FDA and Related Matters Clause Samples
The "FDA and Related Matters" clause outlines the obligations and requirements related to compliance with regulations set by the U.S. Food and Drug Administration (FDA) and potentially other relevant regulatory authorities. This clause typically specifies that products or services covered by the agreement must meet all applicable FDA standards, and may require parties to maintain records, report adverse events, or obtain necessary approvals before marketing or distributing products. Its core practical function is to ensure that all parties adhere to regulatory requirements, thereby reducing legal and safety risks associated with non-compliance.
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FDA and Related Matters. The Company and, to the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinica...
FDA and Related Matters. (a) Except as disclosed in Section (28)(a) of the Neuronetics Disclosure Letter, Neuronetics: (i) is and, since January 1, 2020, has been in material compliance with all statutes, rules or regulations of the FDA and other comparable Governmental
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(b) To the knowledge of Neuronetics, there are no actual or threatened enforcement actions by the FDA or any other Governmental Entity which has jurisdiction over the operations of Neuronetics against Neuronetics. Since January 1, 2020, Neuronetics has not received written notice of any pending or threatened claim, audit, termination or suspension by the FDA or any other Governmental Entity which has jurisdiction over the operations of Neuronetics against Neuronetics, and to the knowledge of Neuronetics, no Governmental Entity is considering such action.
(c) Since January 1, 2020, all material reports, documents, claims and notices required to be filed, maintained or furnished to the FDA or any similar Governmental Entity, including all registrations and reports required to be filed with ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, by Neuronetics have been so filed, maintained or furnished. All such reports, documents, claims and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no material liability exists with respect to the completeness or accuracy of such filing. To the extent applicable, Neuronetics has made available to Greenbrook complete and correct copies of each application or other material filing including all material related supplements, amendments, correspondence and annual reports made with any Governmental Entity made on behalf of Neuronetics relating to the provision of services.
(d) To the extent applicable, any and all preclinical studies and clinical trials being conducted by or on behalf of Neuronetics, including any activities related to any planned or future studies or trials, have been and are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to applicable Laws, rules and regulations, including the applicable
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(e) Since January 1, 2020, the development, manufacture, labeling and storage, as applicable, of materials by Neuronetics has been and is being conducted in compliance in all material respects with all applicable Laws including the FDA’s current Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices.
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FDA and Related Matters. (a) Menlo possesses all Regulatory Authorizations required by the FDA, the EMA, and all other applicable Regulatory Authorities in connection with Menlo Products and the conduct of their businesses as currently conducted. All such Regulatory Authorizations are (i) in full force and effect, (ii) in compliance in all material respects with all formal filing and maintenance requirements, and (iii) in good standing, valid and enforceable. Menlo has filed all material notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA and all other applicable Regulatory Authorities.
(b) The conduct of Menlo’s business and the Menlo Products are in compliance in all material respects with (1) all applicable Laws and Orders of the FDA, EMA and other Regulatory Authorities and (2) all Regulatory Authorizations. Menlo have not received any warning letters, notice of adverse findings, or similar documents that assert a material failure to comply with any applicable Laws or Orders that have not been fully resolved to the satisfaction of the FDA, the EMA or any other Regulatory Authorities, as applicable, and Menlo has no Knowledge (or been notified in writing by a third party) of any pending or threatened action, investigation or inquiry by any Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Menlo, the Menlo Products, or any Menlo Partner. Menlo has not made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA or any other Regulatory Authority, and to Menlo’s Knowledge, no Menlo Partner has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority relating to the Menlo Products, nor to Menlo’s Knowledge, has any Menlo Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Menlo Products.
(c) Menlo does not have Knowledge (and has not been notified in writing by a Menlo Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement wit...
FDA and Related Matters. (a) Parent and its Affiliates possess all Registrations required to conduct the Business as currently conducted, and Section 3.11(a) of the Seller Disclosure Schedule sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parent, (i) neither the FDA nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Products, and there is no false or misleading information or material omission in any Product application or other submission, notification or report to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are in compliance with and have fulfilled and performed in all material respects their respective obligations under each such Registration, and, to the Knowledge of Parent, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parent, any third Person that is a manufacturer or contractor for Parent or any of its Affiliates is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts or Products for Parent or any of its Affiliates, as applicable.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is developed, manufactured, tested, distributed and/or marketed by or on behalf of the Business, each such Product is being developed, manufactured, tested, distributed and/or marketed in material compliance with all applicable requirements under the FDCA and similar Laws, including those relating to investigational use, premarket clearance or marketing approval to market such Product, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record keeping, training, medical device reporting, adverse event reporting, filing of other reports and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Busine...
FDA and Related Matters. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects with the Federal Food, Drug and Cosmetic Act (the “FDCA”) and similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any Permit pursuant to the FDCA and similar federal, state and foreign laws or changing the marketing classification or labeling of the products of the Company. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company to the FDA or any comparable regulatory authority or governmental agency. The Company has fulfilled and performed in all material respects its obligations under each such Permit, and, as of the date hereof, to the knowledge of the Company, the Company is not in breach or default of any such Permit except to the extent that such breach, default, would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company is in compliance in all material respects with all such Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with any applicable laws or Permits. The Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable regulatory authority or governmental agency. The Company has made all notifications, submissions and reports required by the FDCA or similar federal, state and foreign laws, except to the extent that the failure to make such n...
FDA and Related Matters. (a) The Company is and at all times has been in compliance in all respects with (i) all laws, rules, regulations and policies of the Food and Drug Administration (“FDA”) , Health Canada (“HC”) and other Healthcare Regulatory Authorities (as defined below) and (ii) all Healthcare Regulatory Authorizations (as defined below), including all requirements of the FDA, HC, and all other Healthcare Regulatory Authorities, that are applicable to the Company or by which any property, product, or other asset of the Company (including, without limitation, any Product Candidate (as defined below)) is bound or affected. As of the date of this Agreement, the Company has not received any written notification of any pending or, to the knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority. As used herein, “Healthcare Regulatory Authorities” means any entities that are concerned with or regulate the marketing, sale, use, handling and control, safety, efficacy, reliability or manufacturing of food, drug or biological products or medical devices or are concerned with or regulate public health care programs. As used herein, “Healthcare Regulatory Authorizations” means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Healthcare Regulatory Authority, including all investigational new drug applications and new drug applications. As used herein, “Product Candidates” means foods, supplements, biologics, compounds or other products under development, current, active or otherwise, or consideration by the Company or any of its licensees.
FDA and Related Matters. Except as described in the SEC Reports, the Company and its Subsidiaries: (A) are and at all times have been in full compliance with all statutes, rules, regulations, or guidances applicable to Company and its Subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (B) have not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other federal, state, local or foreign governmental authority, court or arbitrator having authority over the Company (“Governmental Authority”) alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possess all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (D) have not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge that any such Governmental Authority is considering such action; and (F) have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct in all material respects on the date filed (or were corrected or sup...
FDA and Related Matters. (a) The Company and its Subsidiaries possess all Registrations required to conduct their respective businesses as currently conducted. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of the Company, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the products of the Company and any of its Subsidiaries. To the Knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission to the FDA or any comparable Regulatory Authority or Governmental Authority. The Company and each of its Subsidiaries are in compliance with, and have fulfilled and performed in all material respects their respective obligations under, each such Registration, and, as of the date hereof, to the Knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of the Company, any third Person that is a manufacturer or contractor for the Company or any of its Subsidiaries is in compliance with all Registrations insofar as they pertain to the manufacture of product components or products for the Company or any of its Subsidiaries, as applicable.
(b) All products developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of the Company or any of its Subsidiaries that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects, in compliance with FDA Laws, and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the operations of the Company or any of its Subsidiaries, including those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals. To the Know...
FDA and Related Matters. (a) Section 3.18 of the Company Disclosure Schedule sets forth a complete and accurate list, referencing relevant records and documents, since January 1, 1993, of (i) all Regulatory or Warning Letters, Notices of Adverse Findings, and Section 305 Notices and similar letters or notices issued by the Food and Drug Administration (the "FDA") or any other federal, state, local, or foreign governmental entity that is concerned with the safety, efficacy, reliability, or manufacturing of medical products, including drugs and devices, relating to 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 and all 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) notice or follow up inquiry to the Company or any of its Subsidiaries by the FDA, (2) litigation or arbitration claim or cause of action commenced, or (3) notice to any insurance carrier of the Company or any of its Subsidiaries tendering the defense or giving 8/12/97 notice of a possible or actual claim against the Company or any of its Subsidiaries, and (B) are in the aggregate material to the conduct of the business of the Company and its Subsidiaries, (iii) all product recalls and safety alerts conducted by or issued to the Company or any of its Subsidiaries and any requests from the FDA or any other drug and medical device regulatory agency requesting the Company or any of its Subsidiaries to cease to investigate, 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 issued with respect to the Company or any of its Subsidiaries, and (v) any other written communications between the FDA or any other drug and medical device regulatory agency, on the one hand, and the Company or any of its Subsidiaries, on the other hand, which communications ar...
FDA and Related Matters. The Company and the Subsidiaries and, to the Company’s Knowledge, others who perform services on the Company’s or a Subsidiary’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and neither the Company nor any Subsidiary received any notice citing action or inaction by the Company, any Subsidiary or others who perform services on the Company’s or any Subsidiary’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity.