Common use of Clinical Trials Clause in Contracts

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company, (x) on behalf of or sponsored by the Company or any of its subsidiaries, taken as a whole, or (y) in which the Company or any of its subsidiariessubsidiaries have participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company or any of its subsidiaries and all applicable statutes and all applicable rules and regulations of the SDA, NMPA U.S. Food and Drug Administration and comparable regulatory agencies outside of China the United States to which they are subject subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical preclinical trials conducted by or, to the knowledge of the Companyby, on behalf of or sponsored by the Company or its subsidiaries, taken as a wholeSubsidiary, or in which the Company or its subsidiariesSubsidiary has participated, taken as a whole, have participated and that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards procedures, standard industry practice, current Good Clinical Practices and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes Good Laboratory Practices and all applicable rules and regulations of the SDA, NMPA FDA and comparable drug regulatory agencies outside of China the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices); (ii) the descriptions in the Registration Statement, the Pricing General Disclosure Package and or the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries Subsidiary have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries Subsidiary have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical preclinical trials that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company’s knowledge, (x) on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or (y) in which the Company or its subsidiariessubsidiaries has participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company or its subsidiaries and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and other comparable regulatory agencies outside of China authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (iv) the Company and its subsidiaries have has operated at all times and are is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described would not, individually or in the Registration Statementaggregate, the Pricing Disclosure Package and the Prospectusreasonably be expected to have a Material Adverse Effect, the clinical and pre-clinical nonclinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiariessubsidiaries has participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company or its subsidiaries, and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and comparable regulatory agencies outside of China the United States to which they are subject subject, including, without limitation, the China Food and Drug Administration, the Pharmaceuticals and Medical Devices Agency of Japan, and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present in all material respects the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the 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 in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance compliance, in each case in all material respects respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and (v) the Prospectus, neither the Company nor any of its subsidiaries have has received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical nonclinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical trials conducted by or, to the knowledge of the CompanyCompany after due inquiry, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiariessubsidiaries have participated, taken as a whole, have participated and that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and comparable regulatory agencies outside of China the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing General Disclosure Package and or the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the of data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the samesuch termination, material modification or suspension.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiariessubsidiaries have participated, taken as a whole, have participated and that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, wereand are intended to be submitted to Regulatory Authorities as a basis for product approval, and were and, if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable statutes, rules and regulations of the SDA, NMPA FDA and comparable drug regulatory agencies outside of China the United States to which they are it is subject (collectively, the “Regulatory Authorities”) ), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and or the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening which could lead to the termination, material modification termination or suspension of any clinical or pre-clinical trials 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 or the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA SDA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described would not, individually or in the Registration Statementaggregate, the Pricing Disclosure Package and the Prospectusreasonably be expected to have a Material Adverse Effect, the clinical and pre-clinical nonclinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiariessubsidiaries has participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company or its subsidiaries, and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and comparable regulatory agencies outside of China the United States to which they are subject subject, including, without limitation, the National Medical Products Administration (formerly known as the China Food and Drug Administration), the Pharmaceuticals and Medical Devices Agency of Japan, and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present in all material respects the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the 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 in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance compliance, in each case in all material respects respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and (v) the Prospectus, neither the Company nor any of its subsidiaries have has received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical nonclinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration StatementThe clinical, the Pricing Disclosure Package preclinical and the Prospectus, the clinical nonclinical trials and pre-clinical trials studies conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or its subsidiariesCompany, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards their protocols and procedures for products or product candidates comparable to those being developed by the Company and in material compliance with all applicable statutes and all applicable rules and regulations of the SDAFDA and other applicable regulatory authorities (including, NMPA and comparable without limitation, any foreign, federal, state or local governmental or regulatory agencies outside of China authority performing functions similar to which they are subject those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory PracticesPractices (as defined by the FDA), as applicable; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly materially present the data derived therefromfrom such trials or studies; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical, clinical or pre-clinical nonclinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration StatementThe clinical, the Pricing Disclosure Package preclinical and the Prospectus, the clinical nonclinical trials and pre-clinical trials studies conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or its subsidiariesCompany, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards their protocols and procedures for products or product candidates comparable to those being developed by the Company and in material compliance with all applicable statutes and all applicable rules and regulations of the SDAFDA and other applicable regulatory authorities (including, NMPA and comparable without limitation, any foreign, federal, state or local governmental or regulatory agencies outside of China authority performing functions similar to which they are subject those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory PracticesPractices (as defined by the FDA), as applicable; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly materially present the data derived therefromfrom such trials or studies; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical, clinical or pre-clinical nonclinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.. (uu)

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiariessubsidiaries have participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and comparable regulatory agencies outside of China the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and or the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s best knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA CFDA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical preclinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or any of its subsidiaries, taken as a whole, or in which the Company or any of its subsidiariessubsidiaries has participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDAFDA and other applicable regulatory authorities (including, NMPA and comparable without limitation, any foreign, federal, state or local governmental or regulatory agencies outside of China authority performing functions similar to which they are subject those performed by the FDA having jurisdiction over such trials) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices); (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) neither the Company nor any of its subsidiaries has no any knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which are materially inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (iv) the Company and each of its subsidiaries have operated at all times since January 1, 2019 and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory AuthoritiesAuthorities except where failures to so comply would not, individually or in the aggregate, have a Material Adverse Effect; and (v) neither the Company nor any of its subsidiaries have has received any written notices, notices or correspondence or other communications from the applicable Regulatory Authorities or any other governmental agency requiring or threatening the termination, material adverse modification or suspension of any clinical or pre-clinical preclinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledgebest knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical trials conducted by or, to the knowledge of the Company’s knowledge, on behalf of or sponsored by the Company or its subsidiaries, taken as a wholeCompany, or in which the Company or its subsidiarieshas participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDAFDA and other applicable regulatory authorities (including, NMPA and comparable without limitation, any foreign, federal, state or local governmental or regulatory agencies outside of China authority performing functions similar to which they are subject those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials conducted by or 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, and to the Company’s best knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except in each case as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, : (1) the clinical and pre-clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or any of its subsidiaries, taken as a whole, or in which the Company or any of its subsidiariessubsidiaries has participated, taken as a whole, have participated and 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 pending are, being conducted in accordance in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable statutes, rules and regulations of the SDA, NMPA FDA and comparable other applicable regulatory agencies outside of China to which they are subject authorities (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii2) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions and fairly present in all material respects and fairly present the data derived therefromfrom such trials; (iii3) neither the Company nor any of its subsidiaries has no any knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (iv4) the Company and each of 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 Regulatory Authorities; and (v5) neither the Company nor any of its subsidiaries have has received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledgebest knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company’s knowledge, (x) on behalf of or sponsored by the Company or its subsidiaries, taken as a wholeCompany, or (y) in which the Company or its subsidiarieshas participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and in material compliance with all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and other comparable regulatory agencies outside of China authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no does not have any knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectusstudies or trials, the results of which the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (iv) the Company and its subsidiaries have has operated at all times and are is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (ia) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical trials conducted by or, to the knowledge of the CompanyCompany after due inquiry, on behalf of or sponsored by the Company or its subsidiaries, taken as a wholeCompany, or in which the Company or its subsidiarieshas participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and comparable drug regulatory agencies outside of China the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and or the Prospectus of the results of such studies and tests are accurate and complete descriptions fairly present in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries have has operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory AuthoritiesAuthorities except for non-compliance which would not reasonably be expected to have a Material Adverse Effect; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the The clinical and pre-clinical preclinical trials conducted by or, to the knowledge of the Companyby, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiariessubsidiaries have participated, taken as a whole, have participated and that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards procedures, standard industry practice, current Good Clinical Practices and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes Good Laboratory Practices and all applicable rules and regulations of the SDA, NMPA FDA and comparable drug regulatory agencies outside of China the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices); (ii) the descriptions in the Registration Statement, the Pricing General Disclosure Package and or the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical preclinical trials that are described in the Registration Statement, the Pricing General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing General Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) None of the Company’s product candidates have received marketing approval or licensure from any Applicable Regulatory Authority. Except as described in the Registration StatementSEC Documents, the Pricing Disclosure Package and the Prospectus, the all clinical and pre-clinical studies and trials sponsored or conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or its subsidiaries, taken as a wholeSubsidiaries, or in which the Company or its subsidiariesSubsidiaries has participated with respect to the Company’s product candidates, taken as a wholeincluding without limitation, have participated any such studies and trials that are described in the Registration Statement, the Pricing Disclosure Package and the ProspectusSEC Documents, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the ProspectusSEC Documents, as applicableapplicable (collectively, “Company Trials”), were, and if still pending are, to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDAHealth Care Laws, NMPA and comparable regulatory agencies outside of China to which they are subject (collectivelyincluding, the “Regulatory Authorities”) and without limitation, current Good Clinical Practices and Good Laboratory Practices, and in keeping with standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus SEC Documents of the structure and results of such studies and tests any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the ProspectusSEC Documents, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the ProspectusSEC Documents; (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 Regulatory Authorities; and (v) neither the Company nor any each of its subsidiaries Subsidiaries have received not received, any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental agency entity requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials Company Trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus SEC Documents or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the ProspectusSEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. No investigational new drug application or comparable submission filed by or on behalf of the Company or any of its Subsidiaries has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial. In using or disclosing patient information received by the Company or any of its Subsidiaries in connection with a Company Trial, the Company or such subsidiary has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, HIPAA and the rules and regulations thereunder and any similar foreign laws and regulations in Europe or elsewhere. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or any other Applicable Regulatory Authority to have engaged in scientific misconduct.

Clinical Trials. (i) Except in each case as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, : (1) the clinical and pre-clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or any of its subsidiaries, taken as a whole, or in which the Company or any of its subsidiariessubsidiaries has participated, taken as a whole, have participated and 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 pending are, being conducted in accordance in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable statutes, rules and regulations of the SDA, NMPA FDA and comparable other applicable regulatory agencies outside of China to which they are subject authorities (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii2) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions and fairly present in all material respects and fairly present the data derived therefromfrom such trials; (iii3) neither the Company nor any of its subsidiaries has no any knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (iv4) the Company and each of 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 Regulatory Authorities; and (v5) neither the Company nor any of its subsidiaries have has received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledgebest knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and pre-clinical trials conducted by or, to the knowledge of the Company’s knowledge, (x) on behalf of or sponsored by the Company or its subsidiaries, taken as a wholeCompany, or (y) in which the Company or its subsidiarieshas participated, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the SDA, NMPA FDA and other comparable regulatory agencies outside of China authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (iv) the Company and its subsidiaries have has operated at all times and are is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) Except as described in the Registration StatementThe clinical, the Pricing Disclosure Package preclinical and the Prospectus, the clinical nonclinical trials and pre-clinical trials studies conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company or its subsidiariesCompany, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical and scientific research standards their protocols and procedures for products or product candidates comparable to those being developed by the Company and in material compliance with all applicable statutes and all applicable rules and regulations of the SDAFDA and other applicable regulatory authorities (including, NMPA and comparable without limitation, any foreign, federal, state or local governmental or regulatory agencies outside of China authority performing functions similar to which they are subject those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory PracticesPractices (as defined by the FDA), as applicable; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly materially present the data derived therefromfrom such trials or studies; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectustrials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and or the Prospectus; (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 Regulatory Authorities; and (v) neither the Company nor any of its subsidiaries have has not received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical, clinical or pre-clinical nonclinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.. (ddd)

Clinical Trials. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the clinical and The pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, taken as a whole, or in which the Company or its subsidiaries, taken as a whole, have participated and 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 pending are, being conducted in all material respects in accordance with standard medical the protocols submitted to the FDA and scientific research standards and procedures for products other applicable regulatory authorities (including, without limitation, any foreign, federal, state or product candidates comparable local governmental or regulatory authority performing functions similar to those being developed performed by the Company and all applicable statutes and all FDA) (collectively, the “Regulatory Healthcare Authorities”), the applicable rules and regulations of the SDARegulatory Healthcare Authorities, NMPA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in material compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Healthcare Authorities; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Healthcare Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical studies or clinical trials 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s best knowledge, there are no reasonable grounds for the same; and (vi) to the knowledge of the Company and its subsidiaries, the investigator-initiated trials described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, were, and if still pending are, being conducted in all material respects in accordance with the protocols submitted to the Regulatory Healthcare Authorities, the applicable rules and regulations of the Regulatory Healthcare Authorities, and current Good Clinical Practices and Good Laboratory Practices.