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

Tests and Preclinical and Clinical Trials. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the 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 government entities, were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 or trials, the results of which the Company believes reasonably call into question the 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 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 governmental entity requiring the termination or suspension of any 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the CompanyCompany or any of its subsidiaries, that are described in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable government governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and and, for studies submitted to regulatory authorities for approval, in all material respects, 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 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 and trialstrials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, the Company and each of its subsidiaries, is not aware of any studies or trials, the results of which the Company believes reasonably materially call into question the 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 stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, the Company has or any of its subsidiaries have not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the CompanyCompany or any of its subsidiaries, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or the Prospectus, neither the Company nor 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable government governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and and, for studies submitted to regulatory authorities for approval, in all material respects, 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 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 and trialstrials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably materially call into question the 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 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 governmental entity requiring the termination or suspension of any 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the 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 the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 or trials, the results of which the Company believes reasonably call into question the 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 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 governmental entity requiring the termination or suspension of any 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, 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 that were conducted, or are being conducted, by or on behalf of the Company and that are described in the Registration Statement, the General Disclosure Package and the Prospectus were and, if still pending, are being, conducted (in the case of those conducted on behalf of the Company, to the Company’s knowledge), in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”) or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations; the descriptions of the studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that and the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects; the Company is not aware of any other studies, tests or preclinical and clinical trials, the results of which call into question, in any material respect, the results described in the Registration Statement, the Pricing General Disclosure Package 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 accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 or trials, the results of which the Company believes reasonably call into question the 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 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 FDA, any foreign, state or local governmental body exercising comparable authority or any governmental entity Institutional Review Board requiring the termination termination, suspension, material modification or suspension clinical hold of any studies, tests or preclinical studies or clinical trials conducted by or on behalf of the Company that are material to the Company or that are related to any material product candidate 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 reasonably be expected to be material to the Acquired Companies, taken as a whole, the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the 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 government entities, Acquired Companies were and, if still ongoing, are being being, conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA or any foreign governmental body exercising comparable authority, procedures and controls pursuant to accepted professional scientific standards to, where applicable, good clinical practice, informed consent and all Authorizations applicable laws, regulations and Applicable Lawsrequirements. The Acquired Companies have filed with the FDA or other appropriate Governmental Entity all material required notices, includingand annual or other reports, without limitationincluding notices of adverse experiences and reports of serious and unexpected adverse experiences, related to the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations use of the jurisdiction its product candidates in which such trials and studies are being conducted; the clinical trials. The descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus areconducted by or, to the Company’s knowledge, on behalf of the Acquired Companies, contained in the SEC Filings are accurate and complete in all material respects and fairly present the data derived from such studies and trialsrespects; except to the extent disclosed in the Registration StatementCompany’s knowledge, the Pricing Disclosure Package there are no other studies, tests or preclinical and the Prospectus, the Company is not aware of any studies or clinical trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package SEC Filings; and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has Acquired Companies have not received any written notices or written correspondence from the FDA FDA, any Governmental Entity exercising comparable authority or any governmental entity institutional review board requiring the termination termination, suspension, material modification or suspension clinical hold of any preclinical studies or clinical trials conducted by or on behalf of the Acquired Companies. The properties, business and operations of the Acquired Companies have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA and any other Governmental Entity. The Acquired Companies have not been informed by the FDA or any other Governmental Entity that the FDA or any other Governmental Entity will prohibit the testing, distribution, marketing, sale, license or use of any product proposed to be developed, produced, tested, distributed or marketed by the Acquired Companies. Neither the Acquired Companies nor, to the Company’s knowledge, other than ordinary course communications any of their officers or employees has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to modifications “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in connection with 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. Neither the design and implementation Acquired Companies nor, to the Company’s knowledge, any officer or employee of such trials, copies the Acquired Companies has been convicted of which communications have been made available any crime or engaged in any conduct that has resulted in or would reasonably be expected to youresult in (i) debarment under 21 U.S.C. Section 335a or any similar state law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation.

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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 studies, tests and trials contained or incorporated by reference 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical studies analytical and clinical trials validation studies sponsored or conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, Prospectus and are intended to be submitted to FDA Governmental Authorities as a basis for product approval or other comparable government entities, were and, if still ongoing, clearance are being conducted in all material respects in accordance with experimental applicable study protocols, procedures and controls pursuant to accepted professional scientific standards approved for such studies, and in compliance with all Authorizations and Applicable Laws, including, without limitation, applicable provisions of the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such analytical and validation studies 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 and trialsstudies; 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 U.S. Food and Drug Administration (“FDA”) or any governmental entity Governmental Entity requiring the termination or suspension of any preclinical studies analytical or clinical trials conducted by or on behalf of validation studies that are described in the CompanyRegistration Statement, other than ordinary course communications with respect to modifications in connection with the design General Disclosure Package and implementation of such trials, copies of which communications have been made available to youthe Prospectus.

Tests and Preclinical and Clinical Trials. The preclinical studies tests and clinical trials trials, and other studies (collectively, “studies”) being conducted by or, to the Company’s knowledge, on behalf knowledge of the Company, for the Company, or that are described in in, or the results of which are referred to in, the Registration Statement, the Pricing General Disclosure Package and or the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoingpending, are being conducted in all material respects in accordance with experimental protocols, procedures all applicable laws and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Lawsregulations, including, without limitation, the Federal Food, Drug and Cosmetic Act (collectively, “FFDCA”) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the rules protocols, procedures and regulations promulgated thereunder controls designed and approved for such studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices with standard medical and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conductedscientific research procedures; the descriptions each description of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, is accurate and complete in all material respects and fairly present presents, in all material respects, the data derived from such studies and trials; except to the extent disclosed in the Registration Statementstudies, the Pricing Disclosure Package and the Prospectus, the Company is not aware and its subsidiaries have no knowledge of any other studies or trials, the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study or trial results described or referred to in the Registration Statement, the Pricing General Disclosure Package or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Prospectus when viewed in Food and Drug Administration of the context in which such results are U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the conduct of its business as described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus, ; and 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 preclinical studies or clinical trials conducted by or on behalf and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies 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 youRegulatory Agencies.

Tests and Preclinical and Clinical Trials. The preclinical studies tests and clinical trials trials, and other studies (collectively, “studies”) being conducted by or, to the Company’s knowledge, on behalf knowledge of the Company, for the Company, or that are described in in, or the results of which are referred to in, the Registration Statement, the Pricing General Disclosure Package and or the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoingpending, are being conducted in all material respects in accordance with experimental protocols, procedures all applicable laws and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Lawsregulations, including, without limitation, the Federal Food, Drug and Cosmetic Act (collectively, “FFDCA”) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the rules protocols, procedures and regulations promulgated thereunder controls designed and approved for such studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices with standard medical and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conductedscientific research procedures; the descriptions each description of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, is accurate and complete in all material respects and fairly present presents, in all material respects, the data derived from such studies and trials; studies, and, except to the extent as disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company is not aware and its subsidiaries have no knowledge of any other studies or trials, the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study or trial results described or referred to in the Registration Statement, the Pricing General Disclosure Package and or the Prospectus when viewed in the context in which such results are described and the clinical stage of developmentProspectus; and, except to the extent as disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the conduct of its business as described in the Registration Statement, the General Disclosure Package and the Prospectus, except where the failure to do so would not reasonably be expected to have a Material Adverse Effect; except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus, ; and 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 preclinical studies or clinical trials conducted by or on behalf and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies 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 youRegulatory Agencies.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by orthe Company were and, if still ongoing, are being conducted in all material respects in accordance with all Governmental Licenses and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); to the Company’s knowledge, the studies, tests and preclinical and clinical trials being conducted on behalf of the 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 government entities, ’s behalf were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedFFDCA; the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question in any material respect the study 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 stage 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 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, 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 or sponsored 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, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package 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 accordance with experimental protocols, standard medical and scientific research standards and procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Lawsapplicable statutes, including, without limitation, the Federal Food, Drug and Cosmetic Act Act, and the all applicable rules and regulations promulgated thereunder of the FDA and for studies submitted to other applicable regulatory authorities for approval(including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) and 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 conductedPractices; the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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, as applicable, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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, as applicable, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The (i) To the Company’s Knowledge, the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the CompanyCompany or its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the Registration StatementSEC Documents, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Documents, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA and comparable regulatory agencies outside of the United States to which they are subject (collectively, procedures the “Regulatory Authorities”) and controls pursuant to accepted professional scientific standards applicable statutes and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedRegulatory Authorities; (ii) to the Company’s Knowledge, the descriptions of the tests and nonclinical and clinical studies conducted by or on behalf of the Company and the results of such studies and trials thereof contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, SEC Documents are accurate and complete in all material respects and fairly present the data derived from such studies and trialsrespects; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Documents, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration StatementSEC Documents; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Pricing Disclosure Package and the Prospectus when viewed Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, (v) neither the Company has not nor any of its Subsidiaries have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities or any other governmental entity agency requiring or threatening the termination termination, material modification or suspension of any preclinical studies or clinical trials conducted by that are material to the Company and that are described in the SEC Documents or on behalf the results of which are referred to in the CompanySEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or 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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 studies, tests and trials contained or incorporated by reference 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical research, non-clinical pre-clinical studies and clinical trials studies and tests conducted or being conducted by oror on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, on behalf of the preclinical studies and clinical trials directed or sponsored by the Company’s collaborators (collectively, the “Studies”) that are described in in, or the results of which are referred to in, the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoingpending, are being conducted with reasonable care and in all material respects in accordance with experimental the protocols, procedures and controls pursuant to accepted professional all Applicable Laws and Governmental Permits and with standard medical and scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedresearch procedures; the descriptions each description of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, Studies is accurate and complete in all material respects and fairly present presents the data derived from such studies and trials; except to the extent disclosed in the Registration StatementStudies, the Pricing Disclosure Package and the Prospectus, the Company is not aware and its Subsidiaries have no knowledge of any other research, non-clinical studies or trials, tests the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study 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 stage 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 and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the EMA, the FDA or any committee thereof or from any other United States or foreign government agency with jurisdiction over the types of products being developed by the Company; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any governmental entity authority requiring the termination termination, suspension or suspension modification of any preclinical studies or clinical trials conducted by or on behalf Study; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of all governmental authorities. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, other than ordinary course communications the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with respect to modifications in connection with the design all Applicable Laws and implementation of such trials, copies of which communications have been made available to youGovernmental Permits.

Tests and Preclinical and Clinical Trials. The Except as described in the Registration Statement and the Prospectus, the studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 comparable foreign 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, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such studies studies, tests and trials contained in the each 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 studies, tests and trials; except to the extent disclosed in the each Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study study, test, or trial results described or referred to in the a Registration Statement, the Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage state of development; and, except to the extent disclosed in the each 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the 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 government governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures protocols designed and controls pursuant to accepted professional scientific standards approved for such studies and trials and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 or trials, the results of which the Company believes reasonably call into question the 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 stage 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 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, 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 's knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted 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, as applicable, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedthereunder; the descriptions of the results of such studies studies, tests and trials contained in the Registration Statement, the Pricing Prospectus or the General Disclosure Package and the Prospectus are, to the Company’s 's knowledge, accurate and complete in all material respects and fairly present the data derived from such studies studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Prospectus or the General Disclosure Package and Package, or would not, singly or in the Prospectusaggregate, result in a Material Adverse Effect, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study study, test, or trial results described or referred to in the Registration Statement, the Pricing Prospectus or the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Prospectus or the ProspectusGeneral Disclosure Package, 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 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, 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 CompanyCompany and its subsidiaries, that are described in the Registration Statement, the Pricing Disclosure Package 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 accordance with their experimental protocols, procedures and controls pursuant protocols submitted to accepted professional scientific standards the FDA or other comparable government entities and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 studies, tests and trials, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, the Company and each of its subsidiaries is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, neither the Company has not nor any of its subsidiaries have 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 CompanyCompany or any of its subsidiaries, 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 preclinical studies analytical and clinical trials validation studies sponsored or conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus, as applicable, Prospectus and are intended to be submitted to FDA Governmental Authorities as a basis for product approval or other comparable government entities, were and, if still ongoing, clearance are being conducted in all material respects in accordance with experimental applicable study protocols, procedures and controls pursuant to accepted professional scientific standards approved for such studies, and in compliance with all Authorizations and Applicable Laws, including, without limitation, applicable provisions of the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such analytical and validation studies and trials contained in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus 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 and trialsstudies; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described and the clinical stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity Governmental Authority requiring the termination or suspension of any preclinical studies analytical or clinical trials conducted by or on behalf validation studies that are described in the Registration Statement, the Time of Sale Prospectus and 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 youProspectus.

Tests and Preclinical and Clinical Trials. (i) The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the CompanyCompany or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Registration StatementSEC Filings, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Filings, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocols, procedures standard medical and controls pursuant to accepted professional scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Authorizations applicable statutes and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any all applicable rules and regulations of the jurisdiction in which such trials U.S. Food and studies are being conductedDrug Administration (the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Filings of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete descriptions in all material respects and fairly present the data derived from such studies and trialstherefrom; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Filings, the results of which the Company believes are inconsistent with or reasonably call into question the study or trial results described or referred to in the Registration StatementSEC Filings; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Pricing Disclosure Package and the Prospectus when viewed Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, (v) neither the Company has not nor any of its subsidiaries have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities or any other governmental entity agency requiring or threatening the termination termination, material modification or suspension of any preclinical studies or clinical trials conducted by that are described in the SEC Filings or on behalf the results of which are referred to in the CompanySEC Filings, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or 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, that are described in the Registration Statement, the Pricing Disclosure Package 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 accordance with their experimental protocols, procedures and controls pursuant protocols submitted to accepted professional scientific standards the FDA or other comparable government entities and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 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 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, copies of which communications have been made available to youthe Agents.

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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question in any material respect the study 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 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 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, copies of which communications have been made available to youthe Underwriters.

Tests and Preclinical and Clinical Trials. The Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 comparable foreign 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, 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 (the “Company Trials”) that are described in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA, the European Medicines Agency or any foreign governmental body exercising comparable authority, and procedures and controls pursuant to to, where applicable, accepted professional and scientific standards standards, and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the Company Trials and the results of such studies and trials thereof, contained in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus 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 and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study or trial results of the Company Trials described or referred to in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described and the clinical stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or Time of Sale Prospectus and 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 preclinical studies 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 studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the CompanyCompany and its subsidiaries, that are described in the Registration Statement, the Pricing Disclosure Package 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 accordance with their experimental protocols, procedures and controls pursuant protocols submitted to accepted professional scientific standards the FDA or other comparable government entities and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 studies, tests and trials, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, the Company and each of its subsidiaries is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, neither the Company has not nor any of its subsidiaries have 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 CompanyCompany or any of its subsidiaries, 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. (i) The preclinical studies and clinical trials conducted by or, to the Company’s knowledgeKnowledge, on behalf of or sponsored by the CompanyCompany or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Registration StatementSEC Filings, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Filings, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocols, procedures standard medical and controls pursuant to accepted professional scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Authorizations applicable statutes and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any all applicable rules and regulations of the jurisdiction in U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which such trials they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and studies are being conductedGood Clinical Practice and Good Laboratory Practice requirements; (ii) except as set forth on the Disclosure Schedule, the descriptions in the SEC Filings of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete descriptions in all material respects and fairly present the data derived from such studies and trialstherefrom; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Filings, the results of which the Company believes are inconsistent with or reasonably call into question the study or trial results described or referred to in the Registration StatementSEC Filings; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Pricing Disclosure Package and the Prospectus when viewed Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, (v) neither the Company has not nor any of its subsidiaries have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities or any other governmental entity agency requiring or threatening the termination termination, material modification or suspension of any preclinical studies or clinical trials conducted by that are described in the SEC Filings or on behalf the results of which are referred to in the CompanySEC Filings, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, copies of which communications have been made available and, to youthe Company’s Knowledge, there are no reasonable grounds for the same.

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, 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 government entities, were and, if still ongoing, are being conducted in all material respects in accordance with their experimental protocols, procedures and controls pursuant protocols submitted to accepted professional scientific standards the FDA or other comparable government entities and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 studies, tests and trials, except in each case as would not, individually or in the aggregate have a Material Adverse Effect; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 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 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, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”) and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable the rules and regulations of the jurisdiction in which such trials and studies are being conductedEMA; the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The (i) To the Company’s Knowledge, the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the CompanyCompany or its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the Registration StatementSEC Reports, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Reports, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA and comparable regulatory agencies outside of the United States to which they are subject (collectively, procedures the “Regulatory Authorities”) and controls pursuant to accepted professional scientific standards applicable statutes and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedRegulatory Authorities; (ii) the descriptions of the tests and nonclinical and clinical studies conducted by or on behalf of the Company and the results of such studies and trials thereof contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, SEC Reports are accurate and complete in all material respects and fairly present the data derived from such studies and trialsrespects; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Reports, the results of which the Company believes could reasonably call into question the study or trial results described or referred to in the Registration StatementSEC Reports; (iv) the Company and its Subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Pricing Disclosure Package Regulatory Authorities; and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, (v) except to the extent as disclosed in the Registration StatementSEC Reports, the Pricing Disclosure Package or the Prospectus, neither the Company has not nor any of its Subsidiaries have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities, any other governmental agency, or any governmental entity institutional review board or ethics committee requiring or threatening the termination termination, material modification, hold or suspension of any preclinical studies or clinical trials conducted by that are material to the Company and that are described in the SEC Reports or on behalf the results of which are referred to in the CompanySEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. Neither the Company nor any of its Subsidiaries has (a) failed to disclose a material fact required to be disclosed to any Regulatory Authorities, copies (b) made an untrue statement of which communications have been a material fact or fraudulent statement to any Regulatory Authority, or (c) has committed any act, made available any statement or failed to youmake any statement that would provide a basis for the FDA or any other Regulatory Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or other similar policies or Laws.

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, 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 government entities, Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations licenses, certificates, approvals, clearances, exemptions, authorizations, permits and Applicable supplements or amendments thereto required by the Health Care Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, regarding 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, 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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study study, test, or trial results described or referred to in the a Registration Statement, the Pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage 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 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, 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 or Zavante (the “Company Trials”) that are described in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA, the European Medicines Agency or any foreign governmental body exercising comparable authority, and procedures and controls pursuant to to, where applicable, accepted professional and scientific standards standards, and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the Company Trials and the results of such studies and trials thereof, contained in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus 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 and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study or trial results of the Company Trials described or referred to in the Registration Statement, the Pricing Disclosure Package Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described and the clinical stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or Time of Sale Prospectus and 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 preclinical studies 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. (i) The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the CompanyCompany or its subsidiary, or in which the Company or its subsidiary have participated, that are described in the Registration StatementSEC Filings, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Filings, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocols, procedures standard medical and controls pursuant to accepted professional scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and in material compliance with all Authorizations statutes and Applicable Laws, all applicable rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the Federal FoodFDA) to which they are subject (collectively, Drug the “Regulatory Authorities”) and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of Practices; (ii) except as set forth on the jurisdiction in which such trials and studies are being conducted; Disclosure Schedule, the descriptions in the SEC Filings of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete descriptions in all material respects and fairly present the data derived from such studies and trialstherefrom; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Filings, the results of which the Company believes are inconsistent with or reasonably call into question the 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 stage of developmentSEC Filings; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, (iv) the Company has not and its subsidiary have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) neither the Company nor any of its subsidiary have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities or any other governmental entity agency requiring or threatening the termination termination, material modification or suspension of any preclinical studies or clinical trials conducted by that are described in the SEC Filings or on behalf the results of which are referred to in the CompanySEC Filings, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, copies of which communications have been made available and, to youthe Company’s Knowledge, there are no reasonable grounds for the same.

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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal FoodFFDCA; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the European Medicines Agency, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to FDA or any committee thereof or from any other United States or foreign government or drug regulatory authorities for approvalagency, 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 conductedor health care facility Institutional Review Board; the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 FDA, the European Medicines Agency 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, copies of which communications have been made available to youthe Representatives.

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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 studies 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 (i) To the Company’s Knowledge, the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the CompanyCompany or its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the Registration StatementSEC Reports, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Reports, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA and comparable regulatory agencies outside of the United States to which they are subject (collectively, procedures the “Regulatory Authorities”) and controls pursuant to accepted professional scientific standards applicable statutes and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedRegulatory Authorities; (ii) to the Company’s Knowledge, the descriptions of the tests and nonclinical and clinical studies conducted by or on behalf of the Company and the results of such studies and trials thereof contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, SEC Reports are accurate and complete in all material respects and fairly present the data derived from such studies and trialsrespects; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Reports, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration StatementSEC Reports; (iv) the Company and its Subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Pricing Disclosure Package and the Prospectus when viewed Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the clinical stage of development; and, (v) except to the extent as disclosed in the Registration StatementSEC Reports, the Pricing Disclosure Package or the Prospectus, neither the Company has not nor any of its Subsidiaries have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities, any other governmental agency, or any governmental entity institutional review board or ethics committee requiring or threatening the termination termination, material modification, hold or suspension of any preclinical studies or clinical trials conducted by that are material to the Company and that are described in the SEC Reports or on behalf the results of which are referred to in the CompanySEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or 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 (the “Company Trials”) that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA, the European Medicines Agency or any foreign governmental body exercising comparable authority, and procedures and controls pursuant to to, where applicable, accepted professional and scientific standards standards, and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the Company Trials and the results of such studies and trials thereof, 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 preclinical studies 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 studies and clinical trials conducted by or, to the Company’s 's knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted 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, as applicable, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedthereunder; the descriptions of the results of such studies studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Final Prospectus are, to the Company’s 's knowledge, accurate and complete in all material respects and fairly present the data derived from such studies 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the CompanyCompany and its subsidiaries, that are described in the Registration Statement, the Pricing Disclosure Package 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 accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 and trials contained in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus are, to the Company’s and its subsidaries’ knowledge, accurate and complete in all material respects and fairly present the data derived from such 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 or trials, the results of which the Company believes reasonably call into question the 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 stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement or the Prospectus, the Company nor any of its subsidiaries has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The (i) To the Company’s knowledge, the preclinical studies and clinical trials conducted by oror on behalf of or sponsored by the Company or its Subsidiaries (including, to the preclinical studies and clinical trials of the Company’s knowledge, product and product candidates conducted by or on behalf of or sponsored by bluebird bio, Inc. prior to its spin-off with the Company), or in which the Company or its Subsidiaries have participated, that are described in the Registration StatementProspectus, or the Pricing Disclosure Package and results of which are referred to in the Prospectus, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the U.S. Food and Drug Administration (the “FDA”) and comparable regulatory agencies outside of the United States to which they are subject (collectively, procedures the “Regulatory Authorities”) and controls pursuant to accepted professional scientific standards applicable statutes and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 conductedRegulatory Authorities; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, (ii) to the Company’s knowledge, the descriptions of the tests and nonclinical and clinical studies conducted by or on behalf of the Company (including, the descriptions of the tests and nonclinical and clinical studies of the Company’s product and product candidates conducted by or on behalf of bluebird bio, Inc. prior to its spin-off with the Company) and the results thereof contained in the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies and trialsrespects; except (iii) to the extent disclosed Company’s knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration StatementProspectus; (iv) the Company and its Subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Pricing Disclosure Package and the Prospectus when viewed Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Change; and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, (v) neither the Company has not nor any of its Subsidiaries have received any written notices notices, correspondence or written correspondence other communications from the FDA Regulatory Authorities or any other governmental entity agency requiring or threatening the termination termination, material modification or suspension of any preclinical studies or clinical trials conducted by that are material to the Company and that are described in the Prospectus or on behalf the results of which are referred to in the CompanyProspectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The preclinical research, non-clinical and pre-clinical studies and clinical trials and tests conducted or being conducted by oror on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, on behalf of the preclinical studies and clinical trials directed or sponsored by the Company’s collaborators (collectively, the “Studies”) that are described in in, or the results of which are referred to in, the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Prospectus were and, if still ongoingpending, are being conducted with reasonable care and in all material respects in accordance with experimental the protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder thereunder, and for studies submitted to regulatory authorities for approval, current Good Clinical Practices with standard medical and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conductedscientific research procedures; the descriptions each description of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, Studies is accurate and complete in all material respects and fairly present presents the data derived from such studies and trials; except to the extent disclosed in the Registration StatementStudies, the Pricing Disclosure Package and the Prospectus, the Company is not aware and its Subsidiaries have no knowledge of any other research, non-clinical studies or trials, tests the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study 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 stage 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 and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the EMA, the FDA or any committee thereof or from any other United States or foreign government agency with jurisdiction over the types of products being developed by the Company; neither the Company nor any of its Subsidiaries has received any notice of, or correspondence from, any governmental entity authority requiring the termination termination, suspension or suspension material modification of any preclinical studies or clinical trials conducted by or on behalf Study; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of all governmental authorities. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, other than ordinary course communications the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with respect to modifications in connection with the design all Authorizations and implementation of such trials, copies of which communications have been made available to youApplicable Laws.

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, 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder thereunder, including 21 C.F.R. Parts 50, 54, 56, 58 and for studies submitted to regulatory authorities for approval312 (collectively, 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“FFDCA”); the descriptions of the results of such studies studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete in all material respects and fairly present the data derived from such studies 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, 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 studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of the 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 Company or other comparable government entitiesits Subsidiaries, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations permits and Applicable Lawslicenses and applicable Laws including, includingas applicable, without limitation, the Federal Food, Drug and Cosmetic Act of 1938, as amended, and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 thereunder. The descriptions of the results of such studies studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus Company SEC Documents are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 studies 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, 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, 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 government entities, were and, if still ongoing, are being conducted in all material respects in accordance with their experimental protocols, procedures and controls pursuant protocols submitted to accepted professional scientific standards the FDA or other comparable government entities and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 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 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, copies of which communications have been made available to youthe Representatives.

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 (the “Company Trials”) that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, Final Prospectus were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the FDA, the European Medicines Agency or any foreign governmental body exercising comparable authority, and procedures and controls pursuant to to, where applicable, accepted professional and scientific standards standards, and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval(collectively, 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“FFDCA”); the descriptions of the Company Trials and the results of such studies and trials thereof, 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 and trialsCompany 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study or trial results of the Company Trials 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 stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package or and the Final 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 preclinical studies 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 studies and clinical trials conducted by or, to the Company’s 's knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted 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, as applicable, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approvalall applicable legislation, 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 conductedregulations, by-laws or guidance from Health Canada; the descriptions of the results of such studies studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are, to the Company’s 's knowledge, accurate and complete in all material respects and fairly present the data derived from such studies 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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 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, 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 knowledgeKnowledge, on behalf of the Company, Company or its Subsidiaries 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 government entities, SEC Filings were and, if still ongoingpending, are being being, conducted in all material respects in accordance with experimental protocolsthe protocols submitted to the U.S. Food and Drug Administration (the “FDA”) or any foreign governmental body exercising comparable authority (together, procedures the “Regulatory Authorities”), standard medical and controls pursuant to accepted professional scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Authorizations applicable statutes and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any all applicable rules and regulations of the jurisdiction in which such trials FDA or any foreign governmental body exercising comparable authority and studies are being conductedapplicable Good Clinical Practice and Good Laboratory Practice requirements; the descriptions of the results of such studies studies, tests and preclinical and clinical trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus areconducted by or, to the Company’s knowledgeKnowledge, on behalf of the Company or its Subsidiaries, contained in the SEC Filings are accurate and complete in all material respects and fairly present the data derived from such studies and trialsrespects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of and has no Knowledge of any studies other studies, tests or preclinical and clinical trials, the results of which the Company believes reasonably call into question the study results described in the SEC Filings; the Company and its Subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the FDA, except where such non-compliance would not, individually or trial results in the aggregate, have a Material Adverse Effect; the Company has not failed to file with the Regulatory Authorities any required filing, declaration, listing, registration, report or submission with respect to the Company’s product candidates that are described or referred to in the Registration StatementSEC Filings, all such filings, declarations, listings, registrations, reports or submissions, as applicable, were in material compliance with applicable laws when filed, and no material deficiencies regarding compliance with applicable law have been asserted by the Pricing Disclosure Package FDA with respect to any such filings, declarations, listings, registrations, reports or submissions; and the Prospectus when viewed in the context in which such results are described and the clinical 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 FDA, any foreign, state or local governmental body exercising comparable authority or any governmental entity Institutional Review Board requiring the termination termination, suspension, material modification or suspension clinical hold 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, 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 knowledgeKnowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted 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 Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 studies, tests and trials contained or incorporated by reference in the Registration Statement, the Pricing Disclosure Package and the Prospectus SEC Filings are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the ProspectusSEC Filings, the Company is not aware of any studies studies, tests or trials, the results of which the Company believes reasonably call into question the study study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus SEC Filings when viewed in the context in which such results are described and the clinical stage state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the ProspectusSEC Filings, 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, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. (i) The preclinical studies and clinical trials conducted by or, to the Company’s knowledgeKnowledge, on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries have participated, that are described in the Registration StatementSEC Filings, or the Pricing Disclosure Package and results of which are referred to in the ProspectusSEC Filings, as applicable, were, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoingpending are, are being conducted in all material respects in accordance with experimental protocols, procedures standard medical and controls pursuant to accepted professional scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Authorizations applicable statutes and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any all applicable rules and regulations of the jurisdiction in U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which such trials they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and studies are being conductedGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Filings of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, are accurate and complete descriptions in all material respects and fairly present the data derived from such studies and trialstherefrom; except (iii) to the extent disclosed Company’s Knowledge, there are no other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trialsSEC Filings, the results of which the Company believes are inconsistent with or reasonably call into question the study or trial results described or referred to in the Registration StatementSEC Filings; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Pricing Disclosure Package and the Prospectus when viewed Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, (v) neither the Company nor any of its subsidiaries has not received any written notices notices, correspondence or written correspondence other communications from the FDA any Regulatory Authority or any governmental entity other Governmental Entity requiring or threatening the termination termination, material modification or suspension of any preclinical studies or clinical trials conducted by that are described in the SEC Filings or on behalf the results of which are referred to in the CompanySEC Filings, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, copies of which communications have been made available and, to youthe Company’s Knowledge, there are no reasonable grounds for the same.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by or, to the knowledge of the Company’s knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocolsprotocols submitted to the FDA pursuant to, procedures and controls pursuant to accepted professional scientific standards and where applicable, all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted thereunder, including those related to regulatory authorities for approval, 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 studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the knowledge of the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies 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 studies, tests or trials, the results of which the Company believes reasonably materially call into question the study 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 stage 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 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, 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, or in which the Company participated, that are described in the Registration Statement, the Pricing General Disclosure Package and or 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 accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”) and for studies submitted to regulatory authorities for approval, current Good Clinical Practices and Good Laboratory Practices and any applicable the rules and other regulations of National Institute of Health Department of Health and Human Services, the jurisdiction in which such trials European Commission, the EMA and studies are being conductedthe TGA; the descriptions of the results of such studies 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 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 studies, tests or trials, the results of which the Company believes reasonably call into question the study 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 stage 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, the EMA, the TGA or any governmental entity 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, copies of which communications have been made available to you. There has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, the TGA or any other applicable regulatory agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect. Neither the Company, nor any Person engaged by the Company has made an untrue statement of a material fact or a fraudulent statement to the FDA, the European commissions, the EMA, the TGA, or any other Governmental Entity responsible for enforcement or oversight with respect to Healthcare Laws, or failed to disclose a material fact required to be disclosed to the FDA, the European Commissions, the EMA, the TGA, or such other Governmental Entity that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991), or for any other Governmental Entity to invoke a similar policy. The research studies and clinical trials of the Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws, including without limitation Good Clinical Practices, that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects (including regulations regarding “Informed Consent” as such term is defined under applicable law in the jurisdictions where clinical trials were or are being conducted) and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board, Ethics Committee, and applicable state, national, or supra national agencies responsible for oversight.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by or, to the knowledge of the Company’s knowledge, on behalf of the 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 government entities, Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and to, where applicable, all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and for studies submitted to regulatory authorities for approval, 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 studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the knowledge of the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies 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 studies, tests or trials, the results of which the Company believes reasonably materially call into question the study 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 stage 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 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, copies of which communications have been made available to you.