Common use of Regulatory Clause in Contracts

Regulatory. Except as described in the Registration Statement, the Time of Sale Prospectus and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, 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 result in the issuance of any such communication or 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 or employees or agents has been convicted of any crime under any Applicable Regulations.

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 Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”)Prospectus requires such licensing, except where for such non-compliance jurisdictions in which the failure to be so licensed would not not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; (iii) except as described in the Pricing Disclosure Package and the Prospectus, each of the Company possesses and the Subsidiaries has all licensesother necessary authorizations, approvals, orders, consents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)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 possess have such Authorizations would not reasonably authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizationsaggregate, 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 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 an investigationagreement which has a definite termination date (collectively, corrective actionthe “Ceded Reinsurance Agreements”) are in full force and effect, 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, threatened dispute between the Company or any of its directorsSubsidiary, officers or employees or agents has been convicted of on one hand, and any crime reinsurer under any Applicable Regulationssuch 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 books and records in accordance with, 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 be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.

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 Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) Prospectus; each of the Company and the Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalall other necessary authorizations, stateapprovals, provincial or foreign statutesorders, 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 licensesconsents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)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 possess have such Authorizations would not reasonably authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizationsaggregate, 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 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 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, 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 directorsbooks and records in accordance with, officers 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 employees be in compliance would not, individually or agents in the aggregate, reasonably be expected to result in a Material Adverse Change. FGRe has been convicted of any crime granted a Class B(iii) insurance license under any Applicable RegulationsThe Insurance Law, 2010, and such license is in full force and effect.

Regulatory. 2.41.1. Except as described set forth in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) Prospectus, each of the Company and its Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalsuch permits, 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 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 any 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 Applicable Regulations and/or to carry on as those being developed by the Company and its businesses as now conducted Subsidiaries (collectively, “AuthorizationsGovernmental Authorities,” and each, a “Governmental Authority”), except where for any of the failure to possess such Authorizations foregoing that would not reasonably be expected to not, individually or in the aggregate, have a Material Adverse EffectChange; each of the Company and its 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 Authorizationsthe Regulatory Permits that, except where individually or in the invalidityaggregate, ineffectiveness if the subject of an unfavorable decision, ruling 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 claimfinding, 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 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 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 suspension or employees 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 RegulationsPreliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, 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 Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.

Regulatory. Except Each of the Company and its Subsidiaries is duly licensed as an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”)Prospectus requires such licensing, except where for such non-compliance jurisdictions in which the failure to be so licensed would not not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse EffectChange; (iii) except as described in the Pricing Disclosure Package and the Prospectus, each of the Company possesses and its Subsidiaries has all licensesother necessary authorizations, approvals, orders, consents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)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 possess have such Authorizations would not reasonably authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizationsaggregate, 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 result in a Material Adverse Change; none of the issuance Company or its Subsidiaries has received any notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the effect that any additional authorization, approval, order, consent, certificate, permit, registration or qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the 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; 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 none of the Company, its Subsidiaries or any of their properties or assets 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 its 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 its 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 an investigationagreement which has a definite termination date (collectively, corrective actionthe “Ceded Reinsurance Agreements”) are in full force and effect, 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, threatened dispute between the Company or any of its directorsSubsidiary, officers or employees or agents has been convicted of on one hand, and any crime reinsurer under any Applicable Regulationssuch 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 its 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 Change; and each of the Company and its Subsidiaries maintains its books and records in accordance with, 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 be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

Regulatory. (a) Except as described in the Registration Statement, the Time of Sale Prospectus and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, 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 have, individually or in the aggregate, a Parent Material Adverse Effect; , each of Parent and its Subsidiaries holds or is in the process of acquiring all authorizations of all applicable Governmental Entities that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (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 (Governmental Entity, a “AuthorizationsParent Regulatory Agency”), except where in each case, that is necessary for the failure to possess such Authorizations lawful operation of the businesses of Parent or any of its Subsidiaries as currently conducted (the “Parent Regulatory Permits”). Except as would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect, and all such Authorizations Parent Regulatory Permits are valid and in full force and effect and Parent and its Subsidiaries are in compliance with the Company is not in violation terms of any term of any such Authorizations, except where the invalidity, ineffectiveness or violation of such Authorizations all Parent Regulatory Permits. (b) Except as would not reasonably be expected to have have, individually or in the aggregate, a Parent Material Adverse Effect; (iv) the Company has not received notice , each 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 Parent and its Subsidiaries is in violation compliance with all regulations and requirements of all Parent Regulatory Agencies, including any Applicable Regulations applicable Good Manufacturing Practices, Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claimrepackaging requirements, litigationlaboratory controls, 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 storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to result have, individually or in the issuance aggregate, a Parent Material Adverse Effect, since January 1, 2019, all Parent Products have been produced, distributed, labeled, marketed and sold, and all raw materials and ingredients in such products have been procured, in compliance in all material respects with all Applicable Laws governing the procurement, production, distribution, labeling and sale of such products, raw materials or ingredients. Except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since January 1, 2019, there have been no recalls, withdrawals or suspensions with respect to any Parent Products produced, distributed, labeled, marketed or sold by Parent or any of its Subsidiaries. Except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since January 1, 2019, neither Parent nor any of its Subsidiaries has received any written notice of or otherwise is aware of, any Parent Regulatory Agency untitled letters, warning letters, notices of warning or withholding, suspension or withdrawal of inspection, seizure, criminal referral or other similar federal, state or private enforcement actions with respect to such communication Parent Products. Except as would not reasonably be expected to have, individually or an in the aggregate, a Parent Material Adverse Effect, since January 1, 2019, neither Parent nor any of its Subsidiaries is subject (or has been subject) to any adverse inspection finding, recall, investigation, corrective actionpenalty assessment, audit or other compliance or enforcement action by any Governmental Entity; and Parent Regulatory Agencies. (vc) 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, Parent nor any of its directorsSubsidiaries is party to any corporate integrity agreements, officers monitoring agreements, consent decrees, settlement orders, or employees similar agreements with or agents has been convicted of imposed by any crime under any Applicable Regulations.Parent Regulatory Agency, except as would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect

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 Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) Prospectus, each of the Company and the Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalall other necessary authorizations, stateapprovals, provincial or foreign statutesorders, 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 licensesconsents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)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 possess have such Authorizations would not reasonably authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizationsaggregate, 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 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 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, 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 directorsbooks and records in accordance with, officers 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 employees be in compliance would not, individually or agents in the aggregate, reasonably be expected to result in a Material Adverse Change. The Company has been convicted of any crime granted a Class B(iii) insurance license under any Applicable RegulationsThe Insurance Law, 2010 and such license is in full force and effect.

Regulatory. Except as described in the Registration Statement, the Time (a) Seller has made available to Buyer complete and correct copies of Sale Prospectus and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity alleging or asserting noncompliance with any Applicable Regulations (as defined in clause all Product INDs and (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in compliance with federal, 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 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 Authorizationspharmaceutical products (“Pharmaceutical Laws”), except where as would not, individually or in the invalidityaggregate, ineffectiveness or violation of such Authorizations would not reasonably be expected to have a Material Adverse Effect; (iv) the Company . 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 result in the issuance of any such communication a material debarment or an investigation, corrective action, 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, threatened against Seller or any of its directorsrespective officers, officers employees, agents or employees or agents has been convicted of any crime under any Applicable Regulationsclinical investigators.

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 Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) Prospectus, each of the Company and the Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalall other necessary authorizations, stateapprovals, provincial or foreign statutesorders, 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 licensesconsents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)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 possess have such Authorizations authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; none of the 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 insurance contract or any reason to believe that termination or cancelation is contemplated; and, except as would not have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company no claims have been made thereunder. There 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 result in the issuance of any such communication or 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 norno pending or, to the Company’s knowledge, 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 directorsbooks and records in accordance with, officers 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 employees be in compliance would not, individually or agents in the aggregate, reasonably be expected to result in a Material Adverse Change. The Company has been convicted of any crime granted a Class B (iii) insurance license under any Applicable RegulationsThe Insurance Law, 2010 and such license is in full force and effect.

Regulatory. 2.42.1. Except as described set forth in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) Prospectus, each of the Company and its Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalsuch permits, 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 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 any 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 Applicable Regulations and/or to carry on as those being developed by the Company and its businesses as now conducted Subsidiaries (collectively, “AuthorizationsGovernmental Authorities,” and each, a “Governmental Authority”), except where for any of the failure to possess such Authorizations foregoing that would not reasonably be expected to not, individually or in the aggregate, have a Material Adverse EffectChange; each of the Company and its 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 Authorizationsthe Regulatory Permits that, except where individually or in the invalidityaggregate, ineffectiveness if the subject of an unfavorable decision, ruling 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 claimfinding, 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 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. 2.42.2. To the Company’s knowledge, the research, studies and clinical trials conducted by or 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 suspension or employees 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 RegulationsPreliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, 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 Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.

Regulatory. Except as set forth in the Registration Statement, Pricing Disclosure Package and the Prospectus, the Company has such permits, licenses, certificates, approvals, clearances, 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 Time of Sale Pricing Prospectus and or the Final Offering Documents: Prospectus, including, without limitation, any Investigational New Drug Application (i“IND”), New Drug Application (“NDA”), or Biologics License Application (“BLA”) as required by the Company has not received notice from any Governmental Entity alleging FDA 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 compliance with other authorizations issued by federal, state, provincial local or foreign statutes, laws, ordinances, rules agencies or bodies engaged in the regulation of pharmaceuticals and regulations applicable to biological products such as those being developed by the Company (collectively, “Applicable RegulationsGovernmental Authorities,” and each, a “Governmental Authority”), except where such non-for any of the foregoing that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; the Company is in compliance with the requirements of the Regulatory Permits and all of the Regulatory Permits are valid and in full force and effect, in each case in all respects, except as 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 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 result in the issuance of any such communication or 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 or employees or agents has been convicted of any crime under any Applicable Regulationsfilings.

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 Pricing Disclosure Package and the 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, each of Sale the Company and the Subsidiaries has all other necessary authorizations, approvals, orders, consents, 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 Final Offering Documents: (i) the Company has not received notice from any Governmental Entity alleging or asserting noncompliance with any Applicable Regulations (as defined foregoing are in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is full force and has been in compliance with federal, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”)effect, except where the failure to have such non-compliance authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; none of the 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 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 Registration Statement, 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 Registration Statement, 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. 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 have result in a Material Adverse Effect; (iii) and each of the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permitsand the Subsidiaries maintains its books and records in accordance with, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”)is otherwise in compliance with, the applicable Insurance Laws of the United States and the various states thereof, except where the failure to possess such Authorizations so maintain its books and records or be in compliance would not reasonably be expected to have a Material Adverse Effectnot, and such Authorizations are valid and individually or in full force and effect and the Company is not in violation of any term of any such Authorizationsaggregate, 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 result in a Material Adverse Effect. Except as disclosed in each of the issuance of any such communication or an investigationRegistration Statement, corrective actionthe Pricing Disclosure Package and the Prospectus, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has takenand its Subsidiaries have made no material change in their insurance reserving practices since December 31, 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 or employees or agents has been convicted of any crime under any Applicable Regulations2017.

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 Prospectus Pricing Disclosure Package and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”)Prospectus requires such licensing, except where for such non-compliance jurisdictions in which the failure to be so licensed would not not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; (iii) except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, each of the Company possesses and the Subsidiaries has all licensesother necessary authorizations, approvals, orders, consents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)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 possess have such Authorizations would not reasonably authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizationsaggregate, 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 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 an investigationqualification would not, corrective actionindividually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as otherwise described in the Registration Statement, the 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 directorsSubsidiaries; and except as otherwise described in the Registration Statement, officers the Pricing Disclosure Package and the Prospectus, none of the Company, the Subsidiaries or employees any of Properties is subject to any outstanding order or agents has been convicted 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 crime under supervisory letter from any Applicable Regulations.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 (i) The Company and each of the Company’s subsidiaries that is engaged in the business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the case may be, under the laws (including, without limitation, laws that relate to companies that control insurance companies) and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in which the conduct of its business as described in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Final Offering Documents: Prospectus requires such licensing or registration (i) the Company has not received notice from any Governmental Entity alleging each such license 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 compliance with federalregistration, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, an “Applicable RegulationsInsurance License”), except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has made all required filings under applicable Insurance Laws in each jurisdiction where such non-compliance filings are required, except for such filings the failure of which to make would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct its business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in full force and effect, except where the failure to have such Insurance Licenses and Authorizations in full force and effect would not reasonably be expected to have a Material Adverse Effect; (iii) . To the Company possesses all licensesCompany’s knowledge there is no threatened action, certificatessuit, approvalsproceeding or investigation that would, clearancesindividually or in the aggregate, consentsresult in the revocation, authorizations, qualifications, registrations, permits, termination or suspension of any of the Insurance Licenses 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 that would not reasonably be expected to have a Material Adverse Effect, . Neither the Company nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the effect that any additional Insurance Licenses and such Authorizations are valid and in full force and effect and needed to be obtained by the Company is not or any of the Insurance Subsidiaries in violation of any term of any case where it would be reasonably expected that the failure to obtain such Authorizationsadditional Insurance Licenses and Authorizations would, except where individually or in the invalidityaggregate, ineffectiveness or violation of such Authorizations would not reasonably be expected to have result in 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 result in the issuance of any such communication or 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 or employees or agents has been convicted of any crime under any Applicable Regulations.

Regulatory. 2.42.1. Except as described set forth in the Registration StatementPricing Disclosure Package and the Prospectus, the Time of Sale Prospectus Company, and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, state, provincial 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”), except where has such non-compliance would not reasonably be expected to have a Material Adverse Effect; (iii) the Company possesses all 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 any 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 Applicable Regulations and/or to carry on its businesses as now conducted those being developed by the Company (collectively, “AuthorizationsGovernmental Authorities,” and each, a “Governmental Authority”), except where for any of the failure to possess such Authorizations foregoing that would not reasonably be expected to not, individually or in the aggregate, have a Material Adverse EffectChange; the Company, and such Authorizations to the Company’s knowledge each of the Physician Sponsors, is in compliance with the requirements of the Regulatory Permits, and 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 Authorizations, except where the invalidity, ineffectiveness or violation of such Authorizations would not reasonably be expected to have a Material Adverse Effecteach 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 result in the issuance of any such communication or 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 filings. 2.42.2. To the Company’s knowledge, the research, studies and clinical trials conducted by or is considering such action. Neither on behalf of the Company norand the Physician Sponsors 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 or the Physician Sponsors, 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 to the Company’s knowledge any of its directorsPhysician Sponsor, officers has received any notice or employees correspondence from the FDA nor any Governmental Authority requiring the termination, 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 RegulationsPreliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, 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 Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.

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 Prospectus Statement and the Final Offering Documents: (i) Prospectus, each of the Company and the Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalall other necessary authorizations, stateapprovals, provincial or foreign statutesorders, 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 licensesconsents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)described in the Registration Statement and the Prospectus and all of the foregoing are in full force and effect, except where the failure to possess have such Authorizations authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; none of the 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 insurance contract or any reason to believe that termination or cancelation is contemplated; and, except as would not have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and the Company no claims have been made thereunder. There 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 result in the issuance of any such communication or 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 norno pending or, to the Company’s knowledge, 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 directorsbooks and records in accordance with, officers 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 employees be in compliance would not, individually or agents in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company has been convicted granted a Class B(iii) insurance license under The Insurance Act (as revised) of any crime under any Applicable Regulationsthe Cayman Islands, and such license is in full force and effect.

Regulatory. Except as described in the Registration Statement, the Time of Sale Prospectus Disclosure Package and the Final Offering DocumentsProspectus 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 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, provincial state 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 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 result in 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 or officers, employees or agents has been convicted of any crime under any Applicable Regulations.

Regulatory. Except (i) The Company and each of the Company’s subsidiaries that is engaged in the business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the case may be, under the laws (including, without limitation, laws that relate to companies that control insurance companies) and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in which the conduct of its business as described in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Final Offering Documents: Prospectus requires such licensing or registration (i) the Company has not received notice from any Governmental Entity alleging each such license 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 compliance with federalregistration, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, an “Applicable RegulationsInsurance License”), except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has made all required filings under applicable Insurance Laws in each jurisdiction where such non-compliance filings are required, except for such filings the failure of which to make would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct its business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in full force and effect, except where the failure to have such Insurance Licenses and Authorizations in full force and effect would not reasonably be expected to have a Material Adverse Effect; (iii) . To the Company’s knowledge there is no threatened action, suit, proceeding or investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company possesses nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the effect that any additional Insurance Licenses and Authorizations are needed to be obtained by the Company or any of the Insurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, individually or in the aggregate, result in a Material Adverse Effect. (ii) The Company and each of its subsidiaries are in compliance in all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permitsmaterial respects with all applicable laws administered by, and supplements all rules, regulations, directives, orders and decrees of any federal, state, local or amendments thereto required by foreign regulatory or supervisory authority, self-regulatory organization or governmental agency or body having jurisdiction over the Company or any such Applicable Regulations and/or to carry on of its businesses as now conducted subsidiaries (each, a “AuthorizationsRegulatory Authority”) (including, without limitation, state insurance regulatory authorities), including applicable regulatory capital requirements, except where the failure to possess such Authorizations so comply would not not, individually or in the aggregate, result in a Material Adverse Effect. (iii) Except as described in the Registration Statement, Pricing Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and neither the Company nor any of its subsidiaries is a party to or otherwise subject to any order, decree, agreement, memorandum of understanding, or other regulatory enforcement action, proceeding or order with or by, or is a party to or recipient of a commitment letter, supervisory letter or similar undertaking to or from, any Regulatory Authority (whether or not in violation such Regulatory Authority has determined that publication would be contrary to the public interest) or has adopted any board resolutions at the request of any term Regulatory Authority. Neither the Company nor any of its subsidiaries has been advised by any such AuthorizationsRegulatory Authority that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, except where decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar undertaking; and there is no unresolved violation, criticism or exception by any Regulatory Authority with respect to any examination of the invalidityCompany and its subsidiaries which, ineffectiveness or violation in the reasonable judgment of such Authorizations would not reasonably be the Company, is expected to have result in 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 result in the issuance of any such communication or 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 or employees or agents has been convicted of any crime under any Applicable Regulations.

Regulatory. Except as described set forth in the Registration StatementPricing Disclosure Package and the Prospectus, the Time of Sale Prospectus Company, and the Final Offering Documents: (i) the Company has not received notice from any Governmental Entity 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 compliance with federal, state, provincial 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”), except where has such non-compliance would not reasonably be expected to have a Material Adverse Effect; (iii) the Company possesses all 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 any 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 Applicable Regulations and/or to carry on its businesses as now conducted those being developed by the Company (collectively, “AuthorizationsGovernmental Authorities,” and each, a “Governmental Authority”), except where for any of the failure to possess such Authorizations foregoing that would not reasonably be expected to not, individually or in the aggregate, have a Material Adverse EffectChange; the Company, and such Authorizations to the Company’s knowledge each of the Physician Sponsors, is in compliance with the requirements of the Regulatory Permits, and 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 Authorizations, except where the invalidity, ineffectiveness or violation of such Authorizations would not reasonably be expected to have a Material Adverse Effecteach 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 result in the issuance of any such communication or 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 or employees or agents has been convicted of any crime under any Applicable Regulationsfilings.

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 Prospectus Disclosure Package and the Final Offering Documents: (i) Prospectus; each of the Company and the Subsidiaries has not received notice from any Governmental Entity 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 compliance with federalall other necessary authorizations, stateapprovals, provincial or foreign statutesorders, 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 licensesconsents, certificates, approvals, clearances, consents, authorizations, qualifications, registrationslicenses, permits, registrations and supplements or amendments thereto required by any such Applicable Regulations and/or qualifications of and from all insurance regulatory authorities necessary to carry on its conduct their respective existing businesses as now conducted (“Authorizations”)described in the Disclosure Package and the Prospectus, and all of the foregoing are in full force and effect, except where the failure to possess have such Authorizations would not reasonably authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be expected to have a Material Adverse Effect, and such Authorizations are valid and in full force and effect and would not, individually or in the Company is not in violation of any term of any such Authorizationsaggregate, 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 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 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, 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 directorsbooks and records in accordance with, officers 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 employees be in compliance would not, individually or agents in the aggregate, reasonably be expected to result in a Material Adverse Change. FGRe has been convicted of any crime granted a Class B(iii) insurance license under any Applicable RegulationsThe Insurance Law, 2010, and such license is in full force and effect.

Regulatory. (i) The Company and each of the Company’s subsidiaries that is engaged in the business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the case may be, under the laws (including, without limitation, laws that relate to companies that control insurance companies) and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in which the conduct of its business as described in the Registration Statement, the Time of Sale Information and the Prospectus requires such licensing or registration (each such license or registration, an “Insurance License”), except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has made all required filings under applicable Insurance Laws in each jurisdiction where such filings are required, except for such filings the failure of which to make would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company and each of the Insurance Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct its business as described in the Registration Statement, the Time of Sale Information and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in full force and effect, except where the failure to be so licensed or registered would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. To the Company’s knowledge there is no threatened action, suit, proceeding or investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the effect that any additional Insurance Licenses and Authorizations are needed to be obtained by the Company or any of the Insurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, individually or in the aggregate, result in a Material Adverse Effect. (ii) The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws administered by, and all rules, regulations, directives, orders and decrees of any federal, state, local or foreign regulatory or supervisory authority, self-regulatory organization or governmental agency or body having jurisdiction over the Company or any of its subsidiaries (each, a “Regulatory Authority”) (including, without limitation, state insurance regulatory authorities), including applicable regulatory capital requirements, except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect. (iii) Except as described in the Registration Statement, the Time of Sale Prospectus Information and the Final Offering Documents: (i) Prospectus, or as would not, individually or in the Company has not received notice from any Governmental Entity 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 compliance with federalaggregate, 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 neither the Company nor any of its subsidiaries is a party to or otherwise subject to any order, decree, agreement, memorandum of understanding, or other regulatory enforcement action, proceeding or order with or by, or is a party to or recipient of a commitment letter, supervisory letter or similar undertaking to or from, any Regulatory Authority (whether or not in violation such Regulatory Authority has determined that publication would be contrary to the public interest) or has adopted any board resolutions at the request of any term Regulatory Authority. Neither the Company nor any of its subsidiaries has been advised or notified by any such AuthorizationsRegulatory Authority that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, except where decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar undertaking; and there is no unresolved violation, criticism or exception by any Regulatory Authority with respect to any examination of the invalidityCompany and its subsidiaries which, ineffectiveness or violation in the reasonable judgment of such Authorizations would not reasonably be the Company, is expected to have result in 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 result in the issuance of any such communication or 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 or employees or agents has been convicted of any crime under any Applicable Regulations.