Common use of Regulatory Authorities Clause in Contracts

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material 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”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations 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). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or and the Prospectus, each of the Company and its subsidiaries: (ai) is and at are in compliance in all times has been in material compliance respects with all statutes, rules or regulations 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, offer for saleprice 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; (bii) has to the knowledge of Company and its subsidiaries, have 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) have not received any FDA Food and Drug Administration (“FDA”) Form 483, notice of adverse finding483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material 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 as would not, individually or in the aggregate, result in a Material Adverse Effect; (civ) possesses have not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of 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) 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 their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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; (dvi) has have not received written notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration arbitration, suspension, debarment or other action exclusion from any Governmental Authority governmental authority or third party Institutional Review Board alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority governmental authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, actionsuspension, suitdebarment or exclusion except for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or proceedingexclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (evii) 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; and (fviii) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 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 (ix) 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 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or any of its subsidiariessubsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal Food, Drug Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither Prospectus. Neither the Company nor any of its subsidiaries has received any written notices or other correspondence from any Governmental Authority the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to or in which the Company and or any of its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Time of Sale Disclosure Package or and the Prospectus, each of the Company and its subsidiariesCompany: (ai) is and at in compliance in all times has been in material compliance respects with all statutes, rules or regulations 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, offer for saleprice 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; (bii) 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 FDA Food and Drug Administration (“FDA”) Form 483, notice of adverse finding483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material 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 as would not, individually or in the aggregate, result in a Material Adverse Effect; (civ) 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 effect) and are not in material 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; (dvi) has not received written notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration arbitration, suspension, debarment or other action exclusion from any Governmental Authority governmental authority or third party Institutional Review Board alleging that any product, operation of its operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority governmental authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, actionsuspension, suitdebarment or exclusion except for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or proceedingexclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (evii) has 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; and (fviii) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 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 (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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each that are described in the Registration Statement, the Time of its subsidiaries, Sale Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal Food, Drug Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Time of Sale Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Time of Sale Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Prospectus. The Company nor any of its subsidiaries has not received any written notices or other correspondence from any Governmental Authority the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to in which the Company and its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA U.S. Food and Drug Administration or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material 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”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations 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). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a wholesubsidiaries.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the The Company and its subsidiaries: (ai) is and at all times has been are in material compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, and decrees, applicable to the ownership, testing, development, manufacture, packaging, processingrecordkeeping, use, dispensing, distribution, marketing, labeling, advertising, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured manufactured, dispensed or distributed by or for the Company or any of its subsidiaries or to the consulting services furnished by the Company and 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; (bii) has have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“a Governmental Authority”) Authority alleging or asserting material 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 as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (ciii) possesses possess all Authorizations required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, or third party other non-governmental authority alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigationsuit, arbitrationproceeding, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept as would not, investigation individually or proceedingin the aggregate, reasonably be expected to result in a Material Adverse Effect; (ev) has have not received notice that any Governmental Authority or 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, reasonably be expected to result in a Material Adverse Effect; and (fvi) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments as are required by any Applicable Laws or Authorizations 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 that 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). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or and the Prospectus, each of the Company and its subsidiaries: (ai) is and at are in compliance in all times has been in material compliance respects with all statutes, rules or regulations rules, regulations, ordinances, opinions, orders, decrees, and guidance applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, advertising, promotion, sale, offer 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, reasonably be expected to result in a Material Adverse Effect; (bii) has have not received any FDA Form 483483 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 FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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 as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (ciii) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational New Drug Application, as described at 21 CFR Sections 312 , and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority Authority, or third party Institutional Review Board is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept as would not, investigation individually or proceedingin the aggregate, reasonably be expected to result in a Material Adverse Effect; (ev) has have 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, reasonably be expected to result in a Material Adverse Effect; and (fvi) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions submissions, registrations and supplements or amendments as are required by any Applicable Laws or Authorizations 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 that 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). The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or any of its subsidiariessubsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal Food, Drug Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. CFR Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither Prospectus. Neither the Company nor any of its subsidiaries has received any notices written notices, correspondence or correspondence other communication from any Governmental Authority the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to or in which the Company and or any of its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is The Company and the Subsidiary: (A) are and at all times has have been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (bB) has have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or written notice from the FDA U.S. Food and Drug Administration or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material 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”); (cC) possesses possess all Authorizations (except as would not reasonably be expected to have a Material Adverse Effect) and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such AuthorizationsAuthorizations (except as would not reasonably be expected to have a Material Adverse Effect); (dD) has have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have has no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (eE) has have not received written notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (fF) has have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). . (b) The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, the Subsidiary were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus SEC Documents when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries the Subsidiary has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials after they were initiated and which were conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a wholeSubsidiary.

Regulatory Authorities. Except as otherwise described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and each of its subsidiaries: (ai) is and at all times has been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer 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 reasonably be expected, singly or in the aggregate, to result in a Material Adverse Change; (bii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter, not approvable letter, approvable letter or complete response letter, or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material noncompliance with or failure to satisfy the requirements of any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments amendments, including pending licenses, certificates, approvals, clearances, authorizations, permits, or supplements, thereto required by any such Applicable Laws (“Authorizations”), except such FDA Forms 483, notices, letters or other correspondence of noncompliance as would not reasonably be expected, singly or in the aggregate, to result in a Material Adverse Change; (ciii) possesses all Authorizations required for the conduct of its business, and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not reasonably be expected, singly or in the aggregate, to result in a Material Adverse Change; (div) has not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, Company operation or activity is in material violation of any Applicable Laws or Authorizations and have has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation proceeding, hearing, enforcement, audit, investigation, arbitration or proceedingother action; (ev) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (fvi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not reasonably be expected, singly or in the aggregate, to result in a Material Adverse Change 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 (vii) 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, investigator notice, or other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or material violation of any Applicable Laws or Authorizations; the Company is not aware of any facts that would cause the Company to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action. The studies, tests descriptions in the Registration Statement and preclinical the Prospectus of the indication for which its products are approved or for which the Company or any of its subsidiaries is seeking approval are accurate and complete in all material respects. The clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company that are described in the Registration Statement and each of its subsidiaries, the Prospectus were and, if still pending, are being conducted in all material respects in accordance compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable local, state and Authorizationsfederal laws, rules, regulations and guidances, including, without limitationbut not limited to, the Federal U.S. federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 58, 312 and 312; the 314. The descriptions of the results of such studies, tests and trials preclinical and clinical trials, including the related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or Statement and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration StatementStatement and the Prospectus, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither . Except as otherwise described in the Prospectus, the Company nor any of its subsidiaries has not received any notices notices, correspondence or correspondence other communication from any Governmental Authority the FDA or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to in which the Company has participated. The Company is not aware of any clinical trial issues, correspondence with the FDA (written or verbal) or any other developments that may reasonably call into question in any material respect the expected clearance or approval pathway, regulatory status, or estimated timeframe for clearance or approval for its products in development described or referred to in the Registration Statement and its subsidiaries taken as a wholethe Prospectus.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or Statement and the Prospectus, each of the Company and its subsidiaries: (ai) is are and at all times has been in compliance in all material compliance respects with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidance applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (bii) has have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA U.S. Food and Drug Administration (the “FDA”), Nuclear Regulatory Commission or any other federal, state state, local or foreign governmental authority having authority over the Company or its subsidiaries (“Governmental Authority”) alleging or asserting material 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”); (ciii) possesses possess all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such AuthorizationsAuthorizations except for such violations as would not have a Material Adverse Effect; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity by the Company or its subsidiaries is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation proceeding, hearing, enforcement, audit, investigation, arbitration or proceedingother action; (ev) has have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (fvi) has have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct in all material respects on the date filed (or were corrected or supplemented by a subsequent submission). The studies; and (vii) have not, tests and preclinical and clinical trials material either voluntarily or involuntarily, initiated, conducted, or issued or caused to the Company and its subsidiaries taken as a wholebe initiated, and conducted by or issued, any Class I or Class II recall, market withdrawal or replacement, post sale warning or other notice or action relating to an alleged lack of safety or efficacy of any product, any alleged product defect, or violation on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all any Applicable Laws and or Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which facts that would reasonably be expected to cause the Company believes reasonably call into question the study, test, or trial results described its subsidiaries to initiate any such notice or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described action; and the clinical state of development; and neither the Company nor does not have any of its subsidiaries has received any notices knowledge or correspondence from reason to believe that any Governmental Authority requiring the termination, suspension or material modification of third party intends to initiate any studies, tests such notice or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a wholeaction.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or and the Prospectus, each of the Company and its subsidiaries: (ai) is and at are in compliance in all times has been in material compliance respects with all statutes, rules or regulations 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, offer for saleprice 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; (bii) has to the knowledge of Company and its subsidiaries, have 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) have not received any FDA Form 483, notice of adverse finding483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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 as would not, individually or in the aggregate, result in a Material Adverse Effect; (civ) possesses have not received notification of nor have reason to believe that any audits by a Governmental Authority have resulted in a determination that any of 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) 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 their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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; (dvi) has have not received written notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration arbitration, suspension, debarment or other action exclusion from any Governmental Authority or third party Institutional Review Board alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, actionsuspension, suitdebarment or exclusion except for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or proceedingexclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (evii) has have 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; and (fviii) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 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 (ix) 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 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or any of its subsidiariessubsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal Food, Drug Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither Prospectus. Neither the Company nor any of its subsidiaries has received any written notices or other correspondence from any Governmental Authority the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to or in which the Company and or any of its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or and the Prospectus, each of the Company and its subsidiaries: (ai) is and at all times has been have not, either voluntarily or involuntarily, disclosed to any Governmental Authority any violations of applicable laws, including any Health Care Laws (as defined in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”Section 1(a)(48)); (bii) has have not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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 as would not, individually or in the aggregate, result in a Material Adverse Effect; (ciii) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational New Drug Application, as described at 21 CFR Part 312, and approvals of any Institutional Review Board) required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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; (div) has not have not, and entities conducting clinical testing on behalf of the Company or any of its subsidiaries have not, received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws applicable laws, including Health Care Laws, or Authorizations Authorizations, and have the Company has no knowledge or reason to believe that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept as would not, investigation individually or proceedingin the aggregate, result in a Material Adverse Effect; (ev) has have not received notice that any Governmental Authority 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 is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; and (fvi) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material 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 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 that 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). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or the U.S. Prospectus, each of the Canadian Prospectus and the Statutory Prospectus, the Company and its subsidiaries: (ai) is are and at all times has have been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer 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, have a Material Adverse Effect; (bii) has have not received any FDA Form 483483 or any non-U.S. counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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, have a Material Adverse Effect; (ciii) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational New Drug application, and approvals of any Institutional Review Board) required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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, have a Material Adverse Effect; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of their respective operations or activity is activities are in violation of any Applicable Laws or Authorizations and have no neither the Company nor the Parent has knowledge or reason to believe that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigation, arbitration, action, suit, investigation proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or proceedingother action; (ev) has have not received notice that any Governmental Authority 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 neither the Company nor the Parent has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (fvi) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, have 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 (vii) 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, investigator notice, or 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 neither the Company nor the Parent is aware of any facts that would cause the Company or any of its subsidiaries to initiate any such notice or action and neither the Company nor the Parent has any 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. The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or any of its subsidiariessubsidiaries that are described in the Registration Statement, the U.S. Prospectus, the Canadian Prospectus or the Statutory Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable U.S. and Canadian federal, state, provincial, territorial and local and all Applicable Laws foreign laws, rules and Authorizationsregulations, including, without limitationbut not limited to, the Federal U.S. federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . The descriptions of the results of such studies, tests and trials preclinical and clinical trials, including the related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or U.S. Prospectus, the Canadian Prospectus and the Statutory Prospectus are and will be accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, respects. Neither the Company nor the Parent is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package U.S. Prospectus, the Canadian Prospectus or the Prospectus when viewed Statutory Prospectus. Except as described in the context in which such results are described Registration Statement, the U.S. Prospectus, the Canadian Prospectus and the clinical state of development; and Statutory Prospectus, neither the Company Company, nor any of its subsidiaries nor the Parent has received any notices notices, correspondence or correspondence other communication from any Governmental Authority the FDA, an Institutional Review Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to or in which the Company and or any of its subsidiaries taken as a wholehave participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or U.S. Prospectus and the Canadian Prospectus, each of the Company and its subsidiariessubsidiary: (ai) is and at all times has been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, development, manufacture, packaging, processing, recordkeeping, use, distribution, marketing, labelinglabelling, promotion, sale, offer 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 reasonably be expected, singly or in the aggregate, to result in a Material Adverse Effect; (bii) has not received any U.S. FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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 not reasonably be expected, singly or in the aggregate, to result in a Material Adverse Effect; (ciii) possesses all Authorizations required for the conduct of its business, and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not reasonably be expected, singly or in the aggregate, to result in a Material Adverse Effect; (div) has not received notice of any pending or threatened claim, action, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, Company operation or activity is in violation of any material Applicable Laws or Authorizations and have has no knowledge or reason to believe that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation proceeding, hearing, enforcement, audit, investigation, arbitration or proceedingother action; (ev) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge or reason to believe that any such Governmental Authority is considering such action; and (fvi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not reasonably be expected, 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 (vii) 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, investigator notice, or 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; the Company is not aware of any facts that would cause the Company to initiate any such notice or action; and the Company does not have any knowledge or reason to believe that any Governmental Authority or third party intends to initiate any such notice or action. The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company that are described in the Registration Statement, the U.S. Prospectus and each of its subsidiaries, the Canadian Prospectus were and, if still pending, are being conducted in all material respects in accordance compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable local, state and Authorizationsfederal laws, rules, regulations and guidances, including, without limitationbut not limited to, the Federal U.S. federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . The descriptions of the results of such studies, tests and trials preclinical and clinical trials, including the related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or U.S. Prospectus and the Canadian Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or U.S. Prospectus and the Prospectus Canadian Prospectus, when viewed in the context in which such results are described and the clinical state of development; . Except as described in the Registration Statement, the U.S. Prospectus and neither the Canadian Prospectus, the Company nor any of its subsidiaries has not received any notices notices, correspondence or correspondence other communication from any Governmental Authority the U.S. FDA, an Institutional Review Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to in which the Company and its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the each General Disclosure Package or and the Prospectus, each of the Company and its subsidiariesCompany: (ai) is and at all times has been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer 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; (bii) has not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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; (ciii) possesses all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption, as described at 21 CFR 812, and approvals of any Institutional Review Board) required for the conduct of the Company’s business (and such Authorizations are valid and in full force and effect effect) and are is not in material 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; (div) has not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of the Company’s operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations or proceedingother actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (ev) has not received notice that any Governmental Authority 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 is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; and (fvi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 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 (vii) 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, investigator notice, or 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 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or, to the knowledge of the Company, LSLLC or any of its subsidiariessubsidiaries that are described in the Registration Statement, any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal U.S. Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the any General Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the any General Disclosure Package or the Prospectus when viewed in Prospectus. Neither the context in which such results are described and Company, nor, to the clinical state knowledge of development; and neither the Company Company, LSLLC nor any of its subsidiaries has received any notices notices, correspondence or correspondence other communication from any Governmental Authority the FDA, an Institutional Review Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to in which the Company and its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the each General Disclosure Package or and the Prospectus, each of the Company and its subsidiariesCompany: (ai) is and at all times has been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer 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; (bii) has not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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; (ciii) possesses all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption, as described at 21 CFR 812, and approvals of any Institutional Review Board) required for the conduct of the Company's business (and such Authorizations are valid and in full force and effect effect) and are is not in material 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; (div) has not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of the Company's operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations or proceedingother actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (ev) has not received notice that any Governmental Authority 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 is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; and (fvi) has, or has had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 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 (vii) 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, investigator notice, or 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 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or, to the knowledge of the Company, LSLLC or any of its subsidiariessubsidiaries that are described in the Registration Statement, any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal U.S. Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the any General Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the any General Disclosure Package or the Prospectus when viewed in Prospectus. Neither the context in which such results are described and Company, nor, to the clinical state knowledge of development; and neither the Company Company, LSLLC nor any of its subsidiaries has received any notices notices, correspondence or correspondence other communication from any Governmental Authority the FDA, an Institutional Review Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to in which the Company and its subsidiaries taken as a wholehas participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or the each Applicable Prospectus, each of the Company and its subsidiaries: (ai) is are and at all times has have been in material compliance with all statutes, rules or regulations 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, offer 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 Change; (bii) has have not received any FDA Form 483483 or any non-U.S. counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 C.F.R. 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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 Change; (ciii) possesses possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption, as described at 21 C.F.R. 812, and approvals of any Institutional Review Board) required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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 Change; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority or third party Institutional Review Board alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge that any such Governmental Authority or third party Institutional Review Board is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations or proceedingother actions that would not, individually or in the aggregate, result in a Material Adverse Change; (ev) has have not received 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 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 Change; and (fvi) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 Change 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 (vii) 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, investigator notice, or 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 that any Governmental Authority or Institutional Review Board 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 Change. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or any of its subsidiaries, subsidiaries that are described in the Registration Statement or any Applicable Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal U.S. Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the 812. Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status contained in the Registration Statement, the General Disclosure Package Statement or the any Applicable Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package Statement or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither any Applicable Prospectus. Neither the Company nor any of its subsidiaries has received any notices notices, correspondence or correspondence other communication from any the FDA, an Institutional Review Board, or other Governmental Authority or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to or in which the Company and or any of its subsidiaries taken as a wholehave participated.

Regulatory Authorities. Except as described in the Registration Statement, the each General Disclosure Package or and the Prospectus, each of LSLLC and its subsidiaries and, solely for periods prior to the Spin Off Date while the Company and its subsidiarieswas a subsidiary of LSLLC, the Company: (ai) is are and at all times has have been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company or for 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; (bii) has have not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material noncompliance with any LSLLC Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such LSLLC Applicable Laws (“"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; (ciii) possesses possess all LSLLC Authorizations (including, without limitation, exemptions under any Investigational Device Exemption, as described at 21 CFR 812, and approvals of any Institutional Review Board) required for the conduct of such entity's business (and such LSLLC Authorizations are valid and in full force and effect effect) and are not in material 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; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of such entity's operations or activity activities is in violation of any LSLLC Applicable Laws or LSLLC Authorizations and have LSLLC has no knowledge that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations or proceedingother actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (ev) has have not received notice that any Governmental Authority 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 LSLLC 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; and (fvi) has have, or have had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any LSLLC Applicable Laws or Authorizations 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 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 (vii) 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, investigator notice, or 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 LSLLC is not aware of any facts that would cause any such entity to initiate any such notice or action and LSLLC 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and 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 and each was a subsidiary of its subsidiariesLSLLC, the Company that are described in the Registration Statement, any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal U.S. Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and preclinical and clinical trials 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 any General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company respects. LSLLC is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results conducted prior to the Spin Off Date described or referred to in the Registration Statement, the any General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor Prospectus. 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 received any notices notices, correspondence or correspondence other communication from any Governmental Authority the FDA, an Institutional Review Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of the Company of, such entity or any of its subsidiaries that are material to the Company and its subsidiaries taken as a wholein which such entity has participated.

Regulatory Authorities. Except as described in the Registration Statement, the each General Disclosure Package or and the Prospectus, each of LSLLC and its subsidiaries and, solely for periods prior to the Spin Off Date while the Company and its subsidiarieswas a subsidiary of LSLLC, the Company: (ai) is are and at all times has have been in material full compliance with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees and guidances applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company or for 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; (bii) has have not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material noncompliance with any LSLLC Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such LSLLC Applicable Laws (“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; (ciii) possesses possess all LSLLC Authorizations (including, without limitation, exemptions under any Investigational Device Exemption, as described at 21 CFR 812, and approvals of any Institutional Review Board) required for the conduct of such entity’s business (and such LSLLC Authorizations are valid and in full force and effect effect) and are not in material 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; (div) has have not received notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority alleging that any product, operation of such entity’s operations or activity activities is in violation of any LSLLC Applicable Laws or LSLLC Authorizations and have LSLLC has no knowledge that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, arbitrationproceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration or other action, suitexcept for any such claims, investigation suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations or proceedingother actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (ev) has have not received notice that any Governmental Authority 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 LSLLC 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; and (fvi) has have, or have had on its behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any LSLLC Applicable Laws or Authorizations 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 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 (vii) 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, investigator notice, or 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 LSLLC is not aware of any facts that would cause any such entity to initiate any such notice or action and LSLLC 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and 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 and each was a subsidiary of its subsidiariesLSLLC, the Company that are described in the Registration Statement, any General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal U.S. Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and preclinical and clinical trials 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 any General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company respects. LSLLC is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results conducted prior to the Spin Off Date described or referred to in the Registration Statement, the any General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor Prospectus. 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 received any notices notices, correspondence or correspondence other communication from any Governmental Authority the FDA, an Institutional Review Board, or other governmental agency or non-governmental authority requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of the Company of, such entity or any of its subsidiaries that are material to the Company and its subsidiaries taken as a wholein which such entity has participated.

Regulatory Authorities. Except as described in the Registration Statement, the General Disclosure Package or and the Prospectus, each of the Company and its subsidiaries: (ai) is and at are in compliance in all times has been in material compliance respects with all statutes, rules or regulations rules, regulations, ordinances, orders, decrees, and guidance applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, offer for 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; (bii) has have not received any FDA Form 483483 or any foreign counterpart thereof, notice of adverse finding, warning letter, clinical hold notice, untitled letter or other correspondence or notice from the FDA FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) Authority alleging or asserting material 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 as would not, individually or in the aggregate, result in a Material Adverse Effect; (ciii) possesses have not received notification of nor have reason to believe that any audits by a Governmental Authority have resulted in a determination that any of 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; (iv) 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 their respective businesses (and such Authorizations are valid and in full force and effect effect) and are not in material 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; (dv) has have not received written notice of any pending or threatened claim, action, suit, proceeding, clinical hold, hearing, enforcement, investigationaudit, investigation or arbitration or other action from any Governmental Authority or third party Institutional Review Board alleging that any product, operation of their respective operations or activity activities is in violation of any Applicable Laws or Authorizations and have the Company has no knowledge or reason to believe that any such Governmental Authority Authority, Institutional Review Board or third party other non-governmental authority is considering any such claim, litigationsuit, arbitrationproceeding, actionclinical hold, suithearing, enforcement, audit, investigation or proceedingarbitration, except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations or arbitrations that would not, individually or in the aggregate, result in a Material Adverse Effect; (evi) has have not received 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; and (fvii) has have, or have had on their behalf, filed, declared, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations 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 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 (viii) 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 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. The studies, tests and preclinical and Any clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each or any of its subsidiariessubsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws applicable federal, state, local and Authorizationsforeign laws, rules and regulations, including, without limitationbut not limited to, the Federal Food, Drug Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the . Any descriptions of the results of such studies, tests and trials preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are are, and will be, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the respects. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question in any material respect the study, test, or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither Prospectus. Neither the Company nor any of its subsidiaries has received any written notices or other correspondence from any Governmental Authority the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by by, or on behalf of of, the Company or any of its subsidiaries that are material to or in which the Company and or any of its subsidiaries taken as a wholehas participated.