Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the Company is, and since January 1, 2008 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of the Company Business (ii) could reasonably be expected to have a material adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could reasonably be expected to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions. (b) The Company holds all required Governmental Authorizations which are material to the operation of the Company Business (collectively, the “Company Permits”). Schedule 2.11(b) of the Company Disclosure Letter identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”). (d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. (e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company. (f) The Company is not the subject of any pending, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither the Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company or any of its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure LetterHoldings, the Company isand each Company Subsidiary are, and since January 1, 2008 has complied 2017 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of the Company, threatened in writing against the CompanyHoldings, nor has any Governmental Body indicated to the Company an intention to conduct the sameor any Company Subsidiary. There is no agreement, judgment, injunction, order or decree binding upon Holdings, the Company or any Company Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of Holdings, the CompanyCompany or any Company Subsidiary, any acquisition of material property by the Company or any Company Subsidiary or the conduct of business by the Company Business or any Company Subsidiary as currently conducted, (ii) could reasonably be expected likely to have a material adverse effect on Holdings or the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the Food and Drug Administration (“FDA”) and except as would not reasonably be expected to have a Company holds Material Adverse Effect, the Company and the Company Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of the Company Business (collectively, the “Company Permits”)) as currently conducted. Schedule Part 2.11(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Each of the Company and each Company Subsidiary is in material compliance with the terms of the Company Permits, except as would not reasonably be expected to have a Company Material Adverse Effect. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of the Company, threatenedthreatened in writing, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each material Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened in writing with respect to an alleged material violation by the Company or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug or medical device products (“Drug Drug/Device Regulatory Agency”).
(d) The Company and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessor such Subsidiary as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution testing and importation or exportation, manufacturing as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) ), except as would not reasonably be expected to have a Company Material Adverse Effect, and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company.
(f) The Company is not the subject of any pending, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither the Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company or any of its officers, employees or agents.,
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the The Company Disclosure Letter, the Company is, and since January 1, 2008 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(b) of the Company Disclosure Letter identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, including Governmental Authorizations related to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketingadvertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including AZ01, AZ17 and AZ21 candidates (the “Company Regulatory PermitsProduct Candidates”). Section 3.14(b) of the Company Disclosure Schedule identifies each Company Permit. The Company has timely maintained and is in material compliance with the terms of the Company Permits and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. No Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company is in compliance in all material respects Permit (other than INDs with the Company) will be available to the Surviving Company Regulatory Permits or its Subsidiaries, as applicable, immediately after the Second Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and has not received immediately prior to the First Effective Time.
(c) There are no Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substances Act or any written notice other similar Law promulgated by the FDA or other written communication from any comparable Governmental Authority responsible for regulation of the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products (“Drug Regulatory Agency since January 1, 2008 regarding Agency”).
(Ad) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Parent all information requested by Parent in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; preclinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical preclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the The Company has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not not, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not not, and no contract manufacturer with respect to any Company Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company in connection with any Company Product Candidate, since April 28, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680, and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No laboratory or manufacturing site owned by the Company, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any other Governmental Authority is considering such action.
(i) The Company has complied with all Laws relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. The Company has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate (as defined in HIPAA) agreements (“Business Associate Agreements”) to which the Company is a party or otherwise bound. The Company has created and maintained written policies and procedures to protect the privacy of all Protected Health Information, has provided training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. The Company has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Authority of any allegation regarding its failure to comply with HIPAA or any other federal or state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful Security Incident, Breach of Unsecured Protected Health Information, unpermitted disclosure of Personal Health Information or breach of personally identifiable information under applicable Laws has occurred with respect to information maintained or transmitted to the Company or an agent or third party subject to a Business Associate Agreement with the Company. The Company is currently submitting, receiving and handling or is capable of submitting, receiving and handling transactions in accordance with the Transactions and Code Sets Rule. All capitalized terms in this Section 3.14(i) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2016, has complied been, in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the Federal Food, Drug, and has Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Public Health Service Act (“PHSA”) and its implementing regulations and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug and biopharmaceutical products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not received any written notices be material to the Company. To the Knowledge of alleged or actual material violation with respect tothe Company, all applicable Legal Requirements. No no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company, or threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to To the Knowledge of the Company, there are no proceedings pending or threatened against the Company with respect to an alleged material violation by the Company of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act PHSA and its implementing regulations or any other similar Legal Requirements Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“any Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for or material to the conduct of the business of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conductedconducted (collectively, of any of its products or product candidates, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has have not received any written notice or other written communication, or to the Knowledge of the Company, any other communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except The Company has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the information and files identified in Schedule 2.11(d) management of the Company Disclosure Letter, clinical data that have been presented by the Company has made available to Company. To the Acquiror true and complete copies Knowledge of the following (to the extent Company, there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reportsno facts that would be reasonably likely to result in any warning, notices untitled or notice of adverse findings, warning letters, filings and letters and other written correspondence to and violation letter or Form FDA-483 from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authoritythe FDA.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, includingas applicable, without limitation, including the Good Clinical Practice (“GCP”) regulations under 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial conducted by or on behalf of the Company has been terminated or suspended prior to completion for safety or non-compliance reasons. Since January 1, 20082016, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or in which the Company or its current products or product candidates have participated.
(f) The To the Knowledge of the Company, the Company is not the subject of any pending, pending or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and ), or any amendments thereto. To the Knowledge of the Company, neither the Company has not nor any of its officers, employees or agents have committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company nor or any of its officers, employees or or, to the Knowledge of the Company, agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to the Knowledge of the Company, threatened against the Company or any of its officers, employees or, to the Knowledge of the Company, agents.
(g) Neither Company, nor any of its officers, directors, employees or agents has been, is, or is in anticipation of being (based on a conviction by the courts or a finding of fault by a regulatory authority): (a) debarred pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a), as amended from time to time; (b) disqualified from participating in clinical trials pursuant to 21 C.F.R. §312.70, as amended from time to time; (c) disqualified as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended from time to time; (d) excluded, debarred or suspended from or otherwise ineligible to participate in a “Federal Health Care Program” as defined in 42 U.S.C. 1320a-7b(f), as amended from time to time, or any other governmental payment, procurement or non-procurement program; or (e) included on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s List of Parties Excluded from Federal Programs, or the FDA Debarment List. Company is not using, nor has it ever used, in any capacity any Person that has ever been, is currently, or to the Knowledge of Company is the subject of a proceeding that could lead to the Company or its officers, directors, employees or agents becoming, as applicable, a Debarred Entity, a Debarred Individual, an Excluded Entity, an Excluded Individual, or a Convicted Entity or a Convicted Individual, nor are they listed on the FDA’s Disqualified/Restricted List. The Company, nor any of its officers, directors, employees or agents, has been excluded or threatened with exclusion under state or federal statutes or regulations, including under 42 U.S.C. § 1320a-7 or relevant regulations in 42 C.F.R. Part 1001, or assessed or threatened with assessment of civil money penalties pursuant to 42 C.F.R. Part 1003. Neither the Company nor to its knowledge its officers, directors, employees or agents has taken any action that would now or in the future constitute an improper inducement under federal or state healthcare laws.
(h) The Company is not a Covered Entity under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), but the Company has complied in all material respects with all Laws relating to patient, medical or individual health information, if required, including (to the extent applicable) the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. The Company has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate (as defined in HIPAA) agreements (“Business Associate Agreements”) to which the Company is a party or otherwise bound. To the extent applicable, the Company has created and maintained written policies and procedures to protect the privacy of all protected health information, provides training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. The Company has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful Security Incident, Breach of Unsecured Protected Health Information or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to the Company or an agent or third party subject to a Business Associate Agreement with the Company. If required, the Company is currently submitting, receiving and handling or is capable of submitting receiving and handling transactions in accordance with the Standard Transaction Rule. All capitalized terms in this Section 2.14(f) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1its inception, 2008 has complied been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal RequirementsLaws, except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger Exchange. No investigation, claim, suit, Legal Proceeding, audit or other action by any Governmental Body is, to the Knowledge of the other Contemplated TransactionsCompany, pending or is threatened against the Company.
(b) The Company holds all required Governmental Authorizations which are necessary for, and material to to, the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.13(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending orLegal Proceeding is, to the Knowledge of the Company, pending or threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit Permits will be available to the Surviving Corporation Company immediately after the Effective Time date hereof on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior without the need to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the obtain any consent or waiver from any Governmental Body. No Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1communication, 2008 or to the Knowledge of the Company, regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company.
(f) The Company is not the subject of any pending, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither the Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company or any of its officers, employees or agents.
Appears in 1 contract
Samples: Exchange Agreement (RetinalGenix Technologies Inc.)
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) The Company and each of the Company Disclosure Letter, the Company isits Subsidiaries are, and since January 1have been, 2008 has complied in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has Company or any Governmental Body indicated to the Company an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company or any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the CompanyCompany or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Company Business or any of its Subsidiaries as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of the Company Business and its Subsidiaries as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Each of the Company and its Subsidiaries is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act, Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of the Company Businessor such Subsidiary as currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is and each of its Subsidiaries have timely maintained and are in compliance in all material respects with the Company Regulatory Permits and has have not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Zordich all information requested by Zordich in the Acquiror true Company’s or its Subsidiaries’ possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries or their respective current products or product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, Neither the Company nor any of its Subsidiaries has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries or their respective current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Neither the Company nor any of its Subsidiaries, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, neither the Company nor any of its Subsidiaries and no contract manufacturer with respect to any Company Product Candidate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company nor Company, any of its Subsidiaries, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, any of its Subsidiaries, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company or its Subsidiaries in connection with any Company Product Candidate, since January 1, 2017, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contains in 21 C.F.R. Parts 210, 211, 600-680, and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by the Company or its Subsidiaries, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer, with respect to any Company Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not be complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any other Governmental Authority is considering such action.
(i) As of the date of this Agreement, except as is set forth on Section 3.14 of the Company Disclosure Schedule and to the Knowledge of the Company, there are no adverse drug-related reactions to the dosing of patients in the Company’s Phase 1 clinical trials to evaluate the safety and tolerability of single and multiple ascending doses of CTI-1601 (the “Phase 1 Trials”) or any significant drug-related findings from any toxicology study.
Appears in 1 contract
Samples: Merger Agreement (Zafgen, Inc.)
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1April 30, 2008 2012 has complied been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal RequirementsLaws, except for any noncompliance, either individually or in the aggregate, which would not result in a Company Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or Governmental Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could reasonably be expected to may have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected to likely have the effect of preventing, materially delaying, delaying or making illegal or otherwise materially interfering with the Merger Transaction or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to for the operation of the business of the Company Business (collectively, the “Company Permits”)) as currently conducted, except for any failure to hold any such Governmental Authorization, either individually or in the aggregate, that would not result in a Company Material Adverse Effect. Schedule 2.11(bPart 2.13(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Laws promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, for the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(dPart 2.13(d) of the Company Disclosure LetterSchedule, the Company has made available to Carnivale all information requested by Carnivale in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Company Product Candidates, including complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaws, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1April 30, 20082012, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or in which the Company or its respective current products or product candidates, including the Company Product Candidates, have participated.
(f) The Company is not the subject of any pending, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither the Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company Company, or any of its their respective officers, employees or agents.
Appears in 1 contract
Samples: Share Purchase Agreement (Carbylan Therapeutics, Inc.)
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the U.S. Food and Drug Administration (or any successor agency thereto) (“FDA”) or other comparable Governmental Authority responsible for regulation of the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or medical device products (“Drug/Device Regulatory Agency”), the Company holds all required Governmental Authorizations which are material to for the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, suspend or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Entity or its Subsidiaries, as applicable, immediately after the Second Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the First Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration the Public Health Service Act (“FDAPHSA”) ), FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug a Drug/Device Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Section 3.14(d) of the Company Disclosure Letter identifies each Company Regulatory Permit. The Company has timely maintained and is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or correspondence or, to the Knowledge of the Company, other written communication from any Drug Drug/Device Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Parent all information requested by Parent in the Acquiror true Company’s possession or control relating to material Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; preclinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; and meeting minutes with any Drug Drug/Device Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical preclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company were or its current products or product candidates, including the Company Product Candidates, have participated, were, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, in accordance in all material respects with the applicable protocols and in compliance in all material respects with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 2008, the The Company has not received any written notices, correspondence, correspondence or other communications from any Drug Drug/Device Regulatory Agency Agency, Governmental Authority, institutional review board, ethics committee or safety monitoring committee requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not not, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products products, including Company Product Candidates, by the FDA pursuant to its “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 theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To The Company has not, and to the Knowledge of the Company, the no contract manufacturer, nor their respective officers, employees or agents, with respect to any Company Product Candidate has not committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or a comparable policy of any other Drug/Device Regulatory Agency. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of the Company in connection with any Company Product Candidate have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-610 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) Neither the Company nor, to the Knowledge of the Company, any manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of the Company, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2021, has complied been, in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding applicable provisions of the Federal Food, Drug, and has Cosmetic Act (“FDCA”), the U.S. Food and Drug Administration (“FDA”) regulations adopted thereunder, the Public Health Service Act (“PHSA”) and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, nonclinical and clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug and biopharmaceutical products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not received any written notices of alleged or actual be material violation with respect to, all applicable Legal Requirementsto the Company. No investigation, claim, suit, proceeding, audit or, to the Company’s Knowledge, investigation or other action by any Governmental Body is pending or, to the Knowledge of the Company’s Knowledge, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which that are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company holds all right, title and interest in and to all Company Permits free and clear of any Encumbrance. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company’s Knowledge, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Corporation, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company’s Knowledge, threatened with respect to an alleged material violation by the Company of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act PHSA or any other similar Legal Requirements Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“any Drug Regulatory Agency”). The Company is not currently conducting or addressing, and, to the Company’s Knowledge, there is no basis to expect that it will be required to conduct or address, any corrective actions, including product recalls or clinical holds.
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical nonclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20082021, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, requiring or to the Knowledge of the Company, threatening to initiate, initiate the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or in which the Company or its current product candidates have participated. The Company has made available to Parent true and complete copies of all material notices, correspondence or other communications received by the Company from any Drug Regulatory Agency.
(fe) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company’s Knowledge, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products products, that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither the Company nor any of its respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) under 42 U.S.C. §§ 1320a-7 or 1320a-7a or any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their its business or products are pending or or, to the Company’s Knowledge, threatened against the Company or any of its respective officers, employees employees, or to the Company’s Knowledge, agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2016 has complied been, in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the Federal Food, Drug, and has Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA, the European Medicines Evaluation Agency (“EMEA”) or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (the FDA, EMEA and each such other comparable Governmental Body, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not received any written notices of alleged or actual be material violation with respect to, all applicable Legal Requirementsto the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company, threatened in writing against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical similar to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“any Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for or material to the conduct of the business of the Company Businessas currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (collectively, including AZ01the “Company Products”) (collectively, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication, or to the Knowledge of the Company, any other communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(das set forth on Section 2.14(d) of the Company Disclosure LetterSchedule, the Company has made available to the Acquiror true and Parent complete copies of the following (to the extent there are any): (x) copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody. The Company has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the management of the clinical data that have been presented by the Company. To the Company’s Knowledge, there are no studies, tests or trials the results of which the Company believes reasonably call into question (i) the study, test or trial results of any Company Products, (ii) the efficacy or safety of any Company Products or (iii) any of the Company’s filings with any Governmental Body.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Products, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial conducted by or on behalf of the Company has been terminated or suspended prior to completion for safety or non-compliance reasons. Since January 1, 20082016, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or in which the Company or its current products or product candidates, including the Company Products, have participated.
(f) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or any comparable applicable Law of any other Drug Regulatory Agency. Neither the Company nor nor, to the Knowledge of the Company, any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could would result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their the Company’s business or products are pending or or, to the Knowledge of the Company, threatened against the Company or or, to the Knowledge of the Company any of its officers, employees or agents.
(g) The Company has complied in all material respects with all Laws relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. The Company has entered into, where required, and are in compliance in all material respects with the terms of all Business Associate (as defined in HIPAA) agreements to which the Company is a party or otherwise bound. The Company has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. To the Company’s Knowledge, no successful Security Incident, Breach of Unsecured Protected Health Information or breach of personally identifiable information under applicable state or federal laws has occurred with respect to information maintained or transmitted to the Company or an agent or third party subject to a Business Associate Agreement with the Company. The Company is currently submitting, receiving and handling or is capable of submitting receiving and handling transactions in accordance in all material respects with the Standard Transaction Rule. All capitalized terms in this Section 2.14(g) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2020 has complied in all material respects withbeen, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except where a failure would not result in a Company Material Adverse Effect, the Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Corporation, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. § 301 et seq.), Food and Drug Administration (“FDA”) the implementing regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated Law enforced by the FDA or other comparable Governmental Body Authorities responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of investigational drug products (“Drug Regulatory Agency”)) that is material to the conduct of the Company’s business.
(d) The Company holds all required Governmental Authorizations issuable issued or granted by any Drug Regulatory Agency or other Governmental Authority which is necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, marketingprocessing, distribution storage, labeling, and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated terminated, or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company has timely maintained and is in compliance in all material respects with the Company Regulatory Permits and has have not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 or other Governmental Authority regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit Permit, or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to PubCo all information requested by PubCo in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and official meeting minutes with from any Drug Regulatory Agency; , and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with involving any other Governmental AuthorityAuthority pertaining to the development of Company Product Candidates. All such information is accurate and complete in all respects.
(e) All clinicalclinical trials, pre-clinical studies and other studies and tests conducted by or on behalf of, or sponsored by, the Company with respect to the Company Product Candidates were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable Laws and regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsAgencies, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the The Company has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company with respect to the Company Product Candidates. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified by the U.S. Food and Drug Administration (“FDA”) from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, neither the Company nor any contract manufacturer with respect to any Company Product Candidate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a 335a, or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company in connection with any Company Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices for human pharmaceuticals codified at 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by the Company, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer, with respect to any Company Product Candidate, (i) is subject to a Drug Regulatory Agency or Governmental Authority shutdown or import or export prohibition, or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law in relation to any Company Product Candidate, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any other Governmental Authority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2018 has complied in all material respects withbeen, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except where a failure would not result in a Company Material Adverse Effect, the Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Corporation, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products (“Drug Regulatory Agency”)Agency”).which is material to the conduct of the Company’s business.
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency or Governmental Authority which is necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is has timely maintained and are in compliance in all material respects with the Company Regulatory Permits and has have not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 or Governmental Authority regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to PubCo all information requested by PubCo in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or their respective product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the The Company has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its respective current product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Neither the Company nor, to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, neither the Company nor any contract manufacturer with respect to any Company Product Candidate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company in connection with any Company Product Candidate, since January 1, 2018, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680, and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by the Company, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer, with respect to any Company Product Candidate, (i) is subject to a Drug Regulatory Agency or Governmental Authority shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any other Governmental Authority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1April 28, 2008 2020 has complied in all material respects withbeen, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Company or its Subsidiaries, as applicable, immediately after the Second Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the First Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is has timely maintained and are in compliance in all material respects with the Company Regulatory Permits and has not not, since April 28, 2020, received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Utah all information requested by Utah in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; preclinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical preclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the The Company has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not not, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not not, and no contract manufacturer with respect to any Company Product Candidate has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company in connection with any Company Product Candidate, since April 28, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680, and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No laboratory or manufacturing site owned by the Company, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any other Governmental Authority is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the U.S. Food and Drug Administration (or any successor agency thereto) (“FDA”) or other comparable Governmental Authority responsible for regulation of the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or medical device products (“Drug/Device Regulatory Agency”), the Company holds all required Governmental Authorizations which are material to for the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, suspend or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Entity or its Subsidiaries, as applicable, immediately after the Second Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the First Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration the Public Health Service Act (“FDAPHSA”) ), FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug a Drug/Device Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Section 3.14(d) of the Company Disclosure Letter identifies each Company Regulatory Permit. The Company has timely maintained and is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or correspondence or, to the Knowledge of the Company, other written communication from any Drug Drug/Device Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Parent all information requested by Parent in the Acquiror true Company’s possession or control relating to material Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; preclinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; and meeting minutes with any Drug Drug/Device Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical preclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company were or its current products or product candidates, including the Company Product Candidates, have participated, were, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, in accordance in all material respects with the applicable protocols and in compliance in all material respects with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 2008, the The Company has not received any written notices, correspondence, correspondence or other communications from any Drug Drug/Device Regulatory Agency Agency, Governmental Authority, institutional review board, ethics committee or safety monitoring committee requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not not, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products products, including Company Product Candidates, by the FDA pursuant to its “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 theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To The Company has not, and to the Knowledge of the Company, the no contract manufacturer, nor their respective officers, employees or agents, with respect to any Company Product Candidate has not committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or a comparable policy of any other Drug/Device Regulatory Agency. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of the Company in connection with any Company Product Candidate have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-610 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) Neither the Company nor, to the Knowledge of the Company, any manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of the Company, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Samples: Merger Agreement (Pulmatrix, Inc.)
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the U.S. Food and Drug Administration (or any successor agency thereto) (“FDA”) or other comparable Governmental Authority responsible for regulation of the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or medical device products (“Drug/Device Regulatory Agency”), the Company holds all required Governmental Authorizations which are material to for the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, suspend or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration the Public Health Service Act (“FDAPHSA”) ), FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug a Drug/Device Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Section 3.14(d) of the Company Disclosure Schedule identifies each Company Regulatory Permit. The Company has timely maintained and is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or correspondence or, to the Knowledge of the Company, other written communication from any Drug Drug/Device Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Magenta all information requested by Magenta in the Acquiror true Company’s possession or control relating to material Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; preclinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; and meeting minutes with any Drug Drug/Device Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical preclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company were or its current products or product candidates, including the Company Product Candidates, have participated, were, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, in accordance in all material respects with the applicable protocols and in compliance in all material respects with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 2008, the The Company has not received any written notices, correspondence, correspondence or other communications from any Drug Drug/Device Regulatory Agency Agency, Governmental Authority, institutional review board, ethics committee or safety monitoring committee requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not not, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products products, including Company Product Candidates, by the FDA pursuant to its “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 theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To The Company has not, and to the Knowledge of the Company, the no contract manufacturer, nor their respective officers, employees or agents, with respect to any Company Product Candidate has not committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or a comparable policy of any other Drug/Device Regulatory Agency. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of the Company in connection with any Company Product Candidate have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-610 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) Neither the Company nor, to the Knowledge of the Company, any manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of the Company, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1February 26, 2008 2019 has complied been, and, to the Company’s knowledge, the entities that owned any of the Company’s material intellectual property prior to such date were, in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the Federal Food, Drug, and has Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not received any written notices of alleged or actual be material violation with respect to, all applicable Legal Requirementsto the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Entity or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“any Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for or material to the conduct of the business of the Company Businessor such Subsidiary as currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (collectively, including AZ01the “Company Products”) (collectively, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has have not received any written notice or other written communication, or to the Knowledge of the Company, any other communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(dSection 2.14(d) of the Company Disclosure LetterSchedule, the Company has made available to Parent all information requested by Parent in the Acquiror true Company’s or its Subsidiaries’ possession or control relating to the Company Products and the development, clinical testing, manufacturing, importation and exportation of the Company Products, including complete copies of the following (to the extent there are any): (x) copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody. The Company has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the management of the clinical data that have been presented to the Company. To the Knowledge of the Company, there are no facts that would be reasonably likely to result in any warning, untitled or notice of violation letter or Form FDA-483 from the FDA. The Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question (i) the study, test or trial results of any Company Products, (ii) the efficacy or safety of any Company Products or (iii) any of the Company’s filings with any Governmental Body.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Products, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. No preclinical or clinical trial currently being conducted by or on behalf of the Company has been terminated or suspended prior to completion for safety or non-compliance reasons. Since January 1February 26, 20082019, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination or suspension of any clinical studies currently being conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Products, have participated. The Company has not received any notices, correspondence, or other communications regarding any clinical studies that have been conducted by or on behalf of, or sponsored by, the Company or in which the Company or its products or product candidates have participated that are anticipated to result in any material liability to Company or have a Company Material Adverse Effect on the Company.
(f) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company nor or any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to the Knowledge of the Company, threatened against the Company or any of its officers, employees or agents.
(g) The Company has complied with all Laws relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time. The Company has entered into, where required, and are in compliance in all material respects with the terms of all Business Associate (as defined in HIPAA) agreements to which the Company or a Subsidiary is a party or otherwise bound. The Company has created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and have implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. The Company has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful Security Incident, Breach of Unsecured Protected Health Information or breach of personally identifiable information under applicable Laws have occurred with respect to information maintained or transmitted to the Company, or an agent or third party subject to a Business Associate Agreement with the Company. The Company is currently submitting, receiving and handling or is capable of submitting receiving and handling transactions in accordance with the Standard Transaction Rule. All capitalized terms in this Section 2.14(g) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
(h) The Company has complied in all material respects with the ICH E9 Guidance for Industry to the extent applicable to its current activities.
Appears in 1 contract
Samples: Merger Agreement (BioPharmX Corp)
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2021 has complied in all material respects withbeen, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Company or its Subsidiaries, as applicable, immediately after the Second Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the First Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, marketingprocessing, storage, labeling, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not not, since January 1, 2021, received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or adverse material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to MEDS all information requested by MEDS in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and summaries of material study data; and inspection reports, notices of adverse findings, warning untitled letters, filings and warning letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, material correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical preclinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the The Company has not received any written notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher, or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened in writing or is pending.
(f) The Company is not the subject of any pendingnot, or and to the Knowledge of the Company, threatened no contract manufacturer with respect to any Company Product Candidate, is the subject of any pending investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the The Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company in connection with any Company Product Candidate, since January 1, 2021, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210 and 211, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No laboratory or manufacturing site owned by the Company, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) The Company and each of the Company Disclosure Letter, the Company isits Subsidiaries are, and since January 1, 2008 has complied in all material respects with2021 have been, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order, or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has Company or any Governmental Body indicated to the Company an intention to conduct the sameof its Subsidiaries. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company or any of its Subsidiaries which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the CompanyCompany or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Company Business or any of its Subsidiaries as currently conducted, (ii) could is reasonably be expected likely to have a material adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the U.S. Food and Drug Administration (or any successor agency thereto) (“FDA”), the Company holds and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of the Company Business and its Subsidiaries as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Each of the Company and its Subsidiaries is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatenedthreatened in writing, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an actual or alleged material violation by the Company or any of its Subsidiaries of the Federal FoodFDCA, Drugthe PHSA, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) the U.S. FDA regulations adopted promulgated thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements applicable Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or medical device products (“Drug Drug/Device Regulatory Agency”).
(d) The Company and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessor such Subsidiary as currently conducted, and, as applicable, the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is and each of its Subsidiaries have timely maintained and are in compliance in all material respects with the Company Regulatory Permits and has not have not, since January 1, 2021 received any written notice or other written communication (in writing or otherwise) from any Drug Drug/Device Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Vibrant all information requested by Vibrant in the Acquiror true Company’s or its Subsidiaries’ possession or control relating to the Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (x) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; and meeting minutes with any Drug Drug/Device Regulatory Agency; Agency and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company were or its Subsidiaries, or in which the Company or its Subsidiaries or their respective current products or product candidates, including the Company Product Candidates, have participated, were, if completed, conducted and wound down, and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures procedures, in compliance with the applicable protocols, and in compliance with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312, and 312. Since January 1, 2008812, the applicable requirements of good laboratory practices and good clinical practices, including the applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects (including “Informed Consent” as such term or similar term is defined under applicable Law) and applicable Law governing the privacy of patient medical records and other personal information, data and biological specimens, and no such informed consent documents would prevent the transfer of such personal information, data and biological specimens to the Company. Neither the Company nor any of its Subsidiaries has not received any written notices, correspondence, or other communications from any Drug Drug/Device Regulatory Agency Agency, Governmental Authority, institutional review board (“IRB”), ethics committee or safety monitoring committee requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination any action to place a clinical hold order on, or suspension of otherwise terminate, delay, or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries or their respective current products or product candidates, including the Company Product Candidates, are participating or have participated (collectively, the “Company Clinical Studies”). For all completed Company Clinical Studies, no study subjects remain on any study drug comprising any product candidates of the Company or its Subsidiaries, including the Company Product Candidates, and no study subjects have requested ongoing administration of any such study drug. Further, no clinical investigator, researcher, or clinical staff participating in any Company Clinical Study has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Neither the Company nor any of its Subsidiaries, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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 theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To Neither the Company nor any of its Subsidiaries or, to the Knowledge of the Company, the any contract manufacturer with respect to any Company Product Candidate has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or a comparable policy of any other Drug/Device Regulatory Agency. Neither None of the Company nor Company, any of its Subsidiaries, or any contract manufacturer with respect to any Company Product Candidate, or any of their respective officers, directors, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section § 335a or (ii) any similar applicable Legal RequirementLaw, or is or has ever been debarred or excluded. To the Knowledge of the Company, no No material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to the Knowledge of the Company, threatened against the Company, any of its Subsidiaries, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of, the Company or its Subsidiaries in connection with any Company Product Candidate, since January 1, 2021 have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211, 600-680, 820, and 1271, and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) No manufacturing site owned by the Company or its Subsidiaries, and to the Knowledge of the Company, no manufacturing site of a contract manufacturer, with respect to any Company Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to the Knowledge of the Company, neither the FDA nor any other Governmental Authority is considering such action.
(i) Since January 1, 2021, the Company or its Subsidiaries has operated in compliance with all Health Care Laws and has timely filed all material reports, applications, statements, documents, registrations, filings, corrections, updates, amendments, supplements, and submissions required to be filed by them under applicable Health Care Laws. Each such filing was true and correct in all material respects as of the date of submission, or was corrected in or supplemented by a subsequent filing, and any material and legally necessary or required updates, changes, corrections, amendments, supplements, or modifications to such filings have been submitted to the applicable governmental authorities.
(j) All payments have been made and there are no remaining payment obligations under any Contract with a Third Party relating to Company Clinical Studies, including any contract research organization or study site.
(k) There are no Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to claims arising from (i) any Company Clinical Studies; or (ii) actual or alleged breach by the Company or it Subsidiaries of any Contract with a Third Party relating to any Company Clinical Studies.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2016 has complied been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”, including AZ01and such required Governmental Authorizations, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has have not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Milan all information requested by Milan in the Acquiror true Company’s possession or control relating to the Company Product Candidates and the development, clinical testing, manufacturing, importation and exportation of the Company Product Candidates, including complete copies of the following (to the extent there are any): (x) serious adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority, in each case to the extent material.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20082016, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiringrequiring or, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated.
(f) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company nor or any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company or any of its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the Company Signal is, and since January 1, 2008 2011, each of Signal and its former Subsidiaries has complied been in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsRequirements except for any non- compliance that would not constitute a Signal Material Adverse Effect. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body or authority is pending or, to the Knowledge of the CompanySignal, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the sameSignal. There is no agreementContract, judgment, injunction, order or decree binding upon the Company Signal which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the CompanySignal, any acquisition of material property by the Company Signal or the conduct of the Company Business business by Signal as currently conducted, (ii) could would reasonably be expected to have a material an adverse effect on the CompanySignal’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could would reasonably be expected to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company Signal holds all required Governmental Authorizations which that are material to the operation of the Company Business its business (collectively, the “Company Signal Permits”)) as currently conducted. Schedule 2.11(bSection 3.12(b) of the Company Signal Disclosure Letter Schedule identifies each Company Signal Permit. The Company As of the date of this Agreement, Signal is in material compliance with the terms of the Company Signal Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of the CompanySignal, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Signal Permit. The rights and benefits of each Company material Signal Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company Signal as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the CompanySignal, threatened with respect to an alleged material violation by the Company Signal of the Federal Food, Drug, and Cosmetic Act Clinical Laboratory Improvement Amendments (“FDCACLIA”), Food and Drug Administration (“FDA”) regulations adopted thereunderstate CLIA regulations, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable a Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”)Body.
(d) The Company Signal holds all required Governmental Authorizations issuable by any Drug Regulatory Agency Governmental Body necessary for the conduct of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, its business as currently conducted, of any of its products or product candidates, including AZ01, AZ17 and AZ21 conducted (the “Company Signal Regulatory Permits”) and no such Company Signal Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled canceled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and Signal has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 Governmental Body regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellationcancelation, termination or material modification of any Company Signal Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company Signal has made available to the Acquiror true and complete copies of Miragen all information in its possession or control relating to the following (to the extent there are any): (xA) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory AgencyGovernmental Body; and meeting minutes with any Drug Regulatory AgencyGovernmental Body; and (yB) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company Signal or in which Signal or its products or services have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal Requirements, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company.
(f) The Company is not the subject of any pending, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither the Company nor any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of the CompanySignal, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company Signal or any of its officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2020, has complied in all material respects with, is not been in material violation of, and has not received any written notices of alleged or actual material violation compliance with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit audit, Order or other Legal Proceeding or action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the U.S. Food and Drug Administration (or any successor agency thereto) (“FDA”) or other comparable Governmental Authority responsible for regulation of the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of drug or medical device products (“Drug/Device Regulatory Agency”), the Company holds all required Governmental Authorizations which that are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.14(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially substantially limit, suspend, suspend or materially modify any Company Permit. The rights and benefits of each Company Permit Permit, if any, will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration the Public Health Service Act (“FDAPHSA”) ), FDA regulations adopted thereunder, the Controlled Substance Substances Act or any other similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug a Drug/Device Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessas currently conducted, and, as applicable, and the development, clinical testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. Section 3.14(d) of the Company Disclosure Schedule identifies and lists each (A) Company Regulatory Permit and (B) Company Product Candidate. The Company has timely maintained and is in compliance in all material respects with the Company Regulatory Permits and has not not, since January 1, 2020, received any written notice or correspondence or, to the Knowledge of the Company, other written communication from any Drug Drug/Device Regulatory Agency since January 1, 2008 regarding (Aw) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (Bx) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the The Company has made available to Parent all information requested by Parent in the Acquiror true Company’s possession or control relating to material Company Product Candidates and the development, testing, manufacturing, processing, storage, labeling, sale, marketing, advertising, distribution and importation or exportation of the Company Product Candidates, including but not limited to complete copies of the following (to the extent there are any): (xy) adverse event reports; pre-clinical, clinical and other study reports and material study data; and inspection reports, notices of adverse findings, untitled letters, warning letters, filings and letters and other written correspondence to and from any Drug Drug/Device Regulatory Agency; Agency and meeting minutes with any Drug Drug/Device Regulatory Agency; Agency and (yz) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority. All such information is accurate and complete in all material respects.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company were or its current products or product candidates, including the Company Product Candidates, have participated, were, since January 1, 2020, and, if still pending, are being conducted in accordance in all material respects in accordance with standard medical and scientific research procedures procedures, in accordance in all material respects with the applicable protocols and in compliance in all material respects with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal RequirementsLaws, including, without limitation, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312812. Since January 1, 20082020, the Company has not received any written notices, correspondence, correspondence or other communications from any Drug Drug/Device Regulatory Agency requiringAgency, Governmental Authority, institutional review board, ethics committee or safety monitoring committee requiring or, to the Knowledge of the Company, threatening to initiateinitiate any action to place a clinical hold order on, the termination or suspension of otherwise terminate, delay or suspend any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or its current products or product candidates, including the Company Product Candidates, have participated. Further, no clinical investigator, researcher or clinical staff participating in any clinical study conducted by or, to the Knowledge of the Company, on behalf of the Company has been disqualified from participating in studies involving the Company Product Candidates, and to the Knowledge of the Company, no such administrative action to disqualify such clinical investigators, researchers or clinical staff has been threatened or is pending.
(f) The Company is not not, and to the Knowledge of the Company, no contract manufacturer with respect to any Company Product Candidate, is the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products products, including Company Product Candidates, by the FDA pursuant to its “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 theretothereto or by any other Drug/Device Regulatory Agency under a comparable policy. To The Company has not, and to the Knowledge of the Company, the no contract manufacturer, nor their respective officers, employees or agents, with respect to any Company Product Candidate has not committed any acts, made any statement, statement or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or a comparable policy of any other Drug/Device Regulatory Agency. Neither None of the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company nor Product Candidate, or any of its their respective officers, employees or agents is currently or has been debarred, convicted of any crime or is engaging or has engaged in any conduct that could result in a material debarment or exclusion under (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, and to the Knowledge of the Company, any contract manufacturer with respect to any Company Product Candidate, or any of its their respective officers, employees or agents.
(g) All manufacturing operations conducted by, or to the Knowledge of the Company, for the benefit of the Company in connection with any Company Product Candidate, since January 1, 2020, have been and are being conducted in compliance in all material respects with applicable Laws, including the FDA’s standards for current good manufacturing practices, including applicable requirements contained in 21 C.F.R. Parts 210, 211 and 600-610 and the respective counterparts thereof promulgated by Governmental Authorities in countries outside the United States.
(h) Neither the Company nor, to the Knowledge of the Company, any manufacturing site of a contract manufacturer or laboratory, with respect to any Company Product Candidate, (i) is subject to a Drug/Device Regulatory Agency shutdown or import or export prohibition or (ii) has received any Form FDA 483, notice of violation, warning letter, untitled letter, reviews (including data integrity reviews) or similar correspondence or notice from the FDA or other Drug/Device Regulatory Agency alleging or asserting noncompliance with any applicable Law, in each case, that have not been complied with or closed to the satisfaction of the relevant Drug/Device Regulatory Agency, and, to the Knowledge of the Company, neither the FDA nor any other Drug/Device Regulatory Agency is considering such action.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of The Company and the Company Disclosure Letter, the Company isSubsidiary are, and since January November 1, 2008 has complied 2018 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal RequirementsLaws. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body Authority is pending or, to the Knowledge of the Company, threatened against the Company, nor has any Governmental Body indicated to Company or the Company an intention to conduct the sameSubsidiary. There is no agreement, judgment, injunction, order agreement or decree Order binding upon the Company or the Company Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the CompanyCompany or the Company Subsidiary, any acquisition of material property by the Company or the Company Subsidiary or the conduct of business by the Company Business or the Company Subsidiary as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, Agreement or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds and the Company Subsidiary hold all required Governmental Authorizations which that are material to the operation of the business of the Company Business and the Company Subsidiary as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 2.15(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Each of the Company and the Company Subsidiary is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company and the Company Subsidiary as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings Legal Proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company or the Company Subsidiary of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act thereunder or any other applicable similar Legal Requirements Law promulgated by the FDA or other comparable Governmental Body Authority responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”).
(d) The Company holds and the Company Subsidiary hold all required material Governmental Authorizations issuable issued by any Drug Regulatory Agency that are necessary for the conduct of the business of the Company Businessor the Company Subsidiary as currently conducted, and, as applicable, and the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no ). All such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified Permits are in any adverse manner, other than immaterial adverse modificationsfull force and effect. The Company is and the Company Subsidiary have fulfilled and performed all of their material obligations with respect to the Company Regulatory Permits and, to the Knowledge of the Company, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Company Regulatory Permit. The Company and the Company Subsidiary are in compliance in all material respects with the terms of the Company Regulatory Permits and neither the Company nor the Company Subsidiary has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure Legal Proceedings relating to comply materially with any term or requirement of any Company Regulatory Permit or (B) any the revocation, withdrawaltermination, suspension, cancellation, termination suspension or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company or the Company Subsidiary, or in which the Company or the Company Subsidiary or their respective current products or product candidates, including the Company Product Candidates, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Regulatory Agencies and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January November 1, 20082018, neither the Company nor the Company Subsidiary has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or the Company Subsidiary.
(f) The Neither the Company nor the Company Subsidiary is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy final policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Knowledge of the Company, neither the Company nor the Company Subsidiary has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policyfinal policy, and any amendments thereto. Neither None of the Company, the Company nor Subsidiary or, to the Knowledge of the Company, any of its their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, the Company Subsidiary or any of its their respective officers, employees or agents.
(g) The Company and the Company Subsidiary have complied in all material respects with all applicable security and privacy standards regarding protection of health information under applicable Laws.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the The Company Disclosure Letter, the and each Company isSubsidiary are, and since January 1, 2008 has complied 2020 have been, in compliance in all material respects with, is not in material violation of, and has not received any written notices of alleged or actual material violation with respect to, all applicable Legal Requirements. No investigation, claim, suit, proceeding, audit audit, action or other action Legal Proceeding by any Governmental Body is pending or, to the Knowledge of the Company, threatened against the Company, nor has Company or any Governmental Body indicated to the Company an intention to conduct the sameSubsidiary. There is no agreement, judgment, injunction, order or decree binding upon the Company or any Company Subsidiary which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the CompanyCompany or any Company Subsidiary, any acquisition of material property by the Company or any Company Subsidiary or the conduct of business by the Company Business or any Company Subsidiary as currently conducted, (ii) could is reasonably be expected likely to have a material adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Except for matters regarding the U.S. Food and Drug Administration (or any successor agency thereto) (“FDA”), the Company holds and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of the Company Business (collectively, the “Company Permits”)) as currently conducted. Schedule Part 2.11(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Each of the Company and each Company Subsidiary is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim is pending or, to the Knowledge of the Company, threatenedthreatened in writing, which seeks to revoke, materially substantially limit, suspend, or materially modify any Company Permit. The rights and benefits of each material Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical to those enjoyed by the Company and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened in writing with respect to an alleged material violation by the Company or any of its Subsidiaries of the Federal Food, Drug, and Cosmetic Act (as amended, the “FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug or medical device products (“Drug Drug/Device Regulatory Agency”).
(d) The Company and each of its Subsidiaries holds all required Governmental Authorizations issuable by any Drug Drug/Device Regulatory Agency necessary for the conduct of the business of the Company Businessor such Subsidiary as currently conducted, and, as applicable, development, clinical testing, manufacturing, marketing, distribution testing and importation or exportation, manufacturing as currently conducted, of any of its products or product candidatescandidates (the “Company Product Candidates”) (collectively, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) ), and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any materially adverse manner, other than immaterial adverse modifications. The Company and each Company Subsidiary is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication (in writing or otherwise) from any Drug Drug/Device Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company were andor its Subsidiaries or in which the Company or its Subsidiaries or their respective current products or product candidates, including the Company Product Candidates, have participated were, and if still pendingpending are being, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance with the applicable regulations of the Drug Drug/Device Regulatory Agencies and other applicable Legal Requirements, including, without limitation, including 21 C.F.R. Parts 11, 50, 54, 56, 58 58, 312 and 312. Since January 1, 2008, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company812.
(f) The Neither the Company nor any of the Company Subsidiaries is not the subject of any pending, or to the Knowledge of the CompanyCompany or the Company Subsidiaries, threatened in writing investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, Company or any of the Company Subsidiaries, neither the Company nor any of the Company Subsidiaries has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither None of the Company nor Company, any of its Subsidiaries or any of their respective officers, employees or agents has been debarred or convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal Requirement. To the Knowledge of the Company, no material debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or threatened against the Company, any Company Subsidiary or any of its their respective officers, employees or agents.
Appears in 1 contract
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and has since January 1its inception been, 2008 has complied in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the Federal Food, Drug, and has Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA, the European Medicines Evaluation Agency (“EMEA”) or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (the FDA, EMEA and each such other comparable Governmental Body, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not received any written notices of alleged or actual be material violation with respect to, all applicable Legal Requirementsto the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company, threatened in writing against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 3.15(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The Except as set forth in Section 3.15(b) of the Company Disclosure Schedule, the rights and benefits of each Company Permit will be available to the Surviving Corporation immediately after the Effective Time on terms substantially identical similar to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Time.
(c) There are no proceedings pending or, to the Knowledge of the Company, threatened with respect to an alleged material violation by the Company of the Federal FoodFDCA, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act or any other similar Legal Requirements Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“any Drug Regulatory Agency”).
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for or material to the conduct of the business of the Company Businessas currently conducted, and, as applicable, the development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidatescandidates (collectively, including AZ01the “Company Products”) (collectively, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication, or any other communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(das set forth on Section 3.15(d) of the Company Disclosure LetterSchedule, the Company has made available to the Acquiror true and Parent complete copies of the following (to the extent there are any): (x) copies of all investigational new drug applications (INDs) submitted to the FDA, and all supplements to and amendments of such INDs; new drug applications; adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other material written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental AuthorityBody. The Company has complied in all material respects with the ICH E9 Guidance for Industry: Statistical Principles for Clinical Trials in the management of the clinical data that have been presented by the Company. To the Company’s Knowledge, except as set forth on Section 3.15(d) of the Company Disclosure Schedule, there are no studies, tests or trials the results of which the Company believes reasonably call into question (i) the study, test or trial results of any Company Products, (ii) the efficacy or safety of any Company Products or (iii) any of the Company’s filings with any Governmental Body.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates, including the Company Products, have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the any applicable Drug Regulatory Agencies Agency and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2008, No preclinical or clinical trial conducted by or on behalf of the Company has been terminated or suspended prior to completion for safety or non-compliance reasons. The Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or to the Knowledge of the Company, Company threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the CompanyCompany or in which the Company or its current products or product candidates, including the Company Products, have participated.
(f) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company, the The Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments theretothereto or any comparable applicable Law of any other Drug Regulatory Agency. Neither the Company nor nor, to the Knowledge of the Company, any of its officers, employees or agents has been convicted of any crime or engaged in any conduct that could would result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Legal RequirementLaw. To the Knowledge of the Company, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their the Company’s business or products are pending or or, to the Knowledge of the Company, threatened against the Company or or, to the Knowledge of the Company any of its officers, employees or agents.
(g) The Company has complied with all Laws relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, all as amended from time to time (collectively “HIPAA”), including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time, in all material respects. The Company has entered into, where required, and is in compliance with the terms of all Business Associate (as defined in HIPAA) agreements to which the Company is a party or otherwise bound in all material respects. The Company has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. To the Company’s Knowledge, no successful Security Incident, Breach of Unsecured Protected Health Information or breach of personally identifiable information under applicable state or federal laws has occurred with respect to information maintained or transmitted to the Company or an agent or third party subject to a Business Associate Agreement with the Company. The Company is currently submitting, receiving and handling or is capable of submitting receiving and handling transactions in accordance in all material respects with the Standard Transaction Rule. All capitalized terms in this Section 3.15(g) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
Appears in 1 contract
Samples: Merger Agreement (Orgenesis Inc.)
Compliance; Permits; Restrictions. (a) Except as set forth in Schedule 2.11(a) of the Company Disclosure Letter, the The Company is, and since January 1, 2008 2020 has complied been, in compliance in all material respects withwith all applicable Laws, is not in material violation ofincluding the Federal Food, Drug, and has Cosmetic Act and the regulations issued thereunder (the “FDCA”) by the U.S. Food and Drug Administration (“FDA”), the Public Health Services Act and its implementing Regulations (“PHSA”) and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body, except for any noncompliance, either individually or in the aggregate, which would not received any written notices be material to the Company. As of alleged or actual material violation with respect tothe date of this Agreement, all applicable Legal Requirements. No no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Knowledge of the Company’s Knowledge, threatened against the Company, nor has any Governmental Body indicated to the Company an intention to conduct the same. There is no agreement, judgment, injunction, order or decree binding upon the Company which (i) has or could would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company, any acquisition of material property by the Company or the conduct of business by the Company Business as currently conducted, (ii) could is reasonably be expected likely to have a material an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) could is reasonably be expected likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Merger or any of the other Contemplated Transactions.
(b) The Company holds all required Governmental Authorizations which are material to the operation of the business of the Company Business as currently conducted (collectively, the “Company Permits”). Schedule 2.11(bSection 4.28(b) of the Company Disclosure Letter Schedule identifies each Company Permit. The Each such Company Permit is valid and in full force and effect, and the Company is in material compliance with the terms of the Company Permits. No action, proceeding, revocation proceeding, amendment procedure, writ, injunction or claim Legal Proceeding is pending or, to the Knowledge of the Company’s Knowledge, threatened, which seeks to revoke, materially limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation Company or its subsidiaries, as applicable, immediately after the Effective Time effectiveness of the Merger on terms substantially identical to those enjoyed by the Company as of the date of this Agreement and immediately prior to the Effective Timeeffectiveness of the Merger.
(c) There As of the date of this Agreement, there are no proceedings pending or, to the Knowledge of the Company’s Knowledge, threatened with respect to an alleged material violation by the Company of the Federal Food, Drug, and Cosmetic Act (“FDCA”), Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act PHSA or any other similar Legal Requirements Law administered or promulgated by any Governmental Body. The Company is not currently conducting or addressing, and to the FDA Company’s Knowledge there is no basis to expect that it will be required to conduct or other comparable Governmental Body responsible for regulation of the developmentaddress, any corrective actions, including, without limitation, product recalls or clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (“Drug Regulatory Agency”)holds.
(d) The Company holds all required Governmental Authorizations issuable by any Drug Regulatory Agency necessary for the conduct of the Company Business, and, as applicable, development, clinical testing, manufacturing, marketing, distribution and importation or exportation, as currently conducted, of any of its products or product candidates, including AZ01, AZ17 and AZ21 (the “Company Regulatory Permits”) and no such Company Regulatory Permit has been (i) revoked, withdrawn, suspended, cancelled or terminated or (ii) modified in any adverse manner, other than immaterial adverse modifications. The Company is in compliance in all material respects with the Company Regulatory Permits and has not received any written notice or other written communication from any Drug Regulatory Agency since January 1, 2008 regarding (A) any material violation of or failure to comply materially with any term or requirement of any Company Regulatory Permit or (B) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Company Regulatory Permit. Except for the information and files identified in Schedule 2.11(d) of the Company Disclosure Letter, the Company has made available to the Acquiror true and complete copies of the following (to the extent there are any): (x) adverse event reports; clinical study reports and material study data; and inspection reports, notices of adverse findings, warning letters, filings and letters and other written correspondence to and from any Drug Regulatory Agency; and meeting minutes with any Drug Regulatory Agency; and (y) similar reports, material study data, notices, letters, filings, correspondence and meeting minutes with any other Governmental Authority.
(e) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company, or in which the Company or its current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of the Drug Regulatory Agencies any applicable Governmental Body and other applicable Legal RequirementsLaw, including, without limitation, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 20082020, the Company has not received any notices, correspondence, or other communications from any Drug Regulatory Agency Governmental Body requiring, or or, to the Knowledge of the Company’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company or in which the Company or any of its current products or product candidates have participated.
(e) As of the date of this Agreement, there has not been and is not now any Form FDA-483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, or proceeding pending or in effect against the Company or any of its officers and employees, and the Company has no liability for failure to comply with the FDCA, PHSA, or other similar Laws. To the Company’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or form the basis for any civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information or any liability (whether actual or contingent) for failure to comply with the FDCA, PHSA or other similar Laws.
(f) The Company is not the subject of any pendingpending or, or to the Knowledge of the Company’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “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. To the Knowledge of the Company’s Knowledge, the Company has not committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. Neither .
(g) None of the Company nor or any of its officers, employees or agents or, to the Company’s Knowledge, agents, has been convicted of any crime or engaged in any conduct that could result in a material (i) debarment or exclusion (i) under 21 U.S.C. Section 335a or 335a, as amended; (ii) any similar applicable Legal Requirementdisqualification from participating in clinical trials pursuant to 21 C.F.R. Section 312.70, as amended; (iii) disqualification as a testing facility under 21 C.F.R. Part 58, Subpart K, as amended; (iv) exclusion, debarment or suspension from or otherwise becomes ineligible to participate in a “Federal health care program” as such term is defined in 42 U.S.C. Section 1320a-7b(f), including under 42 U.S.C. Section 1320a-7 or relevant regulations in 42 C.F.R. Part 1001; (v) assessment or threat of assessment of civil monetary penalties pursuant to 42 C.F.R. Part 1003; or (vi) inclusion on the HHS/OIG List of Excluded Individuals/Entities, the General Services Administration’s System for Award Management, or the FDA Debarment List or the FDA Disqualified/Restricted List. To the Knowledge of the Company, no material No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or or, to the Company’s Knowledge, threatened against the Company or any of its officers, employees or agents.
(h) The Company has materially complied with all applicable Laws relating to patient, medical or individual health information, including the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations promulgated thereunder, all as amended from time to time, including the standards for the privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E, the standards for the protection of Electronic Protected Health Information set forth at 45 C.F.R. Part 160 and 45 C.F.R. Part 164, Subpart A and Subpart C, the standards for transactions and code sets used in electronic transactions at 45 C.F.R. Part 160, Subpart A and Part 162, and the standards for Breach Notification for Unsecured Protected Health Information at 45 C.F.R. Part 164, Subpart D, all as amended from time to time (collectively, “HIPAA”). The Company has entered into, where required, and is in compliance in all material respects with the terms of all Business Associate agreements (“Business Associate Agreements”) to which the Company is a party or otherwise bound. The Company, where required, has created and maintained written policies and procedures to protect the privacy of all protected health information, provide training to all employees and agents as required under HIPAA, and has implemented security procedures, including physical, technical and administrative safeguards, to protect all personal information and Protected Health Information stored or transmitted in electronic form. As of the date of this Agreement, the Company has not received written notice from the Office for Civil Rights for the U.S. Department of Health and Human Services or any other Governmental Body of any allegation regarding its failure to comply with HIPAA or any other state law or regulation applicable to the protection of individually identifiable health information or personally identifiable information. No successful “Security Incident,” “Breach of Unsecured Protected Health Information” or breach of personally identifiable information under applicable state or federal laws have occurred with respect to information maintained or transmitted to the Company or an agent or third party subject to a Business Associate Agreement with the Company. The Company is not currently submitting, receiving and handling transactions that are governed by the Standard Transaction Rule. All capitalized terms in this Section 4.28(h) not otherwise defined in this Agreement shall have the meanings set forth under HIPAA.
(i) The preclinical studies and clinical trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Company SEC Documents, or the results of which are referred to in the Company SEC Documents, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); (ii) the descriptions in the Company SEC Documents of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived therefrom; (iii) to the Company’s Knowledge, there are no other studies or trials not described in the Company SEC Documents, the results of which the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Company SEC Documents; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Company SEC Documents or the results of which are referred to in the Company SEC Documents, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials.
Appears in 1 contract
Samples: Securities Purchase Agreement (Skye Bioscience, Inc.)
