Common use of Certain Regulatory Matters Clause in Contracts

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might Except as has not had and would not reasonably be expected to lead have, individually or in the aggregate, a Parent Material Adverse Effect, (i) each of Parent and its Subsidiaries holds all Governmental Authorizations under the FDCA (including Sections 510(k) and 515 thereof) and the MDD, and all Governmental Authorizations of any Parent Regulatory Agency necessary for the lawful operation of the businesses of Parent or its Subsidiaries in each jurisdiction in which such Parent or its Subsidiaries operates (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent is in compliance with the terms of all Parent Regulatory Permits. The Parent Regulatory Permits cover the Parent Products as they are currently being researched, developed, tested, manufactured, labeled, marketed, distributed, commercialized, sold, imported and exported. No changes have been made to any loss Parent Product (or the testing, manufacturing, labeling or intended use of or refusal to renew any Parent Product) after the submission of the application or other filing for the relevant Parent Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, eventPermits that would require a new Governmental Authorization, or circumstance that could a supplement or amendment to a Governmental Authorization, except those changes for which Parent subsequently obtained the required new Governmental Authorization (or supplement or amendment). (b) Except as has not had and would not reasonably be expected to give rise have, individually or in the aggregate, a Parent Material Adverse Effect, the businesses of each of Parent and its Subsidiaries are being conducted in compliance with, and have appropriate internal controls that are reasonably designed to any such Regulatory Action against any member ensure compliance with the Healthcare Laws. Since January 1, 2013, none of the Seller Group. No member of the Seller Group Parent and its Subsidiaries has received any written notification or, to the knowledge of Parent, other communication from the FDA any Parent Regulatory Agency or any other applicable Governmental Authority indicating that Notified Body, of noncompliance by, or liability of Parent or any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions fromits Subsidiaries under, any applicationsHealthcare Laws, certifications, reports except where such noncompliance or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There liability has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could had and would not reasonably be expected to require investigationhave, corrective action individually or enforcement action by any member of in the Seller Group with respect to the Business Productsaggregate, a Parent Material Adverse Effect. (c) No member Neither Parent nor any of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that its Subsidiaries is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency and, to Parent’s knowledge, no such action is currently contemplated, proposed or pending. (d) All pre-clinical and clinical investigations conducted or sponsored by or on behalf of Parent or any of its Subsidiaries, or used or intended to be used to support any filing or application for a Parent Regulatory Permit, has been or is being conducted in compliance with all applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and the protection of human subjects, including without limitation, Title 21 parts 11, 50, 54, 56 and 812 of the Code of Federal Regulations, (iii) any comparable foreign Laws for any of the foregoing or other Laws (including state and local requirements) regulating the conduct of pre-clinical and clinical investigations and the protection of human subjects, (iv) federal and state Laws restricting the collection, use and disclosure of individually identifiable health information and personal information and (v) all directions, notices, approvals and restrictions issued by the relevant institutional review board or ethics board, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Parent Material Adverse Effect. To the knowledge of Parent, no investigator, employee or agent that has participated or is participating in any clinical investigation conducted or sponsored by or on behalf of any Parent or any of its Subsidiaries, or used or intended to be used to support any filing or application for a Parent Regulatory Permit, (A) is or has been disqualified or restricted by the FDA from receiving investigational drugs, biologics or devices or from conducting any clinical investigation that supports an application for a research or marketing permit; (B) has entered into a restricted agreement with FDA; or (C) is or has been subject to any comparable action by any other Governmental AuthorityEntity. (e) Since January 1, 2013, neither Parent nor any of its Subsidiaries has been or is the subject of any 483 observations, warning letters, untitled letters, inspection or audit reports from any Parent Regulatory Agency or Notified Body or identifying any major or minor non-compliances, subpoenas, investigations, actions, demands or notices relating to any alleged non-compliance, which has had or would reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or to lead to the denial, modification, suspension, cancellation, termination or revocation of any application or grant for marketing approval with respect to any material Parent Product currently pending before or previously approved or cleared by the FDA or such other Parent Regulatory Agency. Since January 1, 2013, neither Parent nor any of its Subsidiaries has been subject to any adverse audit reports from any Notified Body or alleged non-compliance by its customers or other third parties with which it does business, except where such report or allegation of non-compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (f) Since January 1, 2013, for each adverse event and device malfunction requiring the submission of an MDR, an MDV, or any other filing, submission, notice, or report to the FDA or any other Parent Regulatory Agency, Parent and its Subsidiaries have reported, filed, or submitted an MDR, MDV or other required filing, submission, notice or report in a timely manner, except where a failure to report, file, or submit has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. All such MDRs, MDVs and other filings, submissions, notices and reports were complete and accurate in all material respects on the date filed and, to the extent any material new or additional information was learned or obtained after filing, were corrected in or supplemented by a timely subsequent filing, to the extent required by applicable Laws. Parent and its Subsidiaries have maintained and are maintaining all records, reports and other documentation required under the applicable Laws for product complaints and reports of adverse events and device malfunctions (including all required records and documentation related to MDR and MDV reporting), except where the failure to maintain such records, reports and other documentation has not had and would not reasonably be expected to result in, individually or in the aggregate, a Parent Material Adverse Effect. Neither Parent or any of its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, to an institutional review board or ethics board, or in any records or documentation prepared or maintained to comply with the applicable Laws; or failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory Agency; or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of Parent or any of its Subsidiaries. Neither Parent or any of its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Laws or authorized by 21 U.S.C. § 335a(b) or any similar Laws. Neither Parent or any of its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program. (g) As to each Parent Product or Parent Product candidate subject to the FDCA or similar Law in any foreign jurisdiction (including the MDD), except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, each such Parent Product or Parent Product candidate is being or has been designed, developed, manufactured, processed, tested, packaged, labeled, stored, distributed and marketed in compliance with all applicable Laws, including (i) those relating to investigational use and marketing approval or clearance, (ii) the Quality System Regulation at 21 C.F.R. Part 820, ISO 13485 and any other requirements related to good manufacturing practices for medical devices, including those requirements applicable to purchase controls and supplier oversight, and (iii) any comparable foreign Laws for any of the foregoing or other Laws (including state and local requirements) regulating the foregoing. There is no action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of its Subsidiaries of any Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (h) Since January 1, 2013, neither Parent or any of its Subsidiaries have neither voluntarily nor involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued any Recall relating to any Parent Product or is currently considering initiating, conducting or issuing any Recall of any Parent Product, except as (with respect to Recalls other than Class I Recalls) has not had and would not reasonably be expected to, individually or in the aggregate, result in a Parent Material Adverse Effect. To the knowledge of Parent, there are no facts which are reasonably likely to cause, and Parent has not received since January 1, 2010 any written notice from the FDA or any other Parent Regulatory Agency regarding, (i) the Recall of any Parent Product sold or intended to be sold by Parent or any of its Subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such Parent Products or (iv) a negative change in reimbursement status of a Parent Product, that in each case, has had or would reasonably be expected to, individually or in the aggregate, result in a Parent Material Adverse Effect.

Certain Regulatory Matters. Except as set forth on Section 2.24 of (i) Dermavant currently holds or has the Disclosure Schedules: (a) No member of right to acquire all applicable approvals and authorizations from Governmental Authorities necessary for Dermavant to conduct its business in the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities manner in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities such business is being conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business ProductsProduct, including the Development, manufacture and testing of the Product, and all such approvals and authorizations are in good standing and in full force and effect. None of Dermavant, its Controlled Affiliates, or Parent have received any written notice or any other communication from any Governmental Authority regarding any actual or possible revocation, withdrawal, suspension, cancellation, termination, or material modification of any such approvals or authorizations. (cii) No member None of the Seller Group: (i) has Dermavant, its Controlled Affiliates, or Parent have knowingly made an any untrue statement of a material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) any Regulatory Authority or any other Governmental Authority with respect to any product produced sold by any member of the Seller GroupAuthority, or (ii) has failed to disclose a material fact required to be disclosed to any Regulatory Authority or other Governmental Authority, or committed an act, made a statement or failed to make a statement, that provides or would reasonably be expected to provide a basis for the FDA or other Governmental Authority to invoke the FDA’s policy respecting “Fraud, USDA Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy of any other Governmental Authority. (diii) Dermavant is not and has never been, Parent is not and has never been, and, to Dermavant’s knowledge and Parent’s knowledge, none of Dermavant’s Controlled Affiliates have or have ever been, (A) debarred by a Governmental Authority, (B) a party to a settlement, consent or similar agreement with a Governmental Authority regarding the Product, or (C) charged with, or convicted of, violating Applicable Law regarding the Product. (iv) The Product is being, and, to Dermavant’s knowledge and Parent’s knowledge, at all times has been, Developed, tested, manufactured, labeled, and stored in compliance in all material respects with all Applicable Laws, including with respect to investigational use, good clinical practices, good laboratory practices, good manufacturing practices, record keeping, security, and filing of reports. (v) The Product has never been the subject of or subject to (as applicable) any recall, suspension, market withdrawal, seizure, warning letter, other written communication asserting lack of compliance with any Applicable Law in any material respect, or serious adverse event. No member clinical trial of the Seller Group: (i) Product has made been suspended, put on hold or offered terminated prior to completion as a result of any payment, gratuity or other thing of value that is prohibited action by any Law to personnel of the FDA, USDA Regulatory Authority or any other Governmental Authority or voluntarily. To Dermavant’s knowledge and to Parent’s knowledge, no event has occurred or circumstance exists that is reasonably likely to give rise to or serve as a basis for any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); foregoing events. (vi) discovered Dermavant has, with respect to the Product and Program, made available to NovaQuest true and complete copies of all material pre-clinical and clinical data, reports and analyses, all material correspondence with the FDA, material interim analysis from ongoing trials, material tables from recently completed clinical trials where no clinical study report is available, and any potential other information that is material to the Development or actual violation Commercialization of the FCPA or any other applicable anti-corruption Law; Product. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (vii) None of Dermavant, its Controlled Affiliates, or Parent have received any adverse written communication notice from any Governmental Authority alleging that any member regarding the approvability or approval of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption LawProduct. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might Except as has not had and would not reasonably be expected to lead have, individually or in the aggregate, a Company Material Adverse Effect: (i) each of the Company and its Subsidiaries holds all material Governmental Authorizations under the FDCA (including Sections 510(k) and 515 thereof) and the counsel directive 00/00 XXX concerning medical devices promulgated by the Council of the European Communities as amend (“MDD”), and all material Governmental Authorizations of any Company Regulatory Agency necessary for the lawful operation of the businesses of the Company or its Subsidiaries in each jurisdiction in which such Company or its Subsidiaries operates (the “Company Regulatory Permits”); (ii) all such Company Regulatory Permits are valid and in full force and effect; and (iii) the Company is in compliance with the terms of all Company Regulatory Permits. The Company Regulatory Permits cover the Company Products as they are currently being researched, developed, tested, manufactured, labeled, marketed, distributed, commercialized, sold, imported and exported. No changes have been made to any loss Company Product (or the testing, manufacturing, labeling or intended use of or refusal to renew any Company Product) after the submission of the application or other filing for the relevant Company Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, eventPermits that would require a new Governmental Authorization, or circumstance that could a supplement or amendment to a Governmental Authorization, except those changes for which the Company subsequently obtained the required new Governmental Authorization (or supplement or amendment). (b) Except as has not had and would not reasonably be expected to give rise to any such Regulatory Action against any member have, individually or in the aggregate, a Company Material Adverse Effect, the businesses of each of the Seller Group. No member Company and its Subsidiaries are being conducted in compliance with, and have appropriate internal controls that are reasonably designed to ensure compliance with: (i) the FDCA (including all applicable registration and listing requirements set forth in Section 510 of the Seller Group FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (ii) federal Medicare and Medicaid statutes and related state or local statutes; (iii) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), Xxxxx Law (42 U.S.C. §1395nn), False Claims Act (42 U.S.C. § 1320a-7b(a)), Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state or local Laws; (iv) federal, state or local testing, manufacturing, labeling, marketing, distribution, commercialization, sale, import, export, licensing, disclosure, gift ban, code of conduct and reporting requirements, including the Physician Payments Sunshine Act (42 C.F.R. Parts 402-403) and equivalent or related international or state reporting requirements; (v) Laws with respect to the protection of personally identifiable information collected or maintained by a Person; (vi) any comparable foreign Laws for any of the foregoing (including the MDD); and (vii) the rules and regulations promulgated pursuant to all such applicable Laws, each as amended from time to time (collectively, “Healthcare Laws”). Since January 1, 2013, none of the Company and its Subsidiaries has received any written notification or, to the knowledge of the Company, other communication from the FDA any Company Regulatory Agency, any MDD competent authority in any jurisdiction or any other applicable Governmental Authority indicating that public or private entity designated by a Company Regulatory Agency for such purpose (each, a “Notified Body”), of noncompliance by, or liability of the Company or any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions fromits Subsidiaries under, any applicationsHealthcare Laws, certifications, reports except where such noncompliance or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There liability has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could had and would not reasonably be expected to require investigationhave, corrective action individually or enforcement action by any member of in the Seller Group with respect to the Business Productsaggregate, a Company Material Adverse Effect. (c) No member Neither the Company nor any of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that its Subsidiaries is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Company Regulatory Agency and, to the Company’s knowledge, no such action is currently contemplated, proposed or pending. (d) All pre-clinical and clinical investigations conducted or sponsored by or on behalf of the Company or any of its Subsidiaries or used or intended to be used to support any filing or application for a Company Regulatory Permit, has been or is being conducted in compliance in all material respects with all applicable Laws administered or issued by the applicable Company Regulatory Agencies, including (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and the protection of human subjects, including without limitation, Title 21 parts 11, 50, 54, 56 and 812 of the Code of Federal Regulations, (iii) any comparable foreign Laws for any of the foregoing or other Laws (including state and local requirements) regulating the conduct of pre-clinical and clinical investigations and the protection of human subjects, (iv) federal and state Laws restricting the collection, use and disclosure of individually identifiable health information and personal information and (v) all directions, notices, approvals and restrictions issued by the relevant institutional review board or ethics board, except, in each case, for such noncompliance that, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect. To the knowledge of the Company, no investigator, employee or agent that has participated or is participating in any clinical investigation conducted or sponsored by or on behalf of the Company or any of its Subsidiaries or used or intended to be used to support any filing or application for a Company Regulatory Permit, (A) is or has been disqualified or restricted by the FDA from receiving investigational drugs, biologics or devices or from conducting any clinical investigation that supports an application for a research or marketing permit; (B) has entered into a restricted agreement with FDA; or (C) is or has been subject to any comparable action by any other Governmental AuthorityEntity. (e) Since January 1, 2013, neither the Company nor any of its Subsidiaries has been or is the subject of any 483 observations, warning letters, untitled letters, inspection or audit reports from any Company Regulatory Agency or any Notified Body identifying any major or minor non-compliances, subpoenas, investigations, actions, demands or notices relating to any alleged non-compliance, which has had or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect or to lead to the denial, modification, suspension, cancellation, termination or revocation of any application or grant for marketing approval with respect to any material Company Product currently pending before or previously approved or cleared by the FDA or such other Company Regulatory Agency. Since January 1, 2013, neither the Company nor any of its Subsidiaries has been subject to any adverse audit reports from any Notified Body or alleged non-compliance by its customers or other third parties with which it does business, except where such report or allegation of non-compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (f) Since January 1, 2013, for each adverse event and device malfunction requiring the submission of a medical device report under 21 C.F.R. Part 803 (“MDR”), a medical device vigilance report under the MDD (“MDV”), or any other filing, submission, notice or report to the FDA or any other Company Regulatory Agency, the Company and its Subsidiaries have reported, filed, or submitted an MDR, MDV or other required filing, submission, notice or report in a timely manner, except where a failure to report, file or submit has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All such MDRs, MDVs and other filings, submissions, notices and reports were complete and accurate in all material respects on the date filed and, to the extent any material new or additional information was learned or obtained after filing, were corrected in or supplemented by a timely subsequent filing, to the extent required by applicable Laws. The Company and its Subsidiaries have maintained and are maintaining all records, reports and other documentation required under the applicable Laws for product complaints and reports of adverse events and device malfunctions (including all required records and documentation related to MDR and MDV reporting), except where the failure to maintain such records, reports and other documentation has not resulted in and would not reasonably be expected to result in, individually or in the aggregate, a Company Material Adverse Effect. Neither the Company or any of its Subsidiaries, nor, to the knowledge of the Company, any officer, employee or agent of the Company or any of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Company Regulatory Agency, to an institutional review board or ethics board, or in any records or documentation prepared or maintained to comply with applicable Laws or failed to disclose a material fact required to be disclosed to the FDA or any other Company Regulatory Agency; or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of the Company or any of its Subsidiaries. Neither the Company or any of its Subsidiaries nor, to the knowledge of the Company, any officer, employee or agent of the Company or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Laws or authorized by 21 U.S.C. § 335a(b) or any similar Laws. Neither the Company or any of its Subsidiaries, nor, to the knowledge of the Company, any officer, employee or agent of the Company or any of its Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program. (g) As to each Company Product or Company Product candidate subject to the FDCA or similar Law in any foreign jurisdiction (including the MDD), except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, each such Company Product or Company Product candidate is being or has been designed, developed, manufactured, processed, tested, packaged, labeled, stored, distributed and marketed in compliance with all applicable Laws, including (i) those relating to investigational use and marketing approval or clearance, (ii) the Quality System Regulation at 21 C.F.R. Part 820, ISO 13485 and any other requirements related to good manufacturing practices for medical devices, including those requirements applicable to purchase controls and supplier oversight, and (iii) any comparable foreign Laws for any of the foregoing or other Laws (including state and local requirements) regulating the foregoing. There is no action or proceeding pending or, to the knowledge of the Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Company Product or Company Product candidate by the Company or any of its Subsidiaries of any Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (h) Since January 1, 2013, neither the Company nor any of its Subsidiaries have voluntarily nor involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued any recall, removal, market withdrawal, replacement, field action, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to or involving wholesalers, distributors, retailers, healthcare professionals or patients (including any action required to be reported or for which records must be maintained under 21 C.F.R. Part 806) (collectively, a “Recall”) relating to any Company Product or is currently considering initiating, conducting or issuing any Recall of any Company Product, except as (with respect to Recalls other than Class I Recalls) has not had and would not reasonably be expected to, individually or in the aggregate, result in a Company Material Adverse Effect. To the knowledge of the Company, there are no facts which are reasonably likely to cause, and the Company has not received since January 1, 2010 any written notice from the FDA or any other Company Regulatory Agency regarding, (i) the Recall of any Company Product sold or intended to be sold by the Company or any of its Subsidiaries, (ii) a change in the marketing classification or a material change in the labeling of any such Company Products, (iii) a termination, enjoinment or suspension of the manufacturing, marketing, or distribution of such Company Products or (iv) a negative change in reimbursement status of a Company Product, that in each case, has had or would reasonably be expected to, individually or in the aggregate, result in a Company Material Adverse Effect.

Certain Regulatory Matters. (a) The Seller holds all permits, licenses, variances, exemptions, certificates, consents, product listings, establishment registrations, orders, approvals, clearances and other authorizations from Governmental Entities which are required for the conduct of the Business (collectively, the “Permits”), and all periodic reports required to be filed with respect thereto are accurate and complete in all material respects. The Seller is not in default in any material respect under any Permit. (b) Except as set forth on in Section 2.24 2.15(b) of the Disclosure Schedules: (a) No member Schedule, no Governmental Entity has issued any notice, warning letter, regulatory letter, untitled letter or other communication or correspondence to the Seller Parties, alleging that the Seller or any Affiliate of the Seller Group is or was in receipt violation of notice ofany law, regulation, rule, ordinance, clearance, approval, permission, authorization, consent, exemption, guidance or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating guideline applicable to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller GroupSeller, or alleging that any member of the Seller Group or any Affiliate was or is the subject of any pending, threatened or anticipated Action administrative agency or Regulatory Action by any Governmental AuthorityEntity investigation, proceeding, review or inquiry related to such activities, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business ProductsPermits. (c) No member Except as set forth in Section 2.15(c) of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDADisclosure Schedule, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Grouphas timely filed all registrations, or (ii) has failed to disclose a material fact declarations, reports, notices, forms and other filings required to be disclosed filed by it with the any Governmental Entity, and all amendments or supplements to any of the FDAforegoing and has paid all fees and assessments due and payable in connection therewith. The information contained in such declarations, USDA reports, notices, forms and other filings was at the time of filing and is complete and accurate in all material respects, and timely amendments were filed, as necessary, to correct or update any information reflected in such declarations, reports, notices, forms and other Governmental Authorityfilings. (d) No member All of the employees of the Seller Group: who are required to be licensed or registered to conduct the Business are duly licensed or registered in each jurisdiction and with each Governmental Entity in which or with which such licensing or registration is so required and such registrations are in full force and effect. (e) The Seller has not, and to the knowledge of the Seller Parties’, no officer, director, employee or representative of the Seller on behalf of the Seller, has (i) has made or offered used any paymentfunds for unlawful contributions, gratuity gifts, entertainment or other thing of value that is prohibited by any Law unlawful expenses relating to personnel of the FDA, USDA or any other Governmental Authority or any other Personpolitical activity; (ii) has been convicted of made any crime under any applicable Lawsunlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns; or (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group1977, as amended, or any directorrules or regulations hereunder, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption comparable foreign Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. (a) The Company holds all permits, licenses, variances, exemptions, certificates, consents, product listings, establishment registrations, orders, approvals, clearances and other authorizations from Governmental Entities which are required for the conduct of its business (collectively, the “Permits”), and all periodic reports required to be filed with respect thereto are accurate and complete in all material respects. The Company is not in default in any material respect under any Permit. (b) Except as set forth on in Section 2.24 2.15(b) of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice ofSchedule, or is subject to no Governmental Entity has issued any investigationnotice, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483regulatory letter, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, untitled letter or other compliance communication or enforcement action (“Regulatory Actions”), in each case relating correspondence to the Business Products Company, alleging that the Company or any Affiliate of the Company is or was in violation of any law, regulation, rule, ordinance, clearance, approval, permission, authorization, consent, exemption, guidance or guideline applicable to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller GroupCompany, or alleging that the Company or any member of the Seller Group Affiliate was or is the subject of any pending, threatened or anticipated Action administrative agency or Regulatory Action by any Governmental AuthorityEntity investigation, proceeding, review or inquiry related to such activities, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business ProductsPermits. (c) No member Except as set forth in Section 2.15(c) of the Seller Group: (i) Disclosure Schedule, the Company has made an untrue statement of material fact or fraudulent statement to the FDAtimely filed all registrations, United States Department of Agriculture (“USDA”) or any declarations, reports, notices, forms and other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact filings required to be disclosed filed by it with any Governmental Entity, and all amendments or supplements to any of the FDAforegoing and has paid all fees and assessments due and payable in connection therewith. The information contained in such declarations, USDA reports, notices, forms and other filings was at the time of filing and is complete and accurate in all material respects, and timely amendments were filed, as necessary, to correct or update any information reflected in such declarations, reports, notices, forms and other Governmental Authorityfilings. (d) No member All of the Seller Group: employees of the Company who are required to be licensed or registered to conduct the business of the Company are duly licensed or registered in each jurisdiction and with each Governmental Entity in which or with which such licensing or registration is so required and such registrations are in full force and effect. (e) The Company has not, and to the knowledge of the Seller, no officer, director, employee or representative of the Company on behalf of the Company, has (i) has made or offered used any paymentfunds for unlawful contributions, gratuity gifts, entertainment or other thing of value that is prohibited by any Law unlawful expenses relating to personnel of the FDA, USDA or any other Governmental Authority or any other Personpolitical activity; (ii) has been convicted of made any crime under any applicable Lawsunlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns; or (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group1977, as amended, or any directorrules or regulations hereunder, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA comparable foreign law or any other applicable anti-corruption Lawstatute. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Except as disclosed on Schedule 4.22 hereto and except for billing disputes with customers arising in the ordinary course of business that in the Seller Group is in receipt of notice ofaggregate involve immaterial amounts, there are no proceedings or, to Telco's knowledge, investigations pending or, to Telco's knowledge, threatened, before any domestic or is subject to any investigationforeign court, adverse inspection observationadministrative, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled governmental or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities regulatory body in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that following matters are being considered which could reasonably be expected to give rise to have a Material Adverse Effect on Telco, nor has Telco or any of its Subsidiaries received written notice or inquiry from any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA body, government official, consumer advocacy or similar organization or any other applicable Governmental Authority private party, indicating that any of such matters should be considered or may become the Business Products object of consideration or components thereof is misbranded investigation which could reasonably be expected to have a Material Adverse Effect on Telco: (i) reduction of rates charged to customers; (ii) reduction of earnings; (iii) refunds of amounts previously charged to customers; or adulterated(iv) failure to meet any expense, infrastructure, service quality or other commitments previously made to or imposed by any administrative, governmental or regulatory body. (b) No member Except as disclosed on Schedule 4.22 hereto, neither Telco nor any of the Seller Group its Subsidiaries has made any false statements onoutstanding commitments (and no such obligations have been imposed upon Telco and remain outstanding) regarding (i) reduction of rates charged to customers; (ii) reduction of earnings; (iii) refunds of amounts previously charged to customers; or (iv) expenses, or material omissions frominfrastructure expenditures, any applications, certifications, reports service quality or other submissions regulatory requirements, to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group domestic or foreign court, administrative, governmental or regulatory body, government official, consumer advocacy or similar organization, in prior product development efforts, submissions or reports to any Governmental Authority that each case which could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Productshave a Material Adverse Effect on Telco. (c) No member of the Seller Group: (i) Telco has made an untrue statement of material fact or fraudulent statement to the FDAnot transferred, United States Department of Agriculture (“USDA”) or sold any other Governmental Authority with respect to any product produced sold by any member of the Seller Groupinterest in, or (ii) has failed to disclose a material fact required to be disclosed to the FDAotherwise diluted its control over, USDA any federal or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any paymentstate regulatory licenses, gratuity certificates, approvals or other thing authorizations under which it operates, and the transfer of value that is prohibited by any Law such authorizations, subject to personnel of regulatory approval, would not violate the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted terms of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required agreement to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group which Telco is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement ordersor by which Telco is bound, or similar agreements with or imposed by impinge the rights of any Governmental Authoritythird party.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Except as disclosed on Schedule 5.21 hereto and except for billing disputes with customers arising in the ordinary course of business that in the Seller Group is in receipt of notice ofaggregate involve immaterial amounts, there are no proceedings or, to EXCEL's knowledge, investigations pending or, to EXCEL's knowledge, threatened, before any domestic or is subject to any investigationforeign court, adverse inspection observationadministrative, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled governmental or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities regulatory body in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that following matters are being considered which could reasonably be expected to give rise to have a Material Adverse Effect on EXCEL, nor has EXCEL or any of its Subsidiaries received written notice or inquiry from any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA body, government official, consumer advocacy or similar organization or any other applicable Governmental Authority private party, indicating that any of such matters should be considered or may become the Business Products object of consideration or components thereof is misbranded investigation which could reasonably be expected to have a Material Adverse Effect on EXCEL: (i) reduction of rates charged to customers; (ii) reduction of earnings; (iii) refunds of amounts previously charged to customers; or adulterated(iv) failure to meet any expense, infrastructure, service quality or other commitments previously made to or imposed by any administrative, governmental or regulatory body. (b) No member Except as disclosed on Schedule 5.21 hereto, neither EXCEL nor any of the Seller Group its Subsidiaries has made any false statements onoutstanding commitments (and no such obligations have been imposed upon EXCEL and remain outstanding) regarding (i) reduction of rates charged to customers; (ii) reduction of earnings; (iii) refunds of amounts previously charged to customers; or (iv) expenses, or material omissions frominfrastructure expenditures, any applications, certifications, reports service quality or other submissions regulatory requirements, to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group domestic or foreign court, administrative, governmental or regulatory body, government official, consumer advocacy or similar organization, in prior product development efforts, submissions or reports to any Governmental Authority that each case which could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Productshave a Material Adverse Effect on EXCEL. (c) No member of the Seller Group: (i) EXCEL has made an untrue statement of material fact or fraudulent statement to the FDAnot transferred, United States Department of Agriculture (“USDA”) or sold any other Governmental Authority with respect to any product produced sold by any member of the Seller Groupinterest in, or (ii) has failed to disclose a material fact required to be disclosed to the FDAotherwise diluted its control over, USDA any federal or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any paymentstate regulatory licenses, gratuity certificates, approvals or other thing authorizations under which it operates, and the transfer of value that is prohibited by any Law such authorizations, subject to personnel of regulatory approval, would not violate the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted terms of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required agreement to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group which EXCEL is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement ordersor by which EXCEL is bound, or similar agreements with or imposed by impinge the rights of any Governmental Authoritythird party.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Each of the Seller Group is in receipt of notice ofParties shall use commercially reasonable efforts to (and SPAC shall direct SPAC Sponsor to use commercially reasonable efforts to) take, or is subject cause to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial actionbe taken, or other compliance to do or enforcement action (“Regulatory Actions”)cause to be done, in each case relating all actions and things necessary or advisable to consummate and make effective as promptly as practicable the Business Products or to Transactions. Without limiting the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member generality of the Seller Groupforegoing, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding as promptly as practicable following the date of this Agreement, no the Parties shall make, and, if applicable, SPAC shall direct SPAC Sponsor to make, all filings, notices, waiver requests, applications and other submissions to any Governmental Entity (the “Required Regulatory Filings”) that are necessary or advisable in connection with all consents, approvals, orders, authorizations, clearances, licenses, waivers and exemptions that are necessary, proper or advisable to be obtained with respect to the Transactions (the “Required Regulatory Approvals”). The Parties shall promptly and in good faith respond to all information requested of them by any Governmental Entity in connection with such Required Regulatory Filings and otherwise reasonably cooperate in good faith with each other and such Governmental Entities in connection with the Required Regulatory Filings and obtaining the Required Regulatory Approvals. Each Party will (and SPAC shall direct SPAC Sponsor to) promptly furnish to the other Party such information and assistance as the other may reasonably request in connection with its preparation of any Required Regulatory Filings (including, in the case of SPAC, providing any required information concerning SPAC Sponsor) and will take all other commercially reasonable actions necessary or advisable to cause the expiration or termination of any applicable waiting periods with respect to any Required Regulatory Approval as soon as practicable. Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall promptly furnish to SPAC, and SPAC shall (and SPAC shall direct SPAC Sponsor to) promptly furnish to the Company, copies of any notices or substantive written communications received by such Party or any of its Affiliates from any Governmental Entity with respect to the Transactions, and each Party shall permit counsel to the other Party an opportunity to review in advance, and each Party shall consider in good faith the views of such counsel in connection with, any proposed written communications by such Party and/or its Affiliates to any Governmental Entity concerning the Transactions; provided that none of the Parties shall enter into any binding agreement with any Governmental Entity with respect to the Transactions without the written consent of the other Parties. To the extent not prohibited by any applicable Legal Requirement, the Company agrees to provide SPAC and its counsel, and SPAC agrees to provide the Company and its counsel (and, if applicable, to direct SPAC Sponsor to provide to the Company and its counsel), the opportunity, on reasonable advance notice, to participate in any substantive meetings or discussions, either in person or by telephone, between such Party and/or any of its Affiliates (including, in the case of SPAC, the SPAC Sponsor), agents or advisors, on the one hand, and any Governmental Entity, on the other hand, concerning or in connection with the Transactions. Each of the Company and SPAC may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 7.4(a) as “counsel only” and any such sensitive materials, as well as the information contained therein, shall be provided only to a receiving party’s outside and in-house counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the party supplying such materials or information. No Party shall (and SPAC shall direct SPAC Sponsor not to) willfully take any action that will have the effect of delaying, impairing or impeding in any material respect the receipt of any of the Required Regulatory Approvals. SPAC shall be responsible for any acts or omissions of SPAC Sponsor that are not in accordance with the terms of this Section 7.4(a). (b) As promptly as practicable (and in any event within ten (10) Business Product has been recalledDays) following the date hereof, whether voluntary the Company shall prepare and file with the ITA an application to receive the Merger Consideration Tax Ruling and the Capital Restructuring Tax Ruling (the “Specified Tax Approvals”). The Company shall use commercially reasonable efforts to obtain the Specified Tax Approvals. SPAC and the Company shall reasonably cooperate with each other with respect to obtaining the Specified Tax Approvals. Without limiting the generality of the foregoing, the Company and SPAC and their respective Israeli counsels shall cooperate with respect to all filings, notices, waiver requests, applications and other submissions to the ITA that are necessary or advisable in connection with the Specified Tax Approvals (the “Specified Filings”). Each Party will (and SPAC shall direct SPAC Sponsor to) promptly furnish to the other Party such information and assistance as such other Party may reasonably request in connection with its preparation of any Specified Filings (including by providing any required information concerning SPAC Sponsor). For the avoidance of doubt, the Company shall not file any Specified Filings without first consulting with SPAC’s Israeli counsel and granting it the opportunity to review, comment on and approve such filing. The Company shall keep the SPAC and its Israeli counsel reasonably updated of any discussions, meetings, significant conference calls, material correspondences and any exchange of drafts with the ITA relating to the Specified Filings or the Specified Tax Approvals. In connection with obtaining any Specified Tax Approval, each of the Company and SPAC may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 7.4(b) as “counsel only” and any such sensitive materials, as well as the information contained therein, shall be provided only to a receiving party’s outside and in-house counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the party supplying such materials or information. No Party shall (and SPAC shall direct SPAC Sponsor not to) willfully take any action that will have the effect of delaying, impairing or impeding in any material respect the receipt of any of the Specified Tax Approvals. The final text of the Specified Tax Approvals shall be subject to the approval of SPAC, if such Specified Tax Approval includes any condition, restriction, obligation or liability applicable to any SPAC Party; provided, however, that SPAC may not withhold its approval with respect to the Merger Consideration Tax Ruling on the ground that such ruling (i) does not specify that any SPAC Shareholder that was a shareholder of SPAC prior to the initial public offering of SPAC or that is a 5% Holder is not subject to Israeli tax with respect to any portion of the Trust Account, the Merger Consideration or the Company Warrants payable or otherwise and no member deliverable pursuant to this Agreement, by virtue of Section 104H of the Seller Group has received noticeOrdinance, or (ii) does not provide an exemption from withholding with respect to any portion of the Trust Account, the Merger Consideration or the Company Warrants payable or otherwise deliverable to any SPAC Shareholder that was a shareholder of SPAC prior to the initial public offering of SPAC or that is a 5% Holder. If either completed the Merger Consideration Tax Ruling or pendingthe Capital Restructuring Tax Ruling is obtained, the Company shall promptly provide to SPAC a copy of such Merger Consideration Tax Ruling or the Capital Restructuring Tax Ruling, as applicable, including a copy of any executed consent letter delivered to the ITA in accordance with the provisions of such Merger Consideration Tax Ruling or the Capital Restructuring Tax Ruling, as applicable. If the Capital Restructuring Tax Ruling is not timely obtained, the Parties shall cooperate in good faith to effectuate the alternative Capital Restructuring as set forth in Section 7.4(b) of the Company Disclosure Letter. (c) In connection with the Transactions contemplated hereby, each of the Company and SPAC shall (and, to the extent required, shall cause its Affiliates to) comply promptly but in no event later than ten (10) Business Days after the date hereof with the notification and reporting requirements of the HSR Act. Each of the Company and SPAC shall substantially comply with any Antitrust Information or Document Requests. Each of the Company and SPAC shall (and, to the extent required, shall cause its Affiliates to) request early termination of any waiting period under the HSR Act (unless any announcement from the applicable Governmental Entities to the effect that early termination of any waiting period under the HSR Act is temporarily suspended remains in effect) and exercise its commercially reasonable efforts to (i) obtain termination or expiration of the waiting period under the HSR Act and (ii) prevent the entry, in any Legal Proceeding brought by an Antitrust Authority or any other Person, of any proceeding seeking a recallOrder which would prohibit, removalmake unlawful or delay the consummation of the Transactions contemplated hereby. (d) Nothing in this Section 7.4 obligates any Party or any of its Affiliates to agree to (i) sell, license or otherwise dispose of, or corrective action hold separate and agree to sell, license or otherwise dispose of, any entities, assets or facilities of any Business ProductGroup Company or any entity, facility or asset of such Party or any of its Affiliates, (ii) terminate, amend or assign existing relationships and contractual rights or obligations, (iii) amend, assign or terminate existing licenses or other agreements, or (iv) enter into new licenses or other agreements. No member Party shall agree to any of the Seller Group has filed a report under foregoing measures with respect to any other Party or any of its Affiliates, except with SPAC’s and the FDACompany’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no factsprior written consent. (e) Any filing fees required by Governmental Entities, including product quality complaints that would with respect to the Required Regulatory Approvals, any Specified Tax Approval or any registrations, declarations and filings required in connection with the execution and delivery of this Agreement, the performance of the obligations hereunder and the consummation of the Transactions, shall be reasonably likely to result in a voluntary or mandatory product recall or expansion of recallborne fifty percent (50)% by SPAC and fifty percent (50)% by the Company. (f) No member of Without limiting the Seller Group is a party Parties’ obligations under this Section 7.4, in the event that SPAC and the Company disagree, with respect to matters relating to the Required Regulatory Filings, Required Regulatory Approvals, Specified Tax Approvals, Specified Filings, the HSR Act or any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements filing with or imposed by any Governmental AuthorityEntity, the Company’s decision shall control so long as such decision does not result in a disproportionately adverse effect on SPAC or SPAC Parties.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Each of the Seller Group is in receipt of notice ofParties shall use commercially reasonable efforts to take, or is subject cause to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial actionbe taken, or other compliance to do or enforcement action (“Regulatory Actions”)cause to be done, in each case relating all actions and things necessary or advisable to consummate and make effective as promptly as practicable the Business Products or to Transactions. Without limiting the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member generality of the Seller Groupforegoing, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding as promptly as practicable following the date of this Agreement, no Business Product has been recalledthe Parties shall make all filings, whether voluntary notices, waiver requests, applications and other submissions, other than any Specified Filing, to any Governmental Entity (the “Required Regulatory Filings”) that are necessary or advisable in connection with all consents, approvals, orders, authorizations, clearances, licenses, waivers and exemptions, other than any Specified Governmental Approvals, that are necessary, proper or advisable to be obtained with respect to the Transactions (the “Required Regulatory Approvals”). The Parties shall promptly and in good faith respond to all information requested of them by any Governmental Entity in connection with such Required Regulatory Filings and otherwise reasonably cooperate in good faith with each other and no member such Governmental Entities in connection with the Required Regulatory Filings and obtaining the Required Regulatory Approvals. Each Party will promptly furnish to the other Party such information and assistance as the other may reasonably request in connection with its preparation of any Required Regulatory Filings and will take all other commercially reasonable actions necessary or advisable to cause the expiration or termination of any applicable waiting periods with respect to any Required Regulatory Approval as soon as practicable. Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall promptly furnish to SPAC, and SPAC shall promptly furnish to the Company, copies of any notices or substantive written communications received by such Party or, to the knowledge of such Party, any of its Related Parties from any Governmental Entity with respect to the Transactions, and each Party shall permit counsel to the other Party an opportunity to review in advance, and each Party shall consider in good faith the views of such counsel in connection with, any proposed written communications by such Party and/or, to the knowledge of such Party, its Related Parties to any Governmental Entity concerning the Transactions; provided that none of the Seller Group has received notice, either completed or pending, of Parties shall enter into any proceeding seeking a recall, removal, or corrective action of agreement with any Business Product. No member Governmental Entity with respect to the Transactions without the written consent of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business ProductParties. To the Sellers’ Knowledgeextent not prohibited by any applicable Legal Requirement, there are no factsthe Company agrees to provide SPAC and its counsel, including product quality complaints and SPAC agrees to provide the Company and its counsel, the opportunity, on reasonable advance notice, to participate in any substantive meetings or discussions, either in person or by telephone, between such Party and/or, to the knowledge of such Party, any of its Related Parties, agents or advisors, on the one hand, and any Governmental Entity, on the other hand, concerning or in connection with the Transactions. Each of the Company and SPAC may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 7.4(a) as “counsel only” and any such sensitive materials, as well as the information contained therein, shall be provided only to a receiving party’s outside and in-house counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the party supplying such materials or information. No Party shall willfully take any action that would be reasonably likely to result will have the effect of delaying, impairing or impeding in a voluntary or mandatory product recall or expansion any material respect the receipt of recallany of the Required Regulatory Approvals. (fb) No member The Company shall use commercially reasonable efforts to obtain from the ITA the Merger Consideration Tax Ruling and the Price Adjustment Right Tax Ruling (collectively, the “Specified Governmental Approvals”). SPAC shall reasonably cooperate with the Company with respect to obtaining the Specified Governmental Approvals. Without limiting the generality of the Seller Group is a party foregoing, as promptly as practicable following the date of this Agreement, the Company shall make all filings, notices, waiver requests, applications and other submissions to the ITA that have not been made prior to the execution of this Agreement and that are necessary or advisable in connection with the Specified Governmental Approvals (the “Specified Filings”). SPAC will promptly furnish to the Company such information and assistance as the Company may reasonably request in connection with its preparation of any Specified Filings (including by providing any required information concerning SPAC Sponsor). Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall promptly furnish to SPAC, and SPAC shall promptly furnish to the Company, copies of any notices or substantive written communications received by such Party or any of its Affiliates from any Governmental Entity with respect to the Specified Governmental Approvals, and each Party shall permit counsel to the other Party an opportunity to review in advance, and each Party shall consider in good faith the views of such counsel in connection with, any proposed written communications by such Party and/or its Affiliates to any corporate integrity Governmental Entity concerning the Specified Governmental Approvals, other than any such communications made prior to the execution of this Agreement. Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall keep the SPAC reasonably apprised of the progress with respect to obtaining the Specified Governmental Approvals. In connection with obtaining any Specified Governmental Approval, each of the Company and SPAC may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 7.4(b) as “counsel only” and any such sensitive materials, as well as the information contained therein, shall be provided only to a receiving party’s outside and in-house counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the party supplying such materials or information. No Party shall willfully take any action that will have the effect of delaying, impairing or impeding in any material respect the receipt of any of the Specified Governmental Approvals. (c) Nothing in this Section 7.4 obligates any Party or any of its Affiliates to agree to (i) sell, license or otherwise dispose of, or hold separate and agree to sell, license or otherwise dispose of, any entities, assets or facilities of any Group Company or any entity, facility or asset of such Party or any of its Affiliates, (ii) terminate, amend or assign existing relationships and contractual rights or obligations, (iii) amend, assign or terminate existing licenses or other agreements, monitoring or (iv) enter into new licenses or other agreements. No Party shall agree to any of the foregoing measures with respect to any other Party or any of its Affiliates, consent decreesexcept with SPAC’s and the Company’s prior written consent. (d) Any filing fees required by Governmental Entities, settlement ordersincluding with respect to the Required Regulatory Approvals, any Specified Governmental Approval or similar agreements any registrations, declarations and filings required in connection with or imposed the execution and delivery of this Agreement, the performance of the obligations hereunder and the consummation of the Transactions, shall be borne fifty percent (50%) by any Governmental Authoritythe Company and fifty percent (50%) by SPAC.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member The Group Companies have obtained any and all Government Approvals required to be obtained on or prior to the Closing and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary in respect the Group Companies and their operations. All such filings and registrations with applicable Governmental Authorities required in respect of the Seller Group is in receipt Companies, including but not limited to the registrations with the Ministry of notice of, Commerce (or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”predecessors), the State Administration of Industry and Commerce, SAFE, the Ministry of Industry and Information Technology, the Ministry of Culture, the General Administration for Press and Publication, the State Administration for Radio, Film and Television, tax bureau, customs authorities and the local counterparts of each of such Governmental Authorities, as applicable, have been duly completed in each case relating to the Business Products accordance with applicable Law. No Group Company has received any letter or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by notice from any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf Authorities notifying it of the revocation of any member Government Approval issued to it or the need for compliance or remedial actions in respect of the Seller Group, activities carried out directly or alleging indirectly by any Group Company. Each Group Company has been conducting its business activities within the permitted scope of business or is otherwise operating its businesses in full compliance with all relevant Laws and Governmental Orders. No Group Company has reason to believe that any member authorization of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, license or that there are circumstances currently existing permit requisite for the conduct of any part of its business which might reasonably is subject to periodic renewal will not be expected to lead to any loss of granted or refusal to renew any of renewed by the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable relevant Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulteratedAuthorities. (b) No member Except as set forth in Section 3.8(b) of the Seller Group Disclosure Schedule, each of the PRC Subsidiary and Sogou Information upon its formation has made obtained any false statements oncertificates, approvals, permits, licenses, registration receipts and any similar authority necessary under PRC Laws to conduct foreign exchange transactions (collectively, the “Foreign Exchange Authorization”) as now being conducted by it, the lack of which could cause a Material Adverse Effect, and believes it can obtain, without undue burden or material omissions fromexpense, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with such Foreign Exchange Authorization for the requirements conduct of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required foreign exchange transactions as planned to be disclosed to conducted. All existing Foreign Exchange Authorization held by the FDAPRC Subsidiary and Sogou Information upon its formation are valid, USDA or and the PRC Subsidiary and Sogou Information upon its formation is not in default in any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime material respect under any applicable Laws; (iii) while acting in of such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption LawExchange Authorization. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No Xxxx Capital Corporation (the “Broker”) is, and has been at all times since January 1, 2014, registered as a broker-dealer with the SEC under the Exchange Act, and is, and has been since January 1, 2014, in compliance in all material respects with the applicable requirements of the Exchange Act and the rules thereunder, including all applicable net capital requirements and requirements for the protection of customer funds and securities. (b) The Broker is, and has been at all times since January 1, 2014 registered, licensed or qualified as a broker-dealer in each jurisdiction where the conduct of its business requires such registration, licensing or qualification. (c) A true and complete copy of the Uniform Application for Broker-Dealer Registration on Form BD of the Broker on file with the SEC, reflecting all amendments thereof filed with the Central Registration Depository of FINRA prior to the date of this Agreement (the “Form BD”) has been Made Available to Xxxxxxxxx. (x) Seller has Made Available to Purchaser true and complete copies of all examination reports and correspondence with Governmental Authorities related thereto with respect to any examination of the Company or any of the Purchased Subsidiaries conducted by any Governmental Authority since January 1, 2014. To the Knowledge of Seller, any issues raised with respect to any examination of the Company or any of the Purchased Subsidiaries conducted by any Governmental Authority prior to such date have been addressed, other than any such issues that would not, individually or in the aggregate, reasonably be expected to be material to the Acquired Pro Forma Entities, taken as a whole. (e) The Broker is, and has been at all times since January 1, 2014, a member of FINRA and the Seller Group Securities Investor Protection Corporation (the “SIPC”), and is, and has been at all times since January 1, 2014, in compliance in all material respects with all applicable rules and regulations of FINRA and the SIPC, as well as with the terms of its membership agreement with FINRA, including all net capital requirements and requirements with respect to the protection of customer funds and securities. The Company has Made Available to Purchaser prior to the date of this Agreement a current version of the Broker’s membership agreement with FINRA, and FINRA has not notified in writing Seller, the Company or the Broker since January 1, 2014 of any intent to terminate or materially modify such membership agreement. The Broker (i) is not, and is not required to be, a member of any domestic or foreign securities broker-dealer self-regulatory organization other than FINRA and (ii) is duly registered as a broker-dealer under, and in material compliance with, the Laws of all jurisdictions in which it is required to be so registered. (f) The Broker (i) has established, maintains and enforces written compliance, supervisory and control policies and procedures reasonably designed to ensure compliance with Applicable Laws, including those relating to anti-money laundering, advertising, licensing, sales practices, market conduct, maintenance of net capital, supervision, books and records, risk assessment and continuing education (the “Compliance Policies”), and (ii) has been and remains in compliance in all material respects with such Compliance Policies. (g) Each of the Broker’s officers, employees and independent contractors who is required to be registered, licensed or qualified with any Governmental Authority as a registered principal or registered representative is registered, licensed or qualified as such and no such registration, license or qualification is currently under an order of suspension, or the person is in receipt the process of notice ofbeing registered, licensed or qualified as such within the time periods required or permitted by Applicable Law, except for such failures to be so registered as would not, individually or in the aggregate, reasonably be expected to be material to the Acquired Pro Forma Entities, taken as a whole. (h) Since January 1, 2014, the Broker has not engaged in any activities that would be a material business change from the business activities enumerated in any membership agreements or other limitations imposed in connection with its registrations. (i) Except for routine examinations conducted by the SEC, FINRA or any other Governmental Authority in the regular course of the business of the Broker, neither the Broker nor any of its directors, managers, officers, employees, registered representatives nor, to the Knowledge of Seller, any “person associated with” (as such phrase is defined in the Exchange Act) the Broker is the subject of any unresolved civil or administrative proceedings or any Order arising under Applicable Laws which, in each case, would be required to be disclosed on Form BD or Forms U-4 or U-5 that are not so disclosed on such Form BD or Forms U-4 or U-5, and that are, in each case, currently pending against the Broker or, to the Knowledge of Seller, threatened against the Broker or pending or threatened in writing against the other Persons referred to above. Except as disclosed on the Form BD or Forms U-4 or U-5, neither the Broker nor any of its directors, managers, officers, employees, registered representatives or any “person associated with” the Broker (i) has been permanently enjoined by any Order from engaging or continuing any conduct or practice in connection with any activity or in connection with the purchase or sale of any security, or (ii) is ineligible to serve as a broker or a “person associated with” a broker under Section 15(b) of the Exchange Act. (j) Neither the Company nor any of the Purchased Subsidiaries is subject to any cease-and-desist or other Order or enforcement action issued by, or is party to any written agreement, consent agreement or memorandum of understanding with, or is party to any commitment letter or similar undertaking to, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled Order or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial actiondirective by, or other compliance since January 1, 2014 has been ordered to pay any civil penalty by, or enforcement action is a recipient of any supervisory letter from, or has adopted a board or manager resolution at the request or suggestion of, any Governmental Authority that materially restricts the conduct of its business (in each case, as currently in effect or pending, a “Regulatory ActionsAgreement”), in each case relating to nor has the Business Products Company or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller GroupPurchased Subsidiaries been advised in writing since January 1, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action 2014 by any Governmental AuthorityAuthority that it is considering issuing or requesting any such Regulatory Agreement. (k) Since January 1, 2014, the Broker has timely filed all reports, registrations, declarations, notices, statements, and other filings, together with any amendments and updates required to be made with respect thereto, that were required to be filed with any Governmental Authority (including the SEC and FINRA), including all reports, registrations, declarations, notices, statements and filings required under the Exchange Act, except for such filings which the failure to make or that there are circumstances currently existing which might to make timely would not reasonably be expected to lead be material to the Acquired Pro Forma Entities, taken as a whole. As of their respective dates, all such reports, registrations, declarations, notices, statements and other filings complied in all material respects with the Laws enforced or promulgated by the Governmental Authority with which they were filed. Except for normal examinations conducted in the regular course of the business of the Broker, to the Knowledge of Seller, no Governmental Authority has initiated since January 1, 2014 any loss proceeding or investigation into the business or operations of the Broker, the Company, or refusal to renew any of the Regulatory Licenses held their then current respective employees, agents, brokers or representatives. There is no unresolved investigation of any suspected violation by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by report or statement relating to any member examination of the Seller GroupBroker, other than any such violations that would not, individually or (ii) has failed to disclose a material fact required in the aggregate, reasonably be expected to be disclosed material to the FDAAcquired Pro Forma Entities, USDA or any other Governmental Authoritytaken as a whole. (dl) No member To the Knowledge of Seller, there are no unresolved material customer complaints, including those reportable to FINRA pursuant to FINRA Rule 4530 or on any Form U-4, which were made since January 1, 2014 against the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA Broker or any other Governmental Authority or any other Person; (ii) has been convicted “person associated with” the Broker. As of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalledmaterial customer complaints reportable pursuant to FINRA Rule 4530 or on Form U-4 are pending or, whether voluntary or otherwise and no member to the Knowledge of the Seller Group has received noticeSeller, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recallthreatened. (fm) No member Neither the Company nor any of the Seller Group Purchased Subsidiaries is registered or required to be registered as an “investment company” within the meaning of the Investment Company Act. (n) Neither the Company nor any of the Purchased Subsidiaries is registered or required to be registered as an investment adviser under the Investment Advisers Act of 1940, as amended. (o) None of the activities of the Broker requires it to be registered as an exchange or transfer agent, a party clearing agency, an alternative trading system, a government securities dealer, a commodity trading advisor or commodity pool operator. (p) Since January 1, 2014, each of the Company NLRs has filed or furnished with the SEC all forms, reports, schedules, statements and documents (including exhibits and all other information incorporated therein) that were required to be filed or furnished by it under the Securities Act or the Exchange Act, as the case may be, from and after such date (collectively, and as amended, modified or supplemented since the time of filing, the “NLR SEC Filings”). Each NLR SEC Filing (i) as of its date, or, if amended or supplemented prior to the date of this Agreement or the Closing Date, as of the date of the most recent amendment or supplement thereto (and, in the case of registration statements and proxy statements, on the dates of effectiveness and the dates of the relevant meetings, respectively), complied in all material respects as to form with the requirements of the Securities Act, the Exchange Act or the Xxxxxxxx-Xxxxx Act of 2002, as amended, as the case may be, and the rules and regulations of the SEC promulgated thereunder applicable to the NLR SEC Filings, and (ii) did not, at the time it was filed or furnished (or became effective), or, if amended or supplemented prior to the date of this Agreement or the Closing Date, as of the date of the most recent amendment or supplement thereto, contain any corporate integrity agreementsuntrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements made therein, monitoring agreementsin the light of the circumstances under which they were made, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authoritynot misleading.

Certain Regulatory Matters. Except as set forth on Section 2.24 of (i) Dermavant currently holds or has the Disclosure Schedules: (a) No member of right to acquire all applicable approvals and authorizations from Governmental Authorities necessary for Dermavant to conduct its business in the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities manner in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities such business is being conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business ProductsProduct, including the Development, manufacture and testing of the Product, and all such approvals and authorizations are in good standing and in full force and effect. None of Dermavant, its Controlled Affiliates, or Parent have received any written notice or any other communication from any Governmental Authority regarding any actual or possible revocation, withdrawal, suspension, cancellation, termination, or material modification of any such approvals or authorizations. (cii) No member None of the Seller Group: (i) has Dermavant, its Controlled Affiliates, or Parent have knowingly made an any untrue statement of a material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) any Regulatory Authority or any other Governmental Authority with respect to any product produced sold by any member of the Seller GroupAuthority, or (ii) has failed to disclose a material fact required to be disclosed to any Regulatory Authority or other Governmental Authority, or committed an act, made a statement or failed to make a statement, that provides or would reasonably be expected to provide a basis for the FDA or other Governmental Authority to invoke the FDA’s policy respecting “Fraud, USDA Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy of any other Governmental Authority. (diii) Dermavant is not and has never been, Parent is not and has never been, and, to Dermavant’s knowledge and Parent’s knowledge, none of Dermavant’s Controlled Affiliates have or have ever been, (A) debarred by a Governmental Authority, (B) a party to a settlement, consent or similar agreement with a Governmental Authority regarding the Product, or (C) charged with, or convicted of, violating Applicable Law regarding the Product. (iv) The Product is being, and, to Dermavant’s knowledge and Parent’s knowledge, at all times has been, Developed, tested, manufactured, labeled, and stored in compliance in all material respects with all Applicable Laws, including with respect to investigational use, good clinical practices, good laboratory practices, good manufacturing practices, record keeping, security, and filing of reports. (v) The Product has never been the subject of or subject to (as applicable) any recall, suspension, market withdrawal, seizure, warning letter, other written communication asserting lack of compliance with any Applicable Law in any material respect, or serious adverse event. No member clinical trial of the Seller Group: (i) Product has made been suspended, put on hold or offered terminated prior to completion as a result of any payment, gratuity or other thing of value that is prohibited action by any Law to personnel of the FDA, USDA Regulatory Authority or any other Governmental Authority or voluntarily. To Dermavant’s knowledge and to Parent’s knowledge, no event has occurred or circumstance exists that is reasonably likely to give rise to or serve as a basis for any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); foregoing events. (vi) discovered Dermavant has, with respect to the Product and Program, made available to NovaQuest true and complete copies of all material pre-clinical and clinical data, reports and analyses, all material correspondence with the FDA, material interim analysis from ongoing trials, material tables from recently completed clinical trials where no clinical study report is available, and any potential other information that is material to the Development or actual violation Commercialization of the FCPA or any other applicable anti-corruption Law; Product. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. (vii) None of Dermavant, its Controlled Affiliates, or Parent have received any adverse written communication notice from any Governmental Authority alleging that any member regarding the approvability or approval of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption LawProduct. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Subject to the terms and conditions set forth in this Agreement, each of the Seller Group is in receipt of notice ofParties shall use its reasonable best efforts to take, or is subject cause to any investigationbe taken, adverse inspection observationall actions, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial actionand to do, or other compliance cause to be done, all things reasonably necessary, proper or enforcement action (“Regulatory Actions”)advisable to, in each the case relating to of DWM, submit, make or obtain, as applicable, the Business Products or to DWM Required Regulatory Approvals, and, in the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member case of the Seller GroupICLK Parties, submit, make or alleging that any member of obtain, as applicable, the Seller Group was or is ICLK Required Regulatory Approvals, and use its reasonable best efforts to assist and cooperate with the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of other Parties in the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulteratedforegoing efforts. (b) No member With respect to all approvals, authorizations, consents, orders, filings, registrations or notifications under applicable Legal Requirements (including those relating to competition, merger control, antitrust and foreign investment (including national security in relation to foreign investment)) in connection with the execution, delivery and performance of the Seller Group has made any false statements onTransaction Documents and the Transactions contemplated thereunder, or material omissions fromincluding the ICLK Required Regulatory Approvals and the DWM Required Regulatory Approvals, any applicationseach Party shall, certificationssubject to applicable Legal Requirements including applicable confidentiality obligations, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development effortsuse reasonable endeavours to, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement timely furnish to the FDAsuch other Party such necessary information and reasonable assistance as such other Party may reasonably request in connection with its preparation of, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Groupapplication for, or carrying out of (as the case may be), any such approval, authorization, consent, order, filing, registration or notification and (ii) has failed to disclose a material fact required to be disclosed to keep the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted Party timely and reasonably informed of any crime under developments, meetings or discussions with any applicable Laws; Governmental Entity in respect of any such approval, authorization, consent, order, filing, registration or notification (iii) while acting in such capacityor the status thereof, is considered a restricted individual under as the Perishable Agricultural Commodities Act (“PACA”case may be), has been required to post a surety bond in connection with a bankruptcy proceedingincluding the ICLK Required Regulatory Approval or the DWM Required Regulatory Approval, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Lawas applicable. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Each of the Seller Group is in receipt of notice ofParties shall use commercially reasonable efforts to take, or is subject cause to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial actionbe taken, or other compliance to do or enforcement action (“Regulatory Actions”)cause to be done, in each case relating all actions and things necessary or advisable to consummate and make effective as promptly as practicable the Business Products or to Transactions. Without limiting the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member generality of the Seller Groupforegoing, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding as promptly as practicable following the date of this Agreement, no Business Product has been recalledthe Parties shall make all filings, whether voluntary notices, waiver requests, applications and other submissions, other than any Specified Filing, to any Governmental Entity (the “Required Regulatory Filings”) that are necessary or advisable in connection with all consents, approvals, orders, authorizations, clearances, licenses, waivers and exemptions, other than any Specified Governmental Approvals, that are necessary, proper or advisable to be obtained with respect to the Transactions (the “Required Regulatory Approvals”). The Parties shall promptly and in good faith respond to all information requested of them by any Governmental Entity in connection with such Required Regulatory Filings and otherwise reasonably cooperate in good faith with each other and no member such Governmental Entities in connection with the Required Regulatory Filings and obtaining the Required Regulatory Approvals. Each Party will promptly furnish to the other Party such information and assistance as the other may reasonably request in connection with its preparation of any Required Regulatory Filings and will take all other commercially reasonable actions necessary or advisable to cause the expiration or termination of any applicable waiting periods with respect to any Required Regulatory Approval as soon as practicable. Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall promptly furnish to SPAC, and SPAC shall promptly furnish to the Company, copies of any notices or substantive written communications received by such Party or any of its Affiliates from any Governmental Entity with respect to the Transactions, and each Party shall permit counsel to the other Party an opportunity to review in advance, and each Party shall consider in good faith the views of such counsel in connection with, any proposed written communications by such Party and/or its Affiliates to any Governmental Entity concerning the Transactions; provided that none of the Seller Group has received notice, either completed or pending, of Parties shall enter into any proceeding seeking a recall, removal, or corrective action of agreement with any Business Product. No member Governmental Entity with respect to the Transactions without the written consent of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business ProductParties. To the Sellers’ Knowledgeextent not prohibited by any applicable Legal Requirement, there are no factsthe Company agrees to provide SPAC and its counsel, including product quality complaints and SPAC agrees to provide the Company and its counsel, the opportunity, on reasonable advance notice, to participate in any substantive meetings or discussions, either in person or by telephone, between such Party and/or any of its Affiliates, agents or advisors, on the one hand, and any Governmental Entity, on the other hand, concerning or in connection with the Transactions. Each of the Company and SPAC may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 7.4(a) as “counsel only” and any such sensitive materials, as well as the information contained therein, shall be provided only to a receiving party’s outside and in-house counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the party supplying such materials or information. No Party shall willfully take any action that would be reasonably likely to result will have the effect of delaying, impairing or impeding in a voluntary or mandatory product recall or expansion any material respect the receipt of recallany of the Required Regulatory Approvals. (fb) No member The Company shall use commercially reasonable efforts to obtain from the ITA the Merger Consideration Tax Ruling, the Tender-Offer Tax Ruling and the Price Adjustment Right Tax Ruling (collectively, the “Specified Governmental Approvals”). SPAC shall reasonably cooperate with the Company with respect to obtaining the Specified Governmental Approvals. Without limiting the generality of the Seller Group is a party foregoing, as promptly as practicable following the date of this Agreement, the Company shall make all filings, notices, waiver requests, applications and other submissions to the ITA that have not been made prior to the execution of this Agreement and that are necessary or advisable in connection with the Specified Governmental Approvals (the “Specified Filings”). SPAC will promptly furnish to the Company such information and assistance as the Company may reasonably request in connection with its preparation of any Specified Filings (including by providing any required information concerning SPAC Sponsors). Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall promptly furnish to SPAC, and SPAC shall promptly furnish to the Company, copies of any notices or substantive written communications received by such Party or any of its Affiliates from any Governmental Entity with respect to the Specified Governmental Approvals, and each Party shall permit counsel to the other Party an opportunity to review in advance, and each Party shall consider in good faith the views of such counsel in connection with, any proposed written communications by such Party and/or its Affiliates to any corporate integrity Governmental Entity concerning the Specified Governmental Approvals, other than any such communications made prior to the execution of this Agreement. Unless prohibited by any applicable Legal Requirement or Governmental Entity, the Company shall keep the SPAC reasonably apprised of the progress with respect to obtaining the Specified Governmental Approvals. In connection with obtaining any Specified Governmental Approval, each of the Company and SPAC may, as they deem necessary, designate any sensitive materials to be exchanged in connection with this Section 7.4(b) as “counsel only” and any such sensitive materials, as well as the information contained therein, shall be provided only to a receiving party’s outside and in-house counsel (and mutually-acknowledged outside consultants) and not disclosed by such counsel (or consultants) to any employees, officers, or directors of the receiving party without the advance written consent of the party supplying such materials or information. No Party shall willfully take any action that will have the effect of delaying, impairing or impeding in any material respect the receipt of any of the Specified Governmental Approvals. (c) Nothing in this Section 7.4 obligates any Party or any of its Affiliates to agree to (i) sell, license or otherwise dispose of, or hold separate and agree to sell, license or otherwise dispose of, any entities, assets or facilities of any Group Company or any entity, facility or asset of such Party or any of its Affiliates, (ii) terminate, amend or assign existing relationships and contractual rights or obligations, (iii) amend, assign or terminate existing licenses or other agreements, monitoring or (iv) enter into new licenses or other agreements. No Party shall agree to any of the foregoing measures with respect to any other Party or any of its Affiliates, consent decreesexcept with SPAC’s and the Company’s prior written consent. (d) Any filing fees required by Governmental Entities, settlement ordersincluding with respect to the Required Regulatory Approvals, any Specified Governmental Approval or similar agreements any registrations, declarations and filings required in connection with or imposed the execution and delivery of this Agreement, the performance of the obligations hereunder and the consummation of the Transactions, shall be borne entirely by any Governmental Authoritythe Company.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member The Company has conducted, and is conducting, its business in compliance with all applicable rules and regulations including, without limitation, applicable portions of the Seller Group is in receipt of notice ofFD&C Act, or is subject to any investigationthe PHSA, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any and applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member similar laws outside of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulteratedUnited States. (b) No member of (i) the Seller Group Company has made any false statements onobtained all consents, or material omissions fromclearances, any applicationsapprovals, certifications, reports authorizations, licenses and permits of, and has made all material filings with, or other submissions notifications to, all Regulatory Authorities pursuant to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental all Regulatory Authority relating regulations, and all material applicable Legal Requirements, including all consents, clearances, approvals, certifications, authorizations, licenses, and permits to permit the Business Products. There has not been any violation of any laws by any member design, development, testing, and manufacture of the Seller Group Company Product in prior product development effortsjurisdictions where it currently conducts such activities, submissions or reports to (ii) all representations made by the Company in connection with any Governmental Authority that could reasonably be expected to require investigationsuch consents, corrective action or enforcement action by any member of clearances, approvals, certifications, authorizations, licenses, permits, filings and notifications were true and correct in all material respects at the Seller Group with respect to the Business Productstime such representations and warranties were made. (c) No member Neither the Company nor, to the Company’s Knowledge, any officer, employee or agent of the Seller Group: (i) Company, has made an untrue statement of a material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) any Regulatory Authority or any other Governmental Authority with respect to any product produced sold by any member of the Seller GroupEntity, or (ii) has failed to disclose a material fact required to be disclosed to any Regulatory Authority or other Governmental Entity, or committed an act, made a statement, or failed to make a statement that, at the FDAtime such disclosure was made, USDA would reasonably be expected to provide a basis for any Regulatory Authority or other Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any other Governmental Authoritysimilar law outside of the United States. (d) No member To the Company’s Knowledge, the Company has not used in any capacity the services of any Persons debarred under any country’s debarment provisions, including, but not limited to, subsections 306(a) or 306(b) of the Seller Group: (i) has made Generic Drug Enforcement Act of 1992, disqualified as a testing facility under CFR Part 58, subpart K, or offered disqualified as a clinical investigator under 21 CFR 312.70, in connection with any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDAservices performed by Company or its contractors. To the Company’s Knowledge, USDA there are no pending or threatened actions, suits, claims, investigations or legal or administrative proceedings relating to the debarment or disqualification of any Person performing any services for Company. Neither the Company nor, to the Company’s Knowledge, any officer, employee or agent of the Company or any other Governmental Authority or any other Person; (ii) of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in the federal health care programs under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision Section 1128 of the U.S. Foreign Corrupt Practices Social Security Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other similar applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption LawLegal Requirement. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of With respect to the Disclosure SchedulesBusiness: (a) No member Section 3.12(a) of the Seller Group Disclosure Letter sets forth a complete and accurate list of all Regulatory Filings and all material written communications between the Seller, on the one hand, and the FDA or any other Governmental Entity, on the other hand, and all written summaries of material discussions between any such parties. Seller has made available to Purchaser copies of all such documents. (b) Seller has filed with the FDA and all applicable state, local and foreign regulatory bodies for, and received approval of, all Regulatory Filings and all other registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the Business as currently conducted and as currently proposed to be conducted. Seller is and has been in compliance in all material respects with all such Regulatory Filings, registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Seller is and has been in compliance in all material respects with all FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, FDA, state, local and foreign rules, regulations, guidelines and policies relating to good manufacturing practice (“GMP”) and good laboratory practice (“GLP”). Seller has no reason to believe that any party granting any such Regulatory Filing, registration, application, license, request for exemption, permit or other regulatory authorization is considering terminating, limiting, suspending, revoking, canceling, rescinding, refusing to renew in the ordinary course or modifying the same and knows of no basis for any such action. (c) Seller is in receipt of notice ofcompliance in all material respects with all obligations arising under any consent decree, or is subject to any investigationconsent agreement, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, Form 483 issued by or entered into with the FDA form 483or other notice, safety alertresponse or commitment made to the FDA or any comparable state, mandatory local or voluntary recall, other reportable corrective foreign Governmental Entity. (d) Seller has disclosed to Purchaser any warning letters or remedial actionForm 483s or similar notices, or other compliance or enforcement action (“Regulatory Actions”), in each case correspondence relating to the Business Products or to the facilities in which the Business Products are preparedSeller’s compliance status under applicable legal requirements, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable comparable state, local or foreign Governmental Authority indicating that any of Entity within the Business Products or components thereof is misbranded or adulteratedlast three years. (be) No member Neither Seller nor, to Seller’s knowledge, any of the Seller Group its officers, employees, independent contractors or agents has knowingly committed any act, made any false statements on, statement or material omissions from, failed to make any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority statement that could would reasonably be expected to require investigationprovide a basis for the FDA to invoke its policy respecting “Fraud, corrective action or enforcement action by Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any member of the Seller Group with respect to the Business Productsamendments thereto. (cf) No member Neither Seller nor, to Seller’s knowledge, any of the Seller Group: (i) has made an untrue statement of material fact its officers, employees, independent contractors or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) agents has been convicted of any crime or engaged in any conduct which could result in debarment under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA 21 U.S.C. § 335a or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Groupsimilar state, local or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption foreign Law. (eg) During the 24 months immediately preceding the date of this AgreementThere are no proceedings pending or, no Business Product has been recalledto Seller’s knowledge, whether voluntary or otherwise and no member threatened with respect to a violation by Seller of the Seller Group has received noticeFood, either completed Drug and Cosmetic Act, FDA regulations adopted thereunder, the Controlled Substance Act or pending, of any proceeding seeking a recall, removal, other legislation or corrective action of regulation promulgated by any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints Governmental Entity that would reasonably might be reasonably likely expected to result in a voluntary or mandatory product recall or expansion of recallcriminal liability. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice ofNeither Kodak nor Buyer (nor Buyer’s Designee, as applicable) will make any filings with or is subject give any notices to any investigationGovernmental Entity for the purpose of seeking any authorization, adverse inspection observationconsent, finding clearance or approval of deficiencysuch Governmental Entity or to clear any waiting or review period of such Governmental Entity in connection with the Transaction unless Kodak and Buyer (and Buyer’s Designee, fineas applicable) mutually agree. In the event that Kodak and Buyer (and Buyer’s Designee, reprimandas applicable) mutually agree to make any such filing or provide any such notice, sanctionthen promptly thereafter Buyer (and its Designee, assessmentas applicable) and Kodak shall each give notice or file or cause their respective Affiliates to give notice or file, finding and thereafter each shall use its reasonable best efforts to obtain, any authorizations, consents, clearances and approvals of non-compliance, regulatory, untitled Governmental Entities and to clear any waiting or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”)review periods of any Governmental Entities, in each case relating required to consummate the Business Products Transaction (“Governmental Approvals”), and will cooperate with the other party in making any such notices or filings required to be made by such other party. In connection therewith, Buyer (and its Designee, as applicable) and Kodak shall, and shall cause their respective Affiliates to, use reasonable best efforts to furnish promptly to each appropriate Governmental Entity any additional information requested by such Governmental Entity in connection with such filings and shall diligently take, or cooperate in the facilities in which taking of, all steps that are necessary or desirable and proper to expedite the Business Products are preparedtermination of any waiting period under Antitrust Laws and to obtain any required Governmental Approvals. (b) Kodak, assembledon the one hand, testedand Buyer (and its Designee, packagedas applicable), labeledon the other hand, stored or handled, issued shall subject to applicable Law and except as prohibited by any applicable Governmental AuthorityEntity: (i) inform the other of, and/or commercialization activities conducted and use reasonable best efforts to include the other in, all conversations, discussions, hearings or other meetings, whether in person or by telephone, that it or its Representatives has with any Governmental Entity with respect to the Transaction, and shall not participate in any of the foregoing without first consulting with the other, (ii) promptly inform the other of any material or written communication from the United States Federal Trade Commission, the United States Department of Justice or any other Governmental Entity regarding the Transaction and, subject to applicable Law, consult with the other with respect to such communication, and (iii) keep the other reasonably apprised of the status of matters relating to completion of the Transaction, including furnishing to the other copies of all correspondence, filings and written communications (and memoranda setting forth the substance thereof) between it and its Affiliates and its respective Representatives on the one hand, and any Governmental Entity, including any regulatory authority, or members of their respective staffs on the other hand, with respect to the Transaction. Without in any way limiting the foregoing, each such party will also consult and cooperate with one another, and consider in good faith the views of one another, in connection with the analyses, appearances, presentations, memoranda, briefs, arguments, opinions and proposals made or submitted by or on behalf of any member party to or for any Governmental Entity in connection with the Transaction. Each such party shall have the right to review in advance, and, to the extent reasonably practicable, each will consult the other on, all information relating to the other and each of their respective Affiliates that appears in any filing made with, or written materials submitted to, any Governmental Entity in connection with the Transaction; provided that materials may be redacted (x) to remove references concerning the valuation of the Seller GroupAssigned Assets, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (by) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained as necessary to comply with the requirements of contractual arrangements, and (z) as necessary to address reasonable attorney-client or other privilege or confidentiality concerns. If any party or any Affiliate thereof receives a request for additional information or documentary material from any such Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group Entity with respect to the Business ProductsTransaction, then such party will use reasonable best efforts to make, or cause to be made, as soon as possible, an appropriate response in compliance with such request. This Section 5.5(b) shall not apply with respect to any matter related to the Taxes of one party to the extent that such matter is not reasonably likely to affect the other party. (c) No member In furtherance and not in limitation of Section 5.5(a), each party hereto will reasonably cooperate with the other and use their reasonable best efforts to take or cause to be taken all actions, and to do or cause to be done all things, reasonably necessary, proper or advisable on its part under this Agreement and applicable Law to avoid the entry of any permanent, preliminary or temporary injunction or other order, decree, decision, determination or judgment that would delay, restrain, prevent, enjoin or otherwise prohibit consummation of the Seller Group: Transaction and to consummate the Transaction in accordance with the terms of this Agreement; provided, however, that (i) has made an untrue statement in no event shall Buyer (or its Designee, as applicable) be obligated to make any divestiture or disposition of any ownership interest in any material fact or fraudulent statement portion of the assets to be acquired by it pursuant hereto, (ii) the obligation of Buyer (and its Designee, as applicable) under this Section 5.5 is limited solely to the FDAAssigned Assets, United States Department and does not apply to or require any action with regard to any of Agriculture the other assets or businesses or contractual relationships of Buyer (“USDA”and its Designee, as applicable) or any other Governmental Authority with of its Affiliates and (iii) this Section 5.5 does not apply to matters in respect to any product produced sold by any member of receiving Bankruptcy Court approval of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental AuthorityTransaction. (d) No member In the event any Action by any Governmental Entity or other Person is commenced that questions the validity or legality of the Seller Group: (i) has made Transaction or offered any paymentthis Agreement or seeks damages, gratuity an injunction or other thing of value similar restraint in connection therewith, the Parties agree to cooperate and use their reasonable best efforts to defend against and respond thereto, including without limitation by defending any lawsuits or other legal proceedings, whether judicial or administrative, that is prohibited by any Law to personnel challenge this Agreement or the consummation of the FDA, USDA Transaction or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacitytransaction contemplated hereby, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”)and seeking to have lifted, has been required to post a surety bond in connection with a bankruptcy proceedingvacated, or is under PACA employment restrictions; (iv) is involved in a business disputereversed any stay, including informal or formal complaintinjunction, mediationtemporary restraining order, or is aware of any threatened complaints or disputes other restraint entered by any applicable Governmental Authority court or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption LawEntity. (e) During In the 24 months immediately preceding event that Kodak and Buyer and Buyer’s Designee (as applicable) mutually agree to make any filing with or provide any notice to any Governmental Entity, each Party shall have responsibility for its respective fees and costs associated with the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member preparation of the Seller Group has received noticefilings required under antitrust and Transaction control Laws in any other jurisdiction. For all such filings, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of Buyer and Buyer’s Designee (as applicable) shall pay the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recalladministrative filing fees required by Law. (f) No member of the Seller Group is a party to The covenants under this Section 5.5 shall be subject to, and shall not apply to, any corporate integrity agreementsaction, monitoring agreementseffort, consent decreesfiling, settlement ordersconsent, proceedings, or similar agreements with other activity or imposed by matter under any Governmental AuthorityBankruptcy Rules or the Bankruptcy Code (including the Final Sale Order).

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Each Operating Facility is, and since the commencement of power generation at each Operating Facility, has continuously been, a "qualifying cogeneration facility" within the meaning of Section 3(18)(B) of the Seller Group is in receipt Federal Power Act, as amended, and the FERC's regulations thereunder, at 18 C.F.R. Part 292, interpretations thereof by the FERC and courts of notice ofcompetent jurisdiction of PURPA and such regulations (collectively, or is subject to any investigationPURPA, adverse inspection observationthe regulations and all such interpretations, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”the "PURPA REQUIREMENTS"), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member Each of Linden Venture, Camden Cogen and NJ Venture (the Seller Group "PROJECT ENTITIES") is, and has made any false statements oncontinuously been, or material omissions fromsince the commencement of power generation at the Operating Facility owned by such Project Entity, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply compliance with the requirements of any Governmental Authority relating to Federal Power Act, as amended, and the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business ProductsFERC's regulations thereunder. (c) No member Except as set forth in Section II.19 of the Seller Group: Disclosure Schedule, each of the Operating Facilities has in effect a contract with an entity under which such entity (ithe "THERMAL HOST") has made agreed to purchase steam from such Operating Facility and use such steam for an untrue statement industrial or commercial process or for heating or cooling, or has agreed to obtain cooling or chilling service from such Operating Facility, or both, in aggregate amounts which equal or exceed the projected amount of material fact or fraudulent statement "useful thermal energy output" required for continued qualification of the facility as a qualifying cogeneration facility under the PURPA Requirements. All such uses of steam satisfy the requirements to be "useful thermal energy output" as defined in the PURPA Requirements, and, except as set forth in Section II.19 of the Disclosure Schedule, each such contract runs for a period of at least as long as the power purchase agreement of such Operating Facility, subject only to the FDAspecific termination provisions therein. None of the Operating Facilities has materially breached any agreement with a Thermal Host, United States Department or, except as specifically disclosed on Section II.19 of Agriculture (“USDA”) the Disclosure Schedule, has been informed of any alleged material breach by the Operating Facility of an agreement with a Thermal Host, or, to the knowledge of McNaxx, XXM Holdings, CTCI or any other Governmental Authority Acquired Entity, has learned of any material breach or threatened breach by a Thermal Host of any agreement with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authoritysuch Operating Facility. (d) No member None of the Seller GroupAcquired Entities or any "affiliate" thereof, as defined in the Public Utility Holding Company Act of 1935, as amended ("PUHCA") is subject to regulation: (i) has made or offered any paymentas a "public utility" under the Federal Power Act, gratuity or other thing of value that is prohibited than as contemplated by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person18 C.F.R. Section 292.601(c); (ii) has been convicted as a "public-utility company," a "holding company," or a "subsidiary company," "associate company," or "affiliate" of any crime under any applicable Laws; (iii) while acting a "public-utility company" or a "holding company" or an "affiliate" of a "subsidiary company" of a "holding company", as each such term is defined in such capacity, is considered a restricted individual under PUHCA or the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision regulations of the U.S. Foreign Corrupt Practices Act (the “FCPA”)SEC thereunder; (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.or

Certain Regulatory Matters. Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member Each medicinal or pharmaceutical product, product candidate or therapy that is or has been researched, developed, tested (including through clinical trials), manufactured and stored on behalf of the Seller Group Parent or any of its Subsidiaries is being done so in receipt of notice ofcompliance with all applicable Health Laws, except for any noncompliance that is not, or would not reasonably be expected to have a Parent Material Adverse Effect. Parent and its Subsidiaries own or have the right to use all data collected in the course of any clinical trials, to the extent allowed by applicable privacy laws and informed consents received, including the right to use such data in submissions to any Parent Regulatory Agency, except as would not reasonably be expected to be material to Parent and its Subsidiaries, taken as a whole. (b) Since December 31, 2012, all reports, applications, documents, claims, permits and notices required to be filed, maintained or furnished to any Parent Regulatory Agency by Parent and any Subsidiary of Parent have been so filed, maintained or furnished, except where failure to file, maintain or furnish such reports, documents, claims, permits or notices would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (c) Since December 31, 2012, neither Parent, nor any of its Subsidiaries, nor to the knowledge of Parent, any of their respective directors, officers, employees or agents, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991), or similar policies of any other Parent Regulatory Agency set forth in any applicable Health Laws, except as has not had, or would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (d) None of Parent, any Subsidiary of Parent or, to the knowledge of the Parent, any of their respective directors or officers, (i) is a party to, or bound by, any individual integrity agreement or corporate integrity agreement with any Governmental Entity concerning compliance with federal health care program requirements; (ii) is or has been debarred, excluded or received written notice of action or threat of action with respect to debarment, exclusion or other actions under the provisions of 21 U.S.C. Section 335 (a), (b) or (c), 42 U.S.C. Section 1320a-7 or any equivalent Laws in any other applicable jurisdiction; or (iii) has received written notice of or been subject to any other material enforcement action involving any Governmental Entity, including any suspension, consent decree, notice of criminal investigation, adverse inspection observationindictment, finding of deficiencysentencing memorandum, fineplea agreement, reprimand, sanction, assessment, finding of noncourt order or target or no-compliance, regulatory, untitled or warning target letter, FDA form 483and none of the foregoing are pending or, to the knowledge of Parent, threatened against the same. (e) Since December 31, 2012, neither Parent nor any Parent Subsidiary has voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, mandatory or voluntary recallwarning, other reportable corrective or remedial action“dear doctor” letter, or other compliance notice or enforcement action (“Regulatory Actions”)to regulators or to wholesalers, in each case distributors, retailers, healthcare professionals or patients relating to the Business Products an alleged lack of safety, efficacy or to the facilities in which the Business Products are prepared, assembledregulatory compliance of any product that is being researched, tested, packageddeveloped, labeledcommercialized, stored manufactured, sold or handleddistributed by Parent or any Parent Subsidiary, issued by any applicable Governmental Authorityother than notices or actions that would not, and/or commercialization activities conducted by individually or on behalf of any member of in the Seller Groupaggregate, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Grouphave a Parent Material Adverse Effect. To Sellers’ KnowledgeParent’s knowledge, there is are no actfacts which are reasonably likely to cause, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group and Parent has not received any written notification notice from the FDA or any other applicable Governmental Authority indicating Parent Regulatory Agency regarding any Parent Regulatory Agency regulatory, compliance or enforcement action, including, but not limited to, (i) the recall, market withdrawal or replacement of any product sold or intended to be sold by Parent or a Subsidiary of Parent (other than recalls, withdrawals or replacements that any are not material to Parent or the Subsidiaries of Parent, taken as a whole), (ii) a termination or suspension of the Business Products manufacturing, marketing or components thereof is misbranded distribution of any such products or adulterated. (biii) No member a material negative change in reimbursement status of the Seller Group has made any false statements onsuch products, or material omissions fromin each case other than as would not, any applications, certifications, reports or other submissions to any applicable Governmental Authority individually or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development effortsaggregate, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose have a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recallParent Material Adverse Effect. (f) No member Except as would not reasonably be expected to have a Parent Material Adverse Effect, Parent and its Subsidiaries are in compliance in all respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. Section 3801 et seq.) or any foreign equivalent Law (ii) other applicable privacy Laws, and (iii) its internal policies and procedures. Except as would not reasonably be expected to have a Parent Material Adverse Effect, there are no actions, suits, inquiries, investigations, proceedings or claims of any nature or subpoenas, civil investigative demands or other requests for information relating to potential violations of security or privacy Laws, in each case pending (or to the Seller Group is a party to knowledge of Parent, threatened) against or affecting Parent or any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authorityof its Subsidiaries.