Common use of Clinical Studies Clause in Contracts

Clinical Studies. The studies, tests and clinical trials conducted by or on behalf of the Company were and, if still pending, are being conducted in accordance with experimental protocols, procedures and controls pursuant to all Applicable Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were andas described in the Prospectus (the “Clinical Studies”), were, and if still pendingpending are, are in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional and scientific standards and all Applicable applicable Health Care Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company has no knowledge of any studies, tests or trials, trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity requiring the termination, suspension or material modification of any studiesClinical Studies, tests except where any such termination, suspension or preclinical or clinical trials conducted by or on behalf of the Companymodification would not reasonably be expected to result in a Material Adverse Effect.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or or, to the Company’s knowledge, on behalf of the Company or by third parties in connection with companion diagnostics developed for use with the Company’s products, were and, if still pendingongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Authorizations and Applicable Laws Laws, including, without limitation, the Federal Food, Drug and AuthorizationsCosmetic Act and the rules and regulations promulgated thereunder (collectively, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change“FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are are, to the Company’s knowledge, accurate and complete in all material respects and fairly present in all material respects the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question would have an adverse effect on the study, test, or trial results described or referred to development of the Company’s product candidates in the Registration Statement, the pricing Pricing Disclosure Package and the Prospectus when viewed Prospectus; and, except to the extent disclosed in the context in which such results are described and Registration Statement, the clinical state of development; and Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any Governmental Entity Authority requiring the termination, termination or suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests All animal and other preclinical studies and clinical trials currently being conducted by the Company or on behalf of the Company were andare, if still pendingto the Company’s knowledge, are being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls pursuant generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to all Applicable Laws and Authorizationscomparable products to those being developed by the Company, and, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change; the descriptions of the results of such studies, tests and trials contained as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, clinical trial or trial preclinical study results described or referred to in the Registration Statement, the pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of developmentdescribed, except such results as would not reasonably be expected to result in a Material Adverse Effect; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any Governmental Entity other domestic or foreign governmental agency requiring the termination, termination or suspension or material modification of any studies, tests or preclinical studies or clinical trials conducted by or on behalf of the CompanyCompany that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are being conducted in accordance with experimental protocols, procedures and controls pursuant to all Applicable Health Care Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in have a Material Adverse ChangeEffect; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests nonclinical studies and clinical trials conducted by or or, to the Company’s knowledge, on behalf of the Company were and, if still pendingongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, except where such failure to comply would notincluding, individually or in without limitation, the aggregateFederal Food, result in a Material Adverse ChangeDrug and Cosmetic Act and the rules and regulations promulgated thereunder; the descriptions of the results of such studies, tests nonclinical studies and clinical trials contained in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus are are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests nonclinical studies and clinical trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, the Company has no knowledge is not aware of any studies, tests nonclinical studies or clinical trials, the results of which the Company believes reasonably call into question the study, test, study or trial results described or referred to in the Registration Statement, the pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state stage of development; and and, except to the extent disclosed in the Registration Statement or the Prospectus, the Company has not received any written notices or other correspondence from the FDA or any Governmental Entity Authority requiring the termination, suspension or material modification of any nonclinical studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company and its subsidiaries were and, if still pending, are are, in all material respects, being conducted in accordance with experimental established protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, except where such failure to comply would notincluding, individually or in without limitation, the aggregateFederal Food, result in a Material Adverse ChangeDrug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Time of Sale Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Time of Sale Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Time of Sale Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company has not nor any of its subsidiaries have received any written notices or correspondence from any Governmental Entity Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany or any of its subsidiaries.

Clinical Studies. The studies, tests and nonclinical and clinical trials conducted by or or, to the Company’s knowledge, on behalf of the Company were and, if still pendingongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to professional scientific standards and all Authorizations and Applicable Laws Laws, including, without limitation, the Federal Food, Drug and AuthorizationsCosmetic Act and the rules and regulations promulgated thereunder (collectively, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change“FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any Governmental Entity Authority requiring the termination, termination or suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and clinical trials conducted by or on behalf of the Company were and, if still pending, are being conducted in accordance with experimental protocols, procedures and controls pursuant to all Applicable Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or or, to the Company’s knowledge, on behalf of the Company or Subsidiaries were and, if still pendingongoing, 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 Laws, including, without limitation, the Federal Food, Drug and AuthorizationsCosmetic Act and the rules and regulations promulgated thereunder (collectively, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change“FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and and, except to the extent disclosed in the Registration Statement, 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 Authority requiring the termination, termination or suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany or any Subsidiary.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pendingongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, except where such failure to comply would notincluding, individually or in without limitation, the aggregateFederal Food, result in a Material Adverse ChangeDrug 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 Pricing General Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, since December 31, 2001, the Company has not received any written notices or correspondence from the FDA or any Governmental Entity other federal, state, local or foreign governmental or regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studiesTo the knowledge of the Company, tests the pre-clinical and clinical studies and trials conducted by or on behalf of the Company were and each Subsidiary have been and, if still pending, are being conducted with reasonable care and in accordance with experimental protocols, procedures the protocols submitted to the FDA or comparable governmental authorities and controls pursuant to all Applicable Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change(as defined below); the descriptions of the results of such studies, tests pre-clinical and clinical studies and trials contained in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests pre-clinical and clinical studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, neither the Company has no knowledge nor any Subsidiary is aware of any studies, tests pre-clinical or clinical studies or trials, the results of which the Company believes reasonably call into question the study, test, pre-clinical or trial results clinical studies or trials described or referred to in the Registration Statement, the pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of developmentdescribed; and neither the Company nor any of the Subsidiaries has not received any written notices or correspondence from any Governmental Entity governmental authority requiring the termination, suspension or material modification of any studies, tests or preclinical pre-clinical or clinical trials study or trial conducted by or on behalf of the CompanyCompany or any Subsidiary.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pendingongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, except where such failure to comply would notincluding, individually or in without limitation, the aggregateFederal Food, result in a Material Adverse ChangeDrug 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 Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any Governmental Entity other federal, state, local or foreign governmental or regulatory authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or or, to the knowledge of the Company, on behalf of of, the Company with respect to programs that are currently in development or in discovery that are described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, were and, if still pending, are are, in all material respects, being conducted in accordance with applicable experimental protocols, procedures and controls and pursuant to all Applicable Laws applicable laws, including the Health Care Laws, and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Time of Sale Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Time of Sale Disclosure Package and the Prospectus, the Company has no knowledge of any studies, tests or trials, trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Time of Sale Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are being conducted with reasonable care and in accordance with experimental protocols, procedures and controls pursuant to all Applicable Health Care Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in have a Material Adverse ChangeEffect; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company. There have been no material adverse episodes or complications resulting from any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials investigations conducted by or on behalf of the Company and its Subsidiaries were and, if still pending, are are, in all material respects, being conducted in accordance with experimental established protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable applicable Health Care Laws and AuthorizationsRegulatory Permits, except where such failure to comply would notincluding, individually or in without limitation, the aggregateFederal Food, result in a Material Adverse ChangeDrug, and Cosmetic Act and its implementing regulations set forth at 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing General Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, trials the results of which the Company believes reasonably call into question in any material respect, the study, test, or trial results described or referred to in the Registration Statement, the pricing General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company has not nor any of its Subsidiaries have received any written notices or correspondence from any Governmental Entity governmental authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials investigations conducted by or on behalf of the CompanyCompany or any of its Subsidiaries.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or or, to the Company’s knowledge, on behalf of the Company or by third parties in connection with companion diagnostics developed for use with the Company’s products, were and, if still pendingongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Authorizations and Applicable Laws Laws, including, without limitation, the Federal Food, Drug and AuthorizationsCosmetic Act and the rules and regulations promulgated thereunder (collectively, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse Change“FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration StatementStatements, the Pricing Disclosure Package and the Prospectus are Prospectuses are, to the Company’s knowledge, accurate and complete in all material respects and fairly present in all material respects the data derived from such studies, tests and trials; except to the extent disclosed in the Registration StatementStatements, the Pricing Disclosure Package and the ProspectusProspectuses, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question would have an adverse effect on the study, test, or trial results described or referred to development of the Company’s product candidates in the Registration StatementStatements, the pricing Pricing Disclosure Package and the Prospectus when viewed Prospectuses; and, except to the extent disclosed in the context in which such results are described and Registration Statements, the clinical state of development; and Pricing Disclosure Package or the Prospectuses, the Company has not received any written notices or correspondence from the FDA or any Governmental Entity Authority requiring the termination, termination or suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. (i) The studies, tests and preclinical and clinical trials conducted by or on behalf of or sponsored by the Company were andor in which the Company has participated, were, and if still pendingpending are, are to the knowledge of the Company, being conducted in all material respects in accordance with standard medical and experimental protocols, procedures and controls pursuant to accepted professional scientific research standards and procedures and all Applicable Laws applicable Health Care Laws, the rules and Authorizations, except where such failure to comply would not, individually or in regulations of the aggregate, result in a Material Adverse ChangeRegulatory Authorities and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions of the results of such studies, tests studies and trials contained in the Registration Statement, the Pricing Disclosure Package and Statement or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trials and studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (iii) the Company has no knowledge of any studies, tests other studies or trialstrials not described in the Registration Statement and the Prospectus, the results of which the Company believes reasonably are materially inconsistent with or call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of developmentProspectus; and (iv) the Company has not received any written notices notices, correspondence or correspondence other communications from any Governmental Entity Regulatory Authority or any other governmental entity requiring or threatening the termination, modification or suspension or material modification of any studiesstudies or trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement the Prospectus, tests other than such notices, correspondence or preclinical or clinical trials conducted by or on behalf other communications that have been described in each of the Registration Statement and the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company were and, if still pending, are being conducted in accordance with experimental protocols, procedures and controls pursuant to all Applicable Laws and Authorizations, except where such failure to comply would not, individually or in the aggregate, result in a Material Adverse ChangeChange ; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any written notices or correspondence from any Governmental Entity requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

Clinical Studies. The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company and its subsidiaries were and, if still pending, are are, in all material respects, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, except where such failure to comply would notincluding, individually or in without limitation, the aggregateFederal Food, result in a Material Adverse ChangeDrug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Time of Sale Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Time of Sale Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any studies, tests or trials, trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the pricing Time of Sale Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company has not nor any of its subsidiaries have received any written notices or correspondence from any Governmental Entity Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the CompanyCompany or any of its subsidiaries.