Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule: (a) Since January 1, 2017 and as of the date hereof, each Company Group Member has been in compliance with all Laws applicable to such Company Group Member other than any such noncompliance that has not had or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Permits required to conduct the Company Business are in the possession of the applicable Company Group Member, are in full force and effect and are being complied with, in each case, except when such failure would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the current conduct of the Company Business is not, and has not been since January 1, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liability) and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pending, or to the Knowledge of the Company, threatened in writing, that seek revocation, cancellation or modification of any applicable Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. (b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that 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: Plan Funding Agreement (Amryt Pharma PLC), Plan Funding Agreement (Novelion Therapeutics Inc.)
Legal Compliance; Permits. Except as set forth on Section 4.12 5.12 of the Company Plan Investor Disclosure Schedule:
(a) Since since January 1, 2017 and as of the date hereof, each Company Plan Investor Group Member has been in compliance with all Laws applicable to such Company Plan Investor Group Member other than any such noncompliance that has not had or and would not reasonably be expected to have, individually or in the aggregate, a Company Plan Investor Material Adverse Effect. All Permits required to conduct the Company Plan Investor Business are in the possession of the applicable Company Plan Investor Group Member, are in full force and effect and are being complied with, in each case, except when such failure would not reasonably be expected excepted to have, individually or in the aggregate, a Company Plan Investor Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Plan Investor Material Adverse Effect, the current conduct of the Company Plan Investor Business is not, and has not been since January 1, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liability) and, to the Knowledge of the CompanyPlan Investor, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pending, or to the Knowledge of the CompanyPlan Investor, threatened in writing, that seek revocation, cancellation or modification of any applicable Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Plan Investor Material Adverse Effect.
(b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There there is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, to the CompanyPlan Investor’s Knowledge, threatened in writing against any Company Plan Investor Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, had and would not reasonably be expected to have, individually or in the aggregate, a Company Plan Investor Material Adverse Effect.
Appears in 2 contracts
Samples: Plan Funding Agreement (Amryt Pharma PLC), Plan Funding Agreement (Novelion Therapeutics Inc.)
Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule:
(a) Since January 1, 2017 and as Each of the date hereofGroup Companies has during the past three (3) years complied with, each Company and is not currently in violation of, any applicable Law with respect to the conduct of its business, or the ownership or operation of its business, except for failures to comply or violations which would not, individually or in the aggregate have been and are not reasonably likely to be material to the Group Member Companies, taken as a whole. No written notice of non-compliance with any applicable Law has been received during the past three (3) years by any of the Group Companies.
(b) Each Group Company is in compliance with possession of all Laws applicable Permits necessary to own, lease and operate the properties and assets it purports to own, operate or lease and to carry on its business as it is now being conducted (the “Material Permits”), except where the failure to have such Company Group Member other than any such noncompliance that has not had or Material Permits would not reasonably be expected to havenot, individually or in the aggregate, a Company Material Adverse Effect. All Permits required to conduct the Company Business are in the possession of the applicable Company Group Member, are in full force and effect and are being complied with, in each case, except when such failure would not reasonably be expected to havebe material to (i) such ownership, lease, operation or conduct or (ii) the Group Companies, taken as a whole. Except as would not, individually or in the aggregate, a Company Material Adverse Effect. Except as would not reasonably be expected to havebe material to the Group Companies, individually taken as a whole, (A) each Material Permit is in full force and effect in accordance with its terms, (B) no outstanding written notice of revocation, cancellation or in termination of any Material Permit has been received by the aggregateGroup Companies, a Company Material Adverse Effect, (C) to the current conduct Knowledge of the Company Business is not(and after the Reorganization, Newco), none of such Permits upon termination or expiration in the ordinary due course will not be renewed or reissued in the ordinary course of business upon terms and has not been since January 1conditions substantially similar to its existing terms and conditions, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes D) there are no continuing Liability) andLegal Proceedings pending or, to the Knowledge of the CompanyCompany (and after the Reorganization, no event has occurred whichNewco), with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pending, or to the Knowledge of the Company, threatened in writingthreatened, that seek the revocation, cancellation cancellation, limitation, restriction or modification termination of any applicable Material Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(bE) The Company is and shall remain in full compliance with each of the Agreements Group Companies is in compliance with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, all Material Permits applicable to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse EffectCompanies.
Appears in 1 contract
Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule:
(a) Since January 1, 2017 and as 2019, neither the Company nor any of the date hereof, each Company Group Member its Subsidiaries has been in compliance with all Laws conflict with, or in default, breach or violation of, any Law or Permit applicable to such the Company Group Member other than or any such noncompliance of its Subsidiaries or by which any property or asset of the Company or any of its Subsidiaries is bound or affected, except for conflicts, defaults, breaches or violations that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. To the knowledge of the Company, neither the Company nor any of its Subsidiaries has received, at any time since January 1, 2019, any written notice or communication from any Relevant Authority regarding any actual, alleged, or potential violation in any respect of, or a failure to comply with, any Law or Permit, except for any written notice or communication that would not had be, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Permits required No investigation or review by any Relevant Authority with respect to the Company or any of its Subsidiaries has occurred at any time in the past three years or is pending or, to the knowledge of the Company, threatened in writing, nor has any Relevant Authority indicated in writing an intention to conduct the same.
(b) The Company Business are and each of its Subsidiaries is in the possession of all Permits necessary for the applicable conduct and operation of the business of the Company Group Member, are in full force and effect and are being complied with, in each caseits Subsidiaries as currently conducted, except when such where the failure to possess, or the suspension or cancellation of, any of the Permits would not be, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to possess, or the suspension or cancellation of, any of the Permits would not have, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the current conduct of the Company Business is not, and has not been since January 1, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liability) and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pending, or to the Knowledge of the Company, threatened in writing, that seek revocation, cancellation or modification of any applicable Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
Appears in 1 contract
Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule:
(a) Since January 1The Company has, 2017 since the Company’s inception, complied, and as of the date hereofis now complying, each Company Group Member has been in compliance all material respects with all Laws applicable to it or its Business, properties or Assets, including (i) the FDCA and its implementing regulations, and (ii) Laws pertaining to the research (including preclinical, nonclinical, and clinical research or studies), development and testing of all of the Company’s product candidates.
(b) The Company has all Permits required to conduct the Company’s Business in all material respects, and all such Permits are valid and in full force and effect (including all Permits required by the FDA, NIH or any other Governmental Authority engaged in the regulation of the operations of the Company’s Business). All fees and charges with respect to such Permits that are due and owing as of the date hereof have been paid in full and all filing, reporting, and maintenance obligations have been timely satisfied in all material respects. Schedule 2.13(b) lists all current Permits issued to the Company Group Member other than any such noncompliance that with respect to the conduct of the Company’s Business (the “Company Permits”), including the names of the Permits, the holder(s) of the Permits, and their respective dates of issuance and expiration. All Company Permits are valid and in full force and effect and will continue to be so upon consummation of the Contemplated Transactions. To the Company’s Knowledge, no event has not had occurred that, with or without notice lapse or limitation of time or both, would not reasonably be expected to haveresult in the revocation, suspension, or lapse of any Company Permit. The Company is in compliance with the terms of the Company Permits, except for such failures to comply that, individually or in the aggregate, a Company Material Adverse Effect. All Permits required to conduct the Company Business are in the possession of the applicable Company Group Member, are in full force and effect and are being complied with, in each case, except when such failure would not reasonably be expected to havebe material to the Company. The Company, and to the Company’s Knowledge, the Company’s Representatives, have not received any notice or other communication from any Governmental Authority regarding (i) any material adverse change in any Company Permit, or any failure to comply with any applicable Laws of any Governmental Authority or any term or requirement of any Company Permit or (ii) any lapse, revocation, withdrawal, suspension, cancellation, limitation, subjection to an integrity review, termination, material modification of, or any other action against any Company Permit.
(c) (i) None of the Company and, to the Company’s Knowledge, any of its directors or officers, have been convicted of any crime, engaged in any conduct, or have been the subject of any proceeding that has previously caused or would reasonably be expected to result in (A) debarment or suspension from participation in any activities or programs related to pharmaceutical product candidates or pharmaceutical products pursuant to 21 U.S.C. § 335a; (B) exclusion under 42 U.S.C. § 1320a-7 or any similar law, rule or regulation of any Governmental Authority, (C) exclusion, debarment, suspension or ineligibility to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration; (D) charging or conviction of a criminal or civil offense or otherwise named in an action that falls within the ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 000x, 00 X.X.X. § 000x, 00 X.X.X. § 0000x - 7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other statute pertaining to the development, testing, manufacturing, labeling, packaging, distribution, sale, marketing, promotion, or advertising of biologics; or (E) disqualified or deemed ineligible pursuant to 21 C.F.R. Parts 312 (collectively (A)-(E), “Debarred”); (ii) the Company does not employ or use the services of any Person who is Debarred; (iii) the Company has not employed or used the services of any Person who, during the time when such Person was employed by or provided services to the Company, was Debarred; and (iv) neither the Company nor, to the Company’s Knowledge, its directors or officers, has received any notice or other communication from any Governmental Authority threatening, investigating, or pursuing debarment or alleging any acts that could reasonably be expected to result in debarment.
(d) Each of the product candidates of the Company is being and, since the Company’s inception, has been developed, tested, manufactured and held, shipped, and labeled, as applicable, by the Company in material compliance with the FDCA and all other applicable Laws and regulations issued by the FDA, NIH or other Governmental Authority, except for any noncompliance, either individually or in the aggregate, a Company Material Adverse Effect. Except as which would not reasonably be expected to have, individually or in the aggregate, have a Company Material Adverse Effect. No product candidate developed, the current conduct of manufactured, tested, held, shipped, or labeled by the Company Business is not, and has not been since January 1, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liabilityor has been requested by a Governmental Authority or Person to be recalled, withdrawn, removed, suspended or discontinued or otherwise corrected (whether voluntarily or otherwise) and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit(collectively “Recall”). There are no actions pending, or to the Knowledge of the Company, threatened in writing, that seek revocation, cancellation or modification of any applicable Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of Neither the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by nor any Governmental Entity currently pending Authority has sought, is seeking or, to the Company’s Knowledge, threatened in writing is threatening any Recall or seizure, by Action or otherwise, of the product candidates of the Company. There are no Actions (whether completed or pending) seeking the recall, withdrawal, removal, discontinuation, suspension or seizure of any such product candidate, pre-market approvals or other study authorizations, or marketing authorizations, or to the Company’s Knowledge, threatened, against any the Company Group Memberor, to the Company’s Knowledge, any Representative of their respective assetsthe Company, rights nor have any such Actions been pending at any time.
(e) All reports, documents, claims, notices and other submissions required to be filed, maintained, or properties furnished to the FDA, NIH, or any of their respective officer other Governmental Authority by the Company, have been so filed, maintained or directors, furnished and were complete and correct in each caseall material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except for those that have not hadany such reports, and documents, claims or notices the failure of which to so file, maintain or furnish would not reasonably be expected to havenot, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. For all pre-clinical studies and clinical trials conducted or being conducted by, in conjunction with, or on behalf of the Company or a Representative of the Company or otherwise contemplated by the Company or a Representative of the Company (collectively “Studies”), the Company has made available to Parent and Merger Sub true, complete and correct copies of all material study reports, protocols, and statistical analysis plans (collectively, the “Data”). All Data accurately, completely, and fairly reflects the results from and plans for the Studies in all material respects. To the Company’s Knowledge, there are no other studies, the results of which are inconsistent with, or otherwise call into question, the Data.
(f) The Company has made available to Parent each annual report filed by or on behalf of the Company with the FDA, NIH or any similar Governmental Authority with respect to any product candidates, if any. The Company has made available to Parent all material information in its possession about adverse drug experiences obtained or otherwise received by or on behalf of the Company from any source, including information derived from clinical investigations, animal or pre-clinical investigations, and reports in the scientific literature, and unpublished scientific papers relating to any product candidate.
(g) The Company has made available to Parent (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 similar Governmental Authority, including the NIH, and including all supplements and amendments thereto with respect to each product candidate and Study, in each case, if any, (ii) all material correspondence or submissions, including summaries of oral interactions, sent to and received from the FDA, NIH, and similar Governmental Authority by the Company or, to the Company’s Knowledge, a Representative of the Company that concerns or would reasonably be expected to impact a product candidate of the Company or Study, if any and (iii) all existing written records relating to all material discussions and all meetings between the Company and the FDA, NIH, or similar Governmental Authority with respect to each product candidate or Study, if any.
(h) The Studies have, since the Company’s inception, been and are being conducted in all material respects in accordance with all applicable Law and requirements of the FDA, NIH, and similar Governmental Authorities, including, as applicable, the Good Laboratory Practice requirements promulgated by the FDA under and in accordance with 21 C.F.R. Part 58, and the applicable principles of Good Laboratory Practice as promulgated by the European Commission under Directives 2004/9/EC and 2004/10/EC, and the requirements of Good Clinical Practice, informed consent, and all other applicable requirements relating to protection of human subjects and the conduct of clinical trials contained in 21 C.F.R. Parts 50, 56, and 312, the applicable requirements under Clinical Trials Regulation EU No 536/2014, and the applicable International Council on Harmonisation (“ICH”) Guideline for Good Clinical Practice (ICH E6 (R2)), except for any noncompliance, either individually or in the aggregate, which would not reasonably be expected to be material to the Company.
(i) Neither the Company nor, to the Company’s Knowledge, any Representative of the Company, has received any written or other notice or communication from the FDA, NIH, any other Governmental Authority, any Institutional Review Board (“IRB”), or other Person or board responsible for the oversight or conduct of any Study, requiring or threatening the termination, suspension, material modification or restriction, delay, or clinical hold of, or otherwise rejecting, any Study that was, is planned to be, or is being conducted, nor has any such action commenced. All Studies were and, if still pending, are being conducted in all respects in accordance with the protocols, procedures and controls designed and approved for such Studies, with standard medical and scientific research procedures, and in accordance with any requirement of an IRB or other Person or board responsible for review of such Studies. All Studies have obtained all applicable approvals from an IRB or other Person or board responsible for review of such Studies. In the case of any Studies involving human subjects, all subjects, or their legal representatives, have provided their informed consent for participation.
(j) The Company has not, and to the Company’s Knowledge, none of the Company’s Representatives, has made an untrue statement of a material fact or fraudulent or misleading statement to the FDA, NIH, or other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA, NIH or other Governmental Authority, or otherwise committed an act, made a statement, or failed to make a statement that, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “FDA Application Integrity Policy”). Neither the Company nor, to the Company’s Knowledge, any directors and officers, of the Company is the subject of any pending or, to Company’s Knowledge, threatened investigation pursuant to the FDA Application Integrity Policy, or resulting from any other untrue or false statement or omission.
(k) The Company and, to the Company’s Knowledge, the Company’s Representatives, are currently in compliance with, and since the Company’s inception, have complied with, all applicable security and privacy standards regarding protected health information, including the standards under (i) the Health Insurance Portability and Accountability Act of 1996, (42 U.S.C. § 1320d et seq.), as amended, and its implementing Administrative Simplification regulations related to the privacy of Protected Health Information and the Security Standards, as defined by law (45 C.F.R. parts 160, 162 and 164), also known as the HIPAA Privacy Rule, and the Standards for Electronic Transactions, the Security Standards and the Health Information Technology for Economic and Clinical Health Act as incorporated in the American Recovery and Reinvestment Act of 2009 and (ii) any applicable state privacy Laws, including the California Consumer Privacy Act, Cal. Civ. Code §1798.100 et seq., and its implementing regulations, except for any noncompliance, either individually or in the aggregate, which would not reasonably be expected to be result in a Material Adverse Effect. No claims have been asserted or, to the Company’s Knowledge, are threatened against the Company by any Person or Governmental Authority alleging a material violation of any privacy, personal or confidentiality rights under any applicable Laws.
Appears in 1 contract
Samples: Merger Agreement (Opko Health, Inc.)
Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule:
(a) Since January 1, 2017 and Except as of the date hereof, each Company Group Member has been in compliance with all Laws applicable to such Company Group Member other than any such noncompliance that has not had or would not reasonably be expected to haveto, individually or in the aggregate, a be adverse to the Group Companies or the Projects in any material respect, no Group Company Material Adverse Effectis, or has been since the Lookback Date, in violation of any applicable Legal Requirement, Permit or Government Order applicable to the Group Companies or the Projects. All Permits required to conduct the Company Business are in the possession Except as set forth on Section 3.12(a) of the applicable Company Group Member, are in full force Seller Disclosure Schedule and effect and are being complied with, in each case, except when such failure as would not reasonably be expected to haveto, individually or in the aggregate, a Company Material Adverse Effect. Except as would not reasonably be expected adverse to havethe Group Companies or Projects in any material respect, individually or in since the aggregateLookback Date, a Company Material Adverse Effect(i) neither Seller, the current conduct its Affiliates, nor any member of the Company Business is notGroup Companies has received any written request for information, and has not been since January 1notification, 2017demand letter, in default administrative inquiry or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liability) andformal or informal written complaint or claim or, to the Knowledge of the Seller, communication from any Governmental Authority asserting that any member of the Group Companies is not in compliance in any material respect with any applicable Legal Requirement, Permit or Government Order, (ii) no member of the Group Companies has entered into or been subject to any Government Order, or (iii) to the Seller’s Knowledge, neither any member of the Group Companies nor any of the Projects has been the subject of any investigation or non-routine audit by any Governmental Authority with regard to any Legal Requirement or Government Order.
(b) The Group Companies have all Permits that are necessary or otherwise reasonably required for, and material to, the operation of the Business taking into account the current status of the Projects (including those Permits required under Environmental Laws), and a complete and accurate list of each such Permit is set forth on Section 3.12(b) of the Seller Disclosure Schedule (the “Material Permits”). All such Material Permits are valid and in full force and effect, and the applicable Group Company is in compliance in all material respects with its obligations with respect thereto. Each Material Permit is held in the name of a Group Company, and if transfer of such Material Permit may be required between two or more Group Companies for the Group Companies to construct, develop, own, and operate the Project (as contemplated by the Group Companies as of the Closing Date), such transfer does not, to the Seller’s Knowledge, require authorization or approval by any Governmental Authority. To the Knowledge of the Seller, no claim to revoke, limit or modify any of such Material Permits has been served upon any of the Group Companies, or is pending or, to the Seller’s Knowledge, is threatened in writing against any of the Group Companies, and no event has occurred whichand no fact or circumstances exist that, with without notice or the lapse of time or both, would constitute reasonably be expected to result in revocation, limitation or modification of such Material Permits. To Seller’s Knowledge, the Group Companies have made available to Buyer a default true and complete copy of each Material Permit.
(c) Section 3.12(c) of the Seller Disclosure Schedule sets forth all pending applications for Material Permits and all Material Permits that are required to be obtained by the Group Companies for the construction, development, ownership, operation and maintenance of the applicable Project (as the Project is contemplated by the Group Companies as of the Closing Date) that have not been granted or violation of any termissued, condition but excluding, in each case, short-term temporary Permits, that have been submitted by the Seller or provision of any applicable Permitthe Group Companies. There are no actions pending, or to To the Knowledge of the Seller, no Group Company has received written notice from any Governmental Authority stating that it will not issue any Material Permit set forth in Section 3.12(c) of the Seller Disclosure Schedule or would impose conditions on the issuance of any Material Permit set forth in Section 3.12(c) of the Seller Disclosure Schedule that would materially impact the development, ownership, operation or maintenance of the Project, and, to the Seller’s Knowledge, no adverse comments have been filed with respect to such Permits with the applicable issuing Governmental Authority by any Person. To the Seller’s Knowledge, no event has occurred and no fact or circumstance exists that, with or without notice or lapse of time or both, would reasonably be expected to result in the failure or inability to obtain, without material delay, or inability to maintain any Material Permit listed in Section 3.12(c) of the Seller Disclosure Schedule. To the Seller’s Knowledge, all Material Permits listed in Section 3.12(c) of the Seller Disclosure Schedule can be obtained by the Group Companies in the ordinary course of business on commercially reasonable terms consistent with the past practice of the applicable issuing Governmental Authority.
(d) The Group Companies have all Material Permits necessary and sufficient for the construction of the Revolution Wind Project (including all Material Permits necessary for the commencement of the full scope of onshore and offshore construction).
(e) Since the Lookback Date, no Group Company nor any of its officers or directors nor, to the Seller’s Knowledge, its other agents, in connection with the Business, has (i) offered, promised, provided, or authorized the provision of any money, property, or other thing of value, directly or indirectly, to any Person to improperly influence official action or secure an improper advantage, or to encourage the recipient to breach a duty of good faith or loyalty or the policies of his/her employer, nor (ii) otherwise violated any Anti-Corruption Laws.
(f) Since the Lookback Date, no Group Company nor any of its officers or directors nor, to the Seller’s Knowledge, its other agents, in connection with the Business, has violated or is in violation of any Anti-Terrorism and Money Laundering Laws and Regulations.
(g) No Group Company is party to any actual or, to the Seller’s Knowledge, threatened Action relating to any breach or suspected breach of Anti-Corruption Laws or Anti-Terrorism and Money Laundering Laws and Regulations.
(h) To the Knowledge of the Seller, (i) the conduct of the Business of the Group Companies does not, and has not since the Lookback Date, violated any Jxxxx Act Laws, and (ii) except as set forth on Section 3.12(a) of the Seller Disclosure Schedule, none of the Group Companies have, since the Lookback Date, (A) received written notice of any Action whether settled, pending or threatened in writing (1) alleging that any of the Group Companies have violated any Jxxxx Act Laws or (2) challenging the compliance of the vessel strategy (including the chartering and use by the Group Companies of non-U.S.-flagged wind turbine installation vessels paired with U.S.-flagged, coastwise feeder barges and attending tugs) for the development, construction, installation, operation, and maintenance of the Projects (the “Vessel Strategy”) with any Jxxxx Act Laws, and no such Actions are pending against any Group Company, threatened and (B) made any written claim to any Person (including any vessel owner or operator, or any contractor utilizing a vessel in writing, the performance of its work) alleging that seek revocation, cancellation such Person has violated any Jxxxx Act Laws or modification breached the terms and conditions of any charter (or other contract involving the use of a vessel) that require compliance with any Jxxxx Act Laws.
(i) The Vessel Strategy for each of the Revolution Wind Project and the South Fork Project is in compliance with all applicable PermitJxxxx Act Laws, except where such revocation, cancellation or modification has not had and to the extent as would not reasonably be expected to havebe adverse in any material respect to the Revolution Wind Project, individually the South Fork Project, or in the aggregate, a Company Material Adverse EffectGroup Companies.
(bj) The As of Closing, each of South Fork Wind, LLC and Revolution Wind, LLC will be an “exempt wholesale generator” as defined in the Public Utility Holding Company is Act of 2005, and shall remain in full compliance with each have submitted to FERC a notice of the Agreements with Governmental Entities provided on Section 4.12 self-certification of the Company Disclosure Schedule. There is no material proceeding or disciplinary action exempt wholesale generator status pursuant to 18 C.F.R. § 366.7(a) (including fines) by any Governmental Entity currently pending or, to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect2023).
Appears in 1 contract
Samples: Membership Interest Purchase Agreement (Eversource Energy)
Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule:
(a) Since January 1, 2017 and as 2021, neither the Company nor any of the date hereof, each Company Group Member its Subsidiaries has been in compliance with all Laws conflict with, or in default, breach or violation of, any Law or Permit applicable to such the Company Group Member other than or any such noncompliance of its Subsidiaries or by which any property or asset of the Company or any of its Subsidiaries is bound or affected, except for conflicts, defaults, breaches or violations that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. To the knowledge of the Company, neither the Company nor any of its Subsidiaries has received, at any time since January 1, 2021, any written notice or communication from any Relevant Authority regarding any actual, alleged, or potential violation in any respect of, or a failure to comply with, any Law or Permit, except for any written notice or communication that would not had be, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Permits required No investigation or review by any Relevant Authority with respect to the Company or any of its Subsidiaries has occurred at any time in the past three (3) years or is pending or, to the knowledge of the Company, threatened in writing, nor has any Relevant Authority indicated in writing an intention to conduct the same.
(b) The Company Business are and each of its Subsidiaries is in the possession of all Permits necessary for the applicable conduct and operation of the business of the Company Group Member, are in full force and effect and are being complied with, in each caseits Subsidiaries as currently conducted, except when such where the failure to possess, or the suspension or cancellation of, any of the Permits would not be, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as No suspension or cancellation of any of the Permits is pending or, to the knowledge of the Company, threatened, except where the failure to possess, or the suspension or cancellation of, any of the Permits would not have, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the current conduct of the Company Business is not, and has not been since January 1, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liability) and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pending, or to the Knowledge of the Company, threatened in writing, that seek revocation, cancellation or modification of any applicable Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
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Samples: Memorandum of Understanding (Sequans Communications)
Legal Compliance; Permits. Except as set forth on Section 4.12 of the Company Disclosure Schedule:
(a) Since January 1, 2017 and The Company Group has as of the date hereofhereof and, each Company Group Member has been during the past two (2) years complied with, and is not currently in compliance violation of, any applicable Law with all Laws applicable respect to such Company Group Member other than any such noncompliance that has not had the conduct of its business, or the ownership or operation of its business, except for failures to comply or violations which would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Permits required be material to conduct the Company Business are in the possession Group. As of the applicable date hereof and, during the past two (2) years, the Company Group Memberhas not received any written, are in full force and effect and are being complied withor to the Knowledge of the Company, in each caseoral notice of non-compliance with any applicable Law, except when such failure for failures to comply which would not reasonably be expected to havebe material to the Company Group.
(b) The Company Group is in possession of all material Permits necessary to own, individually lease and operate the properties and assets it purports to own, operate or in lease and to carry on its business as it is now being conducted (the aggregate“Material Permits”), except where the failure to have such Material Permits would not have a Company Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, have a Company Material Adverse Effect, the current conduct of the Company Business : (a) each Material Permit is not, in full force and has not been since January 1, 2017, effect in default or violation under any Permit accordance with its terms; (except for such violation that has been remedies and imposes b) no continuing Liability) and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pendingoutstanding written, or to the Knowledge of the Company, threatened in writing, that seek oral notice of revocation, cancellation or modification termination of any applicable PermitMaterial Permit has been received by the Company; (c) there are, except where such revocationand during the past two (2) years there have been, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently Legal Proceedings pending or, to the Knowledge of the Company’s Knowledge, threatened threatened, that seek the revocation, cancellation, limitation, restriction or termination of any Material Permit; and (d) the Company is in writing against any compliance with all Material Permits applicable to the Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse EffectGroup.
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Legal Compliance; Permits. (a) Except as set forth on Section 4.12 3.8(a) of the Company Disclosure Schedule:, the Company Group is, and since the Reference Date has been, in compliance in all material respects with all applicable Laws to which the Company Group is subject. Since the Reference Date, the Company Group has not received any written or, to the Knowledge of the Company Group, any other form of notice, action or assertion from any Governmental Authority that is pending or unresolved, and, to the Knowledge of the Company Group, since the Reference Date, the Company Group has not been under investigation by any Governmental Authority with respect to any actual or alleged violation of or non-compliance with any applicable Law or Order.
(ab) Since January 1The Company Group possesses, 2017 and as has possessed since the Reference Date, all of the date hereof, each Permits necessary for or used by the Company Group Member has been in compliance with for it to lawfully operate its business. Section 3.8(b) of the Company Disclosure Schedule sets forth a complete listing of all Laws applicable such Permits held by the Company Group. Except as set forth on Section 3.8(b) of the Company Disclosure Schedule, (i) all of such Permits held by or issued to such the Company Group Member other than any such noncompliance that has not had or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Permits required to conduct the Company Business are in the possession of the applicable Company Group Member, are in full force and effect and are being complied withwill remain in full force and effect immediately following the consummation of the Transactions, (ii) the Company Group, as applicable, is in compliance in all material respects with the terms and conditions of each casesuch Permit and, except when such failure would not reasonably be expected to have, individually or in since the aggregate, a Company Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse EffectReference Date, the current conduct of the Company Business is not, and Group has not been since January 1, 2017, in default or violation under received any Permit (except for such violation that has been remedies and imposes no continuing Liability) andwritten notice or, to the Knowledge of the CompanyCompany Group, no event has occurred which, with notice or the lapse of time or both, would constitute a default or other notices that it is in violation of any termof the terms or conditions of such Permits, condition or provision of any applicable Permit. There are no actions pending, or and (iii) to the Knowledge of the CompanyCompany Group, no condition exists that with notice or lapse of time or both would constitute a default under such Permits. There is no Legal Proceeding of any kind pending, or, to the Knowledge of the Company Group, threatened in writingto revoke, that seek revocationsuspend, cancellation withdraw, limit, or modification terminate any Permit of the Company Group, nor has any applicable Permit, except where such revocation, cancellation or modification has not had and event occurred which would not reasonably be expected to havegive rise to any right of notice, individually modification, acceleration, payment, cancellation, withdrawal, limitation, or termination thereunder. All fees and charges with respect to such Permits that have become due and payable have been paid in full, and all required applications, notices, and required filings (including any pending renewal applications, notices or filings) with respect to such Permits have been duly filed or made on a timely basis with the aggregateappropriate Governmental Authorities. This Agreement shall not affect the validity of any licenses, a permits, approvals, registrations or consents held by any Company Material Adverse EffectGroup member and there is no requirement for any of the members of the Company Group to obtain any prior consent or approval under any Permit for the consummation of the Transactions.
(bc) The Company is and shall remain in full compliance with each of All foreign investments received by the Agreements with Governmental Entities provided on Section 4.12 members of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, Group in India have been received in accordance with Foreign Exchange Regulations and all statutory filings and reporting required to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directorsbe made thereunder, in each caserelation to such foreign investments, except for those that have not had, and would not reasonably be expected to have, individually or been complied with in the aggregate, a Company Material Adverse Effectaccordance with applicable Laws.
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Samples: Securities Purchase Agreement (Computer Programs & Systems Inc)
Legal Compliance; Permits. Except as set forth on Section 4.12 (a) Neither the Company nor any of its Subsidiaries is or, since January 1, 2015, has been, in any respect in conflict with, or in default, breach or violation of, any Law or Permit applicable to the Company or any of its Subsidiaries or by which any property or asset of the Company Disclosure Schedule:
(a) Since or any of its Subsidiaries is bound or affected, except for conflicts, defaults, breaches or violations that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. To the knowledge of the Company, neither the Company nor any of its Subsidiaries has received, at any time since January 1, 2017 2015, any written notice or communication from any Relevant Authority regarding any actual, alleged, or potential violation in any respect of, or a failure to comply in any material respect with, any Law or Permit, except for any written notice or communication that would not be, or would not reasonably be expected to be, material to the Company and its Subsidiaries, taken as a whole. No investigation or review by any Relevant Authority with respect to the Company or any of its Subsidiaries is pending or, to the knowledge of the date hereofCompany, threatened in writing, nor has any Relevant Authority indicated in writing an intention to conduct the same.
(b) The Company and each of its Subsidiaries is in possession of all Permits necessary for the conduct and operation of the business of the Company Group Member has been in compliance with all Laws applicable and its Subsidiaries as currently conducted, except where the failure to such Company Group Member other than possess, or the suspension or cancellation of, any such noncompliance that has of the Permits would not had be, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. All Permits required to conduct the Company Business are in the possession No suspension or cancellation of any of the applicable Company Group MemberPermits is pending or, are in full force and effect and are being complied withto the knowledge of the Company, in each casethreatened, except when such where the failure to possess, or the suspension or cancellation of, any of the Permits would not have, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the current conduct of the Company Business is not, and has not been since January 1, 2017, in default or violation under any Permit (except for such violation that has been remedies and imposes no continuing Liability) and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or both, would constitute a default or violation of any term, condition or provision of any applicable Permit. There are no actions pending, or to the Knowledge of the Company, threatened in writing, that seek revocation, cancellation or modification of any applicable Permit, except where such revocation, cancellation or modification has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(b) The Company is and shall remain in full compliance with each of the Agreements with Governmental Entities provided on Section 4.12 of the Company Disclosure Schedule. There is no material proceeding or disciplinary action (including fines) by any Governmental Entity currently pending or, to the Company’s Knowledge, threatened in writing against any Company Group Member, any of their respective assets, rights or properties or any of their respective officer or directors, in each case, except for those that have not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
Appears in 1 contract
Samples: Memorandum of Understanding (Advanced Accelerator Applications S.A.)