Regulatory. 2.45.1. Except as set forth in the Pricing Disclosure Package and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each of the Company and its Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits that, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither the Company nor any Subsidiary has failed to file with the FDA, the USDA or the EMA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings. 2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.
Appears in 3 contracts
Sources: Underwriting Agreement (Oasmia Pharmaceutical AB), Underwriting Agreement (Oasmia Pharmaceutical AB), Underwriting Agreement (Oasmia Pharmaceutical AB)
Regulatory. 2.45.1. Except Each of the Company and the Subsidiaries is duly licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Pricing Disclosure Package and the Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as described in the Pricing Disclosure Package and the Prospectus, each of the Company and its the Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse ChangeEffect; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse ChangeEffect; except as otherwise described in the Pricing Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or decree impairing, restricting or prohibiting the payment of dividends by the Company or any of its Subsidiaries; and except as otherwise described in the Pricing Disclosure Package and the Prospectus, none of the Company, the Subsidiaries or any of Properties is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter.
(i) All reinsurance and retrocession treaties and agreements in force as of the date of this Agreement to which the Company or any of its Subsidiaries is a ceding party, (ii) any terminated or expired reinsurance or retrocession treaty or agreement of the Company or any of the Subsidiaries under which there remains any material outstanding reserves or unexpired coverage and (iii) any reinsurance or retrocession treaty or agreement between the Company and/or any of the Subsidiaries on one hand, and any affiliate of the Company, on the other hand, and for each such treaty or agreement described in (i), (ii) or (iii), the effective date of such treaty or agreement and the termination date of any such treaty or agreement which has a definite termination date (collectively, the “Ceded Reinsurance Agreements”) are in full force and effect, and neither the Company nor any Subsidiary has failed to file with the FDASubsidiary, the USDA or the EMA or as applicable, is in default in any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented respect as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The researchprovision of any Ceded Reinsurance Agreement, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, arethere is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, no party to any Ceded Reinsurance Agreement is impaired such that a default thereunder would reasonably be expected. Each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Effect; and each of the Company and the Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States and the applicable requirements of various states thereof, except where the FDA failure to so maintain its books and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice records or correspondence from the FDA be in compliance would not, individually or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred be expected to result in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectusa Material Adverse Effect.
Appears in 3 contracts
Sources: Underwriting Agreement (1347 Property Insurance Holdings, Inc.), Underwriting Agreement (1347 Property Insurance Holdings, Inc.), Underwriting Agreement (1347 Property Insurance Holdings, Inc.)
Regulatory. 2.45.12.41.1. Except as set forth in the Pricing Disclosure Package and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug ApplicationApplication (“IND”), New Drug ApplicationApplication (“NDA”), or New Animal Drug Application, Biologics License Application (“BLA”) as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, FDA or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would not, individually or in the aggregate, could reasonably be expected to result in have a Material Adverse Change; each of the Company and its Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits that, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither the Company nor any Subsidiary has failed to file with the FDA, the USDA or the EMA FDA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA FDA or any Governmental Authority with respect to any such filings.
2.45.22.41.2. The To the Company’s knowledge, the research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and study or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial study or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.
Appears in 2 contracts
Sources: Underwriting Agreement (Xenetic Biosciences, Inc.), Underwriting Agreement (Xenetic Biosciences, Inc.)
Regulatory. 2.45.1. (a) Except as set forth in the Pricing Disclosure Package and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary would not reasonably be expected to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would nothave, individually or in the aggregate, could a Parent Material Adverse Effect, each of Parent and its Subsidiaries holds or is in the process of acquiring all authorizations of all applicable Governmental Entities that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Entity, a “Parent Regulatory Agency”), in each case, that is necessary for the lawful operation of the businesses of Parent or any of its Subsidiaries as currently conducted (the “Parent Regulatory Permits”). Except as would not reasonably be expected to result have, individually or in the aggregate, a Parent Material Adverse Change; each of the Company and its Subsidiaries is in compliance with the requirements of the Regulatory PermitsEffect, and all of the such Parent Regulatory Permits are valid and in full force and effect, effect and Parent and its Subsidiaries are in each case in compliance with the terms of all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating Parent Regulatory Permits.
(b) Except as would not reasonably be expected to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits thathave, individually or in the aggregate, if the subject a Parent Material Adverse Effect, each of an unfavorable decisionParent and its Subsidiaries is in compliance with all regulations and requirements of all Parent Regulatory Agencies, ruling including any applicable Good Manufacturing Practices, Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or findingrepackaging requirements, could laboratory controls, storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to result have, individually or in the aggregate, a Parent Material Adverse Change; neither the Company nor any Subsidiary has failed to file with the FDAEffect, the USDA or the EMA or any Governmental Authority any required applicationsince January 1, submission2019, reportall Parent Products have been produced, documentdistributed, noticelabeled, supplement, or amendmentmarketed and sold, and all raw materials and ingredients in such filings were in material compliance with applicable laws when filed and products have been supplemented procured, in compliance in all material respects with all Applicable Laws governing the procurement, production, distribution, labeling and sale of such products, raw materials or ingredients. Except as necessary would not reasonably be expected to remain have, individually or in material compliance with applicable laws and no material deficiencies the aggregate, a Parent Material Adverse Effect, since January 1, 2019, there have been asserted by the FDAno recalls, the USDA withdrawals or the EMA or any Governmental Authority suspensions with respect to any such filings.
2.45.2Parent Products produced, distributed, labeled, marketed or sold by Parent or any of its Subsidiaries. The researchExcept as would not reasonably be expected to have, studies and pre-clinical and clinical trials conducted by individually or on behalf in the aggregate, a Parent Material Adverse Effect, since January 1, 2019, neither Parent nor any of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any written notice of or correspondence from the FDA otherwise is aware of, any Parent Regulatory Agency untitled letters, warning letters, notices of warning or any Governmental Authority requiring the terminationwithholding, suspension or modification withdrawal of any inspection, seizure, criminal referral or other similar federal, state or private enforcement actions with respect to such researchParent Products. Except as would not reasonably be expected to have, study, pre-clinical trials and individually or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, a Parent Material Adverse Effect, since January 1, 2019, neither Parent nor any Preliminary Prospectusof its Subsidiaries is subject (or has been subject) to any adverse inspection finding, the Pricing Prospectus recall, investigation, penalty assessment, audit or the Prospectus and other compliance or enforcement action by any Issuer Free Writing ProspectusParent Regulatory Agencies.
(c) Neither Parent nor any of its Subsidiaries is party to any corporate integrity agreements, the Company is monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Agency, except as would not aware of any researchreasonably be expected to have, study, pre-clinical trial individually or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statementaggregate, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.a Parent Material Adverse Effect
Appears in 2 contracts
Sources: Merger Agreement (Bioceres Crop Solutions Corp.), Merger Agreement (Marrone Bio Innovations Inc)
Regulatory. 2.45.1. Except Each of the Company and its Subsidiaries is duly licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Pricing Disclosure Package and the Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; except as described in the Pricing Disclosure Package and the Prospectus, each of the Company and its Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each none of the Company and or its Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; except as otherwise described in the Pricing Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or decree impairing, restricting or prohibiting the payment of dividends by the Company or any of its Subsidiaries; and none of the Company, its Subsidiaries or any of their properties or assets is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter.
(i) All reinsurance and retrocession treaties and agreements in force as of the date of this Agreement to which the Company or any of its Subsidiaries is a ceding party, (ii) any terminated or expired reinsurance or retrocession treaty or agreement of the Company or any of its Subsidiaries under which there remains any material outstanding reserves or unexpired coverage and (iii) any reinsurance or retrocession treaty or agreement between the Company and/or any of its Subsidiaries on one hand, and any affiliate of the Company, on the other hand, and for each such treaty or agreement described in (i), (ii) or (iii), the effective date of such treaty or agreement and the termination date of any such treaty or agreement which has a definite termination date (collectively, the “Ceded Reinsurance Agreements”) are in full force and effect, and neither the Company nor any Subsidiary has failed to file with the FDASubsidiary, the USDA or the EMA or as applicable, is in default in any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented respect as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The researchprovision of any Ceded Reinsurance Agreement, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, arethere is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, no party to any Ceded Reinsurance Agreement is impaired such that a default thereunder would reasonably be expected. Each of the Company and its Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and its Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States and the applicable requirements of various states thereof, except where the FDA failure to so maintain its books and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice records or correspondence from the FDA be in compliance would not, individually or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred be expected to result in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectusa Material Adverse Change.
Appears in 2 contracts
Sources: Underwriting Agreement (1347 Property Insurance Holdings, Inc.), Underwriting Agreement (1347 Property Insurance Holdings, Inc.)
Regulatory. 2.45.1FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Except Neither the Company nor any other Subsidiary is required to be licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Pricing Disclosure Package and the Prospectus; each of the Company and the Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Pricing Disclosure Package and the Prospectus, each and all of the Company foregoing are in full force and its Subsidiaries has effect, except where the failure to have such permitsauthorizations, licensesapprovals, orders, consents, certificates, approvalspermits, clearances, authorizations registrations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local qualifications or foreign regulatory agencies or bodies necessary their failure to conduct the business of the Company as described be in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus full force and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither FGRe meets all capital requirements to maintain its license; none of the Company nor any Subsidiary has failed to file with risks insured by FGRe have been re-insured, assigned, or ceded. None of the FDACompany, the USDA or the EMA Subsidiaries or any Governmental Authority any required application, submission, report, document, notice, supplement, of the properties or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf assets of the Company and or any Subsidairy is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its Subsidiaries terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such insurance contract or any reason to believe that termination or cancelation is contemplated; and, if still pendingexcept as would not have a Material Adverse Change, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, areno claims have been made thereunder. There is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the applicable requirements of Cayman Islands, except where the FDA failure to so maintain its books and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice records or correspondence from the FDA be in compliance would not, individually or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectusreasonably be expected to result in a Material Adverse Change. FGRe has been granted a Class B(iii) insurance license under The Insurance Law, the Pricing Prospectus or the Prospectus 2010, and any Issuer Free Writing Prospectus, the Company such license is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus full force and any Issuer Free Writing Prospectuseffect.
Appears in 2 contracts
Sources: Underwriting Agreement (FG Financial Group, Inc.), Underwriting Agreement (FG Financial Group, Inc.)
Regulatory. 2.45.1FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Except Neither the Company nor any other Subsidiary is required to be licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Pricing Disclosure Package and the Prospectus, each of the Company and its the Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither FGRe meets all capital requirements to maintain its license; none of the Company nor any Subsidiary has failed to file with risks insured by FGre have been re-insured, assigned, or ceded. None of the FDACompany, the USDA or the EMA Subsidiaries or any Governmental Authority any required application, submission, report, document, notice, supplement, of the properties or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf assets of the Company and is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its Subsidiaries terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such insurance contract or any reason to believe that termination or cancelation is contemplated; and, if still pendingexcept as would not have a Material Adverse Change, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, areno claims have been made thereunder. There is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the applicable requirements of Cayman Islands, except where the FDA failure to so maintain its books and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice records or correspondence from the FDA be in compliance would not, individually or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectusreasonably be expected to result in a Material Adverse Change. The Company has been granted a Class B(iii) insurance license under The Insurance Law, the Pricing Prospectus or the Prospectus 2010 and any Issuer Free Writing Prospectus, the Company such license is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus full force and any Issuer Free Writing Prospectuseffect.
Appears in 2 contracts
Sources: Underwriting Agreement (FG Financial Group, Inc.), Underwriting Agreement (FG Financial Group, Inc.)
Regulatory. 2.45.1(a) Seller has made available to Buyer complete and correct copies of (i) all Product INDs and (ii) all Purchased Records. Except as set forth All Product INDs are in full force and effect and there are no facts that would constitute a material default or noncompliance under the Pricing Disclosure Package Product IND.
(b) With respect to the Purchased Assets, Seller is in compliance with the Act, including the regulations promulgated thereunder, and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local any state or foreign regulatory agencies Laws applicable to the development, testing, safety or bodies necessary to conduct the business efficacy of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological pharmaceutical products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental AuthorityPharmaceutical Laws”), except for any of the foregoing that as would not, individually or in the aggregate, have a Material Adverse Effect. Seller has not received any written, or, to Seller’s Knowledge, other notice from the FDA or any other Governmental Authority alleging noncompliance with any Pharmaceutical Law or initiating, or threatening to initiate, any action to suspend or terminate a Product IND. In connection with the Purchased Assets, Seller has not and, to the Knowledge of Seller, Seller’s officers, employees, agents or clinical investigators acting for Seller have not (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority or (iii) committed any other act, made any statement or failed to make any statement, that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or for any other Governmental Authority to invoke such a policy.
(c) Seller has filed with the FDA and other applicable Governmental Authorities all required material filings, declarations, listings, registrations, reports, applications or submissions, including but not limited to Product INDs and adverse event reports, required by Pharmaceutical Laws in connection with the Purchased Assets. All such filings, declarations, listings, registrations, reports, applications or submissions were in material compliance with applicable Pharmaceutical Laws when filed and remain in full force and effect.
(d) All preclinical and clinical investigations or trials sponsored by or conducted on behalf of Seller in connection with the Purchased Assets have been and are being conducted in material compliance with applicable Pharmaceutical Laws, including Good Clinical Practices requirements thereunder and Laws restricting the use and disclosure of individually identifiable health information. Seller has not received any written notice or other correspondence from the FDA or any other Governmental Authority commencing, or threatening to initiate, any action to place a clinical hold order on, or to terminate, delay, suspend, or materially modify any proposed or ongoing clinical or pre-clinical studies or tests sponsored by or conducted on behalf of Seller relating to the Purchased Assets. As of the date of this Agreement, there are no ongoing clinical trials or clinical trial commitments related to the Product, other than as set forth on Section 3.7(d) of the Seller Disclosure Schedule (such clinical trials, the “Ongoing Clinical Trials”). Except with respect to the Ongoing Clinical Trials, Seller has completed and closed out all other Gilead-sponsored clinical trials related to the Product.
(e) Neither Seller nor, to the Knowledge of Seller, any officer, employee, or agent of Seller has been convicted of any crime or engaged in any conduct in connection with the Purchased Assets that has resulted in or could reasonably be expected to result in a Material Adverse Change; each of the Company and its Subsidiaries is (i) debarment under 21 U.S.C. Section 335a or any similar Pharmaceutical Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Pharmaceutical Law. There are no claims, actions, proceedings or investigations in compliance connection with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits that, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, Purchased Assets that could reasonably be expected to result in such a Material Adverse Change; neither the Company nor any Subsidiary has failed to file with the FDA, the USDA material debarment or the EMA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, exclusion that are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, arepending or, to the Company’s knowledgeKnowledge of Seller, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA threatened against Seller or any Governmental Authority requiring the terminationof its respective officers, suspension or modification of any such researchemployees, study, pre-clinical trials and agents or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectusinvestigators.
Appears in 2 contracts
Sources: Asset Purchase Agreement, Asset Purchase Agreement (Sierra Oncology, Inc.)
Regulatory. 2.45.12.42.1. Except as set forth in the Pricing Disclosure Package and the Prospectus, the Company, and to the Company’s knowledge, each of the Company physician sponsors of the clinical trials being performed on SL-401 and its Subsidiaries SL-701 (the “Physician Sponsors”), has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug ApplicationApplication (“IND”), New Drug ApplicationApplication (“NDA”), or New Animal Drug Application, Biologics License Application (“BLA”) as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, FDA or other authorizations issued by federal, state, local or foreign agencies or bodies bodies, including Health Canada, engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would not, individually or in the aggregate, could reasonably be expected to result in have a Material Adverse Change; the Company, and to the Company’s knowledge each of the Company and its Subsidiaries Physician Sponsors, is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has not received, and to the Company’s knowledge neither Physician Sponsor has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits that, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither the Company nor any Subsidiary has not failed to file with the FDA, the USDA or the EMA FDA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA FDA or any Governmental Authority with respect to any such filings.
2.45.22.42.2. The To the Company’s knowledge, the research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries the Physician Sponsors have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiariesor the Physician Sponsors, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company Company, nor to the Company’s knowledge any Subsidiary Physician Sponsor, has received any notice or correspondence from the FDA or nor any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and study or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial study or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.
Appears in 1 contract
Regulatory. 2.45.1. Except Each of the Company and the Subsidiaries is duly licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, each of the Company and its the Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse ChangeEffect; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse ChangeEffect; neither the Company nor any Subsidiary has failed to file with the FDA, the USDA or the EMA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented except as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials otherwise described in the Registration Statement, any Preliminary the Pricing Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or decree impairing, restricting or prohibiting the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted payment of dividends by or on behalf of the Company and or any of its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed as otherwise described in the Registration Statement, any Preliminary the Pricing Disclosure Package and the Prospectus, none of the Pricing Prospectus or the Prospectus and any Issuer Free Writing ProspectusCompany, the Company Subsidiaries or any of Properties is not aware subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any researchsupervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, studyits management or its business, pre-clinical trial or clinical trial, the results of which nor has the Company believes reasonably call into question or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. Each of the results described or referred to in Company and the Registration StatementSubsidiaries has filed all statutory financial returns, any Preliminary Prospectusreports, the Pricing Prospectus or the Prospectus documents and any Issuer Free Writing Prospectus.other - 13 -
Appears in 1 contract
Regulatory. 2.45.1. Except as set forth in the Pricing Disclosure Package and the Prospectus, the Company, and to the Company’s knowledge, each of the Company physician sponsors of the clinical trials being performed on SL-401 and its Subsidiaries SL-701 (the “Physician Sponsors”), has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug ApplicationApplication (“IND”), New Drug ApplicationApplication (“NDA”), or New Animal Drug Application, Biologics License Application (“BLA”) as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, FDA or other authorizations issued by federal, state, local or foreign agencies or bodies bodies, including Health Canada, engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would not, individually or in the aggregate, could reasonably be expected to result in have a Material Adverse Change; the Company, and to the Company’s knowledge each of the Company and its Subsidiaries Physician Sponsors, is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has not received, and to the Company’s knowledge neither Physician Sponsor has received any notice of proceedings relating to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits that, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither the Company nor any Subsidiary has not failed to file with the FDA, the USDA or the EMA FDA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA FDA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.
Appears in 1 contract
Regulatory. 2.45.1. Except as set forth described in the Pricing Registration Statement, the Disclosure Package and the ProspectusProspectus or as would not reasonably be expected to result, each of individually or in the aggregate, in a Material Adverse Change: (i) the Company has not received written notice from any Governmental Entity alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and its Subsidiaries has such permitsbeen in material compliance with federal, state or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, authorizations consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (the “Regulatory PermitsAuthorizations”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the business of the Company as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each of the Company and its Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits Authorizations are valid and in full force and effect, in each case in all material respects; neither effect and the Company nor is not in violation of any Subsidiary term of any such Authorizations; (iv) the Company has not received any written notice of proceedings relating to the revocationany claim, terminationaction, modification suit, proceeding, hearing, enforcement, investigation, arbitration or impairment of rights other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any of the Regulatory Permits that, individually Applicable Regulations or in the aggregate, if the subject of an unfavorable decision, ruling Authorizations or finding, could reasonably be expected to result in a Material Adverse Change; neither the Company nor has any Subsidiary has failed to file with the FDA, the USDA or the EMA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to knowledge that any such filings.
2.45.2. The researchGovernmental Entity or third party is considering any such claim, studies and pre-clinical and clinical trials conducted by litigation, arbitration, action, suit, investigation or on behalf of the Company and its Subsidiaries have been andproceeding, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, arenor, to the Company’s knowledge, being conducted in all has there been any material respects in accordance noncompliance with professional and scientific standards and the applicable requirements or violation of the FDA and other Governmental Authorities; neither any Applicable Regulations by the Company nor any Subsidiary has received any notice or correspondence from that could reasonably be expected to require the FDA or any Governmental Authority requiring the termination, suspension or modification issuance of any such researchcommunication or result in an investigation, studycorrective action, pre-clinical trials and or clinical trialenforcement action by any Governmental Entity; and except (v) the Company has not received written notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the extent disclosed in the Registration StatementCompany’s knowledge, any Preliminary Prospectusof its directors, the Pricing Prospectus officers, employees or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware agents has been convicted of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, crime under any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing ProspectusApplicable Regulations.
Appears in 1 contract
Sources: Underwriting Agreement (Heart Test Laboratories, Inc.)
Regulatory. 2.45.1FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Except Neither the Company nor any other Subsidiary is required to be licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Pricing Disclosure Package and the Prospectus; each of the Company and the Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, licenses, permits, registrations and qualifications of and from all insurance regulatory authorities necessary to conduct their respective existing businesses as described in the Disclosure Package and the Prospectus, each and all of the Company foregoing are in full force and its Subsidiaries has effect, except where the failure to have such permitsauthorizations, licensesapprovals, orders, consents, certificates, approvalspermits, clearances, authorizations registrations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local qualifications or foreign regulatory agencies or bodies necessary their failure to conduct the business of the Company as described be in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus full force and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any of the foregoing that effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither FGRe meets all capital requirements to maintain its license; none of the Company nor any Subsidiary has failed to file with risks insured by FGRe have been re-insured, assigned, or ceded. None of the FDACompany, the USDA or the EMA Subsidiaries or any Governmental Authority any required application, submission, report, document, notice, supplement, of the properties or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf assets of the Company and or any Subsidiary is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its Subsidiaries terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such insurance contract or any reason to believe that termination or cancelation is contemplated; and, if still pendingexcept as would not have a Material Adverse Change, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, areno claims have been made thereunder. There is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the applicable requirements of Cayman Islands, except where the FDA failure to so maintain its books and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice records or correspondence from the FDA be in compliance would not, individually or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectusreasonably be expected to result in a Material Adverse Change. FGRe has been granted a Class B(iii) insurance license under The Insurance Law, the Pricing Prospectus or the Prospectus 2010, and any Issuer Free Writing Prospectus, the Company such license is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus full force and any Issuer Free Writing Prospectuseffect.
Appears in 1 contract
Regulatory. 2.45.1. Except as set forth in the Pricing Disclosure Package (i) The Company and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct Company’s subsidiaries that is engaged in the business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the Company case may be, under the laws (including, without limitation, laws that relate to companies that control insurance companies) and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in which the conduct of its business as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectusrequires such licensing or registration (each such license or registration, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, an “Governmental Authorities,” and each, a “Governmental AuthorityInsurance License”), except for any of where the foregoing that failure to be so licensed or registered would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; Effect. The Company and each of the Company and its Insurance Subsidiaries is in compliance with the requirements of the Regulatory Permits, and has made all of the Regulatory Permits are valid and in full force and effect, required filings under applicable Insurance Laws in each case in all material respects; neither jurisdiction where such filings are required, except for such filings the Company nor any Subsidiary has received any notice failure of proceedings relating which to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits thatmake would not reasonably be expected, individually or in the aggregate, if to result in a Material Adverse Effect. The Company and each of the subject Insurance Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, permits, registrations and qualifications of an unfavorable decisionand from all insurance regulatory authorities necessary to conduct its business as described in the Registration Statement, ruling or findingthe Pricing Disclosure Package and the Prospectus (together with the Insurance Licenses, could the “Insurance Licenses and Authorizations”) and all of the foregoing are in full force and effect, except where the failure to have such Insurance Licenses and Authorizations in full force and effect would not reasonably be expected to have a Material Adverse Effect. To the Company’s knowledge there is no threatened action, suit, proceeding or investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of the Insurance Subsidiaries has received any notification from any insurance regulatory authority or other governmental entity to the effect that any additional Insurance Licenses and Authorizations are needed to be obtained by the Company or any of the Insurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, individually or in the aggregate, result in a Material Adverse Effect.
(ii) The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws administered by, and all rules, regulations, directives, orders and decrees of any federal, state, local or foreign regulatory or supervisory authority, self-regulatory organization or governmental agency or body having jurisdiction over the Company or any of its subsidiaries (each, a “Regulatory Authority”) (including, without limitation, state insurance regulatory authorities), including applicable regulatory capital requirements, except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect.
(iii) Except as described in the Registration Statement, Pricing Disclosure Package and the Prospectus, or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries is a party to or otherwise subject to any order, decree, agreement, memorandum of understanding, or other regulatory enforcement action, proceeding or order with or by, or is a party to or recipient of a commitment letter, supervisory letter or similar undertaking to or from, any Regulatory Authority (whether or not such Regulatory Authority has determined that publication would be contrary to the public interest) or has adopted any board resolutions at the request of any Regulatory Authority. Neither the Company nor any of its subsidiaries has been advised by any such Regulatory Authority that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar undertaking; and there is no unresolved violation, criticism or exception by any Regulatory Authority with respect to any examination of the Company and its subsidiaries which, in the reasonable judgment of the Company, is expected to result in a Material Adverse Change; neither the Company nor any Subsidiary has failed to file with the FDA, the USDA or the EMA or any Governmental Authority any required application, submission, report, document, notice, supplement, or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filingsEffect.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus.
Appears in 1 contract
Regulatory. 2.45.1FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Except Neither the Company nor any other Subsidiary is required to be licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory and other authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Pricing Disclosure Package Registration Statement and the Prospectus, each of the Company and its the Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Statement and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse ChangeEffect; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Registration Statement and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse ChangeEffect; neither FGRe meets all capital requirements to maintain its license; none of the Company nor any Subsidiary has failed to file with risks insured by FGre have been re-insured, assigned, or ceded. None of the FDACompany, the USDA or the EMA Subsidiaries or any Governmental Authority any required application, submission, report, document, notice, supplement, of the properties or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf assets of the Company and is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its Subsidiaries terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such insurance contract or any reason to believe that termination or cancelation is contemplated; and, if still pendingexcept as would not have a Material Adverse Effect, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, areno claims have been made thereunder. There is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Effect; and each of the Company and the Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the applicable requirements Cayman Islands, except where the failure to so maintain its books and records or be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. The Company has been granted a Class B(iii) insurance license under The Insurance Act (as revised) of the FDA Cayman Islands, and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials license is in full force and or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectuseffect.
Appears in 1 contract
Regulatory. 2.45.1FG Reinsurance Ltd. (“FGRe”) is licensed to carry on business within the Cayman Islands as a Class B(iii) Insurer, and such license is in full force and effect. Except Neither the Company nor any other Subsidiary is required to be licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of any jurisdiction in order to conduct its business as described in the Pricing Disclosure Package and the Prospectus, each of the Company and its the Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States, Cayman Islands or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither FGRe meets all capital requirements to maintain its license; none of the Company nor any Subsidiary has failed to file with risks insured by FGre have been re-insured, assigned, or ceded. None of the FDACompany, the USDA or the EMA Subsidiaries or any Governmental Authority any required application, submission, report, document, notice, supplement, of the properties or amendment, and all such filings were in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf assets of the Company and is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its Subsidiaries terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. The current reinsurance agreement funded through a Funds at Lloyds syndicate is in effect; all premiums due to FGRe on all such insurance contracts have been paid; FGRe has received no notice of termination or cancellation of any such insurance contract or any reason to believe that termination or cancelation is contemplated; and, if still pendingexcept as would not have a Material Adverse Effect, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, areno claims have been made thereunder. There is no pending or, to the Company’s knowledge, being conducted threatened dispute between the Company or any Subsidiary, on one hand, and any reinsurer under any such treaty or agreement, on the other hand, and, to the Company’s knowledge, each of the Company and the Subsidiaries has filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States, Cayman Islands and the various states thereof, except where the failure, individually or in all material respects the aggregate, to file such return, report, document or information would not reasonably be expected to result in a Material Adverse Change; and each of the Company and the Subsidiaries maintains its books and records in accordance with professional with, and scientific standards is otherwise in compliance with, the applicable Insurance Laws of the United States, the various states thereof and the applicable requirements of Cayman Islands, except where the FDA failure to so maintain its books and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice records or correspondence from the FDA be in compliance would not, individually or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectusreasonably be expected to result in a Material Adverse Change. The Company has been granted a Class B (iii) insurance license under The Insurance Law, the Pricing Prospectus or the Prospectus 2010 and any Issuer Free Writing Prospectus, the Company such license is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus full force and any Issuer Free Writing Prospectuseffect.
Appears in 1 contract
Regulatory. 2.45.1. Except Each of the Company and the Subsidiaries is duly licensed as set forth an insurance brokerage company, insurance agency, insurer or reinsurer, as the case may be, under the insurance laws and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, “Insurance Laws”) of each jurisdiction in which the conduct of its existing business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus requires such licensing, except for such jurisdictions in which the failure to be so licensed would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, each of the Company and its the Subsidiaries has such permitsall other necessary authorizations, approvals, orders, consents, certificates, licenses, certificatespermits, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign registrations and qualifications of and from all insurance regulatory agencies or bodies authorities necessary to conduct the business of the Company their respective existing businesses as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectus, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, “Governmental Authorities,” and each, a “Governmental Authority”), except for any all of the foregoing that are in full force and effect, except where the failure to have such authorizations, approvals, orders, consents, certificates, permits, registrations or qualifications or their failure to be in full force and effect would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse ChangeEffect; each none of the Company and its or the Subsidiaries is in compliance with the requirements of the Regulatory Permits, and all of the Regulatory Permits are valid and in full force and effect, in each case in all material respects; neither the Company nor any Subsidiary has received any notice of proceedings relating notification from any insurance regulatory authority or other governmental authority in the United States or elsewhere to the revocationeffect that any additional authorization, terminationapproval, modification order, consent, certificate, permit, registration or impairment of rights of qualification is needed to be obtained by either the Company or its Subsidiaries to conduct its existing business as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except for any of such notification received where the Regulatory Permits thatfailure to obtain such additional authorization, approval, order, consent, certificate, permit, registration or qualification would not, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse ChangeEffect; neither except as otherwise described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, no insurance regulatory authority has issued any order or decree impairing, restricting or prohibiting the payment of dividends by the Company or any of its Subsidiaries; and except as otherwise described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, none of the Company, the Subsidiaries or any of Properties is subject to any outstanding order or is a party to any written agreement, consent agreement or memorandum of understanding with, or is subject to any order or directive by, or is a recipient of any supervisory letter from any regulatory authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business, nor has the Company or any Subsidiary been advised by any regulatory authority that it is considering issuing or requesting any such agreement, order or letter. Each of the Company and the Subsidiaries has failed filed all statutory financial returns, reports, documents and other information required to be filed pursuant to the applicable Insurance Laws of the United States and the various states thereof, except where the failure, individually or in the aggregate, to file with the FDA, the USDA or the EMA or any Governmental Authority any required application, submissionsuch return, report, document, notice, supplement, document or amendmentinformation would not reasonably be expected to result in a Material Adverse Effect; and each of the Company and the Subsidiaries maintains its books and records in accordance with, and all such filings were is otherwise in material compliance with applicable laws when filed and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDAwith, the USDA applicable Insurance Laws of the United States and the various states thereof, except where the failure to so maintain its books and records or be in compliance would not, individually or in the EMA or any Governmental Authority with respect aggregate, reasonably be expected to any such filings.
2.45.2result in a Material Adverse Effect. The researchExcept as disclosed in each of the Registration Statement, studies the Pricing Disclosure Package and pre-clinical and clinical trials conducted by or on behalf of the Prospectus, the Company and its Subsidiaries have been andmade no material change in their insurance reserving practices since December 31, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus2017.
Appears in 1 contract
Regulatory. 2.45.1. Except as set forth in the Pricing Disclosure Package (i) The Company and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct Company’s subsidiaries that is engaged in the business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the Company case may be, under the laws (including, without limitation, laws that relate to companies that control insurance companies) and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in which the conduct of its business as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Disclosure Package and the Prospectus and any Issuer Free Writing Prospectusrequires such licensing or registration (each such license or registration, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, an “Governmental Authorities,” and each, a “Governmental AuthorityInsurance License”), except for any of where the foregoing that failure to be so licensed or registered would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; Effect. The Company and each of the Company and its Insurance Subsidiaries is in compliance with the requirements of the Regulatory Permits, and has made all of the Regulatory Permits are valid and in full force and effect, required filings under applicable Insurance Laws in each case in all material respects; neither jurisdiction where such filings are required, except for such filings the Company nor any Subsidiary has received any notice failure of proceedings relating which to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits thatmake would not reasonably be expected, individually or in the aggregate, if the subject of an unfavorable decision, ruling or finding, could reasonably be expected to result in a Material Adverse Change; neither Effect. The Company and each of the Company nor any Subsidiary Insurance Subsidiaries has failed to file with the FDAall other necessary authorizations, the USDA or the EMA or any Governmental Authority any required applicationapprovals, submissionorders, reportconsents, documentcertificates, noticepermits, supplement, or amendment, registrations and qualifications of and from all such filings were in material compliance with applicable laws when filed and have been supplemented as insurance regulatory authorities necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by the FDA, the USDA or the EMA or any Governmental Authority with respect to any such filings.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and conduct its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials business as described in the Registration Statement, any Preliminary Prospectusthe Pricing Disclosure Package and the Prospectus (together with the Insurance Licenses, the Pricing Prospectus or the Prospectus “Insurance Licenses and any Issuer Free Writing Prospectus, are accurate Authorizations”) and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; any research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company foregoing are in full force and its Subsidiarieseffect, if still pending, are, except where the failure to have such Insurance Licenses and Authorizations in full force and effect would not reasonably be expected to have a Material Adverse Effect. To the Company’s knowledgeknowledge there is no threatened action, being conducted suit, proceeding or investigation that would, individually or in all material respects the aggregate, result in accordance with professional and scientific standards and the applicable requirements revocation, termination or suspension of any of the FDA Insurance Licenses and other Governmental Authorities; neither Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Insurance Subsidiaries has received any notice notification from any insurance regulatory authority or correspondence from other governmental entity to the FDA effect that any additional Insurance Licenses and Authorizations are needed to be obtained by the Company or any Governmental Authority requiring of the terminationInsurance Subsidiaries in any case where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, suspension individually or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statementaggregate, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to result in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectusa Material Adverse Effect.
Appears in 1 contract
Regulatory. 2.45.1. Except as set forth in the Pricing Disclosure Package (i) The Company and the Prospectus, each of the Company and its Subsidiaries has such permits, licenses, certificates, approvals, clearances, authorizations or amendments thereto (the “Regulatory Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct Company’s subsidiaries that is engaged in the business of insurance or reinsurance (each such subsidiary, an “Insurance Subsidiary”) is duly licensed or registered as an insurance holding company, insurer or as a reinsurer, as the Company case may be, under the laws (including, without limitation, laws that relate to companies that control insurance companies) and the rules, regulations and interpretations of the insurance regulatory authorities thereunder (collectively, the “Insurance Laws”) of each jurisdiction in which the conduct of its business as described in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or Time of Sale Information and the Prospectus and any Issuer Free Writing Prospectusrequires such licensing or registration (each such license or registration, including, without limitation, any Investigational New Drug Application, New Drug Application, or New Animal Drug Application, as required by the FDA, any Clinical Trial Application, as required by national health authorities in European countries, any Marketing Authorization Application, as required by the EMA, or other authorizations issued by federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals and biological products such as those being developed by the Company and its Subsidiaries (collectively, an “Governmental Authorities,” and each, a “Governmental AuthorityInsurance License”), except for any of where the foregoing that failure to be so licensed or registered would not, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Change; Effect. The Company and each of the Company and its Insurance Subsidiaries is in compliance with the requirements of the Regulatory Permits, and has made all of the Regulatory Permits are valid and in full force and effect, required filings under applicable Insurance Laws in each case in all material respects; neither jurisdiction where such filings are required, except for such filings the Company nor any Subsidiary has received any notice failure of proceedings relating which to the revocation, termination, modification or impairment of rights of any of the Regulatory Permits thatmake would not reasonably be expected, individually or in the aggregate, if to result in a Material Adverse Effect. The Company and each of the subject Insurance Subsidiaries has all other necessary authorizations, approvals, orders, consents, certificates, permits, registrations and qualifications of an unfavorable decisionand from all insurance regulatory authorities necessary to conduct its business as described in the Registration Statement, ruling the Time of Sale Information and the Prospectus (together with the Insurance Licenses, the “Insurance Licenses and Authorizations”) and all of the foregoing are in full force and effect, except where the failure to be so licensed or findingregistered would not, could individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; neither Effect. To the Company’s knowledge there is no threatened action, suit, proceeding or investigation that would, individually or in the aggregate, result in the revocation, termination or suspension of any of the Insurance Licenses and Authorizations that would reasonably be expected to have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Insurance Subsidiaries has failed received any notification from any insurance regulatory authority or other governmental entity to file with the FDA, effect that any additional Insurance Licenses and Authorizations are needed to be obtained by the USDA or the EMA Company or any Governmental Authority of the Insurance Subsidiaries in any required applicationcase where it would be reasonably expected that the failure to obtain such additional Insurance Licenses and Authorizations would, submissionindividually or in the aggregate, report, document, notice, supplement, or amendmentresult in a Material Adverse Effect.
(ii) The Company and each of its subsidiaries are in compliance in all material respects with all applicable laws administered by, and all such filings were in material compliance with applicable laws when filed rules, regulations, directives, orders and have been supplemented as necessary to remain in material compliance with applicable laws and no material deficiencies have been asserted by decrees of any federal, state, local or foreign regulatory or supervisory authority, self-regulatory organization or governmental agency or body having jurisdiction over the FDA, the USDA or the EMA Company or any Governmental Authority with respect of its subsidiaries (each, a “Regulatory Authority”) (including, without limitation, state insurance regulatory authorities), including applicable regulatory capital requirements, except where the failure to any such filingsso comply would not, individually or in the aggregate, result in a Material Adverse Effect.
2.45.2. The research, studies and pre-clinical and clinical trials conducted by or on behalf of the Company and its Subsidiaries have been and, if still pending, are being conducted, in all material respects, in accordance with experimental protocols and procedures pursuant to all applicable laws and Regulatory Permits and the results of such research, studies and clinical trials (iii) Except as described in the Registration Statement, any Preliminary the Time of Sale Information and the Prospectus, or as would not, individually or in the Pricing Prospectus aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries is a party to or otherwise subject to any order, decree, agreement, memorandum of understanding, or other regulatory enforcement action, proceeding or order with or by, or is a party to or recipient of a commitment letter, supervisory letter or similar undertaking to or from, any Regulatory Authority (whether or not such Regulatory Authority has determined that publication would be contrary to the Prospectus public interest) or has adopted any board resolutions at the request of any Regulatory Authority. Neither the Company nor any of its subsidiaries has been advised or notified by any such Regulatory Authority that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar undertaking; and there is no unresolved violation, criticism or exception by any Issuer Free Writing Prospectus, are accurate and fairly present, in all material respects, the data derived from such research, studies, and pre-clinical and clinical trials; Regulatory Authority with respect to any research, studies and pre-clinical and clinical trials conducted by or on behalf examination of the Company and its Subsidiariessubsidiaries which, if still pending, are, to in the reasonable judgment of the Company’s knowledge, being conducted is expected to result in all material respects in accordance with professional and scientific standards and the applicable requirements of the FDA and other Governmental Authorities; neither the Company nor any Subsidiary has received any notice or correspondence from the FDA or any Governmental Authority requiring the termination, suspension or modification of any such research, study, pre-clinical trials and or clinical trial; and except to the extent disclosed in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectus, the Company is not aware of any research, study, pre-clinical trial or clinical trial, the results of which the Company believes reasonably call into question the results described or referred to in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus and any Issuer Free Writing Prospectusa Material Adverse Effect.
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