Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary, the right of the Issuer to cause any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date: (1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder; (2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Securities; (3) as of such Event Date, there has not been, in any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Preference Shares, the ADRs or the Deposit Agreement; (4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds; (5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs; (6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or (ii) any law, rule or regulation applicable to the Issuer; (7) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and (8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01.
Appears in 2 contracts
Samples: Subordinated Indenture (Prudential PLC), Subordinated Indenture (Prudential PLC)
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary(i) Since May 2, 2007, the right business of the Issuer to cause any conversion or exchange of the Securities Company and its Subsidiary has not been, and is not currently being, conducted in violation of any series federal, state, local or foreign law, statute or ordinance, common law, or any rule, regulation, standard, Order, agency requirement, license or permit of any Governmental Entity (collectively, “Laws”), except for Preference Shares on any proposed Event Date shallviolations that, unless otherwise provided individually or in a supplemental indenture or Board Resolution pursuant to Section 3.01the aggregate with other such violations, be subject to the fulfillment of the following conditions with respect to such Securities of such serieshave not had, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior would not reasonably be expected to have, a Company Material Adverse Effect. No investigation or review by any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing Governmental Entity with respect to the particular series Company or its Subsidiary is pending or, to the knowledge of Securities;
(3) as the executive officers of such Event Datethe Company, there threatened, nor has not beenany Governmental Entity indicated an intention to conduct the same, in any one instance except for those the outcome of which, individually or in the aggregateaggregate with the outcome of other such matters, an adverse effect on (x) has not had, and would not reasonably be expected to have, a Company Material Adverse Effect, and (y) would not reasonably be expected to prevent, materially delay or materially impair the rights, powers, privileges, validity or enforceability consummation of the Preference Shares, the ADRs or the Deposit Agreement;Transactions.
(4ii) Each of the Preference Shares to be issued on such Event Date shall be duly authorized Company and reserved for issuance upon such conversion and when issued upon such exchangeits Subsidiary has all permits, will be fully paid and not subject to calls for further funds;
(5) no licenses, certifications, approvals, registrations, consents, authorizations, approvals franchises, variances, exemptions and orders issued or exemptionsgranted by any Governmental Entity (“Licenses”) necessary to conduct its business as presently conducted, including all such Licenses of the United States Food and Drug Administration (“FDA”) or any other applicable U.S. or foreign drug regulatory authority (collectively with the FDA, “Regulatory Authorities”) necessary to conduct its business as presently conducted (collectively, the “Regulatory Licenses”), except those Licenses the absence of which, individually or in each case the aggregate with other such as shall have been obtainedabsences, will has not had, and would not reasonably be required prior expected to such Event Date for have, a Company Material Adverse Effect, and would not reasonably be expected to prevent, materially delay or materially impair the issuance and delivery consummation of the Preference Shares to be issued upon Transactions. All such conversion or exchange or the ADRs;
(6) the issuance Regulatory Licenses are valid and delivery of the Preference Shares in full effect and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or (ii) any law, rule or regulation applicable to the Issuer;
(7) there shall have has not occurred any change in law in Englandrevocation or termination of any Regulatory License, or any amendment material impairment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof Company or its Subsidiary under any Regulatory License, except for any such revocation, termination or impairment that, individually or in the event aggregate with other such revocations, terminations and impairments, has not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Each of the Company and its Subsidiary has operated in compliance in all material respects with applicable Laws administered or enforced by the FDA or any other Regulatory Authority, except where the failure so to comply, individually or in the aggregate with other such failures, has not had, and would not reasonably be expected to have, a bankruptcy Company Material Adverse Effect. As of the date of this Agreement, there are no, and have not been any, inspection observations, notices pursuant to 21 U.S.C. Section 305, warning letters, untitled letters or similar documents that assert a lack of compliance by the Company or its Subsidiary with any applicable Laws, Orders or regulatory requirements that have not been fully resolved to the satisfaction of the FDA or any other Regulatory Authority.
(iii) Since October 1, 2008, all preclinical studies and clinical trials, and other studies and tests conducted by or, to the knowledge of the executive officers of the Company, on behalf of the Company or its Subsidiary have been, and if still pending are being, conducted in compliance with all applicable Laws (including those pertaining to Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312 and all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, and 56), except for noncompliances that, individually or in the aggregate with other such noncompliances, have not had, and would not reasonably be expected to have, a Company Material Adverse Effect. Since October 1, 2008, except for such exceptions that, individually or in the aggregate with other such exceptions, have not had, and would not reasonably be expected to have, a Company Material Adverse Effect, no clinical trial conducted by or, to the knowledge of the executive officers of Company, on behalf of the Company or its Subsidiary has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the knowledge of the executive officers of Company, on behalf of the Company or its Subsidiary has commenced, or, to the knowledge of the executive officers of Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any ongoing clinical investigation conducted by or, to the knowledge of the executive officers of Company, on behalf of the Company or its Subsidiary.
(iv) Since October 1, 2008, neither the Company nor its Subsidiary nor, to the knowledge of the executive officers of the Company, any of their executive officers or Employees has been convicted of any crime or engaged in any conduct that in any such case has resulted, or would reasonably be expected to result, in debarment under 21 U.S.C. Section 335a or exclusion from participation in any Federal health care program pursuant to 42 U.S.C. Section 1320a-7.
(v) The Company has made available to Parent complete and correct copies of each Investigational New Drug Application and each similar proceeding state or foreign regulatory filing made on behalf of the Company or its Subsidiary, including all related supplements, amendments and annual reports.
(vi) All material applications, reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by the Company or its Subsidiary, including with respect to its Company Pharmaceutical Products, have been so filed, maintained or furnished. All such applications, reports, documents, claims, permits and notices: (i) have been made available to Parent; and (ii) were complete and accurate in all material respects on the Issuerdate filed (or were corrected in or supplemented by a subsequent filing). Neither the Company nor its Subsidiary, nor, to the knowledge of the executive officers of the Company, any officer, employee or agent or distributor of the Company or its Subsidiary, has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or such holders’ access to any similar policy. As used in this Agreement, the courts of the United Kingdom term “Company Pharmaceutical Product” shall mean RG 7128, PSI-7977, PSI-938 and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01PSI-661.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Gilead Sciences Inc), Merger Agreement (Pharmasset Inc)
Legal and Regulatory Compliance. Notwithstanding (a) The Company and each of its Subsidiaries, and their respective properties and assets, are and have been in compliance in all material respects with all Laws and Orders. Neither the Company nor any provision of its Subsidiaries (A) has received any written notice from any Governmental Entity alleging any violation or potential violation by the Company or any of its Subsidiaries of any Law or Order nor (B) has provided any written notice to any Governmental Entity regarding any violation or potential violation by the Company or any of its Subsidiaries of any Law or Order, and no such notice referred to in clauses (A) or (B) remains outstanding or unresolved as of the date of this Subordinated Indenture to the contrary, the right of the Issuer to cause Agreement. No investigation by any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing Governmental Entity with respect to the particular series Company or any of Securities;its Subsidiaries is pending or, to the knowledge of the Company, threatened.
(3b) Each of the Company and its Subsidiaries has all Permits necessary to conduct its business as presently conducted, including all such Permits required by any applicable Governmental Entity (collectively, “Regulatory Authorities”) necessary to conduct its business as presently conducted or as conducted at the time of such activities, as applicable. All such Permits are valid and in full effect, and no suspension, revocation or termination of any such Permit is pending or, to the knowledge of the Company, threatened. Neither the Company nor any of its Subsidiaries has received any written notice from any Governmental Entity regarding (a) any violation or potential violation by the Company or any of its Subsidiaries of any Permits or the failure to have any required Permits, or (b) any suspension, revocation or termination of any Permits held by the Company or any of its Subsidiaries, and no such notice in either case remains outstanding or unresolved as of such Event Datethe date of this Agreement. The Company and each of its Subsidiaries has operated in compliance in all respects with Laws administered or enforced by any Regulatory Authority. There are no, and have not been any, inspection observations, notices, warning letters, untitled letters or similar documents that assert a lack of compliance by the Company or any of its Subsidiaries with any Laws or requirements of any Regulatory Authority.
(c) None of the Company, any of its Subsidiaries nor, to the knowledge of the Company, any of their respective officers or current or former employees, has been convicted of any crime, and there are currently no investigations regarding any crimes pending or to the knowledge of the Company, threatened.
(d) The Company has made available to the Parent complete and correct copies of each application or other filing including all related supplements, amendments, Permits, correspondence and annual reports made with any Regulatory Authority made on behalf of the Company or any of its Subsidiaries.
(e) To the knowledge of the Company, there has not beenis no information that would reasonably be expected to prevent the acceptance or the subsequent approval of any filing, in any one instance application or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability request for approval of the Preference Shares, the ADRs or the Deposit Agreement;Product by a Regulatory Authority.
(4f) the Preference Shares All applications, reports, documents, claims, Permits and notices required to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchangefiled, will be fully paid and not subject maintained or furnished to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for any Regulatory Authority by the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or (ii) any law, rule or regulation applicable to the Issuer;
(7) there shall have not occurred any change in law in England, Company or any amendment of the Articles of Association of the Issuerits Subsidiaries, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to Products, have been so filed, maintained or furnished (the Issuer“Applications”). All Applications: (A) have been made available to the Parent; and (B) were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) or such holders’ access issued. Neither the Company nor any of its Subsidiaries, nor, to the courts knowledge of the United Kingdom Company, any officer, employee or agent or distributor of the Company or its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to any Regulatory Authority, failed to disclose a material fact required to be disclosed to any Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure or non-disclosure was made, would reasonably be expected to provide a basis for any Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and other Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy or applicable governmental authorities to enforce such rights; andnon-US equivalent thereof.
(8) g) To the knowledge of the Company, no facts exist that would give rise to any of the Products being recalled or the suspension, revocation or termination of use of any such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01Products.
Appears in 2 contracts
Samples: Arrangement Agreement (Privet Fund LP), Arrangement Agreement (Norsat International Inc.)
Legal and Regulatory Compliance. Notwithstanding (a) The Company and each of its Subsidiaries, and, to the knowledge of the Company, their respective properties and assets, are and since January 1, 2008 have been in compliance in all material respects with all applicable Laws and Orders. Neither the Company nor any provision of its Subsidiaries (A) has received any written notice from any Governmental Entity alleging any violation or potential violation by the Company or any of its Subsidiaries of any applicable Law or Order nor (B) has provided any written notice to any Governmental Entity regarding any violation or potential violation by the Company or any of its Subsidiaries of any applicable Law or Order, and no such notice referred to in clauses (A) or (B) remains outstanding or unresolved as of the date of this Subordinated Indenture Agreement. To the knowledge of the Company, no investigation by any Governmental Entity with respect to the contrary, the right Company or any of its Subsidiaries is pending or threatened.
(b) Each of the Issuer to cause any conversion or exchange Company and its Subsidiaries has (and at the time of the Securities performance of all preclinical research, clinical development and manufacturing that it has conducted or sponsored, it did have) all Permits necessary to conduct its business as presently conducted, including all such Permits required by the FDA or any other applicable Governmental Entity responsible for the oversight and approval of the research, development or commercialization of pharmaceutical or medicinal products (collectively with the FDA, “Regulatory Authorities”) necessary to conduct its business as presently conducted or as conducted at the time of such activities, as applicable, except those Permits that are not related to the Key Product the absence of which, individually or in the aggregate, (x) are not, and would not reasonably be, material to the Company and its Subsidiaries, taken as a whole, and (y) would not reasonably be expected to prevent, materially delay or materially impair the consummation of the Transactions. All such Permits are valid and in full effect, and no suspension, revocation or termination of any series for Preference Shares on any proposed Event Date shallsuch Permit is pending or, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment knowledge of the following conditions Company, threatened, except for such noncompliance, suspensions or cancellations with respect to such Securities of such seriesPermits that are not related to the Key Product that, individually or in the aggregate, (x) are not, and would not reasonably be expected to be, material to the Issuer represents Company and warrants its Subsidiaries, taken as a whole, and (y) would not reasonably be expected to prevent, materially delay or materially impair the consummation of the Transactions. Neither the Company nor any of its Subsidiaries has received any written notice from any Governmental Entity regarding (a) any violation or potential violation by the Company or any of its Subsidiaries of any Permits or the failure to have any required Permits, or (b) any suspension, revocation or termination of any Permits held by the Company or any of its Subsidiaries, and no such notice in either case remains outstanding or unresolved as of the date of this Agreement. There are no, and have not been any, inspection observations, notices pursuant to 21 U.S.C. Section 374 or any non-U.S. equivalents thereof, warning letters, untitled letters or similar documents that assert a lack of compliance by the Company or any of its Subsidiaries with any applicable Laws.
(c) All pre-clinical studies and clinical trials related to a Company Pharmaceutical Product, and other studies and tests related to a Company Pharmaceutical Product conducted by or on behalf of the Company or any of its Subsidiaries have, to the knowledge of the Company, been, and if still pending are being, conducted in compliance in all material respects with all applicable Laws (including those pertaining to Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312, all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, and 56 and all applicable registration and publication requirements (including, if applicable, registration on xxxx://xxxxxxxxxxxxxx.xxx)) and any non-U.S. equivalents thereof. No clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has been terminated or suspended prior to completion, and no Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has commenced or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries.
(d) None of the Company, any of its Subsidiaries nor, to the knowledge of the Company, any of their respective officers or current or former employees nor any other person involved in the development of the Company Pharmaceutical Products, has been convicted of any crime or engaged in any conduct that in any such case has resulted in debarment under 21 U.S.C. Section 335a or exclusion from participation in any Federal health care program pursuant to 42 U.S.C. Section 1320a-7 or any applicable non-U.S. equivalent thereof, and there are currently no investigations regarding any debarments or exclusions pending.
(e) The Company has made available to the Parent complete and correct copies of each application or other material filing including all material related supplements, amendments, correspondence and annual reports made with any Regulatory Authority made on behalf of the Company or any of its Subsidiaries relating to the Key Product. The Company has made available to the Parent complete and correct copies of each material application or other material filing including all material related supplements, amendments, correspondence and annual reports made with any Regulatory Authority made on behalf of the Company or any of its Subsidiaries relating to CYT 997.
(f) To the knowledge of the Company, there is no information that would reasonably be expected to prevent the acceptance or the subsequent approval of any filing or application for approval of the Key Product by a Regulatory Authority in the European Union, Australia, Canada or the United States.
(g) As applicable, all material applications, reports, documents, claims, Permits and notices required to be filed, maintained or furnished to any Regulatory Authority by the Company or any of its Subsidiaries, with respect to the Key Product, have been so filed, maintained or furnished (“Product Applications”). All Product Applications: (A) have been made available to the Parent; and (B) were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) or issued. To the knowledge of the Company, neither the Company nor any of its Subsidiaries, nor, to the knowledge of the Company, any officer, employee or agent or distributor of the Company or its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to any Regulatory Authority, failed to disclose a material fact required to be disclosed to any Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure or non-disclosure was made, would reasonably be expected to provide a basis for any Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy or applicable non-US equivalent thereof.
(h) To the knowledge of the Company, all manufacturing operations conducted for the benefit of the holders Company or any of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing its Subsidiaries with respect to the particular series of Securities;
(3) as of such Event Dateany Company Pharmaceutical Product being used, there has not beenor intended for use, in humans (including pursuant to any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Preference Shares, the ADRs or the Deposit Agreement;
(4clinical trial) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;are being conducted in accordance with GMP Regulations.
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) To the Articles of Association knowledge of the Issuer or (ii) any lawCompany, rule or regulation applicable no facts exist that would give rise to the Issuer;Key Product being recalled or the suspension, revocation or termination of any clinical trials.
(7j) there shall have not occurred any change Section 10(j) of the Company Disclosure Letter sets forth a true and complete list of each country in law in England, which a clinical trial related to the Key Product is being or has been conducted by or on behalf of the Company or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01its Subsidiaries.
Appears in 2 contracts
Samples: Acquisition Agreement, Acquisition Agreement
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary, the right of the Issuer to cause any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series(a) The Company and its Subsidiaries are, and have at all times during the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
past two (2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Securities;
(3) as of such Event Date, there has not years been, in compliance, in all material respects, with all applicable Laws. There are no pending Proceedings against the Company or any one instance of its Subsidiaries alleging that the Company or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability such Subsidiary of the Preference SharesCompany is in violation of any applicable Law. Neither the Company nor any of its Subsidiaries, the ADRs nor any of their respective executive officers (in their capacities as such) has received any written notice, order, complaint or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals other communication from any Governmental Authority or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery third party of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery any claim of the Preference Shares and the ADRs to be issued on such Event Date shall not violate a violation of (i) the Articles of Association of the Issuer or any applicable Law, (ii) any lawFDA Form 483 or equivalent written report by inspectors or officials from any Governmental Authority, rule (iii) any FDA or regulation USDA written notice of adverse findings or any equivalent written correspondence, notice or communication from any other Governmental Authority indicating a failure to comply with applicable Law or (iv) any warning letters or other written correspondence from the FDA, USDA or any other Governmental Authority in which the FDA, USDA or such other Governmental Authority asserted that the operations of the Company or any of its Subsidiaries were not in compliance with applicable Law. Neither the Company nor any of its Subsidiaries has made any fraudulent statement to the Issuer;FDA, USDA or any other Governmental Authority, or failed to disclose a fact required under Law to be disclosed to the FDA, USDA or any other Governmental Authority or been convicted of any crime. To the Knowledge of the Company, no event has 25 occurred, and no condition or circumstance exists, that would reasonably be expected to (with or without notice or lapse of time) constitute or result in a violation by the Company or any of its Subsidiaries of, or a failure on the part of the Company or any of its Subsidiaries to comply, in any material respect, with, any applicable Law.
(7b) there shall have not occurred Each Product marketed, manufactured, sold or distributed by the Company or any change of its Subsidiaries has been, for a period of two (2) years prior to the Closing Date, and is being marketed, manufactured, sold or distributed by the Company or such Subsidiary of the Company, in law material compliance with all applicable requirements under the Federal Food Drug and Cosmetic Act, as amended, and regulations promulgated by the FDA thereunder, the Xxxxxx Act of 1946, as amended, and regulations promulgated thereunder, and similar Laws of all other applicable Governmental Authorities, including without limitation other Laws promulgated by the FDA, the U.S. Environmental Protection Agency, the USDA, corresponding state-level Governmental Authorities, and foreign countries that apply to the manufacture, distribution, marketing, sale and labeling of food products (such Laws, collectively or singly, the “Food Laws”), and the processing, manufacture or holding of such products by the Company and its Subsidiaries has been, for a period of two (2) years prior to the Closing Date, and is in Englandall material respects in accordance with the applicable standards prescribed by Food Laws.
(c) Neither the Company nor any of its Subsidiaries has established or maintained, nor is it maintaining, any unlawful fund of corporate monies or other properties. Neither the Company or any of its Subsidiaries, nor to the Knowledge of the Company any of the Company’s or any of its Subsidiary’s Representatives, (i) has, during the past two (2) years, used or is using any corporate funds for any illegal contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii) has, during the past two (2) years used, or is using any amendment corporate funds for any direct or indirect unlawful payments to any foreign or domestic governmental officials or employees, or (iii) is or has, during the past two (2) years violated, in any material respect any provision of the Articles Foreign Corrupt Practices Act of Association 1977 or similar Laws of relevant Governmental Authorities or (iv) has, during the Issuerpast two (2) years, prior to such Event Datemade any unlawful bribe, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (includingrebate, without limitationpayoff, the rights of the holders thereof in the event of a bankruptcy influence payment, kickback or other similar proceeding with respect to the Issuer) or such holders’ access to the courts unlawful payment of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01any nature.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary, the right of the Issuer Company to cause any conversion Exchange or exchange Conversion of the Debt Securities of any series for Exchange Securities or Conversion Securities or Dollar Preference Shares Share on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, shall be subject to the fulfillment of the following conditions with respect to such Debt Securities of such series, and the Issuer Company represents and warrants for the benefit of the holders of Preference Shares Exchange Securities or Conversion Securities, as the case may be, that all such conditions shall have been satisfied prior to any such conversion Exchange or exchange Conversion on the Event Date:
(1a) as of such Event Date, there shall be are no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series Payments and there are no Missed Payments (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder);
(2b) as of such Event Date, no Default or Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Debt Securities;
(3c) as of such Event Date, there has not been, in any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Dollar Preference Shares, the ADRs Shares or the Deposit AgreementConversion Securities or Exchange Securities;
(4d) the Dollar Preference Shares or Conversion Securities or Exchange Securities to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5e) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Dollar Preference Shares or Conversion Securities or Exchange Securities to be issued upon such conversion Conversion or exchange or the ADRsExchange;
(6f) the issuance and delivery of the Dollar Preference Shares and the ADRs or Conversion Securities to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer Company or (ii) any law, rule or regulation applicable to the Issuer;Company; and
(7g) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the IssuerCompany, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Dollar Preference Shares or the ADRs Conversion Securities (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the IssuerCompany) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01.
Appears in 1 contract
Samples: Indenture (HSBC Holdings PLC)
Legal and Regulatory Compliance. Notwithstanding any provision (a) The Company and its Subsidiaries have at all times complied, and each is now in compliance, in all material respects with all applicable Laws, including all Alcohol Laws. As of the date of this Subordinated Indenture to Agreement, there are no pending Proceedings against the contrary, Company or any of its Subsidiaries alleging that the right of the Issuer to cause any conversion Company or exchange of the Securities such Subsidiary is in violation of any series for Preference Shares on applicable Law, including any proposed Event Date shallAlcohol Law. Neither the Company, unless otherwise provided any of its Subsidiaries, nor any of their respective executive officers (in a supplemental indenture or Board Resolution pursuant to Section 3.01their capacities as such) has received any written notice, be subject to the fulfillment of the following conditions with respect to such Securities of such seriesorder, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) complaint or other unpaid amounts then due and owing hereunder;
(2) as communication from any Governmental Authority or third party of such Event Date, no Event any claim of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series a violation of Securities;
(3) as of such Event Date, there has not been, in any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Preference Shares, the ADRs or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or any applicable Law, including any Alcohol Law, (ii) any lawFDA Form 483 or equivalent written report by inspectors or officials from any Governmental Authority, rule (iii) any FDA or regulation USDA written notice of adverse findings or any equivalent written correspondence, notice or communication from any other Governmental Authority indicating a failure to comply with applicable Law or (iv) any warning letters or other written correspondence from the FDA, USDA or any other Governmental Authority in which the FDA, USDA or such other Governmental Authority asserted that the operations of the Company or any of its Subsidiaries were not compliance with applicable Law. Neither the Company nor any of its Subsidiaries has made any fraudulent statement to the Issuer;FDA, USDA or any other Governmental Authority, or failed to disclose a material fact required under Law to be disclosed to the FDA, USDA or any other Governmental Authority or been convicted of any crime. No event has occurred, and no condition or circumstance exists, that could reasonably be expected to (with or without notice or lapse of time) constitute or result in a material violation by the Company or any of its Subsidiaries of, or a failure on the part of the Company or any of its Subsidiaries to comply with, any applicable Law.
(7b) there shall have not occurred any change in law in EnglandEach product marketed, manufactured, sold or distributed by the Company or any amendment of its Subsidiaries has been, for a period of two years prior to the date of this Agreement, and is being marketed, manufactured, sold or distributed by the Company or such Subsidiary, in compliance with all applicable requirements under the Federal Food Drug and Cosmetic Act, as amended, and regulations promulgated by the FDA thereunder, the Xxxxxx Act of 1946, as amended, and regulations promulgated thereunder, and similar Laws of all other applicable Governmental Authorities, including without limitation other Laws promulgated by the FDA, the U.S. Environmental Protection Agency, the USDA, corresponding state-level Governmental Authorities, and foreign countries that apply to the manufacture, distribution, marketing, sale and labeling of food products (such Laws, collectively or singly, the “Food Laws”), and the processing, manufacture or holding of such products by the Company and its Subsidiaries has been, for a period of two years prior to the date of this Agreement, and is in all respects in accordance with the applicable standards prescribed by Food Laws.
(c) Neither the Company nor any of its Subsidiaries has established or maintained, nor is it maintaining, any unlawful fund of corporate monies or other properties. None of the Articles Company’s or any Subsidiary’s Representatives or any of Association their respective Affiliates or family members (i) has used or is using any corporate funds for any illegal contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii) has used or is using any corporate funds for any direct or indirect unlawful payments to any foreign or domestic governmental officials or employees, (iii) has violated or is violating any provision of the IssuerForeign Corrupt Practices Act of 1977 or similar Laws of relevant Governmental Authorities or (iv) has made any unlawful bribe, prior to such Event Daterebate, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (includingpayoff, without limitationinfluence payment, the rights of the holders thereof in the event of a bankruptcy kickback or other similar proceeding with respect to the Issuer) or such holders’ access to the courts unlawful payment of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01any nature.
Appears in 1 contract
Samples: Stock Purchase Agreement (Bespoke Capital Acquisition Corp)
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary, the right of the Issuer to cause any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided Except as set forth in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series------------------------------- Schedule 3.01(p):
(i) The Company and its Subsidiaries are not, and the Issuer represents Company, its Subsidiaries and warrants for the benefit of the holders of Preference Shares that all such conditions shall Predecessor Company have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Securities;
(3) as of such Event Date, there has not been, in default or violation in any one instance material respect of any law, statute, order, rule, regulation, policy or in guideline of any Governmental Entity applicable to any of them, and the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability business of the Preference SharesCompany and its Subsidiaries is, and the ADRs or business of the Deposit Agreement;Company and its Subsidiaries and the Predecessor Company has been, conducted in compliance in all material respects with all applicable laws and regulations.
(4ii) The Company and its Subsidiaries hold the Preference Shares to be issued on licenses, permits, certificates, franchises, tariff approvals and other authorizations identified in Schedule 3.01(p) (the "Licenses"). Each of such Event Date shall be duly authorized Licenses is -------- in full force and reserved for issuance upon such conversion effect and when issued upon such exchangehas not been revoked, will be fully paid suspended, canceled, or modified in any adverse way and is not subject to calls any conditions or requirements that are not generally imposed upon the holders thereof. The licenses listed in Schedule 3.01(p) are the only licenses required for further funds;the conduct of the business of the Company and its Subsidiaries as presently conducted.
(5iii) The Company has no consentsknowledge of any investigation, authorizationsnotice of apparent liability, approvals violation, forfeiture or exemptionsother order or complaint issued by or before the FCC or any other Governmental Entity or of any other proceedings of or before the FCC or any other Governmental Entity relating to the Company or any of its Subsidiaries or the Predecessor Company or to any authorizations under which the Company conducts its business, except in each case such as shall have been obtainednot including personal communications service licenses held by Sprint or its Affiliates (the "Sprint Licenses"). No proceedings are --------------- pending or, will be required prior to such Event Date for the issuance and delivery knowledge of the Preference Shares Company, threatened to be issued upon such conversion revoke or exchange limit any of the Licenses or the ADRs;Sprint Licenses.
(6iv) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate No event has occurred which (i) the Articles results in, or after notice or lapse of Association time or both could reasonably be expected to result in, revocation, suspension, adverse modifications, non-renewal, impairment, restriction or termination of, or order of forfeiture with respect to, any of the Issuer Licenses or the Sprint Licenses, or (ii) affects or could reasonably be expected in the future to affect any law, rule or regulation applicable to the Issuer;
(7) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof in Company or its Subsidiaries under any material Licenses or the event of a bankruptcy or other similar proceeding with respect to the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01Sprint Licenses.
Appears in 1 contract
Samples: Investment Agreement (Ipcs Inc)
Legal and Regulatory Compliance. Notwithstanding (a) The Company and each of its Subsidiaries, and, to the knowledge of the Company, their respective properties and assets, are and since January 1, 2008 have been in compliance in all material respects with all applicable Laws and Orders. Neither the Company nor any provision of its Subsidiaries (A) has received any written notice from any Governmental Entity alleging any violation or potential violation by the Company or any of its Subsidiaries of any applicable Law or Order nor (B) has provided any written notice to any Governmental Entity regarding any violation or potential violation by the Company or any of its Subsidiaries of any applicable Law or Order, and no such notice referred to in clauses (A) or (B) remains outstanding or unresolved as of the date of this Subordinated Indenture Agreement. To the knowledge of the Company, no investigation by any Governmental Entity with respect to the contrary, the right Company or any of its Subsidiaries is pending or threatened.
(b) Each of the Issuer to cause any conversion or exchange Company and its Subsidiaries has (and at the time of the Securities performance of all preclinical research, clinical development and manufacturing that it has conducted or sponsored, it did have) all Permits necessary to conduct its business as presently conducted, including all such Permits required by the FDA or any other applicable Governmental Entity responsible for the oversight and approval of the research, development or commercialization of pharmaceutical or medicinal products (collectively with the FDA, “Regulatory Authorities”) necessary to conduct its business as presently conducted or as conducted at the time of such activities, as applicable, except those Permits that are not related to the Key Product the absence of which, individually or in the aggregate, (x) are not, and would not reasonably be, material to the Company and its Subsidiaries, taken as a whole, and (y) would not reasonably be expected to prevent, materially delay or materially impair the consummation of the Transactions. All such Permits are valid and in full effect, and no suspension, revocation or termination of any series for Preference Shares on any proposed Event Date shallsuch Permit is pending or, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment knowledge of the following conditions Company, threatened, except for such noncompliance, suspensions or cancellations with respect to such Securities of such seriesPermits that are not related to the Key Product that, individually or in the aggregate, (x) are not, and would not reasonably be expected to be, material to the Issuer represents Company and warrants its Subsidiaries, taken as a whole, and (y) would not reasonably be expected to prevent, materially delay or materially impair the consummation of the Transactions. Neither the Company nor any of its Subsidiaries has received any written notice from any Governmental Entity regarding (a) any violation or potential violation by the Company or any of its Subsidiaries of any Permits or the failure to have any required Permits, or (b) any suspension, revocation or termination of any Permits held by the Company or any of its Subsidiaries, and no such notice in either case remains outstanding or unresolved as of the date of this Agreement. There are no, and have not been any, inspection observations, notices pursuant to 21 U.S.C. Section 374 or any non-U.S. equivalents thereof, warning letters, untitled letters or similar documents that assert a lack of compliance by the Company or any of its Subsidiaries with any applicable Laws.
(c) All pre-clinical studies and clinical trials related to a Company Pharmaceutical Product, and other studies and tests related to a Company Pharmaceutical Product conducted by or on behalf of the Company or any of its Subsidiaries have, to the knowledge of the Company, been, and if still pending are being, conducted in compliance in all material respects with all applicable Laws (including those pertaining to Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312, all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54, and 56 and all applicable registration and publication requirements (including, if applicable, registration on hxxx://xxxxxxxxxxxxxx.xxx)) and any non-U.S. equivalents thereof. No clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has been terminated or suspended prior to completion, and no Regulatory Authority, clinical investigator that has participated or is participating in, or institutional review board or ethics committee that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has commenced or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any ongoing clinical trial conducted by or on behalf of the Company or any of its Subsidiaries.
(d) None of the Company, any of its Subsidiaries nor, to the knowledge of the Company, any of their respective officers or current or former employees nor any other person involved in the development of the Company Pharmaceutical Products, has been convicted of any crime or engaged in any conduct that in any such case has resulted in debarment under 21 U.S.C. Section 335a or exclusion from participation in any Federal health care program pursuant to 42 U.S.C. Section 1320a-7 or any applicable non-U.S. equivalent thereof, and there are currently no investigations regarding any debarments or exclusions pending.
(e) The Company has made available to the Parent complete and correct copies of each application or other material filing including all material related supplements, amendments, correspondence and annual reports made with any Regulatory Authority made on behalf of the Company or any of its Subsidiaries relating to the Key Product. The Company has made available to the Parent complete and correct copies of each material application or other material filing including all material related supplements, amendments, correspondence and annual reports made with any Regulatory Authority made on behalf of the Company or any of its Subsidiaries relating to CYT 997.
(f) To the knowledge of the Company, there is no information that would reasonably be expected to prevent the acceptance or the subsequent approval of any filing or application for approval of the Key Product by a Regulatory Authority in the European Union, Australia, Canada or the United States.
(g) As applicable, all material applications, reports, documents, claims, Permits and notices required to be filed, maintained or furnished to any Regulatory Authority by the Company or any of its Subsidiaries, with respect to the Key Product, have been so filed, maintained or furnished (“Product Applications”). All Product Applications: (A) have been made available to the Parent; and (B) were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) or issued. To the knowledge of the Company, neither the Company nor any of its Subsidiaries, nor, to the knowledge of the Company, any officer, employee or agent or distributor of the Company or its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statement to any Regulatory Authority, failed to disclose a material fact required to be disclosed to any Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure or non-disclosure was made, would reasonably be expected to provide a basis for any Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy or applicable non-US equivalent thereof.
(h) To the knowledge of the Company, all manufacturing operations conducted for the benefit of the holders Company or any of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing its Subsidiaries with respect to the particular series of Securities;
(3) as of such Event Dateany Company Pharmaceutical Product being used, there has not beenor intended for use, in humans (including pursuant to any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Preference Shares, the ADRs or the Deposit Agreement;
(4clinical trial) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;are being conducted in accordance with GMP Regulations.
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) To the Articles of Association knowledge of the Issuer or (ii) any lawCompany, rule or regulation applicable no facts exist that would give rise to the Issuer;Key Product being recalled or the suspension, revocation or termination of any clinical trials.
(7j) there shall have not occurred any change Section 10(j) of the Company Disclosure Letter sets forth a true and complete list of each country in law in England, which a clinical trial related to the Key Product is being or has been conducted by or on behalf of the Company or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01its Subsidiaries.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Capital Securities Indenture to the contrary, the right of the Issuer Company to cause any conversion or exchange of the Capital Securities of any a series for Dollar Preference Shares or Exchange Securities on any proposed Event Exchange Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, shall be subject to the fulfillment of the following conditions with respect to such Securities of such series, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event DateCapital Securities:
(1a) as of such Event Exchange Date, there shall be are no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series Payments and there are no Missed Payments (including amounts paid on the Event Exchange Date) or other unpaid amounts then due and owing hereunder);
(2b) as of such Event Exchange Date, no Default or Event of Default, Payment Default, Default or Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Capital Securities;
(3c) as of such Event Exchange Date, there has not been, in any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Dollar Preference Shares, the ADRs Shares or the Deposit AgreementExchange Securities;
(4d) the Dollar Preference Shares to be issued on such Event Exchange Date shall be duly authorized and reserved for issuance upon such conversion and exchange and, when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5e) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Exchange Date for the issuance and delivery of the Dollar Preference Shares or Exchange Securities to be issued upon such conversion or exchange or the ADRsexchange;
(6f) the issuance and delivery of the Dollar Preference Shares and the ADRs or Exchange Securities to be issued on such Event Exchange Date shall not violate (ix) the Articles of Association of the Issuer Company or (iiy) any law, rule or regulation applicable to the Issuer;Company; and
(7g) there shall not have not occurred any change in law in EnglandScotland or in the jurisdiction of the governing law of any Exchange Securities, or any amendment of the Articles of Association of the IssuerCompany, prior to such Event Exchange Date, materially and adversely affecting the rights and privileges attached to the Dollar Preference Shares or the ADRs Exchange Securities (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the IssuerCompany) or such holders’ ' access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary, the right (i) Each of the Issuer NHG Subsidiaries, and their respective predecessors and affiliates, has complied with all applicable laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof), except where any failure to cause comply would not have a Material Adverse Effect, and no action, suit, proceeding, hearing, investigation, charge, complaint, claim, demand, or notice has been filed or commenced against any conversion or exchange of them alleging any failure so to comply.
(ii) Each of the Securities NHG Subsidiaries has all material licenses, certificates, franchises, rights and permits that are necessary for the conduct of its business, and such licenses are in full force and effect. No suspension, revocation or non-renewal of any series for Preference Shares on such license, certificate, franchise, right or permit, or any proposed Event Date shallevent which (whether with notice or the lack of time or both) might result in any such suspension, unless otherwise provided in a supplemental indenture revocation or Board Resolution pursuant failure to Section 3.01renew, be subject to the fulfillment has occurred. Each of the following conditions with respect to such Securities NHG Subsidiaries has posted all deposits of such seriessecurities and cash required by regulatory authorities having jurisdiction over it, and the Issuer represents Disclosure Schedule sets forth a list of such deposits and warrants for the benefit locations thereof. The properties, assets, operations and businesses of the holders NHG Subsidiaries and those of Preference Shares their respective Subsidiaries, are, and have been maintained and conducted, in compliance with all applicable licenses, certificates, franchises, rights and permits, except where failure to do so would not have a Material Adverse Effect.
(iii) Since January 1, 1995, the NHG Subsidiaries have filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that were required to be filed with (a) all appropriate insurance regulatory agencies; and (b) any other appropriate federal, state or local governmental or regulatory authority. All such reports, registrations and filings, as of their respective filing or mailing dates, (a) were true and complete in all material respects (or were amended so as to be so promptly following discovery of any discrepancy); and (b) complied in all material respects with all of the statutes, rules and regulations enforced or promulgated by the governmental or regulatory authority with which they were filed (or were amended so as to be so promptly following discovery of any such non-compliance) and none contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. True and correct copies of all such conditions shall reports, registrations and statements have been satisfied prior provided or made available to any such conversion or exchange on the Event Date:Fidelity.
(1iv) as The Disclosure Schedules contain a true and complete list of all reinsurance policies and agreements, and all excess loss and fidelity insurance policies, of the NHG Subsidiaries and shows the limits, the reinsurer or insurer, and any pending material claims against such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing insurer thereunder with respect to the particular series of Securities;
(3) as of NHG Subsidiaries. Such policies and agreements are in full force and effect, subject to no breach by the NHG Subsidiaries which shall give rise to a right in the insurer or reinsurer to deny any claim by the NHG Subsidiaries. The NHG Subsidiaries have committed no breach under any reinsurance agreements and policies or excess loss and fidelity insurance policies listed in the Disclosure Schedules, except where any such Event Datebreaches, there has not been, in any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability would not have a Material Adverse Effect. None of the Preference Shares, the ADRs NHG Subsidiaries has received notice of any breach under any reinsurance agreements and policies or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized excess loss and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or (ii) any law, rule or regulation applicable to the Issuer;
(7) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof fidelity insurance policies listed in the event Disclosure Schedules. The NHG Subsidiaries have notified each such reinsurer or insurer of a bankruptcy or other similar proceeding all claims, known to them, of which they are required to provide notice in accordance with respect to the Issuer) or terms of such holders’ access to the courts of the United Kingdom reinsurance and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01insurance policies and agreements.
Appears in 1 contract
Samples: Acquisition Agreement (Fidelity National Financial Inc /De/)
Legal and Regulatory Compliance. Notwithstanding (a) The Company is, and has been, in compliance in all material respects with all Legal Requirements that apply to the Company, and the Company has timely filed all reports, data and other information required to be filed with Governmental Authorities. The Company has not received written notice or communication from any Person of any inquiry, proceeding or investigation by Governmental Authorities alleging or based upon a violation of any Legal Requirements by Company or that involves services furnished or data submitted by Company.
(b) No Governmental Authority or other Person has conducted, or has given the Company any notice or communication that it intends to conduct, any audit or other review of the Company’s services to any of its clients with regard to such client’s participation in, provision of this Subordinated Indenture services under, or submission of data in connection with the Medicare or Medi-Cal programs, and no such audit or review would reasonably be expected to result in any liability to the contraryCompany for any reimbursement, the right of the Issuer to cause any conversion penalty or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions interest with respect to such Securities payments received by the Company. To the Company’s Knowledge, other than normal claims disputes, none of such seriesthe Company’s clients has any reimbursement or payment rate appeals, disputes or contested positions currently pending before any Governmental Authority or with any other third-party payor. The Company has used reasonable efforts to confirm that the clients to which it or its Affiliates provides services under Material Contracts have at all times been in compliance with the financial solvency and other applicable requirements of the Kxxx-Xxxxx Act and its implementing regulations. The Company has not on behalf of any of its clients submitted any false or fraudulent claim to any Third Party and has not received any notice from any Third Party for any allegation of a billing mistake, overpayment claim, false claim or fraud by the Company. All billing practices of the Company have been true, fair and correct and in compliance with all applicable federal and state Legal Requirements, and the Issuer represents Company has not billed for or received any payment or reimbursement in excess of amounts permitted by applicable federal and warrants state Legal Requirements. The Company has not knowingly or willfully solicited, received, paid or offered to pay any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, for the benefit purpose of the holders of Preference Shares making or receiving any referral, that all such conditions shall have been satisfied prior to violated any such conversion applicable federal or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest state self-referral or anti-kickback law (including Deferred Interestwithout limitation 42 U.S.C. § 1320a-7b(b)), rule, regulation, and Governmental Authority instructions and guidance. Except as set forth on Schedule 4.14, the Company has complied with all applicable security and privacy standards regarding protected health information under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred all applicable state data privacy and be continuing security laws with respect to the particular series business operations of Securities;the Company. Except as set forth on Schedule 4.14, the Business and operations of the Company has been and is being conducted in compliance with all applicable federal and state licensing and approval requirements of all Governmental Authorities. The Company has not been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree or settlement agreement with or sanction by any Governmental Authority. If required consents timely are obtained and required notices timely are given, the consummation of the transactions contemplated under this Agreement will not adversely affect the reimbursement of the Company’s clients by any third party payor.
(3c) as The Company has at all times operated in compliance with the federal antitrust laws and guidance from the federal antitrust enforcement agencies (the Department of such Event DateJustice (“DOJ”) and the Federal Trade Commission (“FTC” and, there collectively with the DOJ, the “Antitrust Agencies”). The Company has not beennegotiated or entered into any contract with a third-party payor on behalf of independent, competing physicians except in compliance with the antitrust laws and guidance from the Antitrust Agencies. The Company has not received any one instance written notice or in communication, determination letter, business review letter or advisory opinion from, or entered into any consent decree or settlement agreement with, any third-party payor, the aggregate, an adverse effect on Antitrust Agencies or the rights, powers, privileges, validity or enforceability State of California Office of the Preference SharesAttorney General (“AG”), the ADRs or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery neither of the Preference Shares to be issued upon such conversion Antitrust Agencies nor the AG has or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or (ii) any lawis investigating Company’s compliance with federal and/or state antitrust laws, rule or regulation applicable to the Issuer;
(7) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (includingregarding, without limitation, the rights Company’s ability under federal and/or state antitrust laws to negotiate with third-party payors on behalf of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01independent, competing providers.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture (a) Each Seller is, and has at all times in the [***] been, in compliance in all material respects with all Laws and Orders applicable to such Seller related to the contraryCompound, any Product or the right Program or by which any Transferred Asset is bound or affected, and each Seller has obtained and maintained all permits applicable to it as required by any Government Entity for the ownership, use or operation of the Issuer to cause any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be Transferred Assets. Neither Seller has (a) been subject to the fulfillment of the following conditions any Order or Proceeding with respect to such Securities any actual or alleged non-compliance with applicable Law or permit related to the Compound, any Product or the Program; or (b) been charged with or convicted of such seriesany felony or misdemeanor, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing in each case with respect to the particular series of Securities;Compound, any Product or the Program
(3b) as Sellers have provided or made available to Buyer all material documents and communications in their possession from and to any Government Entity related to the Compound, any Product or the Program that may bear on the compliance with the requirements of such Event Dateany Government Entity, including the Regulatory Files and any notice of inspection, inspection report, warning letter, notice of violation, deficiency letter or similar communication.
(c) Neither Seller nor any of their Affiliates has received any written, or to the Knowledge of Sellers, oral communication (including any warning letter, notice of violation, deficiency letter, untitled letter, or similar notice or legal action) from any Government Entity in relation to the Compound, any Product or the Program, and there is no Proceeding pending or, to Sellers’ Knowledge, threatened, alleging that a Seller or any of its Affiliates has not failed to comply with applicable Laws in connection with the Compound, any Product or the Program.
(d) Sellers have conducted each clinical trial of each Product that either or both sponsored in accordance, in all material respects, with all applicable Laws. Sellers have collected, stored, processed and used all clinical data concerning any Product in accordance, in all material respects, with all applicable Laws.
(e) No director, officer, employee or consultant of Sellers nor, to the Knowledge of Sellers, any vendor, contractor or any entity involved in the Development of any Product is or has been, in any one instance or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability of the Preference Shares, the ADRs or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) on the Articles of Association of the Issuer Exclusions List or in Violation or otherwise debarred under U.S. law (including Xxxxxxx 00 X.X.X. §000x) or any foreign equivalent thereof or (ii) any law, rule the subject of an FDA debarment investigation or regulation applicable to the Issuer;
proceeding (7) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, without limitation, the rights of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to by any Regulatory Authority outside the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01U.S.).
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture (a) The Company is (and has been at all times during the past five (5) years) in compliance with all Laws and Orders applicable to the contraryCompany, the right of the Issuer to cause any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series conduct of Securities;
(3the Business. Except as set forth in Section 1.12(a) as of such Event Datethe Disclosure Letter, there the Company has not beenreceived any written notice from any Regulatory Authority that the Company is not in compliance with all applicable Laws. The Company has timely filed all reports, in any one instance or in the aggregatedata and other information required to be filed under applicable Laws, an adverse effect except where a failure to timely file would not have a Material Adverse Effect on the rightsCompany. With respect to the Business, powers, privileges, validity or enforceability of the Preference Shares, the ADRs or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles Company has not been charged and is not, to the Company Parties’ Knowledge, under investigation with respect to, a violation of Association of the Issuer any applicable Law or Order, (ii) the Company is not a party to or bound by any law, rule Order of any Regulatory Authority and (iii) the Company has filed all reports and has all Licenses and Permits required to be filed with any Regulatory Authority on or regulation before the Closing Date and all such reports are accurate and complete in all Material respects and in Material compliance with all applicable to the Issuer;Laws.
(7b) there shall have not occurred any change in law in England, Without limiting the generality of Section 1.12(a) of this Appendix A or any amendment other representation or warranty made by the Company Parties in this Appendix A, the Company complies, in all Material respects, with and has implemented all such measures required for it to comply, in all Material respects, with all applicable obligations of HIPAA and the Articles of Association of the Issuerregulations promulgated thereunder, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (including, including without limitation, the rights privacy and security regulations and the transaction and code set regulations promulgated under HIPAA. With respect to any HIPAA Commitments: (i) the Company is in Material compliance with the HIPAA Commitments; (ii) the Transactions will not violate any of the holders thereof HIPAA Commitments; (iii) the Company has not received written inquiries from the U.S. Department of Health and Human Services or any other Regulatory Authority regarding the Company’s compliance with the HIPAA Commitments; and (iv) the HIPAA Commitments have not been rejected by any applicable certification organization that has reviewed such HIPAA Commitments or to which any such HIPAA Commitment has been submitted.
(c) Without limiting the generality of Section 1.12(a) of this Appendix A or any other representation or warranty made by the Company Parties in this Appendix A, the event of a bankruptcy or other similar proceeding with respect to Company is conducting and has conducted the Issuer) or such holders’ access to the courts Business and its operations in compliance with, and none of the United Kingdom and other Company, the Former Owners or any of the Company’s Managerial Officials or employees (in their capacity as such) has engaged in any activities prohibited under, any applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01Healthcare Laws.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding any provision of this Subordinated Indenture to the contrary, the right of the Issuer to cause any conversion or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series(a) The Company and its Subsidiaries are, and have at all times during the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
past two (2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Securities;
(3) as of such Event Date, there has not years been, in compliance, in all material respects, with all applicable Laws. There are no pending Proceedings against the Company or any one instance of its Subsidiaries alleging that the Company or in the aggregate, an adverse effect on the rights, powers, privileges, validity or enforceability such Subsidiary of the Preference SharesCompany is in violation of any applicable Law. Neither the Company nor any of its Subsidiaries, the ADRs nor any of their respective executive officers (in their capacities as such) has received any written notice, order, complaint or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals other communication from any Governmental Authority or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery third party of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery any claim of the Preference Shares and the ADRs to be issued on such Event Date shall not violate a violation of (i) the Articles of Association of the Issuer or any applicable Law, (ii) any lawFDA Form 483 or equivalent written report by inspectors or officials from any Governmental Authority, rule (iii) any FDA or regulation USDA written notice of adverse findings or any equivalent written correspondence, notice or communication from any other Governmental Authority indicating a failure to comply with applicable Law or (iv) any warning letters or other written correspondence from the FDA, USDA or any other Governmental Authority in which the FDA, USDA or such other Governmental Authority asserted that the operations of the Company or any of its Subsidiaries were not in compliance with applicable Law. Neither the Company nor any of its Subsidiaries has made any fraudulent statement to the Issuer;FDA, USDA or any other Governmental Authority, or failed to disclose a fact required under Law to be disclosed to the FDA, USDA or any other Governmental Authority or been convicted of any crime. To the Knowledge of the Company, no event has occurred, and no condition or circumstance exists, that would reasonably be expected to (with or without notice or lapse of time) constitute or result in a violation by the Company or any of its Subsidiaries of, or a failure on the part of the Company or any of its Subsidiaries to comply, in any material respect, with, any applicable Law.
(7b) there shall have not occurred Each Product marketed, manufactured, sold or distributed by the Company or any change of its Subsidiaries has been, for a period of two years prior to the Effective Date, and is being marketed, manufactured, sold or distributed by the Company or such Subsidiary of the Company, in law material compliance with all applicable requirements under the Federal Food Drug and Cosmetic Act, as amended, and regulations promulgated by the FDA thereunder, the Xxxxxx Act of 1946, as amended, and regulations promulgated thereunder, and similar Laws of all other applicable Governmental Authorities, including without limitation other Laws promulgated by the FDA, the U.S. Environmental Protection Agency, the USDA, corresponding state-level Governmental Authorities, and foreign countries that apply to the manufacture, distribution, marketing, sale and labeling of food products (such Laws, collectively or singly, the “Food Laws”), and the processing, manufacture or holding of such products by the Company and its Subsidiaries has been, for a period of two years prior to the Effective Date and is in Englandall material respects in accordance with the applicable standards prescribed by Food Laws.
(c) Neither the Company nor any of its Subsidiaries has established or maintained, nor is it maintaining, any unlawful fund of corporate monies or other properties. Neither the Company or any of its Subsidiaries, nor to the Knowledge of the Company any of the Company’s or any of its Subsidiary’s Representatives, (i) has, during the past two (2) years, used or is using any corporate funds for any illegal contributions, gifts, entertainment or other unlawful expenses relating to political activity, (ii) has, during the past two (2) years used, or is using any amendment corporate funds for any direct or indirect unlawful payments to any foreign or domestic governmental officials or employees, or (iii) is or has, during the past two (2) years violated, in any material respect any provision of the Articles Foreign Corrupt Practices Act of Association 1977 or similar Laws of relevant Governmental Authorities or (iv) has, during the Issuerpast two (2) years, prior to such Event Datemade any unlawful bribe, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (includingrebate, without limitationpayoff, the rights of the holders thereof in the event of a bankruptcy influence payment, kickback or other similar proceeding with respect to the Issuer) or such holders’ access to the courts unlawful payment of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01any nature.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding (a) Parent is, and has been, in compliance in all material respects with all Legal Requirements that apply to Parent, and Parent has timely filed all reports, data and other information required to be filed with Governmental Authorities. Parent has not received written notice or communication from any Person of any inquiry, proceeding or investigation by Governmental Authorities alleging or based upon a violation of any Legal Requirements by Parent or that involves services furnished or data submitted by Parent.
(b) No Governmental Authority or other Person has conducted, or has given Parent any notice or communication that it intends to conduct, any audit or other review of Parent’s services to any of its clients with regard to such client’s participation in, provision of this Subordinated Indenture services under, or submission of data in connection with the Medicare or Medi-Cal programs, and no such audit or review would reasonably be expected to the contraryresult in any liability to Parent for any reimbursement, the right of the Issuer to cause any conversion penalty or exchange of the Securities of any series for Preference Shares on any proposed Event Date shall, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions interest with respect to such Securities payments received by Parent. To Parent’s Knowledge, other than normal claims disputes, none of such seriesParent’s clients has any reimbursement or payment rate appeals, disputes or contested positions currently pending before any Governmental Authority or with any other third-party payor. Parent has used reasonable efforts to confirm that the clients to which it or its Affiliates provides services under Parent Material Contracts have at all times been in compliance with the financial solvency and other applicable requirements of the Kxxx-Xxxxx Act and its implementing regulations. Parent has not on behalf of any of its clients submitted any false or fraudulent claim to any Third Party and has not received any notice from any Third Party for any allegation of a billing mistake, overpayment claim, false claim or fraud by Parent. All billing practices of Parent have been true, fair and correct and in compliance with all applicable federal and state Legal Requirements, and the Issuer represents Parent has not billed for or received any payment or reimbursement in excess of amounts permitted by applicable federal and warrants state Legal Requirements. Parent has not knowingly or willfully solicited, received, paid or offered to pay any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, for the benefit purpose of the holders of Preference Shares making or receiving any referral, that all such conditions shall have been satisfied prior to violated any such conversion applicable federal or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest state self-referral or anti-kickback law (including Deferred Interest) outstanding without limitation 42 U.S.C. § 1320a-7b(b)), rule, regulation, and Governmental Authority instructions and guidance. Except as set forth on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due Schedule 5.15, Parent has complied with all applicable security and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred privacy standards regarding protected health information under HIPAA and be continuing all applicable state data privacy and security laws with respect to the particular series business operations of Securities;Parent. Except as set forth on Schedule 5.15, the Business and operations of Parent has been and is being conducted in compliance with all applicable federal and state licensing and approval requirements of all Governmental Authorities. Parent has not been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree or settlement agreement with or sanction by any Governmental Authority. If required consents timely are obtained and required notices timely are given, the consummation of the transactions contemplated under this Agreement will not adversely affect the reimbursement of Parent’s clients by any third party payor.
(3c) as of such Event Date, there Parent has at all times operated in compliance with the federal antitrust laws and guidance from the federal Antitrust Agencies. Parent has not beennegotiated or entered into any contract with a third-party payor on behalf of independent, competing physicians except in compliance with the antitrust laws and guidance from the Antitrust Agencies. Parent has not received any one instance written notice or in communication, determination letter, business review letter or advisory opinion from, or entered into any consent decree or settlement agreement with, any third-party payor, the aggregateAntitrust Agencies or the AG, an adverse effect on the rights, powers, privileges, validity or enforceability and neither of the Preference SharesAntitrust Agencies nor the AG has or is investigating Parent’s compliance with federal and/or state antitrust laws, the ADRs or the Deposit Agreement;
(4) the Preference Shares to be issued on such Event Date shall be duly authorized and reserved for issuance upon such conversion and when issued upon such exchange, will be fully paid and not subject to calls for further funds;
(5) no consents, authorizations, approvals or exemptions, except in each case such as shall have been obtained, will be required prior to such Event Date for the issuance and delivery of the Preference Shares to be issued upon such conversion or exchange or the ADRs;
(6) the issuance and delivery of the Preference Shares and the ADRs to be issued on such Event Date shall not violate (i) the Articles of Association of the Issuer or (ii) any law, rule or regulation applicable to the Issuer;
(7) there shall have not occurred any change in law in England, or any amendment of the Articles of Association of the Issuer, prior to such Event Date, materially and adversely affecting the rights and privileges attached to the Preference Shares or the ADRs (includingregarding, without limitation, the rights Parent’s ability under federal and/or state antitrust laws to negotiate with third-party payors on behalf of the holders thereof in the event of a bankruptcy or other similar proceeding with respect to the Issuer) or such holders’ access to the courts of the United Kingdom and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01independent, competing providers.
Appears in 1 contract
Legal and Regulatory Compliance. Notwithstanding (i) The businesses of each of the Company and its Subsidiaries are being conducted in compliance with all federal, state, local or foreign law, statutes or ordinances, common laws, or any provision rule, regulation, standard, judgment, order, writ, injunction, decree, arbitration award, agency requirement, license or permit of this Subordinated Indenture to any governmental entity (collectively, “Laws”), including (A) the contraryFederal Food, Drug and Cosmetic Act, as amended (including the rules and regulations promulgated thereunder, the right “FDCA”); (B) the Public Health Services Act (the “PHSA”) and the regulations promulgated thereunder; (C) federal Medicare and Medicaid statutes and related state or local statutes or regulations; (D) any comparable foreign Laws for any of the Issuer to cause foregoing; (E) the Federal False Claims Act, or any conversion or exchange similar state laws; (F) the privacy and security provisions of the Securities of any series Health Insurance Portability and Accountability Act; and (G) state licensing, disclosure and reporting requirements; except for Preference Shares on any proposed Event Date shallviolations that, unless otherwise provided in a supplemental indenture or Board Resolution pursuant to Section 3.01, be subject to the fulfillment of the following conditions with respect to such Securities of such series, and the Issuer represents and warrants for the benefit of the holders of Preference Shares that all such conditions shall have been satisfied prior to any such conversion or exchange on the Event Date:
(1) as of such Event Date, there shall be no accrued but unpaid interest (including Deferred Interest) outstanding on the Securities of such Series (including amounts paid on the Event Date) or other unpaid amounts then due and owing hereunder;
(2) as of such Event Date, no Event of Default, Payment Default, Payment Event or Capital Security Event Default shall have occurred and be continuing with respect to the particular series of Securities;
(3) as of such Event Date, there has not been, in any one instance individually or in the aggregate, an adverse effect on do not have, and could not reasonably be expected to have, a Material Adverse Effect or prevent, materially delay or materially impair the rights, powers, privileges, validity or enforceability consummation of the Preference Shares, the ADRs or the Deposit Agreement;Transactions.
(4ii) To the Preference Shares knowledge of the Company, no investigation or review by any governmental entity with respect to be issued on such Event Date shall be duly authorized the Company or any of its Subsidiaries is pending or threatened, nor has any governmental entity indicated an intention to conduct the same, except for those the outcome of which, individually or in the aggregate, have not had, and reserved for issuance upon such conversion and when issued upon such exchangeare not reasonably expected to have, will be fully paid and not subject to calls for further funds;a Material Adverse Effect or prevent, materially delay or materially impair the consummation of the Transactions.
(5iii) no The Company and its Subsidiaries have all permits, licenses, certifications, approvals, registrations, consents, authorizations, approvals franchises, variances, exemptions and orders issued or exemptionsgranted by any governmental entity (“Licenses”) necessary to conduct its business as presently conducted (including all Licenses required by state law, the FDCA, the PHSA and the regulations of the FDA) the lack of which could reasonably be expected to have a Material Adverse Effect, and all such Licenses are valid and in full force and effect. All applications and other documents, submitted by the Company or the Company’s Subsidiaries to states or to the FDA in connection with a License, when submitted to the FDA, were true and correct as of the date of submission, except as, individually and in each case the aggregate, has not had and could not reasonably be expected to have a Material Adverse Effect, and any updates, changes, corrections or modification to such as shall applications and other documents required under applicable Laws, have been obtainedsubmitted to the governmental entity, will except as has not had and could not reasonably be required prior expected to such Event Date for the issuance and delivery have a Material Adverse Effect.
(iv) As of the Preference Shares date hereof and to be issued upon such conversion the knowledge of the Company, the Company has not received any written notice or exchange communication of any material noncompliance with any applicable Law or the ADRs;Licenses that has not been cured.
(6v) Neither the issuance and delivery Company, any Subsidiary of the Preference Shares and Company nor any director, officer, agent or employee of the ADRs to be issued on such Event Date shall not violate Company or its Subsidiaries has (i) the Articles of Association of the Issuer used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity, or (ii) made any lawunlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns or violated any provision of the Foreign Corrupt Practices Act of 1977, rule as amended, or regulation any other federal, foreign, or state anti-corruption or anti-bribery Law or requirement applicable to the Issuer;Company or any Subsidiary of the Company.
(7vi) Section 4(t)(vi) of the Schedule of Exceptions sets forth a true and complete list of all Regulatory Authorizations from the FDA and any other federal, state, local or foreign governmental entity that is concerned with or regulates the marketing, sale, use, handling and control, safety, efficacy, reliability or manufacturing of drug or biological products or medical devices or is concerned with or regulates public health care programs or otherwise has regulatory authority over the development, sale, distribution or manufacturing of Products by the Company or its Subsidiaries ((each, a “Regulatory Authority”) relating to the Company and its Subsidiaries their Products and the conduct of their business, and there shall are no other Regulatory Authorizations required for the Company, its Subsidiaries, their Products or the conduct of their business. All such Regulatory Authorizations are, in all material respects, (A) validly registered and on file with applicable Regulatory Authorities and (B) in compliance with all formal filing and maintenance requirements and (C) in good standing. The Company and its Subsidiaries have filed all required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other information with the FDA and all other applicable Regulatory Authorities.
(vii) There are no, and have not occurred been, any change in law in Englandinspection observations, warning or untitled letters, notices pursuant to 21 U.S.C. Section 305 or similar documents that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved or any amendment other Regulatory Authorities, as applicable. None of the Articles Company or any of Association its Subsidiaries has knowledge (or has been notified by a third party) of any pending regulatory action, or inquiry of any sort against any of the IssuerCompany or its Subsidiaries, prior to such Event Datetheir Products, materially and adversely affecting the rights and privileges attached to the Preference Shares any manufacturer, developer or the ADRs (including, without limitation, the rights distributor of the holders thereof in the event of a bankruptcy or other similar proceeding Products (with respect to the Issuer) Products), any Company partner, or such holders’ access any person that licenses Product Intellectual Property to the courts Company or a Subsidiary of the United Kingdom Company (with respect to the Products) by the FDA or any other Regulatory Authority, nor does the Company or any of its Subsidiaries have knowledge or been notified by a third party of the basis for any adverse regulatory action. Without limiting the foregoing, (A) there have been no product recalls, warnings, notifications or safety alerts conducted or issues by the Company or its Subsidiaries, the FDA or any other Regulatory Authorities or otherwise with respect to the Products, none of the foregoing has been requested or demanded by the FDA or any other Regulatory Authorities, and there is no reasonable basis for any of the foregoing; and (B) none of the Company, its Subsidiaries or, to the knowledge of the Company, any of their respective agents or contractors, has been convicted of, charged with, or investigated for, any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, civil fraud charges by a governmental entity, debarment or disqualification by the FDA or any other Regulatory Authority, no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Subsidiary of the Company or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees or similar actions to which the Company or any Subsidiary of the Company is bound or which relate to their Products. Neither the Company nor any Subsidiary of the Company is employing or utilizing the services of any individual who has been debarred, excluded, temporarily denied approval or suspended under any Law or Order which relates to the Products or which the Company or any Subsidiary of the Company is barred from employing or utilizing. Neither the Company nor any Subsidiary of the Company has made any untrue statement of fact or fraudulent statement to the FDA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA or any other Regulatory Authority, and to the Company’s knowledge, no Company partner has made any untrue statement of fact or fraudulent statement to the FDA or any other Regulatory Authority relating to the Products, nor to the Company’s knowledge, has any Company partner failed to disclose any facts required to be disclosed to the FDA or any other Regulatory Authority relating to the Products.
(viii) The Company and each Subsidiary of the Company is in compliance in all material respects with all written communications and requirements of the FDA and all other Regulatory Authorities relating thereto, including all requirements of the FDA and all other Regulatory Authorities.
(ix) The Company and its Subsidiaries have made available to the Purchaser complete and accurate copies all serious adverse event reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Subsidiary of the Company, the conduct of their business or their Products.
(x) All studies conducted or being conducted with respect to the Company’s and its Subsidiaries’ Products by the Company, any Subsidiary of the Company or, to the Company’s knowledge, Company partner have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and those regulations and guidances that relate to the conduct of clinical studies. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Purchaser, including communications with clinical trial sites.
(xi) The manufacture of products by the Company and any Subsidiary of the Company is, or, in the case of any Products manufactured by a Company partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and each Subsidiary of the Company and, to the knowledge of the Company, their respective Company partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207 and all similar applicable Laws and Orders. No Product sold or in inventory has been adulterated or misbranded. All labeling is in compliance with FDA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each Subsidiary of the Company are in material compliance with the FDA and other applicable governmental authorities to enforce such rights; and
(8) such other condition(s) as may be set out in a supplemental indenture or Board Resolution pursuant to Section 3.01Regulatory Authorities.
Appears in 1 contract
Samples: Series B 1 Preference Shares and Warrant Purchase Agreement (Sagent Holding Co.)