FDA and Related Matters Sample Clauses

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) Foamix and the Foamix Subsidiary possess all Regulatory Authorizations required by the FDA, the EMA, and all other applicable Regulatory Authorities in connection with the Foamix 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. Foamix and the Foamix Subsidiary have filed all material required 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 Foamix and Foamix Subsidiary businesses and the Foamix 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. Foamix and the Foamix Subsidiary 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 neither Foamix nor the Foamix Subsidiary has Knowledge (or has 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 Foamix and the Foamix Subsidiary, the Foamix Products, or any Foamix Partner. Neither Foamix nor the Foamix Subsidiary has 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 Foamix’s Knowledge, no Foamix 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 Foamix Products, nor to Foamix’s Knowledge, has any Foamix Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Products. (c) Neither Foamix nor the Foamix Subsidiary has Knowledge (or has been notified in writing by a Foamix Partner)...

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. (a) There are no actual or, to the Knowledge of the Company, threatened enforcement actions by the U.S. Food and Drug Administration (the “FDA”) or any comparable Governmental Authority against the Company or any Company Subsidiary. Since January 1, 2020, neither the Company nor any Company Subsidiary has received written notice of any pending or threatened claim, suit, Proceeding, hearing, audit, inspection, investigation, arbitration or other action by the FDA or any comparable Governmental Authority against the Company or any Company Subsidiary, and, to the Knowledge of the Company, neither the FDA nor any comparable Governmental Authority is considering such action. (b) Since January 1, 2020, all material applications, reports, documents, claims, submissions, and notices required to be filed, maintained, or furnished to the FDA or any comparable Governmental Authority, including all adverse event reports and registrations and reports required to be filed with xxxxxxxxxxxxxx.xxx, by the Company or any Company Subsidiary, have been so filed, maintained or furnished. All such material applications, reports, documents, claims, submissions, and notices were timely filed and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). The Company has delivered or made available to Parent (i) a complete and correct copy of each Investigational New Drug application (“IND”) and New Drug Application (“NDA”) sponsored and presently held by the Company with respect to each Company Product or product candidate, including all supplements and amendments thereto, (ii) copies of all clinical study reports under such INDs and (iii) all material correspondence to or from the Company and each Company Subsidiary and FDA or any other Governmental Authority with respect to such INDs and NDAs, in each case of clauses (i), (ii) and (iii), relating to the CGRP Business. (c) Since January 1, 2020, neither the Company nor any Company Subsidiary has received any FDA Form 483, notice of violation, warning letter, untitled letter or other correspondence or written notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Healthcare Laws or Company Permits. Since January 1, 2020, to the Knowledge of the Company, neither the Company nor any Company Subsidiary has received any written notice from any Person alleging that any operation or activity of the Company or an...

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 Company 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 Governmental Entity 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 or any Company Subsidiary. To the knowledge of the Company, there is no untrue statement of material fact, fraudulent statement or material omission in any product application or other submission by the Company or any Company Subsidiary to the FDA or any comparable Governmental Entity. 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 Permit except to the extent that such breach, default, revocation or termination would not have a Company Material Adverse Effect. Except as set forth on Section 2.31 of the Company Disclosure Schedule, the Company and Company Subsidiaries have 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 Entity alleging or asserting noncompliance with any applicable Laws or Permits. The Company and Company Subsidiaries are not subject to any obligation arising under an administrative or regulatory enforcement 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 Governmental Entity. The Company and Company Subsidiaries have 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 notifications, submission or reports would not have a Compa...

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. (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 the Company Subsidiaries are and have been, since January 1, 2010, in compliance in all respects with (i) all Laws (including all rules, regulations and policies) of the FDA, Drug Enforcement Administration (“DEA”), EMEA and other Healthcare Regulatory Authorities and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and the Company Subsidiaries, or by which any property, product, or other asset of the Company and the Company Subsidiaries (including, without limitation, any Product Candidate (as defined below)) is bound or affected. As of the date of this Agreement, neither the Company nor the Company Subsidiaries has 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. (b) Since January 1, 2010, the Company and the Company Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are in full force and effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization. (c) Section 2.16(c) of the Company Disclosure Schedule contains a complete and accurate list of all of the Product Candidates of the Company Entities, listing, where applicable, those Product Candidates for which the Company Entities have applied for or have authorization or clearance through inaction to test the product in human subjects (“Human Testing Authorization”) according to applicable regulations and listing the type of application made. For those Product Candidates listed in Section 2.16(c) of the Company Disclosure Schedule as having Human Testing Authorization, such Human Testing Authorization has not been revoked or rescinded. No notification has been received by any Company Entity from any Regulatory Authority that would reasonably be expected to preclude the Company from continuing to test such Product Candidates. No applications made or other materials submitted by the Company Entities to any Regulatory Authority contained an untrue statement of material fact, or omitt...

FDA and Related Matters. (i) Schedule 3.1(k) sets forth a list, for the period between January 1, 1993 --------------- and the date hereof, of (A) 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 ("FDA") (or any other federal, state, local or foreign governmental entity that is concerned with the safety, efficacy, reliability or manufacturing of drug products (each, a "Drug Regulatory Agency")) to the Company or PL that, individually or in the aggregate, would have a Material Adverse Effect on the Company, (B) all product recalls, notifications and safety alerts conducted by the Company or PL, whether or not required by the FDA, and any request from the FDA or any Drug Regulatory Agency requesting the Company or PL to cease to investigate, test or market any product, which recalls, notifications, safety alerts or requests would, individually or in the aggregate, have a Material Adverse Effect on the Company, and (C) any criminal, injunctive, seizure or civil penalty actions begun or threatened by the FDA or any Drug Regulatory Agency against the Company or PL and known by the Company or PL and all related consent decrees (including plea agreements) issued with respect to the Company or PL. Copies of all documents referred to in Schedule 3.1(k) have been made available to the Parent. --------------- (ii) The Company has made submissions to obtain material approvals, certifications, authorizations, clearances and permits for marketing, and has made filings with, or notifications to, the FDA and Drug Regulatory Agencies (or has documented a basis for not making such filings or notifications) pursuant to applicable requirements of the Federal Food, Drug and Cosmetics Act, as amended (the "FDA Act"), and applicable laws, regulations and rules with respect to each of the products sold by the Company or PL that is listed on Schedule 3.1(k). The products listed on --------------- Schedule 3.1(k) collectively constitute in excess of 95% of the gross --------------- revenues generated during the twelve (12)-month period ending December 31, 1997 by that portion of the business of the Company and PL which is subject to the jurisdiction of the FDA or any Drug Regulatory Agency. The Company and PL have no reason to believe that any of the material approvals, clearances, authorizations, registrations, certifications, permits, filings or notifications that it or any of its Subsidiaries ...