Common use of Regulatory Clause in Contracts

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration StatementStatement and the Prospectus, as applicable, the Time of Sale Disclosure Package Company and the Final Prospectus: its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the Company has “Applicable Laws”); (ii) have not received any notice from any Governmental Entity (as defined below) court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalany licenses, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesexemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such Authorizations; (iv) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitythreatened; and (v) the Company has have not received any written notice that any Governmental Entity court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take take, action to limit, suspend, materially modify or revoke any Authorizations or has any knowledge that nor is any such Governmental Entity has threatened limitation, suspension, modification or is considering such action. Neither the Company norrevocation threatened; (vi) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any arbitratorcorporate integrity agreements, courtmonitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental body, or regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (iiB) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iiiC) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: : (i) neither the Company nor any subsidiary has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company and each subsidiary is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company and each subsidiary possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company and each subsidiary is not in violation of any term of any such Authorizations; (iv) neither the Company nor any subsidiary has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company or any subsidiary that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) neither the Company nor any subsidiary has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nornor any subsidiary, nor to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or its subsidiaries or any of its properties, assets or operations.

Regulatory. Except as described disclosed in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all material licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and to the Company’s knowledge, such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: : (i) neither the Company nor any subsidiary has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company and each subsidiary is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company and each subsidiary possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company and each subsidiary is not in violation of any term of any such Authorizations; (iv) neither the Company nor any subsidiary has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company or any subsidiary that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) neither the Company nor any subsidiary has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nornor any subsidiary, nor to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all material licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and to the Company’s knowledge, such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any FDA Form 483, notice of adverse finding, warning letter or other correspondence or notice from the FDA or any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of other Governmental Entities and the regulations promulgated pursuant to such laws (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any FDA or similar Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company's knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been or is now subject to FDA's Application Integrity Policy. To the Company's knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity. Neither the Company nor, to the Company's knowledge, any of its directors, officers, employees or agents, have with respect to each of the following statutes, or regulations promulgated thereto, as applicable: (i) engaged in activities under 42 U.S.C. §§ 1320a-7b or 1395nn; (ii) knowingly engaged in any activities under 42 U.S.C. § 1320a-7b or the Federal False Claims Act, 31 U.S.C. § 3729; or (iii) knowingly and willfully engaged in any activities under 42 U.S.C.§ 1320a-7b, which are prohibited, cause for civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other State Health Care Program or Federal Health Care Program.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package Pricing Prospectus and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is conducting and has been conducted its business and operations in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such actionaction or any other action that would result in a Material Adverse Change. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws. “Governmental Entity” shall be defined All initial patient studies and testing conducted by or on behalf of the Company were and, if still ongoing, are being conducted in material compliance with all Applicable Laws in the jurisdictions in which they are being conducted. Except as disclosed in the Registration Statement, the Pricing Prospectus and the Prospectus, the Company has not received any arbitratorwritten notices or statements from the U.S. Food and Drug Administration, court, the European Medicines Agency or any other governmental body, regulatory body, administrative agency or other authorityauthority requiring, body requesting or agency (whether foreign suggesting that Lumega-Z is not a regulated medical food or domestic) having jurisdiction over that MapcatSF is not a Class I medical device. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product as it is currently marketed and sold. The Company or has no knowledge of any regulatory actions that will adversely impact the manufacturer of its properties, assets products or operationsits products.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. The Company is and at all times has been in compliance with all statutes, rules, or regulations applicable to the Company, including, without limitation, all statutes, rules, or regulations relating to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including the Federal Food, Drug, and Cosmetic Act and foreign equivalent laws regulate the research, development, testing, manufacture, packaging, storage, record-keeping, promotion, advertising, distribution, marketing, quality control, labeling, and export and import of pharmaceutical products, laws relating to the conduct of business in the internet and the Federal Hazardous Substances Act, state and foreign laws relating to the same, and licensing and certification Laws covering any material aspect of the business of the Company (“Applicable Laws”), except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require requiring the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any FDA Form 483, notice of adverse finding, warning letter or other correspondence or notice from the FDA or any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of other Governmental Entities and the regulations promulgated pursuant to such laws (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any FDA or similar Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been or is now subject to FDA's Application Integrity Policy. To the Company's knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity. Neither the Company nor, to the Company's knowledge, any of its directors, officers, employees or agents, have with respect to each of the following statutes, or regulations promulgated thereto, as applicable: (i) engaged in activities under 42 U.S.C. §§ 1320a-7b or 1395nn; (ii) knowingly engaged in any activities under 42 U.S.C. § 1320a-7b or the Federal False Claims Act, 31 U.S.C. § 3729; or (iii) knowingly and willfully engaged in any activities under 42 U.S.C.§ 1320a-7b, which are prohibited, cause for civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other State Health Care Program or Federal Health Care Program.

Regulatory. Except as described in the Registration StatementStatement and the Prospectuses, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (i) is and at all times has been in material compliance with all applicable U.S., Canadian and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company has (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (ii) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other U.S. or Canadian federal, state, provincial or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (iv) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to To the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the Prospectuses of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are solely in the opinion of Company’s management materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and the Company has been convicted not received any notices or correspondence from any governmental authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (x) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (y) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package Pricing Prospectus and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration Offering Statement, the Time of Sale Pricing Disclosure Package Materials and the Final ProspectusOffering Circular or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any a Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus, the Company and each of its Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is are and has at all times have been in material compliance with federal, state or foreign all statutes, laws, ordinances, rules and or regulations applicable to (1) the ownership, operation and licensure of the facilities in which they provide testing services, and (2) the research, development,, processing, use, marketing, promotion, sale, or disposal of any test under development, or provided by the Company or any Subsidiary (collectively, “"Applicable Regulations”Laws"); (iiiB) have not received any notice of adverse finding, warning letter, or other correspondence or notice from the Company possesses all United States Food and Drug Administration (the “FDA”), the Drug Enforcement Administration (the “DEA") or any other federal, state, local or foreign governmental or regulatory authority having jurisdiction over the Company’s tests or testing services alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Law (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any Subsidiary is not in material violation of any term of any such Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any Governmental Entity other federal, state, local or foreign governmental or regulatory authority or third party alleging that any producttest, operation or activity is in material violation of any Applicable Regulations Laws or Authorizations or and has any no knowledge that the FDA or any such Governmental Entity other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that the FDA, DEA or any Governmental Entity other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA, DEA or any such Governmental Entity has threatened other federal, state, local or foreign governmental or regulatory authority is considering such action. Neither the Company nor; and (F) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorLaws or Authorizations except where the failure to file such reports, courtdocuments, governmental bodyforms, regulatory bodynotices, administrative agency applications, records, claims, submissions and supplements or other authorityamendments would not result in a Material Adverse Effect, body and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or agency amendments were materially complete and correct on the date filed (whether foreign or domestic) having jurisdiction over the Company were corrected or any of its properties, assets or operationssupplemented by a subsequent submission).

Regulatory. Except as described in the Registration StatementSEC Reports and on Schedule 3.1(f), the Time of Sale Disclosure Package Company and the Final Prospectus: its Subsidiaries (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is are and has at all times have been in material compliance with federal, state or foreign all statutes, laws, ordinances, rules and regulations applicable to the Company including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable RegulationsLaws”); (iiiii) the Company possesses all have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such Authorizations; (iv) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitythreatened; and (v) the Company has have not received any written notice that any Governmental Entity court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take take, action to limit, suspend, materially modify or revoke any Authorizations or has any knowledge that nor is any such Governmental Entity has threatened limitation, suspension, modification or is considering such action. Neither the Company norrevocation threatened; (vi) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any arbitratorcorporate integrity agreements, courtmonitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental body, or regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration StatementSEC Reports, the Time of Sale Disclosure Package Company and the Final Prospectus: its Subsidiaries (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is are and has at all times have been in material compliance with federal, state or foreign all statutes, laws, ordinances, rules and regulations applicable to the Company including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable RegulationsLaws”); (iiiii) the Company possesses all have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such Authorizations; (iv) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitythreatened; and (v) the Company has have not received any written notice that any Governmental Entity court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take take, action to limit, suspend, materially modify or revoke any Authorizations or has any knowledge that nor is any such Governmental Entity has threatened limitation, suspension, modification or is considering such action. Neither the Company norrevocation threatened; (vi) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any arbitratorcorporate integrity agreements, courtmonitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental body, or regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents agent has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any FDA Form 483, notice of adverse finding, warning letter or other correspondence or notice from the FDA or any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of other Governmental Entities and the regulations promulgated pursuant to such laws (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any FDA or similar Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been or is now subject to FDA's Application Integrity Policy. To the Company's knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity. Neither the Company nor, to the Company's knowledge, any of its directors, officers, employees or agents, have with respect to each of the following statutes, or regulations promulgated thereto, as applicable: (i) engaged in activities under 42 U.S.C. §§ 1320a-7b or 1395nn; (ii) knowingly engaged in any activities under 42 U.S.C. § 1320a-7b or the Federal False Claims Act, 31 U.S.C. § 3729; or (iii) knowingly and willfully engaged in any activities under 42 U.S.C.§ 1320a-7b, which are prohibited, cause for civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other State Health Care Program or Federal Health Care Program.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the Final ProspectusOffering Documents: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”), except where such non-compliance would not reasonably be expected to have a Material Adverse Effect; (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) ), except where the failure to possess such Authorizations would not reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations, except where the invalidity, ineffectiveness or violation of such Authorizations would not reasonably be expected to have a Material Adverse Effect; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, officers or employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any FDA Form 483, notice of adverse finding, warning letter or other correspondence or notice from the FDA or any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of other Governmental Entities and the regulations promulgated pursuant to such laws (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any FDA or similar Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been or is now subject to FDA’s Application Integrity Policy. To the Company’s knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents, have with respect to each of the following statutes, or regulations promulgated thereto, as applicable: (i) engaged in activities under 42 U.S.C. §§ 1320a-7b or 1395nn; (ii) knowingly engaged in any activities under 42 U.S.C. § 1320a-7b or the Federal False Claims Act, 31 U.S.C. § 3729; or (iii) knowingly and willfully engaged in any activities under 42 U.S.C.§ 1320a-7b, which are prohibited, cause for civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other State Health Care Program or Federal Health Care Program.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package The Company and the Final Prospectus: its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company has including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable Laws”); (ii) have not received any notice from any Governmental Entity (as defined below) court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalany licenses, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesexemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such Authorizations; (iv) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitythreatened; and (v) the Company has have not received any written notice that any Governmental Entity court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take take, action to limit, suspend, materially modify or revoke any Authorizations or has any knowledge that nor is any such Governmental Entity has threatened limitation, suspension, modification or is considering such action. Neither the Company norrevocation threatened; (vi) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any arbitratorcorporate integrity agreements, courtmonitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental body, or regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. 2.45.1. Except as described set forth in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , each of the Company and its Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalsuch permits, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such Applicable Regulations and/or as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would not, individually or in the aggregate, could reasonably be expected to carry on result in a Material Adverse Change; each of the Company and its businesses as now conducted (“Authorizations”) Subsidiaries is in compliance with the requirements of the Regulatory Permits, and such Authorizations all of the Regulatory Permits are valid and in full force and effect and effect, in each case in all material respects; neither the Company is not in violation nor any Subsidiary has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any term of any such Authorizations; (iv) the Company has not received notice Regulatory Permits that, individually or in the aggregate, if the subject of any claiman unfavorable decision, actionruling or finding, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Change; neither the issuance of Company nor any Subsidiary has failed to file with the FDA, the USDA or the EMA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such communication filings. 2.45.2. The research, studies and pre-clinical and clinical trials conducted by or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) on behalf of the Company has not received notice that and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Governmental Entity has takenPreliminary Prospectus, is taking the Pricing Prospectus or intends to take action to limitthe Prospectus and any Issuer Free Writing Prospectus, suspendare accurate and fairly present, modify in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither on behalf of the Company norand its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any of its directorsSubsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, officers, employees suspension or agents has been convicted modification of any crime under such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statement, any Applicable Regulations. “Governmental Entity” shall be defined as Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any arbitratorIssuer Free Writing Prospectus, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any of its propertiesPreliminary Prospectus, assets the Pricing Prospectus or operationsthe Prospectus and any Issuer Free Writing Prospectus.

Regulatory. Except Each of the Company and the Subsidiaries is duly licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as described in the Pricing Disclosure Package and the Prospectus: (i) , each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Pricing Disclosure Package and the Prospectus and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Effect; none of the issuance Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any such notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as otherwise described in the Pricing Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or decree impairing, restricting or prohibiting the payment of dividends by the Company or any of its Subsidiaries; and except as otherwise described in the Pricing Disclosure Package and the Prospectus, none of the Company, the Subsidiaries or any of Properties is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. (i) All reinsurance and retrocession treaties and agreements in force as of the date of this Agreement to which the Company or any of its Subsidiaries is a ceding party, (ii) any terminated or expired reinsurance or retrocession treaty or agreement of the Company or any of the Subsidiaries under which there remains any material outstanding reserves or unexpired coverage and (iii) any reinsurance or retrocession treaty or agreement between the Company and/or any of the Subsidiaries on one hand, and any affiliate of the Company, on the other hand, and for each such treaty or agreement described in (i), (ii) or (iii), the effective date of such treaty or agreement and the termination date of any such communication treaty or result agreement which has a definite termination date (collectively, the “Ceded Reinsurance Agreements”) are in an investigationfull force and effect, corrective action, or enforcement action by any Governmental Entity; and (v) neither the Company has not received notice that nor any Governmental Entity has takenSubsidiary, as applicable, is taking or intends in default in any material respect as to take action to limitany provision of any Ceded Reinsurance Agreement, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or there is considering such action. Neither the Company norno pending or, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, no party to any Ceded Reinsurance Agreement is impaired such that a default thereunder would reasonably be expected. Each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Effect; and each of the Company and the Subsidiaries maintains its propertiesbooks and records in accordance with, assets and is otherwise in compliance with, the applicable Insurance Laws of the United States and the various states thereof, except where the failure to so maintain its books and records or operationsbe in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.

Regulatory. 2.41.1. Except as described set forth in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , each of the Company and its Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalsuch permits, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application (“IND”), New Drug Application (“NDA”), or Biologics License Application (“BLA”) as required by the FDA or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any such Applicable Regulations and/or to carry on of the foregoing that would not, individually or in the aggregate, have a Material Adverse Change; each of the Company and its businesses as now conducted (“Authorizations”) Subsidiaries is in compliance with the requirements of the Regulatory Permits, and such Authorizations all of the Regulatory Permits are valid and in full force and effect and effect, in each case in all material respects; neither the Company is not in violation nor any Subsidiary has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any term of any such Authorizations; (iv) the Company has not received notice Regulatory Permits that, individually or in the aggregate, if the subject of any claiman unfavorable decision, actionruling or finding, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Change; neither the issuance of Company nor any Subsidiary has failed to file with the FDA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA or any Governmental Authority with respect to any such communication filings. 2.41.2. To the Company’s knowledge, the research, studies and clinical trials conducted by or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) on behalf of the Company has not received notice that and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Governmental Entity has takenPreliminary Prospectus, is taking the Pricing Prospectus or intends to take action to limitthe Prospectus and any Issuer Free Writing Prospectus, suspendare accurate and fairly present, modify in all material respects, the data derived from such research, studies, and clinical trials; any research, studies and clinical trials conducted by or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither on behalf of the Company norand its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any of its directorsSubsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, officers, employees suspension or agents has been convicted modification of any crime under such study or clinical trial; and except to the extent disclosed in the Registration Statement, any Applicable Regulations. “Governmental Entity” shall be defined as Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any arbitratorIssuer Free Writing Prospectus, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company is not aware of any research, study or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any of its propertiesPreliminary Prospectus, assets the Pricing Prospectus or operationsthe Prospectus and any Issuer Free Writing Prospectus.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; and (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. 2.39.1. Except as described set forth in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalsuch permits, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application (“IND”), New Drug Application (“NDA”), or Biologics License Application (“BLA”) as required by the FDA or other authorizations issued by federal, state, local or foreign agencies or bodies, including Health Canada, engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) of the foregoing that would not, individually or in the aggregate, result in a Material Adverse Change; the Company is in compliance with the requirements of the Regulatory Permits, and such Authorizations all of the Regulatory Permits are valid and in full force and effect and the Company is not effect, in violation of any term of any such Authorizationseach case in all material respects; (iv) the Company has not received any notice of any claimproceedings relating to the revocation, actiontermination, suit, proceeding, hearing, enforcement, investigation, arbitration modification or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation impairment of rights of any Applicable Regulations of the Regulatory Permits that, individually or Authorizations in the aggregate, if the subject of an unfavorable decision, ruling or has any knowledge that any such Governmental Entity or third party is considering any such claimfinding, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitya Material Adverse Change; and (v) the Company has not received notice that failed to file with the FDA or any Governmental Entity has takenAuthority any required application, is taking submission, report, document, notice, supplement, or intends amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to take action remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA or any Governmental Authority with respect to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such filings. 2.39.2. To the Company’s knowledge, the research, studies and clinical trials conducted by or on behalf of the Company or being relied on by the Company have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and clinical trials; any research, studies and clinical trials conducted by or on behalf of the Company if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Entity Authorities; neither the Company, nor to the Company’s knowledge any Physician Sponsor, has threatened received any notice or correspondence from the FDA nor any Governmental Authority requiring the termination, suspension or modification of any such study or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is considering such actionnot aware of any research, study or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus. 2.39.3. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws that would be reasonably likely to lead to FDA debarment or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been nor is it now subject to FDA’s Application Integrity Policy. To the Company’s knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package The Company and the Final Prospectus: its Subsidiaries (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is are and has at all times have been in material compliance with federal, state or foreign all statutes, laws, ordinances, rules and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company (collectively, the “Applicable RegulationsLaws”); (iiiii) the Company possesses all have not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Applicable Laws or any licenses, exemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in material violation of any term of any such Authorizations; (iv) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement action, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from threatened which (A) contests the licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Governmental Entity products of the Company, (B) withdraws its approval of, requests the recall, suspension, or third party alleging that seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Company product, operation (C) imposes a clinical hold on any clinical investigation by the Company or activity is in any of its Subsidiaries, (D) enjoins production at any facility of the Company or any of its Subsidiaries, (E) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (F) otherwise alleges any material violation of any Applicable Regulations laws, rules or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations regulations by the Company that could reasonably be expected to require or any of its Subsidiaries, and which, either individually or in the issuance of any such communication or result in an investigationaggregate, corrective action, or enforcement action by any Governmental Entitywould have a Material Adverse Effect; and (v) the Company has have not received any written notice that any Governmental Entity court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take take, action to limit, suspend, materially modify or revoke any Authorizations or has any knowledge that nor is any such Governmental Entity limitation, suspension, modification or revocation threatened; (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. The Company has threatened not been informed by the United States Food and Drug Administration (“FDA”) that the FDA will prohibit the marketing, sale, license or is considering such action. Neither use in the United States of any product produced or marketed by the Company nornor has the FDA halted any approved investigational device exemption, to clinical program or other trial of the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Neither the Company nor any other Subsidiary is required to be licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) ; each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Pricing Disclosure Package and the Prospectus, and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Change; none of the issuance Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any such notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; FGRe meets all capital requirements to maintain its license; none of the risks insured by FGRe have been re-insured, assigned, or ceded. None of the Company, the Subsidiaries or any of the properties or assets of the Company or any Subsidairy is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such communication insurance contract or result in an investigationany reason to believe that termination or cancelation is contemplated; and, corrective actionexcept as would not have a Material Adverse Change, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, no claims have been made thereunder. There is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company norno pending or, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its propertiesbooks and records in accordance with, assets and is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the Cayman Islands, except where the failure to so maintain its books and records or operationsbe in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change. FGRe has been granted a Class B(iii) insurance license under The Insurance Law, 2010, and such license is in full force and effect.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, nor any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as could not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to To the Company’s knowledge, all studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any of its directorsnotices or correspondence from any Governmental Authority requiring the termination, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change, the Company: (iA) is and at all times has been in compliance with all statutes, rules, or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (B) has not received any notice of adverse finding, warning letter, or other similar correspondence or notice from any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations, in each case except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (ivD) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or and has any no knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has not received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations; (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (G) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any knowledge that recall, market withdrawal or replacement, safety alert, or other notice or action relating to the alleged lack of safety of any such Governmental Entity has threatened product or is considering such action. Neither the Company norany alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any of its directors, officers, employees such notice or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsaction.

Regulatory. Except as described in the Registration Offering Statement, the Time of Sale Disclosure Package and the Final ProspectusOffering Circular or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any FDA Form 483, notice of adverse finding, warning letter or other correspondence or notice from the FDA or any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of other Governmental Entities and the regulations promulgated pursuant to such laws (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any FDA or similar Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company's knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been or is now subject to FDA's Application Integrity Policy. To the Company's knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity. Neither the Company nor, to the Company's knowledge, any of its directors, officers, employees or agents, have with respect to each of the following statutes, or regulations promulgated thereto, as applicable: (i) engaged in activities under 42 U.S.C. §§ 1320a-7b or 1395nn; (ii) knowingly engaged in any activities under 42 U.S.C. § 1320a-7b or the Federal False Claims Act, 31 U.S.C. § 3729; or (iii) knowingly and willfully engaged in any activities under 42 U.S.C.§ 1320a-7b, which are prohibited, cause for civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other State Health Care Program or Federal Health Care Program.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any a Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any other federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action. Neither the Company nor; and (F) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorLaws or material Authorizations and that all such reports, courtdocuments, governmental bodyforms, regulatory bodynotices, administrative agency applications, records, claims, submissions and supplements or other authority, body amendments were complete and correct in all material respects on the date filed (or agency (whether foreign were corrected or domestic) having jurisdiction over the Company or any of its properties, assets or operationssupplemented by a subsequent submission).

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration StatementStatement and the Prospectus, as applicable, or as would not constitute a Material Adverse Effect, the Time of Sale Disclosure Package Company and the Final Prospectus: its Subsidiaries (i) are and at all times have been in material compliance with all statutes, rules and regulations applicable to its business (collectively, the Company has “Applicable Laws”); (ii) have not received any notice from any Governmental Entity (as defined below) court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalany licenses, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesexemptions, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such Authorizations; (iv) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity court or arbitrator or governmental or regulatory authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party nor is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, norhearing, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an enforcement, investigation, corrective action, arbitration or enforcement other action by any Governmental Entitythreatened; and (v) the Company has have not received any written notice that any Governmental Entity court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take take, action to limit, suspend, materially modify or revoke any Authorizations or has any knowledge that nor is any such Governmental Entity has threatened limitation, suspension, modification or is considering such action. Neither the Company norrevocation threatened; (vi) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) are not a party to any arbitratorcorporate integrity agreements, courtmonitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental body, or regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as could not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, all studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledgeknowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, any of its directors, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package Pricing Prospectus and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) to the Company’s knowledge, the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) to the Company’s knowledge, the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, laws, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees or agents has been convicted tests and trials in all material respects; and the descriptions in the SEC Documents of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other authorityclinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents. The Company uses commercially reasonable efforts to review, body or agency from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials that are described in the SEC Documents and, based upon (whether foreign or domestici) having jurisdiction over the information provided to the Company or any by the third parties conducting such studies, tests, preclinical studies and clinical trials and the Company’s review of its propertiessuch information, assets or operationsand (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any written notice of adverse finding, warning letter or other correspondence or written notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) to its knowledge, the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company, including, without limitation, all statutes, laws, ordinances, rules and regulations for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (collectively, “Applicable RegulationsLaws”); (iii) to its knowledge, the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) to its knowledge, the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were, in all material respects, complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents (in their capacities as such) has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of a debarment proceeding. “Governmental Entity” shall be defined as any arbitratorTo the Company's knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents (in their capacities as such), has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of any Governmental Entity. Neither the Company nor, to the Company's knowledge, any of its directors, officers, employees or agents (in their capacities as such), have with respect to each of the following statutes, or regulations promulgated thereto, as applicable, knowingly engaged in any activities under the Federal False Claims Act, 31 U.S.C. § 3729.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees or agents has been convicted tests and trials; and the descriptions in the SEC Documents of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other authorityclinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents. The Company has concluded that it uses commercially reasonable efforts to review, body or agency from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (whether foreign or domestici) having jurisdiction over the information provided to the Company or any by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of its propertiessuch information, assets or operationsand (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described would not reasonably be expected to result, individually or in the Registration Statementaggregate, the Time of Sale Disclosure Package and the Final Prospectusin a Material Adverse Change: (i) the Company has not received notice from any governmental agency or court, domestic or foreign, having jurisdiction over the Company or any of its assets or business (each, a “Governmental Entity (as defined belowEntity”) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingproceeding nor, norto the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, action or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Neither the Company nor any other Subsidiary is required to be licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Pricing Disclosure Package and the Prospectus and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Change; none of the issuance Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any such notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; FGRe meets all capital requirements to maintain its license; none of the risks insured by FGre have been re-insured, assigned, or ceded. None of the Company, the Subsidiaries or any of the properties or assets of the Company is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such communication insurance contract or result in an investigationany reason to believe that termination or cancelation is contemplated; and, corrective actionexcept as would not have a Material Adverse Change, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, no claims have been made thereunder. There is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company norno pending or, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its propertiesbooks and records in accordance with, assets and is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the Cayman Islands, except where the failure to so maintain its books and records or operationsbe in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change. The Company has been granted a Class B(iii) insurance license under The Insurance Law, 2010 and such license is in full force and effect.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Reports, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, laws, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation in any material respect of any term of any such material Authorizations; (ivD) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental EntityAuthorizations; and (vE) the Company has not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such actionAuthorizations. Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, any the studies, tests and preclinical studies and clinical trials conducted by or on behalf of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any of its propertiesother federal, assets state, local or operationsforeign governmental or quasi-governmental body exercising comparable authority.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package Pricing Prospectus and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse Change; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time (a) Seller has made available to Buyer complete and correct copies of Sale Disclosure Package and the Final Prospectus: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); all Product INDs and (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations Purchased Records. All Product INDs are valid and in full force and effect and there are no facts that would constitute a material default or noncompliance under the Company Product IND. (b) With respect to the Purchased Assets, Seller is not in violation compliance with the Act, including the regulations promulgated thereunder, and any state or foreign Laws applicable to the development, testing, safety or efficacy of any term of any such Authorizations; pharmaceutical products (iv) “Pharmaceutical Laws”), except as would not, individually or in the Company aggregate, have a Material Adverse Effect. Seller has not received any written, or, to Seller’s Knowledge, other notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiating, or threatening to initiate, any action to suspend or terminate a Product IND. In connection with the Purchased Assets, Seller has not and, to the Knowledge of Seller, Seller’s officers, employees, agents or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed to make any statement, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy. (c) Seller has filed with the FDA and other applicable Governmental Authorities all required material filings, declarations, listings, registrations, reports, applications or submissions, including but not limited to Product INDs and adverse event reports, required by Pharmaceutical Laws in connection with the Purchased Assets. All such filings, declarations, listings, registrations, reports, applications or submissions were in material compliance with applicable Pharmaceutical Laws when filed and remain in full force and effect. (d) All preclinical and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from the FDA or any other Governmental Authority commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of Seller relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product. (e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted of any claimcrime or engaged in any conduct in connection with the Purchased Assets that has resulted in or could reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actionactions, suit, proceeding, hearing, enforcement, investigation, arbitration proceedings or other action from any Governmental Entity or third party alleging that any product, operation or activity is investigations in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance connection with or violation of any Applicable Regulations by the Company Purchased Assets that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, such a material debarment or enforcement action by any Governmental Entity; and (v) the Company has not received notice exclusion that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company norare pending or, to the Company’s knowledgeKnowledge of Seller, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company threatened against Seller or any of its propertiesrespective officers, assets employees, agents or operationsclinical investigators.

Regulatory. Except Since August 31, 2019, except as described in the Registration StatementSEC Documents, the Time of Sale Disclosure Package Company and the Final Prospectusits Subsidiary: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiary (“Applicable Laws”), except as would not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental or quasi-governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company norSince August 31, 2019, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiary. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is was and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action. Neither the Company nor; and (F) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorLaws or material Authorizations and that all such reports, courtdocuments, governmental bodyforms, regulatory bodynotices, administrative agency applications, records, claims, submissions and supplements or other authority, body amendments were complete and correct in all material respects on the date filed (or agency (whether foreign were corrected or domestic) having jurisdiction over the Company or any of its properties, assets or operationssupplemented by a subsequent submission).

Regulatory. Except as described set forth in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is Company, and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company Company’s knowledge, each of the physician sponsors of the clinical trials being performed on SL-401 and SL-701 (collectively, the “Applicable RegulationsPhysician Sponsors”); (iii) the Company possesses all , has such permits, licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application (“IND”), New Drug Application (“NDA”), or Biologics License Application (“BLA”) as required by the FDA or other authorizations issued by federal, state, local or foreign agencies or bodies, including Health Canada, engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any such Applicable Regulations and/or of the foregoing that would not, individually or in the aggregate, have a Material Adverse Change; the Company, and to carry on its businesses as now conducted (“Authorizations”) the Company’s knowledge each of the Physician Sponsors, is in compliance with the requirements of the Regulatory Permits, and such Authorizations all of the Regulatory Permits are valid and in full force and effect and the Company is not effect, in violation of any term of any such Authorizationseach case in all material respects; (iv) the Company has not received, and to the Company’s knowledge neither Physician Sponsor has received any notice of any claimproceedings relating to the revocation, actiontermination, suit, proceeding, hearing, enforcement, investigation, arbitration modification or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation impairment of rights of any Applicable Regulations of the Regulatory Permits that, individually or Authorizations in the aggregate, if the subject of an unfavorable decision, ruling or has any knowledge that any such Governmental Entity or third party is considering any such claimfinding, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitya Material Adverse Change; and (v) the Company has not received notice that failed to file with the FDA or any Governmental Entity has takenAuthority any required application, is taking submission, report, document, notice, supplement, or intends amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to take action remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA or any Governmental Authority with respect to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsfilings.

Regulatory. Except FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Neither the Company nor any other Subsidiary is required to be licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Pricing Disclosure Package and the Prospectus and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Change; none of the issuance Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any such notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; FGRe meets all capital requirements to maintain its license; none of the risks insured by FGre have been re-insured, assigned, or ceded. None of the Company, the Subsidiaries or any of the properties or assets of the Company is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such communication insurance contract or result in an investigationany reason to believe that termination or cancelation is contemplated; and, corrective actionexcept as would not have a Material Adverse Effect, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, no claims have been made thereunder. There is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company norno pending or, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its propertiesbooks and records in accordance with, assets and is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the Cayman Islands, except where the failure to so maintain its books and records or operationsbe in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change. The Company has been granted a Class B (iii) insurance license under The Insurance Law, 2010 and such license is in full force and effect.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have not failed to file, obtain, maintain or submit any material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations that would, individually or in the aggregate constitute a Material Adverse Effect, and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical studies and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus, the Company and each of its Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is are and has at all times have been in material compliance with federal, state or foreign all statutes, laws, ordinances, rules and or regulations applicable to (1) the ownership, operation and licensure of the facilities in which they provide testing services, and (2) the research, development,, processing, use, marketing, promotion, sale, or disposal of any test under development, or provided by the Company or any Subsidiary (collectively, “Applicable RegulationsLaws”); (iiiB) have not received any notice of adverse finding, warning letter, or other correspondence or notice from the Company possesses all United States Food and Drug Administration (the “FDA”), the Drug Enforcement Administration (the “DEA”) or any other federal, state, local or foreign governmental or regulatory authority having jurisdiction over the Company’s tests or testing services alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Law (“Authorizations”), which would, individually or in the aggregate, result in a Material Adverse Effect; (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and neither the Company nor any Subsidiary is not in material violation of any term of any such Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA, DEA or any Governmental Entity other federal, state, local or foreign governmental or regulatory authority or third party alleging that any producttest, operation or activity is in material violation of any Applicable Regulations Laws or Authorizations or and has any no knowledge that the FDA or any such Governmental Entity other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that the FDA, DEA or any Governmental Entity other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations or and has any no knowledge that the FDA, DEA or any such Governmental Entity has threatened other federal, state, local or foreign governmental or regulatory authority is considering such action. Neither the Company nor; and (F) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorLaws or Authorizations except where the failure to file such reports, courtdocuments, governmental bodyforms, regulatory bodynotices, administrative agency applications, records, claims, submissions and supplements or other authorityamendments would not result in a Material Adverse Effect, body and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or agency amendments were materially complete and correct on the date filed (whether foreign or domestic) having jurisdiction over the Company were corrected or any of its properties, assets or operationssupplemented by a subsequent submission).

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received written notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. 2.39.1. Except as described set forth in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalsuch permits, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application (“IND”), New Drug Application (“NDA”), or Biologics License Application (“BLA”) as required by the FDA or other authorizations issued by federal, state, local or foreign agencies or bodies, including Health Canada, engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) of the foregoing that would not, individually or in the aggregate, have a Material Adverse Change; the Company is in compliance with the requirements of the Regulatory Permits, and such Authorizations all of the Regulatory Permits are valid and in full force and effect and the Company is not effect, in violation of any term of any such Authorizationseach case in all material respects; (iv) the Company has not received any notice of any claimproceedings relating to the revocation, actiontermination, suit, proceeding, hearing, enforcement, investigation, arbitration modification or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation impairment of rights of any Applicable Regulations of the Regulatory Permits that, individually or Authorizations in the aggregate, if the subject of an unfavorable decision, ruling or has any knowledge that any such Governmental Entity or third party is considering any such claimfinding, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitya Material Adverse Change; and (v) the Company has not received notice that failed to file with the FDA or any Governmental Entity has takenAuthority any required application, is taking submission, report, document, notice, supplement, or intends amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to take action remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA or any Governmental Authority with respect to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such filings. 2.39.2. To the Company’s knowledge, the research, studies and clinical trials conducted by or on behalf of the Company or being relied on by the Company have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and clinical trials; any research, studies and clinical trials conducted by or on behalf of the Company if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Entity Authorities; neither the Company, nor to the Company’s knowledge any Physician Sponsor, has threatened received any notice or correspondence from the FDA nor any Governmental Authority requiring the termination, suspension or modification of any such study or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is considering such actionnot aware of any research, study or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus. 2.39.3. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable RegulationsLaws that would be reasonably likely to lead to FDA debarment or has been the subject of an FDA debarment proceeding. “Governmental Entity” shall be defined as any arbitratorThe Company has not been nor is it now subject to FDA’s Application Integrity Policy. To the Company’s knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other Governmental Entity.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; and (vi) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Neither the Company nor any other Subsidiary is required to be licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: (i) ; each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Disclosure Package and the Prospectus, and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Change; none of the issuance Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Disclosure Package and the Prospectus, except for any such notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; FGRe meets all capital requirements to maintain its license; none of the risks insured by FGRe have been re-insured, assigned, or ceded. None of the Company, the Subsidiaries or any of the properties or assets of the Company or any Subsidiary is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such communication insurance contract or result in an investigationany reason to believe that termination or cancelation is contemplated; and, corrective actionexcept as would not have a Material Adverse Change, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, no claims have been made thereunder. There is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company norno pending or, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its propertiesbooks and records in accordance with, assets and is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the Cayman Islands, except where the failure to so maintain its books and records or operationsbe in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change. FGRe has been granted a Class B(iii) insurance license under The Insurance Law, 2010, and such license is in full force and effect.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinancesregulations, rules and regulations or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws. The Company has not received any of its directorswritten notices or correspondence from any Governmental Authority requiring the termination, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementStatement and the Prospectuses, the Time Company and each of Sale Disclosure Package its Subsidiaries: (A) is and at all times has been in material compliance with all applicable U.S., Canadian and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries and the Final Prospectus: (i) ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company has (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other U.S. or Canadian federal, state, provincial or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to To the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the Prospectuses of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and the Company has been convicted not received any notices or correspondence from any governmental authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action. Neither the Company nor; and (F) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorLaws or material Authorizations and that all such reports, courtdocuments, governmental bodyforms, regulatory bodynotices, administrative agency applications, records, claims, submissions and supplements or other authority, body amendments were complete and correct in all material respects on the date filed (or agency (whether foreign were corrected or domestic) having jurisdiction over the Company or any of its properties, assets or operationssupplemented by a subsequent submission).

Regulatory. Except Each of the Company and the Subsidiaries is duly licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus: (i) , each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Effect; none of the issuance of Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except for any such communication notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in an investigationa Material Adverse Effect; except as otherwise described in the Registration Statement, corrective actionthe Pricing Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or enforcement action decree impairing, restricting or prohibiting the payment of dividends by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its propertiesSubsidiaries; and except as otherwise described in the Registration Statement, assets the Pricing Disclosure Package and the Prospectus, none of the Company, the Subsidiaries or operations.any of Properties is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. Each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other - 13 -

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package Package, the Prospectus, and the Final ProspectusSEC Reports or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company's knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any a Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration Offering Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusOffering Circular or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration StatementStatement and the Prospectuses, the Time Company and each of Sale Disclosure Package its Subsidiaries: (A) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries and the Final Prospectus: (i) ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company has (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the Prospectuses of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledgeknowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and the Company has not received any notices or correspondence from any governmental authority requiring the termination, any of its directors, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation and to the extent applicable, the United States Public Health Service Act, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received any written notice of adverse finding, warning letter or other correspondence or written notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) to its knowledge, the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company, including, without limitation, all statutes, laws, ordinances, rules and regulations for the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (collectively, “Applicable RegulationsLaws”); (iii) to its knowledge, the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action; (vi) to its knowledge, the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were, in all material respects, complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate or conduct such notice or action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents (in their capacities as such) has been convicted of any crime under any Applicable RegulationsLaws or has been the subject of a debarment proceeding. “Governmental Entity” shall be defined as any arbitratorTo the Company’s knowledge, courtneither the Company, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or nor any of its propertiesdirectors, assets officers, employees or operationsagents (in their capacities as such), has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of any Governmental Entity. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents (in their capacities as such), have with respect to each of the following statutes, or regulations promulgated thereto, as applicable, knowingly engaged in any activities under the Federal False Claims Act, 31 U.S.C. § 3729.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other applicable regulation of its directorsa xxxxxxx, officersxxxxxxxxxx, employees xxxxx, local or agents foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical studies and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementSEC Reports or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change, the Time of Sale Disclosure Package and the Final ProspectusCompany: (iA) is and at all times has been in compliance with all statutes, rules, or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (B) has not received any notice of adverse finding, warning letter, or other similar correspondence or notice from any other Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations, in each case except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (ivD) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or and has any no knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has not received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations; (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (G) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any knowledge that recall, market withdrawal or replacement, safety alert, or other notice or action relating to the alleged lack of safety of any such Governmental Entity has threatened product or is considering such action. Neither the Company norany alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any of its directors, officers, employees such notice or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsaction.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, laws, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, any the studies, tests and preclinical studies conducted by or on behalf of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its propertiesthe results of such studies and tests contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies and tests in all material respects; and to the Company’s knowledge there are no other studies whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents. The Company uses commercially reasonable efforts to review, assets or operationsfrom time to time, the progress and results of the studies, tests and preclinical studies that are described in the SEC Documents and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, and preclinical studies and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, and preclinical studies are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Neither the Company nor any other Subsidiary is required to be licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory and other authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Registration Statement, the Time of Sale Disclosure Package Statement and the Final Prospectus: (i) , each of the Company and the Subsidiaries has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalall other necessary authorizations, state or foreign statutesapprovals, lawsorders, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licensesconsents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Registration Statement and the Prospectus and all of the foregoing are in full force and effect, except where the failure to have such authorizations, approvals, clearancesorders, consents, authorizations, qualifications, registrationscertificates, permits, and supplements registrations or amendments thereto required by any such Applicable Regulations and/or qualifications or their failure to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and be in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claimaggregate, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require result in a Material Adverse Effect; none of the issuance Company or the Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Registration Statement and the Prospectus, except for any such notification received where the failure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; FGRe meets all capital requirements to maintain its license; none of the risks insured by FGre have been re-insured, assigned, or ceded. None of the Company, the Subsidiaries or any of the properties or assets of the Company is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such communication insurance contract or result in an investigationany reason to believe that termination or cancelation is contemplated; and, corrective actionexcept as would not have a Material Adverse Effect, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, no claims have been made thereunder. There is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company norno pending or, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Effect; and each of the Company and the Subsidiaries maintains its propertiesbooks and records in accordance with, assets and is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the Cayman Islands, except where the failure to so maintain its books and records or operationsbe in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company has been granted a Class B(iii) insurance license under The Insurance Act (as revised) of the Cayman Islands, and such license is in full force and effect.

Regulatory. Except as described in the Registration Offering Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusOffering Circular or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Reports, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (i) is and at all times has been in compliance with all applicable U.S. and foreign statutes, rules or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the Company aggregate, reasonably be expected to result in a Material Adverse Effect; (ii) has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting material noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation in any material respect of any term of any such material Authorizations; (iv) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental EntityAuthorizations; and (v) the Company has not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such actionAuthorizations. Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, any the studies, tests and preclinical studies and clinical trials conducted by or on behalf of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any of its propertiesother federal, assets state, local or operationsforeign governmental or quasi-governmental body exercising comparable authority.

Regulatory. Except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as could not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, all studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, 194229821 v2 including, without limitation, the United States Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledgeknowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, any of its directors, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been to the Company’s knowledge in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and each of its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”Authorizations”);(C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions in the SEC Document of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementSEC Documents, the Time of Sale Disclosure Package and the Final ProspectusCompany: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company (“Applicable Laws”), except as could not, individually or in the Company has aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any federal, state, or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, all studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any reasonably believes that the descriptions of its propertiesthe results of such studies, assets or operationstests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Offering Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusOffering Circular or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceedingproceeding nor, norto the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, action or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except as described in the Registration StatementSEC Documents, during the 12-month period immediately preceding the date hereof, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is was and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinances, rules and or regulations applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees or agents has been convicted tests and trials; and the descriptions in the SEC Documents of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other authorityclinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents. The Company has concluded that it uses commercially reasonable efforts to review, body or agency from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials and, based upon (whether foreign or domestici) having jurisdiction over the information provided to the Company or any by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of its propertiessuch information, assets or operationsand (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described set forth in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final Prospectus: (i) , the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federalsuch permits, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, including, without limitation, any Investigational New Drug Application (“IND”), New Drug Application (“NDA”), or Biologics License Application (“BLA”) as required by the FDA or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any such Applicable Regulations and/or of the foregoing that would not, individually or in the aggregate, reasonably be expected to carry on its businesses as now conducted (“Authorizations”) have a Material Adverse Effect; the Company is in compliance with the requirements of the Regulatory Permits and such Authorizations all of the Regulatory Permits are valid and in full force and effect and the Company is effect, in each case in all respects, except as would not in violation of any term of any such Authorizationsreasonably be expected to have a Material Adverse Effect; (iv) the Company has not received any notice of any claimproceedings relating to the revocation, actiontermination, suit, proceeding, hearing, enforcement, investigation, arbitration modification or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation impairment of rights of any Applicable Regulations of the Regulatory Permits that, individually or Authorizations in the aggregate, if the subject of an unfavorable decision, ruling or has any knowledge that any such Governmental Entity or third party is considering any such claimfinding, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entitya Material Adverse Effect; and (v) the Company has not received notice that failed to file with the FDA or any Governmental Entity has takenAuthority any required application, is taking submission, report, document, notice, supplement, or intends amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to take action remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA or any Governmental Authority with respect to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsfilings.

Regulatory. Except as described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations Laws (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaws”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Laws and/or to carry on its businesses as now conducted (“Authorizations”) and to the Company’s knowledge, such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Laws by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s 's knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaws.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time of Sale Disclosure Package and the Final ProspectusCompany: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is was and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinances, rules and or regulations applicable to Company (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) has not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possesses all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical studies and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug, and Cosmetic Act or any other federal, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees or agents has been convicted tests and trials in all material respects; and the descriptions in the SEC Documents of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or other authorityclinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents. The Company uses commercially reasonable efforts to review, body or agency from time to time, the progress and results of the studies, tests and preclinical studies and clinical trials that are described in the SEC Documents and, based upon (whether foreign or domestici) having jurisdiction over the information provided to the Company or any by the third parties conducting such studies, tests, preclinical studies and clinical trials and the Company’s review of its propertiessuch information, assets or operationsand (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final ProspectusProspectus or as would not reasonably be expected to result, individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable RegulationsLaw”); (iiiii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations Law and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iviii) except for that certain letter from the Commission to the Company, dated October 4, 2018 from the Commission’s Division of Enforcement (the “Enforcement Letter”), the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Law or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any material noncompliance with or violation of any Applicable Regulations Law by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (viv) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operationsLaw.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinancesregulations, rules and regulations or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledgeknowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has not received any notices or correspondence from any Governmental Authority requiring the termination, any of its directors, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus, or to the extent that it is not reasonably likely to result in a Material Adverse Effect: (i) neither the Company nor its subsidiary has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) each of the Company and its subsidiary is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) each of the Company and its subsidiary possesses all necessary licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or are to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and each of the Company and its subsidiary is not in violation of any term of any such Authorizations; (iv) neither the Company nor its subsidiary has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company or its subsidiary that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) neither the Company nor its subsidiary has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nornor any subsidiary, nor to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except During the 12-month period immediately preceding the date hereof, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been to the Company’s knowledge in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and each of its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the date hereof, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions in the SEC Document of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementStatement and the Prospectuses, the Time Company and each of Sale Disclosure Package and the Final ProspectusSubsidiaries: (i) is and at all times has been in material compliance with all applicable U.S., Canadian and foreign statutes, rules, regulations, or guidance applicable to Company and the Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company has (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (ii) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other U.S. or Canadian federal, state, provincial or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (iii) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (iv) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (vi) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor, to To the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the EMA, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials; the descriptions in the Prospectuses of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are solely in the opinion of Company’s management materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and the Company has been convicted not received any notices or correspondence from any governmental authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (x) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (y) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is was and at all times has been in material compliance with federalall applicable U.S., state or England, Wales and other foreign statutes, lawsrules, ordinancesregulations, rules and regulations or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials in all material respects; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and except as described in the SEC documents, the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration Statement, the Time (a) Seller has obtained and provided Buyer with copies of Sale Disclosure Package and the Final Prospectus: (i) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearancesexemptions, consentsregistrations, licenses, authorizations, qualifications, registrations, permits, franchises and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted clearances (“AuthorizationsRequired Permits”) necessary for compliance in all material respects with all applicable laws with respect to using, sourcing, manufacturing, development, testing, human clinical testing, production, sale and distribution of the Product, components or accessories. All such Authorizations Required Permits are valid and in full force and effect effect, are up to date and current with respect to the Product, including any fees payable, and the Company is not in violation default in any material respect under any of any term of any such Authorizations; (iv) the Company Required Permits. Seller has not received notice of any claimnoncompliance with any such Required Permits. With respect to any such Required Permits in effect as of the Closing, actionSeller has undertaken, suitor will undertake prior to the Closing Date, proceedingall measures reasonably necessary to facilitate transferability of the same, hearing, enforcement, investigation, arbitration and Seller has not received any notice or other action written communication regarding any material adverse change in the status or terms and conditions of the same. (b) Seller has provided in Section 4.8 of the Disclosure Schedule all written communications with any Governmental Authority concerning its Products. (c) Seller has not received any adverse communication from any Governmental Entity Authority regarding, and there are no facts or third party alleging circumstances that are reasonably expected to be likely to give rise to (A) any productmaterial adverse change in, operation any Required Permit, or activity is in violation any failure to materially comply with any applicable Laws or any term or requirement of any Applicable Regulations Required Permit or Authorizations (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation modification of any Applicable Regulations Required Permit. (d) All nonclinical studies and clinical trials and other uses of Products with humans or animals being conducted by the Company that could reasonably be expected or on behalf of Seller producing data submitted to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; Authority, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws. (ve) the Company has not received notice that Neither Seller nor any Governmental Entity has takenof its Affiliates, is taking or intends to take action to limitofficers, suspenddirectors, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company noremployees, consultants, or, to the CompanySeller’s knowledgeKnowledge, any of its directorsvendors, officerscontractors, employees investigators or agents agents, who has undertaken activities in connection with the business of the Products has been convicted (A) debarred or deemed subject to debarment pursuant to Section 306 of the Federal Food, Drug and Cosmetic Act (“FDCA”), or (B) to Seller’s Knowledge, are any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over such Persons the Company or any subject of its properties, assets or operationsa conviction described in Section 306 of the FDCA.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) is and at all times has been in material compliance with all applicable U.S. and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company has not received notice from any (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action. Neither the Company nor; and (F) have filed, to the Company’s knowledgeobtained, any of its directorsmaintained or submitted all material reports, officersdocuments, employees forms, notices, applications, records, claims, submissions and supplements or agents has been convicted of any crime under amendments as required by any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorLaws or material Authorizations and that all such reports, courtdocuments, governmental bodyforms, regulatory bodynotices, administrative agency applications, records, claims, submissions and supplements or other authority, body amendments were complete and correct in all material respects on the date filed (or agency (whether foreign were corrected or domestic) having jurisdiction over the Company or any of its properties, assets or operationssupplemented by a subsequent submission).

Regulatory. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus: (i) the The Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitrator, court, governmental body, regulatory body, administrative agency or other authority, body or agency (whether foreign or domestic) having jurisdiction over the Company or any of its properties, assets or operations.

Regulatory. Except During the 12-month period immediately preceding the Execution Date, except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is was and at all times has been in material compliance with federalall applicable U.S., state or Irish and other foreign statutes, lawsrules, ordinancesregulations, rules and regulations or guidance applicable to Company and its Subsidiaries (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any material written notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company (collectively, “Governmental Authority”) alleging or asserting material noncompliance with any Applicable Regulations”); (iii) the Company possesses all Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and and, to the Company is Company’s knowledge, are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received written notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither During the Company nor12-month period immediately preceding the Execution Date, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of its directorsthe results of such studies, officerstests and trials contained in the SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, employees tests and trials in all material respects; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledge there are no other studies or agents other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the SEC Documents; and except as described in the SEC documents, the Company has been convicted not received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the SEC Documents and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementStatement and the Prospectuses, the Time Company and each of Sale Disclosure Package its Subsidiaries: (A) is and at all times has been in material compliance with all applicable U.S., Canadian and foreign statutes, rules, regulations, or guidance applicable to Company and its Subsidiaries and the Final Prospectus: (i) ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company has (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other U.S. or Canadian federal, state, provincial or foreign governmental authority having authority over the Company (“Governmental Entity (as defined belowAuthority”) alleging or asserting noncompliance with any Applicable Regulations (as defined below) Laws or Authorizations (as defined below); (ii) the Company is and has been in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the Prospectuses of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledgeknowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and the Company has not received any notices or correspondence from any governmental authority requiring the termination, any of its directors, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.

Regulatory. Except as described in the Registration StatementSEC Documents, the Time Company and each of Sale Disclosure Package and the Final Prospectusits Subsidiaries: (iA) the Company has not received notice from any Governmental Entity (as defined below) alleging or asserting noncompliance with any Applicable Regulations (as defined below) or Authorizations (as defined below); (ii) the Company is and at all times has been in material compliance with federal, state or all applicable U.S. and foreign statutes, lawsrules, ordinancesregulations, rules and regulations or guidance applicable to Company and its Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (collectively, “Applicable RegulationsLaws”), except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (iiiB) have not received any notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, or foreign governmental authority having authority over the Company possesses all (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, permits and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted Laws (“Authorizations”); (C) possess all material Authorizations and such material Authorizations are valid and in full force and effect and the Company is are not in violation of any term of any such material Authorizations; (ivD) the Company has have not received notice of any material claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity Authority or third party alleging that any product, product operation or activity is in violation of any Applicable Regulations Laws or Authorizations or has any and have no knowledge that any such Governmental Entity Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (vE) the Company has have not received notice that any Governmental Entity Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or and the Company has any no knowledge that any such Governmental Entity has threatened or Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or material Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). Neither To the Company's knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company norwere and, if still pending, are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable laws, including, without limitation, the United States Federal Food, Drug and Cosmetic Act and the laws, rules and regulations of the Therapeutic Products Directorate, the European Medicines Agency, the European Commission's Enterprise Directorate General and the regulatory agencies within each Member State granting Marketing Authorization through the Mutual Recognition Procedure or any other federal, provincial, state, local or foreign governmental or quasi-governmental body exercising comparable authority; the descriptions of the results of such studies, tests and trials contained in the Prospectuses are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; the descriptions in the SEC Documents of the results of such clinical trials are consistent in all material respects with such results and to the Company’s knowledgeknowledge there are no other studies or other clinical trials whose results are materially inconsistent with or otherwise materially call into question the results described or referred to in the Prospectuses; and the Company has not received any notices or correspondence from any governmental authority requiring the termination, any of its directors, officers, employees suspension or agents has been convicted material modification of any crime under any Applicable Regulations. “Governmental Entity” shall be defined as any arbitratorstudies, court, governmental body, regulatory body, administrative agency tests or other authority, body preclinical or agency (whether foreign clinical trials conducted by or domestic) having jurisdiction over on behalf of the Company or any its Subsidiaries. The Company has concluded that it uses commercially reasonable efforts to review, from time to time, the progress and results of its propertiesthe studies, assets or operationstests and preclinical and clinical trials and, based upon (i) the information provided to the Company by the third parties conducting such studies, tests, preclinical studies and clinical trials that are described in the Prospectuses and the Company’s review of such information, and (ii) the Company’s actual knowledge, the Company reasonably believes that the descriptions of the results of such studies, tests, preclinical studies and clinical trials are accurate and complete in all material respects.