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 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 Partiesstudies, 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 tests 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 Time of Sale Prospectus and the Prospectus. Except as disclosed Prospectus (the “Company Studies and Trials”) 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 the Company Studies and Trials, and the results thereof, contained in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus, Prospectus are accurate and complete in all material respects; the Company has is 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 aware of any clinical tests, studies or preclinical studies that are trials not described in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus or Prospectus, the results of which are referred to reasonably call into question the results of the Company Studies and Trials described in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus, ; and the Company Parties have has not received any written notices notice or statements correspondence from the FDA, the EMA FDA or any other foreign, state or local Governmental EntityAuthority exercising comparable authority or any institutional review board or comparable authority requiring the termination, and otherwise has no knowledge suspension, clinical hold or reason to believe, that (i) material modification of any investigational new drug application for potential product of the Company is Studies and Trials. The Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been rejected found by the FDA (or determined any foreign, federal, state or local governmental or regulatory authority performing functions similar to be non-approvable or conditionally approvable; those performed by the FDA) to have engaged in scientific misconduct. To the Company’s knowledge, the manufacturing facilities and (ii) any licenseoperations of its suppliers are operated in compliance in all material respects with all applicable statutes, approvalrules, permit or authorization to conduct any clinical trial of any potential product regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company has been, will be or may be suspended, revoked, modified or limitedis subject.

Clinical Studies. All preclinical Except to the extent disclosed in the Registration Statement and the Prospectus (and to the Company’s knowledge, after due inquiry, with respect to such trials, studies or tests conducted by third parties), the clinical trials and pre-clinical studies and tests conducted by or on behalf of or sponsored by the Company Parties that are material to an understanding of the Company’s business are, and an investment in the Company Partiesat all times have been, are or have been adequately described in the Registration Statement, the Disclosure Package and the Prospectus conducted in all material respects. To respects in accordance with the Company’s knowledgeFD&C Act and the regulations promulgated thereunder, after reasonable inquiryincluding all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used by qualified experts in the pre-clinical and preclinical studies conducted by or on behalf clinical development 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 approvaldrugs. The descriptions in the Registration Statement, the Disclosure Package and the Prospectus of the results of such trials, studies and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit are accurate and complete in all material respects and fairly present the data derived from such studiestrials, studies and tests, and the Company has no does not have any knowledge of any large well-controlled clinical study other trials, studies or tests the aggregate 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 described in the Registration Statement, the Disclosure Package Statement and the Prospectus. Except as to the extent disclosed in the Registration Statement, the Disclosure Package Statement and the Prospectus, the Company has not received any written notices or statements other correspondence from the FDA, the European Medicines Agency (“EMA”) FDA or any other Governmental Entity imposingfederal, requiringstate, requesting local or suggesting a clinical hold, termination, suspension or material modification for or of foreign governmental agency with respect to any clinical trials or preclinical pre-clinical studies or tests that are described in the Registration Statement, the Disclosure Package Statement and the Prospectus or the results of which are referred to described in the Registration Statement, the Disclosure Package Statement and the ProspectusProspectus that require the termination, suspension, delay or modification of such trials, studies or tests, or otherwise require the Company Parties to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions would not reasonably be expected to 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 limiteda Material Adverse Effect.

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 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 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 (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 To the Company’s knowledge, the studies, tests and preclinical and clinical studies investigations 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 ongoingpending, are being conducted in material compliance accordance with established protocols, procedures and controls pursuant to, where applicable, accepted professional scientific research standards for products or product candidates comparable to those being developed by the Company, and all laws Applicable Laws (as defined below) and applicable Authorizations (as defined below), including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations applicable thereto in the jurisdictions in which they including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted and with all laws pursuant to GLP, and regulations applicable relating to good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical studies from which data will be submitted investigations were or are subject to support marketing approval. The descriptions good clinical practice regulations or were or are being conducted under an IND, except for such non-compliance with applicable standards, Applicable Laws and applicable Authorizations that, individually or in the Registration Statementaggregate, would not reasonably be expected to have a Material Adverse Change; the Disclosure Package and the Prospectus descriptions of the results of such studies studies, tests and trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and Company has trials; except to the extent disclosed in the Registration Statement and the Prospectus, to the Company’s knowledge, there are no knowledge 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 question, in any material respect, the study, test, or trial results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any Subsidiary has received any written notices or correspondence from any governmental authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical study investigations conducted by or on behalf of the Company or any Subsidiary, except for such written notices and correspondence that are described in the Registration Statement, the Disclosure Package and the Prospectus. Except as have been disclosed in the Registration Statement, the Disclosure Package and the Statement or 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, where such termination, suspension or material modification for or is not related to the safety of any the clinical or preclinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus trial 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 efficacy 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 limitedinvestigational drug.

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 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 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 The Company has operated and currently is in compliance with the United States Federal Food, Drug, and Cosmetic Act, as amended, all applicable rules and regulations of the FDA and other federal, state, local and foreign governmental bodies exercising comparable authority, except where the failure to so operate or be in compliance would not reasonably be expected to have a Material Adverse Effect. The clinical studies 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 StatementStatement and the Prospectus were, and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and all applicable laws and regulations and the 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; preclinical studies conducted by or, to the Company’s knowledge, on behalf of the Company or its subsidiaries that are described in the Registration Statement and the Prospectus were, and, if still pending, are being, 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; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or, to the Company’s knowledge, on behalf of the Company contained in the Registration Statement and the Prospectus are accurate and complete in all material respects; and the Company is not aware of any other trials or studies, the Disclosure Package results of which reasonably call into question the results described or referred to in the Registration Statement and the Prospectus. Except as disclosed in the Registration Statement, the Disclosure Package ; and the Prospectus, the Company has not received any written notices notice or statements correspondence from the FDA, the European Medicines Agency (“EMA”) FDA or any other Governmental Entity imposingforeign, requiringstate or local governmental body exercising comparable authority requiring the termination, requesting suspension, or suggesting clinical hold of any preclinical or clinical studies with respect to product candidates currently under development, or such written notice or correspondence from any Institutional Review Board or comparable authority requiring the termination or suspension of a clinical holdstudy, conducted by or on behalf of the Company, which termination, suspension 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 hold would reasonably be expected 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 limiteda Material Adverse Effect.

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 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 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 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.

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 The studies, tests and preclinical and clinical studies trials conducted by or on behalf of the Company Parties that are material to an understanding 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 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 subsidiaries were and, if still ongoingpending, are being conducted in all material compliance respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all laws Applicable Laws and Authorizations, 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 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 studies, tests and trials contained in the Registration Statement and the Applicable Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except as disclosed in the Applicable 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 results, test results, or trial results of any clinical study conducted by described 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 Applicable Prospectus when viewed in the context in which such results are described and the Prospectusclinical state of development; and, since December 31, 2007, the Company Parties have has not received any written notices or statements correspondence from the FDA, the EMA FDA or any other Governmental Entityfederal, and otherwise has no knowledge state, local or reason to believeforeign governmental or regulatory authority requiring the termination, that (i) suspension or material modification of any investigational new drug application for potential product studies, tests or preclinical or clinical trials conducted by or on behalf of the Company. Any certificate signed by any officer of the Company is or has been rejected any of its subsidiaries and delivered to the Underwriter or determined to counsel for the Underwriter shall be deemed a representation and warranty by the Company to the Underwriter as to the matters covered thereby. The Company acknowledges that the Underwriter and, for purposes of the opinions to be non-approvable or conditionally approvable; delivered pursuant to Section 6 hereof, counsel to the Company and (ii) any licensecounsel to the Underwriter, approval, permit or authorization to conduct any clinical trial of any potential product will rely upon the accuracy and truthfulness of the Company has been, will be or may be suspended, revoked, modified or limitedforegoing representations and hereby consents to such reliance.

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 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 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 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 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 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 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 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 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, 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 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 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 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. All The preclinical studies and tests 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 trials described in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the 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, contained in the Registration Statement, the Time of Sale Prospectus and the Prospectus are accurate and complete 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 is not aware of any tests, studies or trials not described in the Registration Statement, the Pricing Package Time of Sale Prospectus and Prospectus or the Prospectus, 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 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 Time of Sale Prospectus and the Prospectus. Except ; and, except as disclosed described in the Registration Statement, the Disclosure Package Time of Sale Prospectus and the Prospectus, the Company has not received any written notices notice or statements correspondence from the FDA, the European Medicines Agency (“EMA”) FDA or any other Governmental Entity imposingforeign, requiring, requesting state or suggesting a clinical hold, local governmental authority exercising comparable authority or 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 Time of Sale 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 . Any certificate signed by an officer of the Company is and delivered to the Underwriters or has been rejected to counsel for the Underwriters pursuant to or determined in connection with this Agreement shall be deemed to be non-approvable or conditionally approvable; a representation and (ii) any licensewarranty by the Company to the Underwriters as to the matters set forth therein. The Company acknowledges that the Representatives and, approval, permit or authorization to conduct any clinical trial of any potential product for purposes of the opinions to be delivered pursuant to Section 6 hereof, counsel to the Company and counsel to the Representatives, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance. The Company has beena reasonable basis for making each of the representations set forth in this Section 1. The Company acknowledges that the Underwriters and, for purposes of the opinions to be delivered pursuant to Section 6, counsel to the Company and counsel to the Underwriters, will be or may be suspended, revoked, modified or limitedrely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Clinical Studies. All To the Company’s knowledge, the studies, tests and preclinical and clinical studies investigations 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 General Disclosure Package and the Prospectus were and, if still ongoingpending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards for products or product candidates comparable to those being developed by the Company, and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and implementing regulations including good laboratory practice (“GLP”) regulations (21 C.F.R. Part 58) if any such studies, tests or preclinical and clinical investigations are being conducted in material compliance with all laws pursuant to GLP, and good clinical practice and IND requirements (21 C.F.R. Parts 50, 54, 56, and 312) if any such studies, tests or preclinical and clinical investigations were or are subject to good clinical practice regulations applicable thereto in the jurisdictions in which they or were or are being conducted under an IND; 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 General 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, tests and trials; except to the extent disclosed in the Registration Statement, the General 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 General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its Subsidiaries have received any written notices or correspondence from any Governmental Entity requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical study investigations 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 limitedits Subsidiaries.

Clinical Studies. None of the Company’s product candidates has received marketing approval from any Applicable Regulatory Authority. All preclinical clinical and pre-clinical studies (to the extent they are required to comply with Good Laboratory Practices by relevant Regulatory Authorities) and trials conducted by or on behalf of or sponsored by the Company Parties that are material or its subsidiaries, or in which the Company or its subsidiaries have participated, with respect to an understanding of the Company’s business product candidates, including 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 to the Company’s knowledge, being conducted in all material compliance respects in accordance with all laws applicable Health Care Laws of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, 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 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; neither the Company nor any of its subsidiaries has received, and neither the Company nor any clinical study conducted of its subsidiaries have knowledge that any of their respective collaboration partners have received, any written notices, correspondence or other written 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 or any of its subsidiaries 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 or any of its subsidiaries in the Registration Statement, the Disclosure Package and the Prospectusconnection with a Company Trial, the Company or such subsidiary 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 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.