Common use of Research Studies and Trials Clause in Contracts

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary SEC Reports or Prospectus or the ProspectusSupplement, or the results of which are referred to in the Preliminary Prospectus SEC Reports or the ProspectusProspectus Supplement, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus SEC Reports or the Prospectus Supplement do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus SEC Reports or the Prospectus Supplement the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus SEC Reports or the ProspectusProspectus Supplement ; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are not described in the Preliminary Prospectus SEC Reports or the ProspectusProspectus Supplement, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiariessubsidiary, or in which the Company or its Subsidiaries subsidiary has participated, that are described in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus, as applicable, Prospectus were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Registration Statement, the Time of Sale Prospectus or and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; (C) neither the Company nor its subsidiaries have any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Applicable Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Registration Statement, the Time of Sale Prospectus or and the Prospectus; and (D) neither the Company nor any Subsidiary its subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary its subsidiary or in which the Company or any Subsidiary its subsidiary has participated that are described in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or its subsidiary in its product development efforts, submissions or reports to any regulatory authority Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus; and neither except as described in the Registration Statement or Prospectus the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring requiring, suggesting or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. 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 to the Company’s knowledge there is no 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 or any other governmental agency 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. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or and its Subsidiariessubsidiaries, or in which the Company or and its Subsidiaries has subsidiaries have participated, that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or Company, its Subsidiaries subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (FDA, the “FDA”) EMA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any there are no research studies or trials not described in the Preliminary Prospectus or Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus; and neither the Company nor any Subsidiary has its subsidiaries have received any written notices or correspondence from the FDA FDA, the EMA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary and its subsidiaries or in which the Company or any Subsidiary has and its subsidiaries have participated that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company or its subsidiaries in its their product development effortsdevelopment, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and other regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or Registration Statement, the Disclosure Package and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Registration Statement, the Disclosure Package or the Prospectus or that suggest a reasonable possibility of any adverse side effects not described in the Registration Statement, the Disclosure Package and the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse EffectChange; and (F) the research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or any of its Subsidiariessubsidiaries, or in which the Company or its Subsidiaries has subsidiaries have participated, that are described in the Preliminary Prospectus Registration Statement or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, the European Commission, the EMA and Drug Administration (the “FDA”) and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has and its subsidiaries have no knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement or the Prospectus; and (D) neither the Company nor any Subsidiary has of its subsidiaries have received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary of its subsidiaries or in which the Company or any Subsidiary has of its subsidiaries have participated that are described in the Preliminary Prospectus Registration Statement or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or any of its subsidiaries in its any of their product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the ProspectusProspectus Supplement, or the results of which are referred to in the Preliminary Prospectus or the ProspectusProspectus Supplement, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus Supplement do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus Supplement the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the ProspectusProspectus Supplement; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the ProspectusProspectus Supplement, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesSenseonics, or in which the Company or its Subsidiaries has Senseonics have participated, that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries Senseonics and all applicable statutes, rules and regulations of the U.S. Food FDA, the European Commission, the EMA and Drug Administration (the “FDA”) and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has and Senseonics have no knowledge of any research studies or trials not described in the Preliminary Prospectus or Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus; and (D) neither the Company nor any Subsidiary has Senseonics have received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary Senseonics or in which the Company or any Subsidiary has Senseonics have participated that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or Senseonics in its any of their product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Registration Statement, the Time of Sale Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and human manner under state, national or supra-national applicable laws which are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food Department of Health and Drug Administration Human Services (“HHS”), the “FDA”) FDA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the HHS and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus; and neither except as described in the Registration Statement or Prospectus the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company's knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, the TGA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Registration Statement and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, the TGA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement or the Prospectus, and, to the Company’s 's knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, the TGA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and human manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration Administation (the “FDA”) and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and human manner under state, national or supra-national applicable laws which are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus, or the results of which are referred to in the Preliminary Registration Statement, Pricing Disclosure Package and Prospectus or the Prospectus, as applicable, were and, if still pending, are are, being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus do not not, contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus Registration Statement, Pricing Disclosure Package and Prospectus, the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus; and neither except as described in the Company nor any Subsidiary Registration Statement, Pricing Disclosure Package and Prospectus has not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company or any Subsidiary in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesSenseonics, or in which the Company or its Subsidiaries Senseonics has participated, that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries Senseonics and all applicable statutes, rules and regulations of the U.S. Food FDA, the European Commission, the EMA and Drug Administration (the “FDA”) and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has and Senseonics have no knowledge of any research studies or trials not described in the Preliminary Prospectus or Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus; and (D) neither the Company nor any Subsidiary Senseonics has received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary Senseonics or in which the Company or any Subsidiary has Senseonics have participated that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or Senseonics in its any of their product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Information or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Time of Sale Information or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, the European Commission, the EMA and Drug Administration (the “FDA”) and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Time of Sale Information or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Time of Sale Information and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Time of Sale Information or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Information or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company in its any of their product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The (A) Except as disclosed in the documents incorporated or deemed to be incorporated by reference in the Registration Statement, the General Disclosure Package and the Prospectus, the research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiariessubsidiary, or in which the Company or its Subsidiaries subsidiary has participated, that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; (C) neither the Company nor its subsidiary has any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or General Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus; and (D) neither the Company nor any Subsidiary its subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary its subsidiary or in which the Company or any Subsidiary its subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or its subsidiary in its product development efforts, submissions or reports to any regulatory authority Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its Subsidiariessubsidiary, or in which the Company or its Subsidiaries has subsidiary have participated, that are described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries subsidiary and all applicable statutes, rules and regulations of the U.S. Food FDA, the European Commission, the EMA and Drug Administration (the “FDA”) and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has and its subsidiary have no knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus; and (D) neither the Company nor any Subsidiary has its subsidiary have received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary its subsidiary or in which the Company or any Subsidiary has its subsidiary have participated that are described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or its subsidiary in its any of their product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and other regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or Registration Statement, the Disclosure Package and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Registration Statement, the Disclosure Package or the Prospectus or that suggest a reasonable possibility of any adverse side effects not described in the Registration Statement, the Disclosure Package and the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “"FDA”") and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the Prospectus, and, to the Company’s 's knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable Health Care Authorizations, experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company's knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, the TGA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, the TGA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, and, to the Company’s 's knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, the TGA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and human manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. (A) The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiariessubsidiaries, or in which the Company or its Subsidiaries has subsidiaries have participated, that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were and, if still pending, and are being, being conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or and its Subsidiaries subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or Registration Statement, the General Disclosure Package and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; (C) neither the Company nor its subsidiaries have any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or General Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus; and neither (D) the Company nor any Subsidiary has and its subsidiaries have not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary its subsidiaries or in which the Company or any Subsidiary has its subsidiaries have participated that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any material violation of applicable law or regulation by the Company or its subsidiaries in its their product development efforts, submissions or reports to any regulatory authority Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company's knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Registration Statement, the Time of Sale Prospectus, the Preliminary Prospectus or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus, the Preliminary Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health, Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, the TGA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Registration Statement, the Time of Sale Prospectus, the Preliminary Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Registration Statement, the Time of Sale Prospectus, the Preliminary Prospectus or and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Registration Statement, the Time of Sale Prospectus, the Preliminary Prospectus or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, the TGA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Registration Statement, the Time of Sale Prospectus, the Preliminary Prospectus or the Prospectus, and, to the Company’s 's knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law Law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, the TGA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and human manner under state, national or supra-national applicable Laws that are either equal or more stringent than applicable Laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted, where applicable, under the auspices of a neutral and independent Institutional Animal Care and Use Committee or institutional review board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its SubsidiariesSubsidiary, or in which the Company or its Subsidiaries Subsidiary has participated, that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries Subsidiary and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) , HHS, EMEA, Health Canada and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA FDA, HHS, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus, or the results of which are referred to in the Preliminary Registration Statement, Pricing Disclosure Package and Prospectus or the Prospectus, as applicable, were and, if still pending, are are, being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus do not not, contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus Registration Statement, Pricing Disclosure Package and Prospectus, the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus; and neither except as described in the Company nor any Subsidiary Registration Statement, Pricing Disclosure Package and Prospectus has not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the Registration Statement, Pricing Disclosure Package and Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company or any Subsidiary in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the ProspectusProspectus Supplement, or the results of which are referred to in the Preliminary Prospectus or the ProspectusProspectus Supplement, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus Supplement do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus Supplement the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the ProspectusProspectus Supplement; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the ProspectusProspectus Supplement, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Pricing Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Pricing Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Pricing Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Pricing Prospectus or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Pricing Prospectus or the Prospectus; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Pricing Prospectus or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesSenseonics, or in which the Company or its Subsidiaries has Senseonics have participated, that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries Senseonics and all applicable statutes, rules and regulations of the U.S. Food FDA, the European Commission, the EMA and Drug Administration (the “FDA”) and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has and Senseonics have no knowledge of any research studies or trials not described in the Preliminary Prospectus or Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus; and (D) neither the Company nor any Subsidiary has Senseonics have received any written notices or correspondence from the FDA FDA, the European Commission, the EMA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary Senseonics or in which the Company or any Subsidiary has Senseonics have participated that are described in the Preliminary Prospectus Registration Statement, the Time of Sale Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; and (E) there has not been any violation of applicable law or regulation by the Company or Senseonics in its any of their product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the ProspectusSEC Reports, or the results of which are referred to in the Preliminary Prospectus or the ProspectusSEC Reports, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and other regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, the TGA, and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus SEC Reports do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus SEC Reports the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus SEC Reports or that suggest a reasonable possibility of any adverse side effects not described in the ProspectusSEC Reports; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, the TGA, or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the ProspectusSEC Reports, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, the TGA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.Change; (F) neither the Company, nor any Person engaged by the Company has made an untrue statement of a material fact or a fraudulent statement to the FDA, the European commissions, the EMA, the TGA, or any other Governmental Entity responsible for enforcement or oversight with respect to Healthcare Laws, or failed to disclose a material fact required to be disclosed to the FDA, the European Commissions, the EMA, the TGA, or such other Governmental Entity that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991), or for any other Governmental Entity to invoke a similar policy; and (FG) the research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws, including without limitation Good Clinical Practices, that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects (including regulations regarding “Informed Consent” as such term is defined under applicable law in the jurisdictions where clinical trials were or are being conducted) and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board, Ethics Committee, and applicable state, national, or supra national agencies responsible for oversight..

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company's knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus, or the results of which are referred to in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, the TGA and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Registration Statement, the Time of Sale Prospectus or and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, the TGA or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Registration Statement, the Time of Sale Prospectus or the Prospectus, and, to the Company’s 's knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, the TGA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and human manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. (A) The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and other regulations of the U.S. Food FDA, National Institute of Health Department of Health and Drug Administration (Human Services, the “FDA”) European Commission, the EMA, and any other comparable drug and medical device regulatory agencies Health Regulatory Agencies to which they are it is subject; (B) the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither (C) the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Registration Statement, the Pricing Disclosure Package or the Prospectus or that suggest a reasonable possibility of any adverse side effects not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and neither (D) the Company nor any Subsidiary has not received any written notices or correspondence from the FDA FDA, the European Commission, the EMA, or any other foreign, state or local governmental body exercising comparable authority Health Regulatory Agency or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There ; (E) there has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA, or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect; and (F) the research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws that are either equal or more stringent than applicable laws and regulations enforced by the Department of Health and Human Services and FDA governing human, animal or non-human primate research participants and test subjects and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. The research studies and trials conducted by or by, on behalf of, of or sponsored by, by the Company or its Subsidiariessubsidiaries, or in which the Company or its Subsidiaries subsidiaries has participated, that are described in the Preliminary Prospectus or the Prospectusin, or the results of which are referred to in in, the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were andwere, and if still pendingpending are, are being, being conducted in all material respects in accordance with applicable the experimental protocolsprotocols established for each study or trial, procedures as well as any conditions of approval and controls pursuant topolicies imposed by any institutional review board, where applicableethics review board or committee responsible for the oversight of such studies and trials, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statuteslocal, state and federal laws, rules and regulations of the U.S. Food and Drug Administration (FDA, the “FDA”) EMA and other comparable drug and medical device regulatory agencies to which they are subjectsubject (such institutional review boards, ethics review boards, committees, the FDA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws; the descriptions in the Registration Statement, the Pricing Disclosure Package or the Prospectus of the results of such studies and trials contained are accurate and not misleading in all material respects with respect to the Preliminary Prospectus portions of such studies and trials being described and fairly present the data derived from such studies or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleadingtrials; neither the Company nor any Subsidiary has no knowledge of any research other studies or trials not described in the Preliminary Prospectus or Registration Statement, the Prospectus Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question in any material respect the results of the research studies and trials described or referred to in the Preliminary Registration Statement, the Pricing Disclosure Package and the Prospectus or when viewed in the Prospectuscontext in which such results are described and the current state of development; and neither the Company nor any Subsidiary has its subsidiaries have received any written notices notice, correspondence or correspondence other communications from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority Regulatory Authorities requiring or threatening (i) the premature termination, suspension, material modification termination or suspension or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in, or the results of which are referred to in, the Registration Statement, the Pricing Disclosure Package and the Prospectus, or (ii) the material modification of any studies or trials that would cause them to differ from their descriptions in the Preliminary Prospectus or Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or tests, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company or its subsidiaries in its their product development effortsdevelopment, submissions or reports to any regulatory authority Regulatory Authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or or, to the Company’s knowledge, on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus or the Registration Statement and Prospectus, or the results of which are referred to in the Preliminary Prospectus or the Prospectuswere, as applicable, were and, if still pending, are being, being conducted in all material respects in accordance with applicable all of the Healthcare Authorizations, experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries Parties and all applicable statutes, laws, rules and regulations of the U.S. FDA, National Institute of Health Department of Health and Human Services, the European Commission, the EMA and any other Health Regulatory Agencies to which it is subject, including, without limitation, the FDCA and its implementing regulations at 21 C.F.R. Parts 50, 54, 56 and 312, and the Canada Food and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies to which they are subjectDrugs Act; the descriptions of such studies, tests and trials, and the results of such studies and trials thereof, contained in the Preliminary Registration Statement and Prospectus or the Prospectus are accurate and complete in all material respects and do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge is not aware of any research tests, studies or trials not described in the Preliminary Prospectus Registration Statement or the Prospectus Prospectus, the results of which reasonably call into question in any material respect the results of the research tests, studies and trials described in the Preliminary Prospectus Registration Statement or the Prospectus; and neither the Company nor any Subsidiary has not received any written notices notice or correspondence from the FDA FDA, Health Canada or any other foreign, state or local governmental body Governmental Authority exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, clinical hold or material modification or clinical hold of any tests, research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in any of its product development efforts, submissions or reports to the FDA, the European Commission, the EMA or any regulatory authority other Health Regulatory Agency that could reasonably be expected to require investigation, corrective action or result in enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect. The research studies and clinical trials of Company are being conducted in an ethical and humane manner under state, national or supra-national applicable laws and such studies and the clinical trials are conducted under the auspices of a neutral and independent Institutional Animal Care and Use Committee or Institutional Review Board and applicable state, national, or supra national agencies responsible for oversight.

Research Studies and Trials. (A) The research pre-clinical, clinical and other studies and trials conducted by or by, on behalf of, of or sponsored by, by the Company or its Subsidiariessubsidiaries, or in which the Company or its Subsidiaries subsidiaries has participated, that are described in the Preliminary Prospectus or the Prospectusin, or the results of which are referred to in in, the Preliminary Prospectus or Registration Statement and the Prospectus, as applicable, were andwere, and if still pendingpending are, are being, being conducted in all material respects in accordance with applicable the experimental protocolsprotocols established for each study or trial, procedures as well as any conditions of approval and controls pursuant topolicies imposed by any institutional review board, where applicableethics review board or committee responsible for the oversight of such studies and trials, all accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries standards, and all applicable statuteslocal, state and federal laws, rules and regulations of the U.S. Food FDA, the EMA and Drug Administration (the “FDA”) and other comparable drug and medical device regulatory agencies outside of the United States to which they are subjectsubject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Healthcare Laws, except for such failure to conduct such studies and trials that would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Change; (B) the descriptions in the Registration Statement and the Prospectus of the results of such studies and trials contained are accurate and not misleading in all material respects with respect to the Preliminary Prospectus portions of such studies and trials being described and fairly present the data derived from such studies or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleadingtrials; neither (C) the Company nor any Subsidiary has no knowledge of any research other studies or trials not described in the Preliminary Prospectus or Registration Statement and the Prospectus Prospectus, the results of which are inconsistent with or reasonably call into question in any material respect the results of the research studies and trials described or referred to in the Preliminary Registration Statement and the Prospectus or when viewed in the Prospectuscontext in which such results are described and the current state of development; and (D) neither the Company nor any Subsidiary has its subsidiaries have received any written notices notice, correspondence or correspondence other communications from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority Regulatory Authorities requiring or threatening (i) the premature termination, suspension, material modification termination or suspension or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in, or the results of which are referred to in, the Registration Statement and the Prospectus, except for such termination, suspension or clinical hold that would not, singly or in the Preliminary Prospectus aggregate, reasonably be expected to result in a Material Adverse Change, or (ii) the modification of any studies or trials that would cause them to differ from their descriptions in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or tests, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where for such violation modifications that would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse EffectChange.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its SubsidiariesCompany, or in which the Company or its Subsidiaries has participated, that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has no knowledge of any research studies or trials not described in the Preliminary Prospectus or Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus; and neither the Company nor any Subsidiary has not received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus Registration Statement, the General Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.

Research Studies and Trials. The research studies and trials conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries has participatedparticipated that are being relied on for obtaining IND and/or marketing approval from regulatory authorities, that are described in the Preliminary Prospectus or the ProspectusProspectus Supplement, or the results of which are referred to in the Preliminary Prospectus or the ProspectusProspectus Supplement, as applicable, were and, if still pending, are being, conducted in all material respects in accordance with applicable experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or its Subsidiaries and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) FDA and other comparable drug and medical device regulatory agencies to which they are subject, except for research studies and trials intended by the Company to be preliminary in nature with further compliant validation studies to be conducted; the descriptions of the results of such studies and trials contained in the Preliminary Prospectus or the Prospectus Supplement do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; neither the Company nor any Subsidiary has knowledge of any research studies or trials not described in the Preliminary Prospectus or the Prospectus Supplement the results of which reasonably call into question in any material respect the results of the research studies and trials described in the Preliminary Prospectus or the ProspectusProspectus Supplement; and neither the Company nor any Subsidiary has received any written notices or correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any institutional review board or comparable authority requiring or threatening the premature termination, suspension, material modification or clinical hold of any research studies or trials conducted by or on behalf of, or sponsored by, the Company or any Subsidiary or in which the Company or any Subsidiary has participated that are described in the Preliminary Prospectus or the ProspectusProspectus Supplement, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, except where such violation would not, singly or in the aggregate, result in a Material Adverse Effect.