Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (i) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage. (d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws. (e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Laws.
Appears in 3 contracts
Samples: Purchase Agreement, Purchase Agreement (NXP Semiconductors N.V.), Purchase Agreement (Qualcomm Inc/De)
Compliance with Laws; Regulatory Matters. (a) Other than The Company and each of the Company Subsidiaries is, and to the Knowledge of the Company, each of their directors, officers and management level employees (while acting in such capacity) is, and since December 27, 2019 has been, in compliance with all applicable Laws and the terms of the Company’s and each of the Company Subsidiaries’ Permits, except for non-compliance failures to comply or violations which or alleged violations that have not had and would not have or reasonably be expected to havenot, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. Without limiting the generality of the foregoing, each of the Company and each of its the Company Subsidiaries are and, at all times to the Company’s Knowledge, their respective CROs or CMOs are, and have been since January 1December 27, 20142019, have been, acting or operated in compliance with Health Care Laws, including in connection with the conduct of all applicable Laws. To Postmarket Requirements or Commitments, Clinical Trials, pre-clinical and non-clinical studies and the knowledge manufacturing, distribution, sale, promotion and marketing conducted by or on behalf of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable LawSubsidiary with respect to a Product Candidate, except for such violations failures to comply that have not had and would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(ib) The Company and each of its Subsidiaries hold Company Subsidiary holds and, since December 27, 2019, has held all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary material Regulatory Permits required for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses their business as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are . Each such Regulatory Permit is valid and in full force and effecteffect and no such Regulatory Permits will be terminated or become terminable, and (iii) or be impaired, varied or suspended, in whole or in part, as a result of the date of this AgreementTransactions, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), except as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be materialFrom December 27, since January 12019 to the Agreement Date, 2014none of the Company nor any Company Subsidiary, nor, to the knowledge Company’s Knowledge, with respect to any Clinical Trials conducted or sponsored by or on behalf of the CompanyCompany or Company Subsidiaries or Product Candidate, their respective CROs, or CMOs, has: (i) received any written notice from any Governmental Entity or other Person regarding any actual or alleged material violation of, or actual material failure to comply with any provision of, any Health Care Law applicable to, or material Regulatory Permit held by, such entity or to its assets or properties, or received any FDA Form 483s, warning letters, untitled letters, written notice of potential enforcement proceedings or similar correspondence or written notice from any Governmental Entity; (ii) received any written notice of any actual or possible revocation, withdrawal, suspension, cancellation, termination, variation or modification of any material Regulatory Permit held by such entity that remains unresolved as of the Agreement Date; or (iii) filed or otherwise provided any notice or communication to any Governmental Entity or other Person regarding any actual or alleged material violation of, or actual failure to comply with any material provision of any Health Care Law applicable to, or material Regulatory Permit held by, such entity or to its assets or properties and, to the Company’s Knowledge, no such self-disclosure to any Governmental Entity is required or has been made by the Company or any Company Subsidiary. To the Company’s Knowledge, as of the Agreement Date neither the Company nor any Company Subsidiary is under investigation by any Governmental Entity with respect to any material violation of any Health Care Law or the terms of its Subsidiaries hasmaterial Regulatory Permits. As of the Agreement Date, nor have any of their Representatives, violated any Anti-Corruption Laws and there is no material: (iiA) neither Judgment outstanding against or affecting the Company nor or any of its Subsidiaries hasCompany Subsidiary; (B) Judgment outstanding that affects in any material respect the validity, nor have any of their Representatives, offered, paid, promised to payuse, or authorized the payment enforceability of any money, assets or offered, given, promised to give, or authorized the giving of anything of valueproperties, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary Intellectual Property Rights of the Company or any Company Subsidiaries; or (C) monitoring agreement, consent decree, corporate integrity agreement, deferred or non-prosecution agreement or other formal or informal agreements of the Representative knew Company or ought reasonably to have known (after due and proper inquiry) that all any Company Subsidiary in effect with or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of imposed by any Governmental Authority or (5) assisting the CompanyEntity concerning compliance with Health Care Laws, any Subsidiary of the Company, or any Representative and no such agreement has been threatened against such Persons in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantagewriting.
(d) The Company and each From December 27, 2019 through the Agreement Date, there have been no recalls, field notifications, product defect notifications, market withdrawals or replacements, “dear doctor” letters, investigator notices, IND or Clinical Trial safety reports, serious adverse event reports or other notices of its Subsidiaries areaction relating to a quality, and at all times since January 1safety or efficacy concern or alleged lack of regulatory compliance of any Product Candidate that have materially impacted the quality, 2014 have beensafety or efficacy profile of such Product Candidate and, to the Knowledge of the Company, there are no facts or circumstances that would be reasonably likely to result in compliance such action or otherwise require a material change in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each the labeling of its Subsidiaries do notor the variation, and have not since January 1termination or suspension of the development, 2014, carried on testing or Marketing Approval of any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade LawsProduct Candidate.
(e) Since January 1All Regulatory Documentation required to be maintained, 2014filed, submitted, or furnished to a Governmental Entity by or on behalf of the Company or any Company Subsidiary has been so maintained, filed, submitted, or furnished, except as where a failure to do so has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Regulatory Documentation submitted in connection with any Product Candidate, when submitted to the relevant Governmental Entity, was complete and correct and did not omit any information as of the date of submission, except for such inaccuracies or omissions as have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Any necessary or required updates, changes, corrections, or modifications to such Regulatory Documentation have been timely submitted to the relevant Governmental Entity, except where any such failure to make such timely submissions have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(f) None of the Company or any Company Subsidiary, nor, to the Company’s Knowledge, any CRO or CMO, has received notice from any Governmental Entity that (i) any Marketing Approval with respect to a Product Candidate will not or is likely not to be issued, or (ii) asserting in writing that any Regulatory Documentation provided to such Governmental Entity contains material deficiencies or will not be accepted based on data integrity or other compliance concerns.
(g) None of the Company nor any Company Subsidiary, nor, to the Company’s Knowledge, any CRO, or CMO has (i) made an untrue statement of a material fact or fraudulent statement to any Governmental Entity; (ii) failed to disclose a material fact required to be disclosed to any Governmental Entity; or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA to invoke the policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Fraud Policy”) or for any Governmental Entity to invoke a similar policy that may be applicable in another jurisdiction to the Company or any of the Company Subsidiaries. As of the Agreement Date, neither the Company nor any Company Subsidiary is the subject of any pending or, to the Company’s Knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or the subject of any similar investigation by any other Governmental Entity.
(h) None of the Clinical Trials conducted by or on behalf of the Company or any Company Subsidiary with regard to a Product Candidate (i) is the subject of a clinical hold or (ii) has been terminated or suspended prior to completion for safety or non-compliance reasons. No Governmental Entity that has jurisdiction over any ongoing Clinical Trial conducted with regard to a Product Candidate has initiated or, to the Company’s Knowledge, threatened in writing to initiate any material investigation or material Action or to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such Clinical Trial, or to disqualify, restrict or debar any Investigator or other Person involved in any such Clinical Trial.
(i) All material Regulatory Transfer Approvals have been duly received by or issued to the Company or a Company Subsidiary in connection with its Subsidiaries acquisition or receipt of licensing rights to a Product Candidate in the relevant territory.
(j) None of the Company nor any Company Subsidiary nor, to the Company’s Knowledge, any of their respective CROs, or CMOs, employs or contracts with any Persons that are debarred pursuant to Section 306 of the FDCA or foreign equivalent, or that are disqualified pursuant to 21 C.F.R. Part 312.70 or foreign equivalent, or that have been debarred, excluded, or suspended from participation in any health care program. No Actions that could result in such a debarment, disqualification, or exclusion are pending or, to the Company’s Knowledge, threatened in writing against any of the foregoing Persons.
(k) None of the Company nor any Company Subsidiary, nor to the Company’s Knowledge, any of their respective CROs, CMOs or service vendors, has conducted received written notice (i) of any FDA Form 483 or initiated alleged material noncompliance or major or critical findings, as a result of any internal investigation audit or made inspection or any audit or inspection performed by or on behalf of a voluntaryGovernmental Entity or other Person in connection with, directedrelated to, or involuntary disclosure affecting any Product Candidate or (ii) of any alleged material falsification or fraudulent activity regarding any Regulatory Documentation generated or submitted to any Governmental Authority Person in connection with, related to, or affecting any Product Candidate. True and complete copies of any such audit, inspection, and corrective action material that are in the possession or control of the Company or any Company Subsidiary as of the Agreement Date have been Made Available to Parent.
(l) From December 27, 2019 to the Agreement Date, there have been no Unexpected Adverse Events, investigator notices in writing, or other notice of action relating to an alleged lack of quality, safety, efficacy, or regulatory compliance or any other corrective action in relation to any Product Candidate (collectively, “Safety Notices”), in each case, that have materially impacted the quality, safety or efficacy profile of such Product Candidate. There have been no material product complaints with respect to any alleged act or omission arising under or relating Product Candidate, and there are no facts that would be reasonably likely to result in either of the following: (i) a material Safety Notice with respect to any noncompliance Product Candidate, or (ii) a termination or suspension of testing (including Clinical Trials) of any Product Candidate.
(m) As of the Agreement Date, none of the Company’s or any Company Subsidiary’s Product Candidates is the subject of any written material adverse reimbursement or coverage decision or determination from any third-party payor.
(n) To the Company’s Knowledge, each Contract of the Company or any Company Subsidiary with an HCP (including for employment, consulting, speaking, research, authorship, advisory board services or otherwise): (i) complies with applicable Health Care Laws in all material respects; (ii) requires the performance of necessary services with a material respect legitimate business purpose; (iii) provides compensation that is materially consistent with fair market value in an arms-length transaction; and (iv) has been entered into only upon the HCP and the applicable counterparty making any required disclosures to and/or receiving consent, approval or authorization from, any applicable Anti-Corruption LawGovernmental Entity and/or institution with which the HCP is affiliated (if any). Except as has not had and would not, Economic Sanctions/Trade Lawindividually or in the aggregate, or Money Laundering Law. Since January 1, 2014reasonably be expected to have a Company Material Adverse Effect, the Company or the Company Subsidiary party to such Contract with an HCP has documentation demonstrating the need for such services and its Subsidiaries have implemented the basis for the value of the compensation provided. To the Company’s Knowledge, each HCP has obtained any material patient consents in connection with such HCP’s provision of services to the Company or any Company Subsidiary.
(o) To the Company’s Knowledge, each HCP or other Person performing services on behalf of the Company or any Company Subsidiary (i) has at all relevant times obtained and maintained internal controlsin good standing any Permits or professional licensure, policies accreditation, qualification and procedures reasonably designed training required for such Person to detectprovide the particular services in the applicable jurisdiction(s); (ii) has not had a Permit or professional license or accreditation required for the services performed by such HCP or other Person on behalf of the Company or Company Subsidiary suspended or revoked or otherwise restricted; (iii) has not been debarred, prevent excluded, or suspended from participation in any health care program; and deter (iv) has not been and is not currently the subject of any disciplinary actions or investigations by any Governmental Entity. Each of the Company and the Company Subsidiaries has provided or ensured the provision of all material violations of AntiGCP and material protocol and project-Corruption Lawsspecific training, Economic Sanctions/Trade Laws, and Money Laundering required by Health Care Laws.
(p) Each Contract of the Company or any Company Subsidiary with any Person for services related to the promotion or marketing of a Product Candidate, market access, or sales force assistance (i) complies with applicable Health Care Laws and (ii) requires the performance of necessary services with a legitimate business purpose, in each case, except as have not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
Appears in 2 contracts
Samples: Agreement and Plan of Merger (Myovant Sciences Ltd.), Merger Agreement (Myovant Sciences Ltd.)
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company and each of its Subsidiaries hold is in compliance with, and since January 1, 2010 have been in compliance with, and to the knowledge of the Company, is not under investigation with respect to and has not been threatened to be charged with or given written notice of any violation of, any Applicable Law, except to the extent that any non-compliance, investigation or violation would not reasonably be expected to be materially adverse to the Company and its Subsidiaries, taken as a whole.
(b) The Company and each of its Subsidiaries holds all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Ordersorders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses in all respects as currently conductedconducted (the “Company Permits”), (ii) except as would not reasonably be expected to be materially adverse to the Company and its Subsidiaries, taken as a whole. The Company and each of its Subsidiaries are, is and at all times since January 1, 2014 have been, 2010 been in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effecteffect in all respects, except as would not reasonably be expected to be materially adverse to the Company and (iii) its Subsidiaries, taken as a whole. As of the date of this Agreementhereof, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits isis to the knowledge of the Company pending or threatened, nor, to the knowledge of the CompanyCompany do reasonable grounds exist for any such action, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), except as would not have or reasonably be expected to havebe materially adverse to the Company and its Subsidiaries, individually or in the aggregate, taken as a Company Material Adverse Effectwhole.
(c) Except as would not be material, since January 1, 2014, to the knowledge None of the Company, (i) neither the Company nor any of its Company’s Subsidiaries has, nor have or any of their Representativesrespective directors, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries hasofficers, nor have any of their Representativesemployees or, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company’s knowledge, any Subsidiary agents or representatives of the Company or the Representative knew or ought reasonably to have known a Subsidiary (after due and proper inquiryi) that all or a portion of such money or thing of value would be offeredhas used any corporate funds for any illegal contributions, givengifts, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, entertainment or other unlawful expenses relating to political activity, (ii) has used any corporate funds for any direct or improper means indirect unlawful payments to any foreign or domestic government officials or employees, (iii) has violated or is violating any provision of obtaining business the Foreign Corrupt Practices Act of 1977, the UK Bribery Act of 2010 or any improper advantageother applicable anticorruption Laws, (iv) has established or maintained any unlawful fund of corporate monies or other properties, (v) has made any bribe, unlawful rebate, payoff, influence payment, kickback or other unlawful payment of any nature or (vi) violated or operated in noncompliance with any anti-money laundering law, anti-terrorism law or regulation, anti-boycott regulations or embargo regulations, except in the case of clauses (i) through (vi) as would not reasonably be expected to be materially adverse to the Company and its Subsidiaries, taken as a whole.
(d) The Company has made available to Parent accurate and complete copies of (i) the final study reports of all clinical and good laboratory practice (GLP) non-clinical studies conducted by or on behalf of the Company with respect to each Key Product (other than PRO052, PRO055 and PROSPECT) conducted through the date hereof and (ii) all audit reports relating to the drug substance, drug product, packaging and supply of its Subsidiaries aredrisapersen compiled through the date hereof. To the knowledge of the Company, and at all times since January 1required good laboratory practice (GLP) non-clinical studies conducted prior to the date hereof by or on behalf of the Company with respect to drisapersen were included in a submission to the FDA, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly the EMA or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Lawssimilar Governmental Authorities.
(e) Since The Company has delivered or made available to Parent all material forms, licenses, reports, applications, correspondence, and meeting minutes received from or sent to the FDA, the EMA and any other similar Governmental Authority on or after January 1, 20142013 through the date hereof relating to each Key Product (other than PRO052, neither PRO055 and PROSPECT), including any and all written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA, the EMA or comparable foreign Governmental Authorities (in each case, to the extent received on or after January 1, 2013 and prior to the date hereof) which bear in any material way on the Company’s compliance with regulatory requirements of the FDA, the EMA or comparable foreign Governmental Authorities, or on the likelihood or timing of approval of each Key Product (other than PRO052, PRO055 and PROSPECT).
(f) Neither the Company nor any other Person acting on behalf of its Subsidiaries or for the benefit of the Company is marketing, distributing, selling or otherwise commercializing any product on behalf of the Company.
(g) The Company has conducted not received any written notice or initiated other written communication from the FDA, the EMA or any internal other Governmental Authority alleging any material violation of any requirement of Applicable Law, including any failure to maintain systems and programs adequate to ensure compliance with any Applicable Law related to product and trial quality by the Company. The Company has not received any (i) written notices of inspectional observations (including those recorded on Form FDA 483), establishment inspection reports, warning letters, untitled letters, (ii) written notices of any intention to conduct an investigation or made a voluntary, directedreview, or involuntary disclosure to (iii) other documents issued by the FDA, the EMA or any other Governmental Authority with respect to that allege or assert any alleged act or omission arising under or relating to any noncompliance in a material respect lack of compliance with any applicable Anti-Corruption Law, Economic Sanctions/Trade LawApplicable Law by the Company, or Money Laundering Law. Since January 1, 2014, by Persons who are otherwise performing services for the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations benefit of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Lawsthe Company.
Appears in 2 contracts
Samples: Purchase Agreement (Biomarin Pharmaceutical Inc), Purchase Agreement (Prosensa Holding N.V.)
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1December 31, 2014, 2014 have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1December 31, 20142014 through the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) (i) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), ) necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1December 31, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, effect and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1December 31, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, kickbacks or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1December 31, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1December 31, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1December 31, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance non-compliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, Law or Money Laundering Law. Since January 1December 31, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, Laws and Money Laundering Laws.
(f) Neither the Company nor any of its Subsidiaries has violated any applicable export control Law, whether such Law relates to encryption items or otherwise (including the Israeli Defense Export Control Law, 2007, the Israeli Order Governing the Control of Commodities and Services (Engagement in Encryption Items), 1974, the Israeli Order of Import and Export (Supervision of Export of Dual Use Goods, Services and Technologies), 2006, or the Israeli Trading with the Enemy Ordinance, 1939) or any regulations promulgated under any of the foregoing. There are, and since December 31, 2014 there have been, no pending or threatened claims against the Company or any of its Subsidiaries with respect to any marketing, import or export permits, and there are no actions, conditions or circumstances pertaining to the Company’s and its Subsidiaries’ marketing, import or export transactions under any of the Contracts to which any of them is a party that would reasonably be expected to give rise to any future claims.
Appears in 2 contracts
Samples: Purchase Agreement (Mobileye N.V.), Purchase Agreement (Intel Corp)
Compliance with Laws; Regulatory Matters. (a) Other than The Company and each of the Company Subsidiaries is, and since January 1, 2018 has been, in compliance with all Laws and the terms of its Permits, except for non-compliance failures to comply or violations which or alleged violations that have not had and would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Without limiting the generality of the foregoing, each of the Company and each of its the Company Subsidiaries are and, at all times to the Company’s Knowledge, their respective CROs, CMOs or other service vendors or other Persons acting on their behalf are, and have been since January 1, 20142018, have beenacting or operated in material compliance with Health Care Laws, including in connection with the conduct of all Clinical Trials and pre-clinical and non-clinical studies conducted by or on behalf of the Company or any Company Subsidiary with respect to a Product Candidate.
(b) The Company and each Company Subsidiary holds all material Regulatory Permits required for their business as currently conducted. Each such Regulatory Permit is valid and in full force and effect and no such Regulatory Permits will be terminated or become terminable, or be impaired in any material respect, in compliance whole or in part, as a result of the Transactions.
(c) From January 1, 2018, to the Agreement Date, none of the Company nor any Company Subsidiary, nor, to the Company’s Knowledge, their respective CROs, CMOs or other service vendors or other Persons acting on their behalf, has (i) received any written notice from any Governmental Entity or other Person regarding any actual or alleged violation of, or failure to comply with all any provision of, any Law applicable Lawsto, or material Permit (including any Regulatory Permit) held by, such entity or to its assets or properties, or received any FDA Form 483s, warning letters, untitled letters, written notice of potential enforcement proceedings or similar correspondence or written notice from any Governmental Entity, in each case, regarding any Clinical Trials, or any development or manufacturing of any Product Candidate, (ii) received any written notice of any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any material Permit (including any Regulatory Permit) held by such entity, or (iii) filed or otherwise provided any notice or communication to any Governmental Entity or other Person regarding any actual or alleged violation of, or failure to comply with any provision of any Law applicable to, or material Permit (including any Regulatory Permit) held by, such entity or to its assets or properties and, to the Company’s Knowledge, no such self-disclosure to any Governmental Entity is required. To the knowledge Company’s Knowledge, as of the CompanyAgreement Date neither the Company nor any Company Subsidiary is under investigation with respect to any violation of Law or the terms of its Permits. As of the Agreement Date, there is no (i) Judgment outstanding against or affecting the Company or any Company Subsidiary, (ii) Judgment outstanding that affects in any material investigation respect the validity, use, or review enforceability of any assets or properties, including Intellectual Property Rights of the Company or any Company Subsidiaries, or (iii) monitoring agreement, consent decree or other formal or informal agreements of the Company or any Company Subsidiary in effect with or imposed by any Governmental Authority Entity concerning compliance with Health Care Laws, and no such agreement has been threatened against such Persons in writing.
(d) All Regulatory Documentation required to be maintained, filed, submitted, or furnished to a Governmental Entity by or on behalf of the Company or any Company Subsidiary has been so maintained, filed, submitted, or furnished in all material respects. All Regulatory Documentation and conclusions derived therefrom, utilized as the basis for, or submitted in connection with any Product Candidate, when submitted to the relevant Governmental Entity, were complete and correct in all material respects and did not omit any material information as of the date of submission. Any necessary or required updates, changes, corrections, or modifications to such Regulatory Documentation have been timely submitted to the relevant Governmental Entity.
(e) None of the Company or any Company Subsidiary, nor, to the Company’s Knowledge, any CRO, CMO, other Service Provider or other Person acting on its behalf has received notice from any Governmental Entity that (i) any Marketing Approval with respect to a Product Candidate will not or is likely not to be issued, or (ii) asserting in writing that any Regulatory Documentation provided to such Governmental Entity contains deficiencies (unless such deficiencies have been remedied in all material respects) or will not be accepted based on data integrity or other compliance concerns.
(f) None of the Company nor any Company Subsidiary, nor, to the Company’s Knowledge, any CRO, CMO, other Service Provider or other Person acting on its behalf has (i) made an untrue statement of a material fact or fraudulent statement to any Governmental Entity, (ii) failed to disclose a material fact required to be disclosed to any Governmental Entity, or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA to invoke the policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) (the “FDA Fraud Policy”) or for any Governmental Entity to invoke a similar policy that may be applicable in another jurisdiction to the Company or any of its Subsidiaries is pending or is being threatenedthe Company Subsidiaries. To the knowledge None of the Company nor any Company Subsidiary, nor, to the Company’s Knowledge, since any CRO, CMO, other Service Provider, or other Person acting on its behalf is the subject of any pending or, to the Company’s Knowledge, threatened investigation by the FDA under the FDA Fraud Policy, or the subject of any similar investigation by any other Governmental Entity.
(g) None of the Clinical Trials conducted by or on behalf of the Company or any Company Subsidiary with regard to a Product Candidate is or has been (i) the subject of a clinical hold or (ii) terminated or suspended prior to completion for safety or non-compliance reasons. No Governmental Entity that has jurisdiction over any ongoing Clinical Trial conducted with regard to a Product Candidate has initiated or, to the Company’s Knowledge, threatened in writing to initiate any investigation or Action or to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such Clinical Trial, or to disqualify, restrict or debar any Investigator or other Person involved in any such Clinical Trial.
(h) All Regulatory Transfer Approvals have been duly received by or issued to the Company or a Company Subsidiary in connection with its acquisition or receipt of licensing rights to a Product Candidate in the relevant territory.
(i) None of the Company nor any Company Subsidiary nor, to the Company’s Knowledge, any of their respective CROs, CMOs or other service vendors or other Persons acting on their behalf, employs or contracts with any Persons that are debarred pursuant to Section 306 of the FDCA or foreign equivalent, or that are disqualified pursuant to 21 C.F.R. Part 312.70 or foreign equivalent, or that have been debarred, excluded, or suspended from participation in any health care program. No Actions that could result in such a debarment, disqualification, or exclusion are pending or, to the Company’s Knowledge, threatened against any of the foregoing Persons.
(j) None of the Company nor any Company Subsidiary, nor to the Company’s Knowledge, any of their respective CROs, CMOs or service vendors, has received written notice (i) of any alleged material noncompliance, major or critical findings, as a result of any internal audit or inspection or any audit or inspection performed by or on behalf of a Governmental Entity or other Person in connection with, related to, or affecting any Product Candidate or (ii) of any alleged falsification or fraudulent activity regarding any Regulatory Documentation generated or submitted to any Person in connection with, related to, or affecting any Product Candidate. Copies of any such audit, inspection, and corrective action material has been Made Available.
(k) From January 1, 20142018 to the Agreement Date, there have been no Unexpected Adverse Events, investigator notices in writing, or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance or any other corrective action in relation to any Product Candidate (collectively, “Safety Notices”). There have been no material product complaints with respect to any Product Candidate, and there are no facts that would be reasonably likely to result in any of the following: (i) a material Safety Notice with respect to any Product Candidate, or (ii) a termination or suspension of testing (including Clinical Trials) of any Product Candidate.
(l) As of the Agreement Date, neither the Company nor any of its Subsidiaries Company Subsidiary has received any written coverage or oral notice reimbursement decision or communication that determination from any government payor.
(m) To the Company’s Knowledge, each Contract of the Company or any Company Subsidiary with an HCP (including for employment, consulting, speaking, authorship, advisory board services or otherwise) (i) complies with applicable Health Care Laws in all material respects; (ii) requires the performance of its Subsidiaries are necessary services with a legitimate business purpose, (iii) provides compensation that is materially consistent with fair market value in violation of an arms-length transaction and (iv) has been entered into only upon the HCP and the applicable counterparty making any required disclosures to and/ or receiving consent from, any applicable Law, except for such violations that Governmental Entity and/or institution with which the HCP is affiliated (if any). Except as has not had and would not have or reasonably be expected to havenot, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect, the Company or the Company Subsidiary party to such Contract with an HCP has documentation demonstrating the need for such services and the basis for the value of the compensation provided. Each of the Company and the Company Subsidiaries also has disclosed to customers, Governmental Entities or other entities, as applicable, option awards to HCPs or actual ownership of the Company by HCPs (if any). Each HCP has obtained any material patient consents in connection with such HCP’s provision of services to the Company or any Company Subsidiary.
(n) To the Company’s Knowledge, each HCP or other Person performing services on behalf of the Company or any Company Subsidiary (i) The Company has at all relevant times obtained and each of its Subsidiaries hold all authorizationsmaintained in good standing any Permits or professional licensure, licensesaccreditation, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations qualification and clearances of any Governmental Authority (training required for such Person to provide the “Company Permits”particular services in the applicable jurisdiction(s), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effecthas not had a Permit or professional license or accreditation suspended or revoked or otherwise restricted, and (iii) as of has not been and is not currently the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice subject of any violation disciplinary actions or failure to comply with investigations by any Company Permit and no suspension, modification, revocation or cancellation of any Governmental Entity. Each of the Company Permits is, to and the knowledge Company Subsidiaries has provided or ensured the provision of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) all material cGCP and (iii)material protocol and project-specific training, as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectrequired by Health Care Laws.
(co) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary Each Contract of the Company or any Company Subsidiary with any Person for services related to the Representative knew promotion or ought reasonably to have known (after due and proper inquiry) that all or marketing of a portion of such money or thing of value would be offeredProduct Candidate, givenmarket access, or promised, directly or indirectly, to a Person sales force assistance (Ai) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance complies with applicable Health Care Laws in all material respects respects; (ii) requires the performance of necessary services with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do nota legitimate business purpose, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea (iii) provides compensation that is materially consistent with fair market value in violation in any material respect of applicable Economic Sanctions/Trade Lawsan arms-length transaction.
(e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Laws.
Appears in 2 contracts
Samples: Merger Agreement (Urovant Sciences Ltd.), Merger Agreement (Sumitomo Chemical Co., Ltd.)
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the The Company and each of its Subsidiaries are and, at all times since January 1, 20142009, have been, been in compliance with all Laws applicable Lawsto their businesses, operations, properties or assets, except where any non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect. To the knowledge None of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Companyhas received, since January 1, 20142009, neither written notice or any other written communication alleging or relating to a possible material violation of any Law applicable to their businesses, operations, properties or assets. The Company and each of its Subsidiaries hold all permits, licenses, variances, exemptions, authorizations, operating certificates, franchises, orders, clearances and approvals of all Governmental Entities (collectively, “Permits”) necessary for them to own, lease or operate their properties and assets and to carry on their businesses and operations as now conducted, except for any failure to hold such Permits that, individually or in the aggregate, would not reasonably be expected to have a Company Material Adverse Effect, and there has occurred no violation of, default (with or without notice or lapse of time or both) under or event giving to others any right of revocation, non-renewal, adverse modification or cancelation of, with or without notice or lapse of time or both, any such Permit, nor would any such revocation, non-renewal, adverse modification or cancelation result from the consummation of the transactions contemplated hereby, except for such violations, defaults, revocations, non-renewals, modifications or cancelations that, individually or in the aggregate, would not reasonably be expected to have a Company Material Adverse Effect. Notwithstanding anything to the contrary in this Section 3.11(a), no representation or warranty is made in this Section 3.11(a) in respect of the matters referenced in Section 3.12, Section 3.13, Section 3.14, Section 3.15 and Section 3.24.
(b) Neither the Company nor any of its Subsidiaries is subject to any consent decree from any Governmental Entity. Neither the Company nor any of its Subsidiaries has received any written warning or oral notice or communication that untitled letter from the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company U.S. Food and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority Drug Administration (the “Company PermitsFDA”)) or equivalent action from any comparable non-U.S. Governmental Entity since May 8, necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither 2007. Neither the Company nor any of its Subsidiaries has received any written notice of communication from any violation regulatory agency or failure to comply with been notified since May 8, 2007 that any Company Permit and no suspensionproduct approval is withdrawn or modified or that such an action is under consideration. Without limiting the foregoing, modification, revocation or cancellation of any of the Company Permits isand each of its Subsidiaries is in compliance, to in all material respects, with all current applicable statutes, rules, regulations, guidelines, policies or orders administered or issued by the FDA, including the Public Health Service Act (“FDA Laws”) or comparable foreign Governmental Entity (“Foreign Device Laws”) including FDA’s Quality System Regulation, 21 C.F.R. Part 820 and requirements for Investigational Device Exemptions, 21 C.F.R. Part 812. To the knowledge of the Company, pending or threatened, except, there are no facts that would be reasonably likely to result in any Form FDA-483 other than those issues that have been entered into the case of each of clauses Company’s corrective and preventive action (i), (iiCAPA) and (iii)system, as would not established within the Company’s quality system. Since May 8, 2007, there have been no recalls, detentions, withdrawals, seizures, or reasonably be expected termination or suspension of manufacturing requested or threatened relating to havethe Company’s or its Subsidiaries’ products. Since January 1, individually 2009, there have been no material field notifications, material field corrections or in the aggregate, a Company Material Adverse Effectmaterial alerts.
(c) Except as would not be materialAll pre market notifications under Section 510(k) of the Federal Food, since January 1Drug and Cosmetic Act, 201421 U.S.C. § 360(k), and 21 C.F.R. Part 807, Subpart E (“510(k)s”) and pre-market approval applications approved by the FDA in accordance with 21 U.S.C. § 360(e) and 21 C.F.R. Part 814 (“PMAs”) for the Company’s and its Subsidiaries’ products are exclusively owned by the Company or one of its Subsidiaries, and there is no reason to believe that the FDA is considering limiting, suspending, or rescinding any such 510(k)s or PMAs or changing the marketing classification or labeling of any such products. To the knowledge of the Company, there is no false information or significant omission in any product application or product-related submission to the FDA or comparable foreign Governmental Entity. The Company and its Subsidiaries have obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by the Company, and the Company has not received any notice that any Governmental Entity seeks any material additional conditions on the distribution or sale of products in a jurisdiction covered by a regulatory approval. To the knowledge of the Company and its Subsidiaries, any third party that is a manufacturer, contractor, or agent for the Company or its Subsidiaries is in compliance with all Permits and regulatory approvals from the FDA or comparable Governmental Entity insofar as they pertain to the manufacture of product components or products for the Company or its Subsidiaries.
(id) neither Neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, nor any officer, director, managing employee or agent, nor any Representative individual with a five percent (5%) or greater direct or indirect ownership interest, (as those terms are used in obtaining 42 C.F.R. § 1001.1001) of the Company or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company: (i) has engaged in any activities that are material violations of, or are cause for civil penalties or mandatory or permissive exclusion under, any federal or state health care Law, including Sections 1128, 1128A, 1128B, 1128C or 1877 of the U.S. Federal Social Security Act (together with all regulations promulgated thereunder, the “SSA”), the federal TRICARE statute (10 U.S.C. § 1071 et seq.), the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.), the False Statements Accountability Act (18 U.S.C. § 1001), the Program Fraud Civil Remedies Act of 1986 (31 U.S.C. § 3801 et seq.), 18 U.S.C. § 287, the anti-fraud and related provisions of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (e.g., 18 U.S.C. §§ 1035 and 1347), or related federal, state or local statutes; (ii) has engaged in any activities that are material violations of any non-U.S. Law restricting the ability to use or disclose personally identifiable patient health information; (iii) has knowingly and willfully offered, paid, solicited or received any remuneration (interpreted in accordance with 42 U.S.C. § 1320a-7b), directly or indirectly, overtly or covertly, in cash or in kind, in return for, or to induce, the purchase, lease, or order, or the arranging for or recommending of the purchase, lease or order, of any item or service for which payment may be made in whole or in part under any Federal Health Care Program, as defined in 42 U.S.C. § 1320a-7b(f); (iv) has had a civil monetary penalty assessed against them under Section 1128A of SSA; (v) has been excluded from participation under any Federal Health Care Program, or any Representative comparable state health care program or non-U.S. health care program; (vi) has been convicted (as defined in 42 C.F.R. § 1001.2) of any of the categories of offenses described in Sections 1128(a) or 1128(b)(1), (b)(2), or (Bb)(3) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business SSA or any improper advantage.
non-U.S. Law of comparable scope; or (dvii) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation has failed to comply in any material respect with any federal or state Law regarding disclosure of applicable Economic Sanctions/Trade Lawsphysician payments.
(e) Since January 1, 2014, neither All Contracts and other financial relationships between the Company nor any of or its Subsidiaries has conducted or initiated any internal investigation or made a voluntaryand customers, directedvendors, or involuntary disclosure to any Governmental Authority employees, agents and contractors are in material compliance with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption all health care Laws, Economic Sanctions/Trade Laws, including state and Money Laundering federal anti-kickback Laws and state and federal self-referral Laws.
Appears in 2 contracts
Samples: Merger Agreement (TomoTherapy Inc), Merger Agreement (Accuray Inc)
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, Section 3.8(a) of the Company Disclosure Schedule contains a true, correct and each complete list of its Subsidiaries are andall material federal, at all times since January 1state, 2014county, local and foreign permits (including, without limitation, 510(k) clearances, Medicare, Medicaid and other provider numbers, certifications and other permits (other than Environmental Permits)) that have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect been issued to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication Subsidiary and that the Company or any of its Subsidiaries are currently in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority effect (the “"Company Permits”Licenses"), and these Company Licenses constitute all the material permits necessary for the conduct of the Current Company Business and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms use of the Company Permits in all respects, and all of the Facilities as currently used. Each Company Permits are License is valid and in full force and effect, and (iii) as . To the Knowledge of the date Company, each of this Agreementthe Company and its Subsidiary is in compliance in all material respects with all terms and conditions of the Company Licenses. There is no investigation or proceeding pending or, to the Knowledge of the Company, threatened that could result in the termination, revocation, suspension, or restriction of any Company License or the imposition of any fine, penalty or other sanctions for violation of any legal or regulatory requirements relating to any Company License. None of the Company Licenses shall be adversely affected in any material respect by the consummation of the Transactions.
(b) To the Knowledge of the Company, neither the Company nor its Subsidiary has made an untrue statement of a material fact to any Governmental Authority or failed to disclose a material fact required to be disclosed to any Governmental Authority and neither the Company nor its Subsidiary has committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, might reasonably be likely to provide a basis for any Governmental Authority to invoke the U.S. Food and Drug Administration ("FDA") policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities", set forth in 56 Fed. Reg. 46191 (September 10, 1991), as amended, or any similar policy Neither the Company, its Subsidiary nor, to the Knowledge of the Company, any of its Subsidiaries their respective officers, employees or agents has received any written notice been convicted of any violation crime or failure engaged in any conduct that would reasonably be expected to comply result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable state Law. To the Knowledge of the Company, no debarment proceedings or investigations in respect of the Current Company Business or Company Products are pending or threatened against the Company, its Subsidiary or any of their respective officers, employees or agents.
(c) All Company Products have been manufactured and marketed in substantial compliance with any all applicable provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended, and all regulations promulgated thereunder (the "FDCA"), the European Union Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices, as amended, and other applicable Laws. Without limiting the generality of the preceding sentence, (i) the Company Permit is legally authorized to manufacture and no suspension, modification, revocation to sell all Company Products under a 510(k) premarket clearance or cancellation of any CE xxxx issued in the name of the Company Permits isor is exempt from pre-market notification requirements; (ii) all Company Products are produced by properly registered facilities and have been correctly classified and listed with the appropriate Governmental Authority; (iii) all labeling/marketing literature, advertising and web content related to currently marketed Company Products, including indications and intended uses, are covered by the applicable 510(k) clearance or CE xxxx and meet regulatory requirements; (iv) the Company Products are not subject to recall or regulatory action by a Governmental Authority; (v) the facilities at which the Company Products are manufactured and the processes by which they are manufactured are not subject to any regulatory enforcement actions, including FDA Form 483 inspectional observations, FDA Warning Letters, FDA Untitled Letters, civil penalties, FDA prosecution, or FDA injunction, and comply substantially with the GMP regulations (as defined by FDA at 21 C.F.R. Part 820) and other comparable regulatory requirements; (vi) to the Knowledge of the Company, there are no previous or current product or labeling recalls, remediations, corrections or removals that have not been reported to a Governmental Authority, to the knowledge extent such reporting is required, and that any adverse events or reports of death or serious injury related to any Company Product has been reported to a Governmental Authority, to the extent such reporting is required; (vii) all Company Products properly bear or, to the Knowledge of the Company, bore as applicable, a CE xxxx or otherwise comply or complied, as applicable, in all respects with any similar requirements imposed under the Laws of any foreign country in which the Company Products are or were, as applicable, sold; (viii) the Company has all required records relating to such compliance, including technical files, design history files, clinical studies and validations; and (ix) any clinical studies for Company Product approvals or clearances, currently or previously undertaken by or on behalf of the Company have been authorized or approved by the necessary Governmental Entities, to the extent such authorization or approval is required, and have been conducted in compliance with applicable Laws relating to authorization, approval, conduct and patient rights, and all data submitted in support of the marketing of the Products to any Governmental Entities accurately describes the results of such clinical studies.
(d) Neither the Company nor its Subsidiary is now, nor has been since January 1, 2012, in default or material violation of any Law applicable to the Company or its Subsidiary or by which any property or asset of the Company or its Subsidiary is bound, including, (i) Section 1877 of the Social Security Act, codified as the Ethics in Patient Referrals Act of 1989, 42 U.S.C. § 1395nn, as amended, and all regulations promulgated thereunder (known as the "Xxxxx Law"), (ii) Section 1128B(b) of the Social Security Act, codified as the Medicare and Medicaid Patient Protection Act of 1987, 42 U.S.C. § 1320a-7b(b), as amended, and all regulations promulgated thereunder (known as the "Anti-Kickback Statute"), (iii) the federal False Claims Act, 31 U.S.C. § 3729, as amended, and all regulations promulgated thereunder, (iv) the Occupational Safety and Health Act of 1970, as amended, and all regulations promulgated thereunder that apply to the Company or its Subsidiary or the Current Company Business (known as "OSHA"), (v) the FDCA, (vii) state anti-kickback, fee-splitting and patient brokering Laws, (ix) Information Privacy and Security Laws, and (x) state Laws governing the foregoing.
(e) Neither the Company nor its Subsidiary nor any of their respective officers, directors, managing employees or agents nor, to the Knowledge of the Company, any other employees of the Company or its Subsidiary, have engaged in any activities which are cause for criminal or material civil penalties against, or mandatory or permissive exclusion of, the Company from Medicare, Medicaid, or any other federal health care program under 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, or 1395nn, or any similar Law, or the regulations promulgated pursuant to such Laws or related state or local Laws.
(f) The Company's and its Subsidiary's past and present collection, use, analysis, disclosure, retention, storage, security and dissemination of Personal Information comply in all material respects with, and have not violated, (i) any and all applicable Laws, including Information Privacy and Security Laws, (ii) business associate agreements to which the Company or its Subsidiary is a party, (iii) any Person's right of publicity and (iv) each of the Company's and its Subsidiary's privacy policies. To the extent required by applicable Law, each of the Company and its Subsidiary has posted in accordance with Information Privacy and Security Laws a privacy policy governing its use of Personal Information on its website and has complied at all times with such privacy policy.
(g) To the Knowledge of the Company, there are no investigations, suits, claims, actions or proceedings against or affecting the Company or its Subsidiary, pending or threatened, exceptrelating to or arising under (i) the FDCA or the regulations of the FDA promulgated thereunder or similar Laws, (ii) Information and Privacy Security Laws, including alleging a violation of any Person's rights under any Information Privacy and Security Laws or the Company's or its Subsidiary's former or current published privacy policies, or (iii) any other applicable Laws. Neither the Company nor its Subsidiary has received any notices from the United States Department of Health and Human Services Office for Civil Rights, Department of Justice, Federal Trade Commission, the Attorney General of any state or any other Governmental Authority relating to any such violations. Neither the Company nor its Subsidiary has acted in or is acting in a manner that would reasonably be expected to trigger a notification or reporting requirement under any applicable Law or business associate agreement to which the Company or its Subsidiary is a party, or any Information Privacy and Security Laws related to the disclosure of Personal Information. To the Knowledge of the Company, there are no facts, circumstances or conditions that would reasonably be expected to form the basis for any investigation, suit, claim, action, proceeding or imposition of any penalties against or affecting the Company of its Subsidiary relating to or arising under any applicable Law that has had or would reasonably be expected to have a Company Material Adverse Effect, individually or in the aggregate.
(h) There are no pending, concluded, since January 1, 2012, or, to the Knowledge of the Company, threatened investigations, suits, claims, actions or proceedings relating to the Company's or its Subsidiary's participation in any payment program, including without limitation, Medicare, Medicaid, and private third party payor programs ("Payment Programs"). Neither the Company nor its Subsidiary is subject to, nor, since January 1, 2012, has the Company or its Subsidiary been subjected to, any pre-payment utilization review or other utilization review by any Payment Program. No Payment Program is currently requesting or has requested since September 30, 2011 or, to the Knowledge of the Company, is threatening or has since January 1, 2012 threatened any recoupment, refund, or set-off from the Company or its Subsidiary in excess of $10,000. Since January 1, 2012, no Payment Program has imposed a fine, penalty or other sanction on the Company or its Subsidiary. Since January 1, 2012, neither the Company nor its Subsidiary has been excluded from participation in any Payment Program. All billing practices of the Company and its Subsidiary with respect to all Payment Programs have been in compliance with all Laws applicable to the Company and its Subsidiary in all material respects.
(i) The negotiation, execution and consummation of the Transactions will not breach or otherwise violate any applicable Information Privacy and Security Laws, or current published privacy policy applicable to the Company or its Subsidiary.
(j) Complete and accurate copies of the compliance policies and/or procedures and privacy notices of the Company and its Subsidiary relating to Information Privacy and Security Laws have been furnished or made available to Parent. All of the Company's and its Subsidiary's employees who have access to Personal Information that is subject to Information Privacy and Security Laws have received training with respect to compliance with Information Privacy and Security Laws.
(k) To the extent required under the Information Privacy and Security Laws, the Company and its Subsidiary have taken reasonable measures consistent with reasonable industry practices and in compliance with applicable Laws to ensure that Personal Information is protected against loss and unauthorized access, acquisition, use, modification, disclosure or other misuse, and there has been no known unauthorized access, acquisition, use, disclosure, compromise or other misuse of such Personal Information.
(l) Neither the Company nor its Subsidiary collects, has access to, uses or discloses Personal Information that constitutes protected health information under HIPAA.
(m) Neither the Company nor any of the Company's directors, officers, employees or agents have, directly or indirectly, made, offered, promised or authorized any payment or gift of any money or anything of value to or for the benefit of any "foreign official" (as such term is defined in the U.S. Foreign Corrupt Practices Act (the "FCPA")), foreign political party or official thereof or candidate for foreign political office for the purpose of (i) influencing any official act or decision of such official, party or candidate, (ii) inducing such official, party or candidate to use his, her or its influence to affect any act or decision of a foreign governmental authority or (iii) securing any improper advantage, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected ) above in order to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither assist the Company nor or any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative affiliates in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Lawsperson. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1, 2014, neither Neither the Company nor any of its Subsidiaries directors, officers, employees or agents have made or authorized any bribe, rebate, payoff, influence payment, kickback or other unlawful payment of funds or received or retained any funds in violation of any law, rule or regulation. The Company further represents that it has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Lawsmaintained, and Money Laundering Lawshas caused each of its subsidiaries and affiliates to maintain, systems of internal controls (including, but not limited to, accounting systems, purchasing systems and billing systems) to ensure compliance with the FCPA or any other applicable anti-bribery or anti-corruption law.
Appears in 1 contract
Samples: Merger Agreement (Opgen Inc)
Compliance with Laws; Regulatory Matters. (a) Other than (i) Sellers are, and have been since January 1, 2021, in material compliance with all applicable Laws, except for non-compliance any noncompliance, either individually or violations in the aggregate, which would not be material to Sellers, (ii) Sellers have not received any written or, to the Knowledge of Sellers, oral notice alleging any material noncompliance by any Seller with respect to any such Law and (iii) Sellers have not received any written, to the Knowledge of Sellers, oral notice of any investigation by any Governmental Authority regarding an alleged violation of any such Law.
(b) (i) Sellers have not received any adverse communication from any Governmental Authority directly relating to the Product Compound or IV Product or the facilities in which the Product Compound or IV Product is manufactured that has not been fully resolved, including any FDA Form 483 or warning letters directly relating to the Product Compound or IV Product or the facilities in which the Product Compound or IV Product is manufactured or any “Notices of Adverse Findings” from the FDA or similar notices from other Governmental Authority with respect to the Product Compound or IV Product, (ii) there has not been any recall, field correction, market withdrawal or replacement (whether voluntary, involuntary or actual) or other notice of action relating to any alleged lack of safety, efficacy or regulatory compliance concerning the Product Compound or IV Product conducted by or on behalf of Sellers or, to the Knowledge of Sellers, threatened in writing product liability or warranty claim and (iii) no Product Compound or IV Product has been discontinued, suspended or seized due to safety concerns. To the Knowledge of Sellers, there are no facts existing that would be reasonably likely to result in (i) any product recall, field correct or market withdrawal or replacement or other notice of action relating to any alleged lack of safety, efficacy or regulatory compliance concerning the Product Compound or IV Products, (ii) any change in labeling of the Product Compound or IV Products due to safety or efficacy concerns or (iii) termination or suspension of marketing or testing of the Product Compound or IV Products, in each case of the foregoing clauses (i) through (iii), except as has not been and would not reasonably be expected to havebe, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company Business or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse EffectTransferred Assets.
(ic) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits All Transferred Regulatory Filings are valid and in full force and effect. To the Knowledge of Sellers, and (iii) as no event has occurred that, with or without notice or lapse of the date of this Agreementtime or both, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or result in the aggregaterevocation, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, to the knowledge suspension or limitation of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantageTransferred Regulatory Filings.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Laws.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the The Company and each of its Subsidiaries are andin compliance with, at all times and since January 1, 2014, 2013 have been, been in compliance with all applicable Laws. To with, and to the knowledge of the Company, no material are not under investigation or review by any Governmental Authority with respect to the Company and have not been threatened to be charged with or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any given written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable violation of, any Applicable Law, except for such violations to the extent that any non-compliance, investigation or violation would not have or reasonably be expected to havebe materially adverse to the Company and its Subsidiaries, individually or in the aggregate, taken as a Company Material Adverse Effectwhole.
(ib) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses in all respects as currently conductedconducted (the “Company Permits”), (ii) except as would not reasonably be expected to be materially adverse to the Company and its Subsidiaries, taken as a whole. The Company and each of its Subsidiaries are, are and at all times since January 1, 2014 2013 have been, been in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effecteffect in all respects, except as would not reasonably be expected to be materially adverse to the Company and (iii) its Subsidiaries, taken as a whole. As of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits isis to the knowledge of the Company pending or threatened, nor, to the knowledge of the Company, pending or threateneddo reasonable grounds exist for any such action, except, in the case of each of clauses (i), (ii) and (iii), except as would not have or reasonably be expected to havebe materially adverse to the Company and its Subsidiaries, individually or in the aggregate, taken as a Company Material Adverse Effectwhole.
(c) Except as would not reasonably be materialexpected to be materially adverse to the Company and its Subsidiaries, taken as a whole, since January 1, 20142013, to the knowledge none of the Company, (i) neither the Company nor or any of its Subsidiaries has, nor have or any of their Representativesrespective directors, violated any Anti-Corruption Laws and (ii) neither officers, employees, representatives, distributors, consultants or agents acting directly for or on behalf of the Company nor any of or its Subsidiaries has, nor have any in the course of their Representativeshis, her or its actions (i) made, offered, paid, promised to paypromised, or authorized the payment any illegal contributions, gifts, entertainment or payments of any moneyother expenses, or in each case from corporate funds, related to political activity, (ii) unlawfully made, offered, given, promised to givepromised, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value or any direct or indirect unlawful payments to any foreign or domestic Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1A) influencing any act or decision of such person in their capacity as a Government Official in their official capacityOfficial, (2B) inducing a Government Official to do or omit to do any act in violation of their his or her lawful duties, (3C) securing any improper advantage, advantage or (4D) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the CompanyAuthority, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruptionbribery, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
, (diii) The made, offered, promised, or authorized any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment of any nature to any Government Official or (iv) violated any provision of the Foreign Corrupt Practices Act (the “FCPA”) the U.K. Xxxxxxx Xxx 0000 (the “Bribery Act”) or any other Applicable Laws, regulations or conventions to which the Company and each or any of its Subsidiaries areis subject relating to corruption (governmental or commercial), bribery, money laundering, political contributions or gifts, entertainment, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectlygratuities, involving Cubaor to any Governmental Authority or any Government Official or commercial entity, Iranincluding all national and international laws enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions (collectively, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade “Other Anticorruption Laws.
(e) ”). Since January 1, 20142013, neither none of the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a 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 noncompliance with the FCPA, the Bribery Act or any Other Anticorruption Law. Neither the Company nor its Subsidiaries have received any written notice, request, or citation for any actual or potential noncompliance with any of the foregoing in this Section 3.13(c).
(d) None of the Company’s directors or officers or, to the knowledge of the Company, employees, representatives, distributors, consultants or agents, acting directly for or on behalf of the Company, is currently a Sanctions Target or is located, organized or resident in a material respect country or territory that is a Sanctions Target.
(e) At no time during the prior five (5) years has the Company, any of its Subsidiaries, or any of their directors or officers or, to the knowledge of the Company, employees, representatives, consultants or agents, acting directly for or on their behalf, violated applicable Sanctions Laws and Regulations.
(f) At no time during the prior five (5) years has the Company, any of its Subsidiaries, or any of their directors or officers, or, to the knowledge of the Company, employees, representatives, consultants or agents, knowingly engaged in any dealings or transactions with any applicable Anti-Corruption Law, Economic Sanctions/Trade Lawperson, or Money Laundering Law. Since January 1in any country or territory, 2014that is a Sanctions Target, nor is the Company or any of its Subsidiaries currently engaged in any such activities.
(g) The operations of the Company and its Subsidiaries have implemented been conducted at all times in compliance in all material respects with the applicable financial recordkeeping and maintained internal controlsreporting requirements of the U.S. Currency and Foreign Transaction Reporting Act of 1970, policies and procedures reasonably designed to detectas amended, prevent and deter material violations the U.S. Money Laundering Control Act of Anti-Corruption Laws1986, Economic Sanctions/Trade Lawsas amended, and all money laundering-related laws of other jurisdictions where the Company and its Subsidiaries conduct business or own assets, and any related or similar Law issued, administered or enforced by any Governmental Authority (collectively, the “Money Laundering Laws”). No proceeding by or before any Governmental Authority involving the Company or its Subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, is threatened.
(h) The Company and its Subsidiaries have, to the extent required by Applicable Law, maintained, in all material respects, complete and accurate books and records concerning records of payments to any agents, distributors, consultants, representatives, third parties, and Government Officials in accordance with GAAP.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Other than for non-The Company is not in breach or violation of, or default under, and has never been in breach or violation of, or default under its Constitutive Documents. The Company and the Parent are, and since their formation have been, in material compliance with all applicable Laws and Judgments of any Governmental Entity applicable to them or violations which to the conduct by the Company or the Parent of their respective business, or the ownership or use of any of their respective assets and properties, including the Leased Properties. Neither the Company nor the Parent have received, since their formation, a written or, to the Company’s knowledge and the Parent’s knowledge, oral notice or other communication alleging a possible violation by the Company or the Parent of any applicable Law or Judgment of any Governmental Entity applicable to their respective businesses or operations. No event has occurred nor, to the Company’s knowledge or the Parent’s knowledge, does any circumstance exist, that would not have or reasonably be expected to have, individually or in give rise to any obligation on the aggregate, a Company Material Adverse Effect, the Company and each part of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or the Parent to undertake, or to bear all or any of its Subsidiaries is pending or is being threatened. To the knowledge portion of the Companycost of, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation material remedial action of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectnature.
(ib) The Company Company’s engineered microbes and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries areproduct candidates are being, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respectsdeveloped, tested, labeled, manufactured, stored, imported, exported and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii)distributed, as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have beenapplicable, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws Laws, including the FFDCA (including, as applicable, those requirements relating to GMP, GLP, GCP, investigational use, pre-market approval and applications to market a new pharmaceutical product and all applicable Money Laundering LawsLaws referred to in EudraLex Volume 10 (Guidelines for Clinical Trials)). The Company and each of its Subsidiaries do notAffiliates have generated, prepared, maintained and have not since January 1retained all materials that are required to be generated, 2014prepared, carried on any business, directly maintained or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority retained with respect to any alleged act or omission arising under or relating to any noncompliance the Company’s engineered microbes and product candidates pursuant to, and in a material respect with any accordance with, GMP, GLP, GCP and other applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Laws.all such materials are true, correct and complete. Neither
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Compliance with Laws; Regulatory Matters. (a) Other than for non-Each of the Company and its Subsidiaries is in compliance with all Law, including Law enforced by the United States Food and Drug Administration (“FDA”) and comparable foreign regulatory or violations which governmental entities, except where the failure to so comply would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(ib) The Company (i) is not and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of has not been debarred from participation in any Governmental Authority program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (the a) or (b) (“Company PermitsDebarred”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) does not employ or use the Company and each services of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, any person or entity that is Debarred and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending has not employed or threatenedused the services of any person or entity that is or, exceptduring the time when such person or entity was employed by or providing services to the Company, was Debarred, except in the case of each of clauses (i), (ii) and this clause (iii), ) as would not have or reasonably be expected to have, individually or in the aggregate, have a Company Material Adverse Effect.
(c) Except Each of the products and product candidates of the Company and its Subsidiaries is being, and at all times has been, developed, tested, manufactured and stored, as applicable, in compliance with the FDA Act and applicable regulations issued and guidances by the FDA, including those requirements relating to good manufacturing practice, good laboratory practice and good clinical practice, except where the failure to so comply would not reasonably be materialexpected to have a Company Material Adverse Effect.
(d) The Company has made available to Parent each annual report filed by any of the Company and its Subsidiaries with the FDA and any similar state or foreign regulatory or governmental entity with respect to any products and product candidates of the Company or its Subsidiaries.
(e) The Company has made available to Parent as of the date hereof (A) complete and correct copies of each New Drug Application (“NDA”) and each Investigational New Drug application (“IND”), since January 1and each similar state or foreign regulatory filing made on behalf of any of the Company and its Subsidiaries, 2014including all supplements and amendments thereto, (B) all correspondence, other than immaterial correspondence, sent to and received from the FDA and similar state and foreign Governmental Authorities that concerns or would reasonably be expected to impact a product or product candidate of the Company or its Subsidiaries, and (C) all existing written records relating to all material discussions and all meetings between the Company or its Subsidiaries and the FDA or similar foreign regulatory or governmental entities.
(f) The clinical trials (including any post-marketing studies), animal studies and other preclinical tests conducted by the Company or its Subsidiaries were, and if still pending, are, being conducted in all material respects in accordance with all experimental protocols, informed consents, procedures and controls of the Company and its subsidiaries and applicable FDA requirements including, but not limited to, good clinical practice and good laboratory practice regulations. Neither the Company nor its Subsidiaries has received any written notice from the FDA or any other regulatory or governmental entity requiring the termination or suspension or material modification of any animal study, preclinical study or clinical trial conducted by or on behalf of the Company or any Subsidiary which termination, suspension or modification would reasonably be expected to have a Company Material Adverse Effect.
(g) None of the Company and its Subsidiaries is subject to any pending or, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person threatened investigation by (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacityFDA, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute Department of Health and Human Services Office of Inspector General or have Department of Justice pursuant to the purpose Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b) (known as the “Anti-Kickback Statute”) or effect of public or commercial bribery or corruption, acceptance ofthe Federal False Claims Act (31 U.S.C. Section 3729), or acquiescence in extortion, kickbacks, (C) any equivalent statute of similar foreign regulatory or other unlawful or improper means of obtaining business or any improper advantagegovernmental entities.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Laws.
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Compliance with Laws; Regulatory Matters. (ai) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, The business of the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, is being conducted in compliance in all material respects with all applicable Laws. To The Company is not debarred under the knowledge Generic Drug Enforcement Act of 1992 or otherwise excluded from or restricted in any manner from participation in, any government program related to pharmaceutical products and, to its knowledge, does not employ or use the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation services of any applicable Law, except for such violations that would not have individual who is debarred or reasonably be expected to have, individually otherwise excluded or in the aggregate, a Company Material Adverse Effectrestricted.
(iii) The Company and each of its Subsidiaries hold has all authorizationspermits, licenses, permits, certificates, filings, consentsfranchises, variances, exemptions, waiversorders and other governmental authorizations, approvalsconsents and approvals from Governmental Entities (“Permits”) that are necessary to conduct the Company’s business as currently conducted and where the failure to have such Permits would, Orderseither individually or in the aggregate, registrations and clearances of any Governmental Authority be reasonably likely to have a Material Adverse Effect (such Permits, the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the . All such Company Permits are valid and in full force and effect. Each of the Company and its Subsidiaries is, and (iii) as of at all times from January 1, 2003 through the date of this AgreementAgreement has been, neither in material compliance with the terms and requirements of such Company Permits. Since January 1, 2003, none of the Company nor any of and its Subsidiaries has received any written notice regarding (A) any actual or possible violation of any violation or failure to comply with any term or requirement of any Company Permit and no Permits, or (B) any actual or possible revocation, withdrawal, suspension, modificationcancellation, revocation termination or cancellation modification of any Company Permits. No Governmental Entity has at any time since January 1, 2003 challenged in writing the right of any of the Company Permits isand its Subsidiaries to develop, to the knowledge of the Companymanufacture, pending market, license, distribute, promote, offer or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effectsell any products.
(ciii) Except as would not be material, since January 1, 2014, to the knowledge Each of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary product candidates of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries areis being, and at all times since January 1, 2014 have 2003, as applicable, has been, developed, tested, manufactured and stored, as applicable, in substantial compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. .
(iv) The Company has made available to Parent each annual report filed by any of the Company and each of its Subsidiaries do not, with the United States Food and have not Drug Administration (the “FDA”) with respect to any products of the Company or its Subsidiaries or any similar state or foreign Governmental Entity since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws2003.
(ev) The Company has made available to Parent (A) accurate copies of those portions of each New Drug Application (“NDA”), and each similar state or foreign regulatory filing made on behalf of any of the Company and its Subsidiaries since January 1, 2003, including all supplements and amendments and (B) certain correspondence received from the FDA and similar state and foreign Governmental Entities since January 1, 2003 that concerns a product of the Company or its Subsidiaries, in the case of (A) and (B) as set forth in Section 3.1(t)(v) of the Company Disclosure Schedule.
(vi) None of the Company and its Subsidiaries is subject to any pending or, to the knowledge of the Company, threatened, investigation by (A) the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), (B) Department of Health and Human Services Officer of Inspector General or Department of Justice pursuant to the Federal Anti-Kickback Statute (42. U.S.C. Section 1320a-7(b)) or the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), or (C) any equivalent statute of any country in the European Union. None of the Company and its Subsidiaries, nor to the knowledge of the Company (1) any officer or employee of the Company and its Subsidiaries, (2) any authorized agent of the Company and its Subsidiaries or (3) any principal investigator or sub-investigator of any clinical investigation sponsored by the Company or its Subsidiaries has, in the case of each of (1) through (3) on account of actions taken for or on behalf of the Company or any of its Subsidiaries, been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or foreign Law or under 21 U.S.C. Section 335a(b) or any similar state or foreign Law.
(vii) Since January 1, 20142003, neither no clinical trial of a product of the Company nor or any of its Subsidiaries has conducted been suspended, put on hold or initiated terminated prior to completion.
(viii) Neither the Company or any internal investigation of its Subsidiaries nor, to the knowledge of the Company, Aventis or made any of its Affiliates have received a voluntary, directed, FDA Form 483 notice or involuntary disclosure to any Governmental Authority similar notice with respect to the production plant for the Company’s products in Brindisi, Italy. A true and correct copy of any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, item set forth on Section 3.1(t)(viii) of the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed Disclosure Schedule has been made available to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering LawsParent.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to haveThe Company is, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have 2011 has been, in material compliance with, and is not in violation of, any applicable Law with all applicable Laws. To respect to the knowledge conduct of the Business, or the ownership or operation of its properties or assets.
(i) None of the Company or, to the Company’s Knowledge, any of its officers, directors, Employees or agents, including third party contractors (collectively, “Representatives”) has been debarred or suspended from participation in any activities or programs related to pharmaceutical product candidates or pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b) (“Debarred”), (ii) the Company does not employ or is a party to a Contract with any person who is, to the Knowledge of the Company, no material investigation or review by any Governmental Authority with respect Debarred and (iii) to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge Knowledge of the Company, since January 1, 2014, neither the Company nor has not employed or been a party to a Contract with any person who, during the time when such person was employed by the Company, was Debarred.
(c) Each of its Subsidiaries has received any written or oral notice or communication that the product candidates of the Company or any (including the Key Product Candidate) is, among other things, being developed, tested, manufactured and stored, as applicable, by the Company, and to the Knowledge of its Subsidiaries are the Company, by the Representatives, in violation of any material compliance with the FDA Act and/or applicable Law, regulations and guidances issued by the FDA and/or other Governmental Bodies, including Governmental Bodies in foreign jurisdictions, as applicable. No product candidate (including the Key Product Candidate) developed, manufactured, tested, or held by the Company has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such product candidate or pre-market approvals or marketing authorizations are pending, or to the Knowledge of the Company, threatened, against the Company, nor have any such proceedings been pending at any time.
(d) All reports, documents, claims, notices and other submissions required to be filed, maintained, or furnished to the FDA or other Governmental Body by the Company have been so filed, maintained or furnished and were complete and correct in all respects on the date filed (or were corrected in or supplemented by a subsequent filing), except for any such violations that reports, documents, claims or notices the failure of which to so file, maintain or furnish would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(e) The Company has made available to Parent each annual report filed by the Company with the FDA and any similar Governmental Body with respect to any product candidates (including the Key Product Candidate) of the Company that is the subject of clinical investigations, if any. The Company has made available to Parent all material information in its possession about adverse drug experiences obtained or otherwise received by the Company from any source, including information derived from clinical investigations, and reports in the scientific literature, and unpublished scientific papers relating to any product candidate (including the Key Product Candidate) manufactured, tested, or held by the Company.
(f) The Company has made available to Parent as of the date hereof (i) complete and correct copies of each investigational new drug application filed with the FDA and each similar regulatory filing made by or on behalf of the Company with any other Governmental Body, including all supplements and amendments thereto with respect to each product candidate (including the Key Product Candidate), in each case, if any (ii) all material correspondence sent to and received from the FDA and similar foreign Governmental Bodies by the Company that concerns or would reasonably be expected to impact a product candidate (including the Key Product Candidate) of the Company, if any and (iii) all existing written records relating to all material discussions and all meetings between the Company and the FDA or similar foreign Governmental Bodies with respect to each product candidate (including the Key Product Candidate), if any.
(g) The clinical trials, animal studies and other preclinical tests that have been and are being conducted by, or on behalf of, the Company, if any, have been and are being conducted in all material respects in accordance with all applicable Law, regulations and requirements of the FDA and similar foreign Governmental Bodies. The Company has not received any written notice from the FDA or any other Governmental Body requiring the termination or suspension or material modification of any animal study, preclinical study or clinical trial being conducted by or on behalf of the Company. Neither the FDA nor any other applicable Governmental Body nor any clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company has commenced or, to the Knowledge of the Company, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company in respect of any product candidate (including the Key Product Candidate). Schedule 4.18(g) lists all clinical trial investigatory sites with respect to the Key Product Candidate, identifying as to each such site whether the Company has conducted a regulatory and quality assessment and audit of such site. Each such site has been, and is in material compliance with applicable Law, regulations, and requirements of the FDA or similar foreign Governmental Body.
(h) Schedule 4.18(h) lists all pharmaceutical investigational product manufacturing sites with respect to the Key Product Candidate. Each site has been, and is in compliance with applicable Law, regulations, and requirements of the FDA or similar foreign Governmental Body, and has not received any 483s or other notices of violations issued by the FDA, or other Governmental Body. The Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with, or imposed by, any Governmental Body.
(i) The Company has not, and each to the Knowledge of the Company, none of its Subsidiaries hold all authorizationsRepresentatives, licenseshas committed an act, permitsmade a statement, certificatesor failed to make a statement that, filingswould reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, consentsUntrue Statements of Material Facts, variancesBribery, exemptionsand Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, waivers, approvals, Orders, registrations 1991) and clearances of any Governmental Authority amendments thereto (the “Company PermitsFDA Ethics Policy”). The Company is not the subject of any pending or, necessary for to the Knowledge of the Company, threatened investigation pursuant to the FDA Ethics Policy.
(j) The Company and each Subsidiary to own, lease and operate its properties and assetsis in compliance with, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been2011 has complied with, in compliance with the terms of the Company Permits in all material respects, all applicable security and all privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Company Permits are valid Health Information Technology for Economic and in full force and effectClinical Health Act of 2009, including the regulations promulgated thereunder and (iiiii) as of any applicable state privacy Laws.
(k) To the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge Knowledge of the Company, there are no investigations, lawsuits, or regulatory proceedings, pending or threatened, exceptbrought by or before the FDA, the Centers for Medicare and Medicaid Services, the U.S. Office of Inspector General of the U.S. Health and Human Services, or the U.S. Department of Justice in which the case of each of clauses Company is or will be made the defendant or respondent, nor are there any adverse judgments, decrees, or orders, currently in effect that have been issued by such Governmental Bodies against the Company.
(l) The Company does not participate in (i) Medicare (42 U.S.C. §1395 et seq.), (ii) and Medicaid (iii42 U.S.C. § 1396 et seq.), as would not have or reasonably be expected to have, individually other governmental payment program; and no income or in revenue of the aggregate, a Company Material Adverse Effectis derived from any of the foregoing.
(cm) Except as would not be materialThe Company is in material compliance with, and since January 1, 20142011 has complied with, in all material respects, all applicable Laws of all Governmental Bodies, or any self-regulating organization, regarding privacy, security and/or data protection (collectively, “Privacy Laws”). The Company has maintained, enforced and complied with in all material respects written privacy, security and data protection policies (the “Privacy Policies”) with respect to any Proprietary Information providing for, without limitation: (i) clear and conspicuous disclosure of the knowledge Company’s privacy, security and data protection practices, including collection, storage, use and disclosure of, and provision of access and corrections to any Proprietary Information, and (ii) protection from loss, misappropriation, disclosure or corruption of, and unauthorized access to any Proprietary Information. Neither this Agreement nor the Transactions violate or will violate the terms and conditions of any Privacy Policies, any applicable Privacy Laws or the privacy rights of any Person. To the Knowledge of the Company, (i) neither the Company nor no Proprietary Information has been subject to any of its Subsidiaries hasbreach, nor have any of their Representativesmisappropriation, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to payunauthorized disclosure, or authorized the payment of unauthorized access or use by any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantagePerson.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with all applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1, 2014, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Laws.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1December 31, 20142016, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to any material violation of applicable Law by the Company or any of its Subsidiaries is pending or is being threatenedhas been threatened in writing. To the knowledge of the CompanySince December 31, since January 1, 20142016, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) (i) The Company and each of its Subsidiaries hold hold, or each Real Property and, to the knowledge of the Company, each Additional Real Property, assuming the consummation of the transaction contemplated by the applicable Property Acquisition Agreement, benefits from, all authorizations, licenses, permits (including all building permits), permissions, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, allowances, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary of its Subsidiaries to own, lease lease, use, access and operate its properties and assets, and to construct and develop each Development Property (to the extent customary for the applicable stage of construction) and to carry on and operate its businesses as currently conductedconducted (the “Company Permits”), (ii) neither the Company nor any of its Subsidiaries has received written notice from, or on behalf of, any Governmental Authority with jurisdiction over the applicable property that any authorizations, licenses, permits (including all building permits), permissions, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, allowances, registrations or clearances of such Governmental Authority that are necessary for the completion or operation of any Development Property that are customarily issued at a stage of construction after the date hereof will not be issued or granted, will be refused or will be subject to any material conditions that are not customary in such jurisdiction, (iii) the Company and each of its Subsidiaries are, and at all times since January 1December 31, 2014 2016 have been, in compliance with the terms of the Company Permits in all respectsPermits, and all of the Company Permits are valid and in full force and effect, effect and (iiiiv) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) ), (iii), and (iiiiv), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, material to the knowledge of the CompanyCompany and its Subsidiaries, taken as a whole, (i) neither the Company nor any of its Subsidiaries has, nor nor, to the knowledge of the Company, have any of their RepresentativesRepresentatives acting on behalf of the Company or any of its Subsidiaries, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor nor, to the knowledge of the Company, have any of their RepresentativesRepresentatives acting on behalf of the Company or any of its Subsidiaries, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, services and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew knew, or ought reasonably to have known (after due and proper inquiry) ), that all or a portion of such money or thing of value would be offered, given, given or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any official act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any official act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any official act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in improperly obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, Company or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, kickbacks or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1December 31, 2014 2016 have been, in compliance in all material respects with all applicable Anti-Corruption Laws and Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1December 31, 20142016, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1December 31, 20142016, neither the Company nor any of its Subsidiaries has conducted received written notice from any Governmental Authority of any alleged act or initiated omission by the Company or any internal investigation of its Subsidiaries or any Third Party acting at the express direction of the Company or any of its Subsidiaries, arising under or relating to any noncompliance in any material respect with any applicable Anti-Corruption Laws or Economic Sanctions/Trade Laws. Since December 31, 2016, neither the Company nor any of its Subsidiaries has made a voluntary, directed, directed or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a any material respect with any applicable Anti-Corruption Law, Law or Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1December 31, 20142016, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of applicable Anti-Corruption Laws, Laws and Economic Sanctions/Trade Laws, and Money Laundering Laws.
(f) Neither the Company nor any of its Subsidiaries has any Contracts or subcontracts to supply goods or services directly to the United States federal government.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assetsEach Seller is, and to carry on and operate its businesses as currently conducted, (ii) during the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, past two (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have years has been, in compliance in all material respects with all each Law that is or was applicable Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each to the conduct by such Seller of the Business, or the ownership or use of any of its Subsidiaries do notassets included in the Purchased Assets. To the Knowledge of Sellers, and have not since January 1no event has occurred or circumstance related to or affecting the Business exists that (with or without the lapse of time) (i) would constitute or result in a violation by any Seller, 2014or a failure on the part of any Seller, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation to comply in any material respect with any Law, or (ii) would give rise to any obligation on the part of any Seller to undertake, or to bear all or any portion of the cost of, any material remedial action of any nature.
(b) The Governmental Permits include all necessary and applicable Economic Sanctions/Trade Lawsmaterial permits, approvals, clearances, authorizations, licenses and registrations required by any Governmental Authority to be held by the Sellers to permit the manufacture, labeling, sale, distribution and promotion of the Business Products in jurisdictions where the Sellers currently conduct such activities (the “Activities to Date”) with respect to each Business Product, or that are otherwise required to entitle the Sellers to own or lease, operate and use the Purchased Assets and conduct the Business as presently conducted. Subject to Section 6.13, Schedule 3.6(b) hereto sets forth a complete and correct list of all material Governmental Permits held by the Sellers for use primarily in the Business, true and complete copies of which have been made available to the Purchasers. The Sellers are in compliance in all material respects with (i) all terms and conditions of each Governmental Permit, and (ii) all applicable Laws regarding registration, license, certification for each site at which a Business Product is manufactured, labeled, sold, or distributed. To the Knowledge of Sellers, subject to Section 6.13, all material Governmental Permits are freely assignable or transferable to the Purchasers, without notice to, or approval or consent of, any Governmental Authority. All manufacturing operations performed by or on behalf of the Business have been during the past two (2) years and are being conducted in all material respects in compliance with the Quality System Regulations of the FDA and, to the extent applicable to the Sellers, material compliance with counterpart regulations in the European Union and all other countries where the Business Products are marketed and such compliance is required. The Sellers are in compliance in all material respects with all applicable reporting requirements for all Governmental Permits.
(c) The Sellers are in compliance in all material respects with all FDA and non-United States equivalent agencies and similar state and local Laws applicable to the maintenance, compilation and filing of reports, including adverse event reports, with regard to the Business Products. Schedule 3.6(c) hereto sets forth, as of the date of this Agreement, a list of all medical device reports (as such term is used in 21 C.F.R. Part 803) and equivalent reports filed or submitted with the FDA and all non-United States equivalent agencies with respect to the Business Products.
(d) The Sellers have not received any written communication from the FDA or any other Governmental Authority (i) contesting the pre-market clearance or approval of, or the labeling and promotion of any Business Products, or (ii) otherwise alleging any material violation of any Laws by the Sellers related to the operation of the Business.
(e) Since January 1There have been no recalls, 2014field notifications or seizures ordered or adverse regulatory actions taken (or, neither to the Company nor Knowledge of the Sellers, threatened) by the FDA or any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure to any other Governmental Authority with respect to any alleged act Business Products, including any facilities where any Business Products are produced, processed, packaged or omission stored, and within the five (5) years preceding the date hereof the Sellers have not, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any Business Product.
(f) To the Knowledge of the Sellers, all filings with and submissions to the FDA and any similar Governmental Authority made by the Sellers with regard to the Business Products, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(g) No Seller nor any of its directors, officers or employees, nor, to the Knowledge of the Sellers, any of Sellers’ agents, distributors, or any other Person associated with or acting on behalf of any Seller has, in connection with the operation of the Business (i) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”), (ii) violated or is in violation of any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions (the “OECD Convention”), or relating (iii) made, offered to make, promised to make or authorized the payment or giving of, directly or indirectly, any bribe, rebate, payoff, influence payment, kickback or other unlawful payment or gift of money or anything of value prohibited under any applicable Law addressing matters comparable to those addressed by the FCPA or the OECD Convention implementing legislation concerning such payments or gifts in any jurisdiction (any such payment, a “Prohibited Payment”).
(h) No Seller nor, to the Knowledge of the Sellers, any of its directors, officers, agents, employees or Affiliates has been subject to any noncompliance in a material respect investigation by any Governmental Authority with regard to any applicable Anti-Corruption Law, Economic Sanctions/Trade LawProhibited Payment made, or Money Laundering Law. Since January 1alleged to have been made, 2014, in connection with the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations operation of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Lawsthe Business.
Appears in 1 contract
Samples: Asset Purchase Agreement (Orthofix International N V)
Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or Except as set forth in the aggregate, a Company Material Adverse EffectSchedule 5.8(a) hereto, the Company is, and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to the Company or any of its Subsidiaries is pending or is being threatened. To the knowledge of the Company, since January 1, 2014, neither the Company nor any of its Subsidiaries 2015 has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, to the knowledge of the Company, (i) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor have any of their Representatives, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, in compliance in all material respects with each Law that is or was applicable to it or to the conduct by the Company of its business, or the ownership or use of any of its Assets and Properties, including the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Animal Welfare Act, as applicable, and their applicable implementing regulations. No event has occurred or circumstance exists that (with or without the lapse of time) (i) would reasonably be expected to constitute or result in a violation by the Company, or a failure on the part of the Company, to comply in any material respects with any Law, or (ii) would reasonably be expected to give rise to any obligation on the part of the Company to undertake or to bear all or any portion of the cost of, any material remedial action of any nature.
(b) The Company has obtained all necessary and applicable material Permits (i) required by any Regulatory Authority to authorize the design, development, preclinical and clinical testing, manufacture and labeling of the Company Products in jurisdictions where it presently conducts such activities with respect to each Company Product, or (ii) that are otherwise required to entitle the Company to own or lease, operate and use its Assets and Properties and conduct its business and operations as presently conducted. Schedule 5.8(b) hereto sets forth a complete and correct list of all material Permits held by the Company as of the date of this Agreement, true and complete copies of which have been provided to the Purchaser. The Company is in compliance in all material respects with (i) all terms and conditions of each such Permit, and (ii) all applicable Economic Sanctions/Trade Laws regarding registration, license and certification for each site at which a Company Product is manufactured and labeled. 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 Good Manufacturing Practice (cGMP) regulations of the FDA at 21 C.F.R. Parts 210, 211, and 600-680 and counterpart regulations in all other countries where compliance is required, in each case to the extent applicable. The Company is in compliance in all material respects with all applicable reporting requirements for all Permits held by it.
(c) All preclinical studies, and other studies and tests conducted by or, to the knowledge of the Company, on behalf of the Company have been, and if still pending are being, conducted in material compliance with research protocols and all applicable Money Laundering Laws, including the Good Laboratory Practice (cGLP) regulations of the FDA at 21 C.F.R. Part 58, and the Animal Welfare Act and similar foreign laws, if applicable.
(d) Except as set forth in Schedule 5.8(d) hereto, the Company has not received any written notice or other written communication from the FDA or any other Regulatory Authority alleging any violation of any Laws by the Company. The Company and each is not subject to any obligation arising under an administrative or regulatory action, inspection, warning letter, notice of its Subsidiaries do notviolation letter, and or other written notice, response or commitment made to or with the FDA or any comparable Regulatory Authority with respect to a violation of Law, and, to the Knowledge of the Company, no such proceedings have not since January 1, 2014, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Lawsbeen threatened.
(e) Since January 1All filings with and submissions to the FDA and any similar Regulatory Authority made by the Company with regard to the Company Products, 2014whether written or electronically delivered, neither were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, have been updated to be true, accurate and complete in all material respects as of the date of such update.
(f) Neither the Company nor, to the Knowledge of the Company, any of its officers, employees or agents has been convicted of any crime that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in debarment are pending or, to the Knowledge of the Company, threatened against the Company or any of its respective officers, employees or agents.
(g) Neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntarydirectors, directedofficers, employees, agents, distributors, or involuntary disclosure to any Governmental Authority other Person associated with respect to or acting on behalf of the Company is in violation of, or since January 1, 2013 has (i) violated any alleged act provision of the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”) or omission any applicable Law enacted in any jurisdiction in connection with or arising under the OECD Convention Combating Bribery of Foreign Public Officials in International Business Transactions (the “OECD Convention”), or relating (ii) made, offered to make, promised to make or authorized the payment or giving of, directly or indirectly, any noncompliance in a material respect with bribe, rebate, payoff, influence payment, kickback or other unlawful payment or gift of money or anything of value prohibited under any applicable Anti-Corruption LawLaw addressing matters comparable to those addressed by the FCPA or the OECD Convention implementing legislation concerning such payments or gifts in any jurisdiction (any such payment, Economic Sanctions/Trade Law, or Money Laundering Lawa “Prohibited Payment”). Since January 1, 20142013, neither the Company and Company, nor to the Company’s Knowledge, any of its respective directors, officers, agents, employees, Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed or Affiliates has been subject to detect, prevent and deter material violations of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Lawsany investigation by any Governmental Entity with regard to any Prohibited Payment.
Appears in 1 contract
Compliance with Laws; Regulatory Matters. (a) Other than QLT USA has complied with all applicable Laws and each award, judgment, ruling, charge, order, writ, injunction or decree of any Governmental Authority or arbitrator to which QLT USA is a party or subject or by which QLT USA is bound and to which any of the Included Assets is subject, except for any non-compliance that does not, or violations which would not have or reasonably be expected to haveto, result in, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1, 2014, have been, in compliance with all applicable Laws. To the knowledge .
(b) All of the CompanyRegistrations required for the Distribution of the Product in all or any part of the Territory in the manner and in the country(ies) in which such activities are currently conducted are solely and exclusively owned by QLT USA or, no to Seller’s Knowledge, QLT USA’s licensees. Section 4.9 of the Seller Disclosure Schedule sets forth a true, correct and complete list of such Registrations. The Registrations set forth in Section 4.9 of the Seller Disclosure Schedule that are solely and exclusively owned by QLT USA are in full force and effect. Schedule 1.1(a) hereto (Applicable Permits) sets forth a true, correct and complete list of all material investigation permits, approvals, licenses, franchises or review by authorizations, other than the Registrations, from any Governmental Authority held by QLT USA. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Company omitted portions.
(c) To Seller’s Knowledge, the manufacture by third party manufacturers and Distribution by third parties of the Product in all or any of its Subsidiaries is pending or is being threatened. To the knowledge part of the CompanyTerritory has been conducted in compliance with the Registrations and all applicable Laws, since January 1, 2014, neither including the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable LawAct, except for such violations any non-compliance that does not, or would not have or reasonably be expected to haveto, result in, individually or in the aggregate, a Company Material Adverse Effect.
(id) The Company and each of its Subsidiaries hold all authorizations, licenses, permits, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary to own, lease and operate its properties and assets, and to carry on and operate its businesses as currently conducted, (ii) the Company and each of its Subsidiaries are, and at all times since Since January 1, 2014 have been2007, in compliance with the terms of the Company Permits in all respects, and all of the Company Permits are valid and in full force and effect, and (iii) as of the date of this Agreement, neither the Company nor any of its Subsidiaries QLT USA has not received any written or, to Seller’s Knowledge, other notice of any violation proceedings from a Governmental Authority alleging that the Product or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits isIncluded Assets, to or the knowledge of the Companyownership, pending Distribution thereof, violates any applicable Law in any manner that has not been remedied, except for such violations that do not, or threatened, except, in the case of each of clauses (i), (ii) and (iii), as would not have or reasonably be expected to haveto, result in, individually or in the aggregate, a Company Material Adverse Effect.
(ce) Except as QLT USA has completed and filed all annual and other reports required to be filed by QLT USA with the FDA, except where failure to file any such report does not, or would not reasonably be materialexpected to, since result in, individually or in the aggregate, a Material Adverse Effect.
(f) Since January 1, 20142007, no Product has been voluntarily recalled, suspended or discontinued by QLT USA at the request of the FDA or any other Governmental Authority, nor has QLT USA received any notice from the FDA or any other Governmental Authority that it is not in compliance with applicable requirements under the Act and the regulations promulgated thereunder or similar Laws in any foreign jurisdiction, including verbal notice or notice in the form of inspectional observations in a Form FDA-483, warning letter or any other writing; nor has QLT USA or, to Seller’s Knowledge, any of QLT USA’s Product licensees received any notice from the knowledge FDA or any other Governmental Authority that it has commenced any action to withdraw approval, place material Product-specific sales or marketing restrictions on or request the recall of any Product, or that it has commenced any action to enjoin or place material restrictions on the Companyproduction of any Product.
(g) Since January 1, 2007, to Seller’s Knowledge, no officer, employee or agent of QLT USA has made an untrue statement or a material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (iSeptember 10, 1991) or any similar policy. QLT USA has not employed or used in any capacity the services of any individual or entity debarred under 21 U.S.C. § 335a(a) or any similar Laws in connection with a Product, and neither the Company QLT USA, nor any of its Subsidiaries hastheir respective directors, officers, agents or employees, has engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under 21 U.S.C. § 335a(a) or any similar Laws.
(h) Neither Seller nor have QLT USA nor any of their Representativesrespective directors, violated any Anti-Corruption Laws and (ii) neither the Company nor officers, employees or managers, or, to Seller’s Knowledge, any of its Subsidiaries hasthe stockholders, nor have distributors, resellers, consultants, brokers, representatives, agents or other Persons associated with or acting on their behalf has (a) used any of their Representativescorporate funds for an unlawful contribution, offeredgift, paidentertainment or other unlawful expense relating to any political or business activity, promised (b) used any corporate funds to pay, make any direct or authorized the indirect unlawful payment of any money, money or offered, given, promised to give, or authorized the giving anything else of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official official, employee or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew or ought reasonably to have known (after due and proper inquiry) that all or a portion of such money or thing of value would be offered, given, or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any act or decision acting on behalf of any Governmental Authority or any public international organization or to any political party or campaign, (5c) assisting made any direct or indirect unlawful payment of money or anything else of value to any official, employee or Person acting on behalf of any Entity owned or controlled by any Governmental Authority or any public international organization, (d) violated any provision of the CompanyU.S. Foreign Corrupt Practices Act of 1977, as amended, any Subsidiary of the Company, rule or regulation promulgated thereunder or any Representative in obtaining similar Law, (e) established or retaining business for maintained any unlawful or withunrecorded fund of corporate monies or other assets, (f) made any false or directing business to, fictitious entry on the Company, any Subsidiary books of the Company, or any Representative account of QLT USA or (Bg) in a manner which would constitute made or have the purpose or effect of public or commercial bribery or corruptionreceived any bribe, acceptance ofrebate, or acquiescence in extortionpayoff, kickbacksinfluence payment, kickback or other unlawful or improper means of obtaining business or any improper advantagepayment. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(di) The Company and each of its Subsidiaries are, and at all times since January 1, 2014 have been, QLT USA is in compliance in all material respects with all applicable Economic Sanctions/Trade Laws the United States export laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do notregulations, including the International Traffic in Arms Regulations, the FDA, if applicable, and have not since January 1the Export Administration Regulations, 2014and including compliance with all regulations, carried on any business, directly orders and licensing requirements relating to the exportation or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea reexportation of goods or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1, 2014, neither the Company nor any of its Subsidiaries has conducted or initiated any internal investigation or made a voluntary, directed, or involuntary disclosure technology to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a material respect with any applicable Anti-Corruption Law, Economic Sanctions/Trade Law, or Money Laundering Lawsanctioned country. Since January 1, 2014, the Company and Neither QLT USA nor its Subsidiaries have implemented since the Atrix Acquisition Date, nor are they are currently, transacting business with any Person identified as a Specifically Designated National or Blocked Person by the Office of Foreign Assets Control of the United States Department of Treasury or listed on either the Denied Person list or Entity List of the Bureau of Industry and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations Security of Anti-Corruption Laws, Economic Sanctions/Trade Laws, and Money Laundering Lawsthe United States Department of Commerce.
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Compliance with Laws; Regulatory Matters. (a) Other than for non-compliance or violations which would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each of its Subsidiaries are and, at all times since January 1December 31, 20142016, have been, in compliance with all applicable Laws. To the knowledge of the Company, no material investigation or review by any Governmental Authority with respect to any material violation of applicable Law by the Company or any of its Subsidiaries is pending or is being threatenedhas been threatened in writing. To the knowledge of the CompanySince December 31, since January 1, 20142016, neither the Company nor any of its Subsidiaries has received any written or oral notice or communication that the Company or any of its Subsidiaries are in violation of any applicable Law, except for such violations that would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(i) The Company and each of its Subsidiaries hold hold, or each Real Property and, to the knowledge of the Company, each Additional Real Property, assuming the consummation of the transaction contemplated by the applicable Property Acquisition Agreement, benefits from, all authorizations, licenses, permits (including all building permits), permissions, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, allowances, registrations and clearances of any Governmental Authority (the “Company Permits”), necessary for the Company and each Subsidiary of its Subsidiaries to own, lease lease, use, access and operate its properties and assets, and to construct and develop each Development Property (to the extent customary for the applicable stage of construction) and to carry on and operate its businesses as currently conductedconducted (the “Company Permits”), (ii) neither the Company nor any of its Subsidiaries has received written notice from, or on behalf of, any Governmental Authority with jurisdiction over the applicable property that any authorizations, licenses, permits (including all building permits), permissions, certificates, filings, consents, variances, exemptions, waivers, approvals, Orders, allowances, registrations or clearances of such Governmental Authority that are necessary for the completion or operation of any Development Property that are customarily issued at a stage of construction after the date hereof will not be issued or granted, will be refused or will be subject to any material conditions that are not customary in such jurisdiction, (iii) the Company and each of its Subsidiaries are, and at all times since January 1December 31, 2014 2016 have been, in compliance with the terms of the Company Permits in all respectsPermits, and all of the Company Permits are valid and in full force and effect, effect and (iiiiv) as of the date of this Agreement, neither the Company nor any of its Subsidiaries has received any written notice of any violation or failure to comply with any Company Permit and no suspension, modification, revocation or cancellation of any of the Company Permits is, to the knowledge of the Company, pending or threatened, except, in the case of each of clauses (i), (ii) ), (iii), and (iiiiv), as would not have or reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Except as would not be material, since January 1, 2014, material to the knowledge of the CompanyCompany and its Subsidiaries, taken as a whole, (i) neither the Company nor any of its Subsidiaries has, nor nor, to the knowledge of the Company, have any of their RepresentativesRepresentatives acting on behalf of the Company or any of its Subsidiaries, violated any Anti-Corruption Laws and (ii) neither the Company nor any of its Subsidiaries has, nor nor, to the knowledge of the Company, have any of their RepresentativesRepresentatives acting on behalf of the Company or any of its Subsidiaries, offered, paid, promised to pay, or authorized the payment of any money, or offered, given, promised to give, or authorized the giving of anything of value, including but not limited to cash, checks, wire transfers, tangible and intangible gifts, favors, services, services and those entertainment and travel expenses that go beyond what is reasonable and customary and of modest value to any Government Official or to any Person under circumstances where the Company, any Subsidiary of the Company or the Representative knew knew, or ought reasonably to have known (after due and proper inquiry) ), that all or a portion of such money or thing of value would be offered, given, given or promised, directly or indirectly, to a Person (A) for the purpose of (1) influencing any official act or decision of a Government Official in their official capacity, (2) inducing a Government Official to do or omit to do any official act in violation of their lawful duties, (3) securing any improper advantage, (4) inducing a Government Official to influence or affect any official act or decision of any Governmental Authority or (5) assisting the Company, any Subsidiary of the Company, or any Representative in improperly obtaining or retaining business for or with, or directing business to, the Company, any Subsidiary of the Company, Company or any Representative or (B) in a manner which would constitute or have the purpose or effect of public or commercial bribery or corruption, acceptance of, or acquiescence in extortion, kickbacks, kickbacks or other unlawful or improper means of obtaining business or any improper advantage.
(d) The Company and each of its Subsidiaries are, and at all times since January 1December 31, 2014 2016 have been, in compliance in all material respects with all applicable Anti-Corruption Laws and Economic Sanctions/Trade Laws and all applicable Money Laundering Laws. The Company and each of its Subsidiaries do not, and have not since January 1December 31, 20142016, carried on any business, directly or knowingly indirectly, involving Cuba, Iran, Syria, Sudan, North Korea or Crimea in violation in any material respect of applicable Economic Sanctions/Trade Laws.
(e) Since January 1December 31, 20142016, neither the Company nor any of its Subsidiaries has conducted received written notice from any Governmental Authority of any alleged act or initiated omission by the Company or any internal investigation of its Subsidiaries or any Third Party acting at the express direction of the Company or any of its Subsidiaries, arising under or relating to any noncompliance in any material respect with any applicable Anti-Corruption Laws or Economic Sanctions/Trade Laws. Since December 31, 2016, neither the Company nor any of its Subsidiaries has made a voluntary, directed, directed or involuntary disclosure to any Governmental Authority with respect to any alleged act or omission arising under or relating to any noncompliance in a any material respect with any applicable Anti-Corruption Law, Law or Economic Sanctions/Trade Law, or Money Laundering Law. Since January 1December 31, 20142016, the Company and its Subsidiaries have implemented and maintained internal controls, policies and procedures reasonably designed to detect, prevent and deter material violations of applicable Anti-Corruption Laws, Laws and Economic Sanctions/Trade Laws, and Money Laundering Laws.
(f) Neither the Company nor any of its Subsidiaries has any Contracts or subcontracts to supply goods or services directly to the United States federal government.
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