Common use of Clinical Studies Clause in Contracts

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All The studies, tests and preclinical and clinical studies trials conducted by or or, to the Company’s knowledge, on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Time of Sale Prospectus or the Prospectus, or the results of which are referred to in the Registration Statement, the Disclosure Package and Time of Sale Prospectus or the Prospectus Prospectus, as applicable, were and, if still ongoing, are being conducted in all material compliance respects in accordance with all laws Applicable FDA Laws; the descriptions of the results of such studies, tests and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions trials contained in the Registration Statement, the Disclosure Package and Time of Sale Prospectus or the Prospectus of are, to the results of such studies are Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Time of Sale Prospectus or the Prospectus, the Company has no knowledge is not aware of any large well-controlled clinical study studies, tests or trials, the aggregate results of which are inconsistent with or otherwise the Company believes reasonably call into question the study, test or trial results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any notices or correspondence from the FDA or any Governmental Authority requiring the termination or suspension of any studies, tests or preclinical or clinical study trials conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices Time of Sale Prospectus or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and Time of Sale Prospectus or the Prospectus, other than ordinary course communications with respect to modifications in connection with the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, design and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product implementation of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsuch trials.

Clinical Studies. All The studies, tests and preclinical and clinical studies trials conducted by or or, to the Company’s knowledge, on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Disclosure Package and Prospectus the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus, as applicable, were and, if still ongoing, are being conducted in all material compliance respects in accordance with all laws standard medical and scientific research standards and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations applicable thereto in promulgated thereunder (collectively, “FFDCA”); the jurisdictions in which they are being conducted descriptions of the results of such studies, tests and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus of are, to the results of such studies are Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any large well-controlled clinical study studies, tests or trials, the aggregate results of which are inconsistent with or otherwise the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any Governmental Authority requiring the termination or suspension of any studies, tests or preclinical or clinical study trials conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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 Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, design and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product implementation of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsuch trials.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Pricing Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the pricing Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the a Company Party that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the no Company Party has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the a Company Party is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the a Company Party has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiryProspectus, the clinical and preclinical studies conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company Parties 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 Prospectus the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were andProspectus, as applicable, were, and if still ongoingpending are, are being conducted in all material compliance 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 laws applicable statutes and all applicable rules and regulations applicable thereto in of the jurisdictions in U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are being conducted subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and with all laws current Good Clinical Practices and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies are accurate and complete descriptions in all material respects and fairly present the data derived from such studies, and therefrom in all material respects; (iii) the Company has no knowledge of any large well-controlled other clinical study studies not described in the aggregate Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by described or on behalf of the Company that are described referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, ; (iv) the Company has not 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 notices, correspondence or statements other communications from the FDA, the European Medicines Agency (“EMA”) Regulatory Authorities or any other Governmental Entity imposing, requiring, requesting governmental agency requiring or suggesting a clinical hold, threatening the termination, suspension or material modification for or suspension of any clinical or preclinical studies 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 Company Parties have not received any written notices or statements from design and implementation of such studies, and, to the FDACompany’s best knowledge, there are no reasonable grounds for the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsame.

Clinical Studies. All preclinical studies and clinical studies trials conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand its subsidiaries, are or taken as a whole, have been adequately described in the Registration Statement, the Disclosure Package Statement and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and The preclinical studies and clinical trials conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical studies and clinical studies trials from which data will be submitted to support marketing approval, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change. The descriptions in the Registration Statement, the Disclosure Package Statement and the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such studies, and . The Company has no knowledge of any large well-controlled Phase 2 or Phase 3 clinical study trial the aggregate results of which are inconsistent with or otherwise call into question in any material respect the results of any clinical study trial conducted by or on behalf of the Company that are described or referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package Statement and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency NMPA or any comparable drug regulatory agency (each, a “EMARegulatory Authority”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies or clinical trials that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Prospectus. Except as disclosed in the Registration Statement and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental EntityRegulatory Authority, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for any potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and or (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may is reasonably likely to be suspended, revoked, materially modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To Except as disclosed in the Registration Statement, the Pricing Package and Prospectus, to the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company PartiesCompany, are or have been adequately described in the Registration Statement, the Pricing Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties 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 were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study 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. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties and/or its Subsidiaries (collectively, the “Company Parties”) that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) , TGA, MHRA, DEA or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA EMA, TGA MHRA, DEA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug IND application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All The studies, tests and preclinical and clinical studies trials conducted by or or, to the Company’s knowledge, on behalf of the Company Parties that are material to an understanding and/or any of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties its subsidiaries that are described in the Registration Statement, the Pricing Disclosure Package and Prospectus the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus, as applicable, were and, if still ongoing, are being conducted in all material compliance respects in accordance with all laws standard medical and scientific research standards and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations applicable thereto in promulgated thereunder (collectively, “FFDCA”); the jurisdictions in which they are being conducted descriptions of the results of such studies, tests and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus of are, to the results of such studies are Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any large well-controlled clinical study studies, tests or trials, the aggregate results of which are inconsistent with or otherwise the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, neither the Company nor any of its subsidiaries has received any notices or correspondence from the FDA or any Governmental Authority requiring the termination or suspension of any studies, tests or preclinical or clinical study trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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 Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, design and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product implementation of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsuch trials.

Clinical Studies. All The preclinical studies and clinical trials, and other studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties(collectively, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties “studies”) that are described in the Registration Statementin, the Pricing Package and Prospectus or the results of which are referred to in in, the Registration Statement, the Disclosure Package and Statement or the Prospectus were and, if still ongoing, are being conducted in all material compliance respects in accordance with all laws the protocols, procedures and regulations applicable thereto in the jurisdictions in which they are being conducted controls designed and approved for such studies and with all laws standard medical and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus scientific research procedures; each description of the results of such studies are in the Registration Statement or Prospectus is accurate and complete in all material respects and fairly present presents in all material respects the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study other studies the aggregate results of which are materially inconsistent with with, or otherwise reasonably call into question question, the results described or referred to in the Registration Statement or the Prospectus when viewed in the context in which such results are described and the clinical state of any clinical study conducted development; the Company and the Subsidiaries have made all such filings and obtained all such approvals as required by or on behalf the Food and Drug Administration of the Company that are U.S. Department of Health and Human Services or any committee thereof (the “FDA”) or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) to conduct its business as currently conducted and as described in the Registration Statement, the Disclosure Package and Statement or the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, ; neither the Company nor any Subsidiary has not received any written notices notice of, or statements from correspondence from, any Regulatory Agency requiring the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies trials that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, Statement or the Disclosure Package Prospectus; and the ProspectusCompany and the Subsidiaries have operated and currently are in compliance in all material respects with all applicable rules, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, regulations and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product policies of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedRegulatory Agencies.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company PartiesCompany, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties 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 Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entitygovernmental agency, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company PartiesCompany, are or have been adequately described in the Registration Statement, the Pricing Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties 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 were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study 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. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entitygovernmental agency, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All The preclinical studies and tests and clinical studies trials conducted by or on behalf of the Company Parties that are material or, to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package Statement and the Prospectus. Except as disclosed Prospectus were, and, if still pending, are being, conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of such studies, tests and trials, and the results thereof, conducted by or, to the Company’s knowledge, on behalf of the Company contained in the Registration StatementStatement and the Prospectus are accurate and complete in all material respects; the Company has no knowledge of any tests, studies or trials not described in the Disclosure Package Registration Statement and the Prospectus, the results of which reasonably call into question in any material respect the results of the tests, studies and trials described in the Registration Statement and the Prospectus; and the Company has not received any written notices notice or statements correspondence from the FDA, the European Medicines Agency (“EMA”) FDA or any other foreign, state or local Governmental Entity imposing, requiring, requesting Authority exercising comparable authority or suggesting a clinical hold, any institutional review board or comparable authority requiring the termination, suspension suspension, clinical hold or material modification for or of any clinical tests, studies or preclinical studies that are trials described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus, which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect. Additionally, for the past five years, the Company Parties have has not received been excluded, suspended or debarred from participation in any written notices or statements from human clinical research and, to the FDAknowledge of the Company, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is not subject to a governmental inquiry, investigation, proceeding or has been rejected other similar action that could reasonably be expected to result in exclusion, suspension or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limiteddebarment.

Clinical Studies. All clinical and preclinical studies and clinical studies trials conducted by or on behalf of or sponsored by the Company, or in which the Company Parties that are material participated, with respect to an understanding of the Company’s business product and an investment in the Company Partiesproduct candidates, are or have been adequately described in the Registration Statement, the Disclosure Package including any such studies and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties trials that are described in the Registration StatementProspectus, the Pricing Package and Prospectus or the results of which are referred to in the Registration StatementProspectus, the Disclosure Package as applicable (collectively, “Company Trials”) were, and the Prospectus were and, if still ongoingpending are, are to the Company’s knowledge being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects in accordance with the all applicable statutes, rules, regulations and policies of the Regulatory Authorities and experimental protocols, current good clinical practices and good laboratory practices, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus fairly present in all material respects such studies, tests and trials, and the results thereof, and fairly present the data derived from such studies, and therefrom; the Company has no knowledge of any large well-controlled clinical study other studies or trials not described in the aggregate Prospectus, the results of which are inconsistent with or otherwise reasonably call into question the results of any clinical study conducted by or on behalf of the Company that are tests, studies and trials described in the Registration Statement, the Disclosure Package Prospectus; and the ProspectusCompany has not received, nor does it have knowledge after due inquiry that any of its collaboration partners has received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency or any institutional review board or comparable authority requiring or threatening the termination, material modification or suspension of Company Trials, 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. Except as disclosed The Company Trials have been designed to ensure that informed consent from each human subject participating in the Registration Statement, Company Trials is obtained. In using or disclosing patient information received by the Disclosure Package and the ProspectusCompany in connection with a Company Trial, the Company has not received any written notices complied in all material respects, to the extent applicable, with all applicable laws and regulatory rules or statements from the FDArequirements, including, without limitation, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or Health Insurance Portability and Accountability Act of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package 1996 and the Prospectus or rules and regulations thereunder. To the results of which are referred to in the Registration StatementCompany’s knowledge, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product none of the Company is Trials involved any investigator who has been disqualified as a clinical investigator or has been rejected or determined found by the FDA to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedhave engaged in scientific misconduct.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand the Subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the General Disclosure Package and the Final Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties and its Subsidiaries that are described in the Registration Statement, the Pricing General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entitygovernmental agency, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand the Subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the General Disclosure Package and the Final Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties and its Subsidiaries that are described in the Registration Statement, the Pricing General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.Final

Clinical Studies. All The preclinical and clinical studies trials conducted by or or, to the Company’s knowledge, on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus its subsidiary were and, if still ongoing, are being conducted in all material compliance respects in accordance with the protocols filed with the appropriate regulatory authority for each such trial and pursuant to accepted professional scientific standards and all laws applicable FDA regulations and regulations applicable thereto in guidances; the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions of the results of such trials contained in the Registration Statement, the General Disclosure Package Packages and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such trials; except to the extent disclosed in the Registration Statement, the General Disclosure Packages and the Prospectus, neither the Company, nor its subsidiary, is aware of any studies, and Company has no knowledge of any large well-controlled clinical study tests or trials, the aggregate results of which are inconsistent with the Company or otherwise its subsidiary believes reasonably call into question the trial results described or referred to in the Registration Statement, the General Disclosure Packages and the Prospectus when viewed in the context in which such results are described in and the applicable clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Packages or the Prospectus, neither the Company, nor its subsidiary, has received any notices or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical study trials conducted by or on behalf of the Company that are described in or its subsidiary. None of the Registration StatementCompany, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) its subsidiary or any other Governmental Entity imposing, requiring, requesting third party acting by or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product on behalf of the Company is or its subsidiary has been rejected debarred or determined is subject to be non-approvable debarment in any capacity concerning or conditionally approvable; and in connection with the manufacture, testing or development of the Company’s material product candidates (ii) any licenseincluding, approvalwithout limitation, permit the “Hyper Acute® Pancreas” product candidate currently in Phase 3 clinical trials, “Products”), the planning or authorization to conduct any clinical trial management of any potential product pre-clinical or clinical trials involving the Products or the production and analysis of the Company has been, will be or may be suspended, revoked, modified or limiteddata and results generated thereunder.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of (i) To the Company Parties that are material to an understanding knowledge of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledgecompleted studies, after reasonable inquirytests, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study trials conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed Prospectuses were conducted, in all material respects, in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; or that the drug substances used in the Registration Statementclinical trials have not been manufactured, in all material respects, under “current good manufacturing practices”, when required, in the United States, Canada and other jurisdictions in which such clinical trials have been and are being conducted. (ii) There are no pending or, to the knowledge of the Company, threatened (whether written, oral or otherwise), civil, criminal or administrative actions, suits, demands, claims, hearings, investigations, proceedings, complaints, material adverse inspections, material findings of deficiency, warning letters, requests for information or other compliance or enforcement actions by any regulatory authority related to any of the Company’s products, or the services or facilities of the Company and there is no act, omission, event, or circumstance that would reasonably be expected to give rise to any such action, suit, demand, claim, hearing, investigation, proceeding, complaint, material adverse inspection, material finding of deficiency, warning letter, requests for information, other compliance or enforcement action or any such liability. (iii) To the knowledge of the Company, the Disclosure Package research, pre-clinical and clinical validation studies and other studies and tests conducted or being planned by or on behalf of or sponsored by the Company or in which the Company participated or plans to participate were and, if still pending, are being conducted or planned in all material respects in accordance with good clinical practice and medical standard-of-care procedures including in accordance with the protocols submitted to any regulatory authority and the ProspectusCompany does not have knowledge of any other trials, studies or tests, the results of which reasonably call into question, in any material respect, the results of such studies and tests. The Company has not received any written notices or statements other correspondence from the FDA, the European Medicines Agency (“EMA”) such regulatory authorities or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, person requiring the termination, suspension or material modification for of any such research, pre-clinical and clinical validation studies or other studies and tests. The Company has not received any information from any regulatory authority that would reasonably be expected to lead to the denial of any clinical trial application or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus application for marketing approval before such regulatory authority. The Company has not failed to submit to any regulatory authority any necessary clinical trial application or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any a clinical trial of it is conducting or sponsoring. All such submissions and any potential product of new drug submission or new drug application submission, if submitted, were in material compliance with applicable laws when submitted and no material deficiencies have been asserted by any such regulatory authority with respect to any such submissions, except any deficiencies which could not, individually or in the Company has beenaggregate, will be or may be suspended, revoked, modified or limitedhave a Material Adverse Effect.

Clinical Studies. All preclinical studies and clinical studies trials conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand its subsidiaries, are or taken as a whole, have been adequately described in the Registration Statement, the Disclosure Package Statement and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and The preclinical studies and clinical trials conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical studies and clinical studies trials from which data will be submitted to support marketing approval, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change. The descriptions in the Registration Statement, the Disclosure Package Statement and the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such studies, and . The Company has no knowledge of any large well-controlled Phase 2 or Phase 3 clinical study trial the aggregate results of which are inconsistent with or otherwise call into question in any material respect the results of any clinical study trial conducted by or on behalf of the Company that are described or referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package Statement and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency CFDA or any comparable drug regulatory agency (each, a “EMARegulatory Authority”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies or clinical trials that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Prospectus. Except as disclosed in the Registration Statement and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental EntityRegulatory Authority, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for any potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and or (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may is reasonably likely to be suspended, revoked, materially modified or limited.

Clinical Studies. All The studies, tests and preclinical and clinical studies trials conducted by or or, to the Company’s knowledge, on behalf of the Company Parties that are material to an understanding and/or any of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties its subsidiaries that are described in the Registration Statement, the Pricing Disclosure Package and Prospectus the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus, as applicable, were and, if still ongoing, are being conducted in all material compliance respects in accordance with all laws standard medical and regulations applicable thereto in scientific research standards and Applicable Laws, including, without limitation, the jurisdictions in which they are being conducted Health Care Laws; the descriptions of the results of such studies, tests and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus of are, to the results of such studies are Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any large well-controlled clinical study studies, tests or trials, the aggregate results of which are inconsistent with or otherwise the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, neither the Company nor any of its subsidiaries has received any notices or correspondence from the FDA or any Governmental Authority requiring the termination or suspension of any studies, tests or preclinical or clinical study trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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 Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, design and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product implementation of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsuch trials.

Clinical Studies. Except as otherwise described in the Registration Statement and the Prospectus, none of the Company’s product candidates have received marketing approval from any Applicable Regulatory Authority. All preclinical clinical and pre-clinical studies and trials conducted by or on behalf of or sponsored by the Company, or in which the Company Parties that are material has participated with respect to an understanding of the Company’s business product candidates, including without limitation any such studies and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties trials that are described in the Registration StatementStatement and the Prospectus, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus were andProspectus, as applicable (collectively, “Company Trials”), were, and if still ongoingpending are, are being conducted in all material compliance respects in accordance with all laws applicable Health Care Laws, standard medical and scientific research procedures and any applicable rules, regulations applicable thereto in and policies of the jurisdictions jurisdiction in which they such trials and studies are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The conducted; the descriptions in the Registration Statement, the Disclosure Package Statement and the Prospectus of the results of such studies any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived from such studies, and therefrom; the Company has no knowledge of any large well-controlled clinical study other studies or trials not described in the aggregate Registration Statement 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 and the Prospectus; the Company has operated at all times and is currently in compliance in all material respects with all applicable Health Care Laws; the Company has not received, and the Company has no knowledge after due inquiry that any of its collaboration partners have received, any clinical study conducted written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other governmental entity requiring or threatening the termination, material modification or suspension of Company Trials, 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 that are described with the FDA 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 Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed Company in the Registration Statement, the Disclosure Package and the Prospectusconnection with a Company Trial, the Company has not received any written notices complied in all material respects with all applicable laws and regulatory rules or statements from the FDArequirements, the European Medicines Agency (“EMA”) or any other Governmental Entity imposingincluding, requiringwithout limitation, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package HIPAA and the Prospectus or rules and regulations thereunder. To the results of which are referred to in the Registration StatementCompany’s knowledge, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product none of the Company is Trials involved any investigator who has been disqualified as a clinical investigator or has been rejected or determined found by the FDA to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedhave engaged in scientific misconduct.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company PartiesCompany, are or have been adequately described in the Registration Statement, the Disclosure Package Package, and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Package, and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package Package, and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of the aggregate results of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are is described in the Registration Statement, the Disclosure Package Package, and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package Package, and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package Package, and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Package, and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical (i) Except as described in the Registration Statement and the Prospectus, the clinical studies conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company Parties that are material to an understanding of the Company’s business and an investment or its subsidiaries, or in which the Company Partiesor its subsidiaries have participated, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration StatementStatement and the Prospectus, the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus were andProspectus, as applicable, were, and if still ongoingpending are, are being conducted in all material compliance 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 laws applicable statutes and all applicable rules and regulations applicable thereto in of the jurisdictions in FDA and comparable regulatory agencies outside of the United States to which they are being conducted subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and with all laws current Good Clinical Practices and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Disclosure Package Statement and the Prospectus of the results of such studies are accurate and complete descriptions in all material respects and fairly present the data derived from such studies, and therefrom in all material respects; (iii) the Company has no knowledge of any large well-controlled other clinical study studies not described in the aggregate Registration Statement 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 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 study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package Statement and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the Company Parties have not received any written notices or statements from design and implementation of such studies, and, to the FDACompany’s best knowledge, there are no reasonable grounds for the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsame.

Clinical Studies. All The studies, tests and preclinical and clinical studies trials conducted by or or, to the Company’s knowledge, on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties its subsidiaries that are described in the Registration Statement, the Pricing Disclosure Package and Prospectus the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus, as applicable, were and, if still ongoing, are being conducted in all material compliance respects in accordance with all laws standard medical and scientific research standards and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations applicable thereto in promulgated thereunder; the jurisdictions in which they are being conducted descriptions of the results of such studies, tests and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus of are, to the results of such studies are Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no knowledge is not aware of any large well-controlled clinical study studies, tests or trials, the aggregate results of which are inconsistent with or otherwise the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any Governmental Authority requiring the termination or suspension of any studies, tests or preclinical or clinical study trials conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies 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 Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, design and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product implementation of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limitedsuch trials.

Clinical Studies. All preclinical studies and clinical studies trials conducted by or or, to the knowledge of the Company, on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand its subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the The clinical trials and preclinical studies conducted by or or, to the knowledge of the Company, on behalf of the Company Parties and its subsidiaries that are described in the Registration Statement, the Pricing Package Time of Sale Prospectus and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus were and, if still ongoing, are in all material respects, being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical studies and clinical studies trials from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such studies, studies and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectustrials. Except as disclosed in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) EMA or any other Governmental Entity similar governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies trial that are is described in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus or the results of which are referred to Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entitysimilar governmental agency, and otherwise has no knowledge of, or reason to believebelieve that, that (i) any investigational new drug application for any potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Parties, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties that are described in the Registration Statement, the Pricing Disclosure Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, the Company Parties have not received any written notices or statements from the FDA, the EMA or any other Governmental Entity, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand the Subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the General Disclosure Package and the Final Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties and its Subsidiaries that are described in the Registration Statement, the Pricing General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package and the Prospectus. Except as disclosed Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, the . The Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, the . The Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entitygovernmental agency, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical studies and clinical studies trials conducted by or to the knowledge of the Company, on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand its Subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the Disclosure Package Statement and the Prospectus in all material respects. To the Company’s knowledge, after reasonable inquiry, the The clinical trials and preclinical studies conducted by or or, to the knowledge of the Company, on behalf of the Company Parties and its Subsidiaries that are described in the Registration Statement, Statement and the Pricing Package and Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package Statement and the Prospectus were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approvalconducted. The descriptions in the Registration Statement, the Disclosure Package Statement and the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such studiesstudies and trials, and the Company has no knowledge of of, any large well-controlled clinical trial or preclinical study the aggregate results of which the Company reasonably believes are inconsistent with or otherwise call into question the results of any clinical trial or preclinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package Statement and the ProspectusProspectus or the results of which are referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described. Except as disclosed in the Registration Statement, the Disclosure Package Statement and the Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity imposing, Authority requiring, requesting or suggesting termination, suspension, imposition of a clinical hold, termination, suspension hold (which has not been remedied) or material adverse modification for or of any clinical trial or preclinical studies study that are is described in the Registration Statement, the Disclosure Package Statement and the Prospectus or the results of which are referred to in the Registration Statement, Statement and the Disclosure Package Prospectus. Except as disclosed in the Registration Statement and the Prospectus, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental EntityAuthority, and otherwise has no knowledge of, or reason to believe, believe that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Studies. All preclinical and clinical studies conducted by or on behalf of the Company Parties that are material to an understanding of the Company’s business and an investment in the Company Partiesand the Subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the Disclosure Package Prospectus and the Prospectus Supplement in all material respects. To the Company’s knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or on behalf of the Company Parties and its Subsidiaries that are described in the Registration Statement, the Pricing Package Prospectus and the Prospectus Supplement or the results of which are referred to in the Registration Statement, the Disclosure Package Prospectus and the Prospectus Supplement were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Disclosure Package Prospectus and the Prospectus Supplement of the results of such studies are accurate and complete in all material respects and fairly present the data derived from such studies, and the Company has no knowledge of any large well-controlled clinical study the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical study conducted by or on behalf of the Company that are described in the Registration Statement, the Disclosure Package Prospectus and the ProspectusProspectus Supplement or the results of which are referred to in the Registration Statement, the Prospectus and the Prospectus Supplement. Except as disclosed in the Registration Statement, the Disclosure Package Prospectus and the ProspectusProspectus Supplement, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other Governmental Entity governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package Prospectus and the Prospectus Supplement or the results of which are referred to in the Registration Statement, the Disclosure Package Prospectus and the ProspectusProspectus Supplement. Except as disclosed in the Registration Statement, the Prospectus and the Prospectus Supplement, the Company Parties have has not received any written notices or statements from the FDA, the EMA or any other Governmental Entitygovernmental agency, and otherwise has no knowledge or reason to believe, that (i) any investigational new drug application for potential product of the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trial of any potential product of the Company has been, will be or may be suspended, revoked, modified or limited.