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, or in which the Company or its subsidiaries have participated, 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 U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “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 The pre-clinical studies and clinical trials conducted by or, to the knowledge of the CompanyCompany and its subsidiaries, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectusin, or the results of which are referred to in in, the Registration Statement, the Pricing General Disclosure Package and Package, the ProspectusProspectus or any Written Testing-the-Waters Communication were and, as applicable, were, and if still pending arepending, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, and with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and procedures, all applicable statutes and statutes, all applicable rules and regulations of the U.S. United States Food and Drug Administration and comparable regulatory agencies outside of (the United States to which they are subject“FDA”), including the European Medicines Agency (collectivelythe “EMA”), the Israel Ministry of Health (the “Regulatory AuthoritiesIMH”) and current other comparable regulatory agencies to which they are subject and Good Clinical Practices and Good Laboratory Practices; (ii) , except to the descriptions extent where failure to conduct in the Registration Statement, the Pricing Disclosure Package and the Prospectus such manner would not have a Material Adverse Effect. Each description of the results of such studies and tests are trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is accurate and complete descriptions in all material respects and fairly present presents the data derived therefrom; (iii) from such studies and trials, and the Company has or its subsidiaries have 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 with, or otherwise call into question question, the results described or referred to in the Registration Statement, the Pricing General Disclosure Package Package, the Prospectus or any Written Testing-the-Waters Communication. The Company and its subsidiaries have not received any written notices, correspondence or other communications from the Prospectus; FDA, the EMA, the IMH or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (ivcollectively, the “Regulatory Agencies”) requiring or, to the Company’s knowledge, threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company and its subsidiaries have operated at all times and currently are currently in compliance in all material respects with all applicable statutes, rules rules, regulations and regulations policies 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 sameAgencies.

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, or in which the Company or its subsidiaries have participated, 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 U.S. Food and Drug Administration FDA and comparable regulatory agencies outside of the United States to which they are 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 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 nonclinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries have has participated, 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 U.S. Food and Drug Administration FDA and comparable regulatory agencies outside of the United States to which they are 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 when viewed in the context in which such results are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, 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; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and (v) neither the Prospectus, 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 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, and 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, or in which the Company or its subsidiaries have participated, 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 ProspectusProspects, 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 U.S. Food and Drug Administration FDA and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency 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, (x) on behalf of or sponsored by the Company or its subsidiariesCompany, or (y) in which the Company or its subsidiaries have has participated, 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 U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “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 has 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 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’s knowledge, (x) on behalf of or sponsored by the Company or its subsidiariessubsidiary, or (y) in which the Company or its subsidiaries have subsidiary has participated, 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 subsidiary and in material compliance with all applicable statutes and all applicable rules and regulations of the U.S. Food FDA and Drug Administration and other comparable regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which they are subject, including the European Medicines Agency 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 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 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 preclinical studies and trials conducted by or, to the knowledge of the Company, (x) on behalf of or sponsored by the Company or its subsidiariesCompany, or (y) in which the Company or its subsidiaries have has participated, 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 statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the U.S. Food and Drug Administration FDA and comparable regulatory agencies outside of the United States to which they are 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 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 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 preclinical studies or 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 and 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-The clinical trials and preclinical studies conducted by or, to the knowledge of the CompanyCompany after due inquiry, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, 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 U.S. Food and Drug Administration FDA and comparable drug regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions of the results of such trials and studies contained 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 and studies; (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 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 Applicable Laws 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 trials or pre-clinical trials preclinical studies 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 Prospectus, and the ProspectusTime of Sale Information, 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, or (y) in which the Company or its subsidiaries have participated, that are described in the Registration Statement, the Pricing Disclosure Package Prospectus, and the ProspectusTime of Sale Information, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package Prospectus, and the ProspectusTime of Sale Information, 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 U.S. Food FDA and Drug Administration and other comparable regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which they are subject, including the European Medicines Agency 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 Prospectus, and the Prospectus Time of Sale Information 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 Prospectus or the ProspectusTime of Sale Information; (iv) the Company and its subsidiaries have 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 and its subsidiaries have 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 Prospectus and the Prospectus Time of Sale Information or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package Prospectus and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation Time of such trialsSale Information, 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 Prospectus, and the ProspectusTime of Sale Information, 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, or (y) in which the Company or its subsidiaries have participated, that are described in the Registration Statement, the Pricing Disclosure Package Prospectus, and the ProspectusTime of Sale Information, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package Prospectus, and the ProspectusTime of Sale Information, 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 U.S. Food FDA and Drug Administration and other comparable regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which they are subject, including the European Medicines Agency 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 Prospectus, and the Prospectus Time of Sale Information 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 Prospectus or the ProspectusTime of Sale Information; (iv) the Company and its subsidiaries have 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 and its subsidiaries have 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 Prospectus and the Prospectus Time of Sale Information or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package Prospectus and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation Time of such trialsSale Information, 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 its subsidiariesCompany, or in which the Company or its subsidiaries have has participated, 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 U.S. Food and Drug Administration FDA and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory PracticesPractice requirements; (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 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 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 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 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 The clinical and pre-clinical trials conducted by or, to the knowledge Knowledge of the CompanyBorrower, on behalf of or sponsored by the Company Borrower or its subsidiariesSubsidiaries, or in which the Company Borrower or its subsidiaries Subsidiaries have participated, that are described in the Registration Statement, the Pricing Disclosure Package and the ProspectusExchange Act Documents, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the ProspectusExchange Act Documents, 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 Borrower and all applicable statutes and all applicable rules and regulations Requirements of Laws of the U.S. Food and Drug Administration FDA and comparable regulatory agencies outside of the United States to which they are subjectsubject (each, including the European Medicines Agency (collectively, the a “Regulatory AuthoritiesAgency”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the . The descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus Exchange Act Documents of the results of such studies and tests are tests, when they were filed with the SEC, were accurate and complete descriptions in all material respects and fairly present presented the data derived therefrom; (iii) the Company . Borrower has no knowledge Knowledge of any other trials not described in the Registration Statement, the Pricing Disclosure Package and the ProspectusExchange Act 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 Prospectus; (iv) the Company Exchange Act Documents. Borrower and its subsidiaries Subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations Requirements of Laws of the Regulatory Authorities; and (v) neither the Company Agencies. Neither Borrower nor any of its subsidiaries Subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities Agencies or any other governmental agency Governmental Authority 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 Exchange Act Documents or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the ProspectusExchange Act Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the CompanyBorrower’s knowledgeKnowledge, 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 preclinical studies and trials conducted by or, to the knowledge of the Company, (x) on behalf of or sponsored by the Company or its subsidiariesCompany, or (y) in which the Company or its subsidiaries have has participated, 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 U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “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 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 preclinical studies or 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 and 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 The clinical and pre-clinical trials conducted by or, to the knowledge of the Company, after due inquiry, on behalf of or sponsored by the Company or its subsidiaries, or in which (the Company or its subsidiaries have participated, “Clinical Studies”) that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectusin, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects accordance and in accordance compliance with the protocols, procedures and controls designed and approved for such Clinical Studies, with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all procedures, including applicable statutes and all applicable statutes, rules and regulations of the European Medicines Agency, the U.S. Food and Drug Administration and other comparable regulatory agencies outside of the United States and the European Union to which they are subject, including the European Medicines Agency subject (collectively, the “Regulatory Authorities”) and with current Good Clinical Practices and Good Laboratory Practices; (ii) , except where the failure to be in compliance has not resulted and would not reasonably be expected to result in a Material Adverse Effect. The descriptions of the Clinical Studies in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus of Prospectus, or the results of such studies the Clinical Studies which are referred to in the Registration Statement and tests the Prospectus, are accurate and complete descriptions in all material respects and present fairly present the data derived therefrom; (iii) the . The Company has no knowledge of any other trials Clinical Study not described disclosed in the Registration StatementStatement and the Prospectus, or the Pricing Disclosure Package results of which are referred to in the Registration Statement and the Prospectus, the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus; (iv) . Except as disclosed in the Company Registration Statement and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutesthe Prospectus, rules and regulations of the Regulatory Authorities; and (v) neither the Company it nor any of its subsidiaries have 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 clinical or pre-clinical trials that are described disclosed in the Registration Statement, the Pricing Disclosure Package Statement and the Prospectus Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package Statement 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.