Common use of FDA and Regulatory Matters Clause in Contracts

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Group Company and its Subsidiaries hold, and have held at has obtained all times since January 1, 2022, all Permits, including all such material Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and FDA or any other applicable U.S., state or foreign regulatory authority necessary to conduct its Subsidiaries business as currently presently conducted or have been conducted since January 1(collectively, 2022 (the “Company PermitsRegulatory Licenses”), and all of such Company Permits Regulatory Licenses are valid and in full force and effect. There has not occurred any material violation revocation, termination, withdrawal or suspension of or default (with or without notice or lapse of time or both) under any Company PermitRegulatory License, and no proceeding is pending or, to the Knowledge of the Company’s knowledge, no event has occurred which allowsthreatened to revoke, terminate, withdraw, suspend or after notice or lapse adversely modify any such Regulatory License. To the Knowledge of time the Company, each Group Company has, since January 1, 2017, operated its businesses in a manner that would allow, revocation or termination thereof or not reasonably be expected to result in withdrawal of approval of any other material impairment Regulatory License. (b) Except as disclosed on Section 4.28(b) of the rights Company Disclosure Schedule, each Group Company is, and, to the Knowledge of the holder Company, has been since January 1, 2017, in material compliance with all provisions of (i) the FDC Act and the implementing regulations promulgated by the FDA that are applicable to such Group Company or any such Company Permit. The Company Product relating to the development, testing, manufacturing, holding, marketing, selling, distributing, labeling, promoting, advertising, importing or exporting of pharmaceutical products, including but not limited to (A) requirements for obtaining Regulatory Licenses, including generation and each submission to the FDA of its Subsidiaries are truthful and accurate data; (B) manufacture of the Products in compliance in all material respects with the terms FDC Act and current Good Manufacturing Practices; (C) requirements for establishment registration and product listing; (D) payment of all application, program, facility, and drug master file fees invoiced for the Products; (E) recordkeeping and reporting requirements; and (F) label, labeling, promotion and advertising requirements; and (ii) the Controlled Substances Act and the implementing regulations promulgated by the DEA, including but not limited to requirements regarding registration and licensing of facilities that handle Controlled Substances and ordering, receipt, labeling, packaging, storage, security, recordkeeping, reporting, manufacture, sale and distribution of Controlled Substances. (c) Except as set forth on Section 4.28(c) of the Company PermitsDisclosure Schedule, to the Knowledge of the Company, there are no Orders or written statements by any Government Authority stating that any Product is defective or unsafe, in violation of any applicable Laws or fails to meet any standards promulgated by any such Government Authority. Parent has been provided with copies of all complaints and notices of alleged defect, nonconformance, adverse reaction or noncompliance with applicable Laws that have been received in writing since January 1, 2017 by any Group Company and that remain unresolved. No Group Company is subject to any pending Claim of which it has received written notice or, to the Knowledge of the Company, threatened investigation, claim, or enforcement action by the FDA, DEA, the DOJ, the HHS-OIG or any comparable foreign Government Authority pursuant to any Laws, including without limitation the FDC Act, the Controlled Substances Act, the False Claims Act, the Anti-Kickback Statute or any equivalent or similar state or foreign Law. Since January 1, 20222017, neither the no Group Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from claim or investigation by the FDA, the DEA, the DOJ, the HHS-OIG or any Governmental Entity alleging that any operation or activity comparable foreign Government Authority. (d) Except as set forth on Section 4.28(d) of the Company Disclosure Schedule, no Group Company is or has been the subject of any inspection, audit, examination or investigation by a Government Authority, including but not limited to the FDA, the DEA or comparable foreign governmental or regulatory authorities, or has received any notice from the FDA or any other Government Authority, including but not limited to any FDA Form 483, Warning Letter, untitled letter or other similar correspondence or notice, alleging or asserting noncompliance by such Group Company or third party contract manufacturer or provider of its Subsidiaries is bio-analytic testing services with any applicable Laws or Regulatory Licenses with respect to the Products or to the facilities in material violation which the active pharmaceutical ingredients, any intermediates, bulk products or finished Products are manufactured, collected, handled or tested or contesting such Group Company’s business practices or the regulatory status, uses, manufacturing, labeling, commercialization, distribution, or promotion of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company PermitProducts. (be) The clinicalExcept as set forth on Section 4.28(e) of the Company Disclosure Schedule, pre-clinical no Group Company has either voluntarily or at the request of any Government Authority, initiated, conducted, or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice or any notice or action relating to an alleged lack of safety or efficacy of any Product. To the Knowledge of the Company, there are no facts that would reasonably be expected to cause (i) the recall, market withdrawal or replacement of any Product sold by any Group Company or its distributors, (ii) a material change in labeling of any Product, (iii) a termination or suspension of marketing of any Product or (iv) withdrawal of approval of any Regulatory License. (f) All material filings with and material submissions to the FDA or any other studies comparable Government Authority made by any Group Company, including all ANDAs, with regard to the Products, whether written or electronically delivered, were correct and tests conducted complete, in each case, in all material respects, as of the date made, and no deficiencies have been asserted by any applicable Government Authority with respect to any such filings, declarations, listing, registrations, reports or submissions, except for (i) additional information that the FDA has requested in connection with the submissions set forth on Section 4.28(f) of the Company Disclosure Schedule, and (ii) similar requests for additional information that the FDA has made in connection with any of such Group Company’s ANDAs, in each case that such Group Company has addressed and resolved. (g) No action is pending or threatened in writing to be taken by the FDA with regard to the integrity of data submitted to the FDA either by any Group Company prior to the consummation of the Closing or the Company Members on behalf of or sponsored by any Group Company prior to the Company or its Subsidiaries, or consummation of the Closing in which the Products have participated, were and, if still pending, are being conducted each case in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subjectsupport of approval of any products, including without limitation, any applicable Good Clinical Practice a requirement to conduct additional studies as a condition to obtaining or maintaining approval, a requirement to withdraw pending ANDAs, issuance of a warning or untitled letter, seizure of products, withdrawal of approval of ANDAs for products, imposition of the FDA Application Integrity Policy, imposition of civil penalties and Good Laboratory Practice requirements. No IND filed or submitted by criminal prosecution. (h) All studies, tests and non-clinical and clinical trials conducted by, or on behalf of of, any Group Company with respect to the Company or its Subsidiaries Products are being and have been conducted in material compliance with the FDAprotocols and controls pursuant to accepted professional scientific standards and all applicable Laws, nor any comparable application filed with or submitted to another Governmental Entityincluding the FDC Act, has been subject to a clinical hold or otherwise terminated or suspended all regulations promulgated by the FDA or such Governmental Entityrelating thereto, including 21 C.F.R. Parts 50, 54, 56, 58 and 312, as amended, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Lawguidance, including applicable Healthcare Lawsany guidance related to good laboratory practices and good clinical practices. Since January 1, 20222017, all applicationsno Group Company has received any notices, notificationscorrespondence or other communication from any institutional review board, submissionsthe FDA or any comparable foreign Government Authority, informationrecommending or requiring the termination, claimssuspension or material modification of any ongoing or planned clinical trials conducted by, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection withof, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental EntityGroup Company. (di) Since January 1, 2022, neither the (i) Neither any Group Company nor any of its Subsidiaries have officers, employees or, in a capacity on behalf of, and at the direction of, such Group Company, contractors (including clinical trial investigators, contract research organizations and bioanalytical service providers) has committed any act, made any statement or failed to make any statement that would reasonably be likely expected to (A) provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09) (“FDA Application Integrity Policy”) and any amendments thereto, or other similar Laws. Neither (B) violate 18 U.S.C. §§ 371, 1001, 1035, 1341, and 1343; (ii) neither any Group Company nor any of its officers, employees or, in a capacity on behalf of, and at the direction of, such Group Company, contractors (including clinical trial investigators, contract research organizations and bioanalytical service providers) is the subject of any pending or, to the Knowledge of the Company, any threatened investigation by the FDA pursuant to the FDA Application Integrity Policy or 18 U.S.C. §§371, 1001, 1035, 1341, and 1343; and (iii) none of its Subsidiaries, nor any of their respective the officers, employees, contractors, suppliers, agents or other Persons performing research clinical investigators employed by any Group Company has been disqualified or work on behalf of debarred by the Company or FDA for any of its Subsidiaries is purpose, or has been subject charged with or convicted under United States federal Law for conduct relating to the development, approval or otherwise relating to the regulation of any drug product, under the Generic Drug Enforcement Act of 1992 or the FDC Act or have made an untrue statement of a material fact to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits Government Authority with respect to Products (whether in any Product. Since January 1submission to such Government Authority or otherwise), 2022, no manufacturing site owned by the Company, its Subsidiaries, or, or failed to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject disclose a material fact required to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead disclosed to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board Government Authority with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (hi) The Each Group Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, is and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries 2017 has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controlsfederal or state criminal or civil Laws relating to healthcare and government contracting and price reporting (including without limitation the federal Anti-Kickback Statute (42 U.S.C. §1320a−7b(b)), economic sanctionsXxxxx Law (42 U.S.C. §1395nn), False Claims Act (31 X.X.X. §0000 et seq.), Civil Monetary Penalties Law (42 U.S.C. §§1320a-7a and 1320a-7b), Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104−191), as amended by the Health Information Technology for Economic and Clinical Health Act, the Medicaid rebate law (42 U.S.C. §1396r-8), the Veterans Health Care Act of 1992, the Trade Agreements Act of 1979 (19 X.X.X. §0000 et seq.), the U.S. Physician Payment Sunshine Act (42 U.S.C. §1128G) and any comparable state Laws), or the regulations promulgated pursuant to such Laws, or which are cause for civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program (“Program”), and antiboycott Laws(ii) there is no civil, criminal, administrative or other action, suit, demand, claim, hearing, proceeding, notice or demand pending, received by or, to the Knowledge of the Company, threatened against any Group Company that is reasonably likely to result in its exclusion from participation in any Program or other third-party payment programs in which such Group Company participates.

FDA and Regulatory Matters. Except as set forth in Section 3.19 of the Disclosure Letter: (a) The no Seller Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation or other direct or indirect Subsidiary of the businesses Seller Companies engaged in the Business has received, in respect of the Company Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the U.S. Food and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allowsDrug Administration, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of Governmental Entity, alleging or asserting noncompliance with the rights of the holder of any such Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.); (b) each Seller Company Permit. The Company and each of its Subsidiaries are is in compliance in all material respects with applicable health care laws, including without limitation, the terms Federal Food, Drug and Cosmetic Act and the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and the regulations promulgated pursuant to such laws, and comparable state laws (collectively, the “Health Care Laws”); (c) no Seller Company or other direct or indirect Subsidiary of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries Seller Companies engaged in the Business has received written or oral notice of any pending or threatened Action from that any Governmental Entity alleging has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits required by the Health Care Laws that any operation are applicable to the Business, which has not been resolved in such Seller Company’s favor; and (d) no Seller Company or activity other direct or indirect Subsidiary of the Seller Companies engaged in the Business has, in respect of the Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, safety alert, post-sale warning, “dear doctor” letter, or other notice or action material to the Business relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to Sellers’ Knowledge, no Person has initiated or conducted any such notice or action against any Seller Company or any other direct or indirect Subsidiary of its Subsidiaries is the Seller Companies engaged in material violation of any Law that applies to a Company Permitthe Business. The transactions contemplated by this AgreementTo Sellers’ Knowledge, in and of themselvesthe research, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by each Seller Company in respect of the Company or its Subsidiaries, or in which the Products Business have participated, were and, if still pending, are being been conducted in all material respects with reasonable care and in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with experimental protocols, procedures and controls adopted by such Seller Company pursuant to all Health Care Laws and Permits required by the Health Care Laws that are applicable export controls, economic sanctions, and antiboycott Lawsto the Business or to such Seller Company or other direct or indirect Subsidiary of the Seller Companies engaged in the Business.

FDA and Regulatory Matters. (a) The Company Except as has not and its Subsidiaries holdwould not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Obalon, Obalon is, and have held at all times since January 1December 31, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity2017, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entitybeen, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all Healthcare Laws applicable requirements under any Company Permit or Law, including applicable Healthcare Lawsto Obalon and its Products. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports Except as has not and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would not reasonably be likely expected to provide have, individually or in the aggregate, a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work Adverse Effect on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022Obalon, the manufacture design, development, investigation, manufacture, testing, sale, marketing and distribution of Products by or on behalf of the Company Obalon is being, and its Subsidiaries has been and is being since December 31, 2017, conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, including, without limitation, requirements relating to clinical and non-clinical research, product approval or clearance, premarketing notification, labeling, advertising and promotion, record-keeping, adverse event reporting, reporting of corrections and removals, and current good manufacturing practices for medical device products. Obalon and, to Obalon’s knowledge, any contract manufacturers assisting in the knowledge manufacture of the Company there is no civilProducts or Product components are, criminaland, administrativesince December 31, or other Action pending2017, received by orhave been, threatened against the Company or any of its Subsidiaries or any Collaboration Partner in compliance with FDA’s device registration and listing requirements to the extent related required by applicable Healthcare Laws insofar as they pertain to the manufacture of Products or Product components for Obalon, except as has not and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Obalon. Obalon has not received written notification of any Productpending or threatened claim, related to such suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body, including, without limitation, the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services Office of Inspector General or any comparable state or federal Governmental Body alleging potential or actual non-compliance by, or Liability of, Obalon under any Healthcare LawsLaw. (ib) Neither Obalon holds such Permits of Governmental Bodies required for the Company, any conduct of its Subsidiaries nor any of their respective directorsbusiness as currently conducted, officers or employeesincluding, norwithout limitation, those Permits necessary to permit the knowledge of the Companydesign, any other Representative or other Person acting on behalf of the Company or any development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Subsidiaries has (i) violated or is Products in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if jurisdictions where it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, currently conducts such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries activities with respect to any Product: each Product (i) has been charged with or convicted of any criminal offense relating collectively, the “Obalon Licenses”), except to the delivery of an item extent where the failure to hold such Permits would not, individually or service under any Federal Health Care Program, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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 agenciesaggregate, (v) has received written notice that it is the target of any investigation relating be reasonably expected to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is have a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.Material Adverse ​ ​

FDA and Regulatory Matters. (a) The Company has operated and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are is in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither Good Laboratory Practices (the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity “GLP”) of the Company U.S. Food and Drug Administration (the “FDA”) and any other federal, state, local or any foreign regulatory agency exercising comparable authority to the FDA, except for instances of its Subsidiaries is noncompliance which would not reasonably be expected to result, individually or in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreementthe aggregate, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permita Material Adverse Effect. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, has not received any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA written notice or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice communication from the FDA or any other Governmental Entity Authority alleging or asserting any material noncompliance with violation of any applicable Laws or material laws by the Company Permits with respect relating to its business. (c) Each filing or submission to the FDA and any Product. Since January 1, 2022, no manufacturing site owned similar Governmental Authority in any other jurisdiction made by the Company, its Subsidiarieswas true, or, to the knowledge accurate and complete as of the Companydate made. The Company has notified the FDA and all such Governmental Authorities of any changes to such filings or submissions as required by law. (d) The Company possesses all certificates, any of their respective contract manufacturers for Productsauthorizations, is or permits, clearances and approvals issued by the FDA and all material certificates, authorizations, permits, clearances and approvals issued by comparable foreign Governmental Authorities necessary to conduct its business and to produce, market and distribute its products (“Permits”). The Company has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Companyfulfilled all material obligations under each Permit, and no event has occurred which that would reasonably be likely expected to lead constitute a material violation or to any Action by any Governmental Entity cause revocation or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy termination of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) Permit. The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from no knowledge that the FDA or any other comparable Governmental EntityAuthority is considering limiting in any material respect, suspending or revoking any minutes such Permit. (e) There is no materially false or similar summary documentation with respect misleading information or material omission in any product application or other submission made by the Company to meetings with the FDA or any other comparable Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the ProductsAuthority. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company or its Subsidiary hold all material licenses, Permits, franchises, variances, registrations, exemptions, orders and its Subsidiaries holdother governmental authorizations, consents, approvals, and clearances, and have held at all times since January 1, 2022submitted notices to, all PermitsGovernmental Bodies, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of the Company’s Products (any such Permits required pursuant to any applicable Healthcare LawsGovernmental Body, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company and or its Subsidiaries Subsidiary as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and as of the date hereof, all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or of, default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allowsunder, or after event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time would allowor both, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries Subsidiary are in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any Company Permit. Since January 1December 31, 20222020, neither the Company nor any of its Subsidiaries Subsidiary has received written or oral notice of any pending or threatened Action claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity the FDA or other Company Regulatory Agency alleging that any operation or activity of the Company or any of its Subsidiaries Subsidiary is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permitapplicable Law. (b) The clinicalSince December 31, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 20222020, all of the Company’s and its Subsidiaries’ Subsidiary’s Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, Company Regulatory Agencies have been manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed tested by or on behalf of the Company or any of its Subsidiaries Subsidiary in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Lawsstatutes and implementing regulations administered or enforced by the FDA or other Company Regulatory Agency. Since January 1December 31, 20222020, all applications, submissions, notifications, submissions, information, claims, reports information and data utilized by the Company or its Subsidiaries Subsidiary as the basis for, or submitted by or or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries Subsidiary in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, Subsidiary when submitted to the FDA or other Governmental EntityCompany Regulatory Agency, were true true, complete and correct correct, in all material respects respects, as of the date of submission, and any material updates, changes, corrections or modification to such applications, submissions, notifications, submissions, information, claims, reports information and data required under applicable Laws have been submitted to the FDA or other Governmental EntityCompany Regulatory Agency. (dc) Since January 1December 31, 20222020, neither the Company Company, nor any of its Subsidiaries Subsidiary, have committed any act, made any statement or failed to make any statement that would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company nor or its Subsidiary nor, to the Knowledge of the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents suppliers or other Persons entities or individuals performing research or work on behalf of the Company or any of its Subsidiaries is or Subsidiary has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity Body or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely expected to result, in a material debarment or exclusion under applicable Law, including including, without limitation, 21 U.S.C. Section 335a. To No claims, actions, proceedings or, to the knowledge Knowledge of the Company, no Actions investigations that would reasonably be likely expected to result in such a material debarment or exclusion are pending or threatened in writing against the Company or any of its Subsidiaries Subsidiary or any of their respective officers, employees, contractors, suppliers, agents suppliers or other Persons entities or individuals performing research or work on behalf of the Company or any of its SubsidiariesSubsidiary. (ed) Since January 1December 31, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 20222020, none of the Company, any of its SubsidiariesSubsidiary, or, to the knowledge Knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity Company Regulatory Agency alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Product of the Company or its Subsidiary. (e) Since January 1December 31, 20222020, no manufacturing site owned all studies, tests and preclinical studies being conducted by the Company or its Subsidiary, or in which the Company, its SubsidiariesSubsidiary or any Product has participated, orhave been and are being conducted in compliance in all material respects with applicable Laws, including the applicable requirements of Good Laboratory Practices, to the knowledge of the Company, extent any of their respective contract manufacturers for Products, such study or test is or has been subject required to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner conducted in which the Products are manufactured, distributed or marketedcompliance with Good Laboratory Practices. (f) Since January 1December 31, 20222020, (i) there have been no adverse events that should have been reported all studies, tests and preclinical and clinical trials being conducted by the Company or a Subsidiary of its Subsidiary, or in which the Company, but were not reportedits Subsidiary or any Product or Product candidate has participated, to have been and are being conducted in compliance in all material respects with applicable Laws, including the applicable requirements of Good Laboratory Practices or Good Clinical Practices. Since December 30, 2020, neither the Company or its Subsidiary have received any written notices, correspondence or other communication from any institutional review board, the FDA or any other Governmental Entity Company Regulatory Agency, recommending or Review Board with respect to requiring the safety termination, suspension, or efficacy material modification of any Productongoing or planned clinical trials conducted by, and (ii) to or on behalf of, the knowledge of the CompanyCompany or its Subsidiary, with respect to a Product being developed or marketed other than any comments on study design provided by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy as part of such Productany pre-Investigational New Drug Application activities, including any pre-Investigational New Drug Application meetings. (g) The Company has made available to Parent and or its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, Subsidiary are, and at all times since January 1December 31, 2021 2020 have been, in compliance in all material compliance respects with all applicable Healthcare Laws, and to the knowledge of the Company there . There is no civil, criminal, administrative, or other Action pending, received by oror filed since December 31, 2020, or to the Knowledge of the Company, threatened Action against the Company or its Subsidiary alleging any material violation by the Company or its Subsidiary of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such applicable Healthcare Laws. (ih) Neither the Company, any its Subsidiary nor, to the Knowledge of its Subsidiaries nor the Company, any of their respective directors, officers officers, or employees, nor, to the knowledge of the Company, agents or distributors or any other Representative or other Person person while acting on behalf of the Company or its Subsidiary has, at any of its Subsidiaries has time since December 31, 2020, (i) violated or is in violation of of, in any material respect, any provision of the U.S. Foreign Corrupt Practices Act of 19771977 (the “FCPA”), any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 2010, or any other Law laws, Orders, rules, or regulations thereunder, or any comparable foreign law or statute relating to briberythe prevention of corruption and bribery (collectively, corruption, fraud or improper payments (the “Anti-Corruption Laws”); , (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of valuevalue prohibited under any applicable Law addressing matters comparable to those addressed by the FCPA implementing legislation concerning such payments or gifts in any jurisdiction (any such payment, regardless of form or amounta “Prohibited Payment”), to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed been subject to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit investigation by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity Body with regard to any alleged or potential violations of any Anti-Corruption Laws; Prohibited Payment or (viiiv) violated or is in violation of of, in any material respect, any other Laws regarding use of funds for political activity or commercial bribery. . (i) None of the Representatives Company nor its Subsidiary, nor any of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directorsofficers, officers directors or employees, or, nor to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None Knowledge of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative their Representatives acting at the direction of or on behalf of the Company or any of its Subsidiariestheir behalf, is a Person that iscurrently, or is owned or controlled by Persons that are has since December 31, 2020 been: (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Controla Sanctioned Person, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or ordinarily resident in a country Sanctioned Country, (iii) engaging in any unlawful dealings or region that is transactions with or for the subject benefit of such sanctions. Since January 1any Sanctioned Person or in any Sanctioned Country, 2022(iv) engaging in any export, reexport, transfer or provision of any goods, software, technology, data or service without, or exceeding the scope of any licenses or authorizations under all applicable Ex-Im Laws, or (v) otherwise in violation of applicable Sanctions Laws, Ex-Im Laws, or the anti-boycott laws administered by the U.S. Department of Commerce and the U.S. Department of Treasury’s Internal Revenue Service (collectively, “Trade Control Laws”). (j) During the five years prior to the date hereof, none of the Company and nor any of its Subsidiaries have been has, in compliance in all material respects connection with all applicable export controlsor relating to the business of the Company or its Subsidiary, economic sanctionsreceived from any Governmental Authority or any other Person any notice, and antiboycott inquiry, or internal or external allegation; made any voluntary or involuntary disclosure to a Governmental Authority; or conducted any internal investigation or audit concerning any actual or potential violation or wrongdoing related to Anti-Corruption Laws or Trade Control Laws.

FDA and Regulatory Matters. (a) The Company and its the Company Subsidiaries hold, are and have held at all times since January 1, 20222014 have been, and, to the Knowledge of the Company, since their incorporation have been, in compliance in all Permitsmaterial respects with all Healthcare Laws applicable to the Company and the Company Subsidiaries, including or the Company Business. The design, manufacture, testing, and distribution of the Company Product by or on behalf of the Company and the Company Subsidiaries is being and since January 1, 2014 has been, and, to the Knowledge of the Company, since their incorporation has been, conducted in compliance in all such Permits required pursuant to any material respects with all applicable Healthcare Laws, necessary including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products and, to the lawful operation of extent applicable to the businesses Company or any of the Company Subsidiaries, counterpart Laws in the European Union and all other countries where compliance is required. The Company and the Company Subsidiaries and, to the Knowledge of the Company, any contract manufacturers of the Company Product are, and at all times have been, in compliance with the FDA’s registration and listing requirements to the extent required by applicable Healthcare Laws, and the Company Product, if so required, are in conformance in all material respects with all applicable CE Marking certifications and declarations of conformity. Neither the Company nor any of the Company Subsidiaries has received notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity, including, without limitation, the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, or any comparable state, federal or foreign Governmental Entity alleging non-compliance by, or liability of, the Company or the Company Subsidiaries under any Healthcare Law. (b) The Company and each of the Company Subsidiaries holds such permits from the United States or foreign Governmental Entities required for the conduct of its Subsidiaries business as currently conducted or have been conducted since January 1conducted, 2022 including, where applicable and without limitation, those permits to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Company Product in jurisdictions where it currently conducts such activities (the “Activities to Date”) with respect to each Company PermitsProduct (collectively, the “Company Licenses”). The Company and each of the Company Subsidiaries, as the case may be, has fulfilled and performed all such of their material obligations with respect to each Company Permits are valid License and is in full force material compliance with all material terms and effect. There has not occurred any material violation conditions of or default (with or without notice or lapse of time or both) under any each Company PermitLicense, and and, to the Knowledge of the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result results in any other material impairment of the rights of the holder of any such Company PermitLicense. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither Neither the Company nor any of its the Company Subsidiaries has received written any information or oral notice of any pending or threatened Action notification from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such any other Governmental Entity with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1All material applications, 2022filings, all of the Company’s reports, documents, claims, submissions and its Subsidiaries’ Products that are subject notices required to the jurisdiction of the FDA be filed, maintained, or furnished to FDA, state, other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed federal or non-United States equivalent agencies by or on behalf of the Company or any of its the Company Subsidiaries have been so filed, maintained or furnished and were true, complete and correct in all material respects on the date filed (or were corrected in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Lawssupplemented by a subsequent filing). Since January 1, 2022, all All material applications, notifications, submissions, information, claims, reports reports, and data filings utilized by the Company or its Subsidiaries as the basis for, for or submitted by or on behalf of the Company or its Subsidiaries in connection with, with any and all requests for a Company License from the Company Permits FDA or other Governmental Entity relating to the Company or any of its Subsidiaries, or the ProductsProduct, when submitted to the FDA or any other Governmental Entity, were true true, accurate and correct complete in all material respects as of the date of submission, and any material . Any necessary or required updates, changes, corrections or modification modifications to such applications, notifications, submissions, information, claims, reports reports, filings, and other data required under applicable Laws have been submitted to the FDA or other Governmental EntityEntity and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects, and do not contain an untrue statement of material fact or omit to state a material fact necessary to make the statements therein not misleading. (d) Since January 1No Company Product manufacturing site (whether Company- or Company Subsidiary-owned or operated, 2022or that of a current contract manufacturer for the products) has been subject to a Governmental Entity (including FDA) shutdown or import or export prohibition. (e) There have been no adverse regulatory actions taken (or, neither to the Knowledge of the Company, threatened) by the FDA or any other Governmental Entity with respect to any of the Company Product or any facilities where any such Company Product are tested, produced, processed, packaged or stored. (f) All preclinical and clinical trials, if any, that have been or are being conducted by or on behalf of, or sponsored by, the Company or the Company Subsidiaries, or in which the Company or the Company Subsidiaries or their Company Product have participated, and which have been or will be submitted to regulatory authorities in connection with applications for clearance or approval, were and, if still pending, are being or have been conducted in compliance in all material respects with standard medical and scientific research procedures and the experimental protocols, procedures and controls pursuant to applicable Healthcare Laws, including, but not limited to, the Federal Food Drug and Cosmetic Act (“FDCA”) and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 812, the Medical Device Directives, and all applicable EEA Member State Laws governing performance evaluations and clinical trials with medical devices. The Company and the Company Subsidiaries have not received any notices, correspondence or other communication from the FDA or any other Governmental Entity requiring the termination, suspension or material modification of any clinical trials conducted by or on behalf of the Company or any of the Company Subsidiaries, or in which the Company or any of the Company Subsidiaries have participated, and to the Company’s Knowledge, there is no reason to believe that the FDA or any other Governmental Entity is considering such action. (g) The Company has delivered to Parent or Purchaser true, correct and complete copies of all material written communications with any Governmental Entity (specifically including but not limited to the FDA) in any jurisdiction related to the Company Product, as well as correct and complete written summaries of all material oral communications between the Company, any of the Company Subsidiaries or their respective officers, employees, agents or representatives, on the one hand, and any Governmental Entity in any jurisdiction, or their respective employees, agents or representatives, on the other hand. (h) Neither the Company nor any of the Company Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company or the Company Product, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), or otherwise. 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 have has made an untrue statement of material fact to the FDA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity, or committed any an act, made any a statement or failed to make any a statement that that, at the time such disclosure was made, would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” the FDA Fraud Policy or other any similar Lawspolicy. Neither the Company nor any of the Company Subsidiaries, nor, to the Knowledge of the Company, any of its Subsidiariesofficer, nor any of their respective officersemployee, employees, contractors, suppliers, agents agent or other Persons performing research or work on behalf distributor of the Company or any of its Subsidiaries is or the Company Subsidiaries, has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resultedfor 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 would reasonably be likely to resultany similar Law. No claims, in debarment under applicable Lawactions, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions proceedings or investigation that would reasonably be likely expected to result in such a material debarment or exclusion are pending or threatened or, to the Knowledge of the Company, threatened, against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of to the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none Knowledge of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers officers, employees or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeagents. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its the Company Subsidiaries hold, are and have held at all times since January 1, 20222014 have been, and, to the Knowledge of the Company, since their incorporation have been, in compliance in all Permitsmaterial respects with all Healthcare Laws applicable to the Company and the Company Subsidiaries, or to the design, development, use, manufacture, marketing, distribution, import and sale of products of the Company and the Company Subsidiaries, as presently conducted and as presently contemplated to be conducted, including Company Products (the “Company Business”). The design, manufacture, testing, and distribution of the Company Product by or on behalf of the Company and the Company Subsidiaries is being and since January 1, 2014 has been, and, to the Knowledge of the Company, since their incorporation has been, conducted in compliance in all such Permits required pursuant to any material respects with all applicable Healthcare Laws, necessary including the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products and, to the lawful operation of extent applicable to the businesses Company or any of the Company Subsidiaries, counterpart Laws in the European Union and all other countries where compliance is required. The Company and the Company Subsidiaries and, to the Knowledge of the Company, any contract manufacturers of the products that have been or are currently being designed, developed, manufactured or sold by the Company or the Company Subsidiaries prior to the Closing (collectively, the “Company Products”) are, and at all times have been, in compliance with the FDA’s registration and listing requirements to the extent required by applicable Healthcare Laws, and the Company Product, if so required, are in conformance in all material respects with all applicable CE Marking certifications and declarations of conformity. Neither the Company nor any of the Company Subsidiaries has received notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity, including the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, or any comparable state, federal or foreign Governmental Entity alleging material non-compliance by, or liability of, the Company or the Company Subsidiaries under any Healthcare Law. (b) The Company and each of the Company Subsidiaries holds such permits from the United States or foreign Governmental Entities required for the conduct of its Subsidiaries business as currently conducted or have been conducted since January 1conducted, 2022 including, where applicable and without limitation, those permits to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of its Company Product in jurisdictions where it currently conducts such activities (the “Activities to Date”) with respect to each Company PermitsProduct (collectively, the “Company Licenses”). The Company and each of the Company Subsidiaries, as the case may be, has fulfilled and performed all such of their material obligations with respect to each Company Permits are valid License and is in full force material compliance with all material terms and effect. There has not occurred any material violation conditions of or default (with or without notice or lapse of time or both) under any each Company PermitLicense, and and, to the Knowledge of the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result results in any other material impairment of the rights of the holder of any such Company PermitLicense. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither Neither the Company nor any of its the Company Subsidiaries has received written any information or oral notice of any pending or threatened Action notification from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such any other Governmental Entity with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1All material applications, 2022filings, all of the Company’s reports, documents, claims, submissions and its Subsidiaries’ Products that are subject notices required to the jurisdiction of the FDA be filed, maintained, or furnished to FDA, state, other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed federal or non-United States equivalent agencies by or on behalf of the Company or any of its the Company Subsidiaries have been so filed, maintained or furnished and were true, correct and complete in all material respects on the date filed (or were corrected in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Lawssupplemented by a subsequent filing). Since January 1, 2022, all All material applications, notifications, submissions, information, claims, reports reports, and data filings utilized by the Company or its Subsidiaries as the basis for, for or submitted by or on behalf of the Company or its Subsidiaries in connection with, with any and all requests for a Company License from the Company Permits FDA or other Governmental Entity relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or any other Governmental Entity, were true true, correct and correct complete in all material respects as of the date of submission, and any material . Any necessary or required updates, changes, corrections or modification modifications to such applications, notifications, submissions, information, claims, reports reports, filings, and other data required under applicable Laws have been submitted to the FDA or other Governmental EntityEntity and as so updated, changed, corrected or modified remain true, correct and complete in all material respects, and do not contain an untrue statement of material fact or omit to state a material fact necessary to make the statements therein not misleading. (d) Since January 1No Company Product manufacturing site (whether Company- or Company Subsidiary-owned or operated, 2022or that of a current contract manufacturer for the products) has been subject to a Governmental Entity (including FDA) shutdown or import or export prohibition. (e) There have been no adverse regulatory actions taken (or, neither 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 Company Product are tested, produced, processed, packaged or stored. (f) All preclinical and clinical trials, if any, that have been or are being conducted by or on behalf of, or sponsored by, the Company or the Company Subsidiaries, or in which the Company or the Company Subsidiaries or their Company Product have participated, and which have been or will be submitted to a Governmental Entity in connection with applications for clearance or approval, were and, if still pending, are being or have been conducted in compliance in all material respects with standard medical and scientific research procedures and the experimental protocols, procedures and controls pursuant to applicable Healthcare Laws, including, but not limited to, the Federal Food Drug and Cosmetic Act (“FDCA”) and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 812, the Medical Device Directives, and all applicable EEA Member State Laws governing performance evaluations and clinical trials with medical devices. The Company and the Company Subsidiaries have not received any notices, correspondence or other communication from the FDA or any other Governmental Entity requiring the termination, suspension or material modification of any clinical trials conducted by or on behalf of the Company or any of the Company Subsidiaries, or in which the Company or any of the Company Subsidiaries have participated, and to the Knowledge of the Company, there is no reason to believe that the FDA or any other Governmental Entity is considering such action. (g) The Company has provided to Parent or Purchaser true, correct and complete copies of all material written communications with any Governmental Entity (specifically including but not limited to the FDA) in any jurisdiction related to the Company Product, as well as correct and complete written summaries of all material oral communications between the Company, any of the Company Subsidiaries or their respective officers, employees, agents or representatives, on the one hand, and any Governmental Entity in any jurisdiction, on the other hand. (h) Neither the Company nor any of the Company Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company or the Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”). 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 have has made an untrue statement of material fact to the FDA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity, or committed any an act, made any a statement or failed to make any a statement that that, at the time such disclosure was made, would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” the FDA Fraud Policy or other any similar Lawspolicy. Neither the Company nor any of the Company Subsidiaries, nor, to the Knowledge of the Company, any of its Subsidiariesofficer, nor any of their respective officersemployee, employees, contractors, suppliers, agents agent or other Persons performing research or work on behalf distributor of the Company or any of its Subsidiaries is or the Company Subsidiaries, has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resultedfor 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 would reasonably be likely to resultany similar Law. No claims, in debarment under applicable Lawactions, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions proceedings or investigation that would reasonably be likely expected to result in such a material debarment or exclusion are pending or threatened or, to the Knowledge of the Company, threatened, against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of to the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none Knowledge of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers officers, employees or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeagents. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries holdEntities are, and in the past three (3) years have held been, in compliance in all material respects with all Healthcare Laws applicable to such Company Entity, or by which any property, any Products or other asset of the Company Entities is bound or affected. The design, manufacture, testing, sale, marketing, promotion and distribution of the Products by or on behalf of the Company Entities is being, and in the past three (3) years has been, conducted in compliance with all applicable Healthcare Laws in all material respects, including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products and, to the extent applicable to the Company or any of its Subsidiaries, counterpart Laws in the European Union and the United Kingdom and all other countries where compliance is required. The Company Entities and any contract manufacturers assisting in the manufacture of the Products are, and at all times since January 1have been, 2022, all Permits, including all such Permits in compliance with FDA’s registration and listing requirements to the extent required pursuant to any by applicable Healthcare Laws, necessary and the Products, to the extent required by Healthcare Laws, are in conformance in all material respects with all applicable “CE” marking certifications and declarations of conformity. No Company Entity has received written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other Legal Proceeding from any Governmental Authority, including, without limitation, the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, the U.S. Department of Justice, or any comparable state, federal or foreign Governmental Authority alleging non-compliance in any material respect by, or liability of, any Company Entity under any Healthcare Law. (b) Each Company Entity holds, and is and for the lawful operation past three (3) years has been operating in material compliance with, such Permits of the businesses FDA and any similar federal, state, local or foreign Governmental Authority required for the conduct of the Company and its Subsidiaries business as currently conducted or have been conducted since January 1(collectively, 2022 (the “Company Regulatory Permits”), and all such Company required Regulatory Permits are valid and in full force and effect. There Each Company Entity has not occurred any fulfilled and performed all of its material violation of or default (obligations with or without notice or lapse of time or both) under any Company Permitrespect to the Regulatory Permits, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result results in any other material impairment of the rights of the holder of any such Company required Regulatory Permit. The No Company Entity has received any communication from any Governmental Authority regarding, and, to the Knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any material change in any such Permit, or any failure to materially comply with any applicable Healthcare Laws with respect to, or any term or requirement of, any such Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or material modification of any such Permit. (c) No Company Entity has received any information or notification from the FDA or any other Governmental Authority with jurisdiction over the testing, marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval, clearance or certification currently pending before the FDA or any other Governmental Authority. (d) All applications, filings, reports, documents, claims, submissions and notices required to be filed, maintained, or furnished to FDA, state, other federal or non-United States equivalent agencies or Notified Bodies by the Company Entities have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports and medical device reports, with regard to the Products. Except for those adverse event reports and complaints described in Schedule 3.22(d) of the Company Entities Disclosure Schedule, the adverse event reports related to the Products and the complaint review and analysis reports of the Company and each of its Subsidiaries are do not contain any information that would reasonably be expected to result in compliance in all any material respects with the terms of all Company Permits. Since January 1, 2022, neither liabilities to the Company nor Entities. (e) All applications, notifications, submissions, information, claims, reports and statistics, filings, and other data and conclusions derived therefrom utilized as the basis for or submitted in connection with any of its Subsidiaries has received written and all requests for a Regulatory Permit, including from the FDA or oral notice of other Governmental Authority under any pending or threatened Action from any Governmental Entity alleging that any operation or activity of Healthcare Laws, relating to the Company or any of its Subsidiaries is in material violation of Subsidiaries, their respective businesses, or any Law that applies to a Products marketed or developed by the Company Permit. The transactions contemplated by this AgreementEntities, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant when submitted to the terms FDA or any other Governmental Authority, whether oral, written or electronically delivered, were true, accurate and complete as of the date of submission. Any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings, and other data have been submitted to the FDA or other Governmental Authority and as so updated, changed, corrected or modified remain true, accurate and complete, and do not materially misstate any such Company Permitof the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (bf) The No Company Entity has received any written notice or other written communication from the FDA or any other Governmental Authority contesting the pre-market clearance, approval or certification of the uses of or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products (whether Company- or Subsidiary-owned or operated, or that of a contract manufacturer for the Products) has been subject to a Governmental Authority (including FDA) shutdown or import or export prohibition. None of the Company, its Subsidiaries, nor any manufacturing site which assists in the manufacture of the Products (whether Company- or Subsidiary-owned or operated, or that of a contract manufacturer for the Products) has received any Form FDA-483 or other Governmental Authority notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Healthcare Laws or Regulatory Permits or alleging a lack of safety from the FDA or any other Governmental Authority, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened and neither the FDA nor any Governmental Authority is considering such action. (g) During the last three (3) years, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any Product (“Safety Notices”), or seizures ordered or adverse regulatory actions taken (or, to the Knowledge of the Company, threatened) by the FDA or any other Governmental Authority with respect to any of the Products or any facilities where any such Products are tested, produced, processed, packaged or stored. There have been no material product complaints with respect to any of the Company Entities’ Products that are reasonably likely to result in, and there are otherwise no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the Products, (ii) a change in the marketing classification or a material change in labeling of any of the Products; or (iii) a termination or suspension of marketing or testing of any Products. (h) All preclinical, clinical, pre-clinical and other studies and tests that have been or are being conducted by or on behalf of of, or sponsored by by, the Company or its SubsidiariesEntities, or in which the Company Entities or their Products have participated, were and, if still pending, are being or have been conducted in compliance in all material respects in accordance with standard medical and scientific research procedures and the experimental protocols, procedures and controls pursuant to applicable Healthcare Laws Laws, including, but not limited to, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 812, Council Directive 93/42/EEC of June 14, 1993 and Regulation (EU) 2017/745 of the rulesEuropean Parliament and of the Council of April 5, policies 2017, and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirementstheir implementing national Laws. No IND investigational device exemption filed or submitted by or on behalf of the Company or its Subsidiaries Entities with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, FDA has been subject to a clinical hold or otherwise terminated or suspended by the FDA. The Company Entities have not received any notices, correspondence or other communication from the FDA or such any other Governmental EntityAuthority requiring the termination, and neither the FDA nor such Governmental Entity, nor suspension or material modification of any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be studies conducted by or on behalf of any Company Entity, or in which any Company Entity has participated, and to the Company or its Subsidiaries. (c) Since January 1, 2022, all Knowledge of the Company’s and its Subsidiaries’ Products , there is no reason to believe that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Authority is considering such action. Schedule 3.22(h) of the Company Entities Disclosure Schedule lists all clinical study investigatory sites for the Products, identifying as to each such site whether the Company has conducted a regulatory and quality assessment and audit of such site. All material observations resulting from such regulatory and quality assessments and audits have been remediated. (i) The Company has delivered to the Purchaser true, correct and complete copies of all written communications with any Governmental Authority (specifically including but not limited to the FDA) in any jurisdiction, as well as correct and complete written summaries of, and meeting notes from, all material oral communications between any Company Entity or their respective officers, employees, agents or representatives, on the one hand, and any Governmental Authority in any jurisdiction, or their respective employees, agents or representatives, on the other hand. (j) In order to invoke increase reimbursement of the usage of the Eligible Product in Germany, applications have been submitted for (i) either a surcharge (Zusatzentgelt) or the grouping into the higher DRG F08 and (ii) the recognition as a novel treatment (Neue Behandlungsmethode) of clinical benefit under Sec. 137e Fifth Book of the Social Security Code (Fünftes Buch Sozialgesetzbuch). No Company Entity has received any information or notification from any Governmental Authority that these applications will or likely will be rejected. (k) No Company Entity is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company or the Products, by the FDA pursuant to its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” Final Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), or other similar Lawsotherwise. Neither the Company Entities, nor any officer, employee, agent or distributor of any Company Entity has made an untrue statement of material fact to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, 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 or any other Governmental Authority to invoke the FDA Fraud Policy or any similar policy. No Company Entity, officer, employee or, to the Knowledge of the Company, agent or distributor of any Company Entity, has been debarred, suspended or excluded from participating in any federal health care programs, 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. No claims, actions, proceedings or investigation that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its Subsidiariesdirectors, nor any of their respective officers, employeesemployees or agents. No Company Entity is a party to, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decreeongoing reporting obligations pursuant to, individual or any corporate integrity agreement, deferred or non-prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketedAuthority. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at hold all times since January 1, 2022, all Permits, including all such material Permits required pursuant to any applicable Healthcare Laws, under the FDA Laws necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company FDA Permits”), and as of the date of this Agreement, all such Company FDA Permits are valid and in full force and effect. There has Except as would not occurred any reasonably be expected to be, individually or in the aggregate, material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledgeCompany and its Subsidiaries, no event has occurred which allowstaken as a whole, or after notice or lapse of time would allowsince the Reference Date, revocation or termination thereof or result in any other material impairment of (i) the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company FDA Permits. Since January 1, 2022, neither the Company nor and (ii) there has not occurred any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of or default under any Law that applies to a Company FDA Permit. The transactions contemplated by this AgreementContemplated Transactions, in and of themselves, will not cause the revocation or cancellation of any Company FDA Permit pursuant to the terms of any such Company FDA Permit. (b) The clinicalExcept as would not reasonably be expected to be, pre-clinical and other studies and tests conducted by individually or on behalf of or sponsored by in the aggregate, material to the Company or and its Subsidiaries, or in which taken as a whole, since the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022Reference Date, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity Body have been and are being researched, developed, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of and its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit FDA Permits and FDA Laws. (c) Except as would not reasonably be expected to be, individually or Lawin the aggregate, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating material to the Company or any of and its Subsidiaries, or taken as a whole, since the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022Reference Date, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,.” or other similar Laws. Neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents officers or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or employees has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any a crime or engaged in any conduct that has resulted, or would reasonably be likely to result, resulted in debarment under applicable LawFDA Laws, including including, 21 U.S.C. Section 335a. To , and to the knowledge Knowledge of the Company, no Actions claims, actions, proceedings or investigations that would reasonably be likely expected to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, officers or employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (ed) Since January 1Except as would not reasonably be expected to be, 2022individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole, since the Reference Date, (i) the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, and (ii) none of the Company, Company nor any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, Subsidiaries has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity Body alleging or asserting material noncompliance with any applicable FDA Laws or the Company Permits with respect to any Product. Since January 1, 2022the Reference Date, no manufacturing site owned by the Company, Company or its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, Subsidiaries is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another other Governmental Entity. To the knowledge of the Company, no event has occurred which Body. (e) Except as would not reasonably be likely expected to lead to any Action by any Governmental Entity be, individually or any FDA Form 483-related warning letterin the aggregate, untitled letter or request or requirement to make changes material to the Products Company and its Subsidiaries, taken as a whole, since the Reference Date, all studies, tests and preclinical and clinical trials being conducted by the Company or its Subsidiaries have been and are being conducted in compliance with applicable Good Laboratory Practices and Good Clinical Practices. Since the manner in which Reference Date, neither the Products are manufacturedCompany nor its Subsidiaries have received any written notice from any institutional review board, distributed the FDA or marketedother Governmental Body requiring the termination or suspension of any ongoing or planned clinical trials conducted by the Company or its Subsidiaries. (f) Since January 1the Reference Date, 2022, (i) there have been no adverse events that should have been reported by the Company and its Subsidiaries have not initiated, conducted or a Subsidiary issued, any recall, withdraw, suspension, seizure, safety alert, “dear doctor” letter or investigator notice relating to an alleged lack of the Companysafety, but were not reported, to the FDA efficacy or other Governmental Entity or Review Board with respect to the safety or efficacy material regulatory compliance of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 between the Reference Date and the date of this Agreement have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action action, subpoena, suit, demand, claim, hearing, proceeding, notice, demand or other official written communication pending, received by or, to the Knowledge of the Company, threatened in writing by a Governmental Body against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (h) To the knowledge of the Company, no Person has filed against the Company or any of its Subsidiaries an action relating to any Healthcare Law under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (i) Neither the CompanyCompany nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, deferred prosecution agreements, settlement orders or similar agreements with or imposed by any Governmental Body. (j) Neither the Company or any of its Subsidiaries nor any of their respective directors, officers or employees, noremployees or, to the knowledge Knowledge of the Company, any other Representative of their agents or other Person acting on behalf of the Company or any of its Subsidiaries has third-party representatives (i) has violated since the Reference Date or is in violation of any provision of Laws applicable to the Company and its Subsidiaries concerning or relating to bribery, corruption, fraud, or improper payments, including the U.S. Foreign Corrupt Practices Act of 1977, the UK Bribery Act of 2010, and any applicable Law Laws enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments Transactions (the “Anti-Corruption Laws”); , (ii) since the Reference Date has directly or indirectly made, offered to makeoffered, promised to makeauthorized, facilitated or authorized the payment or giving ofpromised any payment, directly or indirectlycontribution, any gift, entertainment, bribe, rebate, payoff, influence paymentkickback, kickback financial or other unlawful advantage or payment or gift of money advantage, or anything else of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; , (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with since the expectation that it will obtain a business advantage for them; (iv) Reference Date has established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (viv) to is, or has been since the knowledge of the Company, been or isReference Date, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption LawsLaws that prohibit bribery, corruption, fraud, or other improper payments; or (viv) since January 1, 2022, the Reference Date has received written notice or inquiry from, or made a voluntary or involuntary disclosure to, the United States Department of Justice, the SEC, the UK Serious Fraud Office, or any other Governmental Entity with regard to Body, or conducted any internal investigation or audit, regarding alleged or potential possible violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (jk) Since January 1Except as would not have a Company Material Adverse Effect, 2022between the Reference Date and the date of this Agreement, none the Company and its Subsidiaries have complied with (i) all applicable Privacy Laws; (ii) all informed consent forms and authorizations; and (iii) all contractual requirements to which the Company and its subsidiaries are subject as it relates to the Processing of Personal Information. The Company and its Subsidiaries have in place all required, and have complied in all material respects with each of their respective, written and published policies and procedures concerning the privacy, security and Processing of Personal Information (the “Privacy Policies”), except as would not have a Company Material Adverse Effect. The Company has provided all requisite notices, obtained all required consents, and satisfied all other requirements of applicable Privacy Laws for their Processing of Personal Information that are necessary and in connection with the consummation of the transaction contemplated hereunder. Without limitation, the transaction to be consummated hereunder will comply with in all material respects with all applicable Privacy Laws. (l) As of the date of this Agreement, no claims, investigations, or alleged violations have been asserted or threatened against the Company or its Subsidiaries by any Person or Government Body alleging a material violation of Privacy Laws and/or Privacy Policies. Neither the Company nor any Company Subsidiary has received any written or, to the Knowledge of the Company, its Subsidiaries oral complaint, claim, subpoena, demand or their respective directorsnotice of investigation from any Governmental Body or other Person regarding the Company or any Company Subsidiary’s collection, officers use or employeesdisclosure of, oror security practices or cybersecurity incidents regarding, to Personal Information in the knowledge possession or under the control of the Company, Company or any other Representative Company Subsidiary or Person acting at the direction of or being held by subcontractors on behalf of the Company or any Company Subsidiary, 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 any inquiry or claim. (m) Since the Reference Date, neither the Company nor any of its Subsidiaries with respect to Subsidiaries, nor any Productofficer, director, or managing employee (as defined in 42 U.S.C. § 1320a-7(b)) of the foregoing: (i) has been convicted of or, to the Knowledge of the Company, charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) to the Knowledge of the Company, has received written notice that it it, he or she is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge Knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (kn) None of Except as would not reasonably be expected to be, individually or in the Companyaggregate, any of material to the Company and its Subsidiaries, any officertaken as a whole, director or employee each of the Company or any of and its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are has an operational healthcare compliance program that: (i) governs all employees and contractors, (ii) is consistent with the subject of any economic sanctions administered or enforced by current guidance from the United States Department of Treasury’s Justice on Evaluation of Corporate Compliance Programs, and General Compliance Program Guidance issued by the U.S. Department of Health and Human Services Office of Foreign Assets ControlInspector General, (iii) is consistent with the United States Department Pharmaceutical Research and Manufacturers of StateAmerica Code on Interactions with Healthcare Professionals, Her Majesty’s Treasury and (iv) includes reasonably appropriate policies, procedures, and trainings, designed to promote compliance with applicable Healthcare Laws and industry codes and standards. The Company and its Subsidiaries further operate in material compliance with such healthcare compliance program. (o) Except as would not reasonably be expected to be, individually or any applicable prohibited party list maintained by any United States Governmental Entityin the aggregate, material to the European Union or Her Majesty’s Treasury or (ii) organized or resident in Company and its Subsidiaries, taken as a country or region that is the subject whole, each of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been (i) has in place current agreements for its marketed product to participate in Federal Health Care Programs and (ii) is in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Lawssuch agreements.

FDA and Regulatory Matters. Except as set forth in the SEC Filings, (ai) The Company and its Subsidiaries holdhas no knowledge of any actual or threatened material enforcement action or investigation by the FDA or any other Governmental Authority. The Company has no knowledge or reason to believe that the FDA or any Governmental Authority is considering such action. The operation of the business of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, sales, and have held distribution of the company’s product candidates is, and at all times since January 1has been, 2022in material compliance with all applicable laws and permits, all Permitsor within the FDA’s exercise of enforcement discretion. (ii) All material reports, including all such Permits documents, claims, permits and notices required pursuant to be filed with, maintained for or furnished to the FDA or any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or Governmental Authority have been conducted since January 1so filed, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of maintained or default (with or without notice or lapse of time or both) under any Company Permit, and to furnished by the Company’s knowledge. All such reports, no event has occurred which allowsdocuments, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company claims and each of its Subsidiaries are in compliance notices were complete and accurate in all material respects on the date filed or furnished (or were corrected in or supplemented by a subsequent filing), such that no liability exists with the terms of all Company Permits. Since January 1respect to such filing, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permitremain complete and accurate. (biii) The clinicalCompany has not received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other correspondence or notice from the FDA or any Governmental Authority (i) alleging or asserting material noncompliance with any applicable laws or permits and the Company has no knowledge or reason to believe that the FDA or any Governmental Authority is considering such action or (ii) materially contesting the pre-clinical and other studies and tests conducted market clearance or approval of, the uses of or the labeling or promotion of any of the Company’s product candidates. (iv) Each of the Company’s product candidates subject to the FDCA that has been developed, manufactured, tested or distributed by or on behalf of the Company is being or sponsored has been developed, manufactured, tested or distributed in compliance with all material applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction, including those relating to investigational use, pre-market clearance or approval, biologics licensing, registration and listing, good manufacturing practices, labeling, advertising, record keeping and filing of required reports. (v) The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company or its Subsidiariesthe clinical trials conducted by third parties, in each case described in, or in the results of which are referred to in, the Products have participated, SEC Filings were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws protocols and procedures filed with the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf appropriate regulatory authorities for each such trial; each description of the Company or its Subsidiaries with results of such preclinical tests and clinical trials contained in the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, SEC Filings is accurate and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries complete in all material respects in compliance with all applicable requirements under any Company Permit or Lawand fairly presents the data derived from such preclinical tests and clinical trials, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the no knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use studies or tests the results of funds for political activity which are inconsistent with, or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fundotherwise call into question, the United Nations results described or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, referred to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state LawsSEC Filings. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder knowledge of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending actual or threatened Action from any Governmental Entity alleging that any operation enforcement action or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated investigation by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity Authority. The Company has no knowledge or reason to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” believe that the FDA or other similar Lawsany Governmental Authority is considering such action. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf The operation of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge business of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against including the Company or any of its Subsidiaries or any of their respective officersmanufacture, employeesimport, contractorsexport, supplierstesting, agents or other Persons performing research or work on behalf development, processing, packaging, labeling, storage, marketing, sales, and distribution of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, areis, and at all times since January 1, 2021 have has been, in material compliance with all applicable Healthcare Laws, laws and to the knowledge of the Company there is no civil, criminal, administrativepermits, or other Action pending, received by or, threatened against within the Company or any FDA’s exercise of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Lawsenforcement discretion consistent with Schedule 3.12. (ib) Neither All material reports, documents, claims, permits and notices required to be filed with, maintained for or furnished to the FDA or any Governmental Authority have been so filed, maintained or furnished by the Company. All such reports, documents, claims and notices were complete and accurate in all material respects on the date filed or furnished (or were corrected in or supplemented by a subsequent filing), such that no liability exists with respect to such filing, and remain complete and accurate. (c) The Company has not received any FDA Form 483, notice of its Subsidiaries nor any of their respective directorsadverse finding, officers or employeeswarning letters, nor, to the knowledge of the Company, any other Representative untitled letters or other Person acting on behalf of correspondence or notice from the Company FDA or any of its Subsidiaries has Governmental Authority (i) violated alleging or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, asserting noncompliance with any applicable Law enacted in any jurisdiction in connection with laws or arising under permits and the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of Company has no knowledge or reason to believe that the UK Bribery Act of 2010 FDA or any other Law relating to bribery, corruption, fraud Governmental Authority is considering such action or improper payments (the “Anti-Corruption Laws”); (ii) madecontesting the investigational device exemption, offered to make, promised to make, facilitated pre-market clearance or authorized the payment or giving approval of, directly the uses of or indirectly, any bribe, rebate, payoff, influence payment, kickback the labeling or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations promotion of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeProduct. (jd) Since January 1, 2022, none of the Company, its Subsidiaries Each Product or their respective directors, officers or employees, or, product candidate subject to the knowledge of the CompanyFDCA that has been developed, any other Representative manufactured, test distributed or Person acting at the direction of marketed by or on behalf of the Company is being or has been developed, manufactured, tested, distributed and marketed in compliance with all applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction, including those relating to investigational use, pre-market clearance or approval, biologics licensing, registration and listing, good manufacturing practices, labeling, advertising, record keeping and filing of required reports. (e) The Company, under a distributor agreement, distributes certain Medical Devices. No Medical Device distributed by the Company is “adulterated” or “misbranded” under the Federal Food, Drug, and Cosmetic Act or similar law of any Governmental Authority. All Medical Devices distributed by the Company have received a pre-market clearance and may be lawfully placed into commerce and sold as they are currently manufactured. (f) The Company has 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, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any Product. The Company is not aware of any facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any Product sold or distributed, or intended to be sold or distributed by the Company; (2) a change in the marketing classification or a material change in the labeling of any such Product, consistent with Schedule 3.12, or (3) a termination or suspension of the currently marketed Products. (g) The Company does not have an investigational device exemption (“IDE”), investigational new drug application (“IND”), premarket clearance or approval, or a biologics license, and has not received any written notice that the FDA or any of its Subsidiaries with respect to any Product: other Governmental Authority has (i) has been charged with commenced, or convicted threatened to initiate, any action to withdraw an IDE, IND, pre-market clearance or approval, or biologics license, or requested the recall of any criminal offense relating to the delivery of an item or service under any Federal Health Care ProgramProduct, (ii) has been debarredcommenced, excluded or suspended from participation in threatened to initiate, any Federal Health Care Program, action to enjoin manufacture or distribution of any Product or (iii) has had a civil monetary penalty assessed against itcommenced, him or her under 42 U.S.C. §1320a-7athreatened to initiate, (iv) is currently listed on any action to enjoin 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 manufacture or other federal agencies, (v) has received written notice that it is the target distribution of any investigation relating to Product produced at any Federal Health Care Program-related offense facility where any Product is manufactured, tested, processed, packaged or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause held for civil penalties, debarment or mandatory or permissive exclusion under federal or state Lawssale. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries holdholds all material Permits, and have held at all times since January 1, 2022has submitted written notices to, all PermitsGovernmental Bodies, including all such Permits required pursuant to any applicable Healthcare Lawsauthorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, necessary for the lawful operation of the businesses business of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company FDA Permits”), and as of the date of this Agreement, all such Company FDA Permits are valid and (i) in full force and effecteffect,(ii) in compliance with all material filing and maintenance requirements and (iii) in material good standing, valid and enforceable. There has not occurred any material violation of of, or default (with or without written notice or lapse of time or both) under any FDA Permit. The Company Permithas fulfilled and performed all of its material obligations with respect to such FDA Permits, and to is in compliance in all material respects with the terms of all FDA Permits. To the Knowledge of the Company’s knowledge, no event has occurred which allows, or after written notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permitsthereof. Since January 1, 20222019, neither the Company nor any of its Subsidiaries has not received written or oral notice of any pending or threatened Action claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity Body alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company FDA Permit. The transactions contemplated by this AgreementContemplated Transactions, in and of themselves, will not cause the revocation or cancellation of any Company FDA Permit pursuant to the terms of any such Company FDA Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 20222019, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity Body are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed stored and distributed tested by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Lawsstatutes and implementing regulations administered or enforced by the FDA, Good Laboratory Practices and Good Clinical Practices. Since January 1, 20222019, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company FDA Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental EntityBody were, were to the Knowledge of the Company, true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental EntityBody. As of the date of this Agreement, the Company has not received any written notice or other written communication from any Governmental Body withdrawing or placing any clinical studies of the Products on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Products. There are no investigations, suits, claims, actions or proceedings pending or threatened in writing against the Company with respect to any of the Products, or alleging any material violation by the Company, the Products of any such Law. (dc) Since January 1, 20222019, neither the Company nor has not (i) made an untrue statement of a material fact or fraudulent statement to any Governmental Body, including the Centers for Medicare and Medicaid Services, the U.S. Department of its Subsidiaries have Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation, (ii) failed to disclose a material fact required to be disclosed to any Governmental Body, including the Centers for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation or (iii) committed any act, made any statement statement, or failed to make any statement that would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity Body to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or any similar policy or any other similar Lawsstatute or regulation regarding the communication or submission of false information to any applicable Governmental Body. Neither the Company, The Company has not committed or engaged in any fraud or falsification or forgery of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf development data, report, studies or publications or of any document or statement voluntarily submitted or required to be submitted to any Governmental Body, including the Centers for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation. None of the Company or any of its Subsidiaries respective officers or employees, or, to the Knowledge of the Company, any agents or clinical investigator acting for the Company, is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resultedresulted in, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely expected to result in such a in, debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating program related to any Federal Health Care Program-related offense or (vi) pharmaceutical products pursuant to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.21 U.S.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries holdholds, and have has held at all times since January 1, 2022the Reference Date, all Permits, including all such material Permits required pursuant to any applicable Healthcare Laws, under the FDA Laws necessary for the lawful operation of the businesses business of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and and, to the Knowledge of the Company, all such Company Permits are valid and in full force and effect. There has Except as would not occurred any material violation have a Company Material Adverse Effect, since the Reference Date, to the Knowledge of or default the Company, (with or without notice or lapse of time or bothi) under any the Company Permitis, and to the Company’s knowledgehas been, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022including the making of all filings, neither the Company nor declarations, listings, registrations, reports, notices, and submissions required thereunder, and (ii) there has not occurred any of its Subsidiaries has received written violation of, default or oral notice of other noncompliance under any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this AgreementThere is no Action pending or, to the Knowledge of the Company, threatened seeking the revocation, withdrawal, suspension, cancellation, termination or modification of any material Company Permit. To the Knowledge of the Company, the Contemplated Transactions, in and of themselves, will not cause the revocation or cancellation of any material Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by To the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all Knowledge of the Company’s and its Subsidiaries’ , since the Reference Date, all Products that are subject to the jurisdiction of the FDA or other Governmental Entity Body are being being, and have been, researched, developed, tested, manufactured, imported, exported, processed, developed, labeled, packaged, handled, stored, tested, marketed, promoted, advertisedcommercialized, detailed wholesaled, and distributed distributed, and all non-clinical and clinical studies for the Products are being, and have been conducted, by or on behalf of the Company or and any of Person acting on its Subsidiaries behalf in compliance in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the and FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental EntityLaws. (dc) Since January 1, 2022, neither the The Company nor any of its Subsidiaries have has not committed any act, made any statement or failed to make any statement or take any act that would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other for any Governmental Body to invoke any similar Lawspolicy or that could otherwise constitute noncompliance with any applicable Law. Neither Since the Reference Date, neither the Company, any of its Subsidiariesofficers or directors, nor any of their respective officersnor, employees, contractors, suppliers, agents or other Persons performing research or work on behalf to the Knowledge of the Company or Company, any of its Subsidiaries is employees, contractors or agents has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity debarred or convicted of any a crime or engaged in any conduct that has resulted, or would reasonably be likely to result, resulted in debarment under applicable LawFDA Laws, including including, 21 U.S.C. Section 335a. To , or has been disqualified as a clinical investigator under FDA Laws, and no claims, Actions, proceedings or investigations that would reasonably be expected to result in such debarment or disqualification are pending or, to the knowledge Knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, directors, employees, contractors, suppliers, agents contractors or other Persons performing research or work on behalf of the Company or any of its Subsidiariesagents. (ed) Since January 1, 2022, the manufacture of Products by or on behalf of Neither the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Lawsnor, including applicable Good Manufacturing Practices. Since January 1, 2022, none to the Knowledge of the Company, any of Person acting on its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, behalf has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s adverse inspectional finding, penalty, fine, sanction, notice of violation letter, Form FDA 483 or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice or communication from the FDA or any other Governmental Entity Body alleging or asserting material noncompliance with any applicable FDA Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by . (e) Neither the Company, its Subsidiaries, orCompany nor, to the knowledge Knowledge of the Company, any Person acting on its behalf has initiated, conducted or issued any material recall, safety alert, “dear doctor” letter, discontinuation, market withdrawal, suspension, or investigator notice relating to an alleged lack of their respective contract manufacturers for Productssafety, is efficacy, or has been subject material compliance of any Product and, to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge Knowledge of the Company, there are no event has occurred which would reasonably be likely to lead to Actions pending seeking, any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to of the Products or the manner in which the Products are manufactured, distributed or marketedforegoing. (f) Since January 1Except as would not have a Company Material Adverse Effect, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, areis, and at all times since January 1, 2021 have between the Reference Date and the date of this Agreement has been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, administrative or other Action action, subpoena, suit, demand, claim, hearing, proceeding, notice or demand pending, received by or, to the Knowledge of the Company, overtly threatened in writing by a Governmental Body against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither . Since the CompanyReference Date, any of its Subsidiaries neither the Company nor any of their respective directorsofficer, officers director, employee, agent or employeescontractor, noror, to the knowledge Knowledge of the Company, any other Representative person engaged by or having a relationship with the Company, is, nor has been, a party to any corporate integrity agreements, individual integrity agreement, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body. (g) Except as would not, individually or in the aggregate, have a Company Material Adverse Effect, neither the Company nor, to the Knowledge of the Company, any officer, director, agent, employee or other Person acting on behalf of its behalf, has since the Company or any of its Subsidiaries has Reference Date (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments as amended (the “FCPA”), or other Anti-Corruption Laws”); and Anti-Bribery Laws in any countries in which the Company conducts business, (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money money, (iii) provided, offered, gifted or promised, directly or indirectly through another Person, anything of value, regardless of form or amount, value to any Person Government Official for the purpose of securing an unlawful advantage(x) unlawfully influencing any act or decision of such Government Official in their official capacity, inducing the recipient such Government Official to violate an official do or omit to do any act in violation of their lawful duty, reward or securing any improper advantage for the recipient for Company or (y) inducing such Government Official to use his or her influence in an unlawful advantage already given, manner to affect or for influence any other improper purpose; (iii) requested, agreed to receive, act or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee decision of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7aBody, (iv) is currently listed on violated any sanctions administered by the list U.S. Treasury Department’s Office of parties excluded from federal procurement programs and non-procurement programs as maintained in the Government Services Administration’s System for Award Management Foreign Assets Control or any other federal agenciesapplicable sanctions, or (v) has received written notice that it is the target subject to any investigation by any Governmental Body with regard to violations of any investigation relating to applicable Anti-Corruption and Anti-Bribery Laws or sanctions. “Government Official” means any Federal Health Care Program-related offense person employed by or (vi) to the knowledge of the Company, has engaged in any activity that is in violation ofan agent of any Governmental Body or any political party or that is a candidate for Governmental Body office, or is cause for civil penalties, debarment the family member or mandatory or permissive exclusion under federal or state Laws. (k) None close Affiliate of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Lawsthese.

FDA and Regulatory Matters. (aA) The Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses Except as set forth in Part 2.11 of the Company Disclosure Schedule, (i) with respect to the Company Products and, to the extent applicable, any currently under development (A) the Company Entities have obtained all necessary and its Subsidiaries as applicable approvals, clearances, authorizations, licenses and registrations required by the United States or foreign governments or government agencies, to permit the design, development, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where it currently conducted or have been conducted since January 1, 2022 conducts such activities (the “"ACTIVITIES TO DATE") with respect to each Company Permits”Product (collectively, the "COMPANY LICENSES"), and all except where the failure to hold such Company Permits are valid and in full force and effect. There Licenses has not occurred any been material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred Company Entities and would not reasonably be expected to be material to the Company Entities; (B) the Company Entities are in material compliance with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Company Product which allows, or after notice or lapse is not required to be the subject of time would allow, revocation or termination thereof or result in any other material impairment of a Company License; (C) the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the terms of all extent any Company Permits. Since January 1Product has been exported from the United States, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity or, as applicable, a subsidiary of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any exporting such Company Permit. (b) The clinicalProduct, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the has exported such Company or its Subsidiaries, or Product in which the Products have participated, were and, if still pending, are being conducted compliance in all material respects with all Legal Requirements, and (ii) the Company Entities are in accordance compliance in all material respects with all applicable Healthcare Laws reporting requirements for all Company Licenses or plant registrations described in clause (i) above. (B) The Company Entities are in material compliance with all FDA and non-United States equivalent agencies and similar state and local laws applicable to the rulesmaintenance, policies compilation and regulations to which they are subjectfiling of reports, including without limitationmedical device reports, any applicable Good Clinical Practice and Good Laboratory Practice requirementswith regard to the Company Products. No IND filed or submitted by or on behalf Part 2.11(b) of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to Disclosure Schedule sets forth a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, list of all applicable adverse event reports related to the knowledge of the Company or its SubsidiariesProducts, threatened to initiate, including any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its SubsidiariesMedical Device Reports (as defined in 21 CFR 803). (cC) Since January 1, 20222000, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf none of the Company or Entities has received any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA written notice or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for written communication from the FDA or any other Governmental Entity to invoke its policy Body (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any laws by any of the Company Entities with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its SubsidiariesProduct. (eD) Since January 1There have been no recalls, 2022, the manufacture of Products by field notifications or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, seizures ordered or adverse regulatory actions taken (or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (ithreatened) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from by the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits Body with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Company Products, is including any facilities where any such Company Products are produced, processed, packaged or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge stored and none of the CompanyCompany Entities has within the last three (3) years, no event has occurred which would reasonably be likely to lead to any Action by either voluntarily or at the request of any Governmental Entity Body, initiated or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner participated in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy recall of any Product, and (ii) to the knowledge of the Company, with respect to a Company Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such provided post-sale warnings regarding any Company Product. (gE) The Company has All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made available to Parent and its advisors true, and correct copies of the following materials in the possession by any of the Company Entities with regard to the Company Products, whether oral, written or any of its Subsidiaries electronically delivered, were true, accurate and complete in all material respects as of the date of this Agreement: (i) each active INDmade, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Companyextent required to be updated, any Collaboration Partner to the extent related to any Productas so updated remain true, are, accurate and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance complete in all material respects with all applicable export controls, economic sanctionsas of the date hereof, and antiboycott Lawsdo not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are and, at all times since January 1, 2021, have been, in compliance in all material respects with all applicable Healthcare Laws. To the terms knowledge of all the Company, there are no facts or circumstances that reasonably would be expected to give rise to any material liability under any Healthcare Laws. The Company Permits. Since January 1, 2022, neither the Company nor any of and its Subsidiaries has have not received written or oral notice notification of any pending action from the FDA or threatened Action from any Governmental Entity other similar regulatory authority alleging that any operation or activity of the Company or any of and its Subsidiaries is in material violation of any Law that applies to a Company Permitapplicable Healthcare Law. The transactions contemplated by this AgreementAll CVR Products are being, and since January 1, 2021, have been, developed, manufactured, packaged, labeled, stored, tested and distributed in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored material compliance with all applicable Healthcare Laws. All regulatory filings made by the Company and its Subsidiaries with the FDA or its Subsidiaries, or in which any similar foreign Governmental Entity with respect to the CVR Products have participated, were and, if still pending, are being conducted complied in all material respects in accordance with all applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirementsLaws. No IND filed or submitted by or on behalf of Neither the Company or nor each of its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, ornor, to the knowledge of the Company or its Subsidiaries, threatened to initiateCompany, any action to place a clinical hold order onofficer, employee, agent or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf investigator of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction Subsidiaries has (i) made an untrue statement of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company a material fact or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted fraudulent statement to the FDA or any other Governmental Entitysimilar regulatory authority, were true and correct in all (ii) failed to disclose a material respects as of the date of submission, and any material updates, changes, corrections or modification fact required to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted be disclosed to the FDA or any other Governmental Entity. similar regulatory authority or (diii) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any an act, made any statement a statement, or failed to make any a statement that that, at the time such disclosure was made, would reasonably be likely expected to provide a reasonable basis for the FDA or any other Governmental Entity similar regulatory authority to invoke its policy with respect to respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” ”, set forth in 56 Fed. Reg. 46,191 (September 10, 1991) or other any similar Lawspolicy. Neither The Company and its Subsidiaries have not, and, to the knowledge of the Company, any of its Subsidiariesno officer, nor any of their respective officersemployee, employees, contractors, suppliers, agents agent or other Persons performing research or work on behalf investigator of the Company or any of and its Subsidiaries is or has been subject to any kind of consent decreebeen, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct for which debarment is mandated under 21 U.S.C. § 335a(a) or (b) or any similar state or foreign Law. Neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any officer, employee, agent or investigator of the Company has been convicted of any crime or engaged in any conduct for which such person could be excluded from participating in the federal healthcare programs under Section 1128 of the Social Security Act of 1935 or any other applicable Healthcare Law. No actions that has resulted, or would reasonably be likely expected to resultresult in material debarment or exclusion are pending or, to the knowledge of the Company, threatened in debarment under applicable Lawwriting against the Company and its Subsidiaries or any of their officers, including 21 U.S.C. Section 335aemployees, agents or investigators. The Company and its Subsidiaries are not party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment all preclinical studies and clinical trials involving any CVR Products, including those conducted or exclusion are pending or threatened against sponsored by the Company or any of and its Subsidiaries or any of their respective officershave been, employeesand if still pending are being, contractors, suppliers, agents or other Persons performing conducted in compliance in all material respects with applicable research or work on behalf protocols and all applicable Healthcare Laws. To the knowledge of the Company Company, neither the FDA nor any similar applicable foreign Governmental Entity has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products ongoing clinical trial conducted by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none or to enjoin the manufacturing of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the CVR Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. Except as set forth in Section 6.16 of the HW Disclosure Schedule and except as would not have a Material Adverse Effect on HW, (a) The Company HW and its Subsidiaries holdare, and have held at all times since January 1, 20222013 have been, in material compliance with all PermitsHealthcare Laws applicable to HW and its Subsidiaries. The design, including manufacture, testing, and distribution of products by or on behalf of HW and its Subsidiaries are being, and since January 1, 2013 have been, conducted in material compliance with all such Permits required pursuant to any applicable Healthcare Laws, necessary including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products and, to the lawful operation extent applicable to HW or any of its Subsidiaries, counterpart Laws in the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), European Union and all such Company Permits are valid and in full force and effectother countries where compliance is required. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company HW and each of its Subsidiaries is, and to the Knowledge of HW any contract manufacturers of HW products are, in material compliance with the FDA’s registration and listing requirements to the extent required by applicable Healthcare Laws, and all HW products, if so required, are in compliance conformance in all material respects with the terms of all Company Permitsapplicable CE Marking certifications. Since January 1, 20222013 through the Agreement Date, neither the Company HW nor any of its Subsidiaries has received any written communication or oral notice notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other Action from any Governmental Entity Authority, including, without limitation, the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, or any comparable state, federal or foreign Governmental Authority alleging that any operation potential or activity of the Company actual non-compliance by, or liability of, HW or any of its Subsidiaries is in material violation of under any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company PermitHealthcare Law. (b) The clinicalHW and its Subsidiaries hold such material Permits of Governmental Authorities from the United States or foreign Governmental Authorities required for the conduct of its business as currently conducted, including, where applicable and without limitation, those Permits to permit the design, development, pre-clinical and other studies clinical testing, manufacture, labeling, sale, shipment, distribution and tests conducted by or on behalf promotion of or sponsored by HW products in jurisdictions where it currently conducts such activities with respect to each HW product (collectively, the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws “HW Licenses”). HW and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries have fulfilled and performed all of their material obligations with the FDA, nor any comparable application filed respect to each HW License and are in material compliance with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiarieseach HW License. (c) Since January 1, 2022, all As of the Company’s and Agreement Date, neither HW nor any of its Subsidiaries’ Products that are Subsidiaries is the subject of any pending or, to the jurisdiction Knowledge of HW, threatened investigation regarding HW, any of its Subsidiaries or any HW products, by the FDA pursuant to the FDA Fraud Policy, or otherwise. As of the FDA Agreement Date, neither HW, nor, to the Knowledge of HW, any officer, employee, agent or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf distributor of the Company HW or any of its Subsidiaries in all has made an untrue statement of material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted fact to the FDA or any other equivalent Governmental EntityAuthority, were true and correct in all failed to disclose a material respects as of the date of submission, and any material updates, changes, corrections or modification fact required to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted be disclosed to the FDA or any other equivalent Governmental Entity. (d) Since January 1Authority, 2022, neither the Company nor any of its Subsidiaries have or committed any an act, made any a statement or failed to make any a statement that that, at the time such disclosure was made, would reasonably be likely expected to provide a basis for the FDA or any other equivalent Governmental Entity Authority to invoke its policy with respect the FDA Fraud Policy or any similar policy. As of the Agreement Date, no claims, actions, proceedings or investigations that would reasonably be expected to “Fraudresult in a material debarment or exclusion are pending or, Untrue Statements to the Knowledge of Material FactsHW, Briberyhave been threatened since January 1, and Illegal Gratuities,” 2013 through the Agreement Date, against HW or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf . As of the Company Agreement Date, none of the key employees of HW or any of its Subsidiaries is or has been subject to any kind are included on the List of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned Excluded Individuals/Entities maintained by the Company, its Subsidiaries, or, to the knowledge Office of the Company, any Inspector General of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company Health and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott LawsHuman Services.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at all times since January 1, 20222019, all Permitsmaterial Permits of all Governmental Entities required under applicable Healthcare Laws, including all such Permits required pursuant to any applicable Healthcare Lawsunder the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or as have been conducted since January 1, 2022 2019 (the “Company Permits”), and all such Company Permits required for the operation of the businesses as currently conducted are valid and in full force and effect. There Since January 1, 2019, there has not occurred any material violation of or of, default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all such Company PermitsPermits required for the operation of the businesses as currently conducted. Since January 1, 20222019, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Healthcare Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 20222019, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity under applicable Healthcare Laws are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed tested and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or applicable Healthcare Law, including applicable Healthcare Lawsstatutes and implementing regulations administered or enforced by the FDA or comparable Governmental Entity. Since January 1, 20222019, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, Subsidiaries when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Healthcare Laws have been submitted to the FDA or other Governmental Entity. (dc) Since January 1, 20222019, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Healthcare Laws. Neither the Company, any of its Subsidiaries, nor nor, to the Company’s knowledge, any of their respective officers, employees, or to the Company’s actual knowledge, contractors, suppliers, suppliers or agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or or, since January 1, 2019, has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely expected to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the CompanyNo claims, no Actions actions, proceedings or investigations that would reasonably be likely expected to result in such a debarment or exclusion are pending or or, to the knowledge of the Company, threatened against the Company or any of its Subsidiaries or or, to the Company’s knowledge, any of their respective officers, employees, or to the Company’s actual knowledge, contractors, suppliers, or agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (ed) Since January 1, 20222019, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 20222019, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any ProductProduct that would be adverse in any material respect to the Company or its Subsidiaries, or (v) other similar written correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Healthcare Laws or the Company Permits with respect to any Product. Since January 1, 20222019, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To Entity with respect to the knowledge Company’s or its Subsidiaries’ Products. (e) Since January 1, 2019, all studies, tests and preclinical and clinical trials being conducted by or on behalf of the CompanyCompany or its Subsidiaries have been and are being conducted in material compliance with applicable Healthcare Laws, no event has occurred which would reasonably be likely to lead to including the requirements of Good Laboratory Practices or Good Clinical Practices, as applicable. Since January 1, 2019, the Company and its Subsidiaries have not received any Action by written or oral notices, correspondence or communication from any Governmental Entity Review Board, the FDA or any FDA Form 483-related warning letterother Governmental Entity, untitled letter recommending or request requiring the termination, suspension or requirement to make changes to material adverse modification of any ongoing or planned clinical trials conducted by, or on behalf of, the Products Company or the manner in which the Products are manufactured, distributed or marketedits Subsidiaries. (f) To the extent required by applicable Laws, since January 1, 2019, all clinical trials conducted by or on behalf of the Company or any of its Subsidiaries and the results of all such clinical trials have been registered and disclosed in all material respects in accordance with such applicable Laws. (g) Since January 1, 20222019, (i) to the extent required by applicable Laws, and except as would not be material to the Company, there have been no adverse events with respect to any Product that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such ProductBoard. (gh) The Company has made available to Parent and its advisors true, true and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active INDinvestigational new drug or marketing application, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence (excluding, for the avoidance of doubt, non-substantive e-mails in the Ordinary Course of Business) to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (hi) Since January 1, 2019, the Company and its Subsidiaries have not either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any replacement, safety alert, warning, investigator notice, or other similar notice or action relating to an alleged lack of safety or efficacy or material regulatory compliance of any Product. (j) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 2019 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (ik) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has since January 1, 2019 (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other applicable Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a an unlawful business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 20222019, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other applicable Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (jl) Since January 1, 20222019, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the actual knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (km) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any employee of the Company, any of its Subsidiaries, or any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury a Sanctioned Person or (ii) organized or resident in a country or region that is the subject of such sanctionsSanctioned Country. Since January 1, 20222019, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, Sanctions and antiboycott Trade Control Laws.

FDA and Regulatory Matters. (a) The Company All approvals of New Drug Applications (“NDAs”) and its Subsidiaries holdAbbreviated New Drug Applications (“ANDAs”) and any supplements and amendments to such NDAs and ANDAs are valid and effective, all necessary reports and submissions have been made to the Food and Drug Administration (“FDA”), and all applicable fees with respect to such applications have held at been paid to FDA. (b) Except as set forth on Schedule 4.25, the Credit Parties possess all times since January 1permits, 2022licenses, all Permitsapprovals, consents and other authorizations, including but not limited to, NDAs, ANDAs, and all supplements and amendments to such Permits required pursuant applications and appropriate state licenses, permits and registrations, submitted to any applicable Healthcare Laws, the appropriate governmental entity necessary for to conduct the lawful operation of the businesses business of the Company and its Subsidiaries as currently conducted or have been conducted since January 1subsidiaries, 2022 (including without limitation, all such registrations, approvals, certificates, authorizations and permits required by the “Company Permits”)FDA, the United States Drug Enforcement Administration, Governmental Authority, and all such Company Permits are valid and in full force and effect. There has not occurred Each Credit Party’s products are and have been, since March, 2009, developed, manufactured, labeled, stored, tested and distributed by such Credit Party for products distributed in the marketplace in compliance with all applicable laws, rules, regulations and orders of the FDA or of any material violation applicable state or other Governmental Authority. (c) The manufacture of or default (products by the Credit Parties will be conducted in compliance with or without notice or lapse the applicable requirements of time or both) under any Company Permit, the FDA’s Current Good Manufacturing Practices and pursuant to the terms of the Consent Decree. All of the Company’s knowledgefacilities are registered with the FDA and all of their products are listed with the FDA as required by the FDA’s regulations, 21 C.F.R. Part 207. (d) The Credit Parties have complied with and will comply with, all the FDA post-approval commitments and reporting requirements, including but not limited to, adverse event reporting obligations. (e) To the knowledge of the Credit Parties, there are no event has occurred which allowsfacts or circumstances that could reasonably be construed as indicating that marketing approval for any of the Credit Parties’ products will be withdrawn or that the Credit Parties will not obtain approval for any products currently pending approval by the FDA or any Governmental Authority. The Credit Parties shall use such prompt, substantial and persistent efforts to take, or after notice cause to be taken, all actions, or lapse to do, or cause to be done, all things reasonably necessary, proper or advisable under applicable laws to obtain all consents and approvals of time would allow, revocation any Governmental Authority. (f) No Exclusion Affiliate (i) has any direct or termination thereof indirect ownership or result control interest (as defined in any other material impairment Section 1124(a)(3) of the rights of SSA) in the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company Borrower or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant except to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored extent expressly permitted by the Company HHS-OIG Agreements, (ii) serves as an officer, director, agent, managing employee or its Subsidiaries, or employee (as defined in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf Section 1126(b) of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge SSA) of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company Borrower or any of its Subsidiaries, directly or the Productsindirectly, when submitted officially or otherwise or (iii) furnishes any services as an independent contractor or consultant to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company Borrower or any of its Subsidiaries. (eg) Since January 1, 2022On the Closing Date, the manufacture of Products by Borrower delivered or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, caused to be delivered to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, Administrative true and correct copies of the following materials in the possession of the Company each HHS-OIG Agreement and all attachments, exhibits, schedules or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Productskind. (h) The Company and its Subsidiaries and, There has not occurred any event or condition the result of which could lead to the knowledge of the Company, any Collaboration Partner an HHS-OIG Agreement ceasing to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Lawsbe Operative. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge Each of the CompanyBorrower’s representations set forth in any HHS-OIG Agreement and any document or agreement related thereto is true, any other Representative or other Person acting on behalf of accurate and complete in all respects, and the Company or any of its Subsidiaries has Borrower is not aware (iafter reasonable diligence and inquiry) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, fact or circumstance that could render any applicable Law enacted Person’s representations in any jurisdiction in connection with such agreements to be false or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officemisleading. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses Except as set forth in Part 2.11 of the Company Disclosure Schedule, (i) with respect to the Company Products and, to the extent applicable, any currently under development (A) the Company Entities have obtained all necessary and its Subsidiaries as applicable approvals, clearances, authorizations, licenses and registrations required by the United States or foreign governments or government agencies, to permit the design, development, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where it currently conducted or have been conducted since January 1, 2022 conducts such activities (the “"Activities to Date") with respect to each Company Permits”Product (collectively, the "Company Licenses"), and all except where the failure to hold such Company Permits are valid and in full force and effect. There Licenses has not occurred any been material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred Company Entities and would not reasonably be expected to be material to the Company Entities; (B) the Company Entities are in material compliance with all terms and conditions of each Company License and with all applicable laws pertaining to the Activities to Date with respect to each Company Product which allows, or after notice or lapse is not required to be the subject of time would allow, revocation or termination thereof or result in any other material impairment of a Company License; (C) the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries Entities are in compliance in all material respects with all Legal Requirements regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the terms of all extent any Company Permits. Since January 1Product has been exported from the United States, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity or, as applicable, a subsidiary of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any exporting such Company PermitProduct, has exported such Company Product in compliance in all material respects with all Legal Requirements, and (ii) the Company Entities are in compliance in all material respects with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above. (b) The clinicalCompany Entities are in material compliance with all FDA and non-United States equivalent agencies and similar state and local laws applicable to the maintenance, pre-clinical compilation and other studies and tests conducted by or on behalf filing of or sponsored by reports, including medical device reports, with regard to the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirementsProducts. No IND filed or submitted by or on behalf Part 2.11(b) of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to Disclosure Schedule sets forth a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, list of all applicable adverse event reports related to the knowledge of the Company or its SubsidiariesProducts, threatened to initiate, including any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its SubsidiariesMedical Device Reports (as defined in 21 CFR 803). (c) Since January 1, 20222000, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf none of the Company or Entities has received any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA written notice or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for written communication from the FDA or any other Governmental Entity to invoke its policy Body (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any laws by any of the Company Entities with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its SubsidiariesProduct. (ed) Since January 1There have been no recalls, 2022, the manufacture of Products by field notifications or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, seizures ordered or adverse regulatory actions taken (or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (ithreatened) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from by the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits Body with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Company Products, is including any facilities where any such Company Products are produced, processed, packaged or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge stored and none of the CompanyCompany Entities has within the last three (3) years, no event has occurred which would reasonably be likely to lead to any Action by either voluntarily or at the request of any Governmental Entity Body, initiated or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner participated in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy recall of any Product, and (ii) to the knowledge of the Company, with respect to a Company Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such provided post-sale warnings regarding any Company Product. (ge) The Company has All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made available to Parent and its advisors true, and correct copies of the following materials in the possession by any of the Company Entities with regard to the Company Products, whether oral, written or any of its Subsidiaries electronically delivered, were true, accurate and complete in all material respects as of the date of this Agreement: (i) each active INDmade, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Companyextent required to be updated, any Collaboration Partner to the extent related to any Productas so updated remain true, are, accurate and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance complete in all material respects with all applicable export controls, economic sanctionsas of the date hereof, and antiboycott Lawsdo not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

FDA and Regulatory Matters. (a) The Company From and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for after the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit.Merger Date: (bi) The clinicalOther than as may be known by an Excluded Individual, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects Solx is in compliance with all requirements of the U.S. Food and Drug Administration (the “FDA”) and non-United States equivalent agencies and similar state and local laws applicable requirements under any Company Permit or Lawto the maintenance, compilation and filing of reports, including applicable Healthcare Laws. Since January 1medical device reports, 2022with regard to any products currently under development by Solx (collectively, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the “Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity.”); (dii) Since January 1, 2022Other than as may be known by an Excluded Individual, neither the Company Solx nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, OccuLogix has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice or other written communication from the FDA or any other Governmental Entity alleging governmental authority (i) contesting the pre-market clearance or asserting material noncompliance with any applicable Laws approval of, the uses of or the Company Permits labeling and promotion of any of the Products or (ii) otherwise alleging any violation of any laws by Solx or OccuLogix; (iii) Other than as may be known by an Excluded Individual, each of Solx and OccuLogix, on behalf of Solx, has conducted, and is continuing to conduct, all clinical trials sponsored by Solx with respect reasonable care and in accordance with all applicable laws and the stated protocols for such clinical trials; and (iv) Subject to the statement made in the immediately following sentence, all filings with and submissions to the FDA and any Product. Since January 1corollary entity in any other jurisdiction made by each of Solx and OccuLogix with regard to the Products, 2022whether oral, no manufacturing site owned by written or electronically delivered, were true, accurate and complete as of the Company, its Subsidiaries, ordate made and, to the knowledge extent required to be updated, as so updated, remain true, accurate and complete as of the Company, date hereof and do not materially misstate any of their respective contract manufacturers for Products, is the statements or has been subject information included therein or omit to state a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement material fact necessary to make changes to the Products or statements therein not misleading. The statement made in the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Companyimmediately preceding sentence, with respect to a Product being developed those of Solx’s filings and submissions made by, or marketed by a Collaboration Partnerunder the direction or authorization of an Excluded Individual, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, is qualified entirely to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy Knowledge of such ProductOccuLogix. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries holdThere is no actual or, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledgeKnowledge, no event has occurred which allows, threatened enforcement action or after notice investigation by the FDA or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1Governmental Authority, 2022which, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of if determined adversely to the Company or any of its Subsidiaries would have a Material Adverse Effect. The Company has no Knowledge or reason to believe that the FDA or any Governmental Authority is considering such action. The operation of the business of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, sales, and distribution of the Company’s product candidates is, and at all times has been, in material violation compliance with all applicable laws and permits, or within the FDA’s exercise of any Law that applies to a Company Permitenforcement discretion. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit.17 (b) All material reports, documents, claims, permits and notices required to be filed with, maintained for or furnished to the FDA or any Governmental Authority have been so filed, maintained or furnished by the Company. All such reports, documents, claims and notices were complete and accurate in all material respects on the date filed or furnished (or were corrected in or supplemented by a subsequent filing), such that no liability exists with respect to such filing, and remain complete and accurate. (c) The clinicalCompany has not received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other correspondence or notice from the FDA or any Governmental Authority (i) alleging or asserting material noncompliance with any applicable laws or permits and the Company has no Knowledge or reason to believe that the FDA or any Governmental Authority is considering such action or (ii) materially contesting the pre-clinical and other studies and tests conducted market clearance or approval of, the uses of or the labeling or promotion of any of the Company’s product candidates. (d) Each of the Company’s product candidates subject to the FDCA that has been developed, manufactured, tested or distributed by or on behalf of the Company is being or sponsored has been developed, manufactured, tested or distributed in compliance with all material applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction, including those relating to investigational use, pre-market clearance or approval, biologics licensing, registration and listing, good manufacturing practices, labeling, advertising, record keeping and filing of required reports. (e) The preclinical tests and clinical trials conducted by the Company or its SubsidiariesCompany, and to Company’s Knowledge the clinical trials conducted by third parties, in each case described in, or in the results of which are referred to in, the Products have participatedCompany SEC Documents, were andwere, and if still pending, are being being, conducted in all material respects in accordance with applicable Healthcare Laws protocols and procedures filed with the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf appropriate regulatory authorities for each such trial; each description of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a results of such preclinical tests and clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of trials contained in the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s SEC Documents is accurate and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries complete in all material respects in compliance with all applicable requirements under any Company Permit or Lawand fairly presents the data derived from such preclinical tests and clinical trials, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the no knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use studies or tests the results of funds for political activity which are inconsistent with, or commercial bribery. None of otherwise call into question, the Representatives of results described or referred to in the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeSEC Documents. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. Except as otherwise might be noted in this Agreement or any associated Transaction Documents: (ai) The no Seller Company and its Subsidiaries holdhas received, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation in respect of the businesses Business, any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the Company U.S. Food and its Subsidiaries as currently conducted Drug Administration, or have been conducted since January 1any other Governmental Entity, 2022 alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “Company PermitsFFDCA”), and all such ; (ii) each Seller Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are is in compliance in all material respects with applicable health care laws, including without limitation, the terms of all FFDCA, and the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and the regulations promulgated pursuant to such laws, and comparable state laws (collectively, “Health Care Laws”); (iii) no Seller Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from that any Governmental Entity alleging has taken, is taking or intends to take action to limit, suspend, modify or revoke any Permits required by the Health Care Laws that any operation or activity are applicable to the Business, which has not been resolved in such Seller Company’s favor; and (iv) no Seller Company has, in respect of the Company Business, either voluntarily or involuntarily, initiated, conducted, issued or caused to be initiated, any recall, market withdrawal, safety alert, post-sale warning, “dear doctor” letter, or other notice or action material to the Business relating to the alleged lack of safety or efficacy of any product or any of its Subsidiaries is in material alleged product defect or violation of any Law that applies and, to a Company Permit. The transactions contemplated by this AgreementSellers’ Knowledge, in and of themselves, will not cause the revocation no Person has initiated or cancellation of any Company Permit pursuant to the terms of conducted any such Company Permit. (b) The clinicalnotice or action against any Seller Company. To Sellers’ Knowledge, pre-clinical and other the research, studies and tests conducted by or on behalf of or sponsored by each Seller Company in respect of the Company or its Subsidiaries, or in which the Products Business have participated, were and, if still pending, are being been conducted in all material respects with reasonable care and in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with experimental protocols, procedures and controls adopted by such Seller Company pursuant to all Health Care Laws and Permits required by the Health Care Laws that are applicable export controls, economic sanctions, and antiboycott Lawsto such Seller Company or the Business.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation Except as set forth on Section 4.23 of the businesses of the Company Disclosure Schedule, each AVR Entity has operated and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are is in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither Good Laboratory Practices (the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity “GLP”) of the Company U.S. Food and Drug Administration (the “FDA”) and any other federal, state, local or any foreign regulatory agency exercising comparable authority to the FDA, except for instances of its Subsidiaries is noncompliance which would not reasonably be expected to result, individually or in material violation of any Law that applies to the aggregate, in a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company PermitMaterial Adverse Effect. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental AVR Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice or other written communication from the FDA or any other Governmental Authority alleging any material violation of any material Laws by such entity relating to its business. (c) Each filing or submission to the FDA and any similar Governmental Authority in any other jurisdiction made by an AVR Entity, was true, accurate and complete as of the date made. Each AVR Entity alleging having made such a filing or asserting material noncompliance with submission has notified the FDA and all such Governmental Authorities of any applicable Laws changes to such filing or the Company Permits with respect to any Product. Since January 1submission as required by Law. (d) Each AVR Entity possesses all certificates, 2022authorizations, no manufacturing site owned permits, clearances and approvals issued by the CompanyFDA and all material certificates, authorizations, permits, clearances and approvals issued by comparable foreign Governmental Authorities necessary to conduct its Subsidiariesbusiness and to produce, ormarket and distribute its products (“Permits”). Each AVR Entity has fulfilled all material obligations under each Permit, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, and no event has occurred which that would reasonably be likely expected to lead constitute a material violation or to any Action by any Governmental Entity cause revocation or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy termination of any Product, and (ii) to the such Permit. No AVR Entity has any knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other comparable Governmental EntityAuthority is considering limiting in any material respect, suspending or revoking any minutes such Permit. (e) There is no materially false or similar summary documentation with respect misleading information or material omission in any product application or other submission made by an AVR Entity to meetings with the FDA or any other comparable Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the ProductsAuthority. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company Except as would not reasonably be expected to be, individually or in the aggregate, materially adverse to the business, assets, results of operations or condition (financial or otherwise) of CYTO and its Subsidiaries, taken as a whole, CYTO and its Subsidiaries hold, hold all Permits and have held at all times since January 1, 2022submitted notices to, all PermitsGovernmental Bodies, including all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and any other Governmental Body that regulates the quality, identity, strength, purity, safety, efficacy or manufacturing of CYTO’s Products (any such Permits required pursuant to any applicable Healthcare LawsGovernmental Body, a “CYTO Regulatory Agency”) necessary for the lawful operation of the businesses of the Company and CYTO or any of its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company CYTO Permits”), and as of the date hereof, all such Company CYTO Permits are valid and in full force and effect. There has not occurred any material violation of or of, default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allowsunder, or after event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time would allowor both, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company CYTO Permit. The Company CYTO and each of its Subsidiaries are in compliance in all material respects with the terms of all Company CYTO Permits, and no event has occurred that, to the Knowledge of CYTO, would reasonably be expected to result in the revocation, cancellation, non-renewal or material adverse modification of any CYTO Permit. Since January 1, 20222018, neither the Company CYTO nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity the FDA or other CYTO Regulatory Agency alleging that any operation or activity of the Company CYTO or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permitapplicable Law. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 20222018, all of the CompanyCYTO’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, CYTO Regulatory Agencies have been manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company CYTO or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Lawsstatutes and implementing regulations administered or enforced by the FDA or other CYTO Regulatory Agency. Since January 1, 20222018, all applications, submissions, notifications, submissions, information, claims, reports information and data utilized by the Company CYTO or its Subsidiaries as the basis for, or submitted by or or, to the Knowledge of CYTO, on behalf of the Company CYTO or its Subsidiaries in connection with, any and all requests for the Company CYTO Permits relating to the Company CYTO or any of its Subsidiaries, or the Products, Subsidiaries when submitted to the FDA or other Governmental EntityCYTO Regulatory Agency, were true true, complete and correct correct, in all material respects respects, as of the date of submission, and any material updates, changes, corrections or modification to such applications, submissions, notifications, submissions, information, claims, reports information and data required under applicable Laws have been submitted to the FDA or other Governmental EntityCYTO Regulatory Agency. (dc) Since January 1Neither CYTO, 2022nor its Subsidiaries, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity CYTO Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither Except as set forth in the CompanyCYTO Disclosure Letter, neither CYTO nor any of its Subsidiaries, nor any of their respective officers, employees, nor, to the Knowledge of CYTO, their contractors, suppliers, agents suppliers or other Persons entities or individuals performing research or work on behalf of the Company CYTO or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity Body or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely expected to result, in a material debarment or exclusion under applicable Law, including including, without limitation, 21 U.S.C. Section 335a. To the knowledge of the Company, no No Actions that would reasonably be likely expected to result in such a material debarment or exclusion are pending or or, to the Knowledge of CYTO, threatened against the Company CYTO or any of its Subsidiaries Subsidiaries, or any of their respective officers, or to the Knowledge of CYTO, their employees, contractors, suppliers, agents suppliers or other Persons entities or individuals performing research or work on behalf of the Company CYTO or any of its Subsidiaries. (ed) Since January 1, 20222018, the manufacture of Products by or on behalf of the Company CYTO and its Subsidiaries has been and is being conducted in compliance in all material compliance respects with all applicable Laws, Laws including applicable the FDA’s current Good Manufacturing Practices. Since January 1, 20222018, none of the CompanyCYTO, any of its Subsidiaries, or, to the knowledge Knowledge of the CompanyCYTO, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity CYTO Regulatory Agency alleging or asserting material noncompliance with any applicable Laws or the Company CYTO Permits with respect to any ProductProduct of CYTO or its Subsidiaries. Since January 1, 20222018, no manufacturing site owned or operated by the CompanyCYTO, its Subsidiaries, or, to the knowledge Knowledge of the CompanyCYTO, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental EntityCYTO Regulatory Agency. To Except as set forth in the knowledge CYTO Disclosure Letter, to the Knowledge of the CompanyCYTO, no event has occurred which would reasonably be likely expected to lead to any Action by any Governmental Entity CYTO Regulatory Agency or any FDA Form 483-related warning letter, untitled letter letter, or request or requirement to make material changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (fe) Since January 1, 20222018, all studies, tests and preclinical and clinical trials being conducted by CYTO or its Subsidiaries, or in which CYTO, its Subsidiaries or any Product or Product candidate has participated, have been and are being conducted in compliance in all material respects with applicable Laws, including the applicable requirements of Good Laboratory Practices or Good Clinical Practices. Since January 1, 2018, neither CYTO nor any of its Subsidiaries have received any written notices, correspondence or other communication from any institutional review board, the FDA or any other CYTO Regulatory Agency, recommending or requiring the termination, suspension, or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, CYTO or any of its Subsidiaries. (f) Except as set forth in the CYTO Disclosure Letter, neither CYTO nor any of its Subsidiaries have either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notification, field correction, market withdrawal, or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action, in each case relating to an alleged lack of safety, efficacy or regulatory compliance of any Product or Product candidate (“CYTO Safety Notices”). Except as set forth in the CYTO Disclosure Letter, CYTO has no Knowledge of any facts which would cause (i) there have been no adverse events that should have been reported a CYTO Safety Notice with respect to any Product sold or intended to be sold by CYTO or its Subsidiaries; (ii) a change in the Company marketing classification or a Subsidiary material change in labeling of any such Products; (iii) a termination or suspension of marketing or testing of any such Products; or (iv) the Company, but were not reported, to imposition of a postmarketing study or risk evaluation and mitigation strategy by the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such ProductCYTO Regulatory Agency. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials Except as set forth in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active INDCYTO Disclosure Letter, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company CYTO and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 2018 have been, in compliance in all material compliance respects with all applicable Healthcare Laws, and to the knowledge of the Company there . There is no civil, criminal, administrative, or other Action pending, received by oror filed since January 1, 2018, or to the Knowledge of CYTO, threatened Action against the Company CYTO or any of its Subsidiaries alleging any material violation by CYTO or its Subsidiary of any Collaboration Partner to the extent related applicable Healthcare Laws. (h) Neither CYTO nor any of its Subsidiaries is a party to any Productcorporate integrity agreements, related to such Healthcare Lawsmonitoring agreements, consent decrees, deferred prosecution agreements, settlement Orders or similar agreements with or imposed by any Governmental Body. (i) Neither the CompanyCYTO, any of its Subsidiaries nor any of their respective directors, officers officers, or employees, nor, to the knowledge Knowledge of the CompanyCYTO, any of its agents or distributors or any other Representative or other Person person while acting on behalf of the Company CYTO or any of its Subsidiaries has has, at any time since January 1, 2018, (i) violated or is in material violation of any provision of the U.S. Foreign Corrupt Practices Act of 19771977 (the “FCPA”), (ii) violated or is in material violation of any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business TransactionsTransactions (the “OECD Convention”), (iii) violated or is in material violation of any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption LawsUK Bribery Act”); , (iiiv) materially violated any anti-bribery or anti-corruption Law in any foreign jurisdiction, (v) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of valuevalue prohibited under any applicable Law addressing matters comparable to those addressed by the FCPA, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already givenUK Bribery Act, or for the OECD Convention implementing legislation concerning such payments or gifts in any other improper purpose; jurisdiction (iii) requested, agreed to receive, or accepted a any such payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained“Prohibited Payment”), or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, been subject to any investigation by any Governmental Entity Body with regard to any alleged or potential violations Prohibited Payment to the Knowledge of any Anti-Corruption Laws; CYTO or (vii) violated or is in material violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 20222018, none CYTO has: (x) distributed Product samples in compliance in all material respects with applicable Healthcare Laws, and the provision of such samples has been appropriately documented in accordance with requirements of the CompanyPrescription Drug Marketing Act of 1987; and (y) filed complete and accurate reports, in all material respects, as required under the Physician Payment Sunshine Act and all applicable state transparency Laws, including Laws requiring certifications of compliance with the PhRMA Code and other compliance program certifications. (k) Except as disclosed in Section 3.19(k) of the CYTO Disclosure Letter, as of the date hereof, neither CYTO nor its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is subject to any pending or threatened investigation, claim, or enforcement Action by FDA, U.S. Department of Health and Human Services-Office of Inspector General (“HHS-OIG”), private whistleblowers, Centers for Medicare & Medicaid (“CMS”), U.S. Department of Veterans Affairs (“VA”), VA Office of Inspector General (“VA OIG”), or U.S. Department of Justice (“DOJ”), or any other state or non-U.S. equivalent Governmental Bodies pursuant to the target Healthcare Laws. CYTO has no Knowledge of any investigation relating fact that would require CYTO to restate or resubmit to the government any Federal data reported under the Medicaid Rebate Statute, Medicare Part B Drug Pricing requirements, 340B Program requirements, Veterans Health Care Program-related offense or (vi) to the knowledge Act of the Company, has engaged in any activity that is in violation of1992, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state the Medicare Part D Coverage Gap Discount Program to comply with such Pricing Reporting Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned refund any monies owed due to a resubmission or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Lawsrestatement.

FDA and Regulatory Matters. (ai) All approvals of New Drug Applications (“NDAs”) and Abbreviated New Drug Applications (“ANDAs”) and any supplements and amendments to such NDAs and ANDAs are valid and effective, all necessary reports and submissions have been made to the Food and Drug Administration (“FDA”), and all applicable fees with respect to such applications have been paid to FDA. (ii) Except as set forth on Schedule 3(w), the Company and its Subsidiaries possess all permits, licenses, approvals, consents and other authorizations, including but not limited to, NDAs, ANDAs, and all supplements and amendments to such applications and appropriate state licenses, permits and registrations, submitted to the appropriate governmental entity necessary to conduct the business of the Company and its Subsidiaries, including without limitation, all such registrations, approvals, certificates, authorizations and permits required by the FDA, the United States Drug Enforcement Administration, Governmental Authority, and all such are in full force and effect. Each of the Company’s and its Subsidiaries’s products are and have been, since March, 2009, developed, manufactured, labeled, stored, tested and distributed by such Person for products distributed in the marketplace in compliance with all applicable laws, rules, regulations and orders of the FDA or of any applicable state or other Governmental Authority. (iii) The manufacture of products by the Company and its Subsidiaries will be conducted in compliance with the applicable requirements of the FDA’s Current Good Manufacturing Practices and pursuant to the terms of the Consent Decree. All of the Company’s facilities are registered with the FDA and all of their products are listed with the FDA as required by the FDA’s regulations, 21 C.F.R. Part 207. (iv) The Company and its Subsidiaries hold, have complied with and have held at all times since January 1, 2022will comply with, all Permitsthe FDA post-approval commitments and reporting requirements, including all such Permits required pursuant to any applicable Healthcare Lawsbut not limited to, necessary for adverse event reporting obligations. (v) To the lawful operation of the businesses knowledge of the Company and its Subsidiaries Subsidiaries, there are no facts or circumstances that could reasonably be construed as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred indicating that marketing approval for any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice its Subsidiaries’s products will be withdrawn or lapse of time would allow, revocation that the Company and its Subsidiaries will not obtain approval for any products currently pending approval by the FDA or termination thereof or result in any other material impairment of the rights of the holder of any such Company PermitGovernmental Authority. The Company and each of its Subsidiaries are in compliance in shall use such prompt, substantial and persistent efforts to take, or cause to be taken, all material respects with the terms of actions, or to do, or cause to be done, all Company Permits. Since January 1things reasonably necessary, 2022, neither the Company nor any of its Subsidiaries has received written proper or oral notice advisable under applicable laws to obtain all consents and approvals of any pending Governmental Authority. (vi) No Exclusion Affiliate (i) has any direct or threatened Action from any Governmental Entity alleging that any operation indirect ownership or activity control interest (as defined in Section 1124(a)(3) of the SSA) in the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant except to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored extent expressly permitted by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or nonHHS-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483OIG Agreements, (ii) warning letterserves as an officer, director, agent, managing employee or employee (iiias defined in Section 1126(b) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (fSSA) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback officially or other unlawful advantage otherwise or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed furnishes any services as an independent contractor or consultant to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries. “Exclusion Affiliate” means the Company’s affiliates (as defined or applied under applicable law including the SSA) or Affiliates, is a Person that isincluding any natural Persons, trusts, or is owned otherwise and including, for the avoidance of doubt, Xxxx Xxxxxxxx, in each case as to which exclusion actions or controlled possible exclusion actions by Persons that are HHS-OIG exist. “Affiliate” means as applied to any (i) Person, any other Person directly or indirectly controlling, controlled by, or under common control with, that Person and (ii) the subject Company, Xxxxxx X. Xxxxxxxx or Xxxx X. Xxxxxxxx, or any of their direct descendants, any economic sanctions administered members of their family, or enforced any trust or other similar entity formed for their benefit or for the benefit of their family. For the purposes of this definition, “control” (including, with correlative meanings, the terms “controlling”, “controlled by” and “under common control with”), as applied to any Person, means the possession, directly or indirectly, of the power (i) to vote 10% or more of the Securities having ordinary voting power for the election of directors of such Person or (ii) to direct or cause the direction of the management and policies of that Person, whether through the ownership of voting securities or by contract or otherwise. “SSA” means the Social Security Act of the United States. “HHS-OIG Agreements” means the HHS-OIG Agreement (Ethex) and the HHS-OIG Agreement (Hermelin). “HHS-OIG Agreement (Ethex)” means Divestiture Agreement entered into by and between the Office of Inspector General of the United States Department of Treasury’s Health and Human Services, K-V Pharmaceutical Corporation, and its subsidiary ETHEX Corporation, which agreement was entered into by the parties thereto, and became effective, on November 15, 2010. “HHS-OIG Agreement (Hermelin)” means that certain Settlement Agreement entered into by and among the Office of Foreign Assets Control, Inspector General of the United States Department of StateHealth and Human Services, Her Majesty’s Treasury or any applicable prohibited party list maintained K-V Pharmaceutical Company, Xxxxx Xxxxxxxxxx and Xxxx Xxxxxxxx, which agreement was entered into by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctionsparties thereto, and antiboycott Lawsbecame effective, on November 15, 2010, together with the Attachment A and Schedule of Divestitures thereto, as in effect on the Closing Date.

FDA and Regulatory Matters. (ai) The All approvals of New Drug Applications (“NDAs”) and Abbreviated New Drug Applications (“ANDAs”) and any supplements and amendments to such NDAs and ANDAs are valid and effective, all necessary reports and submissions have been made to the Food and Drug Administration (“FDA”), and all applicable fees with respect to such applications have been paid to FDA. (ii) Except as set forth on Schedule 3(v), the Company and its Subsidiaries holdpossess all permits, licenses, approvals, consents and other authorizations, including but not limited to, NDAs, ANDAs, and have held at all times since January 1supplements and amendments to such applications and appropriate state licenses, 2022permits and registrations, all Permits, including all such Permits required pursuant submitted to any applicable Healthcare Laws, the appropriate governmental entity necessary for to conduct the lawful operation of the businesses business of the Company and its Subsidiaries as currently conducted or have been conducted since January 1Subsidiaries, 2022 (including without limitation, all such registrations, approvals, certificates, authorizations and permits required by the “Company Permits”)FDA, the United States Drug Enforcement Administration, Governmental Authority, and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all Each of the Company’s and its Subsidiaries’ Products that products are subject to the jurisdiction of the FDA or other Governmental Entity are being researchedand have been, since March 2009, developed, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed tested and distributed by such Person for products distributed in the marketplace in compliance with all applicable laws, rules, regulations and orders of the FDA or on behalf of any applicable state or other Governmental Authority. (iii) The manufacture of products by the Company and its Subsidiaries will be conducted in compliance with the applicable requirements of the FDA’s Current Good Manufacturing Practices and pursuant to the terms of the Consent Decree. All of the Company’s facilities are registered with the FDA and all of their products are listed with the FDA as required by the FDA’s regulations, 21 C.F.R. Part 207. (iv) The Company and its Subsidiaries have complied with and will comply with, all the FDA post-approval commitments and reporting requirements, including but not limited to, adverse event reporting obligations. (v) To the knowledge of the Company and its Subsidiaries, there are no facts or circumstances that could reasonably be construed as indicating that marketing approval for any of the Company’s or its Subsidiaries’ products will be withdrawn or that the Company and its Subsidiaries will not obtain approval for any products currently pending approval by the FDA or any Governmental Authority. The Company and its Subsidiaries shall use such prompt, substantial and persistent efforts to take, or cause to be taken, all actions, or to do, or cause to be done, all things reasonably necessary, proper or advisable under applicable laws to obtain all consents and approvals of any Governmental Authority. (vi) No Exclusion Affiliate (i) has any direct or indirect ownership or control interest (as defined in Section 1124(a)(3) of the SSA) in the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized except to the extent expressly permitted by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or nonHHS-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483OIG Agreements, (ii) warning letterserves as an officer, director, agent, managing employee or employee (iiias defined in Section 1126(b) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (fSSA) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback officially or other unlawful advantage otherwise or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed furnishes any services as an independent contractor or consultant to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries. “Exclusion Affiliate” means the Company’s affiliates (as defined or applied under applicable law including the SSA) or Affiliates, is a Person that isincluding any natural Persons, trusts, or is owned otherwise and including, for the avoidance of doubt, Xxxx Xxxxxxxx, in each case as to which exclusion actions or controlled possible exclusion actions by Persons that are HHS-OIG exist. “Affiliate” means as applied to any (i) the subject of Person, any economic sanctions administered other Person directly or enforced by the United States Department of Treasury’s Office of Foreign Assets Controlindirectly controlling, the United States Department of Statecontrolled by, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entityunder common control with, the European Union or Her Majesty’s Treasury or that Person and (ii) organized the Company, Xxxxxx X. Xxxxxxxx or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.Xxxx X. Xxxxxxxx,

FDA and Regulatory Matters. (a) The Company and All existing Product Registrations held by Seller or any of its Subsidiaries hold, are set forth on Schedule 3.22(a). Seller is the sole and have held at exclusive owner of all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are Product Registrations. Each Product Registration is valid and in full force and effect. There has not occurred any material violation of or default . (with or without notice or lapse of time or bothb) under any Company Permit, Seller and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in with all material respects with Product Registrations and Laws applicable to the terms of Business Products, including all Company Permitspost-approval monitoring, adverse event reporting, clinical study and other obligations. Since January 1To Seller’s Knowledge, 2022, neither the Company nor there have been no serious adverse events relating to any of its Subsidiaries has received written or oral notice of the Products that would adversely affect Buyer’s ability to commercialize the Business Products in any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permitrespect. (bc) The clinicalAll applications, submissions, information, claims, reports and statistics, and other data derived therefrom, utilized as the basis for or submitted in connection with any and all requests for any Product Registrations when submitted to the Regulatory Authority issuing such Product Registration were true, complete and correct in all respects as of the date of submission, or as subsequently corrected or modified, and any required updates, changes, corrections or modifications to any applicable applications, submissions, information, claims, reports or statistics required by any applicable Regulatory Authority to maintain the Product Registrations have been submitted to such Regulatory Authority. (d) Except as set forth on Schedule 3.22(d), Seller has not received from any Regulatory Authority within the Territory any FDA Form 483 or other written notice of Governmental Authorities’ inspectional observations, “untitled letters,” “warning letters” or requests or requirements to make changes to the Business Product. (e) All pre-clinical and other studies and tests clinical trials conducted or currently being conducted by Seller with regard to the Business Products or on behalf of or sponsored the Acquired Assets are in compliance with (i) applicable protocols, procedures and controls, (ii) all applicable Legal Requirements promulgated by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws FDA and the rules, policies and regulations to which they are subjectcomparable foreign Regulatory Authorities relating thereto, including without limitationlimitation the FDA Act, any and its applicable Good Clinical Practice implementing regulations, and Good Laboratory Practice requirements(iii) good laboratory and clinical practice standards. No Except as set forth on Schedule 3.22(e), no IND filed or submitted by or on behalf of the Company or its Subsidiaries Seller with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, FDA regarding the Business Products has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental EntityFDA, and neither the FDA nor such Governmental Entity, nor any Review Board applicable foreign Regulatory Authority within the Territory has commenced, or, to the knowledge Knowledge of the Company or its SubsidiariesSeller, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or ongoing clinical investigation being conducted or proposed to be conducted by or on behalf of Seller involving the Company or its SubsidiariesBusiness Products. (cf) Since January 1, 2022, Seller has made available to Buyer all adverse drug experience reports and safety data from all clinical trials as of the Company’s and its Subsidiaries’ Products that are subject date hereof relating to the jurisdiction Business Products. Seller has disclosed all protocols for all Assumed Clinical Trials and, to the extent required by applicable Legal Requirements, such protocols were approved by all applicable Governmental Authorities. All clinical trials pending on the date of this Agreement in relation to the Business Products are the trials listed on Schedule 1.1(b). (g) None of the FDA officers of Seller have been disqualified or debarred by any Regulatory Authority for any purpose, or have been charged with or convicted under any Legal Requirement for conduct relating to the development or approval or otherwise relating to the regulation of any drug product under any Legal Requirement. Seller is not the subject of pending or, to Seller’s Knowledge, threatened investigations with respect to the Business Products under the FDA’s Application Integrity Policy set forth in Compliance Policy Guide 7150.09, Sec. 120.100 and any amendments thereto, or any similar Legal Requirement of any other Governmental Entity are being researchedRegulatory Authority. Seller has complied with all applicable Legal Requirements relating to the marketing, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed promotion and distributed by or on behalf distribution of the Company or any Business Products. As of its Subsidiaries in all material respects the Closing Date, Seller will be in compliance with all applicable requirements under Legal Requirements in the Territory relating to any Company Permit Rebates, Chargebacks or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests Adjustments for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Business Products. (h) The Company and its Subsidiaries andThere are no investigations, audits, Actions, suits, hearings, charges, claims, demands, written notices or other proceedings of a Regulatory Authority pending or, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by orSeller’s Knowledge, threatened against the Company with respect to Seller or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare LawsAffiliates. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company is and has been in material compliance with all Healthcare Laws applicable to Company and its Subsidiaries holdProducts, or by which any property or other asset of Company is bound or affected. The design, manufacture, testing, and have held at distribution of Products by or on behalf of Company is being, and has been, conducted in material compliance with all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary including, without limitation, the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products. Company and, to Company’s Knowledge, any contract manufacturers assisting in the lawful operation manufacture of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”)Products are, and all such have been, in material compliance with FDA’s establishment registration and product listing requirements to the extent required by applicable Healthcare Laws. Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice notification of any pending or threatened Action claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity alleging that any operation or activity Authority, including, without limitation, the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of the Company Health and Human Services Office of Inspector General, or any of its Subsidiaries is in material violation of comparable state or federal Governmental Authority alleging potential or actual non-compliance by, or Liability of, Company under any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company PermitHealthcare Law. (b) The clinicalCompany holds such Permits of Governmental Bodies from the United States government or government agencies required for the conduct of its business as currently conducted, including, without limitation, those Permits necessary based on the scope of its activities to permit such activities related to the design, development, pre-clinical and other studies clinical testing, manufacture, labeling, sale, shipment, distribution and tests conducted by promotion of its Products in jurisdictions where it currently conducts such activities with respect to each Product (collectively, the “Company Licenses”). Company has fulfilled and performed all of its material obligations with respect to each Company License and is in material compliance with all terms and conditions of each Company License. Company has not received any written information or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by notification from the FDA or such any other Governmental EntityAuthority with jurisdiction over the testing, marketing, sale, use, handling and neither control, safety, efficacy, reliability, or manufacturing of medical devices which would reasonably be expected to lead to the denial of any application for marketing approval or clearance currently pending before the FDA nor such or any other Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its SubsidiariesAuthority. (c) Since January 1All material registrations, 2022listings, all of the Company’s filings, reports, documents, claims, submissions, notices, and its Subsidiaries’ Products that are subject applicable updates required to the jurisdiction of the FDA be filed, maintained, or furnished to FDA, state, or other Governmental Entity are being researchedfederal equivalent agencies by Company have been so filed, manufacturedmaintained, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed or furnished and distributed by or on behalf of the Company or any of its Subsidiaries were complete and correct in all material respects on the date filed (or were corrected in compliance with all applicable requirements under any Company Permit or Lawsupplemented by a subsequent filing), including applicable Healthcare Lawssubmission to FDA of reportable adverse events (i.e., reportable deaths, serious injuries, or malfunctions) as required to be submitted under the Medical Device Reporting (“MDR”) regulation at 21 C.F.R. Part 803, and corrections and removals required under 21 C.F.R. Part 806, with regard to the Products. Since January 1Company has made available all documentation of events that were evaluated for potential submission as an MDR reportable event related to the Products, 2022including documentation regarding events that Company deemed not reportable under the MDR regulation (e.g., all complaints, complaint reviews and investigations, complaint analysis reports, and corrective action reports or plans, and any related reports of Company, which reports are complete and correct in all material respects). All applications, notifications, submissions, information, claims, reports reports, filings, and other data and conclusions derived therefrom utilized by the Company or its Subsidiaries as the basis for, for or submitted by or on behalf of the Company or its Subsidiaries in connection with, with any and all requests for a Company License from the Company Permits FDA or other Governmental Authority relating to the Company or any of its Subsidiariesbusinesses, or the Products, when submitted to the FDA or any other Governmental EntityAuthority, whether oral, written or electronically delivered, were true and correct in all material respects true, accurate and complete as of the date of submission, and any material . Any necessary or required updates, changes, corrections or modification modifications to such applications, notifications, submissions, information, claims, reports reports, filings, and other data required under applicable Laws have been submitted to the FDA or other Governmental EntityAuthority and as so updated, changed, corrected or modified remain true, accurate and complete, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (d) Since January 1, 2022, neither the Company nor has not received any of its Subsidiaries have committed any act, made any statement written notice or failed to make any statement that would reasonably be likely to provide a basis for other communication from the FDA or any other Governmental Entity Authority contesting the pre-market clearance or approval of, the uses of, or the labeling and promotion of any of the Products. No manufacturing site which assists in the manufacture of the Products (whether Company-owned or operated, or that of a contract manufacturer for the Products) has been subject to invoke its policy a Governmental Authority (including FDA) shutdown or import or export prohibition. Except as set forth on Section 3.26 of the Company Disclosure Schedules, neither Company nor, to Company’s Knowledge, any manufacturing site which assists in the manufacture of the Products (whether Company-owned or operated, or that of a contract manufacturer for the Products) has received any Form FDA-483 or other Governmental Authority notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting deficiencies in, deviations from, or noncompliance with any applicable Healthcare Laws or Company Licenses or alleging a significant safety concern with respect to Products, and there is no action or proceeding scheduled, pending, or, to Company’s Knowledge, threatened and, to Company’s Knowledge, neither the FDA nor any Governmental Authority is considering such action. (e) Except as set forth on Section 3.26 (e) of the Company Disclosure Schedules, there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts, or other notices relating to an alleged lack of safety, effectiveness, or regulatory compliance of any Product, or seizures ordered or adverse regulatory actions taken (or, to Company’s Knowledge, threatened) by the FDA or any other Governmental Authority with respect to any of the Products or any facilities where any such Products are tested, produced, processed, packaged, or stored. The FDA has not mandated that Company initiate a recall of any of its Products. There are no recalls of any of Company’s Products contemplated or pending. (f) Section 3.26 (f) of the Company Disclosure Schedules lists all preclinical or clinical trials that have been completed, or are being conducted as of the date hereof, by or on behalf of, or sponsored by, Company. (g) Neither Company, nor, to Company’s Knowledge, any director, officer or employee of Company, nor any agent acting on behalf of or for the benefit of any of Company, has directly or indirectly in connection with Company: (i) offered or paid any remuneration, in cash or in kind, to or made any financial arrangements with, any past, present or potential customers, past or present suppliers, patients, contractors or employees of private third party payors or Government Programs in violation of applicable Health Care Laws; (ii) given or agreed to give, any gift or gratuitous payment of any kind, nature or description (whether in money, property or services) to any customer or potential customer, supplier or potential supplier, contractor, private third party payor or any other person in violation of applicable Healthcare Laws; (iii) made any false entries on any of Company’s books or records for any purpose prohibited by Law; or (iv) made any representations to customers (physicians, hospitals, clinics, managed care organizations, and other healthcare providers and third party payors) regarding appropriate reimbursement coverage and/or codes which would have reasonably expected to result in a submission by such customer to any federal, state, or private third party payor for Products in violation of applicable Healthcare Laws or Private Insurance Programs that have provided reimbursement for any Product. (h) Company has made available to Parent true, correct, and complete copies of all of its material written communications from and to the FDA, including electronic communications, such as faxes and e-mails, and meeting minutes of telephonic or other verbal communications. (i) Company is not the subject of any pending or, to Company’s Knowledge, threatened investigation regarding Company or the Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), or otherwise. Neither Company nor to Company’s Knowledge, any officer, employee, agent or distributor of Company has made an “untrue statement of material fact,” as this phrase is defined in the FDA Fraud Policy, to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, 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 or any other Governmental Authority to invoke the FDA Fraud Policy, or any similar Lawspolicy, or to bring a civil or criminal action against Company. Neither the Company nor, to Company’s Knowledge, any officer, employee, agent or distributor of Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resultedfor 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 would reasonably be likely to resultany similar Law. No claims, in debarment under applicable Lawactions, including 21 U.S.C. Section 335a. To the knowledge of the Companyproceedings, no Actions or investigation that would reasonably be likely expected to result in such a material debarment or exclusion from participating in the federal health care programs are pending or threatened or, to Company’s Knowledge, threatened, against the Company or any of its Subsidiaries or any of their respective officersor, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the to Company’s Knowledge, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers officers, employees or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeagents. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (ai) Except as set forth in the SEC Reports, the Company has no knowledge of any actual or threatened material enforcement action or investigation by the FDA or any other Governmental Authority in respect of the Company or any Company product candidates. The Company and its Subsidiaries holdhas no knowledge or reason to believe that the FDA or any Governmental Authority is considering such action. The operation of the business of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, sales, and have held distribution of the Company’s product candidates is, and at all times since January 1has been, 2022in material compliance with all applicable laws and permits. (ii) All material reports, all Permitsdocuments, including all claims, permits and notices required to be filed with, maintained for or furnished to the FDA or any Governmental Authority have been so filed, maintained or furnished by the Company. All such Permits required pursuant reports, documents, claims, permits and notices filed with, maintained for or furnished to the FDA or any applicable Healthcare Laws, necessary for the lawful operation of the businesses Governmental Authority in respect of the Company and its Subsidiaries Company product candidates were complete and accurate in all material respects on the date filed or furnished (or were corrected in or supplemented by a subsequent filing), such that no liability exists with respect to such filing, and remain complete and accurate. (iii) Except as currently conducted set forth in the SEC Reports, the Company has not, and to the knowledge of the Company no third party (in so far as it relates to Company product candidates) has, received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or have been conducted since January 1other correspondence or notice from the FDA or any Governmental Authority: (i) alleging or asserting material noncompliance with any applicable laws or permits or (ii) materially contesting the pre-market clearance or approval of, 2022 the uses of or the labeling or promotion of any of the Company’s product candidates (the each a “Company PermitsGovernment Notice”). The Company has no knowledge or reason to believe that the FDA or any Governmental Authority is considering providing or otherwise issuing any such Government Notice. Except as disclosed in the SEC Reports, and all such the Company Permits are valid and in full force and effect. There has not occurred received from the FDA or any material violation of Governmental Authority any correspondence concerning the Company product candidates in which the FDA or default (with Governmental Authority alleges or without notice or lapse of time or both) under asserts that any Company Permitproduct candidates may not be safe, effective, or approvable, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of knowledge the rights of the holder of FDA and Governmental Authorities are not considering any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permitaction. (biv) The clinicalEach of the Company’s product candidates subject to the FDCA that has been developed, pre-clinical and other studies and tests conducted manufactured, tested or distributed by or on behalf of the Company is being or sponsored has been developed, manufactured, tested or distributed in compliance with all material applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction, including those relating to investigational use, pre-market clearance or approval, licensing of drugs and medical devices and biologics, registration and listing, good manufacturing practices, labeling, advertising, record keeping and filing of required reports. (v) The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company or its Subsidiariesthe clinical trials conducted by third parties, in each case described in, or in the results of which are referred to in, the Products have participated, SEC Reports were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws protocols and procedures filed with the appropriate regulatory authorities for each such trial; each description of the results of such preclinical tests and clinical trials contained in the SEC Reports is accurate and complete in all material respects and fairly presents the data derived from such preclinical tests and clinical trials, and the rulesCompany has no knowledge of any other studies or tests the results of which are inconsistent with, policies and regulations or otherwise call into question, the results described or referred to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf in the SEC Reports. (vi) None of the Company or its Subsidiaries with Company, the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, Company’s employees and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, agents or, to the knowledge of the Company or its Subsidiaries, threatened to initiateCompany, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized third party engaged by the Company or its Subsidiaries as the basis forfor contract research, or submitted by or on behalf of the Company or its Subsidiaries in connection withcontract manufacturing, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA consulting or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy collaboration services with respect to “FraudCompany products candidates, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject debarred, excluded, suspended or otherwise determined to be ineligible to participate in any kind health care programs of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity Authority, including the FDA, or convicted of any crime or engaged in related to any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiarieshealth care programs, or, to the knowledge of the Company, engaged in any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entityconduct, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing ofthat has resulted, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, would reasonably be expected to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have beenresult, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, exclusion, suspension or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeineligibility. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries holdWith respect to the Contingent Payment Products and, and have held at all times since January 1to the extent applicable, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of other products currently under development by the Company and its Subsidiaries as currently conducted or have been conducted since January 1(collectively, 2022 (the “Company PermitsProducts”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or bothi) under any Company Permit, and to (A) the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of its Products in jurisdictions where it currently conducts such activities (the “Activities to Date”) with respect to each Product (collectively, the “Company Licenses”); (B) the Company and each of its Subsidiaries, as the case may be, is in compliance in all material respects with all terms and conditions of each Company License and with all applicable laws pertaining to the terms Activities to Date with respect to each Product which is not required to be the subject of all a Company Permits. Since January 1, 2022, neither License; (C) the Company nor any and each of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of Subsidiaries, as the Company or any of its Subsidiaries case may be, is in material violation of any Law that applies to compliance with all applicable laws regarding registration, license and/or certification for each site at which a Company Permit. The transactions contemplated by this AgreementProduct is manufactured or labeled, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by from which a Product is sold or on behalf of or sponsored distributed by the Company or its Subsidiaries; and (D) to the extent that any Product has been exported from the United States, or the Company or, as applicable, a Subsidiary of the Company exporting such Product, has exported such Product in which the Products have participated, were and, if still pending, are being conducted compliance in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted law; (ii) all manufacturing operations performed by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has have been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation are being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf Quality Systems Regulations of the Company or its Subsidiaries in connection withFDA and, any and all requests for to the Company Permits relating extent applicable to the Company or any of its Subsidiaries, in all material respects with counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Products under development, sponsored by the Company or any of its Subsidiaries and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA’s Good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company or any of its Subsidiaries, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable law. (b) The Company and each of its Subsidiaries is in compliance with all FDA and non-United States equivalent agencies and similar state and local laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Products. Section 3.21(b) of the Company Disclosure Schedule sets forth a list of all adverse event reports related to the Products, when submitted to including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 3.21(b) of the FDA or other Governmental EntityCompany Disclosure Schedule are complaint review and analysis reports of the Company and each of its Subsidiaries through the date hereof, were true including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entityrespects. (dc) Since January 1, 2022, neither Neither the Company nor any of its Subsidiaries have committed has received any act, made any statement written notice or failed to make any statement that would reasonably be likely to provide a basis for other written communication from the FDA or any other Governmental Entity to invoke its policy with respect to “FraudAuthority (i) contesting the pre-market clearance or approval of, Untrue Statements the uses of Material Facts, Bribery, or the labeling and Illegal Gratuities,” or other similar Laws. Neither the Company, promotion of any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreementProducts, or other similar form of agreement with (ii) otherwise alleging any Governmental Entity or convicted material violation of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of laws by the Company or any of its Subsidiaries. (ed) Since January 1There have been no recalls, 2022, the manufacture of Products by field notifications or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, seizures ordered or adverse regulatory actions taken (or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (ithreatened) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from by the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits Authority with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the CompanyProducts, including any facilities where any such Products are produced, processed, packaged or stored and neither the Company nor any of their respective contract manufacturers for Productsits Subsidiaries has within the last three (3) years, is either voluntarily or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To at the knowledge request of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity Authority, initiated or participated in a recall of any FDA Form 483Product or provided post-related warning letter, untitled letter or request or requirement to make changes to sale warnings regarding any Product. (e) The Company and each of its Subsidiaries have conducted all of their clinical trials with reasonable care and in accordance with all applicable laws and the Products or the manner in which the Products are manufactured, distributed or marketedstated protocols for such clinical trials. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, All filings with and submissions to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or corollary entity in any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held jurisdiction made by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding regard to the Products, whether oral, written or electronically delivered, were true, accurate and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls complete as of the Products. (h) The Company and its Subsidiaries date made, and, to the knowledge of the Companyextent required to be updated, any Collaboration Partner to the extent related to any Productas so updated remain true, are, accurate and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance complete in all material respects with all applicable export controls, economic sanctionsas of the date hereof, and antiboycott Lawsdo not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading.

FDA and Regulatory Matters. (ai) Except as set forth on Disclosure Schedule 3.2(s)(i), each of the Company and the Subsidiary is, and since its incorporation or organization has been, in compliance with all Healthcare Laws applicable to the Company, the Subsidiary and the Company Products, or by which any property or other asset of the Company or the Subsidiary is bound or affected. The design, manufacture, testing, and distribution of Company Products by or on behalf of the Company is being, and has been since its incorporation or organization, as applicable, conducted in compliance with all applicable Healthcare Laws, including the FDA’s current good manufacturing practice regulations at 21 C.F.R. Part 820 for medical device products. The Company and the Subsidiary and, to the Knowledge of the Company, any contract manufacturers assisting in the manufacture of the Company Products are, and at all times have been, in compliance with FDA’s registration and listing requirements to the extent required by applicable Healthcare Laws. Neither the Company nor the Subsidiary has received notification of any pending or threatened Action from any Governmental Entity, including the FDA, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, or any comparable state or federal Governmental Entity alleging potential or actual non-compliance by, or Liability of, the Company or the Subsidiary under any Healthcare Law. (ii) The Company and the Subsidiary hold such Permits of Governmental Entities from the United States government or government agencies required for the conduct of its Subsidiaries hold, and have held at all times since January 1, 2022, all PermitsBusiness as currently conducted, including all such those Permits required pursuant necessary to any applicable Healthcare Lawspermit the design, necessary for the lawful operation of the businesses development, pre-clinical and clinical testing, manufacture, labeling, sale, shipment, distribution and promotion of the Company and its Subsidiaries as Products in jurisdictions where it currently conducted or have been conducted since January 1, 2022 conducts such activities (the “Activities to Date”) with respect to each Company PermitsProduct (collectively, the “Company Licenses”). The Company has fulfilled and performed all of its obligations in all material respects with respect to each Company License and is in compliance in all material respects with all terms and conditions of each Company License, and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permitand, and to the Knowledge of the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result results in any other material impairment of the rights of the holder of any such Company PermitLicense. The Neither the Company nor the Subsidiary has received any information or notification from the FDA or any other Governmental Entity with jurisdiction over the testing, marketing, sale, use, handling and each control, safety, efficacy, reliability, or manufacturing of its Subsidiaries are in compliance medical devices regarding the denial of any application for marketing approval or clearance currently pending before the FDA or any other Governmental Entity. (iii) All filings, reports, documents, claims, submissions and notices required to be filed, maintained, or furnished to FDA, state, other federal equivalent agencies by the Company have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), including adverse event reports and medical device reports, with regard to the terms Company Products. Disclosure Schedule 3.2(s)(iii) sets forth a list of all Company Permits. Since January 1, 2022, neither adverse event reports related to the Company nor Products, including any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity Medical Device Reports required in accordance with 21 C.F.R. Part 803. Set forth on Disclosure Schedule 3.2(s)(iii) are complaint review and analysis reports of the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated and the Subsidiary, including information regarding complaints by this Agreementproduct, in which reports are complete and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. (b) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted correct in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirementsrespects. No IND filed or submitted by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all All applications, notifications, submissions, information, claims, reports reports, filings, and other data and conclusions derived therefrom utilized by the Company or its Subsidiaries as the basis for, for or submitted by or on behalf of the Company or its Subsidiaries in connection with, with any and all requests for a Company License from the Company Permits FDA or other Governmental Entity relating to the Company Company, the Subsidiary or any of its Subsidiariesthe Business, or the Company Products, when submitted to the FDA or any other Governmental Entity, whether oral, written or electronically delivered, were true true, accurate and correct in all material respects complete as of the date of submission, and any material . Any necessary or required updates, changes, corrections or modification modifications to such applications, notifications, submissions, information, claims, reports reports, filings, and other data required under applicable Laws have been submitted to the FDA or other Governmental EntityEntity and as so updated, changed, corrected or modified remain true, accurate and complete, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (div) Since January 1, 2022, neither Neither the Company nor the Subsidiary has received any notice or other communication from the FDA or any other Governmental Entity contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products. No manufacturing site which assists in the manufacture of the Company Products (whether Company-owned or operated, or, to the Knowledge of the Company, that of a contract manufacturer for the Products) has been subject to a Governmental Entity (including FDA) shutdown or import or export prohibition. Neither the Company nor, to the Knowledge of the Company, any manufacturing site which assists in the manufacture of the Products (whether Company-owned or operated, or that of a contract manufacturer for the Products) has received any FDA Form 483 or other Governmental Entity notice of inspectional observations or adverse findings, “warning letters,” “untitled letters” or similar correspondence or notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Healthcare Laws or Company Licenses or alleging a lack of safety from the FDA or any other Governmental Entity, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened. (v) Except as set forth on Disclosure Schedule 3.2(s)(v), there have been no recalls (either voluntary or involuntary), field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating 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 Company Products are tested, produced, processed, packaged or stored. The FDA has not mandated that the Company do a recall of any of the Company Products. There are no recalls of any of the Company Products contemplated or pending. (vi) No preclinical or clinical trials have been completed, or are being conducted as of the date hereof, by or on behalf of, or sponsored by, the Company. (vii) Neither the Company, nor, to the Knowledge of the Company, any director, officer or employee of the Company, nor any agent acting on behalf of or for the benefit of any of the Company, has directly or indirectly in connection with the Company: (A) offered or paid any remuneration, in cash or in kind, to or made any financial arrangements with, any past, present or potential customers, past or present suppliers, patients, contractors or employees of private third party payors or government programs in return for or to induce business or payments from such persons other than in the ordinary course of business; (B) given or agreed to give, any gift or gratuitous payment of any kind, nature or description (whether in money, property or services) to any customer or potential customer, supplier or potential supplier, contractor, private third party payor or any other person other than in connection with promotional or entertainment activities in the ordinary course of business and in compliance with the Company’s compliance program; or (C) made any false entries on any of the Company’s books or records for any purpose prohibited by Applicable Law. (viii) The Company has delivered to Purchaser true, correct and complete copies of all of its Subsidiaries have material written communications with the FDA. (ix) The Company is not the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company or the Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), or otherwise. Neither the Company nor to the Knowledge of the Company, any officer, employee, agent or distributor of the Company has made an untrue statement of material fact to the FDA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity, or committed any an act, made any a statement or failed to make any a statement that that, at the time such disclosure was made, would reasonably be likely expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” the FDA Fraud Policy or other any similar Lawspolicy. Neither the Company nor, to the Knowledge of the Company, any of its Subsidiariesofficer, nor any of their respective officersemployee, employees, contractors, suppliers, agents agent or other Persons performing research or work on behalf distributor of the Company or any of its Subsidiaries is or Company, has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resultedfor 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 would reasonably be likely to resultany similar Law. No claims, in debarment under applicable Lawactions, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions proceedings or investigation that would reasonably be likely expected to result in such a material debarment or exclusion are pending or threatened or, to the Knowledge of the Company, threatened, against the Company or any of its Subsidiaries or any of their respective officersor, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of to the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none Knowledge of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers officers, employees or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeagents. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries holdThere is no actual or, and have held at all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of the Company and its Subsidiaries as currently conducted or have been conducted since January 1, 2022 (the “Company Permits”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any Company Permit, and to the Company’s knowledgeKnowledge, no event has occurred which allows, threatened enforcement action or after notice investigation by the FDA or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are in compliance in all material respects with the terms of all Company Permits. Since January 1Governmental Authority, 2022which, neither the Company nor any of its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of if determined adversely to the Company or any of its Subsidiaries would have a Material Adverse Effect. The Company has no Knowledge or reason to believe that the FDA or any Governmental Authority is considering such action. The operation of the business of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, sales, and distribution of the Company’s product candidates is, and at all times has been, in material violation compliance with all applicable laws and permits, or within the FDA’s exercise of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permitenforcement discretion. (b) All material reports, documents, claims, permits and notices required to be filed with, maintained for or furnished to the FDA or any Governmental Authority have been so filed, maintained or furnished by the Company. All such reports, documents, claims and notices were complete and accurate in all material respects on the date filed or furnished (or were corrected in or supplemented by a subsequent filing), such that no liability exists with respect to such filing, and remain complete and accurate. (c) The clinicalCompany has not received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other correspondence or notice from the FDA or any Governmental Authority (i) alleging or asserting material noncompliance with any applicable laws or permits and the Company has no Knowledge or reason to believe that the FDA or any Governmental Authority is considering such action or (ii) materially contesting the pre-clinical and other studies and tests conducted market clearance or approval of, the uses of or the labeling or promotion of any of the Company’s product candidates. (d) Each of the Company’s product candidates subject to the FDCA that has been developed, manufactured, tested or distributed by or on behalf of the Company is being or sponsored has been developed, manufactured, tested or distributed in compliance with all material applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction, including those relating to investigational use, pre-market clearance or approval, biologics licensing, registration and listing, good manufacturing practices, labeling, advertising, record keeping and filing of required reports. (e) The preclinical tests and clinical trials conducted by the Company or its SubsidiariesCompany, and to Company’s Knowledge the clinical trials conducted by third parties, in each case described in, or in the results of which are referred to in, the Products have participatedCompany SEC Documents, were andwere, and if still pending, are being being, conducted in all material respects in accordance with applicable Healthcare Laws protocols and procedures filed with the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted by or on behalf appropriate regulatory authorities for each such trial; each description of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has been subject to a results of such preclinical tests and clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of trials contained in the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s SEC Documents is accurate and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries complete in all material respects in compliance with all applicable requirements under any Company Permit or Lawand fairly presents the data derived from such preclinical tests and clinical trials, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf of the Company or its Subsidiaries in connection with, any and all requests for the Company Permits relating to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct in all material respects as of the date of submission, and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required under applicable Laws have been submitted to the FDA or other Governmental Entity. (d) Since January 1, 2022, neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the no knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice from the FDA or any other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use studies or tests the results of funds for political activity which are inconsistent with, or commercial bribery. None of otherwise call into question, the Representatives of results described or referred to in the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political officeSEC Documents. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) 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, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state Laws. (k) None of the Company, any of its Subsidiaries, any officer, director or employee of the Company or any of its Subsidiaries or, to the knowledge of the Company, any other Representative acting at the direction of or on behalf of the Company or any of its Subsidiaries, is a Person that is, or is owned or controlled by Persons that are (i) the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Laws.

FDA and Regulatory Matters. (a) The Company and its Subsidiaries hold, and have held at (i) With respect to all times since January 1, 2022, all Permits, including all such Permits required pursuant to any applicable Healthcare Laws, necessary for the lawful operation of the businesses of Company’s existing products and, to the extent applicable, products currently under development by the Company and its Subsidiaries as currently conducted or have been conducted since January 1(collectively, 2022 (the “Company PermitsProducts”), and all such Company Permits are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or bothA) under any Company Permit, and to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other material impairment of the rights of the holder of any such Company Permit. The Company and each of its Subsidiaries are has obtained all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development and pre-clinical testing of its Products in jurisdictions where it currently conducts such activities or contemplated conducting such activities (the “Activities To Date”) with respect to each Product (collectively, the “Regulatory Licenses”); (B) the Company and each of its Subsidiaries, as the case may be, is in compliance with all terms and conditions of each Regulatory License and with all applicable Laws pertaining to Activities To Date with respect to each Product which is not required to be the subject of a Regulatory License; (C) the Company and each of its Subsidiaries, as the case may be, is in compliance with all applicable Laws regarding registration, license, and certification for each site at which a Product is manufactured or used; (D) to the extent any Product has been exported from the United States, the Company or, as applicable, a Subsidiary of the Company exporting such Product, has exported such Product in compliance in all material respects with the terms of all Company Permits. Since January 1, 2022, neither applicable Law; and (E) the Company nor any of is licensed to export its Subsidiaries has received written or oral notice of any pending or threatened Action from any Governmental Entity alleging that any operation or activity of Products in the respective jurisdictions set forth in the Company or any of its Subsidiaries is in material violation of any Law that applies to a Company Permit. The transactions contemplated by this Agreement, in and of themselves, will not cause the revocation or cancellation of any Company Permit pursuant to the terms of any such Company Permit. Disclosure Schedule; (bii) The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Products have participated, were and, if still pending, are being conducted in all material respects in accordance with applicable Healthcare Laws and the rules, policies and regulations to which they are subject, including without limitation, any applicable Good Clinical Practice and Good Laboratory Practice requirements. No IND filed or submitted manufacturing operations performed by or on behalf of the Company or its Subsidiaries with the FDA, nor any comparable application filed with or submitted to another Governmental Entity, has have been subject to a clinical hold or otherwise terminated or suspended by the FDA or such Governmental Entity, and neither the FDA nor such Governmental Entity, nor any Review Board has commenced, or, to the knowledge of the Company or its Subsidiaries, threatened to initiate, any action to place a clinical hold order on, or otherwise modify, terminate or suspend, any proposed or clinical investigation are being conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (c) Since January 1, 2022, all of the Company’s and its Subsidiaries’ Products that are subject to the jurisdiction of the FDA or other Governmental Entity are being researched, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted, advertised, detailed and distributed by or on behalf of the Company or any of its Subsidiaries in all material respects in compliance with all the applicable requirements under any Company Permit or Law, including applicable Healthcare Laws. Since January 1, 2022, all applications, notifications, submissions, information, claims, reports and data utilized by the Company or its Subsidiaries as the basis for, or submitted by or on behalf regulations of the Company or its Subsidiaries in connection withU.S. Food and Drug Administration (the “FDA”) and, any and all requests for to the Company Permits relating extent applicable to the Company or any of its Subsidiaries, or the Products, when submitted to the FDA or other Governmental Entity, were true and correct counterpart regulations in all material respects as other countries where compliance is required; and (iii) the Company and each of its Subsidiaries is in compliance with all applicable reporting requirements for all Regulatory Licenses or plant registrations describe in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the date of submission, United States and any material updates, changes, corrections or modification to such applications, notifications, submissions, information, claims, reports and data required outside the United States under applicable Laws have been submitted to the FDA or other Governmental EntityLaw. (db) Since January 1, 2022, neither Neither the Company nor any of its Subsidiaries have committed any act, made any statement or failed to make any statement that would reasonably be likely to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar Laws. Neither the Company, any of its Subsidiaries, nor any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries is or has been subject to any kind of consent decree, individual or corporate integrity agreement, deferred or non-prosecution agreement, or other similar form of agreement with any Governmental Entity or convicted of any crime or engaged in any conduct that has resulted, or would reasonably be likely to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. To the knowledge of the Company, no Actions that would reasonably be likely to result in such a debarment or exclusion are pending or threatened against the Company or any of its Subsidiaries or any of their respective officers, employees, contractors, suppliers, agents or other Persons performing research or work on behalf of the Company or any of its Subsidiaries. (e) Since January 1, 2022, the manufacture of Products by or on behalf of the Company and its Subsidiaries has been and is being conducted in material compliance with all applicable Laws, including applicable Good Manufacturing Practices. Since January 1, 2022, none of the Company, any of its Subsidiaries, or, to the knowledge of the Company, any of their respective contract manufacturers for Products, has received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to the Company’s or any of its Subsidiaries’ Products, manufacturing processes or procedures related to any Product, or (v) other similar correspondence or written notice or other written communication from the FDA or any other Governmental Entity alleging Authority (i) contesting the pre-market clearance or asserting material noncompliance with any applicable Laws approval of, the uses of or the Company Permits with respect to any Product. Since January 1, 2022, no manufacturing site owned by the Company, its Subsidiaries, or, to the knowledge labeling and promotion of the Company, any of their respective contract manufacturers for Products, is or has been subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Entity. To the knowledge of the Company, no event has occurred which would reasonably be likely to lead to any Action by any Governmental Entity or any FDA Form 483-related warning letter, untitled letter or request or requirement to make changes to the Products or the manner in which the Products are manufactured, distributed or marketed. (f) Since January 1, 2022, (i) there have been no adverse events that should have been reported by the Company or a Subsidiary of the Company, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of any Product, and (ii) to the knowledge of the Company, with respect to a Product being developed or marketed by a Collaboration Partner, there have been no adverse events that should have been reported by such Collaboration Partner, but were not reported, to the FDA or other Governmental Entity or Review Board with respect to the safety or efficacy of such Product. (g) The Company has made available to Parent and its advisors true, and correct copies of the following materials in the possession of the Company or otherwise alleging any of its Subsidiaries as of the date of this Agreement: (i) each active IND, or non-United States equivalent, submitted to regulatory authorities (including the FDA, EMA and any other Governmental Entity performing functions similar to those performed by the FDA or EMA) by or on behalf of the Company or any of its Subsidiaries, including any supplements thereto, relating to the Products, (ii) all material correspondence to or from the FDA or any other Governmental Entity, or any minutes or similar summary documentation with respect to meetings with the FDA or any other Governmental Entity, in each case in this clause (ii) held by the Company or any of its Subsidiaries concerning (A) any Product, (B) the Company’s and its Subsidiaries’ compliance with applicable Laws regarding the Products, and (C) the likelihood or timing of, or requirements for, regulatory approval of any Product and (iii) all material information requested by Parent concerning the safety, efficacy, side effects, toxicity, or manufacturing quality and controls of the Products. (h) The Company and its Subsidiaries and, to the knowledge of the Company, any Collaboration Partner to the extent related to any Product, are, and at all times since January 1, 2021 have been, in material compliance with all applicable Healthcare Laws, and to the knowledge of the Company there is no civil, criminal, administrative, or other Action pending, received by or, threatened against the Company or any of its Subsidiaries or any Collaboration Partner to the extent related to any Product, related to such Healthcare Laws. (i) Neither the Company, any of its Subsidiaries nor any of their respective directors, officers or employees, nor, to the knowledge of the Company, any other Representative or other Person acting on behalf of the Company or any of its Subsidiaries has (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions, any provision of the UK Bribery Act of 2010 or any other Law relating to bribery, corruption, fraud or improper payments (the “Anti-Corruption Laws”); (ii) made, offered to make, promised to make, facilitated or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful advantage or payment or gift of money or anything of value, regardless of form or amount, to any Person for the purpose of securing an unlawful advantage, inducing the recipient to violate an official or lawful duty, reward the recipient for an unlawful advantage already given, or for any other improper purpose; (iii) requested, agreed to receive, or accepted a payment, gift or hospitality from a Person if it is known or suspected that it is offered with the expectation that it will obtain a business advantage for them; (iv) established or maintained, or is maintaining, any unlawful fund of corporate monies or other properties; (v) to the knowledge of the Company, been or is, under administrative, civil, or criminal investigation, indictment, information, suspension, debarment, or audit Laws by any party, in connection with alleged or possible violations of any Anti-Corruption Laws; (vi) since January 1, 2022, received written notice from, or made a voluntary disclosure to, any Governmental Entity with regard to any alleged or potential violations of any Anti-Corruption Laws; or (vii) violated or is in violation of any other Laws regarding use of funds for political activity or commercial bribery. None of the Representatives of the Company are (A) an employee of any Governmental Entity, (B) an employee of any commercial enterprise that is owned or controlled by a Governmental Entity, including any state-owned or controlled university or medical facility, (C) an employee of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank, (D) a Person acting as the director of or in an official capacity for any Governmental Entity, enterprise, or organization identified above, or (E) any official of a political party or candidate for political office. (j) Since January 1, 2022, none of the Company, its Subsidiaries or their respective directors, officers or employees, or, to the knowledge of the Company, any other Representative or Person acting at the direction of or on behalf of the Company or any of its Subsidiaries with respect to any Product: (i) has been charged with the research, development, testing, manufacturing or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program, (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program, (iii) has had a civil monetary penalty assessed against it, him or her under 42 U.S.C. §1320a-7a, (iv) 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, (v) has received written notice that it is the target of any investigation relating to any Federal Health Care Program-related offense or (vi) to the knowledge use of the Company, has engaged in any activity that is in violation of, or is cause for civil penalties, debarment or mandatory or permissive exclusion under federal or state LawsProducts. (kc) None of All filings with and submissions to the Company, FDA and any of its Subsidiaries, corollary entity in any officer, director or employee of other jurisdiction made by the Company or any of its Subsidiaries orwith regard to the Products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the knowledge extent required to be updated, as so updated remain true, accurate and complete as of the Companydate hereof, and do not materially misstate any other Representative acting at the direction of or on behalf of the Company statements or any of its Subsidiaries, is a Person that isinformation included therein, or is owned or controlled by Persons that are (i) omit to state a material fact necessary to make the subject of any economic sanctions administered or enforced by the United States Department of Treasury’s Office of Foreign Assets Control, the United States Department of State, Her Majesty’s Treasury or any applicable prohibited party list maintained by any United States Governmental Entity, the European Union or Her Majesty’s Treasury or (ii) organized or resident in a country or region that is the subject of such sanctions. Since January 1, 2022, the Company and its Subsidiaries have been in compliance in all material respects with all applicable export controls, economic sanctions, and antiboycott Lawsstatements therein not misleading.