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

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to 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 current Good Clinical Practices and Cosmetic Act Good Laboratory Practices and the any applicable rules and regulations promulgated thereunder (collectively, “FFDCA”)of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests studies and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests studies and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably call into question the study, test, study or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Pricing 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 studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable 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 (collectivelyand, “FFDCA”)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, tests studies and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and complete and fairly present the data derived from such studies, tests studies and trialstrials in all material respects; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably materially call into question the study, test, study or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any written notices or 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, 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 (collectivelyand for studies submitted to regulatory authorities for approval, “FFDCA”)current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests studies and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests studies and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably call into question the study, test, study or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Pricing 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 studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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 (collectivelyand current Good Clinical Practices and Good Laboratory Practices and any applicable rules, “FFDCA”)regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained or incorporated by reference in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA or any Governmental Entity governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls (including without limitation any applicable special protocol assessment agreements) 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 (collectivelyand current Good Clinical Practices and Good Laboratory Practices and any applicable rules, “FFDCA”)regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, preclinical tests and preclinical clinical trials, and clinical trials other studies (collectively, “studies”) being conducted by or, to the Company’s knowledge, on behalf knowledge of the Company Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package or the 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 and the rules and regulations promulgated thereunder (collectively, “FFDCA”)) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; the descriptions each description of the results of such studies, tests studies is accurate and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate complete in all material respects and fairly present presents, in all material respects, the data derived from such studies, tests and trials; and, except to the extent as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware and its subsidiaries have no knowledge of any studies, tests or trials, other studies the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus when viewed 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 context 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 which such results 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 and the clinical state of development; and, except or referred to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither ; and the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studiesand its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, tests or preclinical or clinical trials conducted by or on behalf 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(i) To the Company’s Knowledge, tests and the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the Company were andor its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the SEC Documents, or the results of which are referred to in the SEC Documents, as applicable, 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 applicable rules and regulations promulgated thereunder of the Regulatory Authorities; (collectivelyii) to the Company’s Knowledge, “FFDCA”); the descriptions of the results of such studies, tests and trials nonclinical and clinical studies conducted by or on behalf of the Company and the results thereof contained in the Registration Statement, the General Disclosure Package SEC Documents are accurate and the Prospectus are, complete in all material respects; (iii) to the Company’s knowledgeKnowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed there are no other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trialsSEC Documents, the results of which the Company believes reasonably call into question the study, test, 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 General 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 state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, (v) neither the Company nor any Subsidiary has of its Subsidiaries have received any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any Governmental Entity other governmental agency requiring or threatening the termination termination, material modification or suspension of any studies, tests or 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 studiesExcept as would not reasonably be expected to be material to the Acquired Companies, tests and taken as a whole, the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Acquired Companies were and, if still ongoing, are being, conducted in all material respects in accordance with the protocols submitted to the FDA or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, good clinical practice, informed consent and all applicable laws, regulations and requirements. The Acquired Companies have filed with the FDA or other appropriate Governmental Entity all material required notices, and annual or other reports, including notices of adverse experiences and reports of serious and unexpected adverse experiences, related to the use of its product candidates in clinical trials. The descriptions of the preclinical studies and clinical trials conducted 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; to the Company’s knowledge, there are no other studies, tests or preclinical and clinical trials, the results of which call into question the results described in the SEC Filings; and the Acquired Companies have not received any written notices or correspondence from the FDA, any Governmental Entity exercising comparable authority or any institutional review board requiring the termination, suspension, material modification or 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 experimental protocolsall applicable laws, 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”); the descriptions of the results 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 such studiesany product proposed to be developed, tests and trials contained in produced, tested, distributed or marketed by the Registration Statement, Acquired Companies. Neither the General Disclosure Package and the Prospectus areAcquired Companies nor, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studiesany of their officers or employees has committed any act, tests and trials; except made any statement or failed to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of make any studies, tests or trials, the results of which the Company believes statement that would reasonably call into question the study, test, or trial results described or referred be expected to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from provide a basis for the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications 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 and clinical trials conducted or sponsored 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, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, 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 other applicable regulatory authorities (collectivelyincluding, “FFDCA”)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; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA or any Governmental Entity governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, preclinical tests and preclinical clinical trials, and clinical trials other studies (collectively, “studies”) being conducted by or, to the Company’s knowledge, on behalf knowledge of the Company Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package or the 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 and the rules and regulations promulgated thereunder (collectively, “FFDCA”)) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; the descriptions each description of the results of such studies, tests studies is accurate and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate complete in all material respects and fairly present presents, in all material respects, the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware and its subsidiaries have no knowledge of any studies, tests or trials, other studies the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study, test, or trial results described or referred to in the Registration Statement, the 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 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 when viewed in Prospectus, except where the context in which such results 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 and the clinical state of development; and, except or referred to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither ; and the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studiesand its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, tests or preclinical or clinical trials conducted by or on behalf 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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 (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, or would not, singly or in the aggregate, result in a Material Adverse Effect, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company (the “Company Trials”) that are described in the Registration Statement, the Time of Sale Prospectus and the 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 (collectively, “FFDCA”); the descriptions of the Company Trials and the results of such studiesthereof, tests and trials contained in the Registration Statement, the General 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, tests and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results of the Company Trials described or referred to in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or Time of Sale Prospectus and the Prospectus, neither the Company nor any Subsidiary has not received any notices correspondence or correspondence written notice from the FDA FDA, the European Medicines Agency or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the 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 Company or any of its subsidiaries, that are described in the Registration Statement and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable 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 (collectivelyand, “FFDCA”)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, tests studies and trials contained in the Registration Statement, the General Disclosure Package Statement and the Prospectus are, to the Company’s knowledge, accurate in all material respects and complete and fairly present the data derived from such studies, tests studies and trialstrials in all material respects; except to the extent disclosed in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the Company and each of its subsidiaries, is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably materially call into question the study, test, study or trial results described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package Statement or the Prospectus, neither the Company nor or any Subsidiary has of its subsidiaries have not received any written notices or 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 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(i) To the Company’s Knowledge, tests and the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the Company were andor its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the SEC Reports, or the results of which are referred to in the SEC Reports, as applicable, 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 applicable rules and regulations promulgated thereunder of the Regulatory Authorities; (collectivelyii) to the Company’s Knowledge, “FFDCA”); the descriptions of the results of such studies, tests and trials nonclinical and clinical studies conducted by or on behalf of the Company and the results thereof contained in the Registration Statement, the General Disclosure Package SEC Reports are accurate and the Prospectus are, complete in all material respects; (iii) to the Company’s knowledgeKnowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed there are no other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trialsSEC Reports, the results of which the Company believes reasonably call into question the study, test, 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 General 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 state of development; and, (v) except to the extent as disclosed in the Registration Statement, the General Disclosure Package or the ProspectusSEC Reports, neither the Company nor any Subsidiary has of its Subsidiaries have received any notices written notices, correspondence or 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 studies, tests or 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 studiesresearch, tests non-clinical and preclinical 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 the preclinical studies and clinical trials directed or sponsored by the Company’s collaborators (collectively, the “Studies”) that are described in, or the results of which are referred to in, the Company Registration Statement, General Disclosure Package and the 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 (collectivelythereunder, “FFDCA”)and with standard medical and scientific research procedures; the descriptions each description of the results of such studies, tests Studies is accurate and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate complete in all material respects and fairly present presents the data derived from such studiesStudies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware and its Subsidiaries have no knowledge of any studiesother research, non-clinical studies or tests or trials, the results of which the Company believes reasonably are inconsistent with, or otherwise call into question question, the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in Prospectus; the context in which Company and its Subsidiaries have made all such results are described filings and obtained all such approvals as may be required by the clinical state of development; and, except to the extent disclosed in the Registration StatementEMA, the General Disclosure Package FDA or any committee thereof or from any other United States or foreign government agency with jurisdiction over the Prospectus, types of products being developed by the Company; neither the Company nor any Subsidiary of its Subsidiaries has received any notices notice of, or correspondence from the FDA or from, any Governmental Entity governmental authority requiring the termination termination, suspension or suspension material modification of any studiesStudy; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, tests or preclinical or clinical trials conducted by or on behalf 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company or Zavante (the “Company Trials”) that are described in the Registration Statement, the Time of Sale Prospectus and the 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 (collectively, “FFDCA”); the descriptions of the Company Trials and the results of such studiesthereof, tests and trials contained in the Registration Statement, the General 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, tests and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results of the Company Trials described or referred to in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or Time of Sale Prospectus and the Prospectus, neither the Company nor any Subsidiary has not received any notices correspondence or correspondence written notice from the FDA FDA, the European Medicines Agency or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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 (collectivelyFDA or any committee thereof or from any other United States or foreign government or drug regulatory agency, “FFDCA”)or health care facility Institutional Review Board; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Final Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Final Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA FDA, the European Medicines Agency or any Governmental Entity governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the 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(i) To the Company’s Knowledge, tests and the preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the Company were andor its Subsidiaries, or in which the Company or its Subsidiaries have participated, that are described in the SEC Reports, or the results of which are referred to in the SEC Reports, as applicable, 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 applicable rules and regulations promulgated thereunder of the Regulatory Authorities; (collectively, “FFDCA”); ii) the descriptions of the results of such studies, tests and trials nonclinical and clinical studies conducted by or on behalf of the Company and the results thereof contained in the Registration Statement, the General Disclosure Package SEC Reports are accurate and the Prospectus are, complete in all material respects; (iii) to the Company’s knowledgeKnowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed there are no other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trialsSEC Reports, the results of which the Company believes could reasonably call into question the study, test, 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 General Disclosure Package Regulatory Authorities; and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, (v) except to the extent as disclosed in the Registration Statement, the General Disclosure Package or the ProspectusSEC Reports, neither the Company nor any Subsidiary has of its Subsidiaries have received any notices written notices, correspondence or 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 studies, tests or 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company and its subsidiaries, that are described in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in 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 (collectively, “FFDCA”)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 conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package Statement and the Prospectus are, to the Company’s knowledge, accurate in all material respects and complete and fairly present the data derived from such 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 General Disclosure Package Statement and the Prospectus, the Company and each of its subsidiaries is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package Statement or the Prospectus, neither the Company nor any Subsidiary has of its subsidiaries have received any written notices or written correspondence from the FDA or any Governmental Entity governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany or any 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 and clinical trials conducted by or, to the knowledge of the Company’s knowledge, on behalf of the 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 (collectively, “FFDCA”)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 conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General 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, tests and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably materially call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any Governmental Entity governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledgeKnowledge, on behalf of the Company or its Subsidiaries that are described in the 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 all applicable rules and regulations promulgated thereunder (collectively, “FFDCA”)of the FDA or any foreign governmental body exercising comparable authority and applicable Good Clinical Practice and Good Laboratory Practice requirements; the descriptions of the results of such studies, tests and preclinical and clinical trials contained in the Registration Statement, the General 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, tests and trialsrespects; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of and has no Knowledge of any other studies, tests or preclinical and clinical trials, the results of which the Company believes reasonably call into question the studyresults 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, testrules 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 General 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 state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or 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 or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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”); the descriptions of the results of such studies, tests and trials contained in the each Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the each Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the a Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the each Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. (i) The studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledgeKnowledge, on behalf of or sponsored by the Company were andor its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the SEC Filings, or the results of which are referred to in the SEC Filings, as applicable, 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 all applicable rules and regulations promulgated thereunder of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “FFDCARegulatory Authorities”)) and Good 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, tests studies and trials contained in the Registration Statement, the General Disclosure Package are accurate and the Prospectus are, to the Company’s knowledge, accurate complete descriptions in all material respects and fairly present the data derived from such studies, tests 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 General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trialsSEC Filings, the results of which the Company believes are inconsistent with or reasonably call into question the study, test, 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 General 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 state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, (v) neither the Company nor any Subsidiary has of its subsidiaries have received any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any Governmental Entity other governmental agency requiring or threatening the termination termination, material modification or suspension of any studies, tests or 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable 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 (collectively, “FFDCA”)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 conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and complete and fairly present the data derived from such 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 General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Pricing 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 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 described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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 (collectivelyand current Good Clinical Practices and Good Laboratory Practices and any applicable rules, “FFDCA”)regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any Governmental Entity comparable foreign governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. The studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company and its subsidiaries, that are described in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in 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 (collectivelyand for studies submitted to regulatory authorities for approval, “FFDCA”)current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests studies and trials contained in the Registration Statement, the General 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, tests studies and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the Company is not aware of any studies, tests studies or trials, the results of which the Company believes reasonably call into question the study, test, study or trial results described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package Statement or the Prospectus, neither the Company nor any Subsidiary of its subsidiaries has 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 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in 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”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the a Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

Tests and Preclinical and Clinical Trials. (i) The studies, tests and preclinical studies and clinical trials conducted by or, to the Company’s knowledge, or on behalf of or sponsored by the Company were andor its subsidiary, or in which the Company or its subsidiary have participated, that are described in the SEC Filings, or the results of which are referred to in the SEC Filings, as applicable, 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 Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder FDA) to which they are subject (collectively, the “FFDCARegulatory Authorities”)) and current Good Clinical Practices and Good Laboratory Practices; (ii) except as set forth on the Disclosure Schedule, the descriptions in the SEC Filings of the results of such studies, tests studies and trials contained in the Registration Statement, the General Disclosure Package are accurate and the Prospectus are, to the Company’s knowledge, accurate complete descriptions in all material respects and fairly present the data derived from such studies, tests 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 General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trialsSEC Filings, the results of which the Company believes are inconsistent with or reasonably call into question the study, test, or trial results described or referred to in the Registration StatementSEC Filings; (iv) the Company and its subsidiary have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the General Disclosure Package Regulatory Authorities; and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, (v) neither the Company nor any Subsidiary has of its subsidiary have received any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any Governmental Entity other governmental agency requiring or threatening the termination termination, material modification or suspension of any studies, tests or 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to FDA or other comparable 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 (collectively, “FFDCA”)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 conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; , except to the extent disclosed in each case as would not, individually or in the Registration Statement, the General Disclosure Package and the Prospectusaggregate have a Material Adverse Effect, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and, except to the extent disclosed in the Registration Statement, the General Pricing 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 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 and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company (the “Company Trials”) that are described in the Registration Statement, the General Disclosure Package and the 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 (collectively, “FFDCA”); the descriptions of the Company Trials and the results of such studiesthereof, tests and trials contained in the Registration Statement, the General Disclosure Package and the Final Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trialsCompany Trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results of the Company Trials described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or and the Final Prospectus, neither the Company nor any Subsidiary has not received any notices correspondence or correspondence written notice from the FDA FDA, the European Medicines Agency or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the 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(i) To the Company’s knowledge, tests and 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 were andor its Subsidiaries have participated, that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable, 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 applicable rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, Regulatory 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 (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, tests 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 General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration 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 General 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 state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, (v) neither the Company nor any Subsidiary has of its Subsidiaries have received any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any Governmental Entity other governmental agency requiring or threatening the termination termination, material modification or suspension of any studies, tests or 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 studies, tests and preclinical and clinical trials conducted by or, to the knowledge of the Company’s knowledge, on behalf of the 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 (collectivelythereunder, “FFDCA”)including those related to current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General 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, tests and trials; except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably materially call into question the study, test, or trial results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Pricing Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any Governmental Entity governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.