Common use of Regulatory Authorities Clause in Contracts

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, the Company: (i) is in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of the Company, has not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of its business (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (vi) has not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion from any governmental authority or Institutional Review Board alleging that any of its operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (vii) has not received written notice that any governmental authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viii) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ix) has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus. The Company has not received any written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the CompanyCompany and its subsidiaries: (i) is are in compliance in all material respects with all statutes, rules, regulations, ordinances, orders opinions, orders, decrees, and decrees guidance applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, advertising, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company or any of its subsidiaries (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (ii) to the knowledge of the Company, has not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has have not received any Food and Drug Administration (“FDA”) FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits registrations, permits, franchises, privileges, variances, immunities, and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; (viii) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of its business their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (viiv) has have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority alleging that any of its their respective operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, or Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (viiv) has have not received written notice that any governmental authority Governmental Authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (viiivi) hashave, or has have had on its their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ix) has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. CFR Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus. The Neither the Company nor any of its subsidiaries has not received any written notices notices, correspondence or other correspondence communication from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries or in which the Company or any of its subsidiaries has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale each General Disclosure Package and the Prospectus, LSLLC and its subsidiaries and, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company: (i) is are and at all times have been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders orders, decrees and decrees guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursementoffer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company such entity (“"LSLLC Applicable Laws”"), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to have not received any FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the knowledge of the CompanyFDA, has notany Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other Governmental Authority alleging or asserting noncompliance with any LSLLC Applicable Laws or any licenses, either voluntarily certificates, approvals, clearances, authorizations, permits and supplements or involuntarily, disclosed to amendments thereto required by any governmental authority any violations of such LSLLC Applicable LawsLaws ("LSLLC Authorizations"), except such FDA Forms 483 and foreign counterparts thereof, notices, letters or other correspondence alleging or asserting such noncompliance as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses possess all LSLLC Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug ApplicationExemption, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, ) required for the conduct of its such entity's business (and such LSLLC Authorizations are valid and in full force and effect) and are not in violation of any term of any such LSLLC Authorizations, except where the failure to possess such LSLLC Authorization or the violation of such LSLLC Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority alleging that any of its such entity's operations or activities is in violation of any LSLLC Applicable Laws or LSLLC Authorizations and the Company LSLLC has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments arbitrations or exclusions other actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has have not received written notice that any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any LSLLC Authorizations and the Company LSLLC has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiivi) hashave, or has have had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any LSLLC Applicable Laws or LSLLC Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ixvii) has have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “"dear doctor” letter " letter, investigator notice, or investigator other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material LSLLC Applicable Laws or LSLLC Authorizations and the Company LSLLC is not aware of any facts that would cause the Company any such entity to initiate any such notice or action and the Company LSLLC has no knowledge or reason to believe that any governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of LSLLC or any of its subsidiaries or, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company that are described in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal U.S. Food, Drug, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trialstrials conducted by LSLLC or any of its subsidiaries or, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus are, and will be, are accurate and complete in all material respects. The Company LSLLC is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results conducted prior to the Spin Off Date described or referred to in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus. The Neither LSLLC or any of its subsidiaries or, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company has not received any written notices notices, correspondence or other correspondence communication from the FDA, an Institutional Review Board Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company such entity or in which the Company such entity has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale Disclosure Package U.S. Prospectus and the Canadian Prospectus, each of the CompanyCompany and its subsidiary: (i) is and at all times has been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders orders, decrees and decrees guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labelinglabelling, promotion, sale, price reporting, reimbursementoffer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (“Applicable Laws”), except where the failure to so comply would notnot reasonably be expected, individually singly or in the aggregate, to result in a Material Adverse Effect; (ii) to the knowledge of the Company, has not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has not received any Food and Drug Administration (“FDA”) U.S. FDA Form 483 or any foreign counterpart thereof483, notice of adverse finding, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) U.S. FDA or any other governmental authority Governmental Authority alleging or asserting noncompliance non-compliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such U.S. FDA Forms 483, notices, letters or other correspondence of violation as would notnot reasonably be expected, individually singly or in the aggregate, to result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (viii) possesses all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of its business (business, and such Authorizations are valid and in full force and effect) effect and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would notnot reasonably be expected, individually singly or in the aggregate, to result in a Material Adverse Effect; (viiv) has not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority Governmental Authority or Institutional Review Board third party alleging that any of its operations Company operation or activities activity is in violation of any material Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authority, Institutional Review Board Governmental Authority or other non-governmental authority third party is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that would not, individually or in the aggregate, result in a Material Adverse Effectother action; (viiv) has not received written notice that any governmental authority or Institutional Review Board Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiivi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would notnot reasonably be expected, individually singly or in the aggregate, to result in a Material Adverse Effect and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ixvii) has not, either voluntarily or involuntarily, initiated, conducted conducted, or issued, issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter letter, investigator notice, or investigator other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and Authorizations; the Company is not aware of any facts that would cause the Company to initiate any such notice or action action; and the Company has no does not have any knowledge or reason to believe that any governmental authority, Institutional Review Board Governmental Authority or other non-governmental authority third party intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any The clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the Time of Sale Disclosure Package or U.S. Prospectus and the Canadian Prospectus were and, if still pending, are being conducted in compliance in all material respects in compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federallocal, state, local state and foreign federal laws, rules rules, regulations and regulationsguidances, including, but not limited to, the Federal U.S. federal Food, Drug, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any The descriptions of the studies, tests and preclinical and clinical trials, including any the related results and regulatory status, contained in the Registration Statement, the Time of Sale Disclosure Package or U.S. Prospectus and the Canadian Prospectus are, and will be, are accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time U.S. Prospectus and the Canadian Prospectus, when viewed in the context in which such results are described and the clinical state of Sale Disclosure Package or development. Except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus. The , the Company has not received any written notices notices, correspondence or other correspondence communication from the U.S. FDA, an Institutional Review Board Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale each General Disclosure Package and the Prospectus, LSLLC and its subsidiaries and, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company: (i) is are and at all times have been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders orders, decrees and decrees guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursementoffer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company such entity (“LSLLC Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to have not received any FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the knowledge of the CompanyFDA, has notany Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other Governmental Authority alleging or asserting noncompliance with any LSLLC Applicable Laws or any licenses, either voluntarily certificates, approvals, clearances, authorizations, permits and supplements or involuntarily, disclosed to amendments thereto required by any governmental authority any violations of such LSLLC Applicable LawsLaws (“LSLLC Authorizations”), except such FDA Forms 483 and foreign counterparts thereof, notices, letters or other correspondence alleging or asserting such noncompliance as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses possess all LSLLC Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug ApplicationExemption, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, ) required for the conduct of its such entity’s business (and such LSLLC Authorizations are valid and in full force and effect) and are not in violation of any term of any such LSLLC Authorizations, except where the failure to possess such LSLLC Authorization or the violation of such LSLLC Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority alleging that any of its such entity’s operations or activities is in violation of any LSLLC Applicable Laws or LSLLC Authorizations and the Company LSLLC has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments arbitrations or exclusions other actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has have not received written notice that any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any LSLLC Authorizations and the Company LSLLC has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiivi) hashave, or has have had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any LSLLC Applicable Laws or LSLLC Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ixvii) has have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter letter, investigator notice, or investigator other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material LSLLC Applicable Laws or LSLLC Authorizations and the Company LSLLC is not aware of any facts that would cause the Company any such entity to initiate any such notice or action and the Company LSLLC has no knowledge or reason to believe that any governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of LSLLC or any of its subsidiaries or, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company that are described in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal U.S. Food, Drug, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trialstrials conducted by LSLLC or any of its subsidiaries or, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus are, and will be, are accurate and complete in all material respects. The Company LSLLC is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results conducted prior to the Spin Off Date described or referred to in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus. The Neither LSLLC or any of its subsidiaries or, solely for periods prior to the Spin Off Date while the Company was a subsidiary of LSLLC, the Company has not received any written notices notices, correspondence or other correspondence communication from the FDA, an Institutional Review Board Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company such entity or in which the Company such entity has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale each General Disclosure Package and the Prospectus, the Company: (i) is and at all times has been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders orders, decrees and decrees guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursementoffer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (“"Applicable Laws”"), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to has not received any FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the knowledge of the CompanyFDA, has notany Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, either voluntarily certificates, approvals, clearances, authorizations, permits and supplements or involuntarily, disclosed to amendments thereto required by any governmental authority any violations of such Applicable LawsLaws ("Authorizations"), except such FDA Forms 483 and foreign counterparts thereof, notices, letters or other correspondence alleging or asserting such noncompliance as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug ApplicationExemption, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, ) required for the conduct of its the Company's business (and such Authorizations are valid and in full force and effect) and are is not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority alleging that any of its the Company's operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments arbitrations or exclusions other actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has not received written notice that any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiivi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ixvii) has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “"dear doctor” letter " letter, investigator notice, or investigator other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or LSLLC or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or, to the knowledge of the Company, LSLLC or any of its subsidiaries that are described in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal U.S. Food, Drug, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus. The Company Neither the Company, nor, to the knowledge of the Company, LSLLC nor any of its subsidiaries has not received any written notices notices, correspondence or other correspondence communication from the FDA, an Institutional Review Board Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale Disclosure Package and the each Applicable Prospectus, the CompanyCompany and its subsidiaries: (i) is are and at all times have been in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursementoffer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company or any of its subsidiaries (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse EffectChange; (ii) to the knowledge of the Company, has not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has have not received any Food and Drug Administration (“FDA”) FDA Form 483 or any foreign non-U.S. counterpart thereof, notice of adverse finding, warning letter, clinical hold notice or notice, untitled letter or other correspondence or notice from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section C.F.R. 56.102(g)) or any other governmental authority Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such FDA Forms 483 and non-U.S. counterparts thereof, notices, letters or other correspondence alleging or asserting such noncompliance as would not, individually or in the aggregate, result in a Material Adverse EffectChange; (iviii) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug ApplicationExemption, as described at 21 CFR Sections 312 and C.F.R. 812, and approvals of any Institutional Review Board), which are in full force and effect, ) required for the conduct of its business their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse EffectChange; (viiv) has have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority Governmental Authority or Institutional Review Board alleging that any of its their respective operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authority, Governmental Authority or Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments arbitrations or exclusions other actions that would not, individually or in the aggregate, result in a Material Adverse EffectChange; (viiv) has have not received written notice that any governmental authority Governmental Authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse EffectChange; (viiivi) hashave, or has have had on its their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect Change and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ixvii) has have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter letter, investigator notice, or investigator other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Governmental Authority or Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse EffectChange. Any clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the Time of Sale Disclosure Package Statement or the any Applicable Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal U.S. Food, Drug, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312812. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, status contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the any Applicable Prospectus are, and will be, are accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the any Applicable Prospectus. The Neither the Company nor any of its subsidiaries has not received any written notices notices, correspondence or other correspondence communication from the FDA, an Institutional Review Board Board, or other Governmental Authority or non-governmental agency authority requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries or in which the Company has or any of its subsidiaries have participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale each General Disclosure Package and the Prospectus, the Company: (i) is and at all times has been in full compliance in all material respects with all statutes, rules, regulations, ordinances, orders orders, decrees and decrees guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursementoffer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of the Company, has not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has not received any Food and Drug Administration (“FDA”) FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice or notice, untitled letter or other correspondence or notice from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such FDA Forms 483 and foreign counterparts thereof, notices, letters or other correspondence alleging or asserting such noncompliance as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (viii) possesses all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug ApplicationExemption, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, ) required for the conduct of its the Company’s business (and such Authorizations are valid and in full force and effect) and are is not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority alleging that any of its the Company’s operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments arbitrations or exclusions other actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has not received written notice that any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viiivi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ixvii) has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter letter, investigator notice, or investigator other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or LSLLC or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or, to the knowledge of the Company, LSLLC or any of its subsidiaries that are described in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal U.S. Food, Drug, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale any General Disclosure Package or the Prospectus. The Company Neither the Company, nor, to the knowledge of the Company, LSLLC nor any of its subsidiaries has not received any written notices notices, correspondence or other correspondence communication from the FDA, an Institutional Review Board Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the CompanyCompany and its subsidiaries: (i) is are in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company or any of its subsidiaries (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of the CompanyCompany and its subsidiaries, has have not, either voluntarily or involuntarily, disclosed to any governmental authority Governmental Authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) has have not received any Food and Drug Administration (“FDA”) FDA Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) has have not received notification of nor have reason to believe that any audits by a governmental authority Governmental Authority have resulted in a determination that any of its their respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of its business their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (vi) has have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion from any governmental authority Governmental Authority or Institutional Review Board alleging that any of its their respective operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (vii) has have not received written notice that any governmental authority Governmental Authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viii) hashave, or has have had on its their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ix) has have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus. The Neither the Company nor any of its subsidiaries has not received any written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries or in which the Company or any of its subsidiaries has participated.

Regulatory Authorities. Except as described in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, the CompanyCompany and its subsidiaries: (i) is in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of the Company, has have not, either voluntarily or involuntarily, disclosed to any governmental authority Governmental Authority any violations of Applicable Lawsapplicable laws, except such including any Health Care Laws (as would not, individually or defined in the aggregate, result in a Material Adverse EffectSection 1(a)(48)); (iiiii) has have not received any Food and Drug Administration (“FDA”) FDA Form 483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice or notice, untitled letter or other correspondence or notice from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority Governmental Authority alleging or asserting noncompliance with any Applicable Laws applicable laws, including Health Care Laws, or any licenses, certificates, approvals, clearances, authorizations, permits exemptions, registrations, permits, franchises, privileges, variances, immunities, and supplements or amendments thereto required by any such Applicable applicable laws, including Health Care Laws (collectively, “Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iviii) has not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of its respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812Part 312, and approvals of any Institutional Review Board), which are in full force and effect, ) required for the conduct of its business their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has not have not, and entities conducting clinical testing on behalf of the Company or any of its subsidiaries have not, received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment arbitration or exclusion other action from any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority alleging that any of its their respective operations or activities is in violation of any Applicable Laws applicable laws, including Health Care Laws, or Authorizations Authorizations, and the Company has no knowledge or reason to believe that any such governmental authorityGovernmental Authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitrationarbitration or other action, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that as would not, individually or in the aggregate, result in a Material Adverse Effect; (viiv) has have not received written notice that any governmental authority or Governmental Authority, Institutional Review Board or other non-governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority Governmental Authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; and (viiivi) hashave, or has have had on its their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments as are required by any Applicable Laws applicable laws, including Health Care Laws, or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect Effect, and all such reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (ix) has not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus. The Company has not received any written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated.