Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"). As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect. (i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law. (c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information. (d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects. (e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company. (f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Bei Medical Systems Co Inc /De/), Merger Agreement (Bei Medical Systems Co Inc /De/)
Permits; Compliance. (a) Each of the Company and the its Subsidiaries of the Company is in possession of of, and in compliance with, all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesorders, approvals registrations and orders clearances of any Governmental Authority Entity necessary for each of the Company or the its Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As of , except where the date hereoffailure to hold or to comply with, no or the suspension or cancellation of of, or failure to be valid or to be in full force and effect of, any of the Permits is pending orPermits, would not reasonably be expected to have, individually or in the knowledge of the Companyaggregate, threatened. a Company Material Adverse Effect.
(b) Neither the Company nor any Subsidiary of the Company is or, since January 1, 2019 has been, in conflict with, or in default, breach default under or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company, to the conduct of the business or operations of the Company or any of its Subsidiaries, or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches defaults or violations that as would not have reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) In the past five (5) years, none of the Company, any of the Subsidiaries of the Company (including their officers, directors employees), or, to the Knowledge of the Company, agents or any other Representative of the Company or any of the Subsidiaries of the Company (including consultants, distributors, resellers and other business intermediaries and Persons acting on their behalf) has, directly or knowingly indirectly, taken any action which would cause the Company or the Subsidiaries of the Company to be in violation of: (i) With the Foreign Corrupt Practices Act of 1977 or any rules or regulations thereunder; (ii) the UK B▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇; or (iii) any other applicable anticorruption and/or anti-bribery Laws (whether by virtue of jurisdiction or organization or conduct of business) (collectively, the “Applicable Anti-Corruption Laws”).
(d) There are no current, pending, or, to the Knowledge of the Company, threatened Proceedings against the Company, any of the Subsidiaries of the Company or any Representative or affiliate of the Company or any of the Subsidiaries of the Company (in each case as it relates to the Company or the Subsidiaries of the Company) with respect to any Applicable Anti-Corruption Laws. In the products past five (5) years, neither the Company, the Subsidiaries of the Company nor, to the Knowledge of the Company, any Representatives of the Company or any of the Subsidiaries of the Company (including consultants, distributors, resellers, and any other business intermediaries) (in each case as it relates to the Company or the Subsidiaries of the Company), has received notice of (i) any investigation by or request for information from a Governmental Entity relating to any actual or possible violation of Applicable Anti-Corruption Laws by the Company, any of the Subsidiaries of the Company or any Representatives of the Company or any of the Subsidiaries of the Company (including consultants, distributors, resellers, and other business intermediaries) (in each case as it relates to the Company or the Subsidiaries of the Company), or (ii) any other allegation, investigation or inquiry regarding any actual or possible violation of the Applicable Anti-Corruption Laws by the Company, any of the Subsidiaries of the Company or any Representatives of the Company or any of the Subsidiaries of the Company (including consultants, distributors, resellers, and any other business intermediaries) (in each case as it relates to the Company or the Subsidiaries of the Company). In the past five (5) years, none of the Company and its Subsidiaries andor controlled affiliates (including any of their respective officer, directors, employees or, to the extent applicableKnowledge of the Company, products under development their respective agents or other Persons acting on their behalf (collectivelyin each case acting in their capacity as such)), have corruptly offered, made, promised to make, or authorized the making of any gift or payment of money or anything of value either directly or indirectly to any Person, or to a Governmental Official, or to any Person acting in an official capacity for or on behalf of any Governmental Entity, for purposes of (i) influencing any act or decision of any Person, or such Governmental Official in their official capacity, (ii) inducing any Person or such Governmental Official to do or omit to do any act in violation of their lawful duty, (iii) securing an improper advantage or (iv) inducing such Person or Governmental Official to use their influence improperly including with a Governmental Entity to affect or influence any act or decision, including of such Governmental Entity, in order to obtain, retain or direct or assist in obtaining, retaining or directing business to any Person. For purposes of this Section 3.10(d), the "COMPANY PRODUCTS") term “Governmental Entity” shall also include any political party, royal family, government-owned or controlled entity (A) the Company including state-owned or any of its Subsidiaries has obtainedstate-controlled businesses or quasi-government entities), unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities public international organization (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectivelye.g., the "COMPANY LICENSES"); World Bank or Red Cross) and the term “Governmental Official” shall incorporate the definition of Governmental Entity as modified for this Section 3.10(d) and shall also include any candidate for government or political office or member of a royal family.
(Be) The Company has instituted and maintains internal controls, policies and procedures reasonably designed to ensure compliance with Applicable Anti-Corruption Laws. In the past five (5) years, the Company and each of its the Subsidiaries are of Company has kept books and records of their businesses in compliance reasonable detail that accurately and fairly reflect the transactions and assets of such businesses.
(f) In the past five (5) years, and in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date case with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each any of its the Subsidiaries are in compliance in of the Company, all material respects with all applicable Laws regarding registrationof their respective directors, licenseofficers, certification for each site at which a Company Product is manufacturedand, labeled, sold, or distributed; and (D) to the extent any Company Product has Knowledge of the Company, employees or agents, have at all times been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Customs and Trade Laws.
(g) Neither the Company nor any of the Subsidiaries of the Company have, within the past five (5) years, (i) made any voluntary, directed or involuntary disclosure to any Governmental Entity or similar agency with respect to any alleged act or omission arising under or relating to any non-compliance with any Customs and Trade Laws, (ii) to the Knowledge of the Company, been the subject of a current, pending or threatened investigation, inquiry or enforcement proceedings for violations of Customs and Trade Laws or (iii) received any notice, request, penalty or citation for any actual or potential non-compliance with Customs and Trade Laws.
(h) In the past five (5) years, the Company and each of the Subsidiaries of the Company has obtained all applicable import and export licenses and all other necessary consents, notices, waivers, approvals, orders, authorizations and declarations, and has completed all necessary registrations and filings, required under applicable Customs and Trade Laws, that are material to the operations of the Company.
(i) The Company and each Subsidiary of the Company has in place written policies, controls and systems reasonably designed to maintain compliance in all materials respects with applicable Customs and Trade Laws in each jurisdiction in which the Company and each Subsidiary of the Company conducts business.
(j) Since January 1, 2019, neither the Company nor any Subsidiary of the Company has (i) materially breached or violated any Law, or any material certification, representation, clause, provision or requirement pertaining to any Government Contract; (ii) all manufacturing operations performed been audited (except in the ordinary course of business) or investigated by any Governmental Entity with respect to any Government Contract; (iii) conducted or initiated any internal investigation (for which the assistance of outside counsel or an accounting firm was required) or made any disclosure with respect to any alleged or potential irregularity, misstatement, omission or actual or potential violation of Law arising under or relating to a Government Contract; (iv) received any written notice of breach, cure, show cause or default that remains unresolved with respect to a Government Contract; (v) had any Government Contract terminated for cause, default or failure to perform; (vi) represented as qualifying for any preferred bidder status, nor received any other Government Contract based in part or in whole on behalf any preferred bidder status; or (vii) entered into any Government Contracts payable on a cost-reimbursement basis. The Company and each Subsidiary of the Company have been has established and are being conducted in all material respects in maintained adequate internal controls for compliance with their respective Government Contracts. Neither the U.S. Food Company nor any Subsidiary of the Company nor any of their respective directors, officers, principals, or, to the Knowledge of the Company, any current employee, is or has been suspended or debarred, proposed for debarment or suspension, declared ineligible or determined non-responsive from holding, performing or bidding on any Government Contract, and Drug Administration's no such proceeding regarding suspension, debarment, ineligibility or non-responsibility has been commenced or threatened. There are no material outstanding claims or disputes in connection with any of the Company’s or any of its Subsidiary’s Government Contracts. To the Knowledge of the Company, there are no outstanding or unsettled allegations of fraud, false claims or significant overpayments with respect to any Government Contract.
(k) In the "FDA"past five (5) Quality Systems regulations years, (21 CFR Part 820i) the Company, each Subsidiary of the Company, and all of their respective directors, officers, and, to the extent applicable to Knowledge of the Company, counterpart regulations in the European Union employees and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approvalagents, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countriesSanctions; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any Subsidiary of its Subsidiaries the Company has conducted, directly or indirectly, any business in any Sanctioned Jurisdiction or with any Sanctioned Person, in violation of applicable Sanctions; and (iii) neither the Company nor any Subsidiary of the Company, nor any of their directors, officers, employees or agents is a Sanctioned Person. The Company and each Subsidiary of the Company has in place written policies, controls, and systems reasonably designed to maintain compliance with all applicable Sanctions. Neither the Company nor any Subsidiary of the Company has within the last three yearspast five (5) years (x) made any voluntary, either voluntarily directed or at the request of involuntary disclosure to any Governmental AuthorityEntity with respect to any alleged act or omission arising under or relating to any non-compliance with any Sanctions, initiated (y) to the Knowledge of the Company been the subject of a past, current, pending or participated in threatened investigation, inquiry or enforcement proceeding for a recall violation of Sanctions or (z) received any Company Product notice, request, penalty, or provided postcitation for any actual or potential non-sale warnings regarding any Company Productcompliance with Sanctions.
Appears in 2 contracts
Sources: Merger Agreement (Maxlinear Inc), Merger Agreement (Maxlinear Inc)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority Entity necessary for each of the Company or the Subsidiaries of the any Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"). As , except where the failure to have, or the suspension or cancellation of, any of the Company Permits would not reasonably be expected to, individually or in the aggregate, (A) have a Company Material Adverse Effect or (B) prevent or materially delay the performance of this Agreement by the Company, and, as of the date hereofof this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the actual knowledge of the executive officers of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits would not reasonably be expected to, individually or in the aggregate, (A) have a Company Material Adverse Effect or (B) prevent or materially delay the performance of this Agreement by the Company. Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach default or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not have a Material Adverse Effect.
(i) With respect reasonably be expected to individually or in the products of the Company and its Subsidiaries andaggregate, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the have a Company Material Adverse Effect or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission prevent or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to delay the maintenance, compilation and filing performance of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws this Agreement by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Case Credit Corp), Merger Agreement (Case Corp)
Permits; Compliance. (a) Each of the Company and the its Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority Permits necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or and to carry on its business as it is now being conducted conducted, including Permits required under Environmental Laws (the "PERMITS"“Environmental Permits”), except where failure to be in possession of such Permits would not reasonably be expected to have a Material Adverse Effect. As The Company and each of its Subsidiaries are, and have been, in compliance with the date hereofterms and conditions of such Permits, except where failure to so comply would not reasonably be expected to have a Material Adverse Effect and no suspension or cancellation of any of the Permits such Permit is pending or, to the knowledge of the Company’s knowledge, threatened. .
(b) Neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company its certificate of incorporation or any Subsidiary of the Company bylaws or by which any property or asset of the Company or any Subsidiary of the Company is bound or affectedequivalent organizational documents, or (ii) any noteLaw, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation (iii) any contract to which the Company or any Subsidiary of the Company its Subsidiaries is a party or by which the Company or any Subsidiary of the Company its Subsidiaries or any property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound, except with respect to clauses (ii) or (iii), for any such conflicts, defaults, breaches or violations that would not be reasonably expected to have a Material Adverse Effect.
(ic) With respect to The execution and delivery of this Agreement by the products Company do not, and the consummation of the Transactions will not, result in any breach or violation of or result in the termination or cancellation of any Environmental Permit or other material Permit except where the failure for such Permits to be in effect would not reasonably be expected to have a Material Adverse Effect.
(d) Neither the Company and nor any of its Subsidiaries andnor, to the extent applicableknowledge of the Company, products under development (collectivelyany of their respective officers, the "COMPANY PRODUCTS") (A) directors, agents, Company Employees or other person acting on behalf of the Company or any of its Subsidiaries has obtainedhave, unless otherwise exemptdirectly or indirectly, all necessary and taken any action which would cause them to be in violation of the Foreign Corrupt Practices Act of 1977, as amended, or any rules or regulations thereunder or any similar anti-corruption or anti-bribery laws applicable approvals, clearances, authorizations, licenses and registrations required by to the Company or any of its Subsidiaries in any jurisdiction other than the United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"“Company FCPA”); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) andor, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing used any corporate funds for unlawful contributions, gifts, entertainment or submission other unlawful expenses relating to the FDA political activity, made, offered or authorized any other Governmental Authority with regard unlawful payment to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and or United States government officials or employees, whether directly or indirectly, or made, offered or authorized any bribe, rebate, payoff, influence payment, kickback or other similar state and local Governmental Agency Laws applicable to the maintenanceunlawful payment, compilation and filing of reports, including medical device reports, with regard to the Company Productswhether directly or indirectly. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling established reasonable internal controls and promotion of any of procedures intended to ensure compliance with the Company Products or (ii) otherwise alleging any violation of any Laws by the CompanyFCPA.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Sl Industries Inc), Merger Agreement (Handy & Harman Ltd.)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company Acquired Companies is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesOrders, approvals registrations and orders clearances of any Governmental Authority Entity (each, a “Permit”) necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Acquired Companies to own, lease and operate its properties or and assets (including the Company Real Property), and to carry on and operate its business businesses as it is now being currently conducted (including giving effect to the "PERMITS"Company Management Agreement Documents and Company Franchise Agreement Documents) (the “Company Permits”), and all such Company Permits are in full force and effect, in each case except where the failure to have, or the failure to be in full force and effect of, any Company Permits would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the Company, threatened. Neither threatened in writing and no such suspension or cancellation will result from the Company nor any Subsidiary of the Company is in conflict withTransactions, except as would not, individually or in defaultthe aggregate, breach or violation of, (i) any Law applicable reasonably be expected to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Company Material Adverse Effect.
(ib) With Each of the Acquired Companies is in compliance with all Laws applicable to its businesses, except where the failure to comply with such Laws would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. To the Knowledge of the Company, no investigation by any Governmental Entity with respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedthe Acquired Companies is pending, unless otherwise exemptexcept for such investigations the outcomes of which, all necessary and applicable approvalsindividually or in the aggregate, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, would not reasonably be expected to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion have a Company Material Adverse Effect. None of the Acquired Companies has, during the one-year period prior to the date hereof: (i) received any written notice from any Governmental Entity regarding any material violation by the Acquired Companies of any Law; or (ii) provided any written notice to any Governmental Entity regarding any material violation by any of the Acquired Companies of any Law, which notice in either case remains outstanding or unresolved as of the date hereof, except for such notices that would not, individually or in the aggregate, reasonably be expected to have a Company Products Material Adverse Effect. No representation or warranty is made in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE"this Section 3.9(b) with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Lawenvironmental matters.
(c) To Except as would not, individually or in the knowledge of aggregate, reasonably be expected to have a Company Material Adverse Effect, neither the Acquired Companies nor, to the Company’s Knowledge, no filing any trustee, director, officer or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion employee of any of the Company Products Acquired Companies in their capacity as such, has (i) knowingly used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity, (ii) otherwise alleging any violation unlawfully offered or provided, directly or indirectly, anything of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken value to (or to the knowledge received anything of the Company threatenedvalue from) by the FDA any foreign or domestic government employee or official or any other Governmental Authority with Person, or (iii) taken any action, directly or indirectly, that would constitute a violation in any material respect by such Persons of the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the “FCPA”), including making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office, in contravention of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductFCPA.
Appears in 2 contracts
Sources: Merger Agreement (Pebblebrook Hotel Trust), Merger Agreement (LaSalle Hotel Properties)
Permits; Compliance. (a) Each Except as set forth in Section 4.06 of the Company Disclosure Schedule, each of the Company and the Company Subsidiaries of (i) is and has been in compliance in all material respects with any and all Laws applicable to the Company and the Company Subsidiaries or its business, properties or assets, except for failures to comply or violations which would not be materially adverse to the Company and the Company Subsidiaries, taken as a whole, or reasonably expected to materially interfere with the Transactions (including the Mergers), and (ii) is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority permits necessary for each of the Company or the Subsidiaries of the such Company to manufactureSubsidiary, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or applicable to own, lease and operate its properties (including the Leased Real Properties) or to carry on its business as it is now being conducted (the "PERMITS"“Company Permits”). As of , except where the date hereoffailure to have such Company Permit would not be materially adverse to the Company and the Company Subsidiaries, taken as a whole, and no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatenedthreatened in writing. Neither Since January 1, 2020, (x) neither the Company nor any Company Subsidiary has been sanctioned, fined or penalized for any violation of or failure to comply with any applicable Law, (y) neither the Company is nor any Company Subsidiary is, or has been, in conflict with, or in default, breach or violation of, any Company Permit and (iz) neither the Company nor any Law Company Subsidiary has received inspection, report, notice of adverse finding, warning letter, resolution, writ, untitled letter or other correspondence with or from any Governmental Authority alleging or asserting non-compliance with applicable to Laws or any Company Permit by the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affectedSubsidiaries, or except, with respect to clauses (iix), (y) any noteand (z), bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Business Combination Agreement (Rosecliff Acquisition Corp I), Business Combination Agreement (Rosecliff Acquisition Corp I)
Permits; Compliance. (a) Each of the The Company and the Company Subsidiaries of the Company is are in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each Entity ("Permits") that are material to the operation of the business of the Company or and the Subsidiaries Company Subsidiaries, taken as a whole, as they are operated on the date hereof (and, for purposes of Section 7.02(a), as they are operated as of the Company to manufactureClosing Date) (collectively, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"). As of the date hereof, no No suspension or cancellation of any of the Permits Company Permit is pending or, to the knowledge Knowledge of the Company, threatened, except with respect to Company Permits the suspension or cancellation of which would not, individually or in the aggregate, have a Company Material Adverse Effect. Neither Since July 1, 1998, neither the Company nor any Company Subsidiary has (i) been denied or failed to receive any Permit that it had sought that would, if currently possessed by the Company or a Company Subsidiary, be reasonably likely to be material to the operation of the business of the Company and the Company Subsidiaries, taken as a whole, as they are operated on the date hereof (and, for purposes of Section 7.02(a), as they are operated as of the Closing Date), or (ii) had any Permit suspended or canceled that would, if currently possessed by the Company or a Company Subsidiary, be reasonably likely to be material to the operation of the business of the Company and the Company Subsidiaries, taken as a whole, as they are operated on the date hereof (and, for purposes of Section 7.02(a), as they are operated as of the Closing Date).
(b) Except as would not, individually or in the aggregate, have a Company Material Adverse Effect, neither the Company nor any Company Subsidiary is in conflict with, or in default, breach or violation has violated any provision of, or committed or failed to perform any act which, with or without notice, lapse of time, or both, would constitute a default under the provisions of: (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or ; (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permitpermit, franchise or other instrument or obligation to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the is bound or affected; or (iii) any Company is bound, except for any such conflicts, defaults, breaches or violations that Permit.
(c) Except as would not have a Company Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicablesince July 1, products under development (collectively1996, the "COMPANY PRODUCTS") (A) there have been no written notices, citations or decisions by any governmental or regulatory body that any product or service produced, provided, manufactured or marketed at any time by the Company or any of its Company Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATECompany Products and Services") with respect is defective or fails to each meet any applicable standards promulgated by any such governmental or regulatory body. Except as would not have a Company ProductMaterial Adverse Effect, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance complied in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent Laws applicable to the Company, counterpart regulations in the European Union Company and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard respect to the Company Products that is the basis for any approval or clearance contains any material omission or materially false informationand Services.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Covance Inc), Merger Agreement (Parexel International Corp)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is are in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesorders, approvals registrations and orders clearances of any Governmental Authority necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , except where the failure to hold or to comply with, or the Table of the date hereof, no Contents suspension or cancellation of of, or failure to be valid or to be in full force and effect of, any of the Permits is pending orPermits, would not reasonably be expected to have, individually or in the knowledge of the Companyaggregate, threateneda Company Material Adverse Effect. Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach default under or violation of, (i) of any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches defaults or violations that as would not have reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(ib) With respect to Since April 1, 2015, none of the products Company, any of its Subsidiaries or any Representative of the Company and or any of its Subsidiaries andSubsidiaries, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) or any other Person acting on behalf of the Company or any of its Subsidiaries has obtained(including consultants, unless otherwise exemptdistributors, all necessary resellers and any other business intermediaries) has, directly or indirectly, taken any action which would cause them to be in violation of: (i) the principles set out in the Organization for Economic Cooperation and Development Convention on Combating Bribery of Foreign Public Officials in International Business Transactions; (ii) the Foreign Corrupt Practices Act of 1977, as amended, or any rules or regulations thereunder; (iii) the UK ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇; and (iv) any other applicable approvalsanticorruption and/or anti-bribery laws, clearancesstatutes, authorizationsrules, licenses regulations, ordinances, judgments, orders, decrees, injunctions, and registrations required by United States or foreign governments or government agencies, writs of any governmental authority of any jurisdiction applicable to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities or its Subsidiaries (the "ACTIVITIES TO DATE"whether by virtue of jurisdiction or organization or conduct of business) with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"“Applicable Anticorruption Laws”); .
(Bc) Since April 1, 2015, none of the Company, any of its Subsidiaries, or any Representatives of the Company and each or any of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, soldSubsidiaries, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or other Person acting on behalf of the Company have been or any of its Subsidiaries (including consultants, distributors, resellers, and are being conducted any other business intermediaries), has, directly or indirectly, offered, paid, promised to pay, or authorized a payment, of any money or other thing of value (including any fee, gift, sample, commission payment, discount, travel expense, or entertainment) to any of the following persons for the purpose of influencing any act or decision of such person in all material respects his official capacity, inducing such person to do or omit to do any act in compliance violation of the lawful duty of such official, securing any improper advantage, or inducing such person to use his influence with a non-U.S. government or instrumentality thereof to affect or to influence any act or decision of such government or instrumentality, in order to assist the Company in obtaining or retaining business for or with, or directing the business to, any Person: (i) any person who is an agent, representative, official, officer, director, or employee of any non-U.S. Food government or any department, agency, or instrumentality thereof (including officers, directors, and Drug Administration's employees of state-owned, operated or controlled entities) or of a public international organization; (the "FDA"ii) Quality Systems regulations (21 CFR Part 820) andany person acting in an official capacity for or on behalf of any such government, to the extent applicable to the Companydepartment, counterpart regulations in the European Union and all other countries where compliance is requiredagency, instrumentality, or public international organization; (iii) all non-clinical laboratory studies of Company Products under developmentany political party or official thereof; (iv) any candidate for political or political party office (such recipients in paragraphs (i), sponsored by the Company and intended to be used to support regulatory clearance or approval(ii), have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58iii) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in this subsection (c) collectively, “Government Officials”); or (v) any other individual or entity while knowing or having reason to believe that all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause any portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to any Government Official (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law“Prohibited Payments”).
(cd) To There are no current, pending, or, to the knowledge of the Company, no filing threatened charges, proceedings, investigations, audits, or submission to complaints against the FDA Company or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenanceof its Subsidiaries or, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company, any Representative or affiliate of the Company threatened) by the FDA or any other Governmental Authority of its Subsidiaries with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductApplicable Anticorruption Laws.
Appears in 2 contracts
Sources: Merger Agreement, Merger Agreement (Integrated Device Technology Inc)
Permits; Compliance. (a) Each Except as would not individually or in the aggregate, (x) have a Material Adverse Effect or (y) prevent or materially delay the performance of this Agreement by the Company, the Company and the each of its Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals approvals, takeoff and landing authorizations (including "slots" at United States airports), clearances and orders of any Governmental Authority governmental entity necessary for each of the Company or the Subsidiaries of the Company such Subsidiary to manufactureoperate scheduled domestic air transportation, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or and to carry on its business respective businesses substantially in the manner described in the Company 10-Ks and as it is now being conducted (the "PERMITSCompany Permits").
(b) All of the Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, any of the Company Permits would neither, individually or in the aggregate, (a) have a Material Adverse Effect nor (b) prevent or materially delay the performance of this Agreement by the Company. As of the date hereof, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. , except where the failure to have, or the suspension or cancellation of, any of the Company Permits would neither, individually or in the aggregate, (x) have a Material Adverse Effect nor (y) prevent or materially delay the performance of this Agreement by the Company.
(c) Neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, or in default, breach default or violation of, (i) any Law law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedor by which any property, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States asset or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion operation of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each any of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, bound or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products affected or (ii) otherwise alleging any violation Company Permits, except for any such defaults or violations that would neither, individually or in the aggregate, (x) have a Material Adverse Effect nor (y) prevent or materially delay the performance of any Laws this Agreement by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Asa Holdings Inc), Merger Agreement (Delta Air Lines Inc /De/)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the The Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Company Permits”), except where the failure to have such Company Permits does not constitute a Company Material Adverse Effect. As of To the date hereofCompany’s knowledge, no suspension or cancellation of any of the Company Permits is pending or threatened in writing.
(b) Except (i) with respect to compliance with Environmental Laws (as to which certain representations and warranties are made pursuant to Section 4.16) and compliance with Laws related to Taxes (which are the subject of Section 4.15), and (ii) where the failure to be, or to have been, in compliance with such Laws would not, individually or in the aggregate, reasonably be expected to constitute a Company Material Adverse Effect, the Company is, and since January 1, 2020 has been, in compliance with all applicable Laws and Privacy/Data Security Laws.
(c) The Company is, and since inception, has been, in compliance with the terms of any note, bond, mortgage, indenture, or guarantee evidencing any Company Debt.
(d) Since inception, and except where the failure to be, or to have been, in compliance with such Laws would not, individually or in the aggregate, reasonably be expected to constitute a Company Material Adverse Effect, (i) there has been no action taken by the Company or, to the knowledge of the Company, threatened. Neither any officer, director, manager, employee, agent or representative of any the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or acting on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's violation of any applicable Anti-Corruption Law or International Trade Law, (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (ivii) the Company and each has not been convicted of its Subsidiaries are in compliance in all material respects with all violating any Anti-Corruption Laws or International Trade Laws or subjected to any investigation by a Governmental Authority for violation of any applicable reporting requirements -19- for all Company Licenses Anti-Corruption Laws or plant registrations described in clause (i) aboveInternational Trade Laws, includingnor, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To to the knowledge of the Company, no filing has any investigation been threatened or submission pending, (iii) the Company has not conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to the FDA or any other Governmental Authority regarding any alleged act or omission arising under or relating to any noncompliance with regard to any Anti-Corruption Law or International Trade Law, (iv) the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice notice, inquiry or other written communication citation from the FDA or any other a Governmental Authority for any actual or potential noncompliance with any applicable Anti-Corruption Law or International Trade Law, nor has any such notice, inquiry or citation been threatened or is pending and (iv) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any has instituted and maintained policies and procedures reasonably designed to ensure compliance with Anti-Corruption Laws by the Company.
(f) There have been no recallsand International Trade Laws. No officer, field notifications or seizures ordered or adverse regulatory actions taken (or director, manager or, to the knowledge of the Company threatened) by the FDA Company, employee, agent or any other Governmental Authority with respect to any member of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has is a foreign official within the last three years, either voluntarily or at meaning of the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductFCPA.
Appears in 2 contracts
Sources: Merger Agreement (Parsec Capital Acquisitions Corp.), Merger Agreement (Alset Capital Acquisition Corp.)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the The Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any United States Governmental Authority and, to the knowledge of the Company, any foreign Governmental Authority, necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted and substantially as described in the Company’s SEC Reports filed prior to the date hereof (the "PERMITS"“Permits”), and all such Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Permits would not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Registration Rights Agreement to which it is a party or (C) have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened. Neither , except where the Company nor failure to have, or the suspension or cancellation of, any Subsidiary of the Permits would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company is not in conflict with, or in default, breach or violation of, (i) any domestic United States Law or, to the knowledge of the Company, any foreign Law, applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or the Registration Rights Agreement or (C) have a Material Adverse Effect.
(i) With respect to . Since the products enactment of the Company and its Subsidiaries andSOX, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries officers and directors have been and are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (CA) the Company applicable provisions of SOX and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; the related rules and regulations promulgated thereunder and under the Exchange Act and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (ivB) the Company applicable listing and each corporate governance rules and regulations of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable LawNasdaq.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Securities Purchase Agreement (Ascent Solar Technologies, Inc.), Securities Purchase Agreement (Norsk Hydro a S A)
Permits; Compliance. (a) Each Except as set forth in Section 4.06(a) of the Company and the Subsidiaries of Disclosure Schedule, the Company is and each of its Subsidiaries are in possession of all registrationsCompany Permits, franchisesexcept where the failure to possess, grantsor the suspension or cancellation of, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Permits would not have a Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS")Material Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the Company, threatened, except where the failure to possess, or the suspension or cancellation of, any of the Company Permits would not have a Company Material Adverse Effect. Neither the Company nor any Subsidiary of the Company its Subsidiaries is or has been in conflict with, or in default, breach or violation of, (i) any Law or Company Permit applicable to the Company or any Subsidiary of the Company its Subsidiaries or by which any property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Company Material Adverse Effect. Without limiting the generality of the foregoing, all permits and licenses by, or approvals, filings and registrations with, the PRC Governmental Authorities required to be obtained or made in respect of the PRC Subsidiaries and their operations, have been duly obtained or completed in accordance with applicable Laws, except as otherwise would not have a Company Material Adverse Effect.
(b) Notwithstanding the foregoing, this Section 4.06 shall not be deemed to relate to (i) With respect the Company’s reporting obligations under the Securities Act, the Exchange Act, and the rules and regulations promulgated thereunder, (ii) labor, employment and employee benefits matters, (iii) Laws relating to Intellectual Property rights or (iv) Taxes, each of which are the products subject exclusively of the representations and warranties in Section 4.07, Section 4.10, Section 4.12 and Section 4.13, respectively.
(c) Except as set forth in Section 4.06(c) of the Company Disclosure Schedule, each of the Company and its Subsidiaries andis, and since December 31, 2010, has been, in compliance with all Laws applicable to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required or by United States which any property or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion asset of the Company Products or any of its Subsidiaries is bound, except for any non-compliance that would not have a Company Material Adverse Effect. Except as set forth in jurisdictions where Section 4.06(c) of the Company currently conducts such activities (Disclosure Schedule, as of the "ACTIVITIES TO DATE") date of this Agreement, no investigation, charge, assertion or review by any Governmental Authority with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which or any Subsidiary is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) andpending or, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge Knowledge of the Company, no filing threatened, nor has any Governmental Authority alleged any violation of any such Laws or submission to initiated any such investigation or review of the FDA Company or any other Governmental Authority with regard to the of its Subsidiaries, except, in each case, as would not have a Company Products that is the basis for any approval or clearance contains any material omission or materially false informationMaterial Adverse Effect.
(d) The Company is Except as set forth in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Company Disclosure Schedule sets forth and except as would not have a list of all applicable adverse event reports related Company Material Adverse Effect, (i) to the Company’s Knowledge, each holder or beneficial owner of Shares and/or Company ProductsShare Awards (other than the Rollover Shareholders that are reporting persons on the Schedule 13D Amendment No.1 with respect to Pactera Technology International Ltd. filed by Mr. ▇▇▇▇▇ ▇▇▇▇ and others on September 12, 2013) who is a “domestic resident” (as set forth in SAFE Circular 75) and subject to any of the registration or reporting requirements of SAFE Circular 75 or any other applicable SAFE rules and regulations directly relating to SAFE Circular 75 (collectively and including any Medical Device Reports successor PRC Law, the “SAFE Circular 75 Rules and Regulations”) has complied with such reporting and/or registration requirements under the SAFE Circular 75 Rules and Regulations with respect to such holder’s investment in the Company, (as defined in 21 CFR 803). Set forth on Section 4.06(dii) none of the Disclosure Schedule are complaint review Company, its Subsidiaries and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company any such holder has not received any written notice or other written communication from the FDA inquiries, notifications, orders or any other Governmental Authority (i) contesting the pre-market clearance forms of correspondence from SAFE or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority its local branches with respect to any actual or alleged non-compliance with the SAFE Circular 75 Rules and Regulations, and (iii) each of the Company ProductsCompany, including its relevant Subsidiaries and such holder has made all written filings, registrations, reportings or any facilities where any such Company Products are produced, processed, packaged or stored other communications required by SAFE Circular 75 Rules and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductRegulations.
Appears in 2 contracts
Sources: Merger Agreement (Chen Chris Shuning), Merger Agreement (Pactera Technology International Ltd.)
Permits; Compliance. (a) Each of the Company and the its Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the its Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSPermits"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not prevent or materially delay consummation of the Merger and would not have a Company Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not prevent or materially delay consummation of the Merger and would not have a Company Material Adverse Effect. Neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any Subsidiary of the Company its Subsidiaries or by which any property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company its Subsidiaries is a party or by which the Company or any Subsidiary of the Company its Subsidiaries or any property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound, except for any such conflicts, defaults, breaches or violations that would not prevent or materially delay consummation of the Merger and would not have a Company Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Osi Pharmaceuticals Inc), Merger Agreement (Cell Pathways Inc /De)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals approvals, clearances and orders of any Governmental Authority Entity necessary for each of the Company or the Subsidiaries of the any Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business their respective businesses substantially in the manner described in the Company SEC Filings (as defined herein) filed prior to the date hereof and as it is now being conducted (the "PERMITSCompany Permits"). As , and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, any of the date hereofCompany Permits would neither, individually or in the aggregate, (a) have a Company Material Adverse Effect nor (b) prevent or materially delay the performance of this Agreement by the Company, and, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits would neither, individually or in the aggregate, (x) have a Company Material Adverse Effect nor (y) prevent or materially delay the performance of this Agreement by the Company. Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach default or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property property, asset or asset operation of the Company or any Company Subsidiary of the Company is bound or affected, affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not have a Material Adverse Effect.
(i) With respect to neither, individually or in the products of the Company and its Subsidiaries andaggregate, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the have a Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); Material Adverse Effect nor (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission prevent or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to delay the maintenance, compilation and filing performance of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws this Agreement by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Wausau Paper Mills Co), Merger Agreement (Mosinee Paper Corp)
Permits; Compliance. (ai) Each of the The Company and the each of its Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptionsexemptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or and to carry on its business as it is now being conducted (the "PERMITS"collectively, “Permits”). As of the date hereof, and there is no suspension or cancellation of any of the Permits is Action pending or, to the knowledge of the Company, threatenedthreatened regarding suspension or cancellation of any of the Permits. Neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, or in default, breach default or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that which, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect.
(iii) With respect Except as set forth on Schedule 3(n), since December 31, 2006, no event has occurred or, to the products knowledge of the Company, circumstance exists that (with or without notice or lapse of time): (a) would reasonably be expected to constitute or result in a violation by the Company or any of its Subsidiaries, or a failure on the part of the Company and or its Subsidiaries andto comply with, any Legal Requirement; or (b) would reasonably be expected to give rise to any obligation on the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) part of the Company or any of its Subsidiaries has obtainedto undertake, unless otherwise exempt, or to bear all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion any portion of the Company Products cost of, any remedial action of any nature in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") connection with respect a failure to each Company Productcomply with any Legal Requirement, except in either case that would not reasonably be expected to have a Material Adverse Effect. Except as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 20023(n), including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within received any notice or other communication from any regulatory authority or any other person, nor does the last three yearsCompany have any knowledge regarding: (x) any actual, either voluntarily alleged, possible or at potential violation of, or failure to comply with, any Legal Requirement, or (y) any actual, alleged, possible or potential obligation on the request part of the Company or any of its Subsidiaries to undertake, or to bear all or any portion of the cost of, any remedial action of any Governmental Authoritynature in connection with a failure to comply with any Legal Requirement, initiated or participated except in either case that would not reasonably be expected to have a Material Adverse Effect.
(iii) The Company is in compliance in all material respects with the provisions of the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act of 2002 and the rules and regulations promulgated thereunder that are applicable to it and has taken reasonable steps such that the Company expects to be in a recall position to comply with the requirements of any Section 404 of the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act of 2002 and the rules and regulations promulgated thereunder at such time as Section 404 becomes applicable to the Company.
(iv) The Company Product is, and has reason to believe that for the foreseeable future it will continue to be, in compliance with all applicable rules of the Nasdaq Stock Market. The Company has not received notice from Nasdaq that the Company is not in compliance with the rules or provided post-requirements thereof. The issuance and sale warnings regarding any Company Productof the Securities under this Agreement does not contravene the rules and regulations of the Nasdaq Stock Market.
Appears in 2 contracts
Sources: Standby Purchase Agreement (Patrick Industries Inc), Standby Purchase Agreement (Patrick Industries Inc)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, certifications, approvals and orders of any Governmental Authority of competent jurisdiction, including with respect to any Environmental Laws, necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofPermits, no individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, and there have occurred no defaults under, violations of, or events giving rise to a right of termination, amendment or cancellation of any such Permits (with or without notice, the lapse of time or both), except where the failure to have, or the suspension or cancellation of any of the Permits, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect. Neither the Company nor any Company Subsidiary of is, and neither the Company is nor any Company Subsidiary during the past three (3) years has been, in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise Company Material Contract or other instrument or obligation material Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that that, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect.
(i) With respect to . Neither the products Company nor any of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion received any written notice from any Governmental Authority of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are competent jurisdiction alleging that it is not in compliance in all material respects with any Law. Notwithstanding the foregoing, for all terms and conditions purposes of each the Agreement, the Company License and with all does not make any representation or warranty (pursuant to this Section 4.6 or elsewhere in the Agreement) regarding the effect of the applicable Law pertaining antitrust, merger control, competition, or fair trade laws on its ability to execute, deliver, or perform its obligations under the Activities Agreement or to Date consummate the transactions described in this Agreement as a result of the enactment, promulgation, application, or threatened or actual judicial or administrative investigation or litigation under, or enforcement of, any antitrust, merger control, competition, or fair trade law with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf consummation of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations transactions described in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable LawAgreement.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Peregrine Semiconductor Corp), Merger Agreement (Peregrine Semiconductor Corp)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, certifications, approvals and orders of any Governmental Authority of competent jurisdiction, including with respect to any Environmental Laws, necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofPermits, no individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Offer or the Merger or (y) have a Material Adverse Effect. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, and there have occurred no defaults under, violations of, or events giving rise to a right of termination, amendment or cancellation of any such Permits (with or without notice, the lapse of time or both), except where the failure to have, or the suspension or cancellation of any of the Permits, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Offer or the Merger or (y) have a Material Adverse Effect. Neither the Company nor any Company Subsidiary of is, and neither the Company is nor any Company Subsidiary since January 1, 2011 has been, in conflict with, or in default, breach or violation of, (i) any Law or Military Specification applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise Company Material Contract or other instrument or obligation material Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that that, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Offer or the Merger or (y) have a Material Adverse Effect.
(i) With respect to . Neither the products Company nor any of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion received any written notice from any Governmental Authority of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are competent jurisdiction alleging that it is not in compliance in all material respects with all terms and conditions of each Company License and with all applicable any Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable LawMilitary Specification.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Vitesse Semiconductor Corp), Merger Agreement (Microsemi Corp)
Permits; Compliance. (a) Each Except as set forth in Section 4.06 of the Disclosure Schedule, each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSPermits"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not prevent or materially delay consummation of the Offer or the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not, have a Material Adverse Effect. As Except as set forth in Section 4.06 of the Disclosure Schedule, as of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not prevent or materially delay consummation of the Offer or the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not have a Material Adverse Effect. Neither Except as set forth in Section 4.06 of the Disclosure Schedule, neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not prevent or materially delay consummation of the Offer or the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Ericsson MPD Acquisition Corp), Merger Agreement (Microwave Power Devices Inc)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals approvals, clearances and orders of any Governmental Authority Entity necessary for each of the Company or the Subsidiaries of the any Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business their respective businesses substantially in the manner described in the Company SEC Filings (as defined herein) and as it is now being conducted (the "PERMITSCompany Permits"). As , and all such Company Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, any of the Company Permits would neither, individually or in the aggregate, (a) have a Company Material Adverse Effect nor (b) prevent or materially delay the performance of this Agreement by the Company, and, as of the date hereofof this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Company Permits would neither, individually or in the aggregate, (x) have a Company Material Adverse Effect nor (y) prevent or materially delay the performance of this Agreement by the Company. Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach default or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property property, asset or asset operation of the Company or any Company Subsidiary of the Company is bound or affected, affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not have a Material Adverse Effect.
(i) With respect to neither, individually or in the products of the Company and its Subsidiaries andaggregate, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the have a Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); Material Adverse Effect nor (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission prevent or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to delay the maintenance, compilation and filing performance of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws this Agreement by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (James River Corp of Virginia), Merger Agreement (Fort Howard Corp)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company its Subsidiary is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company its Subsidiary to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b6.06(b)), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"). As , except where the failure to have, or the suspension or cancellation of, any of the date hereof, no Company Permits would not prevent or materially delay consummation of the Transactions or otherwise prevent or materially delay the Company from performing its obligations under this Agreement or would not have a Company Material Adverse Effect. No suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any its Subsidiary of the Company is in conflict with, or in default, breach or violation of, in any material respect, (i) any Law applicable to the Company or any its Subsidiary of the Company or by which any property or asset of the Company or any its Subsidiary of the Company is bound or affected, affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Company Permit, franchise or other instrument or obligation to which the Company or any its Subsidiary of the Company is a party or by which the Company or any its Subsidiary of the Company or any property or asset of the Company or any its Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries Subsidiary and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTSCompany Products") ), (A) the Company or any of its Subsidiaries Subsidiary has obtained, unless otherwise exempt, all necessary and applicable approvalsapprovals for the operation of its business as currently conducted, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATEActivities to Date") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSESCompany Licenses"); (B) the Company and each of its Subsidiaries Subsidiary are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries Subsidiary are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, sold or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations relating to a Company Product performed by or and, with respect to manufacturing operations relating to a Company Product performed on behalf of the Company have been and are being conducted in all material respects in compliance with applicable current good manufacturing practices and regulations issued by the U.S. Food and Drug Administration's Administration (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Companyapplicable, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical and clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's current good Laboratory Practice for Non-Clinical Studies laboratory practice regulations (21 CFR Part 58) of Governmental Authorities in the United States and, to the extent applicable to the Companyapplicable, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries Subsidiary are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, including applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Laws of Governmental Agency Laws Agencies applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d6.06(d) of the Company Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Transaction Agreement (Rubicon Medical Corp), Transaction Agreement (Rubicon Medical Corp)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the The Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any United States Governmental Authority and, to the knowledge of the Company, any foreign Governmental Authority, necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted and substantially as described in the Company’s SEC Reports filed prior to the date hereof (the "PERMITS"“Permits”), and all such Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Permits would not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement to which it is a party or (C) have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened. Neither , except where the Company nor failure to have, or the suspension or cancellation of, any Subsidiary of the Permits would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. The Company is not in conflict with, or in default, breach or violation of, (i) any domestic United States Law or, to the knowledge of the Company, any foreign Law, applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement to which it is a party or (C) have a Material Adverse Effect.
(i) With respect to . Since the products enactment of the Company and its Subsidiaries andSOX, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries officers and directors have been and are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (CA) the Company applicable provisions of SOX and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; the related rules and regulations promulgated thereunder and under the Exchange Act and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (ivB) the Company applicable listing and each corporate governance rules and regulations of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in Nasdaq and the United States and outside of the United States under applicable LawBSE.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Securities Purchase Agreement (Ascent Solar Technologies, Inc.), Securities Purchase Agreement (Norsk Hydro a S A)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS")“Permits”) except where the failure to obtain such Permits would not, individually or in the aggregate, prevent or materially delay consummation of the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement, or would not, individually or in the aggregate, have a Material Adverse Effect. As of the date hereofof this Agreement, no suspension or cancellation of any of the material Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) of any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, except where such conflict, default, breach or (ii) violation of any noteLaw would not, bondindividually or in the aggregate, mortgage, indenture, contract, agreement, lease, license, Permit, franchise prevent or other instrument materially delay consummation of the Merger or obligation to which otherwise prevent or materially delay the Company from performing its obligations under this Agreement, or would not, individually or in the aggregate, have a Material Adverse Effect. Neither the Company nor any Subsidiary holds or is required to hold any security clearance issued by a Governmental Authority or is required to be a party to any special security arrangement with a Governmental Authority to conduct any portion of its business, except where such failure to hold any security clearance or be a party to any special security arrangement would not, individually or in the aggregate, prevent or materially delay consummation of the Company is a party Merger or by which otherwise prevent or materially delay the Company from performing its obligations under this Agreement, or any Subsidiary of would not, individually or in the Company or any property or asset of the Company or any Subsidiary of the Company is boundaggregate, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 2 contracts
Sources: Merger Agreement (Navteq Corp), Merger Agreement (Nokia Corp)
Permits; Compliance. (a) Each of the Company and the its Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the its Subsidiaries of the Company to manufacture, market, sell, sell or distribute the Company Earn Out Products (as defined in Section 4.06(b)that are manufactured, other than products under development) marketed, sold or distributed, or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"). As , except where the failure to have, or the suspension or cancellation of, any of the date hereof, no Company Permits would not have a Material Adverse Effect. No suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither Except as would not have a Material Adverse Effect, neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, or in default, breach or violation of, of (i) any Law (other than Laws related to the representations and warranties in Section 3.06(h), 3.14 or Section 3.18, which are solely the subject of such representations and warranties) applicable to the Company or any Subsidiary of the Company its Subsidiaries or by which any property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound or affected, affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation Company Permit to which the Company or any Subsidiary of the Company its Subsidiaries is a party or by which the Company or any Subsidiary of the Company its Subsidiaries or any property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(b) (i) With respect to the products of Earn Out Products, (A) the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has have obtained, unless otherwise exempt, all necessary and applicable approvalsmaterial approvals for the operation of its business as currently conducted, and all material clearances, authorizations, licenses and registrations required by United States or foreign governments or government agenciesany Governmental Authority, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Earn Out Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Earn Out Product, in each case to the extent necessary and applicable to the Company's business as appropriate for the current stage of development or commercialization of each such Company Product currently conducted (collectively, the "COMPANY LICENSESCompany Licenses"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law (other than Laws related to the representations and warranties in Section 3.06(h), 3.14 or Section 3.18, which are solely the subject of such representations and warranties) pertaining to the Activities to Date design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Earn Out Products with respect to each Company Earn Out Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company an Earn Out Product is manufactured, labeled, sold, sold or distributed; and (D) to the extent any Company Earn Out Product has been exported from the United States, the Company has exported such Company Earn Out Product in compliance in all material respects with applicable Law; (ii) with respect to all manufacturing operations relating to an Earn Out Product performed by or by, and on behalf of of, the Company Company, such manufacturing operations have been and are being conducted in all material respects in compliance with applicable current good manufacturing practices and regulations issued by the U.S. Food and Drug Administration's Administration (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Companyapplicable, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical and clinical laboratory studies of Company Earn Out Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted (A) to the extent applicable, in compliance in all material respects with the FDA's current good Laboratory Practice for Non-Clinical Studies laboratory practice regulations (21 CFR Part 58) of Governmental Authorities in the United States and, and (B) to the extent applicable to the Companyapplicable, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, including applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Earn Out Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Laws of any Governmental Agency Laws Authority applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Earn Out Products. Section 4.06(d) of The Company has filed with the Disclosure Schedule sets forth a list of applicable Governmental Authority all applicable adverse event reports related to the Company Earn Out Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Earn Out Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have None of the Company, any Subsidiary of the Company, Alfred E. Mann, Jeffrey Greiner or Jeffrey Goldberg, or, to the knowl▇▇▇▇ ▇▇ ▇▇▇ ▇▇mp▇▇▇, ▇▇▇ ▇▇▇▇▇ dire▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ of the Company or any Subsidiary of the Company (i) has been no recallsconvicted of, field notifications or seizures ordered or adverse regulatory actions taken (or charged with or, to the knowledge of the Company threatenedCompany, investigated for a Medicare, Medicaid or state health program-related offense, (ii) by since January 1, 2003, has been convicted of, charged with or, to the FDA knowledge of the Company, investigated for a violation of Law related to fraud, theft, embezzlement, financial misconduct or obstruction of an investigation, (iii) has been excluded or suspended from participation in Medicare, Medicaid or any other federal or state health program, or (iv) since January 1, 2003, has been subject to any order or any criminal or civil fine or penalty imposed by any Governmental Authority with respect to any such Medicare, Medicaid or any other federal or state health care program.
(g) The Company has not received any notices, citations or decisions by any Governmental Authority that the Company or any Subsidiary fails to meet any applicable standards promulgated by such Governmental Authority for which a plan of correction has not been accepted.
(h) To the knowledge of the Company, (i) none of the Company Productsor any Subsidiary has engaged in any activities that violate in any material respect Medicare and Medicaid statutes, including 42 U.S.C. Sections 1320a-7a and 7b, or the regulations promulgated pursuant to such statutes, or comparable state or local Law or applicable codes; (ii) there is no arrangement providing for any facilities where rebates, kickbacks or other forms of compensation to be paid to any person or entity in return for the referral of business or for the arrangement for recommendation of such Company Products are produced, processed, packaged or stored referrals that is unlawful in any material respect; and neither (iii) none of the Company nor or any Subsidiary has any financial arrangement which render any of its Subsidiaries has within the last three years, either voluntarily or at the request of billings unlawful pursuant to any Governmental Authority, initiated or participated Law in a recall of any Company Product or provided post-sale warnings regarding any Company Productmaterial respect.
Appears in 1 contract
Permits; Compliance. (a) Each Except as set forth in Section 4.13 (Real Property), Section 4.14 (Intellectual Property) and Section 4.16 (Environmental Matters), Section 4.06 of the Company Disclosure Schedule contains a complete and the Subsidiaries of the Company is in possession accurate list of all registrations, material franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSPermits"). As Each of the date hereof, no Company and the Subsidiaries is in possession of all Permits. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Subsidiary of the Company is is, in any material respect, in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, including, without limitation, with respect to design, labeling, testing and inspection of the Company's or any Subsidiaries' products, and any Law of the United States Food and Drug Administration, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary is bound.
(b) Except as set forth in Section 4.06 of the Company is bound, Disclosure Schedule and except for any such conflicts, defaults, breaches or violations that matters which would not have a Material Adverse Effect.
, (i) With respect to the products of the Company and its Subsidiaries andhas not received, to the extent applicableat any time since January 1, products under development (collectively1999, the "COMPANY PRODUCTS") any formal notice or other formal communication from any Governmental Authority or any other person regarding (A) the Company any actual, alleged, possible, or potential violation of or failure to comply with any term or requirement of its Subsidiaries has obtainedany Permit, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registrationany actual, licenseproposed, certification for each site at which a Company Product is manufactured, labeled, soldpossible, or distributed; potential revocation, withdrawal, suspension, cancellation, termination of, or modification to any Permit, and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company applications required to have been and are being conducted in all material respects in compliance filed for the renewal of any Permit have been duly filed on a timely basis with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) andappropriate Governmental Authority, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended filings required to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority made with respect to any of such Permit have been duly made on a timely basis with the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any appropriate Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Intermagnetics General Corp)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, certifications, approvals and orders of any Governmental Authority of competent jurisdiction, including with respect to any Environmental Laws, necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofPermits, no individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Share Purchase or any other Transactions or (y) be material to the Company and the Company Subsidiaries taken as a whole. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened. Neither , and there have occurred no defaults under, or events giving rise to a right of termination, amendment or cancellation of any such Permits (with or without notice, the lapse of time or both), except where the failure to have, or the suspension or cancellation of any of the Permits, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Share Purchase or any other Transactions or (y) be material to the Company nor any Subsidiary of and the Company is Subsidiaries taken as a whole. The Company and all Company Subsidiaries are, and have been since January 1, 2015, in conflict with, or in default, breach or violation of, (i) any material compliance with all Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that that, individually or in the aggregate, would not have a Material Adverse Effect.
reasonably be expected to (ix) With respect prevent or delay beyond the Outside Date the consummation of the Share Purchase or any other Transactions or (y) be material to the products Company and the Company Subsidiaries taken as a whole. As of the date of this Agreement, neither the Company nor any of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion received any written notice from any Governmental Authority of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are competent jurisdiction alleging that it is not in compliance in all material respects with all terms and conditions any Law, except where such non-compliance, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of each Company License and with all applicable Law pertaining the Share Purchase or any other Transactions or (y) be material to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Lawtaken as a whole.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Share Purchase Agreement (Synchronoss Technologies Inc)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties and assets or to carry on its business as it is now being conducted as described in the Company's SEC Reports filed prior to the date hereof (the "PERMITSPermits"), and all such Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Permits would not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement or (C) have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement or (C) have a Material Adverse Effect.
(ib) With respect to Since the products enactment of the Company and its Subsidiaries and, to the extent applicable, products under development ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act of 2002 (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSESSOX"); (B) , the Company and each of its Subsidiaries officers and directors have been and are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (CA) the Company applicable provisions of SOX and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; the related rules and regulations promulgated thereunder and under the Exchange Act and (DB) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf listing and corporate governance rules and regulations of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable LawExchange.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the The Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Company Permits”), except where the failure to have such Company Permits does not constitute a Company Material Adverse Effect. As of To the date hereofCompany’s knowledge, no suspension or cancellation of any of the Company Permits is pending or threatened in writing.
(b) Except (i) with respect to compliance with Environmental Laws (as to which certain representations and warranties are made pursuant to Section 4.16) and compliance with Laws related to Taxes (which are the subject of Section 4.15), and (ii) where the failure to be, or to have been, in compliance with such Laws would not, individually or in the aggregate, reasonably be expected to constitute a Company Material Adverse Effect, the Company is, and since December 31, 2018, has been, in compliance with all applicable Laws and Privacy/Data Security Laws.
(c) The Company is, and since inception, has been, in compliance with the terms of any note, bond, mortgage, indenture, or guarantee evidencing any Company Debt.
(d) Since inception, and except where the failure to be, or to have been, in compliance with such Laws would not, individually or in the aggregate, reasonably be expected to constitute a Company Material Adverse Effect, (i) there has been no action taken by the Company or, to the knowledge of the Company, threatened. Neither any officer, director, manager, employee, agent or representative of any the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or acting on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's violation of any applicable Anti-Corruption Law or International Trade Law, (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (ivii) the Company and each has not been convicted of its Subsidiaries are in compliance in all material respects with all violating any Anti-Corruption Laws or International Trade Laws or subjected to any investigation by a Governmental Authority for violation of any applicable reporting requirements -19- for all Company Licenses Anti-Corruption Laws or plant registrations described in clause (i) aboveInternational Trade Laws, includingnor, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To to the knowledge of the Company, no filing has any investigation been threatened or submission pending, (iii) the Company has not conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to the FDA or any other Governmental Authority regarding any alleged act or omission arising under or relating to any noncompliance with regard to any Anti-Corruption Law or International Trade Law, (iv) the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice notice, inquiry or other written communication citation from the FDA or any other a Governmental Authority for any actual or potential noncompliance with any applicable Anti-Corruption Law or International Trade Law, nor has any such notice, inquiry or citation been threatened or is pending and (iv) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any has instituted and maintained policies and procedures reasonably designed to ensure compliance with Anti-Corruption Laws by the Company.
(f) There have been no recallsand International Trade Laws. No officer, field notifications or seizures ordered or adverse regulatory actions taken (or director, manager or, to the knowledge of the Company threatened) by the FDA Company, employee, agent or any other Governmental Authority with respect to any member of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has is a foreign official within the last three years, either voluntarily or at meaning of the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductFCPA.
Appears in 1 contract
Sources: Merger Agreement (American Acquisition Opportunity Inc.)
Permits; Compliance. (a) Each of the The Company and the Subsidiaries of the Company is are in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority or pursuant to any Maritime Guideline necessary for each of the Company or the Subsidiaries of the Company any Subsidiary to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease own operate and operate use its properties Owned Vessels or to carry on its business as it is now being conducted (the "PERMITS"“Permits”), except where the failure to have any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect and to the Knowledge of the Company the owners of the Chartered Vessels are in possession of all Permits. As Except as disclosed in Schedule 3.11: (i) the Company and the Subsidiaries are in compliance with such Permits, except where the failure to be in compliance would not, individually or in the aggregate, have a Material Adverse Effect; (ii) as of the date hereofof this Agreement, no suspension or cancellation of any of the Permits is pending or, to the knowledge Knowledge of the Company, threatened. Neither , except where the suspension or cancellation of any of the Permits would not, individually or in the aggregate, have a Material Adverse Effect; (iii) neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Company Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset (including any Vessel) of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not not, individually or in the aggregate, have a Material Adverse Effect.
(i) With respect to the products of . Except as otherwise disclosed in Schedule 3.11, the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms conducting and conditions of each Company License and with all applicable Law pertaining to have conducted during the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; last three (C3) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects years their respective businesses in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) andall Laws, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries except where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but a violation thereof would not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated result in a recall of any Company Product or provided post-sale warnings regarding any Company ProductMaterial Adverse Effect.
Appears in 1 contract
Sources: Stock Purchase Agreement (International Shipping Enterprises, Inc.)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders (including licenses, accreditation and other similar documentation or approvals of any local health departments) of any Governmental Authority (including the United States Food and Drug Administration (“FDA”)), necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted and substantially as described in the Company’s SEC Reports filed prior to the date hereof (the "PERMITS"“Permits”). As , and all such Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the date hereofPermits would not, no individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement or (C) have a Material Adverse Effect. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company (including all applicable FDA rules and regulations, guidelines and policies) or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any notePermits, bondexcept, mortgagein each case, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches defaults or violations that would not not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement or (C) have a Material Adverse Effect. Since the enactment of SOX, the Company and each of its officers and directors have been and are in compliance in all material respects with (A) the applicable provisions of SOX and the related rules and regulations promulgated thereunder and under the Exchange Act and (B) the applicable listing and corporate governance rules and regulations of the Nasdaq Stock Market.
(ib) With respect to the products of All clinical trials conducted by the Company and or any of its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) or in which the Company or any of its Subsidiaries has obtainedparticipated that are described in the SEC Reports, unless otherwise exemptor the results of which are referred to in the SEC Reports, all necessary if any, are the only clinical trials currently being conducted by or on behalf of the Company and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, its Subsidiaries. All pre-clinical studies and clinical testingtrials conducted, manufacture, labeling, sale, distribution and promotion of supervised or monitored by the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each any of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are have been conducted in compliance in all material respects with all applicable Laws regarding registrationfederal, licensestate, certification for each site at which a Company Product is manufacturedlocal and foreign laws, labeled, sold, or distributed; and (D) to the extent regulations and requirements of any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) abovegovernmental entity, including, but not limited to, applicable adverse event reporting requirements in the United States FDA good clinical practice and outside of the United States under applicable Law.
(c) To the knowledge of the Companygood laboratory practice requirements, no filing or submission as and to the FDA or any other Governmental Authority with regard to extent applicable. Neither the Company Products that is the basis for nor any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company its Subsidiaries has not received any written notice notices or other written communication correspondence from the FDA or any other Governmental Authority (i) contesting requiring the pre-market clearance termination, suspension or approval modification of any clinical trials conducted by, or on behalf of, the uses of Company or the labeling and promotion of any of its Subsidiaries or in which the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within participated that are described in the last three yearsSEC Reports, either voluntarily if any, or at the request results of any Governmental Authority, initiated or participated which are referred to in a recall of any Company Product or provided post-sale warnings regarding any Company Productthe SEC Reports.
Appears in 1 contract
Sources: Securities Purchase Agreement (Lexicon Pharmaceuticals, Inc./De)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is The Companies are in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptionsexemptions, consents, certificates, approvals approvals, leases, rights and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or and to carry on its the business of the Wireless Cable System as it is now being conducted (collectively, the "PERMITSCompany Permits"). As All of the date hereofCompany Permits are in full force and effect and are enforceable in accordance with their terms, except as would not have a Company Material Adverse Effect. The terms of said Company Permits are not subject to any restrictions or conditions that materially limit or would materially limit the operations of the business of the Company or any of its subsidiaries as presently conducted, other than restrictions or conditions generally applicable to Company Permits of that type. Except as set forth in Exhibit 3.11, there is no suspension action, proceeding or investigation pending or, to the Knowledge of the Company, threatened, regarding suspension, termination, revocation or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatenedCompany Permits. Neither the Company nor any Subsidiary None of the Company is in conflict with, Permits will terminate or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary lapse by reason of the transactions contemplated by this Agreement. Except as set forth on Exhibit 3.08, no application has been or is proposed to be made to amend or modify any Company Permit or by which to acquire any property or asset of additional Company Permit. The Company has no reason to believe that any Company Permit in effect on the Company or any Subsidiary of date hereof will not be renewed in the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effectordinary course.
(ib) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule Exhibit 3.08 hereto sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respectsPermits.
(ec) The None of the Companies is in material conflict with, or in default or violation of the Communications Act, FCC Rules, any Company has not received any written notice or other written communication from the FDA Permit or any other Governmental Authority (i) contesting Laws applicable to it or its business or by which their respective properties are bound or to which their respective properties are subject, and there exist no conditions or circumstances which could result in such a conflict, default or violation, except for such minor violations as do not impair or interfere with the pre-market clearance or approval of, the uses of or the labeling and promotion of any operation of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge Wireless Cable System. None of the Company threatened) by the FDA or Companies has received from any other Governmental Authority Entity any notification with respect to any possible conflicts, defaults or violations of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductLaws.
Appears in 1 contract
Sources: Agreement and Plan of Reorganization (Bellsouth Corp)
Permits; Compliance. (a) Each Except as set forth in Section 4.06 of the Company Disclosure Schedule, each of the Company and the Subsidiaries of the Company Subsidiary is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofCompany Permits would not, no individually or in the aggregate, prevent or materially delay consummation of the Merger or any of the other transactions contemplated by this Agreement or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not, individually or in the aggregate, have a Company Material Adverse Effect. The Company has not received notice that any suspension or cancellation of any of the Company Permits is pending orand, to the knowledge of the Company, no such suspension or cancellation is threatened, except for such suspension or cancellation of Company Permits that would not, individually or in the aggregate, prevent or materially delay consummation of the Merger or any of the other transactions contemplated by this Agreement or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not, individually or in the aggregate, have a Company Material Adverse Effect. Neither Except as set forth in Section 4.06 of the Company Disclosure Schedule, neither the Company nor any the Subsidiary of the Company is in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any the Subsidiary of the Company or by which any property or asset of the Company or any the Subsidiary of the Company is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Company Permit, franchise or other instrument or obligation to which the Company or any the Subsidiary of the Company is a party or by which the Company or any the Subsidiary of the Company or any property or asset of the Company or any the Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not not, individually or in the aggregate, prevent or materially delay consummation of the Merger or any of the other transactions contemplated by this Agreement or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not, individually or in the aggregate, have a Company Material Adverse Effect.
(i) With respect to the products . None of the Company and its Subsidiaries and, to the extent applicable, products under development (collectivelyCompany, the "COMPANY PRODUCTS"Subsidiary or their respective directors, officers, employees, independent contractors or agents have engaged in any activities that would lead to any material penalties of any kind against Company or the Subsidiary under Sections 1128A, 1128B or 1877 of the Social Security Act (42 U.S.C. ss.ss. 1320a-7a, 1320a-7b and 1395nn), the False Claims Act (31 U.▇.▇. ss. 3729 et seq.), the False Statements Act (18 U.S.C. ss. 1001), the Program Fraud Civil Penalties Act (31 U.S.C. ss. 3801 et seq.), the Food, Drug and Cosmetic Act (21 U.S.C. ss. 301 et. seq.) (A) all as amended or superseded), or the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary anti-fraud and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion abuse provisions of the Company Products Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. ss. 1347, 18 U.S.C. ss. 669, 18 U.S.C. ss. 1035, 18 U.S.C. ss. 1518) and the corresponding fraud and abuse, false claims and anti-self referral, manufacturing and marketing statutes and regulations in each state or other jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the CompanySubsidiary has engaged in business operations.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, certifications, approvals and orders of any Governmental Authority of competent jurisdiction, including with respect to any Environmental Laws, necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As of , except where the date hereoffailure to have, no or the suspension or cancellation of, any of the Permits, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect. No suspension or cancellation or proposed adverse modification of any of the Permits is pending or, to the knowledge of the Company, threatened and to the knowledge of the Company, there have occurred no defaults under, or events giving rise to a right of termination, amendment or cancellation of any such Permits (with or without notice, the lapse of time or both), except where the failure to have, or the suspension or cancellation of any of the Permits, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect. As of the date of this Agreement, neither the Company nor any Company Subsidiary have received or been subject to any written notice, charge, claim or assertion or, to the knowledge of the Company any oral notice, charge, claim or assertion, in each case alleging any violations of Permits, nor to the knowledge of the Company has any such notice, charge, claim or assertion been threatened. , except where such notice, charge, claim or assertion, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect.
(b) Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation material Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that that, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect. As of the date of this Agreement, neither the Company nor any of the Company Subsidiaries has received any written notice, or the knowledge of the Company, oral notice, from any Governmental Authority of competent jurisdiction alleging that it is not in compliance in all respects with any Law, except where such non-compliance, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Merger or (y) have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority ("PERMITS") necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (conducted, except where the "PERMITS")failure to have, or the suspension or cancellation of, any of the Permits would not have a Material Adverse Effect on the Company. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not have a Material Adverse Effect on the Company. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except except, with respect to clauses (a) and (b) above, for any such conflicts, defaults, breaches or violations that would not prevent or materially delay consummation of the Offer or the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement or would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or Effect on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, certifications, approvals and orders of any Governmental Authority of competent jurisdiction, including with respect to any Environmental Laws, necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofPermits, no individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Offer or the Merger or (y) have a Material Adverse Effect. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, and there have occurred no defaults under, violations of, or events giving rise to a right of termination, amendment or cancellation of any such Permits (with or without notice, the lapse of time or both), except where the failure to have, or the suspension or cancellation of any of the Permits, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Offer or the Merger or (y) have a Material Adverse Effect. Neither the Company nor any Company Subsidiary of is, and neither the Company is nor any Company Subsidiary since October 1, 2008 has been, in conflict with, or in default, breach or violation of, (i) any Law or Military Specification applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise Company Material Contract or other instrument or obligation material Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that that, individually or in the aggregate, would not reasonably be expected to (x) prevent or delay beyond the Outside Date the consummation of the Offer or the Merger or (y) have a Material Adverse Effect.
(i) With respect to . Neither the products Company nor any of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion received any written notice from any Governmental Authority of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are competent jurisdiction alleging that it is not in compliance in all material respects with all terms and conditions of each Company License and with all applicable any Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable LawMilitary Specification.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Merger Agreement (Symmetricom Inc)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, material franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, clearances, certificates, approvals and orders of any Governmental Authority necessary under applicable Law and necessary for each of the Company or the Subsidiaries of the such Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Company Permits”), except where the failure to have such Company Permits would not have or would not reasonably be expected to have a Company Material Adverse Effect. As of the date hereofEach Company Permit is in full force and effect in accordance with its terms and no suspension, no suspension revocation, cancellation, withdrawal, adverse modification or cancellation termination of any of the Company Permits is pending or has been threatened in writing or, to the knowledge of the Company, threatenedorally. Neither the Company nor any Company Subsidiary of is, nor at any time since the Reference Date has the Company is or any Company Subsidiary been, in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Material Contract or Company Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundexcept, except in each case, for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
be or would not reasonably be expected to be, individually or in the aggregate, material to the Company. Since the Reference Date, (i) With respect to the products none of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its the Company Subsidiaries has obtainedbeen subjected to, unless otherwise exemptor received any notification from, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion any Governmental Authority of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage a violation of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all any applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject or any investigation by a Governmental Authority for actual or alleged violation of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; , (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to claims have been filed against the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise Subsidiaries with any Governmental Authority alleging any violation of any Laws failure by the Company.
(f) There have been no recalls, field notifications Company or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company ProductsSubsidiaries to comply with any applicable Law, including any facilities where any such Company Products are produced, processed, packaged or stored and neither (iii) none of the Company nor any of its the Company Subsidiaries has within the last three yearsmade a voluntary, either voluntarily directed, or at the request of involuntary disclosure to any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings Authority regarding any alleged act or omission arising under or relating to any noncompliance with any applicable Law, in the case of clauses (i) through (iii), except as would not, or would not reasonably be expected to, be material to the Company Productand the Company Subsidiaries, taken as a whole.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Virgin Group Acquisition Corp. II)
Permits; Compliance. (aExcept as set forth in Section 5.02(e) Each of the Disclosure Letter, to the knowledge of the Company, each of the Company and the its Subsidiaries of the Company and each Non-JPM JV is in possession of and in compliance with all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the its Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Applicable Permits”). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofApplicable Permits, no or the failure to be in compliance with any of the Applicable Permits, would not have a Company Material Adverse Effect. No suspension or cancellation of any of the Applicable Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Applicable Permits would not have a Company Material Adverse Effect. Neither To the knowledge of the Company, neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company its Subsidiaries or by which any property of their properties or asset of the Company or any Subsidiary of the Company assets is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Applicable Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company its Subsidiaries is a party or by which the Company or any Subsidiary of the Company its Subsidiaries or any property of their properties or asset of the Company or any Subsidiary of the Company assets is bound, except for any such conflicts, defaults, breaches or violations that would not have a Company Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesorders, approvals registrations and orders clearances of any Governmental Authority necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As of , except where the date hereoffailure to hold or to comply with, no or the suspension or cancellation of of, or failure to be valid or to be in full force and effect of, any of the Permits is pending orPermits, would not reasonably be expected to have, individually or in the knowledge of the Companyaggregate, threateneda Company Material Adverse Effect. Neither the Company nor any Company Subsidiary of the Company is or, since January 1, 2019 has been, in conflict with, or in default, breach default under or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, except for any conflicts, defaults or violations as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) Since January 1, 2017, none of the Company, any of the Company Subsidiaries or, to the knowledge of the Company, any Representative of the Company or any of the Company Subsidiaries (including consultants, distributors, resellers and other business intermediaries) has, directly or indirectly, taken any action which would cause the Company or the Company Subsidiaries to be in material violation of: (i) the Foreign Corrupt Practices Act of 1977, as amended, or any rules or regulations thereunder; (ii) the UK ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇; (iii) Title 5 of the Israeli Penalty Law (Bribery Transactions) and the Israeli Prohibition on Money Laundering Law, 2000; (iv) Article 18 of the Unfair Competition Prevention Law of Japan, as amended; or (v) any other applicable anticorruption and/or anti-bribery Laws (whether by virtue of jurisdiction or organization or conduct of business) (collectively, the “Applicable Anticorruption Laws”).
(c) Since January 1, 2017, none of the Company, any of the Company Subsidiaries or, to the knowledge of the Company, any Representative of the Company or any of the Company Subsidiaries (including consultants, distributors, resellers and other business intermediaries), or any other Person acting on behalf of the Company or any of the Company Subsidiaries (including consultants, distributors, resellers, and any other business intermediaries), has, directly or indirectly, offered, paid, promised to pay, or authorized a payment, of any money or other thing of value (including any fee, gift, sample, commission payment, discount, travel expense, or entertainment) to any of the following persons for the purpose of influencing any act or decision of such person in his official capacity, inducing such person to do or omit to do any act in violation of the lawful duty of such official, securing any improper advantage, or inducing such person to use his influence with a Governmental Authority or instrumentality thereof to affect or to influence any act or decision of such Governmental Authority or instrumentality, in order to assist the Company or a Company Subsidiary in obtaining or retaining business for or with, or directing the business to, any Person: (i) any person who is an agent, representative, official, officer, director, or employee of any Governmental Authority or any department, agency, or instrumentality thereof (including officers, directors, and employees of state-owned, operated or controlled entities) or of a public international organization; (ii) any person acting in an official capacity for or on behalf of any such Governmental Authority, department, agency, instrumentality, or public international organization; (iii) any political party or official thereof; (iv) any candidate for political or political party office (such recipients in paragraphs (i), (ii), (iii) and (iv) of this subsection (c) collectively, “Government Officials”); or (v) any other individual or entity while knowing or having reason to believe that all or any portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to any Government Official.
(d) There are no current, pending, or to the knowledge of the Company, threatened Actions against the Company, any of the Company Subsidiaries or any Representative or affiliate of the Company or any of the Company Subsidiaries (in each case as it relates to the Company or the Company Subsidiaries) with respect to any Applicable Anticorruption Laws. Since January 1, 2017, neither the Company, the Company Subsidiaries nor, to the knowledge of the Company, any Representatives of the Company or any of the Company Subsidiaries (including consultants, distributors, resellers, and any other business intermediaries), has received notice of (i) any investigation by or request for information from a Governmental Authority relating to any actual or possible violation of Applicable Anticorruption Laws by the Company, any of the Company Subsidiaries or any Representatives of the Company or any of the Company Subsidiaries (including consultants, distributors, resellers, and other business intermediaries) (in each case as it relates to the Company or the Company Subsidiaries), or (ii) any noteother allegation, bondinvestigation or inquiry regarding any actual or possible violation of the Applicable Anticorruption Laws by the Company, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company Subsidiaries or any Subsidiary Representatives of the Company or any property or asset of the Company or Subsidiaries (including consultants, distributors, resellers, and any Subsidiary of other business intermediaries) (in each case as it relates to the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effectthe Company Subsidiaries).
(ie) With respect The Company has instituted and maintains internal controls, policies and procedures reasonably designed to the products of the Company and its Subsidiaries andensure compliance with Applicable Anticorruption Laws. Since January 1, to the extent applicable2017, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its the Company Subsidiaries are has kept books and records of their businesses in compliance reasonable detail that accurately and fairly reflect the transactions and assets of such businesses.
(f) Since January 1, 2017, and in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date case with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each any of its Subsidiaries are in compliance in the Company Subsidiaries, all material respects with all applicable Laws regarding registrationof their respective directors, licenseofficers, certification for each site at which a Company Product is manufacturedand, labeled, sold, or distributed; and (D) to the extent any Company Product has knowledge of the Company, employees or agents, have at all times been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable LawUnited States, Israeli, and Japanese, EU and Italian Customs and Trade Laws, as well as Customs and Trade Laws of any other jurisdiction in which the Company or Company Subsidiaries do business, including: (i) the United States Export Control Reform Act of 2018 and implementing Export Administration Regulations; (ii) all manufacturing operations performed by or on behalf of the Company have been Arms Export Control Act and are being conducted implementing International Traffic in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is requiredArms Regulations; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union Israel Defense Export Control Law – 2007 and all other countriesregulations and orders promulgated thereunder, including without limitation all orders and procedures of the Israeli Ministry of Defense, the Israeli Defense Export Controls Agency and the Israeli Ministry of the Economy, the Law Governing the Control of Commodities and Services – 1957, and the Import and Export Order (Control of Dual-Purpose Goods, Services and Technology Exports) – 2006; and (iv) the Israel Control of Products and Services Declaration (Engagement in Encryption), 1974, as amended; and (v) the Foreign Exchange and Foreign Trade Act of Japan.
(g) Neither the Company nor any of the Company Subsidiaries have(i) made any voluntary, directed or involuntary disclosure to any Governmental Authority or similar agency with respect to any alleged act or omission arising under or relating to any non-compliance with any Customs and Trade Laws, (ii) to the knowledge of the Company, been the subject of a current, pending or threatened investigation, inquiry or enforcement proceedings for violations of Customs and Trade Laws or (iii) received any notice, request, penalty or citation for any actual or potential non-compliance with Customs and Trade Laws.
(h) Since January 1, 2017, the Company and each Company Subsidiary has obtained all applicable import and export licenses and all other necessary consents, notices, waivers, approvals, orders, authorizations and declarations, and has completed all necessary registrations and filings, required under applicable Customs and Trade Laws, except as would not reasonably be expected to result in a material violation of its Customs and Trade Laws. The Company has provided the Parent with copies of all currently active export licenses that the Company and each Company Subsidiary has received, and the Company and each Company Subsidiary, as applicable, is in compliance with all such export licenses, except as would not reasonably be expected to result in a material violation of Customs and Trade Laws. The Company and the Company Subsidiaries are have not within the past five (5) years been subject to any audits by any Governmental Authority relating to Customs and Trade Laws, including audits by the Israeli Ministry of Defense, the Israeli Defense Export Controls Agency and the Israeli Ministry of the Economy.
(i) Since January 1, 2017, the Company and each Company Subsidiary has not engaged in any dealings or transactions in or with any Restricted Person in violation of applicable Customs and Trade Laws, or in violation of Sanctions, nor is the Company or any Company Subsidiary currently engaged in any such activities.
(j) The Company and each Company Subsidiary has in place written policies, controls and systems reasonably designed to maintain compliance in all material respects with all applicable reporting requirements -19- for all Customs and Trade Laws in each jurisdiction in which the Company Licenses or plant registrations described in clause and each Company Subsidiary conducts business.
(k) Since January 1, 2019, neither the Company nor any Company Subsidiary has (i) abovematerially breached or violated any Law, includingor any material certification, but not limited torepresentation, applicable adverse event reporting requirements clause, provision or requirement pertaining to any Government Contract; (ii) been audited (except in the United States ordinary course of business) or investigated by any Governmental Authority with respect to any Government Contract; (iii) conducted or initiated any internal investigation (for which the assistance of outside counsel or an accounting firm was required) or made any disclosure with respect to any alleged or potential irregularity, misstatement, omission or actual or potential violation of Law arising under or relating to a Government Contract; (iv) received any written notice of breach, cure, show cause or default that remains unresolved with respect to a Government Contract; (v) had any Government Contract terminated for cause, default or failure to perform; (vi) represented as qualifying for any small business or preferred bidder status, received any small business set-aside Government Contract, nor received any other Government Contract based in part or in whole on any preferred bidder status; or (vii) entered into any Government Contracts payable on a cost-reimbursement basis. The Company and outside each Company Subsidiary has established and maintained adequate internal controls for compliance with their respective Government Contracts. Neither the Company nor any Company Subsidiary nor any of their respective directors, officers, principals, or, to the knowledge of the United States under applicable Law.
(c) Company, any current employee, is or has been suspended or debarred, proposed for debarment or suspension, declared ineligible or determined non-responsive from holding, performing or bidding on any Government Contract, and no such proceeding regarding suspension, debarment, ineligibility or non-responsibility has been commenced or threatened. There are no material outstanding claims or disputes in connection with any of the Company’s or any Company Subsidiary’s Government Contracts. To the knowledge of the Company, there are no filing outstanding or submission to the FDA unsettled allegations of fraud, false claims or significant overpayments, nor any other investigations or audits by any Governmental Authority or Person with regard to any of the Company Products that is the basis for any approval or clearance contains any material omission or materially false informationGovernment Contracts.
(dl) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenanceSince January 1, compilation and filing of reports2017, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or each Company Subsidiary, and all of their respective directors, officers, and, to the knowledge of the Company, employees and agents, have been in compliance with applicable Sanctions; (ii) neither the Company threatenednor any Company Subsidiary has conducted, directly or indirectly, any business in any Sanctioned Jurisdiction or with any Sanctioned Person; and (iii) by neither the FDA Company nor any Company Subsidiary, nor any of their directors, officers, employees or agents is a Sanctioned Person. The Company and each Company Subsidiary has in place written policies, controls, and systems reasonably designed to maintain compliance with all applicable Sanctions. Neither the Company nor any other Company Subsidiary has within the past five (5) years (x) made any voluntary, directed or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any non-compliance with any Sanctions, (y) been the subject of a past, current, pending or, to the knowledge of the Company, threatened investigation, inquiry or enforcement proceeding for a violation of Sanctions or (z) received any notice, request, penalty, or citation for any actual or potential non-compliance with Sanctions.
(m) The Company and each Company Subsidiary and, to the knowledge of the Company, each of the employees who hold security clearances are in compliance with all applicable national security obligations, including those specified in the NISPOM, and any supplements, amendments or revised editions thereof. To the knowledge of the Company, there has been no audit or similar Action relating to the Company’s or any Company Subsidiary’s compliance with the requirements of the National Industrial Security Program that resulted in material adverse findings against the Company or any Company Subsidiary nor has the Company or any Company Subsidiary made any disclosures to applicable Governmental Authority regarding any events of non-compliance with the NISPOM.
(n) The applicable Company Subsidiary has at all times been in material compliance with all requirements and contractual obligations in connection with the Trusted Foundry Program managed by the Defense Microelectronics Activity (“DMEA”) including all material assurances and requirements related to required notices, information security, quality assurance, information protection, and all other material requirements maintained or imposed in connection with the Company Subsidiary's accreditation as a Trusted Foundry. To the knowledge of the Company Products, including any facilities where any such and Company Products Subsidiary there are produced, processed, packaged no facts or stored and neither events that would materially jeopardize the Company nor and Company Subsidiary's accreditation or otherwise restrict or prevent the Company Subsidiary from continuing to operate upon Closing as a result of the transactions contemplated in this Agreement including, but limited to, any change of its Subsidiaries has within the last three years, either voluntarily control notice or at the request of any consent by applicable Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSPermits"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTSCompany Products") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.pre-
Appears in 1 contract
Permits; Compliance. (a) Each Except as set forth in Section 4.06 of the Company Disclosure Schedule, each of the Company and the Company Subsidiaries of the Company (excluding Holdco and Merger Sub) is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (including, without limitation, as applicable, all such permits, licenses, approvals, consents and other authorizations required by the "PERMITS"Food and Drug Administration or any other federal, state, local or foreign agencies or bodies engaged in the regulation of clinical or preclinical studies, pharmaceuticals, biologics, biohazardous substances or activities related to the business now operated by the Company and its Subsidiaries) (the “Company Permits”), except where the failure to have such Company Permits would not reasonably be expected to have a Company Material Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatenedthreatened in writing. Neither Except as set forth in Section 4.06 of the Company Disclosure Schedule, neither the Company nor any Company Subsidiary of the Company (excluding Holdco and Merger Sub) is in conflict with, or in default, breach or violation of, (ia) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Company Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaultsviolations, breaches breaches, defaults or violations that other occurrences which would not have a Company Material Adverse Effect. Neither the Company nor any Company Subsidiary (excluding Holdco and Merger Sub) has received during the three (3) years preceding the date of this Agreement any written notices from any Governmental Authority alleging violation of any applicable Laws, except for any violations which would not, individually or in the aggregate, result in a Company Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Business Combination Agreement (Union Acquisition Corp. II)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company IA Group Companies is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesOrders, approvals registrations and orders clearances of any Governmental Authority Entity (each, a “Permit”) necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or IA Group Companies to own, lease and operate its properties or and assets, and to carry on and operate its business businesses as it is now being currently conducted (the "PERMITS"“IA Group Permits”), and all such IA Group Permits are in full force and effect, in each case except where the failure to have, or the failure to be in full force and effect of, any IA Group Permits would not, individually or in the aggregate, reasonably be expected to have an IA ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the IA Group Permits is pending or, to the knowledge Knowledge of IA Group, threatened and no such suspension or cancellation will result from the Internalization.
(b) Each of the CompanyIA Group Companies is in compliance with all Laws applicable to its businesses, threatenedexcept where the failure to comply with such Laws would not, individually or in the aggregate, reasonably be expected to have an IA ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Adverse Effect. Neither the Company nor No investigation by any Subsidiary Governmental Entity with respect to IA Group or any of the Company IA Group Companies is in conflict withpending, except for such investigations the outcomes of which, individually or in defaultthe aggregate, breach or violation ofwould not reasonably be expected to have an IA ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Adverse Effect. None of the IA Group Companies has, during the one-year period prior to the date hereof: (i) received any Law applicable to written notice from any Governmental Entity regarding any violation by the Company or IA Group Companies of any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, Law; or (ii) provided any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation written notice to which the Company or any Subsidiary Governmental Entity regarding any violation by any of the Company is a party IA Group Companies of any Law, which notice in either case remains outstanding or by which the Company or any Subsidiary unresolved as of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Lawdate hereof.
(c) To Neither the knowledge of the CompanyIA Group Companies nor, no filing to IA Group’s Knowledge, any trustee, director, officer or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion employee of any of the Company Products IA Group Companies, has (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity, (ii) otherwise alleging any violation unlawfully offered or provided, directly or indirectly, anything of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken value to (or to the knowledge received anything of the Company threatenedvalue from) by the FDA any foreign or domestic government employee or official or any other Governmental Authority with Person, or (iii) taken any action, directly or indirectly, that would constitute a violation in any material respect by such Persons of the Foreign Corrupt Practices Act of 1977 and the rules and regulations thereunder (the “FCPA”), including making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office, in contravention of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductFCPA.
Appears in 1 contract
Sources: Stock Purchase Agreement (Global Medical REIT Inc.)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, certifications, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"), except where the failure to have, or the suspension or cancellation of, any of the Company Permits would not prevent or materially delay consummation of the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not reasonably be expected to have a Company Material Adverse Effect. As of the date hereofof this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Company Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except in either case for any such conflicts, defaults, breaches or violations that would not prevent or materially delay the consummation of the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not reasonably be expected to have a Company Material Adverse Effect.
(ib) With respect to the products None of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedSubsidiary or any individual who is currently an executive officer, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agenciesdirector or, to permit the designknowledge of the Company, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion employee of the Company Products or any Subsidiary (i) has been convicted of, charged with or, to the knowledge of the Company, investigated for a Medicare, Medicaid or state health program-related offense, (ii) since January 1, 1999, has been convicted of, charged with or, to the knowledge of the Company, investigated for a violation of Law related to fraud, theft, embezzlement, financial misconduct or obstruction of an investigation, (iii) has been excluded or suspended from participation in jurisdictions where the Company currently conducts such activities Medicare, Medicaid or any federal or state health program, or (the "ACTIVITIES TO DATE"iv) since January 1, 1999, has been subject to any Order or any criminal or civil fine or penalty imposed by, any Governmental Authority with respect to each any such Medicare, Medicaid or any other federal or state health care program.
(c) Except as disclosed in Section 5.06(c) of the Company ProductDisclosure Schedule, since January 1, 1999, there have been no written notices, citations or decisions by any Governmental Authority that the Company or any Subsidiary fails to meet any applicable standards promulgated by such Governmental Authority for which a plan of correction has not been accepted, and the Company does not know of any such failure or facts upon which such a failure could be alleged except, in either case, as appropriate would not reasonably be expected to have a Company Material Adverse Effect. Except as set forth in Section 5.06(c) of the Company Disclosure Schedule, none of the Company or any Subsidiary has received any notice of any potential deficiency in or violation of any applicable Law or Order relating to the Company or any Subsidiary for which a plan of correction has not been accepted except as would not reasonably be expected to have a Company Material Adverse Effect. Except as disclosed in Section 5.06(c) of the current stage of development or commercialization of each such Company Product (collectivelyDisclosure Schedule, the "COMPANY LICENSES"); (B) and except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 1996, the Company and each of its the Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance have complied in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) with respect to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been services provided and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored business operated by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false informationSubsidiaries.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable has made available to Parent prior to the maintenancedate of this Agreement true and complete copies of (i) all material surveys, compilation and filing of reports, including medical device reportsnotices, with regard inquiries, subpoenas and other correspondence related to any certification, licensure or other inspections, and summaries of all proficiency test results relating to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports business of the Company and the Subsidiaries for the period from January 1, 1999 (or, in the case of a Subsidiary, from the date such entity became a Subsidiary) through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in the date hereof; (ii) all material respectswritten inquiries, notices, requests for records, subpoenas and correspondence received by the Company or any Subsidiary related to utilization, reimbursement or other audits or investigations relating to the business of the Company and the Subsidiaries for the period from January 1, 1999 (or, in the case of a Subsidiary, from the date such entity became a Subsidiary) through the date hereof; and (iii) all current licenses or certifications of the Company or any Subsidiary under the Clinical Laboratory Improvement Act of 1988 and the regulations promulgated thereunder ("CLIA").
(e) The Except as disclosed in Section 5.06(e) of the Company has Disclosure Schedule, and except as would not received any written notice or other written communication from the FDA or any other Governmental Authority reasonably be expected to have a Company Material Adverse Effect, (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any none of the Company Products nor any Subsidiary has engaged in any activities that are prohibited under or would violate Medicare and Medicaid statutes, 42 U.S.C. Sections 1320a-7a and 7b, or the regulations promulgated pursuant to such statutes, or comparable state or local Law or rules of professional conduct; (ii) otherwise alleging the Company and the Subsidiaries have timely and accurately filed in all material respects all requisite claims and other reports required to be filed in connection with all applicable state and federal Medicare and Medicaid programs due on or before the date of this Agreement; (iii) there is no arrangement providing for any violation rebates, kickbacks or other forms of compensation that is unlawful to be paid to any Laws by person or entity in return for the Companyreferral of business or for the arrangement for recommendation of such referrals; and (iv) none of the Company nor any Subsidiary has any financial arrangement which render any of its billings unlawful pursuant to the Stark Law or comparable state ▇▇▇.
(f) There have been no recallsTo the knowle▇▇▇ ▇f the Company, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge all agreements of the Company threatened) and the Subsidiaries with third-party payors were entered into by the FDA Company or a Subsidiary, as the case may be, in the ordinary course of business. The Company and the Subsidiaries are in compliance with each of their respective third-party payor agreements, and the Company and the Subsidiaries have properly charged and billed in accordance with the terms of their respective third-party payor agreements, including, where applicable, billing and collection of all deductibles and co-payments, except for any other Governmental Authority with respect such violations that would not reasonably be expected to any have a Company Material Adverse Effect.
(g) Except as disclosed in Section 5.06(g) of the Company ProductsDisclosure Schedule, including (i) no right of the Company or any facilities where Subsidiary to receive reimbursements pursuant to any such Company Products are producedgovernment program or private program has ever been terminated or suspended as a result of any investigation or action whether by any Governmental Authority or other third party, processed, packaged or stored and neither (ii) none of the Company nor any Subsidiary has since January 1, 1999 received notice from any Governmental Authority that it has been the subject of its Subsidiaries has within the last three yearsany inspection, either voluntarily investigation, survey, audit, monitoring or at the request other form of review by any Governmental Authority, initiated professional review organization, accrediting organization or participated in a recall certifying agency for the purpose of any alleged improper activity on the part of such entity, other than routine audits or inquiries and other than those which would not reasonably be expected to have a Company Product Material Adverse Effect, (iii) none of the Company nor any Subsidiary has received any written notice of deficiency from a Governmental Authority in connection with its operations for which a plan of correction has not been accepted, and (iv) none of the Company nor any Subsidiary has received any written notice of any claim, requirement or provided post-sale warnings regarding demand of any Company Productlicensing, accrediting or certifying agency to rework or redesign their operations or any part thereof.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, certifications, approvals and orders Orders of any Governmental Authority of competent jurisdiction, including with respect to any Environmental Laws, necessary for each of the Company or the Company Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofPermits, no individually or in the aggregate, would not (x) reasonably be expected to prevent or delay beyond the Outside Date the consummation of the Merger or (y) be material to the Company and the Company Subsidiaries, taken as a whole. No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, and there have occurred no defaults under, violations of, or events giving rise to a right of termination, amendment or cancellation of any such Permits (with or without notice, the lapse of time or both), except where the failure to have, or the suspension or cancellation of any of the Permits, individually or in the aggregate, would not (x) reasonably be expected to prevent or delay beyond the Outside Date the consummation of the Merger or (y) be material to the Company and the Company Subsidiaries, taken as a whole. Neither Except as, individually or in the aggregate, would not (x) reasonably be expected to prevent or delay beyond the Outside Date the consummation of the Merger or (y) be material to the Company and the Company Subsidiaries, taken as a whole, neither the Company nor any Company Subsidiary of is, and neither the Company is nor any Company Subsidiary during the past three years has been, in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any noteCompany Lease, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise Company Material Contract or other instrument or obligation material Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary is bound. Neither the Company nor any of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion received any written notice from any Governmental Authority of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are competent jurisdiction alleging that it is not in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Merger Agreement (Resonant Inc)
Permits; Compliance. (ai) Each of the Company and the Subsidiaries of the each Company Subsidiary is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesorders, approvals registrations and orders clearances of any Governmental Authority necessary for each of the Company or the Subsidiaries of the any Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As , (ii) all such Permits are in full force and effect, and (iii) as of the date hereofof this Agreement, no suspension suspension, cancellation, withdrawal or cancellation of any of the Permits revocation thereof is pending or, to the knowledge of the Company, threatened, in each case, except where the failure to possess to be valid or to be in full force and effect, or the suspension, cancellation, withdrawal, or revocation any of the Permits, would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach default under or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches defaults or violations that as would not have reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(ib) With respect In the preceding five (5) years, none of the Company, any Company Subsidiary, any of its or their directors, officers or employees, nor, to the products knowledge of the Company, any agents or other Persons, while acting for or on behalf of the Company or any Company Subsidiary (each, an “Associated Person”) taken any action in violation of (i) the Foreign Corrupt Practices Act of 1977, as amended, or any rules or regulations thereunder; (ii) Sections 291 and 291A of the Israeli Penal Law, 1977; (iii) the Israeli Prohibition on Money Laundering Law, 2000; and (iv) any other applicable anticorruption, anti-money laundering and/or anti-bribery laws, statutes, rules, regulations, ordinances, judgments, orders, decrees, injunctions, and writs of any governmental authority of any jurisdiction applicable to the Company or its Subsidiaries and, to the extent applicable, products under development (whether by virtue of jurisdiction or organization or conduct of business) (collectively, the "COMPANY PRODUCTS"“Applicable Anticorruption Laws”). None of the Company, any Company Subsidiary, or any of their respective directors, officers, or employees in their capacity as such are or have in the past five (5) years been the subject of any allegation, voluntary disclosure, investigation, prosecution, or other enforcement action related to the Applicable Anticorruption Laws. The Company and each Company Subsidiary maintains the written policies and procedures listed on Section 3.6(b) of the Company Disclosure Letter, which are designed to ensure compliance with the Applicable Anticorruption Laws.
(Ac) Since January 1, 2016, none of the Company, any Company Subsidiary, any of its or their directors, officers, or employees, nor, to the knowledge of the Company, any Associated Person acting for or on behalf of the Company or any Company Subsidiary has, directly or indirectly, offered, paid, promised to pay, or authorized a payment, of its any money or other thing of value (including any fee, gift, sample, commission payment, discount, travel expense, or entertainment) to any of the following persons for the purpose of influencing any act or decision of such person in his official capacity, inducing such person to do or omit to do any act in violation of the lawful duty of such official, securing any improper advantage, or inducing such person to use his influence with any Governmental Authority or instrumentality thereof to affect or to influence any act or decision of such government or instrumentality, in order to assist the Company in obtaining or retaining business for or with, or directing the business to, any Person: (i) any person who is an agent, representative, official, officer, director, or employee of any Governmental Authority or any department, agency, or instrumentality thereof (including officers, directors, and employees of state-owned, operated or controlled entities) or of a public international organization; (ii) any person acting in an official capacity for or on behalf of any such Governmental Authority, department, agency, instrumentality, or public international organization; (iii) any political party or official thereof; (iv) any candidate for political or political party office (such recipients in paragraphs (i), (ii), (iii) and (iv) of this subsection (c) collectively, “Government Officials”); or (v) any other individual or entity while knowing or having reason to believe that all or any portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to any Government Official or the immediate family member of a Government Official or any individual whose benefit is in the interests of a Government Official.
(d) Since January 1, 2016, the Company and all Company Subsidiaries has obtainedhave complied in all applicable export and re-export controls and sanctions laws and regulations, unless otherwise exemptincluding the Export Administration Act and Regulations, all necessary and applicable approvalsthe Foreign Assets Control Regulations, clearancesthe International Traffic in Arms Regulations, authorizations, licenses and registrations required other controls administered by the United States Department of Commerce or foreign governments or government agenciesthe United States Department of State, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion regulations administered by the Office of Foreign Assets Control of the Company Products in jurisdictions where U.S. Department of the Company currently conducts such activities Treasury (the "ACTIVITIES TO DATE") with respect to each Company Product“OFAC”), as appropriate for the current stage of development or commercialization of each such Company Product and all other applicable import/export controls and sanctions laws and regulations (collectively, the "COMPANY LICENSES"“Trade Laws”), except, in each case, as would not be material to the Company and the Company Subsidiaries, taken as a whole. None of the Company, any Company Subsidiary, any of its or their directors, officers or employees, nor, to the knowledge of the Company, any Associated Person acting for or on behalf of the Company or any Company Subsidiary, has, directly or indirectly, engaged in any transactions or dealings with, or exported any products, technology, or services to, (i) any country or territory that, at the time of such transaction or dealing, was subject to a U.S. Government embargo (including Cuba, Iran, North Korea, Sudan, Syria, and the Crimea Region of Ukraine) (collectively, the “Embargoed Countries”); (Bii) any Person that is located in, or acting on behalf of, or directly or indirectly owned or controlled by any governmental entity of, any Embargoed Country in violation of the Trade Laws; (iii) any Person identified on any applicable export- or sanctions-related restricted party list, including, but not limited to, the Specially Designated Nationals and Blocked Persons List, the Foreign Sanctions Evaders List, or the Sectoral Sanctions Identifications List, which are maintained by OFAC, or the Entity List, Denied Persons List, or Unverified List, which are maintained by the Bureau of Industry and Security of the U.S. Department of Commerce (collectively, the “Prohibited Party Lists”); or (iv) any Person 50 percent or more owned or controlled by, or acting on behalf of, one or more Persons identified on a Prohibited Party List, except, in each case, as would not be material to the Company and the Company Subsidiaries, taken as a whole. None of the Company, any Company Subsidiary or, to the knowledge of the Company, their actual or beneficial owners appears on a Prohibited Party List. Without limiting the foregoing: (a) the Company and each of its Subsidiaries are has obtained all export and import licenses, license exceptions and other consents, notices, waivers, approvals, Orders, authorizations, registrations, declarations and filings with any Governmental Authority required for (i) the export, import and re-export of products, services, software and technologies and (ii) releases of technologies and software to foreign nationals located in compliance the United States and abroad under the Trade Laws (collectively, “Export Approvals”), except where the failure to do so would not reasonably be expected to have, individually or in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of aggregate, a Company License; Material Adverse Effect, (Cb) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (terms of all applicable Export Approvals, except where the "FDA") Quality Systems regulations (21 CFR Part 820) andfailure to do so would not reasonably expected to have, to the extent applicable to the Company, counterpart regulations individually or in the European Union aggregate, a Company Material Adverse Effect and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To no Export Approvals for the knowledge transfer of export licenses to Parent or the CompanySurviving Company are required, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products except for such Export Approvals that is the basis for any approval or clearance contains any can be obtained expeditiously and without material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respectscost.
(e) The Company has not received any written notice Notwithstanding anything contained in this Section 3.6, no representation or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any warranty will be deemed to be made in this Section 3.6 in respect of the Company Products matters referenced in Section 3.8(a) or (ii) otherwise alleging any violation in respect of any Laws by the Companyenvironmental, Tax, employee benefits, intellectual property, labor or healthcare regulatory matters.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSPermits"), except where the failure to have, or the suspension or cancellation of, any of the Permits would not have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTSCompany Products") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-pre- clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATEActivities to Date") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSESCompany Licenses"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with applicable current good manufacturing practices and regulations issued by the U.S. Food and Drug Administration's Administration (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Companyapplicable, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical and clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's current good Laboratory Practice for Non-Clinical Studies laboratory practice regulations (21 CFR Part 58) of Governmental Authorities in the United States and, to the extent applicable to the Companyapplicable, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products, except where such noncompliance would not have a Material Adverse Effect. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis trend reports of the Company from June 2000 through April 2002May 2001 with a monthly summary of complaints, including information regarding complaint aging, complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the Company's knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company Acquired Companies is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easementscertificates, variances, exceptionsexemptions, consentsapprovals, certificatesOrders, approvals registrations and orders clearances of any Governmental Authority Entity (each, a “Permit”) necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Acquired Companies to own, lease and operate its properties or and assets (including the Company Real Property), and to carry on and operate its business businesses as it is now being currently conducted (including giving effect to the "PERMITS"Management Agreement Documents and Franchise Agreement Documents) (the “Company Permits”), and all such Company Permits are in full force and effect, in each case except where the failure to have, or the failure to be in full force and effect of, any Company Permits would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the Company, threatened. Neither threatened in writing and no such suspension or cancellation will result from the Company nor any Subsidiary of the Company is in conflict withTransactions, except as would not, individually or in defaultthe aggregate, breach or violation of, (i) any Law applicable reasonably be expected to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Company Material Adverse Effect.
(ib) With Each of the Acquired Companies is in compliance with all Laws applicable to its businesses, except where the failure to comply with such Laws would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. To the Knowledge of the Company, no investigation by any Governmental Entity with respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedthe Acquired Companies is pending, unless otherwise exemptexcept for such investigations the outcomes of which, all necessary and applicable approvalsindividually or in the aggregate, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, would not reasonably be expected to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion have a Company Material Adverse Effect. None of the Acquired Companies has, during the one-year period prior to the date hereof: (i) received any written notice from any Governmental Entity regarding any material violation by the Acquired Companies of any Law; or (ii) provided any written notice to any Governmental Entity regarding any material violation by any of the Acquired Companies of any Law, which notice in either case remains outstanding or unresolved as of the date hereof, except for such notices that would not, individually or in the aggregate, reasonably be expected to have a Company Products Material Adverse Effect. No representation or warranty is made in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE"this Section 3.9(b) with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Lawenvironmental matters.
(c) To Except as would not, individually or in the knowledge of aggregate, reasonably be expected to have a Company Material Adverse Effect, neither the Acquired Companies nor, to the Company’s Knowledge, no filing any trustee, director, officer or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion employee of any of the Company Products Acquired Companies in their capacity as such, has (i) knowingly used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity, (ii) otherwise alleging any violation unlawfully offered or provided, directly or indirectly, anything of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken value to (or to the knowledge received anything of the Company threatenedvalue from) by the FDA any foreign or domestic government employee or official or any other Governmental Authority with Person, or (iii) taken any action, directly or indirectly, that would constitute a violation in any material respect by such Persons of the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder (the “FCPA”), including making use of the mails or any means or instrumentality of interstate commerce corruptly in furtherance of an offer, payment, promise to pay or authorization of the payment of any money, or other property, gift, promise to give, or authorization of the giving of anything of value to any “foreign official” (as such term is defined in the FCPA) or any foreign political party or official thereof or any candidate for foreign political office, in contravention of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductFCPA.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, certifications, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSCompany Permits"), except where the failure to have, or the suspension or cancellation of, any of the Company Permits would not prevent or materially delay consummation of the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not reasonably be expected to have a Company Material Adverse Effect. As of the date hereofof this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Company Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except in either case for any such conflicts, defaults, breaches or violations that would not prevent or materially delay the consummation of the Merger or otherwise prevent or materially delay the Company from performing its obligations under this Agreement and would not reasonably be expected to have a Company Material Adverse Effect.
(ib) With respect to the products None of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedSubsidiary or any individual who is currently an executive officer, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agenciesdirector or, to permit the designknowledge of the Company, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion employee of the Company Products or any Subsidiary (i) has been convicted of, charged with or, to the knowledge of the Company, investigated for a Medicare, Medicaid or state health program-related offense, (ii) since January 1, 1999, has been convicted of, charged with or, to the knowledge of the Company, investigated for a violation of Law related to fraud, theft, embezzlement, financial misconduct or obstruction of an investigation, (iii) has been excluded or suspended from participation in jurisdictions where the Company currently conducts such activities Medicare, Medicaid or any federal or state health program, or (the "ACTIVITIES TO DATE"iv) since January 1, 1999, has been subject to any Order or any criminal or civil fine or penalty imposed by, any Governmental Authority with respect to each any such Medicare, Medicaid or any other federal or state health care program.
(c) Except as disclosed in Section 5.06(c) of the Company ProductDisclosure Schedule, since January 1, 1999, there have been no written notices, citations or decisions by any Governmental Authority that the Company or any Subsidiary fails to meet any applicable standards promulgated by such Governmental Authority for which a plan of correction has not been accepted, and the Company does not know of any such failure or facts upon which such a failure could be alleged except, in either case, as appropriate would not reasonably be expected to have a Company Material Adverse Effect. Except as set forth in Section 5.06(c) of the Company Disclosure Schedule, none of the Company or any Subsidiary has received any notice of any potential deficiency in or violation of any applicable Law or Order relating to the Company or any Subsidiary for which a plan of correction has not been accepted except as would not reasonably be expected to have a Company Material Adverse Effect. Except as disclosed in Section 5.06(c) of the current stage of development or commercialization of each such Company Product (collectivelyDisclosure Schedule, the "COMPANY LICENSES"); (B) and except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 1996, the Company and each of its the Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance have complied in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) with respect to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been services provided and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored business operated by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false informationSubsidiaries.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable has made available to Parent prior to the maintenancedate of this Agreement true and complete copies of (i) all material surveys, compilation and filing of reports, including medical device reportsnotices, with regard inquiries, subpoenas and other correspondence related to any certification, licensure or other inspections, and summaries of all proficiency test results relating to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports business of the Company and the Subsidiaries for the period from January 1, 1999 (or, in the case of a Subsidiary, from the date such entity became a Subsidiary) through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in the date hereof; (ii) all material respectswritten inquiries, notices, requests for records, subpoenas and correspondence received by the Company or any Subsidiary related to utilization, reimbursement or other audits or investigations relating to the business of the Company and the Subsidiaries for the period from January 1, 1999 (or, in the case of a Subsidiary, from the date such entity became a Subsidiary) through the date hereof; and (iii) all current licenses or certifications of the Company or any Subsidiary under the Clinical Laboratory Improvement Act of 1988 and the regulations promulgated thereunder ("CLIA").
(e) The Except as disclosed in Section 5.06(e) of the Company has Disclosure Schedule, and except as would not received any written notice or other written communication from the FDA or any other Governmental Authority reasonably be expected to have a Company Material Adverse Effect, (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any none of the Company Products nor any Subsidiary has engaged in any activities that are prohibited under or would violate Medicare and Medicaid statutes, 42 U.S.C. Sections 1320a-7a and 7b, or the regulations promulgated pursuant to such statutes, or comparable state or local Law or rules of professional conduct; (ii) otherwise alleging the Company and the Subsidiaries have timely and accurately filed in all material respects all requisite claims and other reports required to be filed in connection with all applicable state and federal Medicare and Medicaid programs due on or before the date of this Agreement; (iii) there is no arrangement providing for any violation rebates, kickbacks or other forms of compensation that is unlawful to be paid to any Laws by person or entity in return for the Companyreferral of business or for the arrangement for recommendation of such referrals; and (iv) none of the Company nor any Subsidiary has any financial arrangement which render any of its billings unlawful pursuant to the Stark Law or comparable ▇▇▇▇▇ ▇aw.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the ▇▇ ▇he knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any Company, all agreements of the Company Productsand the Subsidiaries with third-party payors were entered into by the Company or a Subsidiary, including any facilities as the case may be, in the ordinary course of business. The Company and the Subsidiaries are in compliance with each of their respective third-party payor agreements, and the Company and the Subsidiaries have properly charged and billed in accordance with the terms of their respective third-party payor agreements, including, where applicable, billing and collection of all deductibles and co-payments, except for any such violations that would not reasonably be expected to have a Company Products are producedMaterial Adverse Effect.
(g) Except as disclosed in Section 5.06(g) of the Company Disclosure Schedule, processed(i) no right of the Company or any Subsidiary to receive reimbursements pursuant to any government program or private program has ever been terminated or suspended as a result of any investigation or action whether by any Governmental Authority or other third party, packaged or stored and neither (ii) none of the Company nor any Subsidiary has since January 1, 1999 received notice from any Governmental Authority that it has been the subject of its Subsidiaries has within the last three yearsany inspection, either voluntarily investigation, survey, audit, monitoring or at the request other form of review by any Governmental Authority, initiated professional review organization, accrediting organization or participated in a recall certifying agency for the purpose of any alleged improper activity on the part of such entity, other than routine audits or inquiries and other than those which would not reasonably be expected to have a Company Product Material Adverse Effect, (iii) none of the Company nor any Subsidiary has received any written notice of deficiency from a Governmental Authority in connection with its operations for which a plan of correction has not been accepted, and (iv) none of the Company nor any Subsidiary has received any written notice of any claim, requirement or provided post-sale warnings regarding demand of any Company Productlicensing, accrediting or certifying agency to rework or redesign their operations or any part thereof.
Appears in 1 contract
Sources: Merger Agreement (Unilab Corp /De/)
Permits; Compliance. (a) Each Except as set forth in Section 4.06(a) of the Company and the Subsidiaries of Disclosure Schedule, the Company and each of its Subsidiaries is in possession of all registrationsCompany Permits, franchisesexcept where the failure to possess, grantsor the suspension or cancellation of, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company Permits would not have a Company Material Adverse Effect. Each Company Permit is valid and in full force and effect, except where the failure to be valid or the Subsidiaries of the in full force or effect would not have a Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS")Material Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the Company Permits is pending or, to the knowledge Knowledge of the Company, threatened, and no Company Permit shall be terminated or materially impaired or become terminable, in whole or in part, as a result of the consummation of the Merger, except where the failure to possess, or the suspension, cancellation, termination or impairment of, any of the Company Permits would not have a Company Material Adverse Effect. Neither Except as set forth in Section 4.06(a) of the Company Disclosure Schedule, neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, has infringed or is in default, breach or violation of, (i) any Law or Company Permit applicable to the Company or any Subsidiary of the Company its Subsidiaries or by which any product, service, property or asset of the Company or any Subsidiary of the Company its Subsidiaries is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, infringements, breaches or violations that would not have a Company Material Adverse Effect.
(i. To the Company’s Knowledge, except as set forth in Section 4.06(a) With respect to the products of the Company Disclosure Schedule, no event has occurred, or condition or state of facts exists, which constitutes, or after notice or lapse of time or both, would constitute, a breach or default in any material respect under any such Company Permit, or which permits, or after notice or lapse of time or both, would permit revocation or termination of any such Company Permit, or which would materially and its Subsidiaries and, to adversely affect the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) rights of the Company or any of its Subsidiaries has obtainedunder any such Company Permit.
(b) None of the Company, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agenciesits Subsidiaries or, to permit the designCompany’s Knowledge, developmenttheir respective employees and Representatives has given, pre-clinical and clinical testingloaned, manufacturepaid, labelingpromised, saleoffered or authorized the payments, distribution and promotion directly or indirectly through a third party, of anything of value to any “foreign official,” as defined in the Company Products in jurisdictions where FCPA, to persuade that official to help the Company currently conducts such activities Company, or any other Person, obtain or keep business or to secure some other improper advantage.
(c) To the "ACTIVITIES TO DATE") with respect to each Company Productextent applicable, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are is in compliance compliance, in all material respects respects, with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (Ci) the Company USA PATRIOT Act and (ii) the Trading with the Enemy Act, as amended, and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems foreign assets control regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
Treasury Department (c31 C.F.R. Subtitle B, Chapter V, as amended) To and any other enabling legislation or executive order relating thereto. None of the knowledge Company or any of its Subsidiaries nor, to the Knowledge of the Company, no filing any director, officer or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports employee of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting of its Subsidiaries, is subject to any United States sanctions administered by the pre-market clearance or approval of, the uses Office of or the labeling and promotion of any Foreign Assets Control of the Company Products United States Treasury Department or (ii) otherwise alleging any violation a person on the list of any Laws by the Company“Specially Designated Nationals and Blocked Persons.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither ” Neither the Company nor any of its Subsidiaries and, to the Knowledge of the Company, none of the officers, directors, agents, or employees of the Company or any of its Subsidiaries, has within the last three years, either voluntarily violated or at the request is in violation of any Governmental Authorityother laws, initiated judgments, orders, executive orders, decrees, ordinances, rules, regulations, statutes, case law or participated treaties applicable to the Company, its Subsidiaries or Affiliates related to terrorism financing or money laundering, including The Currency and Foreign Transactions Reporting Act (also known as the “Bank Secrecy Act”, 31 U.S.C. §§ 5311-5330 and 12 U.S.C. §§ 1818(s), 1820(b) and 1951-1959), in a recall of each case, other than any Company Product or provided post-sale warnings regarding any Company Productimmaterial violations.
Appears in 1 contract
Sources: Merger Agreement (Arden Group Inc)
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company Allegiance is in possession of all registrations, material franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptionsexemptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or and to carry on its business as it is now being conducted (collectively, the "PERMITSAllegiance Permits"). As of the date hereof, and there is no suspension or cancellation of any of the Permits is Action pending or, to the knowledge of the CompanyAllegiance, threatened. Neither the Company nor threatened regarding any Subsidiary of the Company Allegiance Permits. Allegiance is not in conflict with, or in default, breach default or violation of, (i) of any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundAllegiance Permits, except for any such conflicts, defaults, breaches defaults or violations that would which, individually or in the aggregate, could not reasonably be expected to have a Material Adverse EffectEffect on Allegiance.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect on Allegiance:
(i) With all necessary clearances or approvals from Governmental Authorities for all drug and device products which are manufactured and/or sold by Allegiance and its subsidiaries have, to the knowledge of Allegiance, been obtained, and Allegiance and its subsidiaries are in substantial compliance with the most current form of each applicable clearance or approval with respect to the products of the Company manufacture, storage, distribution, promotion and sale by Allegiance and its Subsidiaries andsubsidiaries of such products;
(ii) none of Allegiance, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedofficers, unless otherwise exemptemployees or agents (during the term of such person's employment by Allegiance or while acting as an agent of Allegiance, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agenciesor, to permit the designAllegiance's actual knowledge, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion prior to such employment) has made any untrue statement of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development a material fact or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining fraudulent statement to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and & Drug Administration's , (the "FDA") Quality Systems regulations (21 CFR Part 820) andor any similar Governmental Authorities, failed to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended disclose a material fact required to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission disclosed to the FDA or any other similar Governmental Authority with regard Authorities, or committed an act, made a statement or failed to the Company Products make a statement that is the could reasonably be expected to provide a basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other similar Governmental Authority (i) contesting the pre-market clearance Authorities to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" or approval ofsimilar governmental policy, the uses of rule, regulation or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.law;
(fiii) There have been no recallsas to each article of drug, field notifications device, cosmetic or seizures ordered vitamin manufactured (directly or adverse regulatory actions taken (or indirectly) and/or, to the knowledge of Allegiance, distributed by Allegiance, such article is not adulterated or misbranded within the Company threatened) by meaning of the FDA Food, Drug and Cosmetic Act or any other Governmental Authority with respect to similar governmental act or law of any jurisdiction; and
(iv) none of the Company Products, including any facilities where any such Company Products are produced, processed, packaged Allegiance or stored and neither the Company nor any of its Subsidiaries officers, employees or agents (during the term of such person's employment by Allegiance or while acting as an agent of Allegiance, or, to Allegiance's knowledge, prior to such employment), subsidiaries or affiliates has within the last three years, either voluntarily or at the request been convicted of any Governmental Authority, initiated crime or participated engaged in a recall of any Company Product conduct for which debarment or provided post-sale warnings regarding similar punishment is mandated or permitted by any Company ProductApplicable Law.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease and operate its properties or to carry on its business as it is now being conducted and substantially as described in the Company’s SEC Reports filed prior to the date hereof (the "PERMITS"“Permits”), and all such Permits are valid, and in full force and effect, except where the failure to have, or the suspension or cancellation of, or failure to be valid or in full force and effect of, any of the Permits would not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement or (C) have a Material Adverse Effect. As of the date hereof, no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to have, or the suspension or cancellation of, any of the Permits would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Neither the Company nor any Subsidiary of the Company is in conflict with, or in default, breach or violation of, (i) any Law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundPermits, except for any such conflicts, defaults, breaches defaults or violations that would not not, individually or in the aggregate, reasonably be expected to (A) prevent or materially delay consummation of the Transactions, (B) otherwise prevent or materially delay performance by the Company of any of its material obligations under this Agreement or any Ancillary Agreement or (C) have a Material Adverse Effect.
(i) With respect to . Since the products enactment of the Company and its Subsidiaries andSOX, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries officers and directors have been and are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (CA) the Company applicable provisions of SOX and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; the related rules and regulations promulgated thereunder and under the Exchange Act and (DB) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf listing and corporate governance rules and regulations of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable LawNasdaq.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Securities Purchase Agreement (Pathmark Stores Inc)
Permits; Compliance. (a) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, material franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries and each of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiaries to own, lease and operate its properties or to carry on its business as it is now being conducted or presently contemplated to be conducted (the "PERMITS"“Permits”). As of Except as would not have, individually or in the date hereofaggregate, a Material Adverse Effect, (i) no suspension or cancellation of any of the Permits Permit is pending or, to the knowledge Knowledge of the Company, threatened. threatened in writing, and (ii) there have occurred no defaults under, violations of, or events giving rise to a right of termination, amendment or cancellation of any Permit (with or without notice, the lapse of time or both).
(b) Neither the Company nor any Company Subsidiary of is, and neither the Company is nor any Company Subsidiary since December 31, 2012 has been, in conflict with, or in default, breach or violation of, (i) any material Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation Permit to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except except, with respect to subclause (i) only, for any such conflicts, defaults, breaches or violations that would not have have, individually or in the aggregate, a Material Adverse Effect.
. Since December 31, 2012, (i) With respect to neither the products Company nor any of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are received any written notice from any Governmental Authority alleging that it is not in compliance in all material respects with all terms any Law, and conditions of each Company License and with all applicable Law pertaining (ii) to the Activities to Date Knowledge of the Company, neither the Company nor any Company Subsidiary is under investigation by any Governmental Authority with respect to each Company Product which is not required to be the subject any violation or potential violation of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing No Company Product is or submission has been subject to the FDA any Food and Drug Regulations or any other Governmental Authority requirements with regard respect to marking or premarket approval or clearance. Neither the Company Products that is the basis for nor any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company Subsidiaries has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting that, nor to the pre-market clearance or approval of, the uses of or the labeling and promotion of any Knowledge of the Company Products or (ii) otherwise alleging any violation of any Laws by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by is the FDA or any other Governmental Authority with respect investigating whether, any Company Product is or may be subject to any Food and Drug Regulations or any other marking or approval or clearance requirements. Except as disclosed on Section 3.6(c) of the Disclosure Schedule, all Company Products have been developed at private expense and no Governmental Authority has obtained, by contract or otherwise, any rights in any Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither .
(d) Neither the Company nor any of its Subsidiaries Company Subsidiary holds a U.S. security clearance or has within such a clearance in process. Neither the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of Company nor any Company Product Subsidiary (i) is registered under the International Traffic in Arms Regulations administered by the U.S. Department of State (“ITAR”), (ii) manufactures, develops, sells, exports or provided post-sale warnings regarding reexports any equipment, products, software, or technical data that are controlled under the ITAR, or (iii) has any such equipment, software, or technical data in the pipeline or under development. Neither the Company nor any Company ProductSubsidiary (i) manufactures, develops, sells, exports or reexports any equipment, products, software, or technical data that are controlled under the Export Administration Regulations administered by the U.S. Department of Commerce, or (ii) has any such equipment, products, software, or technical data in the pipeline or under development.
Appears in 1 contract
Permits; Compliance. (a) Each of the Company and the Subsidiaries of the The Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary material Permits that are required for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or to own, lease lease, and operate its properties or to carry on its conduct the business as it is now being of the Company in the manner currently conducted by the Company (the "PERMITS"“Company Permits”), except where the failure to have such Company Permits does not constitute a Company Material Adverse Effect. As of the date hereof, no No suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Subsidiary of the The Company is in conflict with, or not in default, breach or violation of, (i) any Law applicable to the Material Contract or Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundexcept, except in each case, for any such conflicts, defaults, breaches or violations that would not individually or in the aggregate have or reasonably be expected to have a Company Material Adverse Effect.
(ib) With respect to the products of the The Company is, and its Subsidiaries andsince April 1, to the extent applicable2021, products under development (collectivelyhas been, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any a violation of any Laws by Law applicable to the Company at any time since April 1, 2021, which violation would be material to the Company.
(fc) There Since April 1, 2021, and except where the failure to be, or to have been in compliance with such Laws would not, individually or in the aggregate, be material to the Company, (i) there has been no recallsaction taken by the Company, field notifications or seizures ordered or adverse regulatory actions taken (or or, to the knowledge of the Company, any officer, director, manager, employee, agent, representative, or sales intermediary of the Company, in each case, acting on behalf of the Company, in violation of any applicable Anti-Corruption Law, (ii) the Company threatened) has not been convicted of violating any Anti-Corruption Laws or, to the knowledge of the Company, subject to any investigation by the FDA or any other a Governmental Authority for violation of any applicable Anti-Corruption Laws, (iii) the Company has not conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority regarding any alleged act or omission arising under or relating to any noncompliance with any Anti-Corruption Law, and (iv) the Company has not received any written notice from a Governmental Authority for any actual or potential noncompliance with any applicable Anti-Corruption Law.
(d) The Company has timely filed all material reports, registrations, and other material documents, together with any material amendments required to be made with respect thereto, that were required to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of be filed with any Governmental AuthorityAuthority since January 1, initiated or participated 2023, and has paid all material fees and assessments due and payable in a recall of any Company Product or provided post-sale warnings regarding any Company Productconnection therewith.
Appears in 1 contract
Sources: Business Combination Agreement (ShoulderUP Technology Acquisition Corp.)
Permits; Compliance. (a) Each Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect or prevent or materially delay the consummation of the transactions contemplated by this Agreement, the Company and the each of its Subsidiaries of the Company is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals approvals, takeoff and landing authorizations (including "slots" at United States and foreign airports), clearances and orders of any Governmental Authority U.S. or foreign governmental entity necessary for each of the Company or the Subsidiaries of the Company such Subsidiary to manufactureoperate scheduled domestic and foreign air transportation, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or and to own, lease and operate its properties or and to carry on its business their respective businesses substantially in the manner described in the Company's annual report on Form 10-K for the fiscal year ended March 31, 1999 (the "Company 10-K") and as it is now being conducted (the "PERMITSCompany Permits").
(b) All of the Company Permits are valid and in full force and effect, except where the failure to have, or the suspension or cancellation of, any of the Company Permits could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect or prevent or materially delay the consummation of the transactions contemplated by this Agreement. As of the date hereof, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, threatened. , except such suspensions or cancellations that could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect or prevent or materially delay the consummation of the transactions contemplated by this Agreement.
(c) Neither the Company nor any Subsidiary of the Company its Subsidiaries is in conflict with, default on or in default, breach or violation of, (i) any Law law applicable to the Company or any Subsidiary of the Company or by which any property or asset of the Company or any Subsidiary of the Company is bound or affected, or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Subsidiary of the Company is a party or by which the Company or any Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is bound, except for any such conflicts, defaults, breaches or violations that would not have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company or any of its Subsidiaries has obtainedor by which any property, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States asset or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion operation of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each any of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, bound or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products affected or (ii) otherwise alleging any violation of Company Permits, except for any Laws by such defaults or violations that could not, individually or in the Company.
(f) There aggregate, reasonably be expected to have been no recalls, field notifications a Material Adverse Effect or seizures ordered prevent or adverse regulatory actions taken (or to materially delay the knowledge consummation of the Company threatened) transactions contemplated by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Productthis Agreement.
Appears in 1 contract
Permits; Compliance. (a) Since January 1, 2008, (i) the business and operations of the Company and the Company Subsidiaries have been conducted in compliance with all applicable Laws (including Insurance Laws) and (ii) the Company has complied with the applicable listing and corporate governance rules and regulations of the NASDAQ Global Market except, in each case, where the failure to so conduct such business and operations or comply with such rules and regulations would not, individually or in the aggregate, have a Material Adverse Effect.
(b) Each of the Company and the Company Subsidiaries of the Company is in possession of all registrations, material franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority necessary for each of the Company or the Subsidiaries of the Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or it to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITS"“Permits”). As of The Company and the date hereofCompany Subsidiaries have complied in all material respects with, and are not in default in any material respect under any, and have maintained and conducted their respective businesses in all material respects in compliance with, such Permits. Each Permit is in full force and effect in accordance with its terms, and there is no suspension or cancellation of any of the Permits is pending proceeding or, to the knowledge of the Company, threatened. investigation to which the Company or any Company Subsidiary is subject before a Governmental Authority that is pending or threatened in writing that would be expected to result in the revocation, failure to renew or suspension of, or placement of a restriction on, any such Permit, except where the failure to be in full force and effect in accordance with their terms, revocation, failure to renew, suspension or restriction would not, individually or in the aggregate, have a Material Adverse Effect.
(c) Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach or violation of, (ia) any Law (including any Insurance Law) applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, or (iib) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise Permit or other instrument or obligation to which the Company or any Company Subsidiary of the Company is a party or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Company Subsidiary of the Company is bound, except except, in either case, for any such conflicts, defaults, breaches or violations that that, individually or in the aggregate, would not have constitute a Material Adverse Effect.
(id) With respect There is no proceeding to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) which the Company or any Company Subsidiary is subject before any Governmental Authority pending or threatened in writing regarding whether the Company or any Company Subsidiary has violated any Law, nor any investigation by any Governmental Authority pending or threatened in writing with respect to possible violations of its Subsidiaries has obtainedany applicable Laws, unless otherwise exemptwhich, all necessary and applicable approvalsif determined or resolved adversely against the Company or any Company Subsidiary, clearanceswould, authorizationsindividually or in the aggregate, licenses and registrations required by United States reasonably be expected to be material to the Company or foreign governments any one or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion more of the Company Products in jurisdictions where Subsidiaries, or would reasonably be expected to prevent or materially delay the Company currently conducts such activities (consummation of the "ACTIVITIES TO DATE") with respect to each Company Producttransactions contemplated by this Agreement. Since January 1, as appropriate for the current stage of development or commercialization of each such Company Product (collectively2008, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in Company Subsidiary has each timely filed all material respects reports, registrations, statements and certifications, together with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not any amendments required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects made with all respect thereto, required to be filed by it with any applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, soldInsurance Regulator, or distributed; and (D) such failure to the extent any Company Product file has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to the maintenance, compilation and filing of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respectsremedied.
(e) The Neither Company has not received nor any Company Subsidiary is subject to any cease-and-desist or other order issued by, or is a party to any written notice agreement, consent agreement or other written communication from memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or has been a recipient of any supervisory letter from, or has adopted any board resolutions at the FDA or request of, any other Governmental Authority that: (i) contesting limits the pre-market clearance ability of Company or approval of, the uses any Company Subsidiary to conduct any line of or the labeling and promotion of any of the Company Products or business; (ii) otherwise alleging requires any violation investments of any Laws by Company Insurance Subsidiary to be treated as non-admitted assets; (iii) requires divestiture of any investments of Company or any Company Subsidiary; (iv) in any manner imposes any requirements on Company or any Company Subsidiary in respect of risk-based capital requirements that add to or otherwise modify the Company.
risk-based capital requirements imposed under Law, (fv) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or in any manner relate to the knowledge ability of Company or any Company Subsidiary to pay or declare dividends or distributions; or (vi) otherwise restricts the conduct of the business, underwriting policies or management of Company threatened) by the FDA or any other Company Subsidiary (each, whether or not set forth in the Company Disclosure Schedule, a “Company Regulatory Agreement”), nor has Company or any Company Subsidiary been advised in writing by any Governmental Authority with respect to any of the Company Products, including any facilities where that it is considering issuing or requesting any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company ProductRegulatory Agreement.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Penn Millers Holding Corp)
Permits; Compliance. (a) Each Except for environmental matters discussed in Section 3.12 and except as set forth in Section 3.06 of the Disclosure Schedule, each of the Company and the Subsidiaries of the each Company Subsidiary is in possession of all registrations, franchises, grants, authorizations (including marketing authorizations), licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority Entity necessary for each of the Company or the Subsidiaries of the any Company to manufacture, market, sell, or distribute the Company Products (as defined in Section 4.06(b), other than products under development) or Subsidiary to own, lease and operate its properties or to carry on its business as it is now being conducted (the "PERMITSPermits"). As , except where the failure to have, or the suspension or cancellation of, any of the date hereofPermits would not reasonably be expected to (a) have a Material Adverse Effect or (b) prevent or materially delay the performance of this Agreement by the Company, and no suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened. Neither the Company nor any Company Subsidiary of the Company is in conflict with, or in default, breach default or violation of, (i) any Law applicable to the Company or any Company Subsidiary of the Company or by which any property or asset of the Company or any Company Subsidiary of the Company is bound or affected, affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company or any Company Subsidiary of the Company is a party to or by which the Company or any Company Subsidiary of the Company or any property or asset of the Company or any Subsidiary of the Company is boundbound by, except for any such conflicts, defaults, breaches defaults or violations that would not reasonably be expected to (A) have a Material Adverse Effect.
(i) With respect to the products of the Company and its Subsidiaries and, to the extent applicable, products under development (collectively, the "COMPANY PRODUCTS") (A) the Company Effect or any of its Subsidiaries has obtained, unless otherwise exempt, all necessary and applicable approvals, clearances, authorizations, licenses and registrations required by United States or foreign governments or government agencies, to permit the design, development, pre-clinical and clinical testing, manufacture, labeling, sale, distribution and promotion of the Company Products in jurisdictions where the Company currently conducts such activities (the "ACTIVITIES TO DATE") with respect to each Company Product, as appropriate for the current stage of development or commercialization of each such Company Product (collectively, the "COMPANY LICENSES"); (B) the Company and each of its Subsidiaries are in compliance in all material respects with all terms and conditions of each Company License and with all applicable Law pertaining to the Activities to Date with respect to each Company Product which is not required to be the subject of a Company License; (C) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable Laws regarding registration, license, certification for each site at which a Company Product is manufactured, labeled, sold, or distributed; and (D) to the extent any Company Product has been exported from the United States, the Company has exported such Company Product in compliance in all material respects with applicable Law; (ii) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the U.S. Food and Drug Administration's (the "FDA") Quality Systems regulations (21 CFR Part 820) and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries where compliance is required; (iii) all non-clinical laboratory studies of Company Products under development, sponsored by the Company and intended to be used to support regulatory clearance or approval, have been and are being conducted in compliance in all material respects with the FDA's good Laboratory Practice for Non-Clinical Studies regulations (21 CFR Part 58) in the United States and, to the extent applicable to the Company, counterpart regulations in the European Union and all other countries; and (iv) the Company and each of its Subsidiaries are in compliance in all material respects with all applicable reporting requirements -19- for all Company Licenses or plant registrations described in clause (i) above, including, but not limited to, applicable adverse event reporting requirements in the United States and outside of the United States under applicable Law.
(c) To the knowledge of the Company, no filing or submission to the FDA or any other Governmental Authority with regard to the Company Products that is the basis for any approval or clearance contains any material omission prevent or materially false information.
(d) The Company is in material compliance with all FDA and non-United States equivalent agencies and similar state and local Governmental Agency Laws applicable to delay the maintenance, compilation and filing performance of reports, including medical device reports, with regard to the Company Products. Section 4.06(d) of the Disclosure Schedule sets forth a list of all applicable adverse event reports related to the Company Products, including any Medical Device Reports (as defined in 21 CFR 803). Set forth on Section 4.06(d) of the Disclosure Schedule are complaint review and analysis reports of the Company through April 2002, including information regarding complaints by product and root cause analysis of closed complaints, which reports are correct in all material respects.
(e) The Company has not received any written notice or other written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, the uses of or the labeling and promotion of any of the Company Products or (ii) otherwise alleging any violation of any Laws this Agreement by the Company.
(f) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or to the knowledge of the Company threatened) by the FDA or any other Governmental Authority with respect to any of the Company Products, including any facilities where any such Company Products are produced, processed, packaged or stored and neither the Company nor any of its Subsidiaries has within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Company Product or provided post-sale warnings regarding any Company Product.
Appears in 1 contract
Sources: Merger Agreement (Aristotle Corp)