Common use of Tests and Preclinical and Clinical Trials Clause in Contracts

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance with and any applicable laws, including, without limitation, the FDCA and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312 and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and 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 Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Pricing General Disclosure Package and 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 Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance with and any applicable laws, including, without limitation, the FDCA and its implementing regulations at 21 C.F.R. Parts 50FDA Laws, 54, 56, 58 and 312 and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and 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 Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Pricing General Disclosure Package and 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 Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, as applicable, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Final Prospectus are, to the Company’s knowledge, 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 Pricing General Disclosure Package and the Final Prospectus, or would not, singly or in the aggregate, result in a Material Adverse Effect, 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 Pricing General Disclosure Package and the Final Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Final Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with all Authorizations and any applicable lawsApplicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Pricing General Disclosure Package and 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 Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with all Governmental Licenses and any applicable lawsApplicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of promulgated thereunder (collectively, “FFDCA”); to the jurisdiction in which such Company’s knowledge, the studies, tests and preclinical and clinical trials and studies being conducted on the Company’s behalf were and, if still ongoing, are being conductedconducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FFDCA; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Pricing General Disclosure Package and the Prospectus, 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 trial results described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s 's knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, as applicable, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials promulgated thereunder and studies are being conductedall applicable legislation, regulations, by-laws or guidance from Health Canada; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company's knowledge, 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 Pricing General Disclosure Package and the Prospectus, or would not, singly or in the aggregate, result in a Material Adverse Effect, 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 Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA FDA, Health Canada or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company (the “Company Trials”) that are described in the Registration Statement, the General Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in all material respects in compliance accordance with the protocols submitted to the FDA, the European Medicines Agency or any foreign governmental body exercising comparable authority, and any applicable lawsprocedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder (collectively, “FFDCA”); the descriptions of the Company Trials and the results of such studiesthereof, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and 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 of the Company Trials described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices correspondence or written correspondence notice from the FDA FDA, the European Medicines Agency or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in compliance accordance with their experimental protocols submitted to the FDA or other comparable government entities and any applicable lawsall Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder and 312 current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus are, to the Company’s knowledge, 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 each case as would not, individually or in the Registration Statement, the Pricing Disclosure Package and the Prospectusaggregate have a Material Adverse Effect, 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 Pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to the Agents.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, or on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Health Care Laws, including, without limitation, the FDCA FFDCA and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 58, and 312 and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package 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 Pricing General Disclosure Package and 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 Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of developmentProspectus; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus Final Offering Memorandum are, to the Company’s knowledge, accurate 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 Pricing General Disclosure Package and the ProspectusFinal Offering Memorandum, 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 Pricing General Disclosure Package and the Prospectus Final Offering Memorandum when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the ProspectusFinal Offering Memorandum, neither the Company nor any of its subsidiaries has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance with and any applicable laws, including, without limitation, the FDCA and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312 and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and 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 Pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with all Authorizations and any applicable lawsApplicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder and 312 current Good Clinical Practices and Good Laboratory Practices and any applicable rules rules, regulations and regulations policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained or incorporated by reference in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus fairly present are, to the data derived from such studiesCompany’s knowledge, tests accurate and trialscomplete in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and 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 Pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, the Company has not received any written notices notice or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder and 312 current Good Clinical Practices and Good Laboratory Practices and any applicable rules rules, regulations and regulations policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Pricing Disclosure Package and 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 Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The Except as would not, individually or in the aggregate, result in a Material Adverse Effect, to the knowledge of the Company as of the date of this Agreement, the studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, or on behalf of the Company or its Subsidiaries, were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any controls pursuant to accepted professional scientific standards and all permits and licenses and applicable lawsLaws including, includingas applicable, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50Cosmetic Act of 1938, 54as amended, 56, 58 and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conducted; the promulgated thereunder. The descriptions of the results of such studies, tests and trials contained in the Registration StatementCompany SEC Documents are, to the Pricing Disclosure Package Company’s knowledge, accurate and the Prospectus 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 StatementCompany SEC Documents. Except to the extent disclosed in the Company SEC Documents or as would not, individually or in the Pricing Disclosure Package and the Prospectusaggregate, result in a Material Adverse Effect, (i) 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 Pricing Disclosure Package and the Prospectus Company SEC Documents when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, and (ii) the Company has and its Subsidiaries have not received any written notices or written correspondence from the FDA United States Food and Drug Administration, any regulatory agencies or any governmental entity other Governmental Authorities requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany or its Subsidiaries, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the knowledge of the Company’s knowledge, on behalf of the Company (the “Company Trials”) that are described in the Registration Statement, the General Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in all material respects in compliance accordance with the protocols submitted to the FDA, the EMA or any foreign governmental body exercising comparable authority, and any applicable lawsprocedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder (collectively, “FFDCA”); the descriptions of the Company Trials and the results of such studiesthereof, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the knowledge of the Company, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and 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 of the Company Trials described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, and the Company has not received any correspondence or written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder and 312 current Good Clinical Practices and Good Laboratory Practices and any applicable rules rules, regulations and regulations policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, 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 Pricing Disclosure Package and the Prospectus, 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 trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any comparable governmental entity requiring the termination or suspension of any of the studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to the Underwriters.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols designed and any applicable lawsapproved for such studies and trials and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder and 312 current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably call into question the study, test, study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of developmentProspectus; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by the Health Care Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder regarding current Good Clinical Practices and 312 Good Laboratory Practices and any applicable rules rules, regulations and regulations policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Final Prospectus are, to the Company’s knowledge, 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 Pricing General Disclosure Package and the Final 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 Pricing General Disclosure Package and the Final Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Final Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 Cosmetic Act and 312 and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedpromulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except . Except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and 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, test or trial results described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company or any Subsidiary has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany or any Subsidiary, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols, procedures and any applicable lawscontrols pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at promulgated thereunder, including 21 C.F.R. Parts 50, 54, 56, 58 and 312 and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted(collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package 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 Pricing General Disclosure Package and 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 Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in compliance accordance with experimental protocols designed and any applicable lawsapproved for such studies and trials and all Authorizations and Applicable Laws, including, without limitation, the FDCA Federal Food, Drug and its implementing Cosmetic Act and the rules and regulations at 21 C.F.R. Parts 50, 54, 56, 58 promulgated thereunder and 312 current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests studies and trials contained in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, the Company is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably call into question the study, test, study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of developmentProspectus; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.