn), the federal False Claims Act (31 U.S.C. § 3729 et seq.), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state or local Laws; (E) state testing, manufacturing, distribution, commercialization, marketing, licensing, disclosure, gift ban, code of conduct and reporting requirements, including the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and equivalent or related state reporting requirements; (F) applicable requirements under Data Protection Laws with respect to the protection of Personal Information collected or maintained by or on behalf of the Company; (G) the Federal Trade Commission Act; (H) the rules and regulations promulgated pursuant to all such applicable Laws with respect to any of the foregoing, each as amended from time to time; (I) any comparable foreign Laws for any of the foregoing; and (J) any other Law that governs the healthcare industry, medical device industry or relationships among healthcare and/or medical device providers, suppliers, distributors, manufacturers and patients, as applicable (collectively, “Healthcare Laws”). Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), there are no Proceedings or subpoenas against the Company or any Subsidiary thereof receives of its Subsidiaries or any payments directly (including through director, officer or current employee of the foregoing pending by or before any third party payment processor) from MedicareGovernmental Entity or, Medicaidto the Knowledge of the Company, threatened in writing against the Company or TRICAREany of its Subsidiaries or any director, officer or current employee of the foregoing by any Governmental Entity, in each case with respect to Healthcare Laws. (diii) To Borrower’s knowledge, none As of the Borrower’s date of this Agreement, neither the Company nor any of its Subsidiaries (A) is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, certificate of compliance, consent decrees, settlement orders or similar material agreements with or imposed by any Governmental Entity, and, to the Knowledge of the Company, no such action is currently proposed to the Company and its Subsidiaries or pending with the Company and its Subsidiaries’ officers, directors (B) has any continuing material reporting obligations pursuant to any agreement contemplated by the foregoing clause (A) of this Section 5.5(e)(iii), (C) is or employees has been a defendant in any litigation arising out of or relating to the federal False Claims Act (31 U.S.C. § 3729 et seq.) or (D) has been served with or received a search warrant, subpoena or civil investigative demand from any Governmental Entity. (iv) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), (A) since the Applicable Date, all reports, claims, permits, adverse event reports, documents, notices, registrations, applications, responses, submissions, modifications, supplements and amendments required to be filed, maintained or furnished to the FDA or any other Regulatory Agency by the Company or any of its Subsidiaries have been so timely filed, maintained or furnished under such applicable legal requirements (“Healthcare Submissions”) and (B) all such Healthcare Submissions were compliant in all respects with applicable legal requirements at the time of filing (or were corrected in or supplemented by a subsequent filing). (v) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), from the Applicable Date to the date of this Agreement, to the Knowledge of the Company, neither the Company nor any of its Subsidiaries nor any officer or employee of the Company or any of its Subsidiaries, has made an untrue statement of material fact or a fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, or committed an act, made a statement, statement or failed to make a statement that could statement, in each case, related to the business and which, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting the “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” policy of the FDA set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). From the Applicable Date to the date of this Agreement, neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any officer or employee of the Company or any of its Subsidiaries, has been debarred or convicted of any crime. From the Applicable Date to the date of this Agreement, to the Knowledge of the Company, neither the Company nor any of its Subsidiaries nor any director, officer or employee of the Company or any of its Subsidiaries, has been excluded from participating in any federal health care program or convicted of any crime except, in each case, as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole). (evi) No BorrowerAll pre-clinical and clinical studies, tests or investigations conducted or sponsored by or on behalf of the Company or any of its Subsidiaries have been or are being conducted in compliance in all material respects with all applicable Healthcare Laws and other requirements under the Healthcare Laws issued by the applicable Regulatory Agencies, including Good Laboratory Practices, Good Clinical Practices, FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and the protection of human subjects, including Title 21 parts 11, 50, 54, 56 and 812 of the Code of Federal Regulations and any comparable state and local legal requirements regulating the conduct of pre-clinical and clinical investigations and the protection of human subjects, except, in each case, as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole). (vii) Except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any Subsidiary thereofof its Subsidiaries has received, is subject since the Applicable Date, any FDA Form 483 observations, notice of adverse finding, warning letters, notice of violation, inspection or audit reports from any Regulatory Agency identifying any non-compliances, subpoenas, investigations, actions, demands or notices relating to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authorityalleged non-compliance, which would reasonably be expected to result be, individually or in the revocationaggregate, transfer, surrendermaterial to the Company and its Subsidiaries (taken as a whole) or to lead to the denial, suspension or revocation of any material Permits License or grant for marketing approval with respect to any Company Product currently pending before or previously approved or cleared by the FDA or such other Regulatory Agency. (viii) Since the Applicable Date, except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any Subsidiary has voluntarily or involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued, any recall, field corrective action, market withdrawal, seizure, suspension, replacement, safety alert, written warning, “dear doctor” letter, investigator notice to healthcare wholesalers, healthcare distributors, healthcare retailers, healthcare professionals or patients (including any action required to be reported or for which records must be maintained under 21 C.F.R. Part 806) relating to any Company Product (collectively, a “Recall”) or, as of Borrower the date hereof, currently intends to initiate, conduct or issue any Subsidiary, in each case, that Recall of any Company Product. Except as would not reasonably be expected to result be material to the Company and its Subsidiaries (taken as a whole), neither the Company nor any of its Subsidiaries has received any written notice from the FDA or any other Regulatory Agency regarding (x) any Recall of any Company Product or (y) a change in the marketing status or classification, or a Material Adverse Effectmaterial change in the labeling, of any such Company Product or (z) a negative change in the reimbursement status of a Company Product. (fix) As The Company and its Subsidiaries have instituted and maintain policies and procedures reasonably designed to ensure 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 the Closing Date, there have been no Regulatory Reporting EventsCompany Products.

Regulatory Matters. (a) With The Acquired Companies hold all material, and are operating in material compliance with, all Governmental Authorizations required for the conduct of its business as currently conducted, and all such Governmental Authorizations are in full force and effect. The Acquired Companies have fulfilled and performed all of their material obligations with respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required PermitsGovernmental Authorizations. (b) Except as would not reasonably be expected expected, individually or in the aggregate, to have a Material Adverse Effect, none each Acquired Company has filed with the applicable regulatory authorities (including the FDA, DEA or any other Governmental Body performing functions similar to those performed by the FDA or DEA) all required filings, declarations, listings, registrations, reports or submissions necessary for the operations of the Borrowers business of the Acquired Companies as presently conducted. Except as would not reasonably be expected, individually or any Subsidiary thereof are in violation of the aggregate, to have a Material Adverse Effect, all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Laws when filed (or were corrected or supplemented by a subsequent submission), and no material deficiencies have been asserted by any applicable Healthcare LawGovernmental Body with respect to any such filings, declarations, listing, registrations, reports or submissions. (c) No Borrower To the Knowledge of the Company, no Acquired Company or any Subsidiary thereof receives any payments directly Person acting on an Acquired Company’s behalf has (including through any third party payment processori) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of a material fact or fraudulent statement to the FDA FDA, DEA, or any Governmental Body or (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or DEA or (iii) committed an act, made a statement, or failed to make a statement that could statement, including with respect to any scientific data or information, that, 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 policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borrower, nor and any Subsidiary thereof, is subject amendments thereto or for any other Governmental Body performing functions similar to those performed by the FDA or DEA to invoke any similar policy or any other statute or regulation regarding the communication or submission of false information to any proceeding, suit orsuch applicable Governmental Body. Neither any of the Acquired Companies nor, to the Knowledge of the Company, any Borrower’s knowledgeofficers, investigation by any Governmental Authorityemployees, which would reasonably be expected to result in the revocation, transfer, surrender, suspension agents or clinical investigators of any material Permits of Borrower the Acquired Companies have been suspended or debarred or convicted of any Subsidiary, crime or engaged in each case, any conduct that would reasonably be expected to result in debarment under 21 U.S.C. § 335a or any similar Law, debarment, or exclusion from participation in any federal health care program as that term is defined by 42 U.S.C. § 1320a-7b(f) or excluded or suspended from any other health care program administered by a Governmental Body, or exclusion from federal procurement programs and non-procurement programs, or is, or has been, debarred, excluded, or suspended per the foregoing. (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, 2021, have been in compliance with all healthcare Laws applicable to the operation of its business as currently conducted, including (i) any and all applicable federal, state and local fraud and abuse Laws, 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.) and the regulations promulgated pursuant to such statutes; (ii) 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; (iii) the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); (iv) Laws that are cause for exclusion from any federal health care program; (v) Laws relating to the billing or submission of claims for health care products or services; (vi) Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and the regulations promulgated pursuant thereto; and (vii) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated pursuant thereto. (e) As of the Agreement Date, no enforcement, regulatory or administrative proceeding is pending, and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened in writing, against the Company under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Controlled Substances Act (21 U.S.C. §§ 801 et seq.), 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. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect All Products being manufactured or developed by the Company as of the date hereof (“Company Products”) that are subject to each Product the jurisdiction of the FDA are being developed, manufactured, used, processed, labeled, stored, tested and except as would notimported or exported in compliance in all material respects with all applicable Laws, individually including all applicable requirements under the federal Food and Drug and Cosmetic Act (“FDCA”), the Public Health Service Act and their applicable implementing regulations. All Company Products that are subject to the jurisdiction of any other Governmental Entity are being developed, manufactured, used, processed, labeled, stored, tested, imported and exported in compliance in all material respects with all comparable applicable Laws of such Governmental Entity. (b) Neither the Company nor any representative of the Company nor, to the knowledge of the Company, any of its licensees or in assignees of any Owned Intellectual Property or, to the aggregateknowledge of the Company, reasonably be expected any Licensed Intellectual Property has received any written notice that the FDA or any other Governmental Entity has initiated, or threatened to have a Material Adverse Effectinitiate, any action to (i) Borrower and its Subsidiaries have receivedsuspend any clinical trial, and such Product is the subject (ii) withdraw approval of, all Regulatory Required Permits needed or suspend or terminate, any Investigational New Drug Application or any comparable foreign regulatory application, in connection each case sponsored by the Company with respect to any Company Product, or otherwise prevent or prohibit the testing, manufacture, marketing preclinical research on or sale clinical study of such Product as currently being conducted any Company Products by or on behalf of Borrowerthe Company, and or (iiiii) such Product has been and is being testedrecall, manufacturedor suspend the manufacture of, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required PermitsCompany Product. (bc) Except as would not reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse Effect, none neither the Company nor, to the knowledge of the Borrowers or Company, any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicareits officers, MedicaidEmployees, or TRICARE. (d) To Borrower’s knowledgeagents or clinical investigators acting for the Company, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an any act, made a statement, any statement or failed to make a any statement that could would reasonably be expected to provide a basis for the FDA to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borrowerand any amendments thereto. Additionally, nor any Subsidiary thereof, is subject to any proceeding, suit orneither the Company nor, to the knowledge of the Company, any Borrower’s knowledgeofficer, investigation by any Governmental Authority, which would reasonably be expected to result in Employee or agent of the revocation, transfer, surrender, suspension Company has been convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in a Material Adverse Effect(i) debarment under 21 U.S.C. Section 335a or any similar applicable state or foreign Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar applicable state or foreign Law. (d) Except as is not material to the Company in any case or in the aggregate, all animal studies or other preclinical tests performed by the Company or by third-party vendors on the Company’s behalf, performed in connection with or as the basis for any regulatory approval required for the Company Products either have been conducted in accordance, in all material respects, with applicable Law, including applicable Good Laboratory Practice regulations as described in 21 CFR Part 58 or comparable applicable foreign Laws. (e) The Company has delivered to Parent copies of any and all written notices of inspectional observations, establishment inspection reports and any other documents received by the Company from any Governmental Entity, including the FDA or any comparable foreign Governmental Entities that identify lack of compliance by the Company with applicable Laws, including Laws of the FDA or comparable foreign Governmental Entities. (f) As Except as is not material to the Company in any case or in the aggregate, there is no Action pending or, to the knowledge of the Closing DateCompany, there threatened, with respect to a violation by the Company of any applicable Law, including the FDCA, FDA regulations adopted thereunder, or the Controlled Substance Act. (g) The Company has not received from any Governmental Entity any (i) inspection reports, (ii) notices of adverse findings, warning or untitled letters, minutes of meetings or (iii) other correspondence concerning the Company Products, in each case in which any Governmental Entity asserted in writing that the operations of the Company may not be in compliance with applicable Laws. (h) To the Company’s knowledge, the Company has not received written notice from any of its suppliers of any material interruption of supply or manufacturing capacity, shortage of raw materials, components or other manufacturing problems that would have a material adverse effect on the subsequent development (as such development is contemplated as of the date of this Agreement) of the Company Products, nor to the knowledge of the Company do any conditions exist that reasonably could be expected to lead to such manufacturing problems. (i) All applications, notifications, submissions, information, claims, reports and statistics and other data that have been no utilized by the Company, or prepared with the intention to be utilized by the Company, as the basis for or submitted in connection with any regulatory notifications, submissions, applications, filings, or Permits to the FDA or any other Regulatory Reporting EventsAuthority relating to the Company Products were true, complete and correct in all material respects as of the date of preparation and submission, as applicable, and/or any necessary or required updates, changes, corrections or modification to such applications, notifications, submissions, information and data have been submitted to the FDA or other Regulatory Authority. (j) Neither the Company nor, to the knowledge of the Company, any agent, Employee or other Person acting on behalf of the Company has, directly or indirectly: (i) made any unlawful contributions, gifts, entertainment or other unlawful payment relating to political activity and related in any way to the Company’s business; or (ii) made any unlawful payment to any foreign or domestic government official or employee, foreign or domestic political parties or campaigns, official of any public international organization, or official of any state-owned enterprise.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to, individually or in the aggregate, be material to the Company and the Company Subsidiaries, taken as a whole, (i) since January 1, 2023, the Company and the Company Subsidiaries have filed, maintained or furnished with the applicable Governmental Entity or regulatory authorities all required filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, notices and other documents (collectively, “Health Care Submissions”) and (ii) all such Health Care Submissions were in compliance with applicable Laws, including applicable Drug Laws, when filed (or were corrected or completed by a Material Adverse Effectsubsequent filing), none and to the Company’s knowledge, no material deficiencies have been asserted by any Governmental Entity with respect to such Health Care Submissions. Each (i) copy of portions of each Investigational New Drug application (including the equivalent regulatory submission outside of the Borrowers United States, an “IND”) with respect to each Company Product or product candidate, including all supplements and amendments thereto, (ii) copy of all clinical study reports under such INDs, and (iii) copy of material correspondence to or from the Company and each Company Subsidiary and FDA or any other Governmental Entity with respect to such INDs, that have been requested by Parent have been materially true and accurate when provided. (b) Since January 1, 2023, neither the Company nor any Company Subsidiary thereof are in violation has received written notice of any pending or, to the knowledge of the Company, threatened, and there are no, Proceedings, hearings, audits, inspections, investigations, arbitrations or other actions by the FDA or any comparable Governmental Entity against the Company or any Company Subsidiary, alleging material non-compliance with applicable Healthcare LawDrug Laws, and, to the knowledge of the Company, neither the FDA nor any comparable Governmental Entity is considering such action. (c) No Borrower Except as would not reasonably be expected to, individually or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarein the aggregate, Medicaidbe material to the Company and the Company Subsidiaries, or TRICARE. (d) To Borrower’s knowledgetaken as a whole, since January 1, 2023, none of the BorrowerCompany, any Company Subsidiary or, to the Company’s knowledge any of their respective employees is or its has been debarred from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b) or any similar Law, has been excluded under 42 U.S.C. Section 1320a-7 or any similar Law, or otherwise excluded, debarred or suspended from participation in any federal health care program as defined in 42 U.S.C. §1320a-b(f) and including the Medicare, Medicaid and TRICARE programs, or has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in such debarment, suspension or exclusion. Except as would not reasonably be expected to, individually or in the aggregate, be material to the Company and the Company Subsidiaries’ officers, directors taken as a whole, since January 1, 2023, to the Company’s knowledge, the Company and the Company Subsidiaries have not, and none of their employees, agents or employees has clinical investigators have, made an any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to the FDAFDA or any other Governmental Entity, or committed an act, made a statement, or failed to make a statement that could that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991)) or any similar policy. (d) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries, taken as a whole, since January 1, 2023, (i) all clinical trials, preclinical trials and other studies and tests conducted by or on behalf of the Company or any Company Subsidiary have been conducted in compliance with applicable protocols, procedures and applicable Drug Laws, including the applicable Good Laboratory Practice Requirements and Good Clinical Practice Requirements, (ii) to the Company’s knowledge, no Governmental Entity has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any Company Subsidiary and (iii) neither the Company nor any Company Subsidiary has received any written notice or communication alleging that the Company has violated or failed to comply with any applicable Drug Laws with respect to such clinical trials or requiring the termination, suspension or modification of any ongoing clinical studies conducted by or on behalf of the Company or any Company Subsidiary. (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which Except as would not reasonably be expected to result be, individually or in the revocationaggregate, transfermaterial to the Company and the Company Subsidiaries, surrendertaken as a whole, suspension since January 1, 2023, the development, testing, manufacture, processing, packaging, labeling, import, export, release, distribution and storage, as applicable, of the Company Products and product candidates of the Company or Company Subsidiaries have been and are being conducted in compliance with all applicable Drug Laws, including the applicable Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements and Good Clinical Practice Requirements. Since January 1, 2023, the Company and the Company Subsidiaries have not been notified in writing by any Governmental Entity of any material Permits of Borrower failure (or any Subsidiaryinvestigation with respect thereto) by them or any licensor, licensee or partner (acting on behalf of the Company) to comply with, or maintain systems and programs to ensure compliance with, any applicable Drug Law, Company Authorizations or requirements pertaining to programs or systems regarding product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment, registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements, in each casecase with respect to any Company Products or product candidates of the Company or any Company Subsidiary, that except for such failures or investigations which would not reasonably be expected to, individually or in the aggregate, be material to result in the Company and the Company Subsidiaries, taken as a Material Adverse Effectwhole. (fi) As of No Company product or product candidate manufactured, tested, distributed, held, marketed or submitted for reimbursement by the Closing DateCompany or any Company Subsidiary has been recalled, withdrawn or suspended since January 1, 2023, (ii) since January 1, 2023, there have been no Regulatory Reporting Eventsfield notifications or corrective actions, investigator notices, safety alerts, IND safety reports, serious adverse event reports or other notices of action relating to a safety concern or alleged lack of safety, efficacy or regulatory compliance (including compliance with Good Manufacturing Practices) of any Company Product or product candidates of the Company or any Company Subsidiary and (iii) no Proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such Company Product or product candidate or pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, threatened against the Company or any Company Subsidiary. (g) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries, taken as a whole, neither the Company nor any Company Subsidiary is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by the FDA or any comparable Governmental Entity with respect to noncompliance with applicable Drug Laws. (h) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries, taken as a whole, neither the Company nor any Company Subsidiary has engaged in an unlawful or unauthorized practice of medicine or other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by the Company or any Company Subsidiary. (i) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries, taken as a whole, the Company has implemented a commercially reasonable compliance program designed to ensure compliance with applicable Drug Laws and industry codes and standards. (j) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries, taken as a whole, no Person has filed against the Company an action relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).

Regulatory Matters. (a) With The Company and its Subsidiaries manufacture, market, test and distribute and, since June 3, 2004, have manufactured, marketed, tested and distributed their own products in compliance with the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and all applicable rules and regulations of the FDA or similar applicable Laws in any state or foreign jurisdiction, including, but not limited to, current “Good Manufacturing Practices,” “Quality System Regulation,” “Adverse Event Reporting,” “Medical Device Reporting” and those Laws related to investigational use of drugs and medical devices, marketing medical devices and drugs, and marketing unapproved “grandfathered drugs,” regulations regarding labeling, advertising and record-keeping, in compliance with the Company’s and its Subsidiaries’ quality control procedures in effect at the time of manufacture, where the failure to be in such compliance has, individually, or in the aggregate, had or would reasonably be expected to have a Company Material Adverse Effect. All of the products currently sold by the Company and its Subsidiaries have been approved or cleared for marketing by the FDA, unless approval or clearance is not required, as the case may be, and all other applicable Governmental Entities performing functions similar to those performed by the FDA. Neither the Company nor any of its Subsidiaries promotes or, to the Knowledge of the Company, has promoted any “off-label” use for such products in violation of existing Law or current regulatory interpretations, or received any notice in writing from the FDA or any Governmental Entity performing functions similar to those performed by the FDA alleging such illegal promotion. Neither the Company nor any Subsidiary has received any written notice or other communication from the FDA, or any other Governmental Entity, that has not been fully and satisfactorily responded to and resolved, questioning its manufacturing, distribution or reporting practices or threatening to revoke or curtail any product clearance or approval or otherwise alleging any violation of the FDCA, its regulations or Law applicable to any products of the Company or its Subsidiaries. Except as set forth in Section 3.16(a) of the Company Disclosure Schedule, none of the products of the Company or its Subsidiaries has been recalled, withdrawn, suspended or discontinued by the Company or its Subsidiaries in the United States or outside the United States, whether voluntary or involuntary. As of the date hereof, to the Knowledge of the Company, there exists no basis for any action by it, the FDA or any other applicable Governmental Entity performing functions similar to those performed by the FDA to revoke, recall, suspend, cancel or withdraw any product, or product approval, clearance, registration, license or other authorization or permit with respect to each Product any product of the Company or its Subsidiaries. All United States and international regulatory approvals or pre-market notifications therefor are owned either by and registered in the name of the Company or one of its Subsidiaries, or in the name of a licensed distributor, and are in full force and effect. (b) Neither the Company nor any of its Subsidiaries has failed to file with the FDA or any applicable Governmental Entity performing functions similar to those performed by the FDA any material required filing, declaration, listing, registration, report or submission; all such filings, declarations, listings, registrations, reports or submissions were to the Knowledge of the Company in compliance with applicable Laws when filed, and no unresolved deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listing, registrations, reports or submissions which, individually or in the aggregate, have had or could be reasonably expected to have a Company Material Adverse Effect. (c) Any clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries were and, if still pending, are to the Knowledge of the Company being conducted in accordance in all material respects with “Good Clinical Practices” and all United States and foreign Laws, as applicable, including the Laws of those States that address clinical trials. As of the date hereof, the Company has no Knowledge of other studies or tests the results of which contain any significant or material inconsistencies with the Company’s or its Subsidiaries’ studies or tests or otherwise call into question the safety or efficacy of the Company’s or its Subsidiaries’ products. Neither the Company nor any of its Subsidiaries has received any written notices or other correspondence from an institutional review board or study site, the FDA or any other applicable Governmental Entity performing functions similar to those performed by the FDA with respect to any of these ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. (d) To the Knowledge of the Company, neither the Company, nor any of its Subsidiaries, nor any employee of the Company, nor any of its Subsidiaries or any Person retained by the Company or any of its Subsidiaries, has made on behalf of the Company or any of its Subsidiaries any false statement or material omissions in any application or other submission relating to products governed by the Department of Health and Human Services or other Governmental Entity. (e) To the Knowledge of the Company, all of the manufacturing facilities and operations of the Company and its Subsidiaries of finished products sold in the United States are in material compliance with applicable FDA regulations, including current Good Manufacturing Practices, when applicable, and meet quality standards set by the FDCA, except as would where the failure to be in such compliance or to meet such standards has not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower had and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Company Material Adverse Effect. (f) The products sold by the Company and its Subsidiaries in the United States are generally classified either as over-the-counter drugs under 21 U.S.C. § 353(b)(i), none “grandfathered drugs” under 21 U.S.C. § 321(p)(1), or as Class I and Class II Medical Devices (as defined in 21 U.S.C. § 360c(a)(1)(A) and (B) and the applicable rules thereunder). The Company and its Subsidiaries, and the products sold by the Company and its Subsidiaries, are in compliance in all material respects with all current and otherwise applicable Laws administered or issued by the FDA and any other applicable Governmental Entity performing functions similar to those performed by the FDA, except where the failure to be in such compliance has not, individually or in the aggregate, had and would not reasonably be expected to have a Company Material Adverse Effect. (g) The Company has made available to Parent all material complaints maintained by the Company and its Subsidiaries (as required by 21 C.F.R. Parts 211 and 820) and all Product Adverse Event Reports or Medical Device Reports received or compiled by the Company and its Subsidiaries since June 3, 2004. To the Knowledge of the Borrowers Company, all such complaints that it was required to report to the FDA or any Subsidiary thereof are in violation of any applicable Healthcare comparable Governmental Entity it reported as required by Law. (ch) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from MedicareExcept as noted in Schedule 3.16(h), Medicaid, or TRICARE. (d) To Borrower’s knowledge, none to the Knowledge of the Borrower’s or Company neither the Company nor any of its Subsidiaries’ officers, directors or employees Subsidiaries has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an any act, made a statement, any statement or failed to make a any statement that could reasonably be expected would violate the FDA’s policy with respect 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. Regulation Reg. 46191 (September 10, 1991). (e) No Borroweror any similar laws, rules or regulations, whether under the jurisdiction of the FDA or any Governmental Entity, and any amendments thereto. Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any Subsidiary thereofofficer, is subject to any proceedingemployee, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension or third party vendors of any material Permits of Borrower the Company or its Subsidiaries, has been convicted of any Subsidiary, crime or engaged in each case, any conduct that would reasonably be expected to result in a Material Adverse Effect(i) debarment under 21 U.S.C. § 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. § 1320a-7 or any similar state or foreign law or regulation. (fi) As To the Knowledge of the Closing DateCompany, there have neither the Company nor any of its Subsidiaries is being investigated by the Office of Inspector General of the Department of Health and Human Services with respect to any matter arising under titles XI, XVIII, or XIX of the Social Security Act, or the implementing regulations. Neither the Company nor any of its Subsidiaries (i) has been no Regulatory Reporting Eventsexcluded from participating in any federal health care program, (ii) has paid a civil money penalty under Title XI of the Social Security Act, or (iii) employs any individual who has been excluded from participating in any federal health care program.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have receivedEach Acquired Company is, and such Product is since the subject ofLookback Date has been, in compliance in all Regulatory Required Permits needed in connection material respects with all applicable Health Care Laws and the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of BorrowerAcquired Companies’ compliance programs, and (ii) each Acquired Company holds all Health Care Permits necessary for the lawful conduct of its businesses as they are currently being conducted and all such Product has been Health Care Permits are valid and is being testedin full force and effect, manufacturedexcept, marketedin each case under this clause (ii), promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as where the case may be, by Borrowers (failure to have or to Borrower’s actual knowledgebe valid or in full force or effect, by or suspension or cancellation of, any applicable third parties) in such Health Care Permit would not be material to the Acquired Companies, taken as a whole. Without limiting the generality of the foregoing, there is no claim pending or threatened, alleging material noncompliance with any Health Care Law or Health Care Permit against any of the Acquired Companies. No Acquired Company is subject to any material order, writ, injunction or judgment with respect to its compliance with all applicable Healthcare Health Care Laws and Regulatory Required or any of the Acquired Company’s Health Care Permits. (b) Except as would not reasonably be expected Since the Lookback Date, no Acquired Company has received any notice from any Governmental Body or Private Program that any of its properties, facilities, equipment, operations, business procedures, or practices fails to have a Material Adverse Effect, none of the Borrowers comply in any material respect with any applicable Health Care Laws or Health Care Permits. No Acquired Company has received any Subsidiary thereof are in violation notice of any claim by any Governmental Body having jurisdiction over the Health Care Permits to revoke, withdraw, suspend or materially restrict any such Health Care Permit. No event has occurred, and no condition exists, that, with or without the lapse of time, the giving of notice or both, would constitute a material breach or violation of, or would constitute grounds for a material adverse claim with respect to, applicable Healthcare LawHealth Care Laws or the Health Care Permits. (c) No Borrower Since the Lookback Date, no Acquired Company has been served with or received any search warrant, subpoena, civil investigative demand or similar process, by or from a Governmental Body, in each case, to the extent related to any of the Acquired Company’s compliance with applicable Health Care Laws or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICAREof the Acquired Company’s Health Care Permits. (d) To Borrower’s knowledgeSince the Lookback Date, none no Acquired Company or any current or former directors, officers, or employees of the Borrower’s Acquired Companies (during their employment with the Acquired Companies) (i) has been convicted of, charged with, entered into any settlement or its Subsidiaries’ officersdeferred prosecution agreement with any Governmental Body to avoid conviction of, directors or employees investigated for, threatened with prosecution for, a violation of any Health Care Law, or (ii) has knowingly made an untrue statement of material fact a fraudulent statement, including certification, to any Governmental Body or fraudulent statement to the FDA agent thereof or knowingly failed to disclose a material fact required to be disclosed to a Governmental Body or agent thereof, in each case, related to any applicable Health Care Law or Health Care Permit. No Acquired Company or any current or former (during employment or contract with the FDAAcquired Companies) directors, committed an actofficers or employees of the Acquired Companies, made a statementis, or failed has been, excluded, suspended, or debarred from participation in Government Programs, subject to make sanction pursuant to 42 U.S.C. § 1320a-7a or § 1320a-8, or has since the Lookback Date received a statement that could reasonably be expected written notice of their exclusion, suspension, or debarment from participation, or is, or at any time since the Lookback Date has been, otherwise ineligible to provide a basis for the FDA to invoke its policy respecting “Fraudparticipate, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991)Government Programs. (e) No BorrowerEach Acquired Company is, and at all times since the Lookback Date has been, in material compliance with (i) HIPAA and all other applicable Laws concerning the privacy or security of Personal Information, including to the extent applicable state data breach notification laws, state health privacy and information security laws, the FTC Act, 15 U.S.C. §§ 41-58, and the FTC Red Flag Rules (collectively, the “Information Privacy or Security Laws”), (ii) any publicly posted privacy statements (“Privacy Statements”) and (iii) contractual requirements, terms of use and industry standards. Since the Lookback Date, no Acquired Company has experienced any “Breach” (as such term is defined by HIPAA) for which such Acquired Company is required to provide notification under 45 C.F.R. § 164.406 or § 164.408(b).No Acquired Company, nor any Subsidiary thereofPerson working on behalf of any of them (A) to the knowledge of the Company, is subject to any proceeding, suit or, to any Borrower’s knowledge, under investigation by any Governmental AuthorityBody for a violation of any Information Privacy or Security Law or (B) has received any written notices, which would reasonably be expected claims or complaints (1) from the United States Department of Health and Human Services Office for Civil Rights, the Justice Department, the Federal Trade Commission, or the attorney general of any state or territory of the United States relating to result in any such violations or (2) from any Governmental Body regarding the revocationAcquired Companies’ or their Affiliates’ or such Person’s information practices or the collection, use, storage, processing, distribution, transfer, surrenderimport, suspension export, protection, disposal or disclosure or other activity (whether electronic or in any other form or medium) of any material Permits Personal Information, or alleging a violation of Borrower any individual’s privacy, personal or confidentiality rights under a Privacy Statement. Neither this Agreement nor the transactions contemplated by this Agreement will violate any Privacy Statement, and all Personal Information collected by the Acquired Companies or their Affiliates, or any Subsidiaryby Person working on their behalf, in each case, that would reasonably be expected from visitors to result in a Material Adverse Effectits or their websites or mobile applications is subject to such Privacy Statements. (f) As Each Acquired Company has timely filed, or caused to be timely filed, all cost reports required for such Acquired Company by any Government Program (collectively, “Cost Reports”), and all Cost Reports were accurate in all material respects when filed and were prepared and submitted in accordance with cost and accounting principles consistently applied and in compliance in all material respects with Cost Report filing requirements under any applicable Health Care Law. There are no material claims, actions, or appeals pending before any Governmental Body with respect to the Cost Reports, on or before the Closing Date. There is no threatened dispute with any Governmental Body regarding the Cost Reports. (g) Each Acquired Company (i) is certified for participation and eligible for reimbursement under the Government Programs in which such Acquired Company participates and (ii) is a party to current payor agreements with, or is otherwise entitled to bill, the Private Programs under which such Acquired Company receives payments. Each Acquired Company is in compliance in all material respects with the conditions of participation or conditions for coverage, as applicable, in the Government Programs and Private Programs in which it participates and terms, conditions, and provisions of all payor agreements it has in effect with the Government Programs and Private Programs. Since the Lookback Date, no Acquired Company (i) has received any notice of denial of payment, recoupment, suspension, or overpayment, set-off, penalty or fine from any Government Program, or any Private Program, with respect to the services provided by an Acquired Company prior to the Closing other than notices of a non-material nature received in the ordinary course of business or (ii) has any outstanding overpayments received from, or refunds due to, Government Programs or Private Programs that are in excess of $100,000. To the knowledge of the Company, there are no outstanding audit inquiries or additional documentation requests made by or with respect to the Government Programs or the Private Programs to which the Acquired Companies have not responded in the ordinary course, nor any denials of valid claims submitted under Government Programs or Private Programs with respect to which the Acquired Companies have not submitted appeals in the ordinary course and pursuant to applicable payer procedures. Prior to the date hereof, the Company has delivered or made available a true and correct list of all material Program Denials of the Acquired Companies that are pending as of the date of this Agreement. Except as would not be material, all claims for payment submitted to a Government Program or Private Program were or are for services actually rendered, properly coded or claimed at the correct level and, except for clerical errors, otherwise true and correct. (h) None of the Acquired Companies or any of their respective Representatives acting on their behalf are, or since the Lookback Date have been, parties to (i) a corporate integrity agreement, a deferred prosecution agreement, or similar government-mandated compliance program with the OIG, the Department of Justice, a state attorney general, Medicaid fraud unit or other Governmental Body, (ii) any settlement agreement, side letter, consent, order or similar contract or arrangement with the OIG, the Department of Justice, any state attorney general, the Medicaid fraud unit or any other Governmental Body under which such Acquired Company has reporting obligations to a Governmental Body or (iii) any continuing material reporting obligations pursuant to a settlement agreement entered into with any Governmental Body, in each case, related to any Health Care Law. (i) Each Acquired Company has (i) verified that all employees and independent contractors providing clinical services have valid and current licenses, permits, and credentials and maintain records of same, (ii) conducted criminal background checks on all applicable employees and independent contractors, and (iii) screened all officers, directors, employees and independent contractors under the HHS/OIG List of Excluded Individuals/Entities and equivalent state Medicaid Program exclusion lists. Since the Lookback Date, no Acquired Company has received notice that any healthcare professional employed by any of the Acquired Companies is under investigation by, or is not in good standing with, any Governmental Body including a medical board. (j) In accordance with 42 C.F.R. § 424.550(b), the initial enrollment of each home health agency owned by any Acquired Company in the Medicare Program will have occurred at least thirty-six (36) months prior to the Closing Date, there and no such agency will have experienced a “change in majority ownership” (as such term is defined at 42 C.F.R. § 424.502) during the thirty-six (36) months preceding the Closing Date, or, if such a change will have occurred for any home health agency owned by any Acquired Company, that the requirements of one of the exceptions set forth at 42 C.F.R. § 424.550(b)(2) will have been satisfied. (k) All of the contracts of the Acquired Companies with a physician or immediate family member of a physician, a physician group, or any entity in which a physician or immediate family member of a physician is an equity owner, are in writing, are signed by the appropriate parties, set forth the services, space or goods to be provided, provide for fair market value compensation, are commercially reasonable, and comply with all applicable Health Care Laws, in each case, to the extent required by applicable Health Care Laws, and except as would not be material to any of the Acquired Companies. (l) All billing practices of the Acquired Companies with respect to the Company Facilities and the Company Management Properties, including the Government Programs and Private Programs, have been in material compliance with all applicable laws, regulations and policies of such third party payors and Government Programs. Since the Lookback Date, (i) no Regulatory Reporting EventsAcquired Company has received written notice regarding a material violation of or failure to comply with the requirements of a Government Program; and (ii) there is no pending, nor to the knowledge of the Company, any material, threatened, proceeding or investigation under the Medicare Program or Medicaid Program involving any Acquired Company or any person who is an officer or director of an Acquired Company.

Regulatory Matters. (a) With Seller has operated and currently is in compliance in all material respects with all applicable statutes and implementing regulations administered or enforced by the United States Food and Drug Administration (“FDA”) or any similar Governmental Entity outside the United States (each, including the FDA, a “Regulatory Authority”). (b) The Company holds, and is operating in compliance in all material respects with, such licenses, permits, authorizations, certificates, franchises, consents and other approvals from any governmental body relating to the Business which are required in order for Seller to operate the Business as presently conducted (collectively, the “Regulatory Permits”), and is in compliance in all material respects with all such Regulatory Permits. The Seller has fulfilled and performed all of its material obligations with respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have receivedRegulatory Permits, and such Product is no event has occurred which allows, or after notice or lapse of time would allow, suspension, revocation or termination thereof or result in any other material impairment of the subject ofrights of the holder of any Regulatory Permit. All applications, all Regulatory Required Permits needed notifications, product reports and submissions submitted in connection with any and all requests for a Regulatory Permit from any Regulatory Authority, were truthful and accurate in all material respects as of the testingdate of submission and as of the date of the marketing authorization, manufactureand with respect to any marketing applications complete in all material respects as of the date of submission. To the knowledge of Seller, marketing any necessary or sale required changes, modifications, updates, or corrections to such applications, notifications, and submissions have been submitted to any Regulatory Authority. (c) All of Seller’s products that are subject to the jurisdiction of a Regulatory Authority are being, and have been, designed, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted and distributed by or, on behalf of Seller in compliance in all material respects with all applicable requirements under any Regulatory Permit or law, including applicable statutes and implementing regulations administered or enforced by the Regulatory Authority. (d) All preclinical studies and clinical trials conducted by or, to the knowledge of Seller, on behalf of Seller have been, and if still pending are being, conducted in compliance in all material respects with the research protocols applicable to each such Product as currently being study or test and all applicable law, including the United States Federal Food, Drug, and Cosmetic Act, its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 812 and applicable good clinical practices or good laboratory practices, and 21 C.F.R. Parts 1000 through 1050. No clinical trial conducted by or, to the knowledge of Seller, on behalf of Seller has been terminated or suspended prior to completion, and no Regulatory Authority, or institutional review board or ethics committee, that has or has had jurisdiction over a clinical trial conducted by or on behalf of BorrowerSeller has commenced, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledgethe knowledge of Seller, threatened to commence, any Proceeding investigation, audit, demand, or assessment to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected or on behalf of Seller. No clinical trial conducted by or, to have the knowledge of Seller, on behalf of Seller, has utilized the services of a Material Adverse Effect, none of the Borrowers clinical investigator or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower other Person that was then or any Subsidiary thereof receives any payments directly later became debarred or disqualified by a Regulatory Authority (including through any third party payment processor) from Medicaredebarment under the Generic Drug Enforcement Act of 1992, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 199121 U.S. C. §§335a-335c). (e) No BorrowerSeller has not had any product or manufacturing site subject to a Governmental Entity shutdown or import or export prohibition, nor received any Subsidiary thereofwritten notice of inspectional observations from a Regulatory Authority, is “warning letters,” “untitled letters” or requests or requirements to make changes to the products or any of Seller’s manufacturing processes or procedures, or similar written correspondence or notice from a Regulatory Authority in respect of the Business or Seller, as applicable, and alleging or asserting noncompliance with any applicable law, Regulatory Permit or such requests or requirements of a Regulatory Authority. To the knowledge of Seller, no contract manufacturer of Seller has had any manufacturing site subject to a Governmental Entity (including FDA or other Regulatory Authority) shutdown, or received any proceeding, suit or, to correspondence or notice from the any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower Regulatory Authority or any Subsidiaryother Governmental Entity, in each casealleging or asserting noncompliance with any applicable law, Regulatory Permit or requirements of a Governmental Entity for problems that would reasonably be expected to result in a Material Adverse Effectcould affect products manufactured by or on behalf of Seller. (f) As There are not and have not been any (i) recalls, field notifications, corrections, product replacements, warnings, “dear doctor” letters, investigator notices, safety alerts, reports of accidental radiation occurrences, notifications of defect or failure to comply under 21 C.F.R. Part 1003 or other notice of any Proceeding investigation, audit, demand, or assessment relating to an alleged lack of safety or regulatory compliance of the Closing Dateproducts issued by Seller (“Safety Notices”) or (ii) material product complaints with respect to the medical device products. To the knowledge of Seller, there are no facts that would be reasonably likely to result in (A) a material Safety Notice with respect to the medical device products, (B) a material change in the labeling of any of the medical device products due to a safety or performance issue, or (C) a termination or suspension of developing and testing of any of the medical device products due to safety or performance issues. All adverse events occurring within or outside the United States have been no submitted to the applicable Regulatory Reporting EventsAuthority in accordance with applicable law.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in If any of the aggregate, reasonably be expected to have a Material Adverse Effect, following occurs: (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (iiA) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers Key Permit or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors any of Subsidiary’s material rights or employees has made an untrue statement of material fact interests thereunder is terminated or fraudulent statement amended in any manner adverse to the FDA Borrower and its Subsidiaries in any material respect and such termination or failed amendment is not otherwise revoked within 90 days (or, if a resolution to disclose such revocation is being pursued in good faith by appropriate proceedings diligently conducted, and solely if the applicable event or circumstance has not actually resulted in a material fact required to be disclosed to reduction of revenues that is in excess of the threshold described in the definition of Material Impact, an additional 90 days thereafter) after the occurrence thereof; (B) the FDA, committed an actCMS, made a statementEMA or any other Governmental Authority (x) terminates, or failed delivers a letter or other written communication to make the Borrower or its Subsidiaries asserting that any Specified Product lacks, a statement required Key Permit, which termination or assertion is not withdrawn or otherwise resolved within 90 days (or, if a resolution to such withdrawal is being pursued in good faith through appropriate proceedings diligently conducted, and solely if the applicable event or circumstance has not actually resulted in a reduction of revenues that could is in excess of the threshold described in the definition of Material Impact, an additional 90 days thereafter) after such Person’s receipt of such termination, letter or other written communication or (y) initiates enforcement action against or issues a warning letter with respect to the Borrower or any of the Subsidiaries, or any of their Specified Products or the Health Care Activities therefor, that causes the Borrower or such Subsidiary to discontinue or suspend the sale of, or withdraw from the market, any of its Specified Products, which discontinuance, suspension or withdrawal would reasonably be expected to provide last for more than 90 days (or, if a basis for resolution to such discontinuance, suspension or withdrawal is being pursued in good faith through appropriate proceedings diligently conducted, and solely if the FDA to invoke its policy respecting “Fraud, Untrue Statements applicable event or circumstance has not actually resulted in a reduction of revenues that is in excess of the threshold described in the definition of Material FactsImpact, Briberyan additional 90 days thereafter) and, in the case of each of the foregoing clauses (A) and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10B), 1991). such event or circumstance has had, or would reasonably be expected to have, a Material Impact; (eii) No Borrowera recall that has resulted in, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which or would reasonably be expected to result in in, a Material Impact; or (iii) the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Subsidiaries enters into one or more settlement agreements with the FDA, CMS, EMA or any other Governmental Authority that results in aggregate liability for all such settlement agreements entered into since the Closing Date, there have been no Regulatory Reporting Events.Date in excess of [**] as of the applicable settlement; or

Regulatory Matters. (a) With respect Parent and each of its Subsidiaries have all material Permits required to each Product conduct its business as currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to result in a liability that is material to Parent and its Subsidiaries, taken as a whole (the “Parent Permits”). (b) The Parent Permits are in full force and effect, except as would notfor any failures to be in full force and effect that, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectliability that is material to Parent and its Subsidiaries, taken as a whole. Parent and each of its Subsidiaries is in compliance under such Parent Permits, except for such failures to comply that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to Parent and its Subsidiaries, taken as a whole. (fc) As Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to Parent and its Subsidiaries, taken as a whole, since January 1, 2020, Parent and each of its Subsidiaries: (i) is and at all times has been in compliance, to the Closing Dateextent applicable, with all statutes, rules, regulations (including all applicable requirements relating to Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices), and with all orders and final guidance administered or issued by any Governmental Entity exercising authority applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product tested, developed, promoted, marketed, manufactured or distributed by Parent and each of its Subsidiaries; (ii) has not received any written notice or correspondence from any Governmental Entity alleging or asserting any noncompliance with any Parent Permits; and (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Parent Permit and, to Parent’s Knowledge, there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that such Governmental Entity is considering such action. (d) Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to Parent and its Subsidiaries, taken as a whole, (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of Parent or any of its Subsidiaries are being conducted or have been no Regulatory Reporting Eventsconducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by Parent or its Subsidiaries and all applicable laws and regulations and (ii) since January 1, 2020, neither Parent nor any of its Subsidiaries has received any written notices or correspondence from a Governmental Entity or any institutional review board or comparable authority requiring the termination, clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of Parent or any of its Subsidiaries.

Regulatory Matters. (a) With respect The Company and each of its Subsidiaries possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Bodies relating to the Company’s and each Product of its Subsidiaries’ products and except product candidates (“Company Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all material respects as presently conducted. Except as would not, individually or in the aggregate, not reasonably be expected to have a Material Adverse Effect, (i) Borrower all such Regulatory Authorizations are (A) in full force and its Subsidiaries have receivedeffect, (B) validly registered and such Product is the subject of, all Regulatory Required Permits needed in connection on file with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, applicable Governmental Bodies and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third partiesC) 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 after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to be material to the business of the Company and its Subsidiaries, taken as a whole, (1) the Company and each of its Subsidiaries has filed, maintained or furnished to the FDA or other applicable Healthcare Laws Governmental Bodies all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and Regulatory Required Permitsresponses 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 in all material respects with applicable Legal Requirements when filed (or were corrected or completed in a subsequent filing). (b) The Company and each of its Subsidiaries is, and since January 1, 2021 has been, in material compliance with applicable Legal Requirements, 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, 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 Company Products, (iv) label and labeling requirements and (vi) applicable promotion and advertising requirements. (c) All non-clinical studies and clinical investigations sponsored by the Company or any of its Subsidiaries are being conducted in material compliance with applicable Legal Requirements, including Good Laboratory Practices and Good Clinical Practices. None of the FDA, any other Governmental Body performing functions similar to those performed by the FDA or any institutional review board has sent any written notices or other correspondence or made any oral communication to the Company or any of its Subsidiaries with respect to any proposed, ongoing or completed clinical or non-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and nonclinical data in the possession of and reasonably available to the Company or any of its Subsidiaries 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 Governmental Body performing functions similar to those performed by the FDA. (d) Neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any officers, employees or agents of the Company or any of its Subsidiaries, has (i) made an untrue statement of a material fact or fraudulent 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 Illegal Gratuities Final Policy. As of the 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 nor 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. (e) Except as would not reasonably be expected to have a Material Adverse Effect, none the Company and each of its Subsidiaries is obtaining and since January 1, 2021, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Borrowers Company’s ongoing clinical studies. In using or any Subsidiary thereof are disclosing patient information received by the Company in violation connection with the Company’s ongoing clinical studies, the Company has 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 any applicable Healthcare Law1996, the FDCA and the rules and regulations thereunder. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (df) To Borrower’s knowledgethe extent required by applicable Legal Requirements, none of all manufacturing operations conducted with respect to any Company Product in commercial distribution or used in human clinical trials have been conducted in accordance with the Borrower’s or its Subsidiaries’ officersFDCA, directors or employees has made an untrue statement of material fact or fraudulent statement Legal Requirements and GMP Regulations, except where the failure to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could comply would not 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in have a Material Adverse Effect. (fg) As Since January 1, 2021, no Company Product has been recalled, withdrawn, suspended or discontinued. (h) The Company and each of its Subsidiaries is, and since January 1, 2021 has been, in material compliance with all applicable Healthcare Laws. Neither the Company nor any of its Subsidiaries is subject to any enforcement, regulatory or administrative proceedings regarding alleged non-compliance with any Healthcare Laws and, to the knowledge of the Closing DateCompany, there have no such enforcement, regulatory or administrative proceeding has been no Regulatory Reporting Eventsthreatened.

Regulatory Matters. (a) With respect To Sellers’ Knowledge, Sellers hold all Product Registrations necessary for the lawful operation of the Business as currently conducted including all applicable authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended, and the regulations promulgated thereunder, the Food and Drug Act, as amended, and any other authorization required by a Governmental Authority in the U.S. that is concerned with the quality, identity, strength, purity, safety, efficacy, testing, manufacturing, sale or distribution, sale, import or export, as applicable, of the Product (any such Governmental Authority, a “Regulatory Agency”). All such Product Registrations and Governmental Authorizations are valid and in full force and effect. In the past three (3) years there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to each others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, of any Product and Registration, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has not been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of be materially adverse to the Borrowers or any Subsidiary thereof Business. Sellers are in violation compliance in all material respects with the terms of all Product Registrations, and no event has occurred that, to Sellers’ Knowledge, would reasonably be expected to result in a penalty under or the revocation, cancellation, non-renewal or adverse modification of any applicable Healthcare LawProduct Registration, except as would not be material with respect to the Purchased Assets. (b) Sellers have made available to Purchaser complete and correct copies of all written information to the extent related to the Product and the Laser received by Sellers from any Regulatory Agency which would reasonably be expected to result in the revocation, cancellation, non-renewal or material modification of any Product Registration except as would not be material with respect to the Product, the Laser and the Purchased Assets. (c) No Borrower Sellers have completed and filed all material reports, documents, claims, permits and notices required by any Regulatory Agency in order to maintain the Product Registrations. To Sellers’ Knowledge, all such reports, documents, claims, permits and notices were complete and accurate in all respects on the date filed (or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, were corrected in or TRICARE. (d) To Borrower’s knowledgesupplemented by a subsequent filing). With respect to the Purchased Assets, none of the Borrower’s Sellers, their Affiliates or its Subsidiariesany of their officers or employees, and to Sellers’ officersKnowledge, directors none of Sellers’ agents or employees distributors, has made an untrue statement of a material fact or a fraudulent statement to the FDA or FDA, failed to disclose a material fact required to be disclosed to the FDA, FDA or committed an act, made a statement, or failed to make a statement that could that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991)) or for the FDA, or any other Regulatory Agency to invoke any similar policy. With respect to the Purchased Assets, none of Sellers, their Affiliates or any of their officers or employees, and to Sellers’ Knowledge, none of Sellers’ agents or distributors, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. With respect to the Business, none of Sellers, their Affiliates or any of its or their officers or employees, and to Sellers’ Knowledge, none of Sellers’ agents or distributors, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program. No Regulatory Agency has commenced or, to Sellers’ Knowledge, threatened to initiate any action alleging any violations of any federal, state or local or any payor “fraud and abuse,” consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements or to seek exclusion, whether voluntary or otherwise, of Sellers, their employees, and/or their Affiliates from participation in any federally or state-funded program. None of Sellers or, to Sellers’ Knowledge, any employee of any Seller, has received any written notice to such effect. (d) In the past three (3) years, none of Sellers or any of their Affiliates has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of the Product. No Seller is aware of any facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of Product or Lasers sold or intended to be sold by Seller or any of its Affiliates, (ii) a change in the marketing classification or a material change in the labeling of the Product, or (iii) a termination or suspension of the marketing of the Product or the Laser. (e) No BorrowerIn the past three (3) years, nor any Subsidiary thereof, is subject to any proceeding, suit no Seller or, to Sellers’ Knowledge, any Borrower’s knowledgeother Person has received any written notice that any Regulatory Agency has: (i) commenced, investigation or threatened to initiate, any action to request the recall of any Product or Laser sold by Sellers; (ii) commenced, or threatened to initiate, any Governmental Authorityaction to enjoin manufacture or distribution of any Product or Laser sold or intended to be sold by Sellers; or (iii) issued any demand letter, finding of deficiency or non-compliance or adverse inspection report (including any FDA Form 483s, FDA Notices of Adverse Findings, Untitled Letters, or Warning Letters) in respect of the Product or Laser. (f) No Seller has received any written information from the FDA which would reasonably be expected to result in lead to the revocation, transfer, surrender, suspension denial of any material Permits of Borrower application for marketing approval currently pending before the FDA relating to the Product or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectLaser. (fg) As In the past three (3) years, no Seller has received any warning letters from the FDA or any other Regulatory Agency regarding inappropriate advertising or marketing of the Closing DateProduct or Laser or any written notice of any actual or potential violation of law or regulation with respect to the Product or Laser. (h) In the past three (3) years, there have been no Regulatory Reporting Eventsaudits, inspections, examinations or, to Sellers’ Knowledge, investigations of records by a Governmental Authority (other than in respect of Taxes) relating to the Products or Laser.

Regulatory Matters. (a) With respect Section 3.16(a) of the Company Disclosure Letter sets forth a true and complete list, as of the date of this Agreement, and the Company has made available to each Product Parent true and complete copies of all Regulatory Authorizations from the FDA, EMA and all other applicable Regulatory Authorities held by the Company relating to the Company Products and/or necessary to conduct its business as presently conducted, except as those Regulatory Authorizations the absence of which would notnot reasonably be expected to, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, . All such Regulatory Authorizations are (i) Borrower in full force and its Subsidiaries have receivedeffect, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been validly registered and is being testedon file with applicable Regulatory Authorities, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third partiesiii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable, except where any such failure would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect. Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, the Company has filed all required notices and responses to notices, supplemental applications, reports (including all adverse event/experience reports) and other information with the FDA, EMA and all other applicable Healthcare Laws and Regulatory Required PermitsAuthorities. (b) Except as would not reasonably be expected to to, individually or in the aggregate, have a Company Material Adverse Effect, none to the knowledge of the Borrowers Company, (i) the Company is in compliance with applicable Health Laws, (ii) the Company has not received any written notice or other communication from any Subsidiary thereof are in Regulatory Authority (A) withdrawing or placing any of the Company Products on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Company Products or (B) alleging any material violation of any applicable Healthcare LawHealth Law and (iii) as of the date hereof, there are no investigations, suits, claims, actions or proceedings against any of the Company Products. (c) No Borrower Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, all pre-clinical studies and clinical trials currently being conducted or conducted since January 1, 2015 with respect to the Company Products by or at the direction of the Company have been and are being conducted in compliance with applicable Law, including the applicable requirements of Health Laws, Good Laboratory Practices and Good Clinical Practices and any Subsidiary thereof receives any payments directly 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 through the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et seq.) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009) governing the privacy of patient medical records and other personal information and data. To the knowledge of the Company, the Company has not received any third party payment processor) material notifications or other communications from Medicareany institutional review board, Medicaidethics committee or safety monitoring committee raising any issues, including from any Regulatory Authority in any jurisdiction that requires or would require the termination or suspension or investigation of any clinical studies conducted by, or TRICAREon behalf of, the Company, or in which the Company have participated and, to knowledge of the Company, no such action has been threatened against the Company. (di) To Borrower’s knowledgeExcept as would not reasonably be expected to, none individually or in the aggregate, have a Company Material Adverse Effect, any manufacture of the Borrower’s Company Products, including any clinical supplies used in any clinical trials, by or its Subsidiaries’ officerson behalf of the Company has been conducted in compliance with the applicable specifications and requirements of current Good Manufacturing Practices and applicable Law, directors and (ii) to the knowledge of the Company, no Company Product has been adulterated or employees misbranded. (e) Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, the Company has not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to the FDAany Regulatory Authority or any other Governmental Entity, or (iii) committed an act, made a statement, or failed to make a statement that could statement, including with respect to any scientific data or information, that, at the time such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for any Regulatory Authority or any other Governmental Entity to invoke the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991), or any similar policy. The Company is not, and since January 1, 2015 has not been, the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA. Neither the Company, nor, to the knowledge of the Company, any of its respective officers, employees, or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion under 21 U.S.C. § 335a or any other Health Laws. (ef) No BorrowerExcept as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the Company is in compliance and, since January 1, 2015, has been in compliance, in each case, in all material respects with all Health Laws applicable to the operation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a- 7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes and (ii) the FDCA. Neither the Company nor any Subsidiary thereofits Representatives (in each case, acting in the capacity of a Representative of the Company), is subject to any proceedingenforcement, suit orregulatory or administrative proceedings against or affecting the Company relating to or arising under the FDCA, the Anti-Kickback Statute, or similar Health Laws, and, to any Borrowerthe Company’s knowledge, investigation by any Governmental Authorityas of the date of this Agreement, which would reasonably be expected to result no such enforcement, regulatory or administrative proceeding has been threatened in the revocationwriting, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiaryexcept, in each case, that as would not have, and would not reasonably be expected to result have, individually or in the aggregate, a Company Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower Licensor has provided or made available, when requested by Licensee to conduct its due diligence review, any and all documents and communications in its Subsidiaries have possession from and to any Governmental Authority, or prepared by any Governmental Authority, related to the Product, that may bear on the compliance with the requirements of any Governmental Authority, including any notice of inspection, inspection report, warning letter, deficiency letter, or similar communication; (ii) Neither Licensor nor any of its Affiliates has received, with respect to Product, any oral or written communication (including any warning letter, untitled letter, or similar notices) from any Governmental Authority and, there is no action pending or, to Licensor’s knowledge, threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that with respect to Product, Licensor or any of its Affiliates is not currently materially in compliance with any and all Laws implemented by such Product is Governmental Authority. Neither Licensor nor any of its Affiliates has received any written notice from any Governmental Authority claiming that the subject ofresearch, all Regulatory Required Permits needed in connection with the testingdevelopment, manufacture, marketing THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. use, offer for sale, sale, or sale import of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) not in material compliance with all applicable Healthcare Laws and Regulatory Required Permits.permits; and (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (diii) To BorrowerLicensor’s knowledge, none of the Borrower’s Licensor, any of its Affiliates or its Subsidiaries’ any of their respective officers, directors employees or employees agents has made made, with respect to Product, an untrue statement of a material fact or fraudulent statement to the FDA any Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any such Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With The Company and the Company Subsidiaries hold, and since January 1, 2022 have held, such Regulatory Authorizations required for the conduct of their business as presently or, during that time period, conducted, including those necessary to permit the design, development, pre-clinical and clinical testing, manufacturing, distribution and promotion of the Company Product, as applicable, in the jurisdictions where it currently conducts such activities with respect to each Product and the Company Product, except as to the extent where failure to hold such Regulatory Authorizations would not, individually or in the aggregate, be reasonably expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole). Except as would not reasonably be expected to have result in a Material Adverse Effectmaterial liability to the Company and the Company Subsidiaries (taken as a whole), (i) Borrower the Company and its the Company Subsidiaries have receivedfiled, and such Product is the subject of, all Regulatory Required Permits needed in connection maintained or furnished with the testingapplicable Regulatory Authorities all required filings, manufacturedeclarations, marketing or sale of such Product as currently being conducted by or on behalf of Borrowerlistings, registrations, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all adverse event/experience reports) and other required information (collectively, the “Health Care Submissions”) and (ii) all such Product has been Health Care Submissions were complete and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) accurate and in compliance with all applicable Healthcare Health Laws and Regulatory Required Permitswhen filed (or were corrected or completed in a subsequent filing). (b) Except as would not reasonably be expected to have result in a Material Adverse Effectmaterial liability to the Company and the Company Subsidiaries (taken as a whole), none since January 1, 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 Borrowers Company or any Company Subsidiary thereof are 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 applicable Healthcare Health Law. (c) No Borrower 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 any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarebeing conducted with respect to the Company Product by, Medicaidon behalf of, or TRICAREat 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 the Agreement, no clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. Except as would not reasonably be expected to have, individually or in the aggregate, a material and adverse effect on the Company and the Company Subsidiaries (taken as a whole), neither the Company nor either Company Subsidiary has received any written notifications or other communications from any Regulatory Authority that requires or would require the termination or suspension or investigation, or place a clinical hold order on or otherwise delay or restrict any clinical studies currently conducted by, or on behalf of, the Company, or in which the Company or either Company Subsidiary has participated and, to knowledge of the Company, no such action has been threatened in writing against the Company or either Company Subsidiary. (d) To BorrowerExcept as would not reasonably be expected to result in a material liability to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2022, the Company, the Company Subsidiaries and, to the Company’s knowledge, any other Collaboration Partner are, and have been, in compliance with applicable Health Laws, including the FDCA and applicable regulations and Good Manufacturing Practices and other standards required by the FDA. As of the Agreement Date, neither the Company nor, to the knowledge of the Company, any manufacturing site that assists in the manufacturing of the Company Product or material Company Product components (whether Company-owned or operated or that of a Collaboration Partner) has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export detention, refusal or prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, adverse findings, “warning letters,” “untitled letters” or similar written notice alleging or asserting material noncompliance with any applicable Health Law, and to the Company’s knowledge, no such action or proceeding is pending or threatened. (e) No Company, Company Subsidiary nor any of their respective employees, officers, or directors nor, to the 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 exclusion, debarment or disqualification. Additionally, and only to the extent applicable, none of the Borrower’s or its Subsidiaries’ Company, any Company Subsidiary nor their respective directors, officers, directors employees or employees to the Company’s knowledge, Collaboration Partners has been restricted in any material respect, suspended, excluded or threated with exclusion from, participation in any federal or state health care program under any applicable Health Law. (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 Health Laws. (g) The Company and the Company Subsidiaries have not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDAFDA or any Governmental Entity, or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case), at the time such disclosure or statement was made or failure to make occurred, establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy. Regulation 46191 (September 10, 1991). (e) No Borrower, Neither the Company nor any Company Subsidiary thereofis, is or has since January 1, 2022 been, the subject to of any proceeding, suit pending or, to any Borrowerthe Company’s knowledge, threatened, investigation by any Governmental Authoritythe FDA pursuant to its Fraud, which would reasonably be expected to result in the revocationUntrue Statements of Material Facts, transferBribery, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectand Illegal Gratuities Final Policy. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect The Company, its directors, officers and employees, and, to each Product the Company’s knowledge, its agents, affiliates and except as would notrepresentatives, individually or in the aggregateare, reasonably be expected to have a Material Adverse Effect, and at all times: (i) Borrower have operated and currently operate its Subsidiaries have receivedbusiness in 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, and such Product is the subject of“Applicable Regulatory Authorities”) applicable to the ownership, all Regulatory Required Permits needed in connection with the testing, development, manufacture, marketing packaging, processing, use, distribution, storage, import, export or sale disposal of such Product as currently being conducted by or on behalf any of Borrower, and the Company’s product candidates; (ii) such Product has been 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 is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished supplements or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, amendments thereto required by any applicable third partiessuch Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted as described in compliance with all applicable Healthcare Laws the General Disclosure Package and the Prospectus and such Regulatory Required Permits. Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (biv) Except as would has not reasonably be expected to have a Material Adverse Effectreceived notice of any claim, none of action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Borrowers Applicable Regulatory Authorities alleging that any product operation or any Subsidiary thereof are activity is in material violation of any applicable Healthcare Law. 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; (cv) No Borrower has not received notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any Subsidiary thereof receives material Regulatory Authorizations and has no knowledge that any payments directly of the Applicable Regulatory Authorities is considering such action; (including through 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 third 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 materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); (vii) is not a party payment processorto 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 been excluded, suspended or debarred from Medicareparticipation in any government health care program or human clinical research or, Medicaidto the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement other similar action that could reasonably be expected to provide a basis result in debarment, suspension, or exclusion. The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA, 42 U.S.C. §§ 1320d et seq.; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the FDA to invoke its policy respecting “FraudFederal Food, Untrue Statements of Material Facts, BriberyDrug, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10Cosmetic Act, 1991)21 U.S.C. §§ 301 et seq. (e) No Borrower; the Public Health Service Act, nor 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any Subsidiary thereofsimilar federal, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectstate and local laws and regulations. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to (i) The businesses of the Borrower has been and is being conducted in compliance in all material respects with all applicable Healthcare Laws, and all Permits, (ii) each Product (whether manufactured by the Borrower or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to the Borrower or any of its Subsidiaries) has been, and except currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all applicable Requirements of Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as would not, individually or defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in the aggregateGroup Members’ documentation, except to the extent any failure to so comply could not reasonably be expected to have a Material Adverse Effectresult in any adverse consequences to the Loan Parties (other than immaterial consequences), (iiii) each contract between the Borrower and any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and the Borrower and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements and comply in all material respects with all applicable Healthcare Laws, (iv) the Borrower and its Subsidiaries have receivedare in compliance in all material respects with applicable Requirements of Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither the Borrower nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that the Borrower, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Requirement of Law or any Permit. (b) Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to the Borrower or any of its Subsidiary is pending or, to the subject ofknowledge of the Loan Parties, threatened. None of the Borrower or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Requirement of Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products. (c) The Borrower and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Regulatory Required Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits needed necessary in connection with the testing, manufacturemanufacturing, marketing or sale selling of such Product Products, as such testing, manufacturing, marketing or selling are currently being conducted by or on behalf of Borrowerconducted, and (ii) to carry on the business of the Borrower and each of its Subsidiaries. All such Permits are valid and in full force and effect and the Borrower and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of the Borrower or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished should cease or distributed as that such Product should be withdrawn from the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsmarketplace. (bd) Except as would could not reasonably be expected to have a Material Adverse Effectmaterially adverse impact on the Borrower and its Subsidiaries, none of the Borrowers there have been no adverse clinical test results and there have been no Product recalls or voluntary Product Market Withdrawals from any Subsidiary thereof are in violation of any applicable Healthcare Lawmarket (other than those recalls or Market Withdrawals disclosed on Schedule 4.23(d)). (ce) No There has been no material untrue statement of fact and no fraudulent statement made by the Borrower or any Subsidiary thereof receives of its Subsidiaries or any payments directly (including through any third party payment processor) from Medicareof their respective agents or representatives to the FDA, MedicaidNRC, or TRICARE. (d) To Borrower’s knowledgeany other Governmental Authority, none of the Borrower’s or its Subsidiaries’ officers, directors or employees and there has made an untrue statement of material fact or fraudulent statement to the FDA or failed been no failure to disclose a any material fact required to be disclosed to the FDA, committed an actNRC or any other Governmental Authority. (f) To the best knowledge of the Loan Parties, made a statementno insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or failed to make a statement that (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to provide have a basis materially adverse impact on the revenues of the Borrower and its Subsidiaries. None of the Borrower or any of its Subsidiaries has been the subject of any "for the FDA to invoke its policy respecting “Fraudcause" inspection, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth investigation or audit by any Governmental Authority in 56 Fed. Regulation 46191 (September 10, 1991)connection with any alleged improper activity. (eg) No BorrowerThere is no arrangement relating to the Borrower or any of its Subsidiaries providing for any rebates, nor kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Subsidiary thereofPerson to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Borrower and each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable Healthcare Laws. (h) None of the Borrower or any of its Subsidiaries, or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for any federal or state health program- related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Loan Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for a violation of any Requirement of Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any proceedingjudgment, suit stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of its Subsidiaries or, to the knowledge of the Loan Parties, any Borrower’s knowledgeindividual who is an officer, investigation by any Governmental Authoritydirector, which would reasonably be expected to result in employee or manager of the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, of its Subsidiaries has been convicted of any crime or engaged in each case, any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a Material Adverse Effectdebarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Requirement of Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of its Subsidiaries are pending or, to the knowledge of the Loan Parties, threatened against the Borrower or any of its Subsidiaries or any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries. (fi) As All studies, tests and preclinical and clinical trials conducted relating to the Products, sponsored by the Borrower or any of its Subsidiaries have been conducted, and are currently being conducted, in all material respects in accordance with all applicable Requirement of Law and IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Requirement Law, the Borrower and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or on behalf of the Closing DateBorrower or such Subsidiary, there as applicable. (j) To the knowledge of the Loan Parties, none of the clinical investigators in any clinical trial sponsored by the Borrower or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Borrower or any of its Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the Products. (k) The Group Members are, to the extent directly applicable to the Group Members, currently conducting its business in material compliance with all regulations promulgated under HIPAA. To the extent the Group Members create any de-identified protected health information, the Group Members do so in compliance with the HIPAA regulations. The Group Members have been not failed to notify any individual or required third party, including any appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which a Group Member is a party, or any applicable requirement related to the unauthorized access, use or disclosure of protected health information. The Group Members have no Regulatory Reporting Eventsknowledge of any complaints to or investigations by any Governmental Authority with respect to HIPAA compliance by the Group Members, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all applicable laws governing the privacy, security or confidentiality of protected health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to the extent not preempted by HIPAA, and has conducted its businesses in material compliance with such laws since such laws first became applicable to it.

Regulatory Matters. (a) With respect to each Product and except Except as would notnot reasonably be expected to be, individually or in the aggregate, material to the Acquired Corporation, taken as a whole, the 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 have be, individually or in the aggregate, material to the Acquired Corporations, taken as a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject ofwhole, all Regulatory Required Permits needed in connection with the testingsuch filings, manufacturepermits, marketing claims, responses, declarations, listings, registrations, reports or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) submissions were in compliance with all applicable Healthcare Laws when filed (or were corrected or supplemented by a subsequent submission) and, and Regulatory Required Permitsno 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 expected, individually or in the aggregate, to have a Material Adverse Effect, none all preclinical and clinical investigations sponsored by the Acquired Corporations are being conducted in compliance with all applicable clinical protocols, informed consents and Laws, including Good Clinical Practices requirements (preclinical and clinical), Good Manufacturing Practices and pharmacovigilance. As of the Borrowers Agreement Date, the Acquired Corporations have not received any written notices or other correspondence from the FDA or any Subsidiary thereof are in violation other Specified Governmental Body with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination, suspension or material modification of any applicable Healthcare Lawsuch studies or tests. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none the Knowledge of the Borrower’s or its Subsidiaries’ officersCompany, directors or employees no Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Specified Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, any Specified Governmental Body or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA or any other Specified Governmental Body to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy (or similar rule, regulation or policy). Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which Except as has not had or would not reasonably be expected to result have, individually or in the revocationaggregate, transfera Material Adverse Effect, surrender, suspension no Acquired Corporation is the subject of any material Permits pending or, to the Knowledge of Borrower 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 Subsidiary, crime or engaged in each case, 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 healthcare laws applicable to the operation of its business as currently conducted, including (i) any and all applicable federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7(b)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant thereto; (iii) Laws which are cause for exclusion from any federal health care program; and (iv) Laws relating to the billing or submission of claims, collection of accounts receivable, underwriting the cost of, or provision of management or administrative services in connection with, any and all of the foregoing, by an Acquired Corporation. No enforcement, regulatory or administrative proceeding is pending, or, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened, against any Acquired Corporation under the Federal Drug and Cosmetics Act, the Anti-Kickback Statute, or similar Laws other than any such proceeding that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (fe) As of the Closing 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 have has been (i) no Regulatory Reporting Eventsadverse 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, individually or in the aggregate, a Material Adverse Effect.

Regulatory Matters. (a) With respect Borrower, each Subsidiary, and to each Product the knowledge of Borrower, their respective directors, officers, employees, and agents are, and at all times within the last three years have been, in compliance with all applicable Healthcare Laws, except as where failures to so comply would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Borrower has not received any written notification, (i) Borrower and its Subsidiaries have receivedcorrespondence, and such Product is the subject or any other communication from any governmental authority asserting non-compliance by, or liability of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing Borrower or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any Subsidiary under any applicable third parties) Healthcare Laws, except where such non-compliance would not, whether individually or in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not the aggregate, reasonably be expected to have a Material Adverse Effect. Borrower is not a party to or has any ongoing reporting obligations pursuant to or under any order by a governmental authority or corporate integrity agreements, none deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of the Borrowers correction or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower similar agreements with or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation imposed by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of governmental authority. Neither Borrower or any Subsidiary, nor any officers, employees or, to the knowledge of Borrower, agents of Borrower or any Subsidiary has been excluded, suspended or debarred from any government healthcare program or convicted of any crime or engaged in each case, any conduct that would reasonably be expected to result in debarment under any applicable Healthcare Law, and, to the knowledge of Borrower, no such Action is currently contemplated, proposed or pending. (b) Borrower and each Subsidiary has obtained and maintained all Permits, including any Permits required pursuant to any applicable Healthcare Laws, and all of such Permits are in full force and effect, except where failures to possess or maintain the same, would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Borrower and each Subsidiary has fulfilled and performed all of its material obligations with respect to the Permits, and, to the knowledge of Borrower, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other impairment of the rights of the holder of any Permit, except where such revocations, terminations or impairments would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (fc) As of the Closing DateAll clinical or preclinical studies, there tests or trials that have been no Regulatory Reporting Eventsor are being conducted by or on behalf of, or sponsored by, Borrower or any Subsidiary, or in which Borrower’s or any Subsidiary’s products or product candidates have participated, and which have been or will be submitted to the FDA or other regulatory authorities in connection with applications for Permits, were and, if still pending, are being conducted in compliance in all material respects with all applicable Healthcare Laws. No investigational new drug application or other allowance to commence a clinical trial filed with or submitted to the FDA or other governmental authority by or on behalf of Borrower or any Subsidiary has been terminated or suspended by the FDA or other such governmental authority, and neither the FDA nor any applicable governmental authority has commenced, or to the knowledge of Borrower, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Borrower or any Subsidiary.

Regulatory Matters. (a) With During the past two (2) years the Company and the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) and the members of the SpinCo Group have filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority having jurisdiction over the safety, efficacy, approval, development, testing, labeling, manufacture, store, sale, commercialization or distribution of the products of the SpinCo Business (each, a “Specified SpinCo Governmental Authority”)) all required material filings, declarations, listings, registrations, reports or submissions, including, but not limited to, adverse event reports, except, in each Product and except case, as would notnot have, and would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with all applicable Laws (including all applicable Regulatory Laws) when filed, and, as of the date of this Agreement, no deficiencies have been asserted in writing by any applicable Specified SpinCo Governmental Authority to the Company or any of its Subsidiaries with respect to any such filings, declarations, listing, registrations, reports or submissions, except as would not have, and would not reasonably be expected to have have, individually or in the aggregate, a SpinCo Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not have, and would not reasonably be expected to have have, individually or in the aggregate, a SpinCo Material Adverse Effect, none of the Borrowers or any Subsidiary thereof Company and the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) have for the past two (2) years had appropriate internal controls that are in violation of any reasonably designed to ensure compliance with, all applicable Healthcare LawLaws, including all Regulatory Laws. (c) No Borrower Except as would not have, and would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect, all preclinical and clinical studies or tests sponsored by the Company or the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) and the members of the SpinCo Group in the past two (2) years have been conducted in material compliance with applicable Law, including all applicable Regulatory Laws and Regulatory Authorizations, rules, regulations and binding guidance, including Good Clinical Practices and Good Laboratory Practice Requirements and federal and state laws, rules, regulations and binding guidance restricting the use and disclosure of individually identifiable health information. In the past two (2) years and through the date of this Agreement, the Company or the Company’s Subsidiaries (in each case, solely with respect to the SpinCo Business) and the members of the SpinCo Group have not received any Subsidiary thereof receives written notices or other material correspondence from any payments directly (including through Specified SpinCo Governmental Authority with respect to any third party payment processor) from Medicareongoing clinical or pre-clinical studies or tests withdrawing, Medicaidplacing, or TRICAREthreatening to withdraw or place any such studies on “clinical hold” requiring the termination, suspension or material modification of such studies or tests. (d) To Borrower’s knowledge, none Except as set forth on Section 5.14(d) of the BorrowerSpinCo Disclosure Schedule, in the past two (2) years, neither the Company or the Company’s or its Subsidiaries’ officersSubsidiaries (in each case, directors or employees has made an untrue statement of material fact or fraudulent statement solely with respect to the SpinCo Business) has received any written notification from any Specified SpinCo Governmental Authority of any material violation of any Food and Drug Law or Healthcare Law or any pending or threatened Actions under any Regulatory Laws, including any FDA or failed warning letter, FDA Form 483, untitled letter, “it has come to disclose a material fact required to be disclosed to the FDA, committed an act, made a statementour attention” letter, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements other written notice of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991)potential enforcement proceedings or similar correspondence or written notice from any Specified SpinCo Governmental Authority. (e) No BorrowerExcept as would not have, and would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect, during the past two (2) years and through the date of this Agreement, neither the Company nor its Subsidiaries (in each case, solely with respect to the SpinCo Business), nor to the Knowledge of SpinCo, any Subsidiary thereofof its or their officers, employees, or agents, have been (i) disqualified, suspended or debarred for any purpose, or received written notice of action or threat of action with respect to debarment under the provisions of 21 U.S.C. § 335a or any equivalent provisions in any other jurisdiction; (ii) excluded under 42 U.S.C. Section 1320a-7 or otherwise from participation in the Medicare program, any state Medicaid program or any other federal healthcare program; or (iii) formally charged with or convicted of any crime or engaged in any conduct for which debarment is subject mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. (f) Except as set forth on Section 5.14(f) of the SpinCo Disclosure Schedule, during the past two (2) years and through the date of this Agreement, neither the Company nor its Subsidiaries (in each case, solely with respect to the SpinCo Business) has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any proceedingrecall or any field corrective action, suit ormarket withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Borrower’s knowledgeSpinCo Business product, investigation by or is currently considering initiating, conducting or issuing any Governmental Authorityrecall of any SpinCo Business product, except in each case as would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect. To the Knowledge of SpinCo, there are no facts which would reasonably be expected to result cause, and neither the Company nor any Subsidiary (with respect to the SpinCo Business) has received in the revocationpast two (2) years any written notice from the FDA or any other Specified SpinCo Governmental Authority regarding, transfer(i) the recall, surrendermarket withdrawal or replacement of any SpinCo Business product sold or intended to be sold by the SpinCo Business, (ii) a change in the marketing classification or a material change in the labelling of any such SpinCo Business products, (iii) a termination, enjoinment or suspension of any material Permits the manufacturing, marketing, or distribution of Borrower such SpinCo Business products, or any Subsidiary(iv) a negative change in reimbursement status of a SpinCo Business product, that in each case, that would reasonably be expected to result have, individually or in the aggregate, a SpinCo Material Adverse Effect. (fg) As Neither the Company nor its Subsidiaries (in each case, solely with respect to the SpinCo Business), (i) is a “business associate” or “covered entity” as such terms are defined in HIPAA, or (ii) has submitted or currently submits claims for its respective products or services to Medicare, or Medicaid, or any other U.S. federal healthcare program, except in each case as would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect. (h) Except as would not have, and would not reasonably be expected to have, individually or in the aggregate, a SpinCo Material Adverse Effect, during the past two (2) years, none of the Closing DateCompany nor its Subsidiaries (in each case, there solely with respect to the SpinCo Business), nor any of their respective directors, officers managing employees, nor to the Knowledge of SpinCo, any of their independent contractors or agents, have been no knowingly and willfully offered or paid any remuneration (including any kickback, bribe, rebate, payoff, influence payment or inducement) directly or indirectly, overtly or covertly, in cash or in kind, to any Person to induce such Person (i) to refer an individual to a Person for the furnishing or arranging for the furnishing of any item or service in violation of any Regulatory Reporting EventsLaw; or (ii) to purchase, lease, order, arrange for or recommend purchasing, leasing or ordering any good, facility, service or item in violation of any Regulatory Law.

Regulatory Matters. (a) With respect Section 3.24(a) of the Company Disclosure Letter sets forth a true and complete list of each Permit received by (or applied for by) the Company or any of its Subsidiaries from the FCC, any State PUC, foreign regulatory authorities or other Governmental Authority to each Product own or operate businesses regulated by Communications Laws. Except as set forth on Section 3.24(a) of the Company Disclosure Letter and except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, (i) Borrower as of the date of this Agreement, each Permit is valid and in full force and effect in accordance with its terms, and there is no outstanding written notice of cancellation, termination, modification, or notice of apparent liability or any written threatened cancellation, termination or modification in connection therewith nor are any of such Permits subject to any restrictions or conditions that limit the operations of the Company or any of its Subsidiaries have received, and such Product is the subject of, all Regulatory Required (other than restrictions or conditions generally applicable to Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsthat type). (b) Except Since January 1, 2014 through the date of this Agreement, and except as would not not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, none the Company and its Subsidiaries have taken all steps reasonably necessary to maintain and preserve the effectiveness of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare LawPermits. (c) No Borrower Except as would not, individually or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarein the aggregate, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide have a basis for Company Material Adverse Effect, as of the FDA to invoke its policy respecting “Frauddate of this Agreement, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit there are no existing or, to any Borrower’s knowledgethe Knowledge of the Company, investigation by threatened Legal Actions before any Governmental Authority, which including the FCC and the State PUCs, regarding the Permits or the operations of the Company of any of its Subsidiaries (except Legal Action of general applicability to the industry and not specific to the Company or its Subsidiaries), that would reasonably be expected to result in the revocation, transfercancellation, surrendersuspension, suspension nonrenewal, placement of material restrictions on, or material adverse modification of any material of, the Permits that would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company is not aware of Borrower any fact relating to its or any Subsidiaryof its Subsidiaries’ respective businesses, operations (including but not limited to operations in each caseforeign jurisdictions), financial condition, direct or indirect foreign ownership or control, or legal status, including any officer’s, director’s or current employee’s status, that might reasonably be expected to impair the ability of the parties to this Agreement to obtain, on a timely basis, any authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority or third party necessary for the consummation of the transactions contemplated by this Agreement, or that might result in one or more material conditions being placed on any such authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority (including the FCC and any State PUC) or third party necessary for the consummation of the transactions contemplated by this Agreement. (d) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, to the Company’s Knowledge, no event has occurred that results in, or after notice or lapse of time, or both, would reasonably be expected to result in the revocation, cancellation, suspension, nonrenewal, placement of restrictions on, or material adverse modification of any of the Permits. (e) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. (f) As , to the Company’s Knowledge, the Company’s Subsidiaries are not in violation of any Communications Laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, each of the Closing DateCompany and its Subsidiaries is in compliance in all material respects with the Communications Laws applicable to, and the terms and conditions of, any Permit, and have all Permits from, have made all required filings with, and have made all required payments due to, all Governmental Authorities, including any state regulatory authority, the FCC and the Universal Service Administrative Company (in connection with any federal Universal Service Fund assessments and contributions), required to conduct their respective businesses as presently conducted as of the date of this Agreement. Except as set forth in Section 3.24(e) of the Company Disclosure Letter, there have been no Regulatory Reporting Eventsis not pending, or to the Company’s Knowledge threatened, any audits, examinations, investigations, or other proceedings in respect of any such filing and/or reporting requirements, in each case, which would reasonably be expected to be material to the Company.

Regulatory Matters. (a) With respect The Company is in compliance with all statutes, rules or regulations of the FDA, the DEA, the EMA, the MHRA and other comparable governmental agencies engaged in the regulation of pharmaceutical drugs applicable to each Product 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 as where noncompliance would not, individually singularly or in the aggregate, have a Material Adverse Effect. The nonclinical studies and clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Prospectus; and the Company has not received any written notices or correspondence from the FDA, the DEA, the EMA, the MHRA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse EffectEffect and, (i) Borrower and its Subsidiaries have receivedto the Company’s knowledge, and such Product is there are no reasonable grounds for the subject of, all Regulatory Required Permits needed same. In using or disclosing patient information received by the Company in connection with the testingCompany Studies and Trials, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product the Company has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) complied in compliance all material respects with all federal, state, local or foreign applicable Healthcare Laws laws and Regulatory Required Permits. regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder (b) Except as would not reasonably be expected to have a Material Adverse Effect“HIPAA”). Neither the Company, none of the Borrowers nor its subsidiaries or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicaretheir respective directors, Medicaidofficers, or TRICARE. (d) To Borroweremployees or, to the Company’s knowledge, none of the Borrower’s agents is or its Subsidiaries’ officerssince January 1, directors 2015 has been debarred, suspended or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit excluded or, to the knowledge of the Company, engaged in any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, conduct that would reasonably be expected to result in a Material Adverse Effect. (f) As debarment, suspension or exclusion from any federal or state government health care program or human clinical research. To the Company’s knowledge, none of the Closing DateCompany Studies and Trials involved any investigator, there 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 clinical investigator or has been found by the FDA to have been no Regulatory Reporting Eventsengaged in scientific misconduct. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules and regulations of the FDA, the DEA, the EMA, the MHRA or comparable regulatory agencies outside of the United States to which the Company is subject.

Regulatory Matters. (a) With (i) Each Group Member has, and it and its Products are in conformance in all material respects with, all Regulatory Required Permits required to conduct its respective businesses as now conducted; (ii) to the knowledge of Holdings and the Borrower, neither the FDA nor other Governmental Authority has provided notice of or is considering limiting, suspending, revoking or terminating such Regulatory Required Permits; (iii) the Group Members have fulfilled and performed, in all material respects, their obligations under each material Regulatory Required Permit, and, to the knowledge of each Group Member, no event has occurred or condition or state of facts exists which would constitute a breach or default, or would cause revocation, limitation, suspension, or termination of any such Regulatory Required Permit, except (x) with respect to Core Business Segments, in each Product of cases (i), (ii) and (iii) to the extent such Regulatory Required Permit are not material to the business of the Group Members, and (y) other than with respect to Core Business Segments, in each of cases (i), (ii) and (iii), to the extent it would not reasonably be expect to have a Material Adverse Effect. (b) All Products that are subject to Health Care Laws, to the knowledge of each Group Member, have been and are being researched, designed, developed, tested, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance in all material respects with applicable Health Care Laws or any other Applicable Law, including, without limitation, the Applicable Laws related to clinical and non-clinical testing, product approval or clearance, current good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and listing, and medical device and other post-market reporting, and all other importation and distribution requirements, except as it would not, individually or in the aggregate, not be reasonably be expected to have a Material Adverse Effect. (c) Except as it would not be reasonably expected to have a Material Adverse Effect or as it has been publicly disclosed, (i) Borrower and its Subsidiaries with respect to any Product, the Group Members have received, and such Product is the subject of, received all Regulatory Required Permits needed required in connection with the design, testing, manufacture, marketing processing, assembly, packaging, labeling, marketing, distribution, commercialization, import, export, or sale of such Product as currently being conducted by or on behalf of Borrower, such Group Member; and (ii) such Product no Group Member has been and is being testedrestrained in its ability to manufacture, manufacturedprocess, marketeddistribute, promotedsupply, soldimport, importedexport, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaidmarket, or TRICAREsell any of its Products. (d) To Borrower’s knowledge, none As of the Borrower’s or its Subsidiaries’ Closing Date, no Group Member is undergoing any inspection related to Regulatory Required Permits, except as set forth on Schedule 4.26. (e) To the knowledge of each Group Member, no Group Member nor any of their respective officers, directors or employees has (A) made an any untrue statement of material fact fact, fraudulent statement, or fraudulent statement material omission to the FDA or any other Governmental Authority or in any documents or records required to be maintained under the Applicable Laws; (B) failed to disclose a material fact required to be disclosed to the FDA, FDA or any other Governmental Authority; or (C) committed an act, made a statement, or failed to make a statement that could would reasonably be expected to provide a the basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991); or (D) been investigated by FDA or any other Governmental Authority, including but not limited to the Office of the Inspector General for the Department of Health and Human Services, or the Department of Justice, for data or healthcare program fraud. To the knowledge of each Group Member, no Group Member, nor any of their respective officers, directors, employees, or, to their knowledge, contractors, have made or offered any payment, gratuity, or other thing of value that is prohibited by any Applicable Law to personnel of the FDA or any other Governmental Authority. (ef) No BorrowerNone of the Products related to the Core Business Segments have been subject to a Recall, nor is any Subsidiary thereof, is subject to such action currently under consideration by any proceeding, suit Group Member or, to the knowledge of the Group Members, any Borrower’s knowledgemanufacturer or supplier of a Product, investigation by any Governmental Authority, which except as this would not be reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in have a Material Adverse Effect. (fg) As There are no civil, criminal, or administrative actions, suits, demands, claims, hearings, notices of the Closing Dateviolation, there investigations, proceedings, demand letters, or other communications relating to any alleged hazard or alleged defect in design, manufacture, materials, or workmanship, including, without limitation, any failure to warn or alleged breach of express or implied warranty or representation, relating to any Product provided by any Group Member, or alleging that any such Products are otherwise unsafe or ineffective for their intended use, that are presently pending or threatened in writing, other than as it would not reasonably be expected to have been no Regulatory Reporting Eventsa Material Adverse Effect.

Regulatory Matters. (a) With respect to each Product and except Except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, (i) Borrower the Company and its Subsidiaries have receivedobtained all Permits (including, and such Product is for the subject ofavoidance of doubt, all Regulatory Required Permits needed in connection with establishment registrations, device listings and 510(k) clearances (or their foreign equivalents)) required by any Health Authority to permit the testing, manufacture, marketing or sale conduct of such Product their respective businesses as currently being conducted by or on behalf of Borrowerconducted, and (ii) all of such Product has been Permits are in full force and effect, (iii) the Company is in compliance with, and is being testednot in default under, manufacturedeach such Permit and (iv) none of such Permits shall be terminated or impaired or become terminable, marketedin whole or in part, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as a result of the case may be, transactions contemplated by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsthis Agreement. (b) Except as would not reasonably be expected to have have, individually or in the aggregate, a Company Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicaresince January 1, Medicaid, or TRICARE. (d) To Borrower’s knowledge2015, none of the Borrower’s Company, any of its Subsidiaries or, to the knowledge of the Company, any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and its Subsidiaries’ officers, directors or employees has ) have (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Health Authority, (ii) failed to disclose a material fact required to be disclosed to the FDAFDA or any other Health Authority, or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its the policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). ) (ethe “FDA Fraud Policy”) No Borroweror for any other Health Authority to invoke a similar policy that may be applicable to the Company or any of its Subsidiaries in another jurisdiction. None of the Company, nor any Subsidiary thereof, is subject to any proceeding, suit of its Subsidiaries or, to the knowledge of the Company, any Borrowerof their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and its Subsidiaries) are the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or the subject of any similar investigation by any Governmental other Health Authority, which that, assuming such investigations were determined or resolved adversely, would reasonably be expected to result have, individually or in the revocationaggregate, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Company Material Adverse Effect. (c) Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, since January 1, 2015, the Company and each of its Subsidiaries and, to the knowledge of the Company, each Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and its Subsidiaries), has been in compliance in all material respects with all Health Laws, including those relating to laboratory developed tests. None of the Company, any of its Subsidiaries or, to the knowledge of the Company, any Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and its Subsidiaries) (5) have received any written notice or other written communication from any Health Authority (including a warning, untitled or notice of violation letter or Form FDA-483) alleging any violation of any Health Law, including any failure to maintain systems and programs adequate to ensure compliance with any such Health Laws, or contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any product subject to any Health Law, or (6) are subject to any material enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under any Health Law and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. (d) Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and its Subsidiaries have, since January 1, 2015, filed with the applicable Health Authority all required and material Filings, including adverse event reports. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Filings were in material compliance with Applicable Law when filed, and no deficiencies have been asserted in writing by any applicable Health Authority with respect to any such Filings. (e) None of the Company or any of its Subsidiaries, any of their respective officers, directors or managing employees (as such terms are defined in 42 C.F.R. § 1001.1001) or, to the knowledge of the Company, any other Company Service Provider or agent (as such term is defined in 42 C.F.R. § 1001.1001) of the Company or any of its Subsidiaries has been disqualified, debarred or deregistered by any Governmental Authority. (f) As Except as disclosed on Schedule 5.14(f) of the Closing DateCompany Disclosure Schedule, there as of the date hereof, neither the Company nor any of its Subsidiaries have been no Regulatory Reporting Eventsreceived any written coverage or reimbursement decision from any government payor.

Regulatory Matters. (a) With respect Except as has not had and would not reasonably be expected to each Product and except as would nothave, individually or in the aggregate, reasonably be expected to have a Material Adverse EffectEffect on the Company, (i) Borrower each of the Company and its Subsidiaries have receivedhold all material Permits required to own, lease, maintain, operate, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product conduct its business as currently being conducted conducted. Since January 1, 2019, neither the Company nor any of 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 on behalf requirement of Borrowerany Permit or (b) any actual or possible revocation, and (ii) such Product has been and is being testedwithdrawal, manufacturedsuspension, marketedcancellation, promotedtermination, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by modification of any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required PermitsPermit. (b) Except as has not had and would not reasonably be expected to have have, individually or in the aggregate, a Material Adverse EffectEffect on the Company, none of the Borrowers Company or its applicable Subsidiary has filed with the applicable regulatory authorities (including the FDA or any Subsidiary thereof are 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 ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, and all such filings, declarations, listings, registrations, reports or submissions were in violation 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 Healthcare LawGovernmental Authority with respect to any such filings, declarations, listing, registrations, reports or submissions. (c) No Borrower 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 in compliance with the FDCA and other applicable Healthcare Laws. As of the date of this Agreement, since January 1, 2019, none of the Company or any Subsidiary thereof receives of its Subsidiaries has received any payments directly (including through written notices or other written communication from the FDA or any third party payment processor) from Medicareother 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, Medicaid, suspension or TRICAREmaterial modification of such studies or tests. (d) To Borrower’s knowledgeThe 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 Company currently being developed by the Company, including any material supplements and amendments thereto, in each case, as of the date hereof. (e) 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, none the Company or any of the Borrower’s or its Subsidiaries’ officers, directors or employees Subsidiaries has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or (iii) committed an any other act, made a statement, any statement or failed to make a statement any statement, including with respect to scientific data or information, that could (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 policy respecting “Fraudfraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Policy or for any Governmental Authority to invoke any similar policy or law. Regulation 46191 (September 10As of the date of this Agreement, 1991). (e) No Borrower, nor none of the Company or any Subsidiary thereof, of its Subsidiaries is the subject to of any proceeding, suit pending or, to any Borrower’s knowledgethe 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 Governmental Authorityof its Subsidiaries, which would reasonably be expected or any directors, officers, employees, or, to result in the revocationknowledge of the Company, transferagents or clinical investigators of the Company or any of its Subsidiaries, surrenderhas been excluded, suspension suspended or debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in a Material Adverse Effect(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) As 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 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 Closing DateCompany, 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 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 Authorization held by the Company 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 with respect to any such Governmental Authorization. (h) Since January 1, 2019, there have been no Regulatory Reporting Eventsrecalls, 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 would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, the Company, its Subsidiaries and, to the Knowledge of the Company, all Development Partners in connection with any product or product candidate of the Company or any of its Subsidiaries, have implemented compliance programs that conform to and ensure material compliance with applicable Healthcare Laws and industry standards. (j) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, no Person has filed against the Company or any of its Subsidiaries any action relating to the Company or any of its Subsidiaries under any applicable federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (k) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, there are no claims, actions or proceedings pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries, in each case, alleging that the Company or any of its Subsidiaries has any liability (whether in negligence, breach of warranty, strict liability, failure to warn or otherwise) arising out of or relating to any claimed injury or damage to individuals or property as a result of the claimed ownership, possession, exposure to or use of any product or product candidate, including the Product, of the Company or any of its Subsidiaries.

Regulatory Matters. (a) With Except as set forth on Section 4.15(a) of the Company Disclosure Letter, and except with respect to licenses, approvals, consents, registrations and permits required under applicable Environmental Laws (as to which certain representations and warranties are made pursuant to Section 4.18), the Company and its Subsidiaries hold all material permits, approvals, authorizations, certificates, registrations and licenses issued by the FCC or the state public service or public utility commissions or other similar state regulatory bodies (“State PSCs”), and all other material regulatory permits, approvals, licenses and other authorizations, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to the Company or any of its Subsidiaries by a Governmental Authority (the “Company Licenses”) that are required for the Company and each Product of its Subsidiaries to conduct its business, as presently conducted, except where the failure to hold Company Licenses has not had and except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, (i) Borrower and Effect or materially impair the ability of the Company to perform its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (obligations under this Agreement or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsconsummate the Transactions. (b) Except as Each Company License 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, has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. 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 would not reasonably be expected to have a Company Material Adverse Effect, none or (ii) any pending proceeding by or before the FCC or State PSCs to suspend, revoke or cancel such Company License, or any judicial review of a decision by the FCC or State PSCs with respect thereto, unless such pending proceeding or judicial review has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or materially impair the ability of the Borrowers Company to perform its obligations under this Agreement or to consummate the Transactions. To the Knowledge of the Company, there has not been any Subsidiary event, condition or circumstance that would preclude any Company License from being renewed in the ordinary course (to the extent that such Company License is renewable by its terms), except where the failure thereof are in violation to be renewed would not reasonably be expected to have a Company Material Adverse Effect or materially impair the ability of any applicable Healthcare Lawthe Company to perform its obligations under this Agreement or to consummate the Transactions. (c) No Borrower or any Subsidiary thereof receives any payments directly The licensee of each Company License is in compliance with such Company License and has fulfilled and performed all of its obligations with respect thereto, including all reports, notifications and applications required by the Communications Act of 1934, as amended (including through any third party payment processor) from Medicare, Medicaidthe “Communications Act”), or TRICAREthe 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 (i) for exemptions, waivers or similar concessions or allowances and (ii) where such failure of such licensee to be in compliance, fulfill or perform its obligations or pay such fees or contributions has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or materially impair the ability of the Company to perform its obligations under this Agreement or to consummate the Transactions. (d) To Borrower’s knowledge, none Section 4.15(d) of the Borrower’s Company Disclosure Letter sets forth a list of all material regulatory permits, approvals, authorizations, certificates, registrations and licenses issued or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement granted to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower Company or any Subsidiaryof its Subsidiaries by the FCC or any PSC, in each case, that constitute Company Licenses, together with the name of the entity holding such Company License. The Company or a wholly owned Subsidiary of the Company directly or indirectly owns one hundred percent (100%) of the equity interests and controls one hundred percent (100%) of the voting power and decision-making authority of each licensee of the Company Licenses, except where the failure to own such equity or control such voting power and decision making authority of such licensees has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. No Company License, order or other agreement, obtained from, issued by or concluded with any State PSC would impose restrictions of the ability of any Subsidiary of the Company to make payments, dividends or other distributions to the Company or any other Subsidiary that limits, or would reasonably be expected to result limit, the cash funding and management alternatives of the Company on a consolidated basis in a Material Adverse Effectmanner disproportionate to restrictions applied by other State PSCs. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except Except as would notnot reasonably be expected to, individually or in the aggregate, reasonably be expected material to have the Company and the Company Subsidiaries (taken as a Material Adverse Effectwhole), (i) Borrower the Company and its each of the Company Subsidiaries have receivedis, and such Product is the subject ofsince January 1, all Regulatory Required Permits needed in connection with the testing2020 has been, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Drug Laws and Healthcare Laws and Regulatory Required Permitsapplicable to its business or operations. (b) Except as would not reasonably be expected to, individually or in the aggregate, be material to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2020, the Company and the Company Subsidiaries have timely filed, maintained or furnished with the applicable regulatory authorities all required filings, declarations, listings, registrations, reports, field alerts, submissions, applications, amendments, modifications, notices and other documents (collectively “Health Care Submissions”) and all such Health Care Submissions were complete and accurate and in compliance with applicable Laws when filed (or were corrected or completed by a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Lawsubsequent filing). (c) No Borrower The Company has delivered or made available to Parent (i) a complete and correct copy of each Investigational New Drug application submitted in the United States (each, an “IND”) including all supplements and amendments in respect of such INDs and each form of Investigational Medicinal Product Dossier submitted outside of the United States for currently active clinical trials (each, an “IMPD”) (together with a list of each country in which such IMPDs have been submitted), in each case, with respect to each Product, (ii) a complete and correct copy of each New Drug Application (including the equivalent regulatory submission outside of the United States, an “NDA”) with respect to each Product, including all supplements and amendments thereto, (iii) copies of all clinical study reports under such INDs and (iv) all material correspondence to or from the Company and each Company Subsidiary and FDA or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICAREother Governmental Entity with respect to such INDs. (d) To Borrower’s knowledgeExcept as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, since January 1, 2020, none of the Borrower’s Company, any Company Subsidiary or its Subsidiaries’ officersany of their respective employees is or has been debarred from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b). Except as would not reasonably be expected to, directors individually or employees has in the aggregate, be material to the Company and the Company Subsidiaries (taken as a whole), since January 1, 2020, to the knowledge of the Company, the Company and the Company Subsidiaries have not, and none of their respective representatives have, made an any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to the FDAFDA or any other Governmental Entity, or committed an act, made a statement, statement or failed to make a statement that could that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991)) or any similar policy. (e) No BorrowerExcept as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, since January 1, 2020, (i) all clinical trials conducted by or on behalf of the Company or any Company Subsidiary have been conducted in compliance with applicable protocols, procedures and applicable Drug Laws and Healthcare Laws, (ii) no Governmental Entity has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any Company Subsidiary and (iii) neither the Company nor any Company Subsidiary thereofhas received any written notice or communication alleging that the Company has violated or failed to comply with any applicable Drug Laws or Healthcare Laws with respect to such clinical trials. (f) Since January 1, is subject to 2020, neither the Company nor any proceedingCompany Subsidiary, suit ornor, to the knowledge of the Company, any Borrower’s knowledgeof their respective officers or employees, investigation nor, to the knowledge of the Company, any licensor, licensee, partner, third-party contractor, supplier, manufacturer, distributor, consultant or vendor in relation to Products has been notified by any Governmental AuthorityEntity (including through the receipt of any FDA Form 483, Warning Letter, Untitled Letter, Notice of Violation or injunction), qui tam relator or other third party of any failure (or any investigation with respect thereto) to comply with, or maintain systems and programs to ensure compliance with, any Drug Law or Healthcare Law, including those pertaining to programs or systems regarding product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, postmarketing commitments and requirements, and requirements applicable to the conflict of interest of clinical investigators and Adverse Drug Reaction Reporting requirements, in each case with respect to any Products, except for such failures or investigations, which would not reasonably be expected to, individually or in the aggregate, be material to the Company and the Company Subsidiaries (taken as a whole), and, to the knowledge of the Company, there are no facts or circumstances that, now or with the passage of time, would create a basis for the giving of any such notice. (g) As of the date of this Agreement, (i) no Product has been recalled, withdrawn or suspended since January 1, 2020 and, to the knowledge of the Company, except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), no facts or circumstances exist that could reasonably be expected to result in such actions, and (ii) no Proceedings (whether completed or pending) seeking the revocationrecall, transfer, surrenderwithdrawal, suspension or seizure of any material Permits Product are pending or, to the knowledge of Borrower the Company, threatened against the Company or any Company Subsidiary, in each case, that . (h) Except as would not reasonably be expected to result be, individually or in the aggregate, material to the Company and the Company Subsidiaries (taken as a whole), the Company has implemented a commercially reasonable compliance program, including appropriate policies, procedures, and trainings, designed to ensure compliance with applicable Drug Laws, Healthcare Laws and industry codes and standards. (i) Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect. (f) As , since January 1, 2020, the collection, access, maintenance, transmission, use and disclosure of Personal Information by the Company and all Company Subsidiaries is and has been in compliance with HIPAA. Neither the Company nor any Company Subsidiary has received any written or, to the knowledge of the Closing DateCompany, oral complaint, claim, subpoena, demand or notice of investigation from any Governmental Entity or other Person, including inquiries or other communications from the Department of Health and Human Services Office for Civil Rights, regarding the Company or any Company Subsidiary’s collection, use or disclosure of, or security practices or Cybersecurity Incidents regarding, Personal Information, including with respect to any alleged “breach” or successful “security incident”, as such terms are defined under HIPAA, in the possession or under the control of the Company or any Company Subsidiary or being held by subcontractors on behalf of the Company or any Company Subsidiary, and, to the knowledge of the Company, there have been are no Regulatory Reporting Eventsfacts or circumstances that, now or with the passage of time, would create a basis for any inquiry or claim.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower The Company and its Subsidiaries are and have receivedbeen in compliance in all material respects with all applicable rules, regulations, decrees, guidance, pronouncements, circulars, standards and policies of the FDA and the SAMR and any other applicable Regulatory Authority, including cGMP, cGLP, and such Product is cGCP (collectively, “Regulatory Requirements”). (b) No IND filed by or on behalf of the subject of, all Regulatory Required Permits needed in connection Company with the testingFDA or SAMR has been terminated by the FDA or SAMR, manufactureand none of the FDA, marketing the SAMR, or sale any other Regulatory Authority has recommended, commenced, or, to the Knowledge of such Product as currently being the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise delay or suspend, proposed or ongoing clinical investigations or trials conducted or proposed to be conducted by or on behalf of Borrowerthe Company and its Subsidiaries. (c) All operations of the Company and its Subsidiaries and all of the manufacturing facilities and operations of the Company’s and its Subsidiaries’ suppliers of products and product candidates and the components thereof manufactured in or imported into the United States are in compliance with applicable Regulatory Requirements, and meet sanitation standards set by the Federal Food, Drug and Cosmetic Act of 1938, as amended. All of the operations of the Company and its Subsidiaries and all of the manufacturing facilities and operations of the Company’s and its Subsidiaries’ suppliers of products and product candidates and the components thereof manufactured in or imported into the PRC are in compliance with applicable SAMR Regulatory Requirements, and all the operations of the Company and its Subsidiaries and all of the manufacturing facilities and operations of the Company’s and its Subsidiaries’ suppliers of products and product candidates manufactured outside of the United States or the PRC are in compliance with applicable Regulatory Requirements in each jurisdiction in which the activity takes place. (d) Except as would not be material to the Company and its Subsidiaries, (i) the Company and its Subsidiaries have obtained, in accordance with applicable Law, all Permits required under any applicable Law or required by the SAMR, FDA or any other applicable Regulatory Authority for the lawful operation of their respective businesses, as presently conducted, (ii) each such Permit is valid and in full force and effect, (iii) there are currently no Actions pending that seek the revocation, cancellation or adverse modification of any Permit; and (iv) to the Knowledge of the Company, there is no expectation nor awareness that any of the Permits will not be renewed or extended on expiry of the current term on the same terms, or will only be extended or renewed on less favorable terms than currently. All Regulatory Documentation has been maintained and retained in accordance with applicable Laws, and such Regulatory Documentation is in the possession or control of the Company and its Subsidiaries. (e) The Company and its Subsidiaries are not subject to any unresolved notice, citation, suspension, revocation, warning, administrative proceeding, review or investigation or other Action by a Regulatory Authority that alleges or asserts that the Company or its Subsidiaries has violated any applicable Healthcare Laws, including an FDA Form 483, FDA warning letter, untitled letter, or similar notice of alleged non-compliance. There has not been a recall or market withdrawal or any product candidates by or on behalf of the Company or its Subsidiaries. The Company and its Subsidiaries have complied with all adverse event reporting requirements applicable to its product candidates. (f) All material reports, documents, claims, permits and notices related to the conduct of the business of the Company and its Subsidiaries required to be filed, maintained or furnished to the FDA, the SAMR, any Regulatory Authority have been so filed, maintained or furnished, and all such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were promptly corrected in or supplemented by a subsequent filing). (i) Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any of their respective officers, employees, agents, or distributors, or any other Person involved in development of any data included in any filing of the Company or its Subsidiaries submitted to a Regulatory Authority has been convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by 21 U.S.C. § 335a, nor has any such Person been so debarred, and (ii) such Product has been and is being testedneither the Company nor any of its Subsidiaries, manufacturednor, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as to the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none Knowledge of the Borrowers or Company, any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ their respective officers, directors employees or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borroweragents, nor any Subsidiary thereofother Person involved in the development of any data included in any filing of the Company or its Subsidiaries submitted to a Regulatory Authority has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under 42 U.S.C. § 1320a-7, is subject to nor has any proceeding, suit orsuch Person been excluded from participation in such programs. Neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any Borrower’s knowledgeof their respective directors, investigation by any Governmental Authority, senior managers or legal representatives is prohibited under applicable PRC Laws from holding the current offices which would reasonably be expected to result in they occupy within the revocation, transfer, surrender, suspension of any material Permits of Borrower Company or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectof its Subsidiaries. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With The Company and the Company Affiliates hold all material licenses and other material rights, accreditations, permits and authorizations required by law, ordinance, regulation or ruling of any Governmental Authority necessary to operate their businesses. The Company and the Company Affiliates are certified for participation and reimbursement under Titles XVIII and XIX of the Social Security Act and have current provider agreements for such Government Programs and with such Private Programs, including any private insurance program under which they directly or indirectly are presently receiving payments. Set forth in Section 3.26(a) of the Disclosure Letter is a correct and complete list in all material respects, with respect to the Company and the Company Affiliates, of such licenses and provider numbers under all Government Programs. (b) No material violation, default, order or deficiency exists with respect to any material licenses and other material rights, accreditations, permits and authorizations required by law (collectively, the “Rights”), ordinance, regulation or ruling of any Governmental Authority necessary to operate the Company’s and the Company Affiliates’ businesses in all material respects as presently operated. The Company has not received any written notice of any action pending or recommended by any state or federal agencies having jurisdiction over such Rights, either to revoke, withdraw or suspend any license, right or authorization, or to terminate the participation of the Company or any of the Company Affiliates in any Government or Private Program. Since September 30, 2004, the Company has renewed or intends to renew, and has not received any notice or communication from the other party of an intent to terminate or not renew, each Product and except as would notprovider or third-party payer agreement of the Company necessary for the operation of the Business. (c) Except, individually or in the aggregate, reasonably be expected to as have a Material Adverse Effect, (i) Borrower and its Subsidiaries have receivednot had, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have have, a Material Adverse Effect, none the Company and the Company Affiliates have timely filed all reports required to be filed and timely filed all claims or b▇▇▇▇▇▇▇ prior to the date hereof in accordance with the Government and Private Programs, all fiscal intermediaries and other insurance carriers and all such reports and b▇▇▇▇▇▇▇ are complete and accurate in all material respects and have been prepared in compliance in all material respects with all applicable laws, rules and regulations governing reimbursement and payment claims. The Company and the Company Affiliates have paid or caused to be paid all known and undisputed refunds, overpayments, discounts or adjustments which have become due pursuant to such reports and b▇▇▇▇▇▇▇ including any hospice Medicare cap liability and to the knowledge of the Borrowers Company have no liability under any Government or Private Program (including, but not limited to any Subsidiary thereof hospice Medicare cap liability) for any refund, overpayment, discount or adjustment. To the knowledge of the Company, there are no other reports or claims or b▇▇▇▇▇▇▇ required to be filed by the Company in violation of order to be paid under any applicable Healthcare Law. (c) No Borrower Government or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from MedicarePrivate Program for services rendered in connection with the business, Medicaid, or TRICAREexcept for reports not yet due. (d) To Borrower’s knowledge, none Neither the Company nor any of the Borrower’s or its Subsidiaries’ officersCompany Affiliates nor any of their employees is a party to, directors or employees has made an untrue statement nor subject to, the terms of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDAany corporate integrity agreement (“CIA”), committed an actcertificate of compliance agreement (“CCA”), made a statementmonitoring agreement, consent decree, settlement order, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting similar agreement with or imposed by any Governmental Authority (collectively, “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991Governmental Agreements”). (e) No BorrowerExcept as permitted under applicable Laws, to the knowledge of the Company, neither the Company nor any Subsidiary thereofof the Company Affiliates have: (i) offered, is subject paid, solicited or received anything of value, paid directly or indirectly, overtly or covertly, in cash or in-kind (including any kick-back, self referral, bribe, or rebate) (collectively, “Remuneration”) to or from any proceedingphysician or actual or potential referral source, suit orfamily member of a physician or actual or potential referral source, or an entity in which a physician or actual or potential referral source or physician family member or actual or potential referral source family member has an ownership or investment interest, including:(A) payments for personal or management services pursuant to a medical director agreement, consulting agreement, management contract, personal services agreement, or otherwise; (B) payments for the use of premises leased to or from a physician, a family member of a physician or an entity in which a physician or actual or potential referral source or family member has an ownership or investment interest; or (C) payments for the acquisition or lease of equipment, goods or supplies from a physician or actual or potential referral source, a family member of a physician or actual or potential referral source or an entity in which any Borrower’s knowledgeof them has an ownership or investment interest; (ii) except for lawful discounts offered in the ordinary course of business consistent with industry practice, investigation offered, paid, solicited or received any Remuneration (excluding fair market value payments for equipment or supplies) to or from any health care provider, pharmacy, drug or equipment supplier, distributor or manufacturer, including discounts, rebates, or other reductions in price on a good or service received by the Company or any of the Company Affiliates; (iii) except for lawful discounts offered in the ordinary course of business consistent with industry practice, offered, paid, solicited or received any Remuneration to or from any person or entity in order to induce business, including payments intended not only to induce actual or potential referrals of patients, but also to induce the purchasing, leasing, ordering or arrangement for any good, facility, service or item; (iv) entered into any financial relationships within the meaning of 42 C.F.R. § 411.354; including any joint venture, partnership, co-ownership or other arrangement involving any ownership or investment interest by any Governmental Authorityphysician, or family member of a physician, or an entity in which would reasonably be expected physician or physician family member has an ownership or investment interest, directly or indirectly, through equity, debt, or other means, including an interest in an entity providing goods or services to result the Company or any of the Company Affiliates; (v) entered into any compensation arrangement or business venture, including any joint venture, partnership, co-ownership or other arrangement involving any ownership or investment interest by any person or entity including a hospital, pharmacy, drug or equipment supplier, distributor or manufacturer, that is or was in a position to make or influence actual or potential referrals, furnish items or services to, or otherwise generate business for the revocation, transfer, surrender, suspension Company or the Company Affiliates; or (vi) entered into any agreement providing for the actual or potential referral of any material Permits patient for the provision of Borrower goods or services by the Company or the Company Affiliates, or payments by the Company or any Subsidiary, in each case, that would reasonably be expected of the Company Affiliates as a result of any referrals of patients to result in a Material Adverse EffectCompany (excluding commercial payer Contracts providing for such referrals and payments). (f) As To the knowledge of the Closing DateCompany, there neither the Company nor any of the Company Affiliates nor any independent contractor providing professional services on behalf of and in connection with the Company and the Company Affiliates has engaged in any activities which are prohibited under 42 U.S.C. §§ 1320a-7b, 42 U.S.C. §§ 1395nn or 31 U.S.C. §§ 3729-3733 (or other federal or state statutes related to false or fraudulent claims) or the regulations promulgated thereunder pursuant to such statutes, or similar state or local statutes or regulations, or which are prohibited by rules of professional conduct, including the following: (i) knowingly and willfully making or causing to be made a false statement or representation of a material fact in any application for any benefit or payment; (ii) knowingly and willfully submitting claims for services when such services did not fully satisfy any conditions for payment; (iii) knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit or payment; (iv) failing to disclose knowledge by a claimant of the occurrence of any event affecting the initial or continued right to any benefit or payment on its own behalf or on behalf of another, with intent to fraudulently secure such benefit or payment; (v) billing for referrals from physicians with a financial relationship with the Company or any of the Company Affiliates that does not meet an exception; and (vi) knowingly and willfully soliciting or receiving any Remuneration, directly or indirectly, overtly or covertly, in cash or in-kind or paying or offering to pay or receive such remuneration (A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part by Medicare or Medicaid, or (B) in return for purchasing, leasing, or ordering or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part by Medicare or Medicaid. (g) To the knowledge of the Company, neither the Company nor any of the Company Affiliates have been no Regulatory Reporting Eventsengaged in any activities which are prohibited under the Federal Controlled Substances Act, the Federal Food, Drug and Cosmetic Act, or the regulations promulgated pursuant to such statutes or any similar state or local statutes or regulations concerning the dispensing and sale of controlled substances. (h) To the knowledge of the Company, neither the Company nor any of the Company Affiliates nor, to the knowledge of the Company, any of their respective officers, directors, employees, or agents or persons who provide professional services to the Company or any Company Affiliate, has, in connection with activities directly or indirectly related to the Company or such Company Affiliate, engaged in any activities which are prohibited under the Federal Controlled Substances Act, the Federal Food, Drug and Cosmetic Act, or the regulations promulgated pursuant to such statutes or any similar state or local statutes or regulations concerning the dispensing and sale of controlled substances. (i) The Company and each of the Company Affiliates: (i) is in material compliance with all applicable Laws and any other applicable guidance relating to the operation of each of its pharmacies, the repackaging of drug products, the wholesale distribution of prescription drugs or controlled substances, and the dispensing of prescription drugs or controlled substances; (ii) is in compliance with all applicable Laws and any other applicable guidance relating to the labeling, packaging, advertising, or adulteration of prescription drugs or controlled substances; and (iii) is not subject to any sanction or other adverse action by any Governmental Authority for the matters described above in clauses (i) and (ii).

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any SubsidiarySubsidiary thereof, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to the Transferred Products and the Commercial Business, Seller is in compliance and has, since January 1, 2014, been in compliance, in each Product case, in all material respects with all applicable healthcare and except as would notpharmaceutical related Laws including, individually or in the aggregate, reasonably be expected but not limited to have a Material Adverse Effect, (i) Borrower the Federal Food, Drug and Cosmetic Act and its Subsidiaries have receivedstate counterparts; and (ii) Laws which are cause for debarment or exclusion from any federal, state or local healthcare program, in each case as applicable (“Healthcare Laws”). Seller has not received any written, or, to Seller’s knowledge, other notice from the FDA or any other Governmental Entity alleging noncompliance with any provisions of applicable Healthcare Laws. Seller is not subject to any enforcement, regulatory or administrative proceedings relating to or arising under applicable Healthcare Laws, and, to Seller’s knowledge, no such enforcement, regulatory or administrative proceeding has been threatened. (b) Seller has filed with the applicable regulatory authorities (including the United States Food and such Product is Drug Administration and any successor agency thereto (the subject of“FDA”) or any other Governmental Entity with jurisdiction over the Development, testing, approval, safety, efficacy, manufacturing, distribution, marketing, license, payment, reimbursement or sale of pharmaceutical products (a “Regulatory Authority”)) all Regulatory Required Permits needed required material filings, declarations, listings, registrations, reports, applications or submissions, including but not limited to adverse event reports, required in connection with the testingTransferred Products. All such filings, manufacturedeclarations, marketing listings, registrations, reports, applications or sale submissions were in material compliance with applicable Laws when filed, remain in full force and effect, and no material deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listing, registrations, reports, applications or submissions. (c) To the knowledge of such Product Seller, except as currently set forth in documents either delivered or made available to Buyer, all preclinical and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection with the Transferred Products have been and are being conducted in material compliance with applicable Laws, rules, regulations and binding guidances, including Good Clinical Practices requirements and federal and state Laws, rules, regulations and binding guidances restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from the FDA or any other Regulatory Authority commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of Seller relating to the Transferred Products, or otherwise alleging noncompliance with any applicable Laws with respect thereto. (d) Each of the Transferred Products is being, and at all times has been, Developed, tested, marketed, sold, and labeled, as applicable, in compliance in all material respects with all applicable Laws. There has not been any product recall, market withdrawal, replacement, “dear doctor” letter, investigator notice, safety notice, warning letter, untitled letter, inspectional observation or other written notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Transferred Products (“Safety Notice”) conducted by or on behalf of BorrowerSeller or, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to BorrowerSeller’s actual knowledge, any Safety Notice conducted by or on behalf of any applicable third partiesThird Party. To the knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time) is reasonably likely to give rise to any material actual, alleged, possible or potential action to enjoin Development, manufacturing, marketing or distribution of any Transferred Product. Seller has made available to Buyer copies of material complaints and notices of alleged defect or adverse reaction with respect to the Transferred Products that have been received in compliance with all applicable Healthcare Laws and Regulatory Required Permitswriting by Seller since January 1, 2014. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (de) To Borrower’s knowledgethe knowledge of Seller, none of in connection with the Borrower’s or its Subsidiaries’ officersTransferred Products, directors or employees Seller has not: (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Regulatory Authority; (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or any other Regulatory Authority; or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy. Regulation 46191 (September 10As of the date of this Agreement, 1991). (e) No Borrower, nor any Subsidiary thereof, Seller is not subject to any proceeding, suit pending or, to any BorrowerSeller’s knowledge, threatened investigation by any Governmental Authoritythe FDA pursuant to its Fraud, which would reasonably be expected Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. None of Seller or, to result in the revocationknowledge of Seller, transferits officers, surrenderemployees, suspension agents or clinical investigators has been suspended or debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in a Material Adverse Effect(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) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With At all times since January 1, 2018, (i) the Company has developed, tested, manufactured, labeled, marketed, promoted and stored, as applicable, each of the Company Products, and, (ii) to the Knowledge of the Company, all Company vendors have marketed and promoted each of the Company Products, in compliance with applicable Laws (in the United States and outside of the United States), including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices, as applicable, except in the case of both (i) and (ii) as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. During the three (3) years prior to the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice or other communication from any Governmental Authority alleging any violation of any Law with respect to each such activities or any “warning letters” with respect to any Company Product or any manufacturing, promotional, marketing or distribution processes or procedures, except as would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company and its Subsidiaries, taken as a whole. To the Knowledge of the Company as of the date of this Agreement, there are no existing conditions at the Company or any of its Subsidiaries or, to the Knowledge of the Company as of the date of this Agreement, at any contract manufacturer with respect to any Company Product, that would result in a Governmental Authority shutdown or import or export prohibition, “warning letters,” “untitled letters” or written requests to make material changes with respect to any Company Product including the design, manufacture or distribution of Company Products, or the way in which the Company Products are marketed or promoted, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. As of the date hereof, all material deficiencies and non-conformities discovered during audits and inspections performed by the Company, its Subsidiaries or Governmental Authorities have been corrected and resolved in all material respects. (b) During the three (3) years prior to the date of this Agreement, none of the Company nor any of its Subsidiaries or, to the Knowledge of the Company as of the date of this Agreement, any contract manufacturer, with respect to any Company Product, has received any written notices, information request letters, correspondence, orders or other written communications from any Governmental Authority issuing, requiring or causing any recall, seizure, detention, market withdrawal or replacement, safety alert, warning letter, investigator notice or other notice relating to an alleged lack of safety or efficacy of or manufacturing deficiencies of any Company Product, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower be material to the Company and its Subsidiaries, taken as a whole. None of the Company nor any of its Subsidiaries have receivedor, to the Knowledge of the Company as of the date of this Agreement, any contract manufacturer with respect to any Company Product, has taken any such action voluntarily. (c) All studies and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being trials conducted by or on behalf of Borrower, and (ii) such Product has the Company or any of its Subsidiaries have been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) conducted in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except Laws, except as would not not, individually or in the aggregate, reasonably be expected to have be material to the Company and its Subsidiaries, taken as a Material Adverse Effect, none whole. As of the Borrowers date of this Agreement, no trial conducted by or on behalf of the Company or any Subsidiary thereof of its Subsidiaries has been terminated or suspended prior to completion primarily for safety or other non-business reasons. As of the date of this Agreement, no applicable Governmental Authority, clinical investigator who has participated or is participating in a trial conducted by or on behalf of the Company or any of its Subsidiaries, or institutional review board that has or has had jurisdiction over a trial conducted by or on behalf of the Company or any of its Subsidiaries, has commenced, or, to the Knowledge of the Company as of the date of this Agreement, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing investigation conducted by or on behalf of the Company or any of its Subsidiaries. There are in violation no pending or, to the Knowledge of the Company as of the date of this Agreement, threatened actions or proceedings by any Governmental Authority seeking to (or that would reasonably be expected to) prohibit or impede the sale of any applicable Healthcare Law. (c) No Borrower Company Product into any market, except as would not, individually or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarein the aggregate, Medicaidreasonably be expected to be material to the Company and its Subsidiaries, or TRICAREtaken as a whole. (d) To Borrower’s knowledge, none All Authorizations exclusively relating to the Company Products as of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement date of material fact or fraudulent statement to this Agreement are listed on Section 4.18(d) of the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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,” Company Disclosure Letter. Except as set forth in 56 Fed. Regulation 46191 on Section 4.18(d) of the Company Disclosure Letter, neither the Company nor any of its Subsidiaries has received any written notice or request within the past twelve (September 1012) months from any Governmental Authority that requests or requires the conduct or generation of additional trials, 1991)studies or tests to maintain any such Authorization. (e) No Borrower, None of the Company nor any Subsidiary thereof, of its Subsidiaries is subject a party to any proceedingcorporate integrity agreement, suit ormonitoring agreement, to any Borrower’s knowledgedeferred prosecution agreement, investigation consent decree, settlement order, or other similar agreement, in each case, entered into with or imposed by any Governmental Authority, which would reasonably be expected and, to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As Knowledge of the Closing DateCompany as of the date of this Agreement, there have been no Regulatory Reporting Eventssuch action is pending.

Regulatory Matters. (a) With respect Section 3.24(a) of the Company Disclosure Letter sets forth a true and complete list of each Permit received by (or applied for by) the Company or any of its Subsidiaries from the FCC, any State PUC, foreign regulatory authorities or other Governmental Authority to each Product own or operate businesses regulated by Communications Laws. Except as set forth on Section 3.24(a) of the Company Disclosure Letter and except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, (i) Borrower as of the date of this Agreement, each Permit is valid and in full force and effect in accordance with its terms, and there is no outstanding written notice of cancellation, termination,modification, or notice of apparent liability or any written threatened cancellation, termination or modification in connection therewith nor are any of such Permits subject to any restrictions or conditions that limit the operations of the Company or any of its Subsidiaries have received, and such Product is the subject of, all Regulatory Required (other than restrictions or conditions generally applicable to Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsthat type). (b) Except Since January 1, 2014 through the date of this Agreement, and except as would not not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, none the Company and its Subsidiaries have taken all steps reasonablý necessary to maintain and preserve the effectiveness of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare LawPermits. (c) No Borrower Except as would not, individually or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarein the aggregate, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide have a basis for Company Material Adverse Effect, as of the FDA to invoke its policy respecting “Frauddate of this Agreement, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit there are no existing or, to any Borrower’s knowledgethe Knowledge of the Company, investigation by threatened Legal Actions before any Governmental Authority, which including the FCC and the State PUCs, regarding the Permits or the operations of the Company of any of its Subsidiaries (except Legal Action of general applicability to the industry and not specific to the Company or its Subsidiaries), that would reasonably be expected to result in the revocation, transfercancellation, surrendersuspension, suspension nonrenewal, placement of material restrictions on, or material adverse modification of any material of, the Permits that would not, individuallyor in the aggregate, reasonably be expected to have a Company Material Adverse Effect. The Company is not aware of Borrower any fact relating to its or any Subsidiaryof its Subsidiaries' respective businesses, operations (including but not limited to operations in each caseforeign jurisdictions),financial condition, direct or indirect foreign ownership or control, or legal status, **MSPSC Electronic Copy ** 2016-UA-225 Filed on 11/14/2016 ** including any officer's, director's or current employee's status, that might reasonably be expected to impair the ability of the parties to this Agreement to obtain, on a timely basis, any authorization, consent, Order, declaration or approval of, or ability to contract with, any Governmental Authority or third party necessary for the consummation of the transactions contemplated by this Agreement, or that might result in one or more material conditions being placed on any such authorization, consent, Order, declaration or approval of, or ability to contract with, any GovernmentalAuthority (including the FCC and any State PUC) or third party necessary for the consummation of the transactions contemplated by this Agreement. (d) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, as of the date of this Agreement, to the Company's Knowledge, no event has occurred that results in, or after notice or lapse of time, or both, would reasonably be expected to result in the revocation, cancellation, suspension, nonrenewal, placement of restrictions on, or material adverse modification of any of the Permits. (e) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. (f) As , to the Company's Knowledge, the Company's Subsidiaries are not in violation of any Communications Laws. Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, each of the Closing DateCompany and its Subsidiaries is in compliance in all material respects with the Communications Laws applicable to, and the terms and conditions of, any Permit, and have all Permits from, have made all required filings with, and have made all required payments due to, all Governmental Authorities, including any state regulatory authority, the FCC and the Universal Service Administrative Company (in connection with any federal Universal Service Fund assessments and contributions), required to conduct their respective businessesas presently conducted as of the date of this Agreement. Except as set forth in Section 3.24(e) of the Company Disclosure Letter, there have been no Regulatory Reporting Eventsis not pending, or to the Company's Knowledge threatened, any audits, examinations, investigations, or other proceedings in respect of any such filing and/or reporting requirements, in each case, which would reasonably be expected to be material to the Company.

Regulatory Matters. (a) With respect The Company and each of its Subsidiaries possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (“Regulatory Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Bodies relating to the Company’s and each Product of its Subsidiaries’ products and except product candidates (“Company Products”) or that are necessary for the Company or any of its Subsidiaries to conduct its business in all material respects as presently conducted. Except as would not, individually or in the aggregate, not reasonably be expected to have a Material Adverse Effect, (i) Borrower all such Regulatory Authorizations are (A) in full force and its Subsidiaries have receivedeffect, (B) validly registered and such Product is the subject of, all Regulatory Required Permits needed in connection on file with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, applicable Governmental Bodies and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third partiesC) 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 after 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 has filed, maintained or furnished to FDA or other applicable Healthcare Laws Governmental Bodies all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and Regulatory Required Permitsresponses 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 Material Adverse Effect, none all preclinical and clinical investigations sponsored by the Company or any of its Subsidiaries are being 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 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 Borrowers Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of and reasonably available to the Company or any Subsidiary thereof are of its Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of its Subsidiaries and the applicable Governmental Bodies, in violation each case with respect to any clinical studies proposed or currently conducted by, or on behalf of, the Company or any of any applicable Healthcare Lawits Subsidiaries. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none the knowledge of the Borrower’s or Company, neither the Company nor any of its Subsidiaries’ officers, directors or employees Subsidiaries has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy. Regulation 46191 (September 10As of the date of this Agreement, 1991). (e) No Borrower, neither the Company nor any Subsidiary thereof, of its Subsidiaries is the subject to of any proceeding, suit pending or, to any Borrowerthe 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 Governmental Authorityof its Subsidiaries nor, which would reasonably be expected to result in the revocationknowledge of the Company, transferany officers, surrenderemployees, suspension agents or clinical investigators of the Company or any of its Subsidiaries has been suspended or debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (d) Except as would not reasonably be expected to have a Material Adverse Effect, the Company 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)), the civil False Claims Act (31 U.S.C. § 3729 et seq.); (ii) the Federal Food, Drug and Cosmetics Act (“FDCA”); (iii) the Health Insurance Portability and Accountability Act of 1996 and the Health Information and Technology for Economic and Clinical Health Act (collectively “HIPAA”); (iv) Legal Requirements which are cause for exclusion from any federal health care program; and (v) Legal Requirements relating to 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 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. To the knowledge of the Company, 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. (e) To the extent required by applicable Legal Requirements, all manufacturing operations conducted for the benefit of the Company with respect to any Company Product used in human clinical trials have been conducted in accordance with GMP Regulations, except where the failure to comply would not reasonably be expected to have a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect 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 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 is validly held, free and clear of all Encumbrances and, in each Product case, to the Knowledge of the Seller and except upon the grant of the Telecom Approvals, shall remain so immediately following the consummation of the transactions contemplated by this Agreement and the Ancillary Agreements. Except as set forth on Section 3.10(b) of the Disclosure Schedule, to the Knowledge of the Seller, there is no circumstance, Law, event or other reason that exists or is likely to exist that would notprevent 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, individually or in the aggregate, reasonably be expected to have each holder of a Material Adverse Effect, Communications License (i) Borrower and its Subsidiaries have received, and such Product is the subject of, has operated in all Regulatory Required Permits needed material respects in connection compliance with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrowerall terms thereof including all systems build-out requirements, and (ii) such Product is in all material respects in compliance with, and the conduct of its business has been and is being testedin all material respects in compliance with, manufacturedthe applicable Law, marketedand has filed all registrations, promotedstatements, solddocuments and reports and paid all fees required by all applicable Law, importedin each case, possessedrelating to the Communications Licenses and any other applicable Law. There is no pending or, ownedto the Knowledge of the Seller, warehousedthreatened action by or before any Governmental Authority to revoke, promotedcancel, labeledsuspend, furnished modify or distributed as refuse to renew any of the case may beCommunications Licenses, by Borrowers (or there is not now issued, outstanding or, to Borrower’s actual knowledgethe Knowledge of the Seller, threatened, any notice by any applicable third partiesGovernmental Authority of any violation or complaint, or any application, complaint, or proceeding (other than applications, proceedings, or complaints that generally affect the Seller's industry as a whole) relating to the business or operations of the Seller or any Acquired Subsidiary. To the Knowledge of the Seller, no Person has asserted in writing to a Governmental Authority that a material Communications License should be modified or revoked, or that the Seller or any Acquired Subsidiary is not in material compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARECommunications License. (d) To Borrower’s knowledge, none the Knowledge of the Borrower’s Seller, no event has occurred which would permit the revocation or its Subsidiaries’ officers, directors termination of any of the Communications Licenses or employees has made an untrue statement the imposition of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statementany restriction thereon, or failed to make that would prevent any of the Communications Licenses from being renewed on a statement that could reasonably be expected to provide a routine basis for or in the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991)ordinary course. (e) No BorrowerTo the Knowledge of the Seller, Section 3.10(e) of the Disclosure Schedule sets forth a complete list of all Telecom Approvals required by Seller in connection with the consummation of the transactions contemplated by this Agreement and the Ancillary Agreements. Assuming the receipt of the Telecom Approvals, to the Knowledge of the Seller, none of the execution, delivery or performance of this Agreement or any of the other Ancillary Agreements by the Seller, nor the consummation by Seller of the transactions contemplated hereby or thereby, will result in any Subsidiary thereofrevocation, is subject cancellation, suspension or modification of any Communications Licenses or give rise to any proceeding, suit or, to any Borrower’s knowledge, investigation by the right of any Governmental Authority, which would reasonably be expected Authority to result in the revocation, transfer, surrender, suspension of take any material Permits of Borrower such action or to fail to renew any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectCommunications License. (f) As 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 Closing Datebusiness as presently conducted and for the ownership, lease or operation of the Seller's and the Acquired Subsidiaries' properties (collectively, "Other Licenses"). All of such Other Licenses are valid and in full force and effect and, to the Knowledge of the Seller, upon grant of any Regulatory Approvals applicable to the Other Licenses, shall remain so immediately following the consummation of the transactions contemplated by this Agreement and the other Ancillary Agreements, and the Seller and the Acquired Subsidiaries have duly performed and are in compliance in all material respects with all of their respective obligations under such Other Licenses. Except as set forth on Section 3.10(g) of the Disclosure Schedule, to the Knowledge of the Seller, there have been is no circumstance, Law, event or other reason that exists or is likely to exist that would prevent the granting of the Regulatory Reporting EventsApprovals 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 exist that may (with or without notice or lapse of time) constitute or result directly or indirectly in a violation of or failure to comply with any term or requirement of any such Other License, or result directly or indirectly in the revocation, withdrawal, suspension, cancellation or termination of, or any modification to, any such Other License.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower The Company and its Subsidiaries have receivedoperated and currently are in compliance in all material respects with all applicable laws, rules and such Product regulations of the jurisdictions in which they are conducting business. Each of the Company and its Subsidiaries (i) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the subject ofownership, all Regulatory Required Permits needed in connection with the testing, development, manufacture, marketing packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or sale disposal of such Product as currently being conducted any product candidate under development, manufactured or distributed by or on behalf of Borrower, and the Company ("Applicable Laws"); (ii) such Product has been not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and is being testedDrug Administration (the "FDA") or any other similar federal, manufacturedstate, marketedlocal or foreign governmental or regulatory authority (each a "Governmental Authority") alleging or asserting material noncompliance with any Applicable Laws or any licenses, promotedcertificates, soldapprovals, importedclearances, possessedauthorizations, owned, warehoused, promoted, labeled, furnished permits and supplements or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, amendments thereto required by any applicable third partiesApplicable Laws to conduct the Company’s business as described in Registration Statement ("Authorizations"); (iii) possesses all material Authorizations and such Authorizations are valid and in compliance with all applicable Healthcare Laws full force and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of effect and neither the Borrowers or any Subsidiary thereof are Company nor its Subsidiaries is in material violation of any applicable Healthcare Law. such Authorizations; (civ) No Borrower has not received notice of any pending or completed claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any Subsidiary thereof receives any payments directly (including through any other Governmental Authority or third party payment processoralleging that any product candidate operation or activity is in material violation of any Applicable Laws or Authorizations and the Company has no knowledge that the FDA or any other Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) from Medicarehas not received notice that the FDA or Governmental Authority has taken, Medicaidis taking or intends to take action to limit, suspend, materially modify or TRICARE. revoke any material Authorizations and has no knowledge that the FDA or any other Governmental Authority is considering such action; and (dvi) To Borrower’s knowledgehas filed, none 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 Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to the knowledge of the Borrower’s or Company, any of its Subsidiaries’ officers, directors or managing employees (as defined in 42 U.S.C. ▇ ▇▇▇▇▇-▇(▇)) is or has made an untrue statement of material fact been excluded, suspended or fraudulent statement to the FDA debarred from participation in any state or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statementfederal health care program, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is made subject to any proceeding, suit pending or, to any Borrowerthe Company’s knowledge, investigation by any Governmental Authority, threatened or contemplated action which would could reasonably be expected to result in the revocation, transfer, surrendersuch exclusion, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectdebarment. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect The Company is and has been in substantial compliance with all material Laws applicable to the Company’s products and activities, including, without limitation, product design, development, testing, clinical trials, manufacturing, marketing, distribution, labeling, storage and transport, in all jurisdictions in which such acts or any of them occurred or are reasonably likely to occur or such products or any of them have been or are likely to be sold or used (including any Laws administered by the United States Food and Drug Administration (“FDA”). The labeling claims and advertising and promotional claims made by the Company for any Company products are and have been in compliance with FDA approval for each Product such product in each jurisdiction where it is marketed in all material respects, and except supported by proper research, development, design, testing, analysis and disclosure that conforms in all material respects with applicable Laws. (b) The products, activities and facilities of the Company, as would notwell as, individually to the Knowledge of the Company, its suppliers, distributors, contractors and other intermediaries, are and have been in substantial compliance with all applicable requirements of Clinical Laboratory Improvement Amendments (“CLIA”), the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act (“FDCA”) and implementing FDA regulations, including, but not limited to, regulations relating to registration, listing, labeling, advertising and promotion, clinical studies and manufacturing requirements, all to the extent applicable to any of the Company’s products or in services. The Company is not and has not been subject to any obligation or requirement arising under any consent decree, consent agreement, or warning letter issued by or entered into with the aggregateFDA or any other Governmental Authority or other notice, reasonably be expected response or commitment made to have a Material Adverse Effectthe FDA or any other Governmental Authority. (c) The Company has made available to Acquiror true, correct and complete copies of (i) Borrower all customer complaints relating to any Company products and its Subsidiaries all MedWatch forms received by the Company or filed with the FDA within the last three (3) years; (ii) all warning letters, untitled letters, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or other correspondence relating to any Company products and the Company’s compliance with Laws from the FDA or any other Governmental Authority and all of the Company’s responses thereto within the last three (3) years; (iii) a list of all Company Products marketed within the last three (3) years, each of which have receivedbeen sold or distributed in material compliance with all applicable Laws; (iv) all correspondence, meeting minutes or related documents concerning material communications between FDA and the Company, including requests for information and responses thereto; (v) all written audit reports pertaining to assessment of compliance with Good Manufacturing Practice(GMP) requirements by the Company and their suppliers in the Company’s possession or reasonably accessible by the Company; and (vi) all product labeling and advertising currently in use or within the past three (3) years, including that posted on the Company’s website and in user manuals. (d) Since January 1, 2011, no exemptions or approvals for any Company product have been subjected to reevaluation, revocation, rescission, withdrawal, modification, cancellation or suspension by the FDA or other Governmental Authority and no Company product has been discontinued (other than for commercial or other business reasons), recalled or subject to a voluntary recall, field notification, field correction or removal or safety alert (whether voluntarily or otherwise), nor has the production of such products been enjoined,. Since January 1, 2011, no proceedings have occurred (whether completed or pending) seeking to recall, reclassify, re-label, suspend, detain or seize any Company product. To the Knowledge of the Company, there are no facts which are reasonably likely to cause: (A) the recall, suspension, field notification, field correction or removal, reclassification, re-labeling, detention, seizure or safety alert of any Company product or any product intended to be sold by the Company; (B) a change in the marketing classification or approval or a material change in labeling of any such products; or (C) a termination or suspension of marketing of any such products, All Company products manufactured, distributed, or developed by the Company that are subject to the jurisdiction of the FDA or comparable Governmental Authority are being and have been designed, researched, tested, manufactured, prepared, packed, assembled, packaged, labeled, stored, processed, distributed, and such Product is marketed in substantial compliance with all applicable Laws, requirements and implementing regulations thereunder; (ii) the subject ofCompany is, and at all Regulatory Required Permits needed times since January 1, 2011 has been, in connection substantial compliance with the testingwritten procedures, manufacturerecord-keeping, marketing and FDA reporting requirements for pharmaceutical drug reporting and comparable requirements, where applicable, of other Governmental Authorities; and (iii) the Company has not introduced into commercial distribution any Company products which upon their shipment by the Company were adulterated or sale of such Product misbranded as currently being defined by the FDCA. (e) All nonclinical, or pre-clinical, trials and clinical trials conducted by or on behalf of Borrowerthe Company have been, and (ii) such Product has been and is are being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) conducted in substantial compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) requirements and all applicable Healthcare Laws relating thereto, including the FDCA and Regulatory Required Permitsits applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56 and 312. (bf) Except as would not reasonably be expected Neither the Company nor, to have a Material Adverse Effect, none the Knowledge of the Borrowers Company, any director, officer, employee or agent thereof, has committed any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, any statement or failed to make a any statement that could would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Regulation Reg. 46191 (September Sept. 10, 1991). (e) No Borrowerand any amendments thereto. Neither the Company nor, nor to the Knowledge of the Company, any Subsidiary director, officer, employee or agent thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care laws (including without limitation the U.S. federal Anti-Kickback Statute, S▇▇▇▇ Law, False Claims Act, Health Insurance Portability and Accountability Act, Patient Protection and Affordable Care Act and any comparable state laws), or the regulations promulgated pursuant to such laws (each, a “Health Care Law”). There is subject to any no civil, criminal, administrative or other proceeding, suit notice or demand pending, received or, to the Knowledge of the Company, threatened against the Company that relates to an alleged violation of any Borrower’s knowledgeHealth Care Law. Neither the Company nor, investigation to the Knowledge of the Company, any director, officer, employee or agent thereof, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any Governmental Authoritysimilar Law or authorized by 21 U.S.C. sec. 335a(b) or any similar Law. There are no consent decrees (including plea agreements) or similar actions to which the Company or, to the Knowledge of the Company, any director, officer, employee or agent thereof, are bound or which would relate to Company products. No claims, actions, proceedings or investigations that could reasonably be expected to result in such disqualification, debarment, penalty or exclusion are pending or, to the revocationKnowledge of the Company, transferthreatened against the Company or any of their collective officers, surrenderemployees or agents (g) There are no investigations, suspension audits, actions, inquiries or other proceedings pending, or to the Knowledge of the Company threatened, with respect to a violation by the Company of any material Permits of Borrower Law that reasonably would be expected to result in administrative, civil, or any Subsidiarycriminal liability, in each case, and there are no facts or circumstances existing that would reasonably be expected to serve as a basis for such an investigation, audit, action, inquiry or other proceeding. (h) The Company is in substantial compliance with all applicable DEA and FDA import and export requirements, including, without limitation, import-for-export requirements, export notifications or authorizations and record keeping requirements, Schedule 2.26(h) sets forth a list of (i) all recalls, field notifications, field corrections or removals, corrective or preventive actions (CAPA) instituted as part of the Company’s GMP requirements, import alerts, detentions, seizures and safety alerts with respect to any Company products issued between January 1, 2011 and the date of this Agreement, and the dates, if any, such CAPA, recalls, field notifications, field corrections or removals, import alerts, detentions, seizures and safety alerts were resolved or closed, and (ii) to the Knowledge of the Company, any complaint files with respect to any Company products that are open as of the date of this Agreement. There are no outstanding recalls, field notifications, field corrections or removals, import alerts, detentions, seizures, safety alerts or product complaints with respect to any Company products, and to the Knowledge of the Company, there are no facts that would be reasonably likely to result in a Material Adverse Effectproduct recall, field notification, field correction or removal, import alert, detention, seizure or safety alert with respect to any Company products. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower To the Knowledge of Seller, each of the Asset Sellers and each of the Target Companies and their Subsidiaries are in compliance in all material respects with all applicable laws, rules and regulations of the United States and each foreign jurisdiction, including of the FDA, the U.S. Drug Enforcement Administration ("DEA"), the Centers for Medicare and Medicaid Services, or similar foreign Governmental Entity ("Foreign Authorities"), with respect to the manufacture, sale, labeling, storing, testing, distribution, promotion and marketing of the Products. Each of the Asset Sellers and each of the Target Companies and their Subsidiaries have all material permits, approvals, registrations and licenses related to the Manufacturing Facilities from the FDA, DEA and Foreign Authorities to conduct the Business as currently conducted. Section 4(u)(i) of the Disclosure Schedule sets forth a complete and correct index of all applications, approvals, registrations, licenses, permits or the like obtained by the Asset Sellers and each of the Target Companies and its Subsidiaries have receivedwith respect to the Manufacturing Facilities from the FDA, DEA and such Product is the subject of, all Regulatory Required Permits needed Foreign Authorities in connection with the testing, manufacture, marketing or sale conduct of the Business within the past four years and Seller has previously made all such Product as currently being conducted by or on behalf of Borrower, and information available to Buyer. (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as Within the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effectpast four years, none of the Borrowers Asset Sellers nor any of the Target Companies or their Subsidiaries is in receipt of notice of, has been or is subject to, any Subsidiary thereof adverse inspection, finding of deficiency, finding of non-compliance, compelled or voluntary recall, investigation, penalty for corrective or remedial action, corrective action plan or other compliance or enforcement action, in each case relating to the Products or the Manufacturing Facilities by the FDA, DEA or Foreign Authorities, including compliance with current good manufacturing practices as regulated and/or required by the FDA, any Foreign Authorities or the World Health Organization (collectively the "cGMPs"). There are in violation no pending or, to the Knowledge of any applicable Healthcare LawSeller, threatened, actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or complaints by the FDA, DEA or Foreign Authorities, including compliance with cGMPs. (ciii) No Borrower There are no pending actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarecomplaints by the FDA, Medicaid, DEA or TRICAREForeign Authorities relating to the Manufacturing Facilities or the Products. (div) To Borrower’s knowledgeNone of the Asset Sellers nor any of the Target Companies or their Subsidiaries has made any materially false statements on, or material omissions from, the applications, approvals, reports and other submissions to the FDA, DEA or Foreign Authorities prepared or maintained to comply with the requirements of the FDA, DEA or Foreign Authorities. (v) None of the Asset Sellers nor any of the Target Companies or their Subsidiaries has received within the past four years any notification, written or oral, that remains unresolved, from Foreign Authorities, the FDA, the DEA or other authorities indicating that any Product is misbranded or adulterated as defined in the FDC Act and the rules and regulations promulgated thereunder or any similar law, rule or regulation, whether under the jurisdiction of the FDA, DEA or any similar Foreign Authority. The Asset Sellers and the Target Companies and their Subsidiaries have properly handled and stored all Products included in the Inventory in compliance in all material respects with all applicable laws, rules and regulations and none of the Borrower’s Products included in the Inventory are misbranded or its adulterated as defined in the FDC Act and the rules and regulations promulgated thereunder or any similar law, rule or regulation, whether under the jurisdiction of the FDA, DEA or of any Foreign Authority. (vi) Within the past four years no Product has been recalled, suspended, discontinued, or withdrawn from the market, and no Product is currently involved in any ongoing, threatened or potential recall, discontinuance, withdrawal from market, or suspension as a result of any action by the FDA, DEA or any Foreign Authority against any of the Asset Sellers or any of the Target Companies or their Subsidiaries’ officers. (vii) Section 4(u)(vii) of the Disclosure Schedule sets forth all ANDAs, directors or employees has made an untrue statement NDAs, and Marketing Authorizations and all amendments and supplements thereto submitted to the FDA and any Foreign Authority, respectively, by each of the Asset Sellers (to the extent related to the Business) and each of the Target Companies and their Subsidiaries (the "Business Applications") and sets forth which Business Applications are pending and which have been approved. (viii) Each of the Asset Sellers and each of the Target Companies and their Subsidiaries have complied in all material fact or fraudulent statement respects with all applicable laws and regulations in connection with the preparation and submission to the FDA or applicable Foreign Authority of the Business Applications. Each of the ANDA Products and Marketing Authorization Products has been approved by, and is currently in good standing with the FDA or the applicable Foreign Authority to whom the corresponding Business Application was submitted. All required notices, supplemental applications and annual or other reports, including adverse events/experiences reports, with respect to each ANDA Product and Marketing Authorization Product for which a Business Application has been approved, have been filed with the FDA or the applicable Foreign Authority to whom the corresponding Business Application was submitted. (ix) None of the Asset Sellers (to the extent related to the Business) nor any of the Target Companies or their Subsidiaries has committed any act, failed to disclose a material fact required to be disclosed to the FDA, committed an take any act, made a statement, any statement or failed to make a any statement that could reasonably be expected to provide would violate the laws and regulations enforced by the FDA, the DEA, the Centers for Medicare and Medicaid Services, the U.S. Federal Trade Commission or any applicable Foreign Authorities regarding (A) the promotion, sale or distribution of any product (including the promotion of a basis product for other than the use for which such product is approved by the FDA or applicable Foreign Authorities), (B) payments or other remuneration including prohibitions against kickbacks and the offering or giving of anything of value to invoke its foreign government officials, or (C) the FDA's policy respecting “with respect to "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” " set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991) or any Compliance Policy Guide (Section 120.100 of the FDA Compliance Policy Guide (7150.09). (e) No Borrower, issued July 1, 1991), or any other similar laws, rules or regulations, whether under the jurisdiction of the FDA, DEA or any Foreign Authority, and any and all amendments thereto. None of the Asset Sellers nor any of the Target Companies or their Subsidiaries, nor to the Knowledge of Seller, any Subsidiary thereofofficer, is subject to any proceedingemployee, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension or third party vendors of any material Permits of Borrower the Asset Sellers or any Subsidiary, of the Target Companies or their Subsidiaries has been convicted of any crime or engaged in each case, any conduct that would reasonably be expected to result in a Material Adverse Effect(i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state or foreign law or regulation. (fx) As Each of the Closing DateAsset Sellers and each of the Target Companies and their Subsidiaries have complied in all material respects with the requirements of (A) the Medicaid Drug Rebate Program, there 42 U.S.C. Section 1396r-8(a), (B) any state supplemental rebate program, (C) the Public Health Service Pricing Program established by the Veterans Health Care Act of 1992 for Section 340B entities, 42 U.S.C. Section 256b and (D) the Federal Supply Schedule Program, codified in 10 U.S.C. Section Section 2301-14, 40 U.S.C. Section Section 471-514, 41 U.S.C.Section Section 251-260 and in certain sections of Titles 10, 31, 40, and 41 and known collectively as the Competition in Contracting Act. (xi) Each of the Asset Sellers and each of the Target Companies and their Subsidiaries have been no Regulatory Reporting Eventscomplied in all material respects with the requirements of any state price reporting statute or regulation.

Regulatory Matters. (a) With respect to each Product The Regulatory Approvals are in full force and except as would not, individually effect. There is no Action or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, Proceeding by any applicable third parties) Governmental or Regulatory Authority pending or, to the Knowledge of Seller, threatened seeking the recall of any Product or the revocation or suspension of the Regulatory Approvals. Seller has made available to Buyer complete and correct copies of the Regulatory Approvals. Seller has paid the FDA product and establishment fees for the Product for the FDA fiscal year 2001 and will have paid prior to Closing such fees for the FDA fiscal year in compliance with all applicable Healthcare Laws and Regulatory Required Permitswhich the Closing shall occur. (b) Except as would set forth in Section 6.09(b) of the Seller Disclosure Schedule or except as could not reasonably be expected to have a Material an Adverse Effect, none during the three (3) years prior to the date of this Agreement, with respect to the Borrowers Product only, neither Seller nor its Affiliates has received or been subject to: (i) any FDA Form 483's with respect to the Product; (ii) any FDA Notices of Adverse Findings with respect to the Product; or (iii) any warning letters or other written correspondence from the FDA or any Subsidiary thereof are other Governmental or Regulatory Authority with respect the Product in violation which the FDA or such other Governmental or Regulatory Authority asserted that the operations of Seller were not in compliance with applicable Law, with respect to the Product in the United States. Except as could not reasonably be expected to have an Adverse Effect, during the three (3) years prior to the date of this Agreement, there has not been any occurrence of any applicable Healthcare Lawproduct recall, market withdrawal or replacement, or post-sale warning conducted by or on behalf of Seller concerning the Product in the United States or any product recall, market withdrawal or replacement conducted by or on behalf of any entity as a result of any alleged defect in the Product in the United States, and Seller has made available to Buyer every complaint and notice of alleged defect or adverse reaction with respect to the Product in the United States that has been received in writing by Seller and its Affiliates or that has been orally transmitted to and recorded by Seller and its Affiliates. (c) No Borrower Other than the Regulatory Approvals and the IND, there are no licenses, permits, certificates or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, other authorizations or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation approvals issued by any Governmental Authority, which would reasonably be expected or Regulatory Authority held by Seller or its Affiliates that relate exclusively to result the Product and are used in connection with the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectBusiness. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except Except as would notnot be material to the Company Group, individually or in the aggregate, reasonably be expected to have taken as a Material Adverse Effect, whole: (i) Borrower and its Subsidiaries have received, and such Product is the subject of, Company Products are in compliance with all current applicable Device Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and Laws; (ii) such Product has been and each member of the Company Group is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Device Regulatory Laws relating to the sourcing, procurement, and the import of raw materials for the Company Products and the methods and materials used in, and the facilities and controls used for, the design, manufacture, processing, packaging, labeling, storage, distribution, export, and import, if applicable, of the Company Products; (iii) each member of the Company Group has received confirmation from the Notified Body that a formal application for conformity assessment of the Company Products has been accepted and that the Company Products may continue to be placed on the market of the European Union countries until December 31, 2028; and (iv) since January 1, 2021, all such raw materials and all Company Products have been sourced, procured, processed, manufactured, packaged, labeled, stored, handled, distributed, exported, and imported, if applicable, by the Company Group in compliance with all applicable Device Regulatory Required PermitsLaws. (b) Except as would not reasonably be expected material to have the Company Group, taken as a Material Adverse Effect, none whole: (i) all preclinical and clinical investigations sponsored by or on behalf of a member of the Borrowers or Company Group with respect to any Subsidiary thereof Company Product are being, and since January 1, 2021, have been, conducted in violation compliance with applicable Device Regulatory Laws, including Good Clinical Practices and Good Laboratory Practices requirements, and federal and state Laws restricting the use and disclosure of any applicable Healthcare Lawindividually identifiable health information; and (ii) each member of the Company Group complies with, and since January 1, 2021, has complied with, all requirements under the Laws relating to monitoring and reporting of adverse events during clinical trials. (c) No Borrower action has been taken by any Governmental Authority or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicareis in the process of being taken that would slow, Medicaidhalt or enjoin the development, manufacturing, or TRICAREmarketing of the Company Products or the operation of the business of the Company Group or subject the development, manufacturing, or marketing of the Company Products or a member of the Company to regulatory enforcement action. (d) To Borrower’s knowledgeExcept as would not be material to the Company Group, none taken as a whole, since January 1, 2021, the members of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement Company Group have maintained records relating to the FDA development, manufacture, testing, storage, handling, labeling, packaging, sale, marketing, promotion, distribution, import or failed to disclose a export of the Company Products in material fact required to compliance with all applicable Device Regulatory Laws. Except as would not be disclosed material to the Company Group, taken as a whole, each member of the Company Group and each of their respective contractors and agents have submitted to FDA, committed an actNotified Bodies and all other applicable regulatory authorities, made a statementinstitutional review boards, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraudaccreditation bodies, Untrue Statements of Material Factsall required supplemental applications, Bribery510(k) premarket notifications, CE Mark applications, pre-market approval applications and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10de novo classification requests, 1991)as applicable, notices, filings and annual or other reports and information. (e) No BorrowerExcept as would not be material to the Company Group, nor any Subsidiary thereoftaken as a whole, is subject to any proceedingsince January 1, suit or2021, to any Borrower’s knowledge, investigation all manufacturing operations for the Company Products conducted by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension or on behalf of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As member of the Closing Date, there Company Group have been no Regulatory Reporting Events.and are being conducted in compliance with the QSR and any similar requirements of the FDA, Notified Bodies and any other Company Product regulatory authority, and the Company Products are not adulterated within the meaning of

Regulatory Matters. (a) With respect The Company and each of its Subsidiaries have all material permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to conduct the research, development (clinical or otherwise), manufacture, or commercialization of the Company product candidate STS101 or otherwise the Company’s and each Product of the Subsidiary’s business as currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries (the “Company Permits”). The Company has timely submitted all renewal applications, reports, forms, registrations and documents required to be filed and paid all fees and assessments in connection with the Company Permits and has not received any written notice from a Governmental Entity alleging that it has failed to hold any Company Permit. The Company is in compliance with the rules and regulations of the Governmental Entity issuing such Company Permit. (b) The Company Permits are in full force and effect, except as would notfor any failures to be in full force and effect that, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have result in a Material Adverse Effectliability that is material to the Company and its Subsidiaries. The Company and each of its Subsidiaries is in compliance under such Company Permits, none of except for such failures to comply that, individually or in the Borrowers or any Subsidiary thereof are aggregate, would not reasonably be expected to result in violation of any applicable Healthcare Lawa liability that is material to the Company and its Subsidiaries, taken as a whole. (c) No Borrower Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, since January 1, 2021, the Company and each of its Subsidiaries: (i) is and at all times has been in compliance, with the Health Care Laws; (ii) has not received any Subsidiary thereof receives written notice or correspondence from any payments directly Governmental Entity alleging or asserting any noncompliance with any Company Permit or Health Care Law; and (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Company Permit and, to the Knowledge of the Company, there is no action or proceeding pending or threatened (including through any third party payment processor) from Medicareprosecution, Medicaidinjunction, seizure, civil fine, suspension or TRICARErecall), in each case alleging that such Governmental Entity is considering such action. Neither the Company nor any of its Subsidiaries has been subject to any adverse inspection, finding, penalty assessment or other Legal Proceeding or investigation or non-routine audit by any Governmental Entity, nor are there any non-routine internal investigations or inquiries currently being conducted by the compliance program of the Company that would reasonably be expected to be materially adverse to the Company. (d) To Borrower’s knowledgeAll applications, none of the Borrower’s or its Subsidiaries’ officersfilings, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact reports, documents, claims, submissions and notices required to be disclosed filed, maintained, or furnished to any Governmental Entity, including the FDA, committed an actby the Company or its Subsidiaries have been so filed, made maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a statementsubsequent filing), including adverse event reports with regard to any Company products. Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company or failed to make a statement that could reasonably be expected to provide a basis for its products, by the FDA pursuant to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” Final Policy set forth in 56 Fed. Regulation 46191 Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”). (e) No Borrower, nor or otherwise. Since January 1, 2021, none of the Company, any Subsidiary thereofof its Subsidiaries, is subject to any proceeding, suit or, to the Knowledge of the Company, any Borrower’s knowledgeofficer, investigation by employee, agent or distributor of the Company or any of its Subsidiaries has made an untrue statement of material fact to the FDA or any other Governmental AuthorityEntity, which failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity, or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to result provide a basis for the FDA or any other Governmental Entity to invoke the FDA Fraud Policy or any similar policy. Since January 1, 2021, none of the Company, any of its Subsidiaries, or, to the Knowledge of the Company, any officer, employee, agent or distributor of the Company or any of its Subsidiaries, has been convicted of any crime for which such Person could be excluded from participating in the revocationfederal health care programs under Section 1128 of the Social Security Act of 1935, transferas amended, surrender, suspension of any material Permits of Borrower or any Subsidiarysimilar Law. No claims, in each caseactions, proceedings or investigation that would reasonably be expected to result in a Material Adverse Effectmaterial debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. (e) Neither the Company nor any of the Company Subsidiaries is or has at any time been a party to any corporate integrity agreement, judgment, order, deferred prosecution agreement, monitoring agreement, consent decree or settlement agreement that (i) requires the payment of money by the Company or any Company Subsidiary to a Governmental Entity, (ii) requires any recoupment of money of the Company or any Company Subsidiary by any Governmental Entity or (iii) prohibits or limits any activity currently conducted by such Person under any Health Care Law. Neither the Company nor any of the Company Subsidiaries is a defendant or named party in any current or pending qui tam or False Claims Act litigation. (f) As Neither the Company, the Company Subsidiaries, any of their respective directors or officers, employees, nor, to the Knowledge of the Closing DateCompany, there independent contractors or agents, (i) has been or is currently debarred, excluded, or suspended from contracting with the federal or state government or from participating in any payment program, including Federal Health Care Programs, (ii) is currently subject to or has been threatened with, an investigation or proceeding that could reasonably be expected to result in such debarment, exclusion or suspension, or (iii) has been assessed or threatened with assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003. (g) The Company and the Company Subsidiaries have never, directly or indirectly, conducted or coordinated research that have been conducted, or supported with any federal funds or grants. Each of the Company and the Company Subsidiaries, as applicable, maintains in compliance all records required to be maintained under FDA and Research Laws, and/or are necessary to document research subjects’ consent/authorization to participate in research conducted or coordinated by the Company or any Company Subsidiary. All financial relationships between the Company, a Company Subsidiary, or officer, employee, or agent thereof, on the one hand, and any: (i) sponsor, funder, or supporter of research or clinical trials conducted by the Company, a Company Subsidiary, or any employee, agent or affiliate thereof; or (ii) pharmaceutical or device company, distributor, wholesaler, or any officer, employee, representative, agent, of affiliate thereof (including but not limited to pharmaceutical representatives and sales employees, contract research organizations, site management organizations or similar Persons) are in compliance with the FDA and Research Laws. No officer, employee or agent of a member of the Company (or any Company Subsidiary) (including any physician investigator engaged by such Person) has been, or has been threatened in writing to be: (a) debarred under FDA proceedings under 21 U.S.C. § 335a; (b) disqualified under FDA investigator disqualification proceedings; (c) subject to FDA’s Application Integrity Policy; or (d) subject to any enforcement proceeding arising from false statements to FDA pursuant to 18 U.S.C. § 1001. (h) Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of the Company or any of its Subsidiaries including with respect to Company product candidate STS101 are being conducted or have been conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable laws and regulations and (ii) since January 1, 2021, neither the Company nor any of its Subsidiaries has received any written notices or correspondence from a Governmental Entity or any institutional review board or comparable authority requiring the termination, clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries. There have been no Regulatory Reporting Eventsrecalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any Company product, or seizures ordered or adverse regulatory actions taken (or, to the Knowledge of the Company, threatened) by the FDA or any other Governmental Entity with respect to any of the Company products or any facilities where any such products are tested, produced, processed, packaged or stored.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have have, either individually or in the aggregate, a Material Adverse Effect, none neither the Company nor any of its Subsidiaries is, nor since January 1, 2021, has been, or has been required to be, registered, licensed or qualified as a bank, trust company, commodity trading advisor, commodity pool operator, introducing broker, futures commission merchant, swap dealer, transfer agent, real estate broker, municipal advisor, insurance company or insurance broker. (b) Since June 10, 2022, neither the Company nor any of its Subsidiaries has provided any investment management or investment advisory services, including sub-advisory services, that require such Company or Subsidiary to be registered (or to rely on an exemption from registration) as an “investment adviser” within the meaning of the Borrowers Investment Advisers Act of 1940 (the “Investment Advisers Act”)or has been required to be registered (or to rely on an exemption from registration) under any similar applicable Law in any jurisdiction. Prior to such date, since January 1, 2021, to the extent the Company or any Subsidiary thereof are of the Company provided such services, such services were provided by a Subsidiary of the Company that was a duly registered investment adviser under the Investment Advisers Act and, to the extent required, duly registered in violation any similar capacity in any other jurisdiction, and all such services were provided by the Company and any Subsidiary of any the Company in compliance with applicable Healthcare Law, except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (c) No Borrower The Company Broker-Dealer is the only Subsidiary of the Company that is a Broker-Dealer. Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (i) since January 1, 2021, the Company Broker-Dealer has been duly registered as a Broker-Dealer with the SEC and each state and other jurisdictions in which it is required to be so registered, (ii) the Company Broker-Dealer is, and since January 1, 2021 has been, a member in good standing of FINRA and has not been, nor been required to be, a member of any Subsidiary thereof receives other Self-Regulatory Organization, and (iii) to the knowledge of the Company, each natural person whose functions require him or her to be licensed as a representative or principal of, and registered with, the Company Broker-Dealer is registered with FINRA and all applicable states and other jurisdictions, such registrations are not, and since January 1, 2021 have not been, suspended, revoked or rescinded and remain in full force and effect, and no such natural person is registered with more than one Broker-Dealer in any payments directly (including through jurisdiction where such multiple registrations would violate any third party payment processor) from Medicare, Medicaid, or TRICAREapplicable Law. (d) To Borrower’s knowledge, none The Company has made available to Parent complete and correct copies of the BorrowerCompany Broker-Dealer’s current Form BD as of the date of this Agreement. The Company will make available to Parent complete and correct copies of any Form BD filed with the SEC before the Closing Date by it or any of its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could . Except as would not reasonably be expected to provide have, either individually or in the aggregate, a basis for Material Adverse Effect, (i) the FDA to invoke its policy respecting “Fraud, Untrue Statements current Form BD of Material Facts, Briberythe Company Broker-Dealer is, and Illegal Gratuities,any Form BD of the Company Broker-Dealer filed before the Closing Date will be at the time of filing, in compliance in all material respects with the applicable requirements of the Exchange Act, the rules thereunder and the rules of any Self-Regulatory Organization, as applicable and (ii) no fact relating to the Company Broker-Dealer or any “control affiliate” set forth of the Company Broker-Dealer, as defined in 56 Fed. Regulation 46191 (September 10Form BD, 1991)requires any response in the affirmative to any question in Item 11 of Form BD, except to the extent that such facts have been reflected on Form BD of the Company Broker-Dealer, as applicable. (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which Except as would not reasonably be expected to result have, either individually or in the revocationaggregate, transfera Material Adverse Effect, surrender(i) none of the Company Broker-Dealer, suspension or any of the Company’s other Subsidiaries, nor any of the Company Broker-Dealer’s “associated persons” (as defined in the Exchange Act) is (A) ineligible pursuant to Section 15(b) of the Exchange Act to serve as a Broker-Dealer or as an “associated person” of a Broker-Dealer, (B) subject to a “statutory disqualification” as defined in Section 3(a)(39) of the Exchange Act, (C) subject to any material Permits disciplinary proceedings or Orders that would be required to be disclosed on Form BD or Forms U-4 or U-5 (and which disciplinary proceedings or Orders are not actually disclosed on such person’s current Form BD or current Forms U-4 or U-5) to the extent that such person or its associated persons is required to file such forms, or (D) subject to a disqualification that would be a basis for censure, limitations on the activities, functions or operations of, or suspension or revocation of Borrower the registration of such person as broker-dealer, municipal securities dealer, government securities broker or government securities dealer under Section 15, Section 15B or Section 15C of the Exchange Act, and (ii) as of the date of this Agreement, there is no Legal Proceeding pending or, to the knowledge of the Company, threatened by any Subsidiary, in each case, Governmental Entity that would reasonably be expected to result in a Material Adverse Effectany of the circumstances described in the foregoing clauses (i)(A), (i)(B), (i)(C) and (i)(D). (f) The Brokerage Services performed by the Company Broker-Dealer since January 1, 2021 have been conducted in compliance with all material requirements of the Exchange Act, the rules and regulations of the SEC, FINRA, and any applicable state securities regulatory authority or Self-Regulatory Organization, as applicable, in each case except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect. Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (A) the Company Broker-Dealer has established, in compliance with requirements of applicable Law, and maintained in effect at all times required by applicable Law since January 1, 2021, written policies and procedures reasonably designed to achieve compliance with the Exchange Act and the rules of each applicable Self-Regulatory Organization (“BD Compliance Policies”), including those required by (i) applicable FINRA rules, including FINRA Rule 3110, 3120 and 3130, (ii) anti-money laundering laws, including a written customer identification program in compliance therewith, (iii) privacy laws including policies and procedures with respect to the protection of nonpublic personal information about customers, clients and other third parties and (iv) identity theft laws, and (B) such BD Compliance Policies have been approved by such principals, managers and other supervisors as are required under the aforementioned laws, rules and regulations. (g) The Company Broker-Dealer currently maintains, and since January 1, 2021 has maintained, “net capital” (as such term is defined in Rule 15c3-1(c)(2) under the Exchange Act) equal to or in excess of the minimum “net capital” required to be maintained by the Company Broker-Dealer, and in an amount sufficient to ensure that it is not required to file a notice under Rule 17a-11 under the Exchange Act. (h) Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (i) no Governmental Entity has, since January 1, 2021, formally initiated any administrative proceeding or investigation into the Company Broker-Dealer and (ii) the Company Broker-Dealer has not received a written “▇▇▇▇▇ notice”, other written indication of the commencement of an enforcement action from the SEC, FINRA or any other Governmental Entity, or other notice alleging any material noncompliance with any applicable Law governing the operations of Broker-Dealers. As of the Closing Datedate of this Agreement, there have the Company has no knowledge of any unresolved material violation or material exception raised in writing by any Governmental Entity with respect to the Company Broker-Dealer. Except as would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (i) since January 1, 2021, the Company Broker-Dealer has not settled any claim or proceeding of the SEC, FINRA or any other Governmental Entity and (ii) the Company Broker-Dealer has not had an order, decree or judgement entered against it by a Governmental Entity in connection with any applicable Law governing the operation of Broker-Dealers. As of the date hereof, the Company Broker-Dealer is not currently subject to, or has received any written notice of, an examination, inspection, investigation or inquiry by a Governmental Entity, and no examination or inspection has been started or completed for which no Regulatory Reporting Eventsexamination report is available.

Regulatory Matters. (a) With Since May 6, 2022, the Company and, to the Company’s knowledge, each License Counterparty has (i) filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA) all material filings, declarations, listings, registrations, reports or submissions, including adverse event reports and investigational new drug safety reports required to be filed by one of the Acquired Companies or any License Counterparty by applicable healthcare or pharmaceutical Laws or the applicable Governmental Body, in each case, that relate to ozureprubart or are otherwise material to the Acquired Companies (taken as a whole), and (ii) all such filings, declarations, listings, registrations, reports or submissions made by the Company and, to the Company’s knowledge, each License Counterparty was in compliance with applicable Laws in all material respects when filed, and no deficiencies that have been asserted by any applicable Governmental Body with respect to each Product any such filings, declarations, listing, registrations, reports or submissions remain outstanding. (b) Since May 6, 2022, all clinical trials and pre-clinical studies, including any use of Biological Materials in connection with such trials or studies, conducted by or on behalf of the Acquired Companies or, to the Company’s knowledge, any License Counterparty that relate to ozureprubart (and, except as would not, individually or in the aggregate, reasonably be expected to be material to the Acquired Companies (taken as a whole), that relate to any Product other than ozureprubart) have a Material Adverse Effectbeen and are being conducted in compliance with applicable Laws in all material respects, including, as applicable: (i) Borrower Good Laboratory Practices or Good Clinical Practices requirements, (ii) applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, (iii) approved clinical protocols, ethics approvals and its Subsidiaries have receivedinformed consents, (iv) applicable Laws restricting the use and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale disclosure of such Product as currently being conducted by or on behalf of Borrowerindividually identifiable health information, and (iiv) such Product applicable Laws relating to the collection, storage, transfer, use, disclosure, import, export and disposal of Biological Materials. As of the Agreement Date and since May 6, 2022, neither the FDA, nor any other Governmental Body performing functions similar to those performed by the FDA, has been and is being testedsent any written notices or other correspondence to the Acquired Companies, manufacturedor, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as to the case may be, by Borrowers (or to BorrowerCompany’s actual knowledge, by to a License Counterparty, with respect to any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effectongoing clinical trial or pre-clinical study requiring the termination or suspension of such trial or study, none or the material modification of the Borrowers such trial or any Subsidiary thereof are in violation of any applicable Healthcare Lawstudy. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from MedicareNeither the Acquired Companies nor, Medicaid, or TRICARE. (d) To Borrowerto the Company’s knowledge, none any License Counterparty or any Entity acting on behalf of the Borrower’s any Acquired Company or its Subsidiaries’ officersLicense Counterparty has, directors or employees has since May 6, 2022 (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or any Governmental Body or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy. Regulation 46191 (September 10As of the Agreement Date, 1991). (e) No Borrowerneither the Acquired Companies nor, nor to the Company’s knowledge, any Subsidiary thereof, is subject to License Counterparty or any proceeding, suit Entity acting on behalf of any Acquired Company or, to any Borrowerthe Company’s knowledge, any License Counterparty 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 Governmental AuthorityAcquired Company nor, which would reasonably be expected to result in the revocationknowledge of the Company, transferany current or former officers, surrenderemployees, suspension agents or clinical investigators of the Acquired Companies or any Person or individual acting on the Acquired Companies’ behalf has been suspended or debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in a Material Adverse Effect(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. There are no pending, or, to the Company’s knowledge, threatened, adverse inspections, including inspectional observations (such as Form FDA 483 observations); findings of deficiency or non-compliance; warning letters or other regulatory letters or sanctions; clinical holds, compelled or voluntary recalls, field notifications or alerts; import alerts, holds, or detentions; or other compliance or enforcement action against the Acquired Companies or, to the Company’s knowledge, any License Counterparty, in each case, with respect to (or otherwise relating to) any Product. (fd) As The Acquired Companies and, to the Company’s knowledge, all License Counterparties are in compliance in all material respects and have been in compliance in all material respects with all healthcare and pharmaceutical Laws applicable to the operation of the Closing Datebusiness of the Acquired Companies as currently conducted), there including (i) any applicable 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”) and Public Health Service Act (“PHS Act”) and the regulations and guidances issued pursuant to the FDCA and PHS Act; (iii) as applicable, 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) applicable Laws which are cause for exclusion from any federal health care program; (v) applicable Laws relating to the billing or submission of claims for health care products or services; (vi) applicable Laws relating to the collection, storage, transfer, use, disclosure, import, export and disposal of Biological Materials, and (vii) foreign equivalents of any of the foregoing. The Acquired Companies and, to the Company’s knowledge, any License Counterparty are not subject to any enforcement, regulatory or Legal Proceeding against or affecting the Acquired Companies or any License Counterparty relating to or arising under the FDCA, PHS Act, the Anti-Kickback Statute, or other healthcare or pharmaceutical Laws, and, to the Company’s knowledge, no such enforcement, regulatory or Legal Proceeding has been threatened in writing, including by the issuance of a warning letter, untitled letter, Form 483, or similar notice of potential violations of healthcare or pharmaceutical Laws. (e) To the extent required by applicable Laws, all manufacturing operations conducted by, or to the knowledge of the Company, on behalf of the Acquired Companies with respect to any Product have been no Regulatory Reporting Eventsconducted in accordance with GMP Regulations in all material respects.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower The Corporation: (A) complies in all material respects with all statutes, rules or regulations of any Governmental Authority pertaining to the business of the Corporation; and its Subsidiaries have received(B) has not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any Governmental Authority alleging or asserting noncompliance with any applicable Laws set forth in (A) of this subsection (y)(i) of this Schedule “B”, or any exemptions, Authorizations and supplements or amendments thereto required by any such applicable Laws, and, to the knowledge of the Seller, no Governmental Authority is considering such action against the Corporation. 63 (ii) There are no actual and, to the knowledge of the Seller, the Corporation has not committed any material breach of the rules of any Relevant Regulator and, to the knowledge of the Seller, there are no threatened enforcement proceedings by any Governmental Authority that has jurisdiction over the operations of the Corporation against the Corporation. The Corporation has not received written notice of any pending or, to the knowledge of the Seller, threatened claim by any Governmental Authority that has jurisdiction over the operations of the Corporation against the Corporation, and to the knowledge of the Seller, no Governmental Authority is considering such Product action. The Corporation is not subject to any obligation or requirement arising under any investigation or inspection report issued by or entered into with any Governmental Authority or any Authorization from or agreement with any Governmental Authority with regard to the subject ofbusiness of the Corporation, all Regulatory Required Permits needed in connection the products of the Corporation or the performance of any services by the Corporation. (iii) All material reports, documents, claims and notices required to be filed, maintained or furnished to any Governmental Authority by the Corporation have been so filed, maintained or furnished. All such reports, documents, claims and notices were complete and correct on the date filed such that no material liability exists with respect to the testing, manufacture, marketing completeness or sale accuracy of such Product as currently being filing. (iv) The Corporation has not received any notices, correspondence or other communication from any Governmental Authority requiring the termination, suspension or material modification of any ongoing activities conducted by by, or on behalf of, the Corporation, or in which the Corporation participates, nor, to the knowledge of Borrowerthe Seller, and is any Governmental Authority considering such action. (iiv) such Product The Corporation has not been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished convicted of any crime or distributed as the case may be, by Borrowers (engaged in any conduct which could result in debarment or to Borrower’s actual knowledge, disqualification by any applicable third parties) in compliance with all applicable Healthcare Laws Governmental Authority and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, there is subject to any proceeding, suit no proceeding pending or, to any Borrower’s knowledgethe knowledge of the Seller, investigation by any Governmental Authority, which would threatened that reasonably might be expected to result in the revocation, transfer, surrender, suspension of criminal liability or debarment or disqualification by any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectGovernmental Authority. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect Except as set forth on Schedule 5.19, each Loan Party is, and for the last six (6) years, has been, conducting its business in compliance in all material respects with all Healthcare Laws applicable to the Loan Party, its property, any Product or other asset of such Loan Party. (b) Each Loan Party and its Subsidiaries is in compliance in all material respects with Applicable Law governing the reporting and recordkeeping of Product modifications, adverse event reporting, recordkeeping for each Product Product, reporting of corrections and except as removals, and all other manufacturing and release documents and records are true in all material respects, and no Loan Party or any of its Subsidiaries has received or been subject to any written or oral communications from the FDA or any other Governmental Authority asserting that any Loan Party or any of its Subsidiaries was not in compliance with Applicable Law or any Permit which would notreasonably be expected, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (c) Each Loan Party and its Subsidiaries owns, free and clear of all Liens, except Liens permitted under this Credit Agreement, all Permits that are necessary (i) for the research, development and commercialization of the Products, including without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling any of the Products, and (ii) to carry on the business of the Loan Parties and their Subsidiaries. Each Permit is valid and in full force and effect and the Loan Parties and their Subsidiaries are in material compliance with all of the terms and conditions of such Permits and has made all declarations and filings with the applicable Governmental Authorities reasonably necessary to the conduct of the business of such Loan Party or Subsidiary. None of the Loan Parties or their Subsidiaries has received any notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof, has issued an order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that any Product should be withdrawn from the market which would reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. (d) No Loan Party nor any of its Subsidiaries has made any material untrue statement of fact and no Loan Party or any of its Subsidiaries or any of their respective agents or representatives has made any fraudulent statement to the FDA or any other Governmental Authority, and no Loan Party nor any of its Subsidiaries has failed to disclose any material fact otherwise required to be disclosed to the FDA or any other Governmental Authority. (e) Each Product (whether manufactured by the Borrower or any of its Subsidiaries, any of their respective Affiliates or a third party manufacturer under the direction of the Borrower or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all Applicable Laws, including, without limitation, all Healthcare Laws and all required Permits. (f) As There have been no adverse clinical test results, clinical holds, serious adverse health events or injuries, or enforcement actions by any Governmental Authority with respect to any of the Closing DateProducts, and there have been no Regulatory Reporting Eventsrecalls or voluntary market withdrawal from any market, except as set forth on Schedule 5.19. No investigational Product or product candidate that has not yet received the requisite FDA marketing approval or clearance has been, or is being, marketed, sold, commercialized, or promoted in the United States. (g) To the knowledge of the Loan Parties, none of the clinical investigators who is providing or has provided services in connection with any clinical trial sponsored by any Loan Party or any of their Subsidiaries has been or is disqualified, debarred, or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Loan Parties or any of their Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the Products. (h) Except as set forth on Schedule 5.19 (other than routine surveillance audits and inspections), no investigation by any Governmental Authority with respect to the Borrower or any of its Subsidiaries is pending or, to the knowledge, threatened in writing. None of the Borrower or any of its Subsidiaries has received any written or oral communications from any Governmental Authority of any noncompliance with any Applicable Laws or any written or oral communication from any Governmental Authority of any material issues, problems, or concerns regarding the quality or performance of the Products which would reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. No Loan Party nor any of their Subsidiaries has been served with or received any search warrant, subpoena, or civil investigative demand from any Governmental Authority regarding any actual or alleged violation of Healthcare Laws, except as set forth on Schedule 5.19. (i) Except as set forth on Schedule 5.19, no Loan Party nor any of its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any improper activity. No Loan Party, nor any of its Subsidiaries, nor any officer, director, employee, or any other personnel of any Loan Party or Subsidiary is a party to a corporate integrity agreement or has any reporting obligations pursuant to a settlement agreement, plan of correction, deferred prosecution agreement, consent decree or other remedial measure entered into with any Governmental Authority. (j) No Loan Party or any of its Subsidiaries, and to the knowledge of such Loan Party or Subsidiary, nor any officer, director, employee, or contractor of any Loan Party or Subsidiary (except with respect to the actions of former employees and officers of any Loan Party or Subsidiary which are public knowledge or have otherwise been disclosed in writing to the Administrative Agent and the Lenders), in such capacity on behalf of any such Person, directly or indirectly, has: (i) offered or paid or solicited or received any remuneration, in cash or in kind, or made any financial arrangements, in material violation of any applicable Healthcare Law; (ii) given any gift or gratuitous payment of any kind, nature or description (whether in money, property or services) in material violation of any applicable Healthcare Law; (iii) established or maintained any unrecorded fund or asset for any purpose or made any misleading, false or artificial entries on any of its books or records in material violation of applicable Healthcare Laws; or (iv) knowingly or willfully offered, paid, solicited or received any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind (A) in return for referring an individual to a person for the furnishing or arranging of any item or service for which payment may be made in whole or in part by any “federal health care program” (as defined in 42 U.S.C. § 1320a-7b(f)), commercial health insurer, or self-pay patient, or (B) in return for purchasing, leasing, ordering or arranging for or recommending purchasing, leasing or ordering any good, facility, service or item for which payment may be made in whole or in part by any “federal health care program” (as defined in 42 U.S.C. § 1320a-7b(f)), commercial health insurer, or self-pay patient, or otherwise made any payment to any Person with the intention that any part of such payment would be in material violation of any applicable Healthcare Law. To the knowledge of any Loan Party, no Person has filed, or has threatened in writing to file, against any Loan Party or any Subsidiary, an action under any federal or state whistleblower statute related to alleged noncompliance with applicable Healthcare Laws, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (k) Except where any of the following would not be reasonably expected, individually or in the aggregate, to result in a Material Adverse Effect, no Loan Party or any of its Subsidiaries, nor any officer, director, employee, contractor, or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in any Loan Party or Subsidiary, is: (i) excluded, debarred, disqualified, or suspended from any “federal health care program” (as such term is defined in 42 U.S.C. § 1320a-7b(f)) or any other medical reimbursement program; (ii) “suspended” or “debarred” from selling products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4); (iii) listed on the General Services Administration list of excluded parties; or (iv) made a party to any other action by any Governmental Authority that may prohibit it from selling products or providing services to any governmental or other purchaser pursuant to any Applicable Law. To the knowledge of any Loan Party, no such debarment, disqualification, suspension, exclusion, or prohibition is threatened or pending. (l) Each of the Loan Parties and their Subsidiaries maintains and adheres to, in all material respects, compliance policies and procedures that are designed to promote compliance with and to detect, prevent, and address material violations of Laws, including all material Healthcare Laws, applicable to it and/or its assets, business or operations (collectively, “Health Care Compliance Program”). No Loan Party or any of its Subsidiaries is aware of any complaints from employees, independent contractors, vendors, physicians, customers, patients or other Persons that could reasonably be considered to indicate a violation of any Applicable Law, including any applicable Healthcare Law, which would be reasonably expected, individually or in the aggregate, to result in a Material Adverse Effect. (m) The Loan Parties and their Subsidiaries are and have been for the last six (6) years, to the extent directly applicable, conducting their business in material compliance with all - 98 - regulations promulgated under HIPAA. To the extent the Loan Parties or any of their Subsidiaries create any de-identified protected health information, the Loan Parties and their Subsidiaries do so in compliance with the HIPAA regulations. No Loan Party nor any of its Subsidiaries have (i) suffered any breach of unsecured health protected health information (except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect), or (ii) failed to notify any individual or required third party, including any appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which any Loan Party or any of its Subsidiaries is a party, or any applicable requirement related to the unauthorized access, use or disclosure of protected health information. The Loan Parties have no knowledge of any complaints to or investigations by any Governmental Authority with respect to HIPAA compliance by the Loan Parties or any of their Subsidiaries, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all Applicable Laws governing the privacy, security or confidentiality of health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to the extent not preempted by HIPAA, and has conducted its businesses in material compliance with such laws since such laws first became applicable to it.

Regulatory Matters. (a) With respect Since January 1, 2017, the Products have been and are being researched, developed, tested, investigated, produced, manufactured, labeled, distributed, stored, sold, imported and exported, and all business operations of the Sellers relating to each pre-clinical and clinical investigations sponsored by the Sellers or involving Products, or to the marketing, advertising, medical information and medical affairs activities and communications, sale and pricing of the Products (including by means of the outsourcing by Sellers of any of the foregoing activities) have been and are being conducted in all material respects in compliance with Health Care Laws. (b) Except as set forth on Section 3.14(b) of the Disclosure Letter and as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), the Sellers have all Regulatory Approvals and have all the applicable documentation related to such Regulatory Approvals as provided for in the definition of Product Approvals. Each Product Approval is valid and in full force and effect except as would not, individually or in the aggregate, reasonably be expected to have be material to the Business (taken as a Material Adverse Effect, (i) Borrower and its Subsidiaries have receivedwhole). The Sellers are in compliance in all material respects with, and since January 1, 2017, have fulfilled and performed in all material respects their respective obligations under, each such Regulatory Approval. There is no action or proceeding by any Governmental Authority pending or, to the Knowledge of the Sellers, threatened seeking the revocation or suspension of any of the Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of BorrowerApprovals, and (ii) such Product since January 1, 2017, no event has been and is being testedoccurred or condition or state of facts exists that would constitute a breach or default, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effectcause revocation, none termination, or modification of any of the Borrowers Product Approvals, in each case except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole). Since January 1, 2017, Sellers have filed with the FDA and any Subsidiary thereof other applicable Governmental Authority all material filings, notices, registrations, reports or submissions which are required under any Product Approval or by any Health Care Law to have been filed or obtained as of the date of the Original Agreement. All such documents were when filed or submitted, and continue to be, in violation material compliance with applicable Health Care Laws and to the Knowledge of the Sellers, no material deficiencies have been asserted by any applicable Healthcare LawGovernmental Authority with respect to any such filings or Product Approvals since January 1, 2017. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from MedicareAll Product Regulatory Materials disclosed to Buyer are true, Medicaid, or TRICAREcorrect and complete in all material respects. (d) To Borrower’s knowledgeExcept as would not, none individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), since January 1, 2017, Sellers have not received any written notice of adverse finding, written notice of violation, warning letter, untitled letter, regulatory letter, notice of inspectional observations (Form FDA 483), correspondence regarding the termination or suspension or delay or modification of any ongoing clinical or pre-clinical studies or tests, establishment inspection reports or other correspondence or notice from the FDA or any other applicable Governmental Authority that assert (i) any deficiency in the conduct of any research, formulation, pre-clinical or other testing, clinical trial, investigation, post-market research (including research required by a Governmental Authority) in connection with the Products, or the manufacture, processing, packaging, holding, distribution, marketing or selling of the Borrower’s Products, or its Subsidiaries’ officers(ii) any other lack of compliance with Health Care Laws in connection with the Products. Except as would not, directors individually or employees in the aggregate, reasonably be expected to be material to the Business (taken as a whole), since January 1, 2017, Sellers have not received written notice of any pending or threatened civil, criminal, administrative or regulatory claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration, inquiry, search warrant, subpoena, or request for information by any Governmental Authority relating to any violation of Health Care Laws against the Sellers or, to the Knowledge of the Sellers, any person that has or is conducting or overseeing any research, development, pre-clinical or clinical testing of the Products, or that manufactures, packages, labels, imports, exports, stores, distributes or sells the Products pursuant to a manufacturing, supply or other arrangement with the Sellers, in each case since January 1, 2017. (e) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), neither the Sellers, nor, to the Knowledge of the Sellers, any member, officer, director, partner, employee, contractor or agent of any of the Sellers has made an untrue statement of material fact or a fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDAFDA or any other Governmental Authority, or committed an act, made a statement, statement or failed to make a statement that could that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borroweror for any other Governmental Authority to invoke any similar policy since January 1, nor any Subsidiary thereof2017. Except as would not, is subject to any proceedingindividually or in the aggregate, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in be material to the revocationBusiness (taken as a whole), transferneither the Sellers nor any member, surrenderofficer, suspension director, partner, employee, contractor or agent of the Sellers has been assessed or threatened with assessment of a civil monetary penalty, debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a or any Health Care Laws or exclusion under 42 U.S.C. Section 1320a 7 or any Health Care Laws since January 1, 2017. Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a Material Adverse Effectwhole), neither the Sellers nor, to the Knowledge of the Sellers, any member, officer, director, partner, employee or agent of the Sellers, are subject to any proceeding by any Governmental Authority that would reasonably be expected to result in such suspension, exclusion or debarment and to the Knowledge of the Sellers, there are no facts that would reasonably be expected to give rise to such suspension, exclusion or debarment. Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), the Sellers are not currently, and have not been, since January 1, 2017, (i) a party to any consent decree, judgment, order, or settlement, or any actual or potential settlement agreement, corporate integrity agreement or certification of compliance agreement, or (ii) a defendant or named party in any unsealed qui tam/False Claims Act litigation, in each case that relates to the Products. (f) As To the Knowledge of the Closing DateSellers, the Sellers have not received any notice or other correspondence from the FDA, any other Governmental Authority or any safety oversight board commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of the Sellers relating to any Product, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole). (g) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), all manufacturing operations conducted by or on behalf of the Sellers or that Sellers use in the Ordinary Course of Business to manufacture their Products related to the Products have been, since January 1, 2017, and are being conducted in accordance, in all material respects, with Good Manufacturing Practice requirements for the Products and there has not been any notice or other correspondence from the FDA or any other Governmental Authority to recall, suspend or otherwise restrict the manufacture of the Products since January 1, 2017. Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), since January 1, 2017, the Sellers have not either voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product, and to the Knowledge of the Sellers, there have been are no Regulatory Reporting Eventsfacts that are reasonably likely to cause the recall of any Product.

Regulatory Matters. (a) The Regulatory Approvals are in full force and effect. There is no Action or Proceeding by any Governmental or Regulatory Authority pending or, to the Knowledge of Sellers, threatened seeking the recall of any of the Products or the revocation, cancellation, modification or suspension of the Regulatory Approvals or seeking to enjoin the production of any of the Products. Sellers have made available to Buyer complete and correct copies of the Regulatory Approvals and Sellers have provided Buyer with all material written communications from the FDA or other Governmental or Regulatory Authority relating to those Regulatory Approvals. The Sellers have operated the Facility in compliance with cGMPs. (b) Sellers have timely filed with the FDA all required notices, supplemental applications and annual or other reports or documents, including adverse event reports, with respect to the Regulatory Approvals. With respect to each Product of the Products for which a Regulatory Approval has been approved by the FDA, the Sellers have acted in compliance with 21 U.S.C. Sections 351, 352 and except 355; 21 C.F.R. Parts 210, 211, or 314 et seq, respectively, and all terms and conditions of such Regulatory Approvals. (c) Except as would notset forth in Section 6.12(c) of the Sellers Disclosure Schedule, individually during the two (2) years prior to the date of each of this Agreement and Closing, with respect to the Products, Sellers and, to the Knowledge of Sellers, any third party contractor that manufactures or in the aggregatemanufactured such Products for Sellers, reasonably be expected to have a Material Adverse Effect, not received or been subject to: (i) Borrower and its Subsidiaries have receivedany FDA Form 483s with respect to such Products; (ii) any FDA Notices of Adverse Findings with respect to such Products; or (iii) any warning letters or other written correspondence from the FDA or any other Governmental or Regulatory Authority in which the FDA or such other Governmental or Regulatory Authority asserted that the operations of Sellers or such third party contractors were not in compliance with applicable Law including cGMPs with respect to such Products in the United States. Except as set forth in Section 6.12(c) of the Sellers Disclosure Schedule, and such Product is during the subject oftwo (2) years prior to the date of this Agreement, all Regulatory Required Permits needed in connection with the testingthere has not been any occurrence of any product recall, manufacturemarket withdrawal or replacement, marketing or post-sale of such Product as currently being warning conducted by or on behalf of BorrowerSellers concerning any of the Products in the United States or any product recall, market withdrawal or replacement conducted by or on behalf of any entity as a result of any alleged defect in such Products in the United States, and (ii) Sellers have made available to Buyer every complaint and notice of alleged defect or adverse reaction with respect to such Product Products in the United States that has been received in writing by Sellers or that, to the Knowledge of Sellers, has been orally transmitted to and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, recorded by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARESellers. (d) To Borrower’s knowledge, none Except as set forth in Section 6.12(d) of the Borrower’s Sellers Disclosure Schedule, during the two (2) years prior to the date of each of this Agreement and Closing, with respect to the Sellers’ contract manufacturing business at the Facility, Sellers, have not received or its Subsidiaries’ officers, directors been subject to: (i) any FDA Form 483s with respect to such business; (ii) any FDA Notices of Adverse Findings with respect to such business; or employees has made an untrue statement of material fact (iii) any warning letters or fraudulent statement to other written correspondence from the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, any other Governmental or failed to make a statement that could reasonably be expected to provide a basis for Regulatory Authority in which the FDA to invoke its policy respecting “Fraud, Untrue Statements or such other Governmental or Regulatory Authority asserted that the operations of Material Facts, Bribery, and Illegal Gratuities,” set forth Sellers were not in 56 Fed. Regulation 46191 (September 10, 1991)compliance with applicable Law including cGMPs. (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation Sellers have paid all fees required by any Governmental AuthorityRegulatory Authority with respect to the Regulatory Approvals, which would reasonably be expected including filing fees applicable to result in the revocationProducts, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected and all establishment fees applicable to result in a Material Adverse Effectthe Facility. (f) As Except as set forth on Section 6.12(f) of the Closing DateSellers Disclosure Schedule, since June 15, 2005, Sellers have, with respect to the Products, (i) timely filed with the appropriate Governmental or Regulatory Authority all reports required by applicable Law or any rebate agreement to be filed by or on behalf of it with respect to average manufacturer price (as defined under the Social Security Act, 42 U.S.C. Sections 1396r-8(k)(1)), Best Price and average sales price, and each such report has been complete and accurate; and (ii) timely paid all rebate amounts due and owing to a Governmental or Regulatory Authority in accordance with applicable Law and any rebate agreement entered into with such Governmental or Regulatory Authority. Since June 15, 2005, no deficiency with respect to such reports or rebates has been asserted in writing against Sellers with respect to the Products or the Business. (g) Sellers have not submitted any Investigational New Drug Applications to the FDA for the Products and there have been are currently no Regulatory Reporting Eventsclinical trials being conducted with respect to the Products.

Regulatory Matters. (a) With respect to each Product To the knowledge of the Company and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in for non-compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as which would not reasonably be expected to have a Material Adverse Effect, none all establishments of the Borrowers Company and its Subsidiaries have been maintained and all products of the Company and its Subsidiaries have been developed, tested, manufactured, produced, fabricated, processed, handled, possessed, packaged, labelled, stored, transported, advertised, promoted, marketed, imported, exported, sold or any Subsidiary thereof are distributed in violation material compliance with applicable Health Product Regulatory Laws and the material requirements of any applicable Healthcare LawGovernmental Entities. (b) Except for non-compliance which would not reasonably be expected to have a Material Adverse Effect, all reports, applications, documents, claims, permits and notifications required to be filed, maintained or furnished with each relevant Governmental Entity have been duly filed, maintained or furnished by the Company or its Subsidiaries, including all adverse event reports. (c) No Borrower Except as would not be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect, each of the Company and its Subsidiaries has not voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, nor is there currently under consideration by the Company, its Subsidiaries or, to the knowledge of the Company, any Governmental Entity, any recall, market withdrawal or replacement, field corrections, safety alert, warning or other notice of action related to an alleged misbranding, adulteration, lack of safety, efficacy or regulatory compliance of any product or establishment of the Company or its Subsidiaries or any Subsidiary thereof receives other form of product retrieval from the marketplace in respect of any payments directly (including through such products or any third party payment processor) from Medicare, Medicaid, revocation or TRICAREsuspension of an Authorization with respect to such products or establishments. (d) To Borrower’s knowledge, none the knowledge of the Borrower’s Company and except as would not be reasonably expected to have, individually or its Subsidiaries’ officersin the aggregate, directors a Material Adverse Effect, there are no facts or employees has made an untrue statement of material fact or fraudulent statement circumstances relating to the FDA or failed to disclose a material fact required to be disclosed to the FDACompany's business, committed an actproducts, made a statementestablishments, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, Authorizations that would reasonably be expected to result in (A) the recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its Subsidiaries, (B) a Material Adverse Effectchange in the marketing classification or a material change in the labelling of any products, or (C) a termination or suspension of the Authorizations for such products or establishments. (fe) As There are no claims against or involving the Company or any of its Subsidiaries pursuant to any product warranty or with respect to any implied representation or warranty, or the production, distribution or sale of defective or inferior products or with respect to any warnings (or failure to warn) or instructions concerning such products, and, to the knowledge of the Closing DateCompany, none has been threatened nor is there have been no Regulatory Reporting Eventsany valid basis for any such claim.

Regulatory Matters. (a) With respect The Company and each of its Subsidiaries have all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to each Product conduct its business as currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole (the “Company Permits”). (b) The Company Permits are in full force and effect, except as would notfor any failures to be in full force and effect that, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have result in a Material Adverse Effectliability that is material to the Company and its Subsidiaries, none taken as a whole. The Company and each of its Subsidiaries is in compliance under such Company Permits, except for such failures to comply that, individually or in the Borrowers or any Subsidiary thereof are aggregate, would not reasonably be expected to result in violation of any applicable Healthcare Lawa liability that is material to the Company and its Subsidiaries, taken as a whole. (c) No Borrower Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, since January 1, 2022, the Company and each of its Subsidiaries: (i) is and at all times has been in compliance, to the extent applicable, with all Healthcare Laws and with all Judgments and final guidance having the effect of Law administered or issued by any Subsidiary thereof receives Governmental Entity exercising authority applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any payments directly product tested, developed, promoted, marketed, manufactured or distributed by the Company and each of its Subsidiaries; (ii) has not received any written notice or correspondence from any Governmental Entity alleging or asserting any noncompliance with any Company Permits; (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Company Permit; and, (iv) there is no Legal Proceeding pending or, to the Knowledge of the Company, threatened in writing (including through any third party payment processor) from Medicareprosecution, Medicaidinjunction, seizure, civil fine, suspension or TRICARErecall), in each case, alleging that such Governmental Entity is considering such action. The Company has not been required to make any written notices to any Governmental Entity or Person under any Healthcare Law. (d) To Borrower’s knowledgethe Knowledge of the Company, none of the BorrowerCompany nor its Subsidiaries, nor any of the Company’s or its Subsidiaries’ directors, officers, directors employees, or employees contractors has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDAFDA or any Governmental Entity, or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case), at the time such disclosure or statement was made or failure to make occurred, establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy. Regulation 46191 (September 10As of the date of this Agreement, 1991)none of the Company nor its Subsidiaries, nor any of the Company’s or its Subsidiaries’ directors, officers, employees, or, to the Knowledge of the Company, contractors are 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. (e) No BorrowerExcept for matters that, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result individually or in the revocationaggregate, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would not reasonably be expected to result in a Material Adverse Effectliability that is material to the Company and its Subsidiaries, taken as a whole, (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of the Company or any of its Subsidiaries are being conducted or have been conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable laws and regulations and (ii) since January 1, 2022, neither the Company nor any of its Subsidiaries has received any written notices or correspondence from a Governmental Entity or any institutional review board or comparable authority requiring the termination, clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries. (f) As None of the Closing DateCompany, there the Company Subsidiaries or any of their respective officers or directors or, to the Knowledge of the Company, employees or agents, have been no Regulatory Reporting Eventsdebarred, suspended, or excluded from participation in any Federal Healthcare Program, subject to sanction pursuant to 42 U.S.C. §1320a-7a or §1320a-8, or engaged in any conduct that could reasonably result in debarment, suspension, or exclusion from participation in any Federal Healthcare Program.

Regulatory Matters. (a) With respect The Company and each of the Company Subsidiaries possesses all material Regulatory Authorizations from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Governmental Entities relating to the Company’s and each Product and except of the Company Subsidiaries’ product candidates (“Company Products”) or that are necessary for the Company or any of the Company Subsidiaries to conduct its business in all material respects as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) presently conducted. Except as would not reasonably be expected to have a Material Adverse Effect, none be material to the businesses of the Borrowers Company and the Company Subsidiaries, taken as a whole, (i) all such Regulatory Authorizations are in full force and effect, (ii) the Company and each of the Company Subsidiaries has fulfilled and performed all of its obligations with respect to such Regulatory Authorizations, and (iii) no event has occurred which allows, or after 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 the Company Subsidiaries has filed, maintained or furnished to FDA or other applicable Governmental Entities all required documents, correspondences, filings, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications, reports (including all reportable adverse event/experience reports) and (2) all such submissions were complete and accurate and in compliance with applicable Law when filed (or were corrected or completed in a subsequent filing). (b) All preclinical and clinical investigations conducted or sponsored by the Company or any Subsidiary thereof are of the Company Subsidiaries have been conducted in violation material compliance with applicable Law, rules and regulations, including Good Clinical Practices. To the Knowledge of the Company, there have been no serious or unanticipated adverse effects associated with the Company Products during clinical trials that have not been reported to any applicable Governmental Entities as required by applicable Laws. Neither the FDA nor any other Governmental Entity performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company or any of the Company Subsidiaries with respect to any 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 the Company Subsidiaries has received any written notifications from any institutional review board, ethics committee or safety monitoring committee responsible for review, oversight, or approval of any clinical trial involving a Company Product 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 trials proposed or currently conducted by, or on behalf of, the Company or any of the Company Subsidiaries, and, to Knowledge of the Company, no such action has been threatened. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data in the possession of the Company or any of the Company Subsidiaries and all material written correspondence that exists as of the date of this Agreement between the Company or any of the Company Subsidiaries and the applicable Healthcare LawGovernmental Entities, including the FDA. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none the Knowledge of the Borrower’s or its Subsidiaries’ officersCompany, directors or employees neither the Company nor any of the Company Subsidiaries has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or any other Governmental Entity or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” Gratuities Final Policy that is set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borrower, . Neither the Company nor any Subsidiary thereof, of the Company Subsidiaries is the subject to of any proceeding, suit pending or, to any Borrowerthe Company’s knowledgeKnowledge, 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 Governmental Authorityof the Company Subsidiaries nor, which would reasonably be expected to result in the revocationKnowledge of the Company, transferany officers, surrender, suspension employees or agents of the Company or any of the Company Subsidiaries has been suspended or debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, 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 would not reasonably be expected to have a Company Material Adverse Effect, the Company and each of the Company Subsidiaries is and since January 1, 2020, has been in compliance with the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”) and applicable rules and regulations implementing the FDCA. Neither the Company nor any of the Company Subsidiaries is subject to any enforcement, regulatory or administrative proceedings regarding compliance with such Laws and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened. (fe) As To the extent required by applicable Law, to the Knowledge of the Closing DateCompany, there all manufacturing operations conducted for the benefit of the Company with respect to any Company Product used in human clinical trials have been no Regulatory Reporting Eventsconducted in accordance with GMP Regulations, except where the failure to comply would not reasonably be expected to be material to the business of the Company. The Company has not engaged in activities that are, as applicable, prohibited under, or cause for false claim liability, civil penalties, or mandatory or permissive exclusion from, Medicare, Medicaid or any other applicable Governmental Entity health care program. The Company is not a party to, or bound by, any Judgments, prosecution agreements, monitoring agreements or similar agreements with, or imposed by, any Governmental Entity.

Regulatory Matters. (a) With Since the Lookback Date, neither Seller nor any of its Affiliates has received any written adverse communication from any Regulatory Authority relating to the Product Business, the Products or the facilities in which any of the Products is manufactured that has not been fully resolved, including (i) any FDA Form 483 or warning letters or in the form of other written correspondence directly relating to any of the Products or the facilities in which any of the Products is manufactured or (ii) any “Notices of Adverse Findings” from the FDA or similar written notices from other Governmental Authorities with respect to any of the Products, in each case (clauses (i) and (ii)), except as would not, individually or in the aggregate, be reasonably expected to be material to the Product Business or the Purchased Assets and Assumed Liabilities, taken as a whole. The Purchased Marketing Authorizations are all of the Marketing Authorizations held by Seller and its Affiliates in respect of the Products in the Territory. The Purchased Marketing Authorizations (i) have been validly granted or acknowledged by the relevant Governmental Authority; and (ii) are in full force and effect. (b) Since the Lookback Date, (i) there has not been any product recall (whether voluntary or involuntary), dear doctor letter, post-sale warning, safety notice, investigator notice or other written notice of action relating to the safety or efficacy of any Product or its compliance with applicable regulations, or market withdrawal or replacement conducted by or on behalf of Seller or any of its Affiliates in the Territory concerning a Product and to Seller’s Knowledge, no events exist that would reasonably be expected to require Seller or its relevant Affiliate to conduct the same, and (ii) neither Seller nor any of its Affiliates has received any written notice that any Governmental Authority in the Territory has commenced, or threatened to initiate, any action to request a recall of a Product in the Territory, in each case (clause (i) and (ii)), except as would not, individually or in the aggregate, be reasonably expected to be material to the Product Business or the Purchased Assets and Assumed Liabilities, taken as a whole. Since the Lookback Date, to Seller’s Knowledge, no Product has been Manufactured or sold which was or is defective or unsafe in any material respect, was or is of unmerchantable quality or unfit for its intended purpose in any material respect or does not comply in any material respect with any express or implied representation or warranties made with respect to such Product. Seller has made available to Buyer copies of all written notices of alleged material defect or material Adverse Events regarding the Product in the Territory received by Seller or its Affiliates from any Governmental Authority in the Territory in the 24 months prior to the date hereof. From the Lookback Date, there has not been reported to Seller or any of its Affiliates any Adverse Event related to the Products that resulted or, to Seller’s Knowledge, would be reasonably likely to result, in the FDA or equivalent Governmental Authority placing a clinical hold or taking any other action which would be material to the ongoing development, Manufacture or sale of the Products. (c) From the Lookback Date, to Seller’s Knowledge, all units of Product distributed and sold in the Territory have been researched, developed, tested, Manufactured, distributed, imported, exported and marketed in compliance in all material respects with applicable Law, including cGMP, and the applicable Purchased Marketing Authorizations and Product specifications. Neither Seller nor any of its Affiliates has received written notice of any Product Liability Claim with respect to the Product in the Territory since the Lookback Date. (d) All material reports, registrations, filings or submissions with respect to a Product or the Product Business that were required to be filed by Seller or any of its Affiliates since the Lookback Date with the FDA or any other similar Regulatory Authority in the Territory have been filed. All such reports and filings were in compliance with applicable Laws when filed or as amended or supplemented, and no material deficiencies have been asserted in writing to Seller or any of its Affiliates by any such Regulatory Authority with respect to such reports and filings that have not been cured, except, in each case, as would not, individually or in the aggregate, reasonably be expected to have be material to the Product Business, taken as a Material Adverse Effect, (i) Borrower whole. Seller and its Subsidiaries Affiliates are and since the Lookback Date have receivedbeen in compliance in all material respects with, and such Product is possess and have possessed since the subject ofLookback Date, all Regulatory Required Permits needed licenses, permits and approvals necessary for the conduct of the Product Business and have paid all material fees and assessments due and payable in connection with therewith. (e) All research and development activities, including all preclinical studies and clinical trials, of the testing, manufacture, marketing or sale of such Product as currently being Products conducted by or on behalf of BorrowerSeller with respect to the Product Business have been and, if still pending, are being, conducted in material compliance with the applicable protocol for such study or trial, to the extent applicable, good laboratory practices and good clinical practices, as applicable, and (ii) all Laws applicable to such studies and trials. No clinical trial conducted by or on behalf of Seller with respect to the Product Business has been terminated or suspended prior to scheduled completion, and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to neither the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereofother Regulatory Authority has initiated, is subject to any proceeding, suit or, to Seller’s Knowledge, threatened in writing to initiate, any Borrower’s knowledgeaction to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits Product conducted by or on behalf of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectSeller. (f) To Seller’s Knowledge, Seller is not subject to any investigation that is pending or threatened, in each case by the FDA, the Department of Health and Human Services Office of Inspector General or the Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) or the Federal False Claims Act (31 U.S.C. §3729) with respect to the Product Business. (g) With respect to the conduct of the Product Business, including arrangements with healthcare professionals in the conduct of the Product Business, or the use of the Purchased Assets, Seller has not since the Lookback Date committed a material breach of the Corporate Integrity Agreement. Other than the Corporate Integrity Agreement and related provisions in the Stipulation and Order of Settlement and Dismissal entered into by Novartis Pharmaceuticals Corporation effective July 1, 2020, neither Seller nor its Affiliates, with respect to the Product Business, the Products or the Purchased Assets, is a party to any corporate integrity agreement, consent decree, deferred prosecution agreement or similar agreement with or imposed by any Governmental Authority. (h) As of the Closing Datedate hereof, there have been no Regulatory Reporting EventsSandoz has not submitted an Abbreviated New Drug Application to the FDA for a generic version of the lifitegrast ophthalmic solution product being sold under the brand name Xiidra®. (i) The Product Business (x) is majority owned by persons who are not citizens or residents of the United States, (y) is comprised of assets, more than 50 percent of which are located outside the United States, and (z) meets the requirements for abbreviated financial statements set forth in Rule 3-05(e)(1)(i), (ii), (iii) and (iv) of Regulation S-X under the Securities Act of 1933.

Regulatory Matters. (a) With respect The Company and the Company’s Subsidiaries hold all permits, approvals, authorizations, certificates, registrations and licenses set forth in Section 3.21(a) of the Company Disclosure Letter issued by the FCC or the state public service or public utility commissions or other similar state regulatory bodies (“State PSCs”), and all other material regulatory permits, approvals, licenses and other authorizations, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to the Company or any of its Subsidiaries by a Governmental Entity (the “Company Licenses”) that are required for the Company and each Product Subsidiary of the Company to conduct its business, as presently conducted, except where the failure to hold Company Licenses has not had, and except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is Effect on the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required PermitsCompany. (b) Except as Each Company License 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, has not had, and would not reasonably be expected to have have, individually or in the aggregate, a Material Adverse EffectEffect on the Company. No Company License is subject to (i) any conditions or requirements that have not been imposed generally upon licenses in the same service, none unless such conditions or requirements are set forth on the face of the Borrowers applicable authorization or have not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company, or (ii) any pending proceeding by or before the FCC or State PSCs to suspend, revoke or cancel such Company License, or any Subsidiary thereof are judicial review of a decision by the FCC or State PSCs with respect thereto, unless such pending proceeding or judicial review has not had, and would not reasonably be expected to have, individually or in violation the aggregate, a Material Adverse Effect on the Company. The Company has no knowledge of any applicable Healthcare Lawevent, condition or circumstance that would preclude any Company License from being renewed in the ordinary course (to the extent that such Company License is renewable by its terms), except where the failure thereof to be renewed has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company. (c) No Borrower or any Subsidiary thereof receives any payments directly The licensee of each Company License is in compliance with such Company License and has fulfilled and performed all of its obligations with respect thereto, including all reports, notifications and applications required by the Communications Act of 1934, as amended (including through any third party payment processor) from Medicare, Medicaidthe “Communications Act”), or TRICAREthe 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 (i) for exemptions, waivers or similar concessions or allowances and (ii) where such failure of such licensee to be in compliance, fulfill or perform its obligations or pay such fees or contributions has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company. (d) To Borrower’s knowledge, none Section 3.21(d) of the Borrower’s Company Disclosure Letter sets forth a list of all material regulatory permits, approvals, authorizations, certificates, registrations and licenses issued or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement granted to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower Company or any Subsidiaryof its Subsidiaries by the FCC or any PSC, in each case, that constitute Company Licenses, together with the name of the entity holding such Company License. The Company or a wholly owned Subsidiary of the Company directly or indirectly owns one hundred percent (100%) of the equity interests and controls one hundred percent (100%) of the voting power and decision-making authority of each licensee of the Company Licenses, except where the failure to own such equity or control such voting power and decision making authority of such licensees has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on the Company. No Company License, order or other agreement, obtained from, issued by or concluded with any State PSC would impose restrictions of the ability of any Subsidiary of the Company to make payments, dividends or other distributions to the Company or any other Subsidiary of the Company that limits, or would reasonably be expected to result limit, the cash funding and management alternatives of the Company on a consolidated basis in a Material Adverse Effectmanner disproportionate to restrictions applied by other State PSCs. (e) The Company does not have knowledge of any facts that would materially impair, delay or preclude the Company’s ability to obtain any Governmental Consents. (f) As The Company is not aware of any pending FCC, FERC or State PSC regulatory proceeding that has had or would reasonably be expected to have, individually or in the Closing Dateaggregate, there have been no Regulatory Reporting Eventsa Material Adverse Effect on the Company.

Regulatory Matters. (a) With respect to each Product and except Except as would notnot reasonably be expected to have, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries the Acquired Corporations have receivedfiled with all applicable Regulatory Authorities all required material applications, and such Product is filings, declarations, listings, registrations, reports or submissions. To the subject ofknowledge of the Company, all Regulatory Required Permits needed such applications, filings, declarations, listings, registrations, reports or submissions were in connection material compliance with applicable Legal Requirements when filed, and, as of the testingdate of this Agreement, manufacture, marketing or sale no material deficiencies have been asserted in writing to any of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, Acquired Corporations by any applicable third parties) Regulatory Authority or Governmental Body with respect to any such applications, filings, declarations, listings, registrations, reports or submissions, except for those deficiencies that have been addressed in compliance with all applicable Healthcare Laws and Regulatory Required Permitsfull by the Company or as would not reasonably be expected to be material to the Acquired Corporations, taken as a whole. (b) Except as would not reasonably be expected to have have, individually or in the aggregate, a Material Adverse Effect, none all preclinical and clinical investigations conducted by, or on behalf of, the Acquired Corporations since July 1, 2022 have been and are being conducted in material compliance with all applicable Legal Requirements, including Good Clinical Practices requirements in each relevant jurisdiction, and including Legal Requirements restricting the use and disclosure of individually identifiable health information. Since July 1, 2022, no Acquired Corporation has received any material written notice from a Regulatory Authority with respect to any ongoing clinical or preclinical investigations requiring the Borrowers termination, suspension or any Subsidiary thereof are in violation material modification of any applicable Healthcare Lawsuch studies or tests. (c) No Borrower Except as would not reasonably be expected to have, individually or any Subsidiary thereof receives any payments directly in the aggregate, a Material Adverse Effect, since July 1, 2022, no Acquired Corporation has (including through any third party payment processori) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of a material fact or fraudulent statement to the FDA or a Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to a Regulatory Authority, or (iii) to the FDAknowledge of the Company, committed an any other act, made a statement, any statement or failed to make a statement any statement, that could (in any such case) would reasonably be expected to provide establish a reasonable basis for the FDA any Regulatory Authority to invoke its any policy respecting “related to fraud or untrue statements (e.g., the FDA’s Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy). Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which Except as would not reasonably be expected to result have, individually or in the revocationaggregate, transfera Material Adverse Effect, surrender, suspension no Acquired Corporation is the subject of any material Permits pending, or, to the knowledge of Borrower the Company, threatened investigation by a Regulatory Authority with respect to the matters specified in the foregoing clauses (i) – (iii). Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, since July 1, 2022 to the date of this Agreement, no Acquired Corporation nor, to the knowledge of the Company, any Subsidiaryofficers, employees, agents or clinical investigators (acting on behalf of the business of the Acquired Corporation) has been suspended, disqualified, debarred or convicted of any crime by a Regulatory Authority or, to the knowledge of the Company, engaged in each case, any conduct that would reasonably be expected to result in debarment or exclusion under 21 U.S.C. Section 335a, 42 U.S.C. Section 1320a-7 or a similar Legal Requirement. (d) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect: (i) each Acquired Corporation and the products manufactured or marketed by or on behalf of such Acquired Corporation have, since July 1, 2022, been in compliance with all Legal Requirements issued by a Regulatory Authority applicable to the operation of such Acquired Corporation’s business; (ii) no Acquired Corporation or, to the knowledge of the Company, third party that manufactures or commercializes finished product on behalf of the Acquired Corporations (but only in their capacity as such) has been subject to any enforcement, regulatory or administrative proceedings against or affecting such Acquired Corporation or such third party initiated by a Regulatory Authority and no such enforcement, regulatory or administrative proceeding has been threatened in writing; and (iii) no Acquired Corporation or, to the knowledge of the Company, third party that manufactures or commercializes finished product on behalf of any Acquired Corporation (but only in their capacity as such) is party to or has any ongoing obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body. (e) Except as would not reasonably be expected to be material to the Acquired Corporations, taken as a whole, since July 1, 2022, (i) the products manufactured or marketed by or on behalf of the Acquired Corporations have complied in all material respects with all applicable Legal Requirements, including GMP, and (ii) the promotional materials and claims made by the Acquired Corporations for the products manufactured or marketed by or on behalf of the Acquired Corporations have complied with all applicable Legal Requirements. (f) As of Except as would not reasonably be expected to have, individually or in the Closing Dateaggregate, a Material Adverse Effect, since July 1, 2022, (i) there have been no product recalls conducted by the Acquired Corporations, no product recalls of product manufactured by or on behalf of the Acquired Corporations, and no written requests from any Governmental Body requiring any Acquired Corporation to cease manufacturing, marketing, distributing or selling any products of the Acquired Corporations, (ii) no Regulatory Reporting EventsAuthority has initiated an injunction, seizure, or import or export prohibition against any Acquired Corporation, any product manufactured or marketed by or on behalf of any Acquired Corporation, or any third-party establishment that manufactures or tests product on behalf of any Acquired Corporation (but only in their capacity as such), and (iii) no Acquired Corporation has received any written notice of adverse observational inspections or other written warning after inspection of a manufacturing facility similar to an FDA Form 483 from a Regulatory Authority, and, to the knowledge of the Company, all adverse observations that have been received have been addressed to the satisfaction of the relevant Governmental Body. (g) Except as would not reasonably be expected to be material to the Acquired Corporations, taken as a whole, since July 1, 2022, (i) no third-party audit or inspection of any Acquired Corporation manufacturing facility has resulted in major findings requiring corrective actions, and (ii) the Acquired Corporations have taken all steps required to comply with any corrective action plan arising out of any third party auditor or internal quality audit or inspection. (h) Since July 1, 2022, no Acquired Corporation has been, with respect to any Governmental Body, party to any consent decree, judgment, order, or settlement that (i) requires the payment of money by the Acquired Corporation to any Governmental Body or third party, (ii) requires any recoupment of money from the Acquired Corporation by any Governmental Body or (iii) prohibits any activity currently conducted in the ordinary course of business by the Acquired Corporation. (i) To the knowledge of the Company, since July 1, 2022, no Person has filed against the Company a Legal Proceeding relating to the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.) or equivalent state statute, which was disclosed to the Company.

Regulatory Matters. (a) With Except as set forth on Section 3.17(a) of the Company Disclosure Letter, and except with respect to each Product Permits required under applicable Environmental Laws (as to which certain representations and except as would notwarranties are made pursuant to Section 3.12), individually the Company and the Company Subsidiaries hold all Permits issued by the FCC or in the aggregate, reasonably be expected to have a Material Adverse Effect, state public service or public utility commissions or other similar state regulatory bodies (i) Borrower and its Subsidiaries have received“State PSCs”), and such Product is all other material regulatory Permits, including franchises, ordinances and other agreements granting access to public rights of way, issued or granted to the subject ofCompany 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 business, as presently conducted in all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsmaterial respects. (b) Except as would Each Company License is in full force and effect and has not reasonably be expected been suspended, revoked, cancelled or adversely modified. No Company License is subject to (i) any conditions or requirements that have a Material Adverse Effectnot been imposed generally upon licenses in the same service, none unless such conditions or requirements are set forth on the face of the Borrowers 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 Subsidiary thereof are judicial review of a decision by any Governmental Entity, including the FCC or State PSCs with respect thereto. To the knowledge of the Company, there has not been any event, condition or circumstance that would preclude any Company License from being renewed in violation of any applicable Healthcare Lawthe ordinary course (to the extent that such Company License is renewable by its terms). (c) No Borrower The licensee of 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 any Subsidiary thereof receives any payments directly 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 through any third party payment processor) from Medicarecontribution remittances, Medicaidhave 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 TRICAREthreatened 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) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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,” Except as set forth in 56 Fed. Regulation 46191 Section 3.17(d) of the Company Disclosure Letter, neither the Company nor any Company Subsidiary has (September 10i) implemented, 1991or 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 requirements of federal and 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 BorrowerCompany License, nor Order or other agreement, obtained from, issued by or concluded with any State PSC would impose restrictions on the ability of any Company Subsidiary thereofto make payments, is subject dividends or other distributions to the Company or any proceedingCompany Subsidiary that limits, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which or would reasonably be expected to result in limit, the revocation, transfer, surrender, suspension cash funding and management alternatives of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result the Company on a consolidated basis in a Material Adverse Effectmanner disproportionate to restrictions applied by other State PSCs. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect Except as set forth in Section 3.13(a) of the Disclosure Schedule, the Company and its Subsidiaries are in compliance in all material respects with all applicable Laws. During the past three (3) years, none of the Company or any of its Subsidiaries has received any written notice, from a Governmental Authority, applicable to each Product and the Company or any of its Subsidiaries or their respective businesses, assets, rights or properties, that alleges that such Person is not in compliance with any Law or is subject to investigation, audit or review, except as for allegations of non-compliance which would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and result in any material liability to the Company or any of its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed or otherwise interfere in connection any material respect with the testing, manufacture, marketing or sale conduct of such Product their respective businesses as currently being conducted. Except as set forth in Section 3.13(a) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries, during the past three (3) years, has conducted by any formal internal investigation in which external advisors were engaged or consulted concerning any actual or alleged material violation of Law on behalf the part of Borrowerthe Company, and (ii) such Product has been and is being testedits Subsidiaries or any of its Affiliates or any of their respective officers, manufactureddirectors, marketedemployees, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished agents or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsrepresentatives. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 Section 3.13(b) of the Disclosure Schedule, all material approvals, permits, consents, registrations, clearances, exemptions, franchises, authorizations, certificates, variances and licenses of all Governmental Authorities (September 10collectively, 1991). (e“Permits”) No Borrowerthat are materially necessary to permit the Company and any of its Subsidiaries to carry on their businesses as currently conducted have been obtained and complied with by each of the Company and its Subsidiaries, nor any Subsidiary thereofexcept where the failure to obtain such Permits would not, is subject to any proceedingindividually or in the aggregate, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in any material liability to the Company or any of its Subsidiaries or otherwise interfere in any material respect with the conduct of their respective businesses as currently conducted, and such Permits are in full force and effect. To the Knowledge of the Company, no event has occurred that would result in, or after notice or lapse of time would result in, a violation, cancellation, revocation or default of any Permit or a material impairment of the rights of the holder of any such Permit, except where such violation, cancellation, revocation, transferdefault or material impairment would not, surrenderindividually or in the aggregate, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As any material liability to the Company or any of its Subsidiaries or otherwise interfere in any material respect with the conduct of their respective businesses as currently conducted. To the Knowledge of the Closing DateCompany, there have been no Regulatory Reporting Eventsnone of the Company or its Subsidiaries has received any written notice of any actions relating to revocation, suspension, modification or limitation of any such Permit which remains unresolved, except where such revocation, suspension, modification or limitation would not, individually or in the aggregate, reasonably be expected to result in any material liability to the Company or any of its Subsidiaries or otherwise interfere in any material respect with the conduct of their respective businesses as currently conducted.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in If any of the aggregate, reasonably be expected to have a Material Adverse Effect, following occurs: (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed any other applicable Governmental Authority or Notified Body (A) issues a letter or other communication asserting that any Material Product lacks a required Product Authorization and the Borrower fails to disclose a material fact required take reasonable actions to be disclosed to the FDAcontest such assertion, committed an act, made a statement(B) initiates enforcement action against, or failed issues a warning letter with respect to make any Transaction Party, or any of their Material Products or the manufacturing facilities therefor, that causes any Transaction Party to discontinue marketing or withdraw any of its Material Products from the Major Markets, or causes a statement that delay in the manufacture of any of its Material Products for the Major Markets, which discontinuance, withdrawal or delay could reasonably be expected to provide last for more than three months, or (C) withdraws, or requires the withdrawal of, any Material Product from the Major Markets for safety or effectiveness reasons, or otherwise imposes restrictions on the distribution or use of any Material Product in the Major Markets, which restrictions on distribution or use would reasonably be expected to significantly impact commercial sales of such Material Product in the Major Markets, in each case, for more than three consecutive months, except that this clause (C) will in no event apply in instances where the Borrower is selling a basis for replacement product in the FDA to invoke its policy respecting “Fraud, Untrue Statements same commercial quantities as the withdrawn Material Product; (ii) a recall of Material Facts, Bribery, and Illegal Gratuities,” set forth any Product in 56 Fed. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, the Major Markets which would reasonably be expected to result in liability of the revocationTransaction Parties to any third parties in excess of the Threshold Amount, transferexcept that any portion of such liability that is covered by the Borrower’s insurance will not count towards the Threshold Amount; or (iii) any Transaction Party enters into a settlement agreement with the FDA or any other Governmental Authority with respect to any Product and relating to the Major Markets, surrenderthat results in aggregate liability to any third parties as to any single or related series of transactions, suspension incidents or conditions in excess of the Threshold Amount, except that any portion of such liability that is covered by the Borrower’s insurance will not count towards the Threshold Amount. The occurrence and continuation of any material Permits matter listed in clauses (i)-(iii) above shall not constitute an Event of Borrower or any SubsidiaryDefault for so long as the Unrestricted Cash, in each case, that would reasonably be expected at all times following such occurrence until the circumstances giving rise to result in a Material Adverse Effect. (f) As such occurrence have been resolved to the reasonable satisfaction of the Closing DateAdministrative Agent, there have been is no Regulatory Reporting Events.less than the applicable amount set forth below, or such lesser amount as the Administrative Agent deems acceptable in its reasonable discretion (taking into account the aggregate principal amount of the Loan funded as of such measurement date, as set forth below): $ 15,000,000 $ 4,500,000 $ 20,000,000 $ 6,000,000 $ 25,000,000 $ 7,000,000

Regulatory Matters. (ai) With The Asset Sellers and each of the Target Companies and the Target Subsidiaries are in compliance with all applicable Laws of the United States and each foreign jurisdiction, including of the rules and regulations of the FDA and any governmental agency of any other country having jurisdiction of the Manufacturing Facilities or the manufacture, sale, labeling, storing, testing and distribution of the Products, as applicable (each, a “Regulatory Authority”), with respect to each Product the manufacture, sale, labeling, storing, testing and distribution of the Products, except as for such instances of noncompliance that would not, individually or and in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower . Each of the Target Companies and its the Target Subsidiaries have receivedall material permits, approvals, registrations and such Product is licenses related to the subject of, all Manufacturing Facilities from the Regulatory Required Permits needed in connection with Authorities to conduct the testing, manufacture, marketing or sale of such Product Business as currently being conducted by or on behalf of Borrower, and conducted. (ii) such Product has been and is being testedSince January 1, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers 2003 (or to Borrower’s actual knowledgeits date of formation, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effectif later), none of the Borrowers Asset Sellers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s Target Companies or its Subsidiaries’ officersthe Target Subsidiaries is in receipt of notice of, directors has been or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to to, any proceedingadverse inspection, suit orcompelled or voluntary recall, to any Borrower’s knowledgeinvestigation, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower penalty for corrective or any Subsidiaryremedial action or corrective action plan, in each casecase relating to the Products or the Manufacturing Facilities by the Regulatory Authorities, that including compliance with current good manufacturing practices as regulated and/or required by the Regulatory Authorities, except for such instances which would reasonably be expected to result not, individually and in the aggregate, have a Material Adverse Effect. (fiii) As of the Closing Datedate of this Agreement, there are no pending actions, suits, proceedings, hearings, investigations, charges, claims, demands, notices or complaints by the Regulatory Authorities relating to the Manufacturing Facilities or the Products. (iv) None of the Asset Sellers or any of the Target Companies or the Target Subsidiaries has received, since January 1, 2003 (or its date of formation, if later), any written notification, that remains unresolved, from any Regulatory Authorities indicating that any Product is misbranded or adulterated as defined in the FDA Act and the rules and regulations promulgated thereunder or any similar Law, except for such instances which would not, individually and in the aggregate, have been no Regulatory Reporting Eventsa Material Adverse Effect. The Asset Sellers and the Target Table of Contents Companies and the Target Subsidiaries have properly handled and stored all Products included in the Inventory in compliance in all material respects with all applicable Laws and none of the Products included in the Inventory are misbranded or adulterated as defined in the FDA Act and the rules and regulations promulgated thereunder or any similar Law, except for such instances which would not, individually and in the aggregate, have a Material Adverse Effect. (v) This representation does not relate to Tax matters, employee benefit matters, environmental matters or labor matters, which are covered by Sections 4(i), (n), (o) and (p), respectively.

Regulatory Matters. (a) With respect All of Credit Parties’ and their Subsidiaries’ material Products and material Regulatory Required Permits (limited to each Product and except as those Regulatory Required Permits the loss of which would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect) are listed on Schedule 4.17 on the Closing Date. With respect to each material Product, (i) Borrower the Credit Parties and its their Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrowerthe Credit Parties, and have provided Agent with all notices and other information required by Section 4.1, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, marketed or sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers Credit Parties (or to Borrower’s actual the Credit Parties’ knowledge, by any applicable third parties) in material compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none None of the Borrowers Credit Parties or any Subsidiary thereof are in violation of any applicable Healthcare LawLaw in any material respect. (c) No Borrower or any Subsidiary thereof receives any payments directly To the Credit Parties’ knowledge (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledgeafter reasonable inquiry), none of the Borrower’s Credit Parties or its their Subsidiaries’ officers, directors directors, employees, shareholders, their agents or employees affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). MidCap / Apyx Medical / Credit, Security and Guaranty Agreement (d) Except as would not reasonably be expected to result in a Material Adverse Effect, each Product (i) has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (ii) has been and/or shall be manufactured in accordance with Good Manufacturing Practices. (e) No BorrowerCredit Party, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any BorrowerCredit Party’s knowledge, investigation by any Governmental Authorityfederal, which would state or local government or quasi-governmental body, agency, board or authority or any other administrative or investigative body (including the Office of the Inspector General of the United States Department of Health and Human Services),which could reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably Subsidiary thereof or otherwise be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower SIGA has provided or made available, when requested by MMT to conduct its due diligence review, documents and communications in its Subsidiaries have receivedpossession from and to any Governmental Authority, and such Product is or prepared by any Governmental Authority, related to the subject ofProduct, all Regulatory Required Permits needed in connection that may bear on the compliance with the testingrequirements of any Governmental Authority, manufactureincluding any notice of inspection, marketing inspection report, warning letter, deficiency letter, or sale of such Product as currently being conducted by or on behalf of Borrower, and similar communication (collectively “Compliance Communications”); (ii) such Product Neither SIGA nor any of its Affiliates has been received, with respect to SIGA Intellectual Property and the Product, any oral or written communication (including any warning letter, untitled letter, or similar notices) from any Governmental Authority and, there is being testedno action pending or, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to BorrowerSIGA’s actual knowledge, by threatened (including any applicable third parties) prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that with respect to the SIGA Intellectual Property or Product, SIGA or any of its Affiliates is not currently materially in compliance with any and all applicable Healthcare Laws implemented by such Governmental Authority (collectively, a “Non-Compliance Action”). Neither SIGA nor any of its Affiliates has received any oral or written notice from any Governmental Authority claiming that the Development, Commercialization or Promotion of the Product is not in material compliance with all Laws and Regulatory Required Permits.permits; (biii) Except as would not As to any Product, during the Term SIGA shall provide, or make available, to MMT copies of any (A) Compliance Communications within five (5) Business Days after provision to, or receipt from, any Governmental Authority and (B) Non-Compliance Action within five (5) Business Days after receipt from a Governmental Authority; except (in the cases of (A) and (B)) to the extent that SIGA’s counsel reasonably be expected believes that such disclosure to MMT could violate applicable privacy Laws or have a Material Adverse Effectsignificant adverse impact on SIGA’s legal position or defense (including the loss of attorney-client privilege). In the event that SIGA determines that disclosure could violate applicable privacy laws or have a significant adverse impact on its legal position or defense, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law.SIGA shall promptly notify MMT that it is exercising its right not to disclose; and (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (div) To BorrowerSIGA’s knowledge, none of the Borrower’s SIGA, any of its Affiliates or its Subsidiaries’ any of their respective officers, directors employees or employees agents has made made, with respect to the SIGA Intellectual Property or the Product, an untrue statement of a material fact to any Governmental Authority or fraudulent statement to the FDA or has failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any such Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect Except for those matters that would not reasonably be expected to each Product and except as would nothave, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, : (i) Borrower and its Subsidiaries have receivedthe Company Entities are, and such Product since the Lookback Date have been, in compliance with all applicable Regulatory Laws and Healthcare Laws; (ii) each of the Company Entities holds and is in compliance with, and since the subject Lookback Date has held and been in compliance with, all Permits required under Regulatory Laws for the operation of its respective business; (iii) there is, and since the Lookback Date there has been, no Proceeding arising under Regulatory Laws or Healthcare Laws that is pending or, to the Knowledge of the Company, threatened against any of the Company Entities; (iv) none of the Company Entities has received any written notice of, or is subject to, any order, settlement, judgment, injunction, decree, corporate integrity agreement, deferred prosecution agreement, Form-483, warning letter, recall or import alert, in each case involving uncompleted, outstanding or unresolved liabilities or corrective or remedial obligations relating to or arising under Regulatory Laws or Healthcare Laws; (v) none of the Company Entities is, and since the Lookback Date none of the Company Entities has been, excluded from participating in any Governmental Health Program or debarred under any Regulatory Laws; (vi) all Regulatory Required Permits needed in connection with the testingproducts manufactured or otherwise produced, manufacturedistributed or sold, marketing or sale of such Product as currently being conducted services rendered, by or on behalf of Borrower, the Company Entities have been manufactured and produced in accordance with applicable Regulatory Laws; (iivii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees Company Entities has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, any other similar Governmental Authority and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (eviii) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Eventsproduct recalls (whether voluntary of involuntary) since the Lookback Date.

Regulatory Matters. For the past five (a5) With respect years, the Company and, to the Knowledge of Seller, each Product of its officers, managers, members, directors, employees, and except as contractors have materially complied with all Healthcare Laws applicable to the Company Business. For the past five (5) years, the Company has not received any (i) written notice or any oral, notice, warning, or other communications from any Governmental Entity, including the Office of Inspector General, any United States Attorney, the Department of Justice, or any attorney general of any jurisdiction, or any third party alleging that the Company has been or is in violation, breach or noncompliance with, or threatening any investigation under, (A) any applicable Healthcare Laws, (B) any applicable FDA Laws, or (ii) other written documents issued by any third parties or Governmental Entity alleging lack of compliance with any applicable Healthcare Law by the Company including, but not limited to, any applicable FDA Laws. For the past five (5) years, there has been no act, omission, misrepresentation, event, or circumstance of the Company or, to the Knowledge of Seller, any of its officers, managers, members, directors, employees, or contractors of the Company that would not, individually or in the aggregate, reasonably be expected to give rise to or form the basis for any claim against the Company for the material violation of any Healthcare Laws. (a) For the past five (5) years, the Company has not been subject to any audit, inspection, inquiry, or investigation by a Governmental Entity, asserting any noncompliance with the requirements of any Healthcare Laws other than those audits, inspections, inquiries, or investigations that have a Material Adverse Effect, been (i) Borrower and its Subsidiaries have received, and such Product is in the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, Ordinary Course and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished resolved with a finding of no fault or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance no observations of noncompliance with all applicable Healthcare Laws and Regulatory Required PermitsLaws. (b) Except as would not reasonably For the past five (5) years, the Company has timely filed all reports, applications, statements, documents, claims and notices, registrations, filings, amendments, supplements and submissions required under Healthcare Laws to be expected filed, maintained or furnished to any Governmental Entity by the Company with respect to their products and services have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a Material Adverse Effectsubsequent filing). For the past five (5) years, none to the extent applicable, the Company has promptly reported to USDA and the United States National Institutes of the Borrowers Health’s Office of Laboratory Animal Welfare all events, incidents, and violations relating to animal research and welfare required by Animal Research and Welfare Laws. No basis for liability exists with respect to any such filing, notification submission or any Subsidiary thereof are in violation of any applicable Healthcare Lawreport. (c) No Borrower For the past five (5) years, the Company has not received notice from any third parties or Governmental Entities regarding, nor identified through internal auditing and reporting, any allegation of research misconduct (defined as falsification or fabrication of data, or plagiarism, as those terms are defined in 42 C.F.R. § 93), including violations of any human subject protections and informed consent requirements, made involving research studies, data studies, real world evidence studies, pharmacovigilance activities or other research for which the Company provided services. For the past five (5) years, the Company has not received any written notice, correspondence, or other communication from any Governmental Entity recommending, requiring, or threatening a clinical hold or partial clinical hold, the termination, suspension or material modification of any ongoing clinical trials or other research studies or organizational activities which the Company has conducted, where such clinical hold, termination, suspension or material modification is based in whole or in part on the Company’s acts or omissions. To the extent the Company conducts research that is funded by the United States government or any Subsidiary thereof receives any payments directly (state government through grant, contract or other transactions authority, such research is, to the extent required by applicable Law, being conducted in material compliance with funding agency requirements, including through any third party payment processor) from Medicarethe United States National Institutes for Health’s Grants Policy Statement, Medicaidto the extent applicable. In the event notice was provided, or TRICAREin the event such misconduct was discovered by the Company, the Company has taken such actions as reasonably necessary and within its authorities/power, consistent with Laws and contract, to ensure that truthful information was relayed to the FDA and other applicable Governmental Entities. Since the Lookback Date, the Company has at all times compensated research subjects for participation in accordance with applicable Laws, customer contractual commitments, study protocols, and only as approved by applicable institutional review boards or ethics committees. (d) To Borrower’s knowledgeFor the past five (5) years, none the Company has not: (a) billed nor remitted claims for goods or services to any federal, state, or any commercial healthcare insurance program, (b) practiced medicine or provided clinical personnel to or on behalf of any site or itself sponsor any pre-clinical or clinical research activities requiring professional licensure, or (c) provided pharmacy or laboratory services, contracted laboratory tests, contracted with any pharmacy or laboratory for such services, or takes custody of prescriptions, controlled substances or biospecimens, other than, in each case of this clause (c), pre-clinical contract research organization services. For the Borrower’s past five (5) years, the Company has complied in all material respects with all material requirements of any grants and contracts with any Governmental Entities, including those applicable requirements set out by the U.S. Government Accountability Office, including the Federal Acquisition Regulation (48 C.F.R. § 1 et seq.). For the past five (5) years, the Company has not provided informed consent development services to any customer in material violation with any Healthcare Law or Data Security Requirements. (e) Neither the Company nor, to the Knowledge of Seller, any of its Subsidiaries’ employees, owners, directors, or officers, directors or employees contractors or agents has made an untrue statement of material fact or fraudulent statement to the FDA any Governmental Entity or failed to disclose a material fact required to be disclosed to any Governmental Entity. Neither the FDACompany nor, committed an actto the Knowledge of Seller, made a statement, or failed to make a statement that could reasonably be expected any agent of the Company (including any Person engaged by the Company to provide a basis for the FDA any service with respect to invoke its policy respecting “Fraud, Untrue Statements products) has been convicted of Material Facts, Briberyany crime or engaged in any conduct that has resulted in debarment or disqualification by any Governmental Entity, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit there are no proceedings pending or, to any Borrower’s knowledgethe Knowledge of Seller, investigation threatened that would result in criminal liability or debarment or disqualification by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectEntity. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect Since January 1, 2017, the Products have been and are being researched, developed, tested, investigated, produced, manufactured, labeled, distributed, stored, sold, imported and exported, and all business operations of the Sellers relating to each pre-clinical and clinical investigations sponsored by the Sellers or involving Products, or to the marketing, advertising, medical information and medical affairs activities and communications, sale and pricing of the Products (including by means of the outsourcing by Sellers of any of the foregoing activities) have been and are being conducted in all material respects in compliance with Health Care Laws. (b) Except as set forth on Section 3.14(b) of the Disclosure Letter and as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), the Sellers have all Regulatory Approvals and have all the applicable documentation related to such Regulatory Approvals as provided for in the definition of Product Approvals. Each Product Approval is valid and in full force and effect except as would not, individually or in the aggregate, reasonably be expected to have be material to the Business (taken as a Material Adverse Effect, (i) Borrower and its Subsidiaries have receivedwhole). The Sellers are in compliance in all material respects with, and since January 1, 2017, have fulfilled and performed in all material respects their respective obligations under, each such Regulatory Approval. There is no action or proceeding by any Governmental Authority pending or, to the Knowledge of the Sellers, threatened seeking the revocation or suspension of any of the Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of BorrowerApprovals, and (ii) such Product since January 1, 2017, no event has been and is being testedoccurred or condition or state of facts exists that would constitute a breach or default, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effectcause revocation, none termination, or modification of any of the Borrowers Product Approvals, in each case except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole). Since January 1, 2017, Sellers have filed with the FDA and any Subsidiary thereof other applicable Governmental Authority all material filings, notices, registrations, reports or submissions which are required under any Product Approval or by any Health Care Law to have been filed or obtained as of the date hereof. All such documents were when filed or submitted, and continue to be, in violation material compliance with applicable Health Care Laws and to the Knowledge of the Sellers, no material deficiencies have been asserted by any applicable Healthcare LawGovernmental Authority with respect to any such filings or Product Approvals since January 1, 2017. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from MedicareAll Product Regulatory Materials disclosed to Buyer are true, Medicaid, or TRICAREcorrect and complete in all material respects. (d) To Borrower’s knowledgeExcept as would not, none individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), since January 1, 2017, Sellers have not received any written notice of adverse finding, written notice of violation, warning letter, untitled letter, regulatory letter, notice of inspectional observations (Form FDA 483), correspondence regarding the termination or suspension or delay or modification of any ongoing clinical or pre-clinical studies or tests, establishment inspection reports or other correspondence or notice from the FDA or any other applicable Governmental Authority that assert (i) any deficiency in the conduct of any research, formulation, pre-clinical or other testing, clinical trial, investigation, post-market research (including research required by a Governmental Authority) in connection with the Products, or the manufacture, processing, packaging, holding, distribution, marketing or selling of the Borrower’s Products, or its Subsidiaries’ officers(ii) any other lack of compliance with Health Care Laws in connection with the Products. Except as would not, directors individually or employees in the aggregate, reasonably be expected to be material to the Business (taken as a whole), since January 1, 2017, Sellers have not received written notice of any pending or threatened civil, criminal, administrative or regulatory claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration, inquiry, search warrant, subpoena, or request for information by any Governmental Authority relating to any violation of Health Care Laws against the Sellers or, to the Knowledge of the Sellers, any person that has or is conducting or overseeing any research, development, pre-clinical or clinical testing of the Products, or that manufactures, packages, labels, imports, exports, stores, distributes or sells the Products pursuant to a manufacturing, supply or other arrangement with the Sellers, in each case since January 1, 2017. (e) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), neither the Sellers, nor, to the Knowledge of the Sellers, any member, officer, director, partner, employee, contractor or agent of any of the Sellers has made an untrue statement of material fact or a fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDAFDA or any other Governmental Authority, or committed an act, made a statement, statement or failed to make a statement that could that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “"Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ", set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borroweror for any other Governmental Authority to invoke any similar policy since January 1, nor any Subsidiary thereof2017. Except as would not, is subject to any proceedingindividually or in the aggregate, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in be material to the revocationBusiness (taken as a whole), transferneither the Sellers nor any member, surrenderofficer, suspension director, partner, employee, contractor or agent of the Sellers has been assessed or threatened with assessment of a civil monetary penalty, debarred or convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a or any Health Care Laws or exclusion under 42 U.S.C. Section 1320a 7 or any Health Care Laws since January 1, 2017. Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a Material Adverse Effectwhole), neither the Sellers nor, to the Knowledge of the Sellers, any member, officer, director, partner, employee or agent of the Sellers, are subject to any proceeding by any Governmental Authority that would reasonably be expected to result in such suspension, exclusion or debarment and to the Knowledge of the Sellers, there are no facts that would reasonably be expected to give rise to such suspension, exclusion or debarment. Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), the Sellers are not currently, and have not been, since January 1, 2017, (i) a party to any consent decree, judgment, order, or settlement, or any actual or potential settlement agreement, corporate integrity agreement or certification of compliance agreement, or (ii) a defendant or named party in any unsealed qui tam/False Claims Act litigation, in each case that relates to the Products. (f) As To the Knowledge of the Closing DateSellers, the Sellers have not received any notice or other correspondence from the FDA, any other Governmental Authority or any safety oversight board commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of the Sellers relating to any Product, except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole). (g) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), all manufacturing operations conducted by or on behalf of the Sellers or that Sellers use in the Ordinary Course of Business to manufacture their Products related to the Products have been, since January 1, 2017, and are being conducted in accordance, in all material respects, with Good Manufacturing Practice requirements for the Products and there has not been any notice or other correspondence from the FDA or any other Governmental Authority to recall, suspend or otherwise restrict the manufacture of the Products since January 1, 2017. Except as would not, individually or in the aggregate, reasonably be expected to be material to the Business (taken as a whole), since January 1, 2017, the Sellers have not either voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, "dear doctor" letter, investigator notice, or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product, and to the Knowledge of the Sellers, there have been are no Regulatory Reporting Eventsfacts that are reasonably likely to cause the recall of any Product.

Regulatory Matters. (a) With respect The Company and its subsidiaries, and its and their respective directors, officers and employees, and, to each Product the Company’s knowledge, its and except as would nottheir respective agents, individually or in the aggregateaffiliates and representatives, reasonably be expected to have a Material Adverse Effectare, and at all times: (i) Borrower have operated and currently operate its Subsidiaries have receivedbusiness in compliance in all material respects with applicable provisions of the Health Care Laws (as defined below) of the FDA, the Department of Health and such Product is Human Services (“HHS”) and any comparable foreign or other regulatory authority to which they are subject (collectively, the subject of“Applicable Regulatory Authorities”) applicable to the ownership, all Regulatory Required Permits needed in connection with the testing, development, manufacture, marketing packaging, processing, use, distribution, storage, import, export or sale disposal of such Product as currently being conducted any of the Company’s product candidates or any product manufactured or distributed by or on behalf of Borrower, and the Company; (ii) such Product has been 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 is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished supplements or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, amendments thereto required by any applicable third partiessuch Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in compliance with all applicable Healthcare Laws full force and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none effect and neither the Company nor any of the Borrowers or any Subsidiary thereof its subsidiaries are in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the Applicable Regulatory Authorities alleging that any product operation or activity is in material violation of any applicable Healthcare Law. 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; (cv) No Borrower has not received notice that any of the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any Subsidiary thereof receives material Regulatory Authorizations and has no knowledge that any payments directly of the Applicable Regulatory Authorities is considering such action; (including through 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 third Health Care Laws or Regulatory Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); (vii) is not a party payment processorto 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 been excluded, suspended or debarred from Medicareparticipation in any government health care program or human clinical research or, Medicaidto the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement other similar action that could reasonably be expected to provide a basis result in debarment, suspension, or exclusion. The term “Health Care Laws” means Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal ▇▇▇▇-▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇.▇.▇. § ▇▇▇▇▇-▇▇(▇); the civil False Claims Act, 31 U.S.C. §§ 3729 et seq.; the criminal False Claims Act 42 U.S.C. 1320a-7b(a); any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA, 42 U.S.C. §§ 1320d et seq.; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a; the Physician Payments ▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇ ▇.▇.▇. § ▇▇▇▇▇-▇▇; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. §§ 17921 et seq.; the FDA to invoke its policy respecting “FraudFederal Food, Untrue Statements of Material Facts, BriberyDrug, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10Cosmetic Act, 1991)21 U.S.C. §§ 301 et seq. (e) No Borrower; the Public Health Service Act, nor 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws; and any Subsidiary thereofsimilar federal, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectstate and local laws and regulations. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower each Credit Party and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrowersuch Credit Party, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers Credit Parties’ (or to Borrower’s Credit Parties’ actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers Credit Parties or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower As of the Closing Date, no Credit Party or any Subsidiary thereof receives any material payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrowereach Credit Party’s knowledge, none of the Borrower’s Credit Parties’ or its their Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No BorrowerCredit Party, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any BorrowerCredit Party’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower any Credit Party or any SubsidiarySubsidiary thereof, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no material Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have have, individually or in the aggregate, a Seller Material Adverse EffectEffect or be material to the MRT Program, none taken as a whole, and in each case solely with respect to the MRT Program: (a) Seller Parent and each of its Subsidiaries is developing, testing, labeling, packaging, manufacturing, marketing, distributing, and storing, and at all times has developed, tested, labeled, packaged, manufactured, marketed, distributed, and stored the product(s) and product candidate(s) relating to the MRT Program in compliance in all material respects with (i) the FDC Act, (ii) the medicinal products laws of the Borrowers European Union and applicable implementing regulations and guidelines issued by applicable Governmental Entities in the European Union, including the EMA, and (iii) any other applicable Governmental Entities in any other country where Seller Parent or any Subsidiary thereof are of its Subsidiaries has developed, tested, labeled, packaged, manufactured, distributed or stored any such product(s) and product candidate(s). Seller Parent and each of its Subsidiaries has complied in violation of all material respects with all applicable security and privacy standards regarding protected health information under (i) HIPAA and (ii) any applicable Healthcare Lawprivacy Laws with respect to the product(s) and product candidate(s) relating to the MRT Program. (b) All preclinical studies and other studies and tests of the product(s) and product candidate(s) relating to the MRT Program conducted by or on behalf of the Seller have been, and if still pending are being, conducted in material compliance, to the extent applicable, with good laboratory practices, good clinical practices and all applicable Laws, including the FDC Act and the respective counterparts thereof outside the United States. (c) No Borrower All documents filed by Seller Parent or any Subsidiary thereof receives of its Subsidiaries with the FDA or any payments directly (including through any third party payment processorother Governmental Entity with respect to the product(s) from Medicare, Medicaidand product candidate(s) relating to the MRT Program, or TRICAREthe manufacturing, handling, storage or shipment of such product(s) or product candidate(s), were, at the time of filing, true, complete and accurate in all material respects. (d) To Borrower’s knowledgeWith respect to the product(s) or product candidate(s) relating to the MRT Program, none the Seller has not received any written notice of the Borrower’s FDA regulatory actions against Seller Parent or any of its Subsidiaries’ officers, directors including notice of adverse findings, regulatory, untitled or employees warning letters or mandatory recalls, or any other notice from any governmental entity alleging or asserting material noncompliance with any Law. Neither Seller Parent, its Subsidiaries nor their respective suppliers or contract manufacturers have received an FDA Form 483 or any other written notice from a Governmental Entity of inspectional observations related to or affecting the product(s) and product candidate(s) relating to the MRT Program, which has made an untrue statement of material fact or fraudulent statement to not been closed out by the FDA or failed to disclose a the relevant Governmental Entity. (e) The Seller and each of the Selling Subsidiaries has filed with the FDA and any other applicable Governmental Entity all notices, registration applications, order forms, reports, supplemental applications and annual or other reports or documents, including adverse experience reports, that are required by Law and material fact required to be disclosed to the FDAcontinued development or handling of the product(s) and product candidate(s) relating to the MRT Program. (f) Neither Seller Parent nor any of its Subsidiaries have received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit or, to the Seller’s Knowledge, investigation from the FDA or any other Governmental Entity alleging that any operation or activity of Seller Parent or any of its Subsidiaries in connection with the MRT Program is in material violation of the FDC Act or the respective counterparts thereof promulgated by applicable state Governmental Entities or Governmental Entities outside the United States, including, as applicable, the medicinal products and medical device Laws of the European Union. No civil, criminal or administrative action, suit, demand, claim, complaint, hearing, proceeding or, to the Seller’s Knowledge, investigation for which the Seller has received written notice is pending or, to the Seller’s Knowledge, threatened against Seller Parent or any of its Subsidiaries in connection with the MRT Program. To the Seller’s Knowledge, there has not been any material violation of any laws by Seller Parent or any of its Subsidiaries in its product development efforts, submissions or reports to any Governmental Entity in connection with the MRT Program that could reasonably be expected to require investigation, corrective action or enforcement action. (g) With respect to the MRT Program, (i) neither Seller Parent nor any of its Subsidiaries have committed an any act, made a statement, any statement or failed to make a any statement that could would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or any such similar policies set forth in 56 Fed. Regulation 46191 any applicable Laws and (September 10, 1991). (eii) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit orneither the Seller nor, to the Seller’s Knowledge, any Borrower’s knowledgeof its officers, investigation by employees or agents, has been convicted of any Governmental Authoritycrime or engaged in any conduct that has resulted, which or would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiaryresult, in each casedebarment or exclusion under applicable Law, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.including 21 U.S.

Regulatory Matters. (ai) With Each Group Member has, and it and its Products are in conformance in all material respects with, all Regulatory Required Permits required to conduct its respective businesses as now conducted; (ii) to the knowledge of Holdings and the Borrower, neither the FDA nor other Governmental Authority has provided notice of or is considering limiting, suspending, revoking or terminating such Regulatory Required Permits; (iii) the Group Members have fulfilled and performed, in all material respects, their obligations under each material Regulatory Required Permit, and, to the knowledge of each Group Member, no event has occurred or condition or state of facts exists which would constitute a breach or default, or would cause revocation, limitation, suspension, or termination of any such Regulatory Required Permit, except (x) with respect to Core Business Segments, in each Product of cases (i), (ii) and (iii) to the extent such Regulatory Required Permit are not material to the business of the Group Members, and (y) other than with respect to Core Business Segments, in each of cases (i), (ii) and (iii), to the extent it would not reasonably be expect to have a Material Adverse Effect. (b) All Products that are subject to Health Care Laws, to the knowledge of each Group Member, have been and are being researched, designed, developed, tested, investigated, manufactured, prepared, assembled, packaged, tested, labeled, distributed, sold and marketed in compliance in all material respects with applicable Health Care Laws or any other Applicable Law, including, without limitation, the Applicable Laws related to clinical and non-clinical testing, product approval or clearance, current good manufacturing practices, labeling, advertising and promotion, record-keeping, establishment registration and listing, and medical device and other post-market reporting, and all other importation and distribution requirements, except as it would not, individually or in the aggregate, not be reasonably be expected to have a Material Adverse Effect. (c) Except as it would not be reasonably expected to have a Material Adverse Effect or as it has been publicly disclosed, (i) Borrower and its Subsidiaries with respect to any Product, the Group Members have received, and such Product is the subject of, received all Regulatory Required Permits needed required in connection with the design, testing, manufacture, marketing processing, assembly, packaging, labeling, marketing, distribution, commercialization, import, export, or sale of such Product as currently being conducted by or on behalf of Borrower, such Group Member; and (ii) such Product no Group Member has been and is being testedrestrained in its ability to manufacture, manufacturedprocess, marketeddistribute, promotedsupply, soldimport, importedexport, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaidmarket, or TRICAREsell any of its Products. (d) To Borrower’s knowledge, none As of the Borrower’s or its Subsidiaries’ Closing Date, no Group Member is undergoing any inspection related to Regulatory Required Permits, except as set forth on Schedule 4.26. (e) To the knowledge of each Group Member, no Group Member nor any of their respective officers, directors or employees has (A) made an any untrue statement of material fact fact, fraudulent statement, or fraudulent statement material omission to the FDA or any other Governmental Authority or in any documents or records required to be maintained under the Applicable Laws; (B) failed to disclose a material fact required to be disclosed to the FDA, FDA or any other Governmental Authority; or (C) committed an act, made a statement, or failed to make a statement that could would reasonably be expected to provide a the basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991); or (D) been investigated by FDA or any other Governmental Authority, including but not limited to the Office of the Inspector General for the Department of Health and Human Services, or the Department of Justice, for data or healthcare program fraud. To the knowledge of each Group Member, no Group Member, nor any of their respective officers, directors, employees, or, to their knowledge, contractors, have made or offered any payment, gratuity, or other thing of value that is prohibited by any Applicable Law to personnel of the FDA or any other Governmental Authority. (ef) No BorrowerNone of the Products related to the Core Business Segments have been subject to a Recall, nor is any Subsidiary thereof, is subject to such action currently under consideration by any proceeding, suit Group Member or, to the knowledge of the Group Members, any Borrower’s knowledgemanufacturer or supplier of a Product, investigation by any Governmental Authority, which except as this would not be reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in have a Material Adverse Effect. (fg) As There are no civil, criminal, or administrative actions, suits, demands, claims, hearings, notices of the Closing Dateviolation, there investigations, proceedings, demand letters, or other communications relating to any alleged hazard or alleged defect in design, manufacture, materials, or workmanship, including, without limitation, any failure to warn or alleged breach of express or implied warranty or representation, relating to any Product provided by any Group Member, or alleging that any such Products are otherwise unsafe or ineffective for their intended use, that are presently pending or threatened in writing, other than as it would not reasonably be expected to have been no Regulatory Reporting Eventsa Material Adverse Effect.

Regulatory Matters. (a) With To the Company's knowledge, the Company and its subsidiaries are in compliance in all material respects with all applicable statutes, rules and regulations of the U.S. Food and Drug Administration and similar federal, state or local Governmental Entities (collectively, the "FDA") and similar foreign Governmental Entities ("FOREIGN AUTHORITIES") with respect to each Product and except as would notthe sale, individually or in the aggregatelabeling, reasonably be expected to have a Material Adverse Effectstoring, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacturedevelopment, distribution, or marketing of the products being distributed or sale of such Product as currently being conducted developed by or on behalf of Borrowerthe Company and its subsidiaries. The Company has previously made available to Parent true and complete copies of all applications, approvals, clearances, registrations or licenses obtained by the Company or any of its subsidiaries from the FDA or Foreign Authorities, or required in connection with the conduct of the business of the Company and (ii) its subsidiaries as currently conducted and has made all such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or information available to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required PermitsParent. (b) Except as would not reasonably be expected The Company has made available to have a Material Adverse EffectParent true and correct copies of all material written communications, none and material oral communications to the extent reduced to written form, between the Company and its subsidiaries, on the one hand, and the FDA or Foreign Authorities, on the other hand, in each case since January 1, 2004, with respect to the products being distributed or developed by or on behalf of the Borrowers Company and its subsidiaries (collectively, the "FDA CORRESPONDENCE"). The Company shall promptly deliver to Parent copies of all FDA Correspondence received or reduced to written form from the date hereof through the Closing. Neither the Company nor any of its subsidiaries is in receipt of written notice of, or, to the Company's knowledge, is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, compelled or voluntary recall, investigation, penalty for corrective or remedial action or other compliance or enforcement action, in each case relating to any products being distributed or developed by or on behalf of the Company or any Subsidiary thereof of its subsidiaries or to the facilities in which any such products are in violation of any applicable Healthcare Lawmanufactured, collected or handled, by the FDA or Foreign Authorities. (c) No Borrower To the Company's knowledge, there are no pending or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicarethreatened actions, Medicaid, proceedings or TRICAREenforcement actions by the FDA or Foreign Authorities which would prohibit or materially adversely impact the conduct of the business of the Company and its subsidiaries as currently conducted. (d) To Borrower’s knowledge, none Neither the Company nor any of the Borrower’s or its Subsidiaries’ officers, directors or employees subsidiaries has made an untrue statement of any material fact false statements on, or fraudulent statement omissions from, the applications, approvals, reports and other submissions to the FDA or failed Foreign Authorities prepared or maintained to disclose a material fact required to be disclosed comply with the requirements of the FDA or Foreign Authorities relating to the FDACompany, its subsidiaries or any product being distributed or developed by or on behalf of the Company or any of its subsidiaries. (e) Neither the Company nor any of its subsidiaries has received any notification, written or oral, that remains unresolved, from FDA or Foreign Authorities indicating that any product of the Company or any of its subsidiaries is misbranded or adulterated as defined in the U.S. Food, Drug & Cosmetic Act, 21 U.S.C. Section 321, et seq., as amended, and the rules and regulations promulgated thereunder, or has violated in any similar respect the laws, rules or regulations of any Foreign Authority. (f) No product of the Company or any of its subsidiaries has been recalled or withdrawn from the market as a result of any action by the FDA or any Foreign Authority against the Company or any of its subsidiaries or, to the Company's knowledge, any licensee, distributor or marketer of any product of the Company or any of its subsidiaries, whether in the United States or elsewhere. (g) To the Company's knowledge, neither the Company nor any of its subsidiaries has committed an any act, made a statement, any statement or failed to make a any statement that could would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “with respect to "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” " set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borrowerand any amendments thereto. None of the Company, nor any Subsidiary thereof, is subject to any proceeding, suit orits subsidiaries and, to any Borrower’s the Company's knowledge, investigation by any Governmental Authoritymanager, which would reasonably be expected to result in officer, employee or agent of the revocation, transfer, surrender, suspension Company or any of its subsidiaries has been convicted of any material Permits of Borrower crime or engaged in any Subsidiary, in each case, conduct that would reasonably be expected to result in a Material Adverse Effect(i) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. (fh) As The FDA complaint handling system of the Closing Date, there Company and its subsidiaries has been made available for review by Parent and contains complete and correct information about all product defect claims and all products returned to the Company or any of its subsidiaries because of warranty or other problems. The records of the Company and its subsidiaries relating to credits and allowances made with respect to any product have been no Regulatory Reporting Eventsmade available to Parent and, to the Company's knowledge, are true and correct in all material respects. Neither the Company nor any of its subsidiaries maintains any records of warranty or other product defect claims other than the Company's FDA complaint handling system.

Regulatory Matters. (ai) With The businesses of Borrowers have been and are being conducted in compliance in all material respects with all applicable Law, including the Healthcare Laws, and all Permits, (ii) each Product (whether manufactured by Accuray or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to Accuray or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed in compliance with all applicable Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in company documentation, except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Credit Parties (other than immaterial consequences), (iii) each contract between Accuray and any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and Accuray and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements, (iv) Accuray and its Subsidiaries are in compliance in all material respects with applicable Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither Accuray nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that Accuray, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Law or any Permit. 2. Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to Accuray or any of its Subsidiary is pending or, to the knowledge of the Credit Parties, threatened. None of Accuray or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products. 3. Accuray and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of Accuray and each of its Subsidiaries. All such Permits are valid and in full force and effect and Accuray and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of Accuray or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product and except as would not, individually should cease or in that such Product should be withdrawn from the aggregate, marketplace. 4. There have been no adverse clinical test results which have or could reasonably be expected to have a Material Adverse Effectmaterially adverse impact on Accuray or any of its Subsidiaries, and there have been no Product recalls or voluntary Product withdrawals from any market (i) Borrower other than specific and discrete batches or lots not made in conjunction with a larger recall). 5. Neither Accuray nor any of its Subsidiaries have received, and experienced any significant failures in its manufacturing of any Product such Product is that the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale amount of such Product as currently being conducted successfully manufactured by Accuray or on behalf any of Borrower, its Subsidiaries in accordance with all specifications thereof and the required payments related thereto in any twelve (ii12) month period have decreased by more than twenty percent (20%) with respect to the quantities of such Product produced in the prior twelve (12) month period. 6. There has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an no material untrue statement of material fact or and no fraudulent statement made by Accuray or any of its Subsidiaries or any of their respective agents or representatives to the FDA FDA, NRC, or failed any other Governmental Authority, and there has been no failure to disclose a any material fact required to be disclosed to the FDA, committed an actNRC or any other Governmental Authority. 7. To the best knowledge of the Credit Parties, made a statementno insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or failed to make a statement that (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to provide have a basis materially adverse impact on the revenues of Accuray and its Subsidiaries. None of Accuray or any of its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity. 8. There is no arrangement relating to Accuray or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the FDA to invoke arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by Accuray and each of its policy respecting “FraudSubsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable Law, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991)including the Healthcare Laws. 9. None of Accuray or any of its Subsidiaries, or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for any federal or state health program-related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Credit Parties, within the past five (e5) No Borroweryears, nor has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for a violation of any Subsidiary thereofLaw related to fraud, is theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any proceedingjudgment, suit stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Accuray or any of its Subsidiaries or, to the knowledge of the Credit Parties, any Borrower’s knowledgeindividual who is an officer, investigation by director, employee or manager of Accuray or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower Authority or any Subsidiary, in each case, that has otherwise resulted or would reasonably be expected to result in a Material Adverse Effectdebarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of Accuray or any of its Subsidiaries are pending or, to the knowledge of the Credit Parties, threatened against Accuray or any of its Subsidiaries or any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries. (f) As 10. All studies, tests and preclinical and clinical trials conducted relating to the Products, sponsored by Accuray or any of its Subsidiaries have been conducted, and are currently being conducted, in all material respects in accordance with all applicable Law and IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Law, Accuray and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or on behalf of Accuray or such Subsidiary, as applicable. 11. To the knowledge of the Closing DateCredit Parties, there have none of the clinical investigators in any clinical trial sponsored by Accuray or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Credit Parties, no Regulatory Reporting Eventssuch disqualification, or other sanction of any such clinical investigator is pending or threatened. None of Accuray or any of its Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the Products.

Regulatory Matters. (a) With respect Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, (i) each Product of the Company and the Company Subsidiaries holds all Company Permits, including (x) all authorizations under the United States Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act, as amended (the “PHSA”), and the regulations of the United States Food and Drug Administration (the “FDA”) promulgated thereunder, and (y) authorizations of any applicable Governmental Entity that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of the Company Products (any such Governmental Entity, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company or any Company Subsidiary (the “Company Regulatory Permits”); (ii) all such Company Regulatory Permits are valid and in full force and effect; and (iii) the Company is in compliance with the terms of all Company Regulatory Permits. All Company Regulatory Permits are in full force and effect, except where the failure to be in full force and effect would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (b) Except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, (i) Borrower the businesses of each of the Company and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently each Company Subsidiary are being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Laws, including (i) the FDCA; (ii) the PHSA; (iii) federal Medicare and Medicaid statutes and related state or local statutes; (iv) provincial formulary and drug pricing statutes; (v) any comparable foreign Laws for any of the foregoing applicable in jurisdictions in which material quantities of any of the Company Products or Company Product candidates are sold or intended by the Company to be sold; (vi) federal, state or provincial criminal or civil Laws (including the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), ▇▇▇▇▇ Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. §1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state, provincial or local Laws); (vii) state or provincial licensing, disclosure and reporting requirements; and (viii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Company Healthcare Laws Laws”). Since April 1, 2011, neither the Company nor any Company Subsidiary has received any written notification or communication from any Company Regulatory Agency, including the FDA, the Centers for Medicare and Regulatory Required PermitsMedicaid Services, and the Department of Health and Human Services, of noncompliance by, or liability of Company or the Company Subsidiaries under, any Company Healthcare Laws, except where such noncompliance or liability would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (bc) Except as The Company and the Company Subsidiaries are not party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency. (d) All pre-clinical and clinical investigations in respect of a Company Product or Company Product candidate conducted or sponsored by each of the Company and the Company Subsidiaries are being conducted in compliance with all applicable Laws administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations, (ii) any applicable federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (ce) No Borrower Since April 1, 2011, neither the Company nor any Company Subsidiary has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicareforeign agency with jurisdiction over the development, Medicaidmarketing, labeling, sale, use handling and control, safety, efficacy, reliability, or TRICAREmanufacturing of drugs which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Company Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Company Regulatory Agency. (df) To Borrower’s knowledgeSince April 1, none 2011, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Company Regulatory Agency by the Company and the Company Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since April 1, 2011 neither the Company nor any Company Subsidiaries, nor, to the knowledge of the Borrower’s Company, any officer, employee, agent or its distributor of the Company or any of the Company Subsidiaries’ officers, directors or employees has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Company Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDAFDA or any other Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement that could statement, in each such case, related to the business of the Company or any of the Company Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borroweror for the FDA or any other Company Regulatory Agency to invoke any similar policy, nor except for any Subsidiary thereofact or statement or failure to make a statement that, is subject to any proceedingindividually or in the aggregate, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which has not had and would not reasonably be expected to result have a Company Material Adverse Effect. Neither the Company nor any of the Company Subsidiaries, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Company or any of the Company Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law applicable in other jurisdictions in which material quantities of any of the Company Products or Company Product candidates are sold or intended by the Company to be sold. Since April 1, 2011, neither the Company nor any of the Company Subsidiaries, nor, to the knowledge of the Company, any officer, employee, agent or distributor of the Company or any of the Company Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program. (g) As to each Company Product or Company Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar applicable Law in any foreign jurisdiction in which material quantities of any of the Company Products or Company Product candidates are sold or intended by the Company to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on behalf of the Company or any of the Company Subsidiaries, except as would not, individually or in the revocationaggregate, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result have a Company Material Adverse Effect, each such Company Product or Company Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no action or proceeding pending or, to the knowledge of the Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Company Product or Company Product candidate by the Company or any of the Company Subsidiaries of any Law, except as would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. (fh) As Since April 1, 2011, neither the Company nor any of the Closing DateCompany Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Company Product, other than notices or actions that are not material to the Company or the Company Subsidiaries, taken as a whole. To the knowledge of Company, there have been are no facts which are reasonably likely to cause, and the Company has not received any written notice from the FDA or any other Company Regulatory Reporting EventsAgency regarding (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by the Company or a Company Subsidiary (other than recalls, withdrawals or replacements that are not material to the Company or the Company Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Company Products, (iii) a termination or suspension of the manufacturing, marketing, or distribution of such Company Products, or (iv) a material negative change in reimbursement status of a Company Product. (i) Notwithstanding anything contained in this Section 3.13, no representation or warranty shall be deemed to be made in this Section 3.13 in respect of environmental, Tax, employee benefits or labor Law matters.

Regulatory Matters. (a) With respect to each Product and except Except as would not, individually or in the aggregate, not reasonably be expected to have a Company Material Adverse Effect, (i) Borrower the Company and its the Company Subsidiaries have receivedin effect all Regulatory Permits (including, and such Product is for the subject ofavoidance of doubt, all Regulatory Required Permits needed in connection with establishment registrations and device listings, 510(k) clearances and Emergency Use Authorizations (EUAs) (or their foreign equivalents)) required by any Health Authority to permit the testing, manufacture, marketing or sale conduct of such Product their respective businesses as currently being conducted by or on behalf of Borrowerconducted, and (ii) all of such Product has been Regulatory Permits are in full force and effect and (iii) the Company is in compliance with, and is being testednot in default under, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and each such Regulatory Required PermitsPermit. (b) Except as would not reasonably be expected to have a Company Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicaresince January 1, Medicaid, or TRICARE. (d) To Borrower’s knowledge2018, none of the Borrower’s or its Subsidiaries’ Company, any of the Company Subsidiaries or, to the Knowledge of the Company, any of their respective directors, officers, directors employees or employees has Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and the Company Subsidiaries) have (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Health Authority or (ii) failed to disclose a material fact required to be disclosed to the FDAFDA or any other Health Authority. None of the Company, committed an actany of the Company Subsidiaries or, made a statementto the Knowledge of the Company, any of their respective directors, officers, employees or Collaboration Partners (solely with respect to such Collaboration Partners’ activities with the Company and the Company Subsidiaries) are the subject of any pending or, to the Company’s Knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or failed to make a statement that could the subject of any similar investigation by any other Health Authority, that, assuming such investigations were determined or resolved adversely, would reasonably be expected to provide have a basis for Company Material Adverse Effect. (c) Except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 2018, the FDA Company and each of the Company Subsidiaries and, to invoke its policy respecting “Fraudthe knowledge of the Company, Untrue Statements each Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and the Company Subsidiaries), has been in compliance in all material respects with all Health Laws. None of the Company, any of the Company Subsidiaries or, to the Knowledge of the Company, any Collaboration Partner (solely with respect to such Collaboration Partner’s activities with the Company and the Company Subsidiaries) (i) have received any material written notice from any Health Authority (including a warning, untitled or notice of violation letter or Form FDA-483) alleging any violation of any Health Law, including any allegations of failure to maintain systems and programs required by applicable Health Laws, or contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any product subject to any Health Law, (ii) are subject to any material enforcement, regulatory or administrative proceedings against or affecting the Company relating to or arising under any Health Law and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened, or (iii) are a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or other similar agreement, in each case, entered into with or imposed by any Governmental Body, and, to the Knowledge of the Company, no such action is pending as of the date hereof. (d) Except as would not reasonably be expected to have a Company Material FactsAdverse Effect, Briberythe Company and the Company Subsidiaries have, since January 1, 2018, filed with the applicable Health Authority all required and material filings, including Medical Device Reports or similar required reports of adverse events or device malfunctions, and Illegal Gratuities,” set forth reports of corrections or removals. Except as would not reasonably be expected to have a Company Material Adverse Effect, all such filings were in 56 Fed. Regulation 46191 (September 10material compliance with applicable Law when filed, 1991)and no deficiencies have been asserted in writing by any applicable Health Authority with respect to any such filings. (e) No BorrowerExcept as would not reasonably be expected to have a Company Material Adverse Effect, (i) all preclinical studies and clinical trials conducted by or on behalf of the Company and the Company Subsidiaries have been conducted in compliance with all applicable Laws, (ii) as of the date hereof, no clinical trial conducted by or on behalf of the Company and the Company Subsidiaries has been terminated or suspended prior to completion primarily for safety or other non-business reasons, (iii) as of the date hereof, neither the FDA nor any Subsidiary thereofother applicable Governmental Body, clinical investigator who has participated or is subject to any proceedingparticipating in, suit or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company and the Company Subsidiaries has commenced, or, to the Knowledge of the Company and the Company Subsidiaries, threatened to initiate, any Borroweraction to place a clinical hold order on, or otherwise terminate, delay or suspend, any ongoing clinical investigation conducted by or on behalf of the Company and the Company Subsidiaries. (f) Neither the Company nor the Company Subsidiaries operates or operate a clinical laboratory within the meaning of Health Laws. Except as would not reasonably be expected to have a Company Material Adverse Effect, neither (i) the Company, (ii) the Company Subsidiaries, nor (iii) to the Company’s knowledgeKnowledge, investigation by any Governmental Authoritycustomer of the Company or the Company Subsidiaries, which has introduced into U.S. commercial distribution any Company Product as a laboratory developed test. (g) None of the Company, any of the Company Subsidiaries or, to the Knowledge of the Company, any of their respective directors, officers, employees, or Collaboration Partners has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result in the revocationbeing disqualified, transferdebarred or deregistered, surrender, suspension of or excluded by any material Permits of Borrower Governmental Body from participation in any Federal Health Care Program (as that term is defined in 42 U.S.C. § 1320a-7b(f)) or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effectunder 21 U.S.C. § 335a or comparable foreign applicable Law. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. Except as set forth in the correspondingly lettered subsection of Section 3.27 of the Company Disclosure Schedule: (a) With respect During the three (3) years prior to each Product and except as would notthe date hereof, individually neither the Company nor any of its Subsidiaries has received or in the aggregate, reasonably be expected to have a Material Adverse Effect, been subject to: (i) Borrower any United States Food and its Subsidiaries have receivedDrug Administration (“FDA”) Form 483’s or equivalent report by inspectors or officials from any other Governmental Entity of any situation requiring attention or correction or of conditions or circumstances that are objectionable or otherwise contrary to applicable Law; (ii) any FDA Notices of Adverse Findings or any equivalent correspondence, and notice or communication from any other Governmental Entity indicating a failure to comply with applicable Law; or (iii) any warning letters or other written correspondence from the FDA or any other Governmental Entity in which the FDA or such other Governmental Entity asserted that the operations of the Company or any Company Product is were not in compliance with applicable Law. (b) During the subject ofthree (3) years prior to the date hereof, all Regulatory Required Permits needed in connection with the testingthere has not been any occurrence of any product recall, manufacturemarket withdrawal or replacement, marketing or post-sale of such Product as currently being warning conducted by or on behalf of Borrowerthe Company or its Subsidiaries or, and (ii) such Product has been and is being testedto the Knowledge of the Company, by or on behalf of any Person as a result of any alleged defect in any product manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished sold or distributed as delivered by the case may be, by Borrowers (Company or to Borrower’s actual knowledge, any of its Subsidiaries or by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none party on behalf of the Borrowers Company or any Subsidiary thereof are in violation of any applicable Healthcare Lawpursuant to a co-pack agreement or otherwise (collectively, “Company Products” and each, a “Company Product”). (c) No Borrower The marketing, manufacture, packaging, labeling and sale of Company Products currently complies, and has, for the three (3) years prior to the date hereof, complied, in all material respects with all Laws and applicable self-regulatory authority policies. Neither the Company nor any of its Subsidiaries has received any written notice or charge that has not been complied with or withdrawn by any Subsidiary thereof receives Governmental Entity asserting any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICAREmaterial violation of such Laws. (d) To Borrower’s knowledge, none of During the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement three (3) years prior to the FDA or failed date hereof, the Company and its Subsidiaries have complied in all material respects with all post-approval and other reporting requirements as required by all Laws, including, but not limited to, all adverse event and other reporting requirements applicable to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.the

Regulatory Matters. (ai) With None of the Company, any of the Company Subsidiaries or any of their respective properties is, directly or indirectly, a party to or subject to any enforcement order, decree, directive, agreement, memorandum of understanding or similar arrangement with, or a commitment letter, requested board resolutions or similar submission to, or extraordinary supervisory letter from or order to pay any civil monetary penalty by any Regulatory Agency that requires corrective action, restricts the conduct of business or otherwise relates to capital adequacy, the ability to pay dividends, credit or risk management policies, management or the business of the Company or any of the Company Subsidiaries. Neither the Company nor any of the Company Subsidiaries has adopted any policies, procedures or board resolutions related to the foregoing at the request or suggestion of, any Governmental Entity. (ii) Neither the Company nor any of the Company Subsidiaries has been advised by, and the Company does not have any knowledge of facts which could give rise to an advisory notice by, any Regulatory Agency that such Regulatory Agency is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such enforcement order, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission or any request for the adoption of any policy, procedure or board resolution related to the foregoing. (iii) Except for normal examinations conducted by the Regulatory Agencies in the ordinary course of the business of the Company and the Company Subsidiaries, there is no pending proceeding before, or, to the Knowledge of the Company, examination or investigation by, any Governmental Entity into the business or operations, policies, practices or disclosures of the Company or any of the Company Subsidiaries. There are no unresolved violations, criticisms, comments or management required actions with respect to each Product and any examinations of the Company or any of the Company Subsidiaries, except as for any such violations, criticisms, comments or management required actions that would notnot reasonably be expected to, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose Company and the Company Subsidiaries, taken as a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991)whole. (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effectmaterial Product, (i) Borrower the Credit Parties and its their Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrowerthe Credit Parties, and have provided Agent with all notices and other information required by Section 4.1, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, marketed or sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers Credit Parties (or to Borrower’s actual the Credit Parties’ knowledge, by any applicable third parties) in material compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none None of the Borrowers Credit Parties or any Subsidiary thereof are in violation of any applicable Healthcare LawLaw in any material respect. (c) No Borrower or any Subsidiary thereof receives any payments directly To the Credit Parties’ knowledge (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledgeafter reasonable inquiry), none of the Borrower’s Credit Parties or its their Subsidiaries’ officers, directors directors, employees, shareholders, their agents or employees affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (d) Except as would not reasonably be expected to result in a Material Adverse Effect, each Product (i) has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service MidCap / Viewray / Credit, Security and Guaranty Agreement has been conducted in accordance with all applicable Permits and Laws; and (ii) has been and/or shall be manufactured in accordance with Good Manufacturing Practices. (e) No BorrowerCredit Party, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any BorrowerCredit Party’s knowledge, investigation by any Governmental Authorityfederal, which would reasonably be expected to result in the revocationstate or local government or quasi-governmental body, transferagency, surrender, suspension of any material Permits of Borrower board or authority or any Subsidiary, in each case, that would other administrative or investigative body (including the Office of the Inspector General of the United States Department of Health and Human Services),which could reasonably be expected to result in a Material Adverse Effect. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (ai) Schedule 10.1(g) sets forth, as of the Effective Date, a list of all material Regulatory Approvals granted to any Depomed Entity by, or application therefor pending with, any Governmental Authority to manufacture, have made, test, market, package, import, distribute, sell and commercialize the Products in the Territory. (ii) All Products sold under the Regulatory Approvals are manufactured, marketed, distributed and sold in accordance with such Regulatory Approvals, including the specifications and standards contained therein, except as has not been and would not, individually or in the aggregate, reasonably be expected to be materially adverse to the Business. (iii) With respect to each the Business, neither any Depomed Entity, nor, to the Knowledge of Depomed, any officer, employee, or agent of any Depomed Entity, (A) has made an untrue statement of a material fact or a fraudulent statement to the FDA, failed to disclose a material fact required to be disclosed to the FDA or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, 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 set forth in the FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09), or (B) has been 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 any similar Legal Requirement. (iv) Since April 2, 2015, no Depomed Entity has (A) voluntarily nor involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, market withdrawal or replacement, safety alert, “dear doctor” letter, investigator notice, or other notice or action relating to an alleged lack of safety, or efficacy of any Product, Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions marked [***]. and to the Knowledge of Depomed, there are no facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any Product sold or intended to be sold by any Depomed Entity, (2) a change in the marketing classification or a material change in the labeling of any such Products or (3) a termination or suspension of the marketing of such Products; or (B) received any written notice that any Governmental Authority has (1) commenced, or threatened to initiate, any action to request the recall or to enjoin the manufacture or distribution of any Product sold or intended to be sold by any Depomed Entity or (2) commenced, or threatened to initiate, any action to withdraw any Regulatory Approvals issued relating to any Product. (v) Except for ordinary course inquiries or as set forth on Schedule 10.1(g)(v), since April 2, 2015, Depomed has not received, with respect to the Products marketed and sold in the Territory, any written notice or communications from any Governmental Authority alleging any safety or quality concerns with respect to any Product or noncompliance with any applicable Legal Requirements or Regulatory Approvals, except as would not, individually or in the aggregate, reasonably be expected to be materially adverse to the operation of the Business. Depomed is not subject to any enforcement proceedings by the FDA related to the Products and, to the Knowledge of Depomed, no such proceedings have a Material Adverse Effect, been threatened. (ivi) Borrower All clinical trials and its Subsidiaries studies for the Products that have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing been or sale of such Product as currently are being conducted by or on behalf of BorrowerDepomed or its Affiliates, were conducted, and (ii) such Product has been and is are being testedconducted, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance all material respects in accordance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse EffectLegal Requirements, none including Health Legal Requirements. To the Knowledge of the Borrowers Depomed, there is no Legal Proceeding pending or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation threatened by any Governmental AuthorityAuthority to suspend, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of investigate or terminate any material Permits of Borrower ongoing clinical trials or studies for any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectProduct. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (i) the Bidder has been in material compliance with, and has not been notified by any Governmental Authority of any failure (or any investigation with respect thereto) by the Bidder to comply in all material respects with any Health Law; (a) With respect to each Product and except as would notthe Bidder has filed, individually maintained or in furnished with the aggregateapplicable Health Authorities all material filings, reasonably be expected to have a Material Adverse Effectdeclarations, (i) Borrower and its Subsidiaries have receivedlistings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence, and other documents required under applicable Health Laws (collectively, “Health Submissions”) and (b) all such Product Health Submissions were materially complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed by a subsequent filing) in all material respects; (iii) no manufacturing site of the Bidder, or to the Knowledge of the Bidder, any of its contract manufacturers for pharmaceutical products (including active ingredients and excipients) (a) is subject to a shutdown by a Governmental Authority or import or export prohibition or (b) has received any FDA Form 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from a Health Authority alleging or asserting noncompliance with any applicable Health Law, in each case that have not been materially complied with or closed to the subject ofsatisfaction of the relevant Governmental Authority, all Regulatory Required Permits needed and, to the Knowledge of the Bidder, no Governmental Authority is considering such action; (iv) neither the Bidder nor any of its subsidiaries, have received any written notice from any Health Authority (a) terminating, withdrawing, refusing to renew, or refusing to grant any material governmental licence, Permit, registration, or authorisation, including any IND, NDA, CTA, other clinical trial application or regulatory approval application, in connection with the testingany jurisdiction; or (b) placing a clinical hold order on, manufactureor otherwise terminating or suspending, marketing or sale of such Product as currently being any material ongoing clinical trial conducted by or on behalf of Borrowerthe Bidder, and (ii) and, to the Knowledge of the Bidder, there are no facts which could form the basis for such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits.an Action; (bv) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or Bidder, any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicareits subsidiaries or, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none to the Knowledge of the Borrower’s or Bidder, any of its Subsidiaries’ officers, directors employees or employees has agents (authorised to speak on behalf of the Bidder), have (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Health Authority, failed to disclose a material fact required to be disclosed to the FDAany Health Authority, or committed an act, made a statement, or failed to make a statement that could statement, including with respect to any scientific data or information, that, 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 policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991)., and any amendments thereto, or for any other Health Authority to invoke any similar policy; or (ii) been debarred pursuant to 21 U.S.C. section 335a (a) or (b) or any comparable Health Law; and (vi) none of the Bidder, any of its respective officers, directors, or, to the Knowledge of the Bidder, its managing employees, agents (as those terms are defined in 42 C.F.R. § 1001.2), or any other person described in 42 C.F.R. § 1001.1001(a): (a) has been charged with or convicted of any criminal offense relating to the delivery of an item or service under any federal health care program as defined in 42 U.S.C. §1320a-b(f) and including the Medicare, Medicaid and TRICARE programs (“Federal Health Care Program”); (b) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (c) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a; (d) is currently listed on the list of parties excluded from federal procurement programs and non-procurement programs as maintained in the Government Services Administration’s System for Award Management or other federal agencies; (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit oris, to any Borrower’s knowledgethe Knowledge of the Bidder, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension target or subject of any material Permits of Borrower current or potential investigation relating to any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse Effect. Federal Health Care Program-related offense; or (f) As has engaged in any activity that is in material violation of the Closing Date, there have been no Regulatory Reporting Eventsor is cause for civil penalties or mandatory or permissive exclusion under federal or state Laws.

Regulatory Matters. (ai) With Seller is operating, and during the past five (5) years has operated, the Business with respect to each Product the Purchased Assets, in compliance in all material respects with all applicable Health Care Laws, (ii) during the past five (5) years, Seller has not received any written notification of any pending or, to the Knowledge of Seller, threatened, Proceeding from any Governmental Authority, including the FDA, alleging non-compliance by Seller under any applicable Health Care Laws with respect to the Purchased Assets, and except (iii) during the past five (5) years, neither Seller, its offers or directors, nor to the Knowledge of Seller, any of its employees or HCPs that has participated in the Exploitation of the Purchased Assets, has been excluded, suspended or debarred from participation in any federal health care program (as defined in 42 U.S.C. § 1320a-7b(f)) or human clinical research or, to the Knowledge of Seller, is subject to a Proceeding that could reasonably be expected to result in such debarment, suspension, or exclusion. (b) Except as would not, individually or in the aggregate, reasonably be expected to be material to the Purchased Assets, the Assumed Liabilities or the Business, Seller holds such Permits issued by the FDA required for the conduct of the Business as currently conducted (collectively, the “FDA Permits”), and all other state, regional or national Permits required for the conduct of the Business as currently conducted. All such Permits and FDA Permits are in full force and effect and no such Permits or FDA Permits will be terminated or become terminable, or be impaired, varied or suspended, to the detriment of the Business in whole or in part, as a result of the transactions contemplated hereby. (c) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower all reports, documents, claims and its Subsidiaries have receivednotices required to be filed, and such Product is maintained, or furnished to the subject of, all Regulatory Required Permits needed FDA by Seller in connection with the testingBusiness or the Purchased Assets have been so filed, manufacturemaintained or furnished and (ii) all such reports, marketing documents, claims and notices were complete and correct in all material respects on the date filed (or sale of such Product as currently being were corrected in or supplemented by a subsequent filing). (d) The clinical and pre-clinical studies conducted or sponsored by or on behalf of BorrowerSeller with respect to the Purchased Assets have been and, if still pending, are being conducted in compliance in all material respects with all applicable Health Care Laws and FDA Permits. (e) Except as set forth in Section 5.11(e) of the Seller Disclosure Schedule, the Product is being, and has been, during the past five (ii5) such Product has been and is being testedyears, manufacturedinvestigated, researched, procured, developed, Manufactured, produced, packaged, Labeled, marketed, promoted, soldtested, distributed, imported, possessedexported, ownedhandled, warehousedcommercialized, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) sold and stored in compliance with all applicable Healthcare Health Care Laws. Without limiting the generality of the foregoing, the Seller and, to the Knowledge of Seller, the Seller’s contract research organizations, contract manufacturing organizations of the Product, are, and have been during the past five (5) years, acting or operating in compliance with all Health Care Laws and Regulatory Required Permitshold such Permits applicable to such organizations’ respective activities with respect to the Product. (bf) During the past five (5) years, there have been no recalls, field notifications, product defect notifications, market withdrawals or replacements, “dear doctor” letters, investigator notices, clinical trial safety reports, serious adverse event reports or other comparable notices of action relating to a quality, safety or efficacy concern or alleged lack of regulatory compliance of the Product that have materially impacted the quality, safety, or efficacy profile of the Product, to the Knowledge of Seller, there are no facts or circumstances that would be reasonably likely to result in such action or otherwise require a material change in the Labeling of or the, variation, termination, or suspension of the development, testing of the Product. (g) Except as would not reasonably be expected to have a Material Adverse Effect, none set forth in Section 5.11(g) of the Borrowers Seller Disclosure Schedule, during the past five (5) years, neither the Seller, nor to the Knowledge of Seller, any of their respective contract research organizations, contract manufacturing organization, or service vendors, has received written notice (i) of any FDA Form-483, or alleged material noncompliance or major or critical findings pertaining to the Seller’s or such organizations’ or vendors’ activities with respect to the Product, in any case as a result of any internal audit or inspection or any Subsidiary thereof are audit or inspection performed by or on behalf of a Governmental Authority in violation connection with, related to, or affecting the Product or (ii) of any applicable Healthcare Lawalleged material falsification or fraudulent activity regarding any documentation generated or submitted to any Person in connection with, related to, or affecting the Product. (ch) No Borrower or During the past five (5) years, neither the Seller, nor to the Knowledge of Seller, any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicareof its contract research organizations, Medicaidcontract manufacturing organization, or TRICARE. (d) To Borrower’s knowledgeservice vendors have received serious and unexpected adverse event reports, none investigator notices in writing, or other notice alleging a lack of quality, safety, efficacy, or regulatory compliance of the Borrower’s or its Subsidiaries’ officersProduct (collectively, directors or employees has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991Safety Notices”). (e) No Borrower, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that have materially impacted the quality, safety or efficacy profile of the Product. During the past five (5) years, neither the Seller, nor to the Knowledge of Seller, any of its contract research organizations, contract manufacturing organization, or service vendors have received material product complaints with respect to the Product that remain unresolved, and, to the Knowledge of Seller, neither the Seller nor any of its contract research organizations, contract manufacturing organization, or service vendors have received notice of facts that either individually or collectively would reasonably be expected to result in a Material Adverse Effectmaterial Safety Notice with respect to the Product. (fi) As of the Closing Date, there have been no Regulatory Reporting Eventsexcept as disclosed in Section 5.11(i) of the Seller Disclosure Schedule, to the Knowledge of Seller, the Product is not the subject of any written material adverse reimbursement or coverage decision or determination from any third-party payor.

Regulatory Matters. (a) With respect Except as has not had and would not reasonably be expected to each Product and except as would nothave, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower each of Apple and its Subsidiaries have receivedholds (A) all authorizations under the Federal Food, Drug, and such Product is Cosmetic Act of 1938 (the subject of“FDCA”) and all amendments thereto, all Regulatory Required Permits needed in connection with the testingPublic Health Service Act (the “PHSA”), manufacture, marketing or sale and the regulations of such Product as currently being conducted by or on behalf of Borrowerthe U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the research, quality, identity, strength, purity, safety, efficacy, manufacturing, packaging, labelling, storage, transport, marketing, distribution, sale, pricing, import or export of any of the Apple Products (any such Governmental Authority, a “Apple Regulatory Agency”) necessary for the lawful operation of the businesses of Apple or any of its Subsidiaries as currently conducted (the “Apple Regulatory Permits”); (ii) all such Product has been Apple Regulatory Permits are valid and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers in full force and effect; and (or to Borrower’s actual knowledge, by any applicable third partiesiii) Apple and its Subsidiaries are in material compliance with the terms of all applicable Healthcare Laws and Apple Regulatory Required Permits. (b) Except as As of the date hereof, neither Apple nor any of its Subsidiaries (i) has entered into material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Apple Regulatory Agency, or (ii) has received written notice from any Apple Regulatory Agency that alleges any material noncompliance or notifies the recipient that it is under investigation or the subject of an inquiry by any such Apple Regulatory Agency for alleged material noncompliance with any Applicable Law related to the operation of the business of Apple. (c) All pre-clinical and clinical investigations in respect of an Apple Product conducted or sponsored by Apple or any of its Subsidiaries for submission to an Apple Regulatory Agency are being, and have been, conducted in material compliance with all Applicable Laws administered or issued by the applicable Apple Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such material noncompliance that has not had and would not reasonably be expected to have have, individually or in the aggregate, a Material Adverse Effect. (d) Apple has submitted certain BLA filings to FDA in support of a marketing authorization approval for OLT-200, and Apple has not taken any action to withdraw these filings. Apple has not received any communication from FDA indicating that FDA has refused or will refuse to accept or file the BLA. (e) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, none during the period beginning on January 1, 2017 and ending on the date of this Agreement, neither Apple nor any of its Subsidiaries has received any written notice from the FDA or the European Medicines Agency (the “EMA”) or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, distribution, storage, transport, packaging or manufacturing of Apple Products that would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Borrowers Apple Regulatory Permits or any Subsidiary thereof are in violation of any applicable Healthcare Lawapplication for marketing approval currently pending before the FDA or such other Apple Regulatory Agency. (cf) No Borrower Since November 1, 2018 all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any Subsidiary thereof receives other Apple Regulatory Agency by Apple and its Subsidiaries have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). Since January 1, 2017, neither Apple nor any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors nor, to the knowledge of Apple, any officer, employee, agent or employees distributor of Apple or any of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Apple Regulatory Agency, failed to disclose a material fact required to be disclosed to the FDAFDA or any other Apple Regulatory Agency, or committed an act, made a statement, or failed to make a statement that could statement, in each such case, related to the business of Apple or any of its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Regulation Reg. 46191 (September 10, 1991). (e) No Borroweror for the FDA or any other Apple Regulatory Agency to invoke any similar policy, nor except for any Subsidiary thereof, is subject act or statement or failure to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which make a statement that has not had and would not reasonably be expected to result have, individually or in the revocationaggregate, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that a Material Adverse Effect. Except as has not had and would not reasonably be expected to result have, individually or in the aggregate, a Material Adverse Effect, (i) neither Apple nor any of its Subsidiaries, nor, to the knowledge of Apple, any officer, employee, agent or distributor of Apple or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Apple Products are sold or where Apple has publicly announced an intention to sell an Apple Product; and (ii) neither Apple nor any of its Subsidiaries, nor, to the knowledge of Apple, any officer or employee of Apple or any of its Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could reasonably be expected to be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935 or any similar program, including any conduct that would constitute material non-compliance with the Federal Anti-Kickback Statute, Federal False Claims Act, or their respective state equivalents. (g) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, as to each Apple Product subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material quantities of any of the Apple Products are sold that has been researched, developed, manufactured, tested, distributed or marketed by or on behalf of Apple or any of its Subsidiaries, each such Apple Product is being or has been researched, developed, manufactured, stored, distributed and marketed in material compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There are no Proceedings pending or, to the knowledge of Apple, threatened in writing, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Apple Product by Apple or any of its Subsidiaries of any Applicable Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (fh) As Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (i) neither Apple nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory material compliance of any Apple Product and (ii) to the knowledge of Apple, neither Apple nor any of its Subsidiaries has received, any written notice from the FDA or any other Apple Regulatory Agency regarding (A) the recall, correction, market withdrawal, or replacement of any Apple Product sold (other than recalls, corrections, withdrawals, or replacements that are not material to Apple and its Subsidiaries, taken as a whole), (B) a material change in the marketing classification or a material change in the labeling of any such Apple Products, (C) a termination or suspension of the Closing Datemanufacturing, there have been no Regulatory Reporting Eventsmarketing, or distribution of such Apple Products, or (D) a material negative change in reimbursement status of an Apple Product.

Regulatory Matters. (a) With respect to each Product and except Except as would not, individually or in the aggregate, reasonably be expected to have be material to the business of the Acquired Companies, taken as a Material Adverse Effect, whole: (i) Borrower and its Subsidiaries the Acquired Companies own, possess or validly have receivedthe right to use all permits required to research, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testingdevelop, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrowermarket, commercialize, distribute and sell its products; (ii) such Product all products of the Acquired Companies are and, since January 1, 2019, have been researched, developed, manufactured and marketed in accordance with applicable specifications, Permits and applicable Laws, including GMPs, GLPs, GCPs, GDPs and GVPs; (iii) since January 1, 2019, (A) no product of the Acquired Companies or manufacturing site has shut down, been subject to any import or export prohibition, received any FDA Form 483 or other Governmental Body notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes to any product of the Acquired Companies or any manufacturing operations for any product of the Acquired Companies and is being tested(B) there have been no recalls, manufacturedfield notifications, marketedfield corrections, promotedwarnings, sold“dear doctor” letters, importedinvestigator notices, possessedsafety alerts or other written notices of action issued by a Governmental Body or the Acquired Companies relating to an alleged lack of safety, ownedefficacy, warehousedor regulatory compliance of any product of the Acquired Companies (collectively, promoted“Safety Notices”). Each Acquired Company has complied in all material respects with its obligations to make filings, labeleddeclarations, furnished listings, registrations, reports or distributed submissions with the applicable regulatory authorities (including the FDA and the DEA or any other Governmental Body performing functions similar to those performed by the FDA and the DEA) relating to Acquired Company drug products, including but not limited to adverse event reports. Except as would not reasonably be expected, individually or in the case may beaggregate, by Borrowers (or to Borrower’s actual knowledgebe material to the business of the Acquired Companies, taken as a whole, no written deficiencies have been asserted by any applicable third parties) in compliance Governmental Body with all applicable Healthcare Laws and Regulatory Required Permitsrespect to any such filings, declarations, listing, registrations, reports or submissions. (b) Except as would not reasonably be expected expected, individually or in the aggregate, to have a Material Adverse Effect, none be material to the business of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. Acquired Companies, taken as a whole, no Acquired Company has (ci) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from Medicare, Medicaid, or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA, FDA or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth 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 Illegal Gratuities Final Policy. Neither any of the Acquired Companies nor, to the Knowledge of the Company, any officers, directors, employees, agents or clinical investigators of any of the Acquired Companies or, to the Acquired Companies’ Knowledge, anyone acting on behalf of the Acquired Companies, is, has been, or is threatened in 56 Fedwriting to be: (i) excluded, debarred, suspended or otherwise (c) Except as would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole, the Acquired Companies are in compliance and, since January 1, 2019, have been in compliance with all Healthcare Laws applicable to the operation of its business as currently conducted. Regulation 46191 As of the Agreement Date, to the Knowledge of the Company no enforcement, regulatory or administrative proceeding is pending, and no such enforcement, regulatory or administrative proceeding has been threatened in writing, against the Company under the Healthcare Laws, other than any such proceeding that would not reasonably be expected, individually or in the aggregate, to be material to the business of the Acquired Companies, taken as a whole. None of the Acquired Companies has received any written notice, warning letter, or similar written communication that (September 10A) alleges a material violation of, 1991)or asserts a material failure to comply with, any applicable Healthcare Law, or (B) imposes a written obligation to undertake, or to bear all or any portion of the cost of, any remedial action of any nature. (ed) No BorrowerSince January 1, nor 2019 , the Company and its Subsidiaries have performed periodic audits of all manufacturing sites that supply regulatory starting materials, drug substances, drug product intermediates, drug products or finished products to the Company or the Subsidiaries to the extent permitted by any Subsidiary thereofContract relating to such manufacturing site or required by applicable Healthcare Law. To the Knowledge of the Company, is subject there are no written findings deemed critical by the auditor or inspector resulting from such audits or inspections since January 1, 2019 that have not been remediated in all material respects. To the Knowledge of the Company, any such manufacturing site has performed in all material respects all tasks required by such written remediation plans. The Company has made available to any proceedingParent complete and accurate copies of all reports from all regulatory audits or inspections conducted since January 1, suit 2019 by the Company and its Subsidiaries or, to any Borrower’s knowledgethe extent in the possession or control of the Company and its Subsidiaries, investigation by their Representatives or any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would reasonably be expected to result in a Material Adverse EffectBodies. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. Except as described in the Registration Statement and the Prospectus, the preclinical and clinical studies conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, the results of which are referred to in the Registration Statement and the Prospectus, as applicable (a) With respect collectively, the “Studies”), were, and if still pending are, being conducted in all material respects in accordance with all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to each Product which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”). The Company has no knowledge of any other studies not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus. The Company and its subsidiaries are, and since May 1, 2018, have operated in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities and all other applicable federal, state or foreign health care laws and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export, or disposal of any product candidates under development by the Company or any of its subsidiaries (collectively, the “Health Care Laws”), except where such non-compliance would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its subsidiaries, to the knowledge of the Company, have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination or suspension of any such Studies, and, to the knowledge of the Company, there are no reasonable grounds for the same. Except as would not, individually whether singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and neither the Company nor any of its Subsidiaries have receivedsubsidiaries has received any claim, and such Product action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that it is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have a Material Adverse Effect, none of the Borrowers or any Subsidiary thereof are in violation of any applicable Healthcare Law. (c) No Borrower or any Subsidiary thereof receives any payments directly (including through any third party payment processor) from MedicareHealth Care Laws, Medicaidand, or TRICARE. (d) To Borrower’s knowledge, none to the knowledge of the BorrowerCompany, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action has been threatened. Neither the Company, its subsidiaries nor, to the knowledge of the Company, any of the Company’s or its Subsidiariessubsidiaries’ officers, directors directors, employees, contractors or employees has made an untrue statement agents is a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Regulatory Authority with respect to Health Care Laws. Neither the Company, any of material fact or fraudulent statement its subsidiaries nor, to the FDA knowledge of the Company, any of the Company’s or failed to disclose a material fact required to be disclosed to the FDAits subsidiaries’ employees, committed an actofficers, made a statementdirectors, contractors or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraudagents has been excluded, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth suspended or debarred from participation in 56 Fed. Regulation 46191 any U.S. federal health care program (September 10, 1991as defined in 42 U.S.C. § 1320a-7b(f). (e) No Borrower, nor any Subsidiary thereof, or human clinical research or is subject to any proceedinga governmental inquiry, suit orinvestigation, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower proceeding or any Subsidiary, in each case, other similar action that would reasonably be expected to result in a Material Adverse Effectsuch debarment, suspension or exclusion. (f) As of the Closing Date, there have been no Regulatory Reporting Events.

Regulatory Matters. (a) With respect to each Product All Key Permits held by Holdings, the Borrower and except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, Subsidiaries are (i) legally and beneficially owned exclusively by Holdings, the Borrower or such Subsidiary, free and its Subsidiaries have received, and such Product is the subject of, clear of all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of BorrowerLiens other than Liens permitted pursuant to Section 8.3, and (ii) such Product has been validly registered and is being testedon file with the applicable Governmental Authority, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws filing and Regulatory Required Permits. maintenance requirements (bincluding any fee requirements) Except as would not reasonably be expected to have a Material Adverse Effectthereof, none of the Borrowers or any Subsidiary thereof and are in violation of any good standing, valid and enforceable with the applicable Healthcare Law. (c) No Borrower Governmental Authority. All notices, registrations and listings, supplemental applications or any Subsidiary thereof receives any payments directly notifications, reports (including through any third party payment processorreports of adverse experiences) from Medicareand other filings required to be filed by Holdings, Medicaidthe Borrower, or TRICARE. (d) To Borrower’s knowledgethe Subsidiaries or, none to the knowledge of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement received from any of material fact or fraudulent statement their respective suppliers with respect to any Product have been filed with the FDA and all other applicable Governmental Authorities. To the knowledge of the Borrower, the factual basis for the application to the FDA or failed in respect of, and leading to, the Wakix ODE was true, correct and complete in all material respects as of the date such factual basis was represented to disclose a material fact the FDA and as of the date such factual basis was required to be disclosed represented to the FDA, committed an actand no misstatements or omissions in such factual basis have arisen between such dates and the date hereof. None of Holdings, made a statementthe Borrower or any of the Subsidiaries has received any written notice that any Key Permits have been or are being revoked, withdrawn, suspended, limited or failed to make a statement that could 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. Regulation 46191 (September 10, 1991)challenged. (ei) No Borrower, nor any Subsidiary thereof, is subject Except where the failure to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which do so would reasonably be expected to result in the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would not reasonably be expected to result in a Material Adverse Effect, the Products, as well as the business of Holdings, the Borrower and the Subsidiaries, comply with (A) all applicable Laws, including, without limitation, all applicable requirements of the FD&C Act, the PHSA and similar state Laws and (B) all Product Authorizations and other Key Permits; (ii) none of Holdings, the Borrower and the Subsidiaries, nor, to the knowledge of the Borrower, their respective suppliers, have received any inspection reports, warning letters or untitled letters with respect to any Product of Holdings, the Borrower and the Subsidiaries, from any Governmental Authority that assert a lack of compliance with the FD&C Act, the PHSA and similar state Laws; (iii) none of Holdings, the Borrower or any of the Subsidiaries has received any written notice of, or otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry against Holdings, the Borrower or any of the Subsidiaries, or any of their respective suppliers with respect to the Products, and, to the knowledge of the Borrower, there is no basis for any adverse regulatory action against Holdings, the Borrower or any of the Subsidiaries or their respective suppliers, with respect to the Products; and (iv) without limiting the foregoing, (A) to the knowledge of the Borrower (1) there have been no Product recalls, safety alerts, withdrawals, clinical holds, marketing suspensions or removals, undertaken or issued by any Person, whether or not at the request, demand or order of any Governmental Authority or otherwise, with respect to any Product, (2) no such Product recalls, safety alerts, corrections, withdrawals, marketing suspensions or removals have been requested, demanded or ordered by any Governmental Authority, and, to the knowledge of the Borrower, there is no basis for the issuance of any such product recalls, safety alerts, corrections, withdrawals, marketing suspensions or removals by any Person with respect to any Products, and (B) none of Holdings, the Borrower or any of the Subsidiaries has received any written notice of, and does not otherwise have knowledge of, any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been commenced or threatened in writing by any Governmental Authority with respect to or in connection with any Products, or any consent decrees (including plea agreements) which relate to any Products, and, to the knowledge of the Borrower, there is no basis for the commencement for any criminal injunctive, seizure, detention or civil penalty actions by any Governmental Authority relating to the Products or for the issuance of any consent decrees. None of Holdings, the Borrower and the Subsidiaries nor, to the knowledge of the Borrower, any of their respective suppliers is employing or utilizing the services of any individual who has been debarred under any FDA regulations. (c) All clinical trials conducted by or, to the knowledge of Borrower, on behalf of Holdings, the Borrower and the Subsidiaries with respect to any Product have been conducted in compliance with cGCPs. None of Holdings, the Borrower and the Subsidiaries has received any written notice from FDA or any other Governmental Authority alleging any non-compliance with cGCPs or otherwise terminating or suspending any clinical trial (in-whole or in-part) conducted by or on behalf of Holdings, the Borrower and the Subsidiaries with respect to any Product. No clinical trial conducted by or, to the knowledge of the Borrower, on behalf of Holdings, the Borrower and the Subsidiaries with respect to any Product has used any clinical investigator who has been disqualified under FDA regulations. (d) With respect to Products, (i) all design, manufacturing, storage, distribution, packaging, labeling, sale, recordkeeping and other activities by Holdings, the Borrower or any of its Subsidiaries and, to the knowledge of the Borrower, their respective suppliers relating to the Products have been conducted, and are currently being conducted, in compliance with the applicable requirements of the FD&C Act, the PHSA and other requirements of the FDA and all other applicable Governmental Authorities, including, without limitation, cGMPs and adverse event reporting requirements, and (ii) none of Holdings, the Borrower or any of its Subsidiaries, or, to the knowledge of the Borrower, any of their respective suppliers, has received written notice or threat of commencement of action by any Governmental Authority to withdraw its approval of to enjoin production of the Products at any facility, or otherwise to seize any Product. To the knowledge of Borrower, no Product in the inventory of Holdings, the Borrower or any of its Subsidiaries, or otherwise currently in commercial distribution is adulterated or misbranded. All advertising or other promotion of all Products by Holdings, the Borrower or any of its Subsidiaries has been conducted in compliance with applicable FDA requirements for advertising and promotion of pharmaceuticals. (e) All manufacturing facilities owned or operated by Holdings, the Borrower or any of the Subsidiaries, or, to the knowledge of the Borrower, used in the production of any Product, are and have been operated in compliance with cGMPs and all other applicable Laws. To the knowledge of the Borrower, the FDA has not issued any written Form 483, Warning Letter, or untitled letter with respect to any such facility, or otherwise alleged any non-compliance with cGMPs. (f) As The Borrower has made available to the Lenders all written material adverse event reports and communications to or from FDA (if any) and other relevant Governmental Authorities of which it has or had a copy, including written inspection reports, warning letters, untitled letters, and material reports and studies, other than opinions of counsel that are attorney-client privileged, with respect to regulatory matters relating to Holdings, the Borrower and the Subsidiaries, the conduct of their business, the operation of any manufacturing facilities owned or operated by Holdings, the Borrower or any of the Closing DateSubsidiaries, there and the Products. The Borrower has made available to the Lenders all Key Permits and material written correspondence submitted to or received from FDA, CMS or other Governmental Authority (including minutes and official contact reports relating to any material communications with any Governmental Authority) of which it has or had a copy. (g) All studies, tests and preclinical and clinical trials conducted relating to the Products by or, to the knowledge of Borrower, on behalf of Holdings, the Borrower or any of and the Subsidiaries and, to the knowledge of the Borrower, their respective licensees, licensors and third party services providers and consultants, have been conducted, and are currently being conducted, in full compliance with all applicable Laws, including, but not limited to, the FD&C Act, the PHSA, current good clinical practices and, to the extent required by FDA guidances and regulations, current good laboratory practices, except to the extent that the failure to do so would not reasonably be expected to result in a Material Adverse Effect. Material written summaries related to such studies, tests and trials have been made available to the Lenders. To the knowledge of the Borrower, the summaries and descriptions of any of the foregoing provided to the Lenders are accurate in all material respects and contain no material omissions. None of Holdings, the Borrower and the Subsidiaries, or, to the knowledge of the Borrower, any of their respective licensees, licensors or third party services providers or consultants, has received from the FDA or other applicable Governmental Authority any written notices or correspondence requiring the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the Products. (h) There has been no material untrue statement of fact and no fraudulent statement made by Holdings, the Borrower or any of the Subsidiaries, or, to the Borrower’s knowledge, any of their respective agents or representatives to the FDA or any other Governmental Authority, and there has been no failure to disclose any material fact required to be disclosed to the FDA or any other Regulatory Reporting EventsAgency. (i) There is no arrangement relating to Holdings, the Borrower or the Subsidiaries providing for any rebates, kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by Holdings, the Borrower and the Subsidiaries for their services have been true and correct in all material respects and are in compliance in all material respects with all applicable Laws, including the Federal False Claims Act or any applicable state false claim or fraud law. None of Holdings, the Borrower and the Subsidiaries has received any written notice from the United States Department of Justice, any U.S. Attorney, any State Attorney General, or other similar Governmental Authority alleging any violation of the Federal Anti-kickback Statute, the Federal False Claims Act, the Foreign Corrupt Practices Act, any applicable federal Laws, or similar state or foreign Laws. (j) The transactions contemplated by the Investment Documents (or contemplated by the conditions to effectiveness of any Investment Document) will not impair Holdings’, the Borrower’s or any of the Subsidiaries’ ownership of or rights under (or the license or other right to use, as the case may be) any Key Permits relating to the Products. (k) No right of Holdings, the Borrower or any of the Subsidiaries to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other Third Party, and none of Holdings, the Borrower or any Subsidiary has been the subject of any inspection, investigation, or audit, by any Governmental Authority for the purpose of any alleged improper activity. (l) None of Holdings, the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, agent or managing agent of Holdings, the Borrower or any of the Subsidiaries has been convicted of, or, to the Borrower’s knowledge, charged with or investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any such program; or, to the Borrower’s knowledge, within the past five (5) years, has been convicted of, or, to the Borrower’s knowledge, charged with or investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Holdings, the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is an officer, director, employee, agent or managing agent of Holdings, the Borrower or any of the Subsidiaries has been convicted of any crime that has resulted or would reasonably be expected to result in a debarment under 21 U.S.C. Section 335a. No debarment proceedings under any FDA regulation in respect of the business of Holdings, the Borrower or any of the Subsidiaries are pending or, to the Borrower’s knowledge, threatened against Holdings, the Borrower, any of the Subsidiaries or, to the knowledge of the Borrower, any individual who is an officer, director, manager, employee, agent or managing agent of Holdings, the Borrower or any of the Subsidiaries.

Regulatory Matters. (a) With respect The Company and each of its Subsidiaries have all permits, licenses, registrations, authorizations, certificates, orders, approvals, franchises, variances and other similar rights issued by or obtained from any Governmental Entities (collectively, “Permits”) required to each Product conduct its business as currently conducted, including all such Permits required by any Governmental Entity, except for such Permits the absence of which would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole (the “Company Permits”). (b) The Company Permits are in full force and effect, except as would notfor any failures to be in full force and effect that, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, (i) Borrower and its Subsidiaries have received, and such Product is the subject of, all Regulatory Required Permits needed in connection with the testing, manufacture, marketing or sale of such Product as currently being conducted by or on behalf of Borrower, and (ii) such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished or distributed as the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permits. (b) Except as would not reasonably be expected to have result in a Material Adverse Effectliability that is material to the Company and its Subsidiaries, none taken as a whole. The Company and each of its Subsidiaries is in compliance under such Company Permits, except for such failures to comply that, individually or in the Borrowers or any Subsidiary thereof are aggregate, would not reasonably be expected to result in violation of any applicable Healthcare Lawa liability that is material to the Company and its Subsidiaries, taken as a whole. (c) No Borrower Except for matters that, individually or in the aggregate, would not reasonably be expected to result in a liability that is material to the Company and its Subsidiaries, taken as a whole, since January 1, 2022, the Company and each of its Subsidiaries: (i) is and at all times has been in compliance, to the extent applicable, with all Healthcare Laws and with all Judgments and final guidance having the effect of Law administered or issued by any Subsidiary thereof receives Governmental Entity exercising authority applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any payments directly product tested, developed, promoted, marketed, manufactured or distributed by the Company and each of its Subsidiaries; (ii) has not received any written notice or correspondence from any Governmental Entity alleging or asserting any noncompliance with any Company Permits; (iii) has not received written notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Company Permit; and, (iv) there is no Legal Proceeding pending or, to the Knowledge of the Company, threatened in writing (including through any third party payment processor) from Medicareprosecution, Medicaidinjunction, seizure, civil fine, suspension or TRICARErecall), in each case, alleging that such Governmental Entity is considering such action. The Company has not been required to make any written notices to any Governmental Entity or Person under any Healthcare Law. (d) To Borrower’s knowledgethe Knowledge of the Company, none of the BorrowerCompany nor its Subsidiaries, nor any of the Company’s or its Subsidiaries’ directors, officers, directors employees, or employees contractors has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDAFDA or any Governmental Entity, or (iii) committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case), at the time such disclosure or statement was made or failure to make occurred, establishes a statement that could reasonably be expected to provide a reasonable basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 FedGratuities Final Policy. Regulation 46191 (September 10As of the date of this Agreement, 1991)none of the Company nor its Subsidiaries, nor any of the Company’s or its Subsidiaries’ directors, officers, employees, or, to the Knowledge of the Company, contractors are 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. (e) No BorrowerExcept for matters that, nor any Subsidiary thereof, is subject to any proceeding, suit or, to any Borrower’s knowledge, investigation by any Governmental Authority, which would reasonably be expected to result individually or in the revocationaggregate, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, in each case, that would not reasonably be expected to result in a Material Adverse Effectliability that is material to the Company and its Subsidiaries, taken as a whole, (i) the studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of the Company or any of its Subsidiaries are being conducted or have been conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable laws and regulations and (ii) since January 1, 2022, neither the Company nor any of its Subsidiaries has received any written notices or correspondence from a Governmental Entity or any institutional review board or comparable authority requiring the termination, clinical hold or partial clinical hold, suspension or material modification of any investigational new drug application, studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries. (f) As None of the Closing DateCompany, there the Company Subsidiaries or any of their respective officers or directors or, to the Knowledge of the Company, employees or agents, have been no Regulatory Reporting Events.debarred, suspended, or excluded from participation in any Federal Healthcare Program, subject to sanction pursuant to

Regulatory Matters. (a) With respect to (i) The businesses of the Borrower has been and is being conducted in compliance in all material respects with all applicable Healthcare Laws, and all Permits, (ii) each Product (whether manufactured by the Borrower or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to the Borrower or any of its Subsidiaries) has been, and except currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all applicable Requirements of Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as would not, individually or defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in the aggregateGroup Members’ documentation, except to the extent any failure to so comply could not reasonably be expected to have a Material Adverse Effectresult in any adverse consequences to the Loan Parties (other than immaterial consequences), (iiii) each contract between the Borrower and any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and the Borrower and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements and comply in all material respects with all applicable Healthcare Laws, (iv) the Borrower and its Subsidiaries have receivedare in compliance in all material respects with applicable Requirements of Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither the Borrower nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA or any other Governmental Authority asserting that the Borrower, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Requirement of Law or any Permit. (b) Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to the Borrower or any of its Subsidiary is pending or, to the subject ofknowledge of the Loan Parties, threatened. None of the Borrower or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Requirement of Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products. (c) The Borrower and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Regulatory Required Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits needed necessary in connection with the testing, manufacturemanufacturing, marketing or sale selling of such Product Products, as such testing, manufacturing, marketing or selling are currently being conducted by or on behalf of Borrowerconducted, and (ii) to carry on the business of the Borrower and each of its Subsidiaries. All such Permits are valid and in full force and effect and the Borrower and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of the Borrower or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product has been and is being tested, manufactured, marketed, promoted, sold, imported, possessed, owned, warehoused, promoted, labeled, furnished should cease or distributed as that such Product should be withdrawn from the case may be, by Borrowers (or to Borrower’s actual knowledge, by any applicable third parties) in compliance with all applicable Healthcare Laws and Regulatory Required Permitsmarketplace. (bd) Except as would could not reasonably be expected to have a Material Adverse Effectmaterially adverse impact on the Borrower and its Subsidiaries, none of the Borrowers there have been no adverse clinical test results and there have been no Product recalls or voluntary Product Market Withdrawals from any Subsidiary thereof are in violation of any applicable Healthcare Lawmarket (other than those recalls or Market Withdrawals disclosed on Schedule 4.23(d)). (ce) No There has been no material untrue statement of fact and no fraudulent statement made by the Borrower or any Subsidiary thereof receives of its Subsidiaries or any payments directly (including through any third party payment processor) from Medicare, Medicaid, of their respective agents or TRICARE. (d) To Borrower’s knowledge, none of the Borrower’s or its Subsidiaries’ officers, directors or employees has made an untrue statement of material fact or fraudulent statement representatives to the FDA or failed any other Governmental Authority, and there has been no failure to disclose a any material fact required to be disclosed to the FDA, committed an act, made a statement, FDA or failed to make a statement that could 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. Regulation 46191 (September 10, 1991)any other Governmental Authority. (ef) No BorrowerNone of the Borrower or any of its Subsidiaries has been the subject of any "for cause" inspection, nor investigation or audit by any Subsidiary thereofGovernmental Authority in connection with any alleged improper activity. (g) There is no arrangement relating to the Borrower or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Borrower and each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable Healthcare Laws. (h) None of the Borrower or any of its Subsidiaries, or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for any federal or state health program- related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Loan Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for a violation of any Requirement of Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any proceedingjudgment, suit stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of its Subsidiaries or, to the knowledge of the Loan Parties, any Borrower’s knowledgeindividual who is an officer, investigation by any Governmental Authoritydirector, which would reasonably be expected to result in employee or manager of the revocation, transfer, surrender, suspension of any material Permits of Borrower or any Subsidiary, of its Subsidiaries has been convicted of any crime or engaged in each case, any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a Material Adverse Effectdebarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Requirement of Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of its Subsidiaries are pending or, to the knowledge of the Loan Parties, threatened against the Borrower or any of its Subsidiaries or any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries. (fi) As All studies, tests and preclinical and clinical trials conducted relating to the Products, sponsored by the Borrower or any of its Subsidiaries have been conducted, and are currently being conducted, in all material respects in accordance with all applicable Requirement of Law and IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Requirement Law, the Borrower and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or on behalf of the Closing DateBorrower or such Subsidiary, there as applicable. (j) To the knowledge of the Loan Parties, none of the clinical investigators in any clinical trial sponsored by the Borrower or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Borrower or any of its Subsidiaries has received from the FDA or other applicable Governmental Authority any notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the Products. (k) The Group Members are, to the extent directly applicable to the Group Members, currently conducting its business in material compliance with all regulations promulgated under HIPAA. To the extent the Group Members create any de-identified protected health information, the Group Members do so in compliance with the HIPAA regulations. The Group Members have been not failed to notify any individual or required third party, including any appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which a Group Member is a party, or any applicable requirement related to the unauthorized access, use or disclosure of protected health information. The Group Members have no Regulatory Reporting Eventsknowledge of any complaints to or investigations by any Governmental Authority with respect to HIPAA compliance by the Group Members, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all applicable laws governing the privacy, security or confidentiality of protected health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to the extent not preempted by HIPAA, and has conducted its businesses in material compliance with such laws since such laws first became applicable to it.