FDA and Related Matters. (a) Section 4.9 of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA, EMEA and all other Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(h)) and used in the conduct of the Company’s business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiaries have filed all required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other information with the FDA, EMEA and all other applicable Regulatory Authorities. (b) Without limiting the generality of any other representations and warranties made by the Company under this Agreement, to the knowledge of the Company, the conduct of the business of the Company and the Company Subsidiaries as currently conducted is in compliance in all material respects with (1) all written communications, requirements and applicable Laws and Orders of the FDA, EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations, including all requirements of the FDA, the EMEA and all other Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company or any Company Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or any other Regulatory Authorities, as applicable. None of the Company or any of the Company Subsidiaries has knowledge (or has been notified by a third party) of any pending regulatory action, investigation or inquiry of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of the Company, a Company Subsidiary, the Core Products or any Person that manufactures, develops or distributes the Core Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a “Company Partner”), and, to the knowledge of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Products. Neither the Company nor any Company Subsidiary is, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority relating to the Products, nor to the knowledge of the Company, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the Products. (c) The Company and the Company Subsidiaries have made available to Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Company Subsidiary, the conduct of their business, or the Core Products. (d) (d) All preclinical studies and clinical trials conducted or being conducted with respect to the Company’s and the Company Subsidiaries’ Products by or at the direction of the Company or any Company Subsidiary have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent. (e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each Company Subsidiary are in material compliance with FDA, EMEA and other applicable Regulatory Authority requirements.
Appears in 2 contracts
Sources: Merger Agreement (Indevus Pharmaceuticals Inc), Merger Agreement (Endo Pharmaceuticals Holdings Inc)
FDA and Related Matters. (a) Section 4.9 3.18 of the Company Disclosure Letter Schedule sets forth a true complete and complete list accurate list, referencing relevant records and documents, since January 1, 1993, of all Regulatory Authorizations from the FDA, EMEA and all other Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(h)) and used in the conduct of the Company’s business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effectall Regulatory or Warning Letters, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirementsNotices of Adverse Findings, and Section 305 Notices and similar letters or notices issued by the Food and Drug Administration (ivthe "FDA") in good standingor any other federal, valid and enforceable. The Company and the Company Subsidiaries have filed all required notices and responses to noticesstate, supplemental applicationslocal, reports (including adverse experience reports) and other information or foreign governmental entity that is concerned with the FDAsafety, EMEA efficacy, reliability, or manufacturing of medical products, including drugs and all other applicable Regulatory Authorities.
(b) Without limiting the generality of any other representations and warranties made by the Company under this Agreementdevices, relating to the knowledge of the Company, the conduct of the business of the Company and its Subsidiaries, (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received by the Company or any of its Subsidiaries as currently conducted is in compliance in and all material respects with Drug and Medical Device Reports, adverse drug experience reports, and therapeutic failure reports filed by the Company or any of its Subsidiaries, which complaints or reports pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) all written communications, requirements and applicable Laws and Orders notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, EMEA and other Regulatory Authorities and (2) all Regulatory Authorizationslitigation or arbitration claim or cause of action commenced, including all requirements or (3) notice to any insurance carrier of the FDACompany or any of its Subsidiaries tendering the defense or giving notice of a possible or actual claim against the Company or any of its Subsidiaries, the EMEA and all other Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with (iii) all product recalls, notifications recalls and safety alerts, alerts conducted by or issued to the Company or any of its Subsidiaries and any request requests from the FDA, the EMEA FDA or any Regulatory Authority other drug and medical device regulatory agency requesting the Company or any Company Subsidiary of its Subsidiaries to cease to investigate, test test, or market any product, (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency against the Company or any of its Subsidiaries and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are noof its Subsidiaries, and have not been, (v) any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar other written documents received by communications between the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA FDA or any other Regulatory Authoritiesdrug and medical device regulatory agency, as applicable. None of on the one hand, and the Company or any of the Company Subsidiaries has knowledge (or has been notified by a third party) of any pending regulatory action, investigation or inquiry of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of the Company, a Company Subsidiary, the Core Products or any Person that manufactures, develops or distributes the Core Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a “Company Partner”), and, to the knowledge of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company its Subsidiaries, on the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Productshand. Neither the Company nor any Company Subsidiary is, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority relating to the Products, nor to the knowledge of the Company, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the Products.
(c) The Company and the Company Subsidiaries have made available has delivered to Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company referred to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Company Subsidiary, the conduct of their business, or the Core Products.
(d) (d) All preclinical studies and clinical trials conducted or being conducted with respect to the Company’s and the Company Subsidiaries’ Products by or at the direction in Section 3.18 of the Company or any Company Subsidiary have been Disclosure Schedule, as well as copies of all complaints and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent.
(e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each Company Subsidiary are in material compliance with FDA, EMEA and other applicable Regulatory Authority requirements.other
Appears in 1 contract
Sources: Merger Agreement (Immucor Inc)
FDA and Related Matters. (a) Section 4.9 of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA, EMEA and all other Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(h9.14(g)) and used in the conduct of the Company’s 's business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the conduct of the Company’s 's business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiaries have filed all required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other information with the FDA, EMEA and all other applicable Regulatory Authorities.
(b) Without limiting the generality of any other representations and warranties made by the Company under this Agreement, to the knowledge of the Company, the conduct of the business of the Company and the Company Subsidiaries as currently conducted is in compliance in all material respects with (1) all written communications, requirements and applicable Laws and Orders of the FDA, EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations, including all requirements of the FDA, the EMEA and all other Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company or any Company Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or any other Regulatory Authorities, as applicable. None of the Company or any of the Company Subsidiaries has knowledge (or has been notified by a third party) of any pending regulatory action, investigation or inquiry of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of the Company, a Company Subsidiary, the Core Products or any Person that manufactures, develops or distributes the Core Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a “"Company Partner”"), and, to the knowledge of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s 's and the Company Subsidiaries’ ' Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s 's knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Products. Neither the Company nor any Company Subsidiary is, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority relating to the Products, nor to the knowledge of the Company, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the Products.
(c) The Company and the Company Subsidiaries have made available to Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Company Subsidiary, the conduct of their business, or the Core Products.
(d) (d) All preclinical studies and clinical trials conducted or being conducted with respect to the Company’s 's and the Company Subsidiaries’ ' Products by or at the direction of the Company or any Company Subsidiary have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent.
(e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each Company Subsidiary are in material compliance with FDA, EMEA and other applicable Regulatory Authority requirements.
Appears in 1 contract
Sources: Merger Agreement (Endo Pharmaceuticals Holdings Inc)
FDA and Related Matters. (a) Section 4.9 3.18 of the Company Disclosure Letter Schedule sets forth a true complete and complete list accurate list, referencing relevant records and documents, since January 1, 1993, of all Regulatory Authorizations from the FDA, EMEA and all other Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(h)) and used in the conduct of the Company’s business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effectall Regulatory or Warning Letters, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirementsNotices of Adverse Findings, and Section 305 Notices and similar letters or notices issued by the Food and Drug Administration (ivthe "FDA") in good standingor any other federal, valid and enforceable. The Company and the Company Subsidiaries have filed all required notices and responses to noticesstate, supplemental applicationslocal, reports (including adverse experience reports) and other information or foreign governmental entity that is concerned with the FDAsafety, EMEA efficacy, reliability, or manufacturing of medical products, including drugs and all other applicable Regulatory Authorities.
(b) Without limiting the generality of any other representations and warranties made by the Company under this Agreementdevices, relating to the knowledge of the Company, the conduct of the business of the Company and its Subsidiaries, (ii) all United States Pharmacopoeia product problem reporting program complaints or reports, MedWatch FDA Forms 3500, and device experience network complaints received by the Company or any of its Subsidiaries as currently conducted is in compliance in and all material respects with Drug and Medical Device Reports, adverse drug experience reports, and therapeutic failure reports filed by the Company or any of its Subsidiaries, which complaints or reports (A) pertain to any incident involving death, serious injury, or a serious adverse drug experience, and for which incident there has been any (1) all written communications, requirements and applicable Laws and Orders notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, EMEA and other Regulatory Authorities and (2) all Regulatory Authorizationslitigation or arbitration claim or cause of action commenced, including all requirements or (3) notice to any insurance carrier of the FDA, Company or any of its Subsidiaries tendering the EMEA and all other Regulatory Authorities in warning letters, notices defense or giving 8/12/97 notice of adverse findings and Section 305 notices and similar letters a possible or noticesactual claim against the Company or any of its Subsidiaries, and (B) are in connection with the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iii) all product recalls, notifications recalls and safety alerts, alerts conducted by or issued to the Company or any of its Subsidiaries and any request requests from the FDA, the EMEA FDA or any Regulatory Authority other drug and medical device regulatory agency requesting the Company or any Company Subsidiary of its Subsidiaries to cease to investigate, test test, or market any product, which recalls, safety alerts, or requests are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iv) any civil penalty actions begun by the FDA or any other drug and medical device regulatory agency against the Company or any of its Subsidiaries and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are noof its Subsidiaries, and have not been, (v) any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar other written documents received by communications between the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA FDA or any other Regulatory Authoritiesdrug and medical device regulatory agency, as applicable. None of on the one hand, and the Company or any of its Subsidiaries, on the other hand, which communications are in the aggregate material to the conduct of the business of the Company Subsidiaries and its Subsidiaries. The Company has knowledge (or has been notified by a third party) delivered to the Parent copies of any pending regulatory actionall documents referred to in Section 3.18 of the Company Disclosure Schedule, investigation or inquiry as well as copies of any sort all complaints and other information required to be maintained by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any Company pursuant to Section 820 of Title 21 of the CompanyCode of Federal Regulations ("CFR") or 21 CFR Section 211, a to the extent that such complaints or other information relate to events that are, in the aggregate, material to the conduct of the business of the Company Subsidiaryand its Subsidiaries.
(b) The Company and its Subsidiaries have obtained all material consents, approvals, certifications, authorizations, and permits of, and have made all filings with, or notifications to, the Core Products or any Person that manufactures, develops or distributes the Core Products FDA and all other drug and medical device regulatory agencies pursuant to a developmentapplicable requirements of all FDA laws, commercializationrules, manufacturingand regulations, supply or other collaboration arrangement with and all corresponding state and foreign laws, rules, and regulations applicable to the Company and its Subsidiaries. All representations made by the Company or any of its Subsidiaries in connection with any such consents, approvals, certifications, authorizations, permits, filings, and notifications were true and correct in all material respects at the time such representations were made, and the products of the Company Subsidiary and its Subsidiaries comply with, and perform in accordance with the specifications described in, such representations. The Company and its Subsidiaries are in all material respects in compliance with all applicable FDA laws, rules, and regulations, and all corresponding applicable state and foreign laws, rules, and regulations (eachincluding Good Manufacturing Practices, a “as defined in 21 CFR Parts 210, 211, and 820, Medical Device Reporting requirements, and Adverse Experience Reporting) applicable to the business of the Company. The Company Partner”)has not received any notice that any of the consents, andapprovals, certifications, authorizations, registrations, permits, filings, or notifications that it has received or made to operate its business have been or are being revoked or challenged. Except as set forth on Section 3.18 of the Company Disclosure Schedule, to the knowledge of the Company, there is are no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications investigations or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s knowledgeinquiries pending, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted material threat of any crime investigation or engaged in any conduct which would reasonably be expected to result in criminal liabilityinquiry, debarment or disqualification by the FDA, the EMEA FDA or any other Regulatory Authority, drug and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Products. Neither the Company nor any Company Subsidiary is, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority medical device regulatory agency relating to the Products, nor to the knowledge operation of the Company, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the Products.
(c) The Company and the Company Subsidiaries have made available to Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Company Subsidiary, the conduct of their business, or the Core Products.
(d) (d) All preclinical studies and clinical trials conducted or being conducted with respect to the Company’s and the Company Subsidiaries’ Products by or at the direction of the Company or any Company Subsidiary have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent.
(e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials business of the Company and each Company Subsidiary are in material its Subsidiaries or its compliance with FDAFDA 8/12/97 laws, EMEA rules, and other regulations, and corresponding state and foreign laws, rules, and regulations, applicable Regulatory Authority requirementsto the business of the Company and its Subsidiaries. None of the matters set forth on Section 3.18 of the Company Disclosure Schedule is reasonably likely to have, individually or in the aggregate, a Company Material Adverse Effect.
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Sources: Merger Agreement (Isomedix Inc)
FDA and Related Matters. (a) Section 4.9 of the Company Disclosure Letter sets forth a true and complete list of all All Regulatory Authorizations from the FDA, EMEA and all other applicable Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Company and the Company Subsidiaries, their Products (as defined in Section 9.14(h)) and used in the conduct of the Company’s business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the conduct of the Company’s their business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iiiii) in compliance with all formal filing and maintenance requirements, and (iviii) in good standing, valid and enforceable. The Company and the Company Subsidiaries have filed all required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other information with the FDA, EMEA and all other applicable Regulatory Authorities. The Company and the Company Subsidiaries possess all Regulatory Authorizations required for the conduct of their businesses as currently conducted.
(b) Without limiting the generality of any other representations and warranties made by the Company under this Agreement, including the representations and warranties contained in Sections 3.4 and 3.6, to the knowledge of the Company’s knowledge, the conduct of the business of the Company and the Company Subsidiaries as currently conducted is Subsidiaries, the conduct of their business and their Products are in compliance in all material respects with (1) all written communications, requirements and applicable Laws and Orders of the FDA, EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations. There are no, and have not been, any inspection reports, warning letters, notice of adverse findings, Section 305 notices or similar documents that assert a lack of substantial compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or any other Regulatory Authorities, as applicable, none of the Company and the Company Subsidiaries has knowledge (or has been notified in writing by a third party) of any pending regulatory action, investigation or inquiry of any sort (other than non-material routine or periodic inspections or reviews) against any of the Company and the Company Subsidiaries, their Products or any manufacturer, developer or distributor of the Products, and, to the Company’s knowledge, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities or otherwise with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and there is no reasonable basis for any of the foregoing; and (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiaries are bound or which relate to their Products. Neither the Company nor any Company Subsidiary is, to the Company’s knowledge, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the Company’s knowledge, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the Company’s knowledge, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority relating to the Products, nor to the Company’s knowledge, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the Products.
(c) To the extent of any disclosure in the Company Disclosure Letter with respect to any of the representations and warranties in Section 3.9(b) and otherwise, the Company and each Company Subsidiary is in compliance in all material respects with all written communications and requirements of the FDA, the EMEA and all other Regulatory Authorities relating thereto, including all requirements of the FDA, the EMEA and all other Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company or any Company Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by .
(d) Neither the Company or, to the knowledge of the Company, by nor any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or any other Regulatory Authorities, as applicable. None of the Company or any of the Company Subsidiaries Subsidiary has knowledge (or has been notified in writing by a third partyCompany Partner) of any pending regulatory action, investigation or inquiry action of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of the Company, a Company Subsidiary, the Core Products Subsidiaries or any Person that which manufactures, develops or distributes the Core Products products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a “Company Partner”), and, to the knowledge of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Products. Neither the Company nor any Company Subsidiary is, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority relating to the Products, nor to the knowledge of the Company, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the Products.
(ce) The Company and the Company Subsidiaries have made available to Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Company Subsidiary, the conduct of their business, or the Core their Products.
(df) (d) All To the Company’s knowledge, all preclinical studies and clinical trials conducted or being conducted with respect to the Company’s Company and the Company Subsidiaries’ Products by or at the direction of the Company or Company, any Company Subsidiary or Company Partner have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable those regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of such studies, tests and trials related to the Core Products and conducted by or at the direction of the Companytrials, and all other material information related to such studies, tests and trials, have been made available to Parent.
(eg) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each or any Company Subsidiary are in material compliance with FDA, EMEA and other applicable Regulatory Authority requirements.
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FDA and Related Matters. (a) Section 4.9 of the Company Disclosure Letter 2.31.1. Schedule 2.31 sets forth a true complete and complete list of all Regulatory Authorizations from the FDAaccurate list, EMEA referencing relevant records and all other Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(h)) and used in the conduct of the Company’s businessdocuments, and there are no other Regulatory Authorizations required for the Companylast five (5) years, the Company Subsidiaries or the Core Products in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiaries have filed all required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other information with the FDA, EMEA and all other applicable Regulatory Authorities.
(b) Without limiting the generality of any other representations and warranties made by the Company under this Agreement, to the knowledge of the Company, the conduct of the business of the Company and the Company Subsidiaries as currently conducted is in compliance in all material respects with (1) all written communications, requirements and applicable Laws and Orders of the FDA, EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations, including all requirements of the FDA, the EMEA and all other Regulatory Authorities in regulatory or warning letters, notices of adverse findings and Section 305 notices and similar letters or noticesnotices issued to the Company or any Subsidiary by the Food and Drug Administration (the “FDA”) or any other governmental entity that is concerned with the safety, and efficacy, reliability or manufacturing of the medical devices developed, manufactured or sold by the Company or any Subsidiary (hereinafter for purposes of this Section 2.31, “Medical Device Regulatory Agency”); (ii) all reports, filings or communications made by the Company or any of its Subsidiaries to or with a Medical Device Regulatory Agency regarding the medical devices developed, manufactured or sold by the Company or any Subsidiary (but excluding any reports, filings or communications in connection with applications seeking approval from any such Medical Device Regulatory Agency for the marketing and sale of such medical devices); (iii) all product recalls, notifications recalls and safety alerts, alerts conducted by or issued to the Company or any Subsidiary and any request requests from the FDA, the EMEA FDA or any Medical Device Regulatory Authority Agency requesting the Company or any Company Subsidiary to cease to investigate, test test, manufacture, market or market sell any product, ; (iv) any civil penalty actions begun by the FDA or any Medical Device Regulatory Agency against the Company or any Subsidiary and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are no, ; and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or (v) any other Regulatory Authorities, as applicable. None of communications between the Company or any of Subsidiary on the Company Subsidiaries has knowledge (or has been notified by a third party) of any pending regulatory action, investigation or inquiry of any sort by one hand and the FDA, EMEA FDA or any Medical Device Regulatory Agency on the other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of the Company, a hand. The Company Subsidiary, the Core Products or any Person that manufactures, develops or distributes the Core Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a “Company Partner”), and, has delivered to the knowledge Investors copies of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) all documents referred to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Products. Neither the Company nor any Company Subsidiary is, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, no Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, the EMEA or any other Regulatory Authority relating to the Products, nor to the knowledge of the Company, has any Company Partner failed to disclose any facts required to be disclosed to the FDA, the EMEA or any other Regulatory Authority relating to the ProductsSchedule 2.31.
(c) 2.31.2. The Company and the Company its Subsidiaries have obtained all consents, approvals, certifications, authorizations and permits of, and have made available all filings with, or notifications to, all Medical Device Regulatory Agencies pursuant to Parent complete and accurate copies applicable requirements of all Regulatory Authorizations federal laws, rules and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and dataregulations, and all other material Regulatory Authority communicationscorresponding state and foreign laws, documents rules and other information submitted by the Company to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating regulations applicable to the Company or any Company Subsidiary, the conduct of their Subsidiary and relating to its business, or the Core Products.
(d) (d) All preclinical studies and clinical trials conducted or being conducted with respect to the Company’s and the Company Subsidiaries’ Products by or at the direction of the Company or any Company Subsidiary have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent.
(e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, its Subsidiaries are in material compliance with all applicable registration federal laws, rules and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 regulations and all similar corresponding applicable Laws state and Ordersforeign laws, rules and regulations relating to medical device manufacturers. To The Company has no reason to believe that any of the knowledge consents, approvals, authorizations, registrations, certifications, permits, filings or notifications that it or any of its Subsidiaries has received or made to operate their respective businesses have been or are being questioned, challenged or revoked. There are no investigations or inquiries by the FDA or any Medical Device Regulatory Agency pending or threatened relating to the operation of the Company, no Product sold by ’s or the Company Company’s Subsidiaries’ businesses or held in inventory by the Company has been adulterated Company’s or misbranded. All labeling is in any Subsidiary’s compliance with FDAapplicable laws, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each Company Subsidiary are in material compliance with FDA, EMEA and other applicable Regulatory Authority requirementsrules or regulations relating to medical device manufacturers.
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