FDA Regulatory Matters. (a) The Company has developed, tested, manufactured and stored, as applicable, its product candidates, including the Products, in compliance in all material respects with Federal Food, Drug and Cosmetic Act of 1938, as amended, to the extent applicable, and applicable regulations issued by the FDA.
(b) Section 4.7(b) of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA with respect to the Company’s product candidates currently in effect, and there are no other material Regulatory Authorizations required for the Company in connection with the conduct of the Company’s business as currently conducted. All such Regulatory Authorizations owned by the Company are (i) in full force and effect and the Company has not received written notice from any Governmental Entity or third Person that any such Regulatory Authorization is subject to any adverse action, (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, except, in the case of each of the foregoing clauses (i) – (iv), as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) To the knowledge of the Company, the clinical trials conducted by or on behalf of the Company (which, for the avoidance of doubt, shall not include investigator-sponsored clinical trials) were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical trial protocols, informed consents and applicable requirements of the FDA, including, as applicable, the FDA’s good clinical practices and good laboratory practices regulations.
(d) The Company is not subject to any investigation that is pending or, to the knowledge of the Company which has been threatened, in connection with any of the Company’s product candidates, including the Products.
(e) Since January 1, 2007, the Company has complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “HIPAA”), and (ii) other applicable state privacy laws.
(f) Since January 1, 2007, all material reports, applications, documents, claims, permits and notices required to be fil...
FDA Regulatory Matters. (a) Borrower has all Permits issued or allowed by the U.S. Food and Drug Administration (“FDA”) or any comparable governmental authority (including but not limited to new drug applications, abbreviated new drug applications, biologics license applications, investigational new drug applications, over-the-counter drug monograph, device pre-market approval applications, device pre-market notifications, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, XX Xxxxx, pricing and reimbursement approvals, labeling approvals or their foreign equivalent, controlled substance registrations, and wholesale distributor permits (hereinafter “Permits”) that are required to conduct its business as currently conducted, or as proposed to be conducted. To the knowledge of Borrower, neither the FDA nor any comparable governmental authority is considering limiting, suspending, or revoking such Permits or changing the marketing classification or labeling or other significant parameter affecting the products of the Borrower. To the knowledge of Borrower, there is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable governmental authority. The Borrower has fulfilled and performed their obligations under each Permit, and no event has occurred or condition or state of facts exists which would constitute a breach or default under, or would cause revocation or termination of, any such Permit. To the knowledge of Borrower, any third party that is a manufacturer or contractor for the Borrower is in compliance with all Permits required by the FDA or comparable governmental authority and all Public Health Laws insofar as they reasonably pertain to the manufacture of product components or products regulated as medical devices and marketed or distributed by the Borrower.
FDA Regulatory Matters. This Agreement involves a product subject to regulation by the U.S. Food and Drug Administration (FDA) for which FDA clearance or approval will be sought. Accordingly, the parties agree on the provisions described in Appendix B.
FDA Regulatory Matters. 3.21.1 The Company and its Subsidiaries are, and since January 1, 2018, have at all times been, in compliance with all FDA Laws as applied to the conduct of its business, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
3.21.2 Neither the Company nor any of its Subsidiaries has received any written Form FDA-483, notice of adverse finding, warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other written notice from the FDA or any other Governmental Entity. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each Subsidiary has made all notifications, submissions, responses and reports required by FDA Laws or any other Law, including such obligation arising under any administrative, enforcement or regulatory action, inspection, warning letter, notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Entity and all such notifications, submissions and reports were correct and complete in all material respects as of the date of submission to the FDA or any comparable Governmental Entity.
3.21.3 To the Knowledge of the Company, no product distributed or sold by or on behalf of the Company or any Subsidiary has been either voluntarily or involuntarily seized, withdrawn, recalled, detained or subject to a suspension of manufacturing or sale as a result of a violation of an FDA Law.
FDA Regulatory Matters. (a) Amneal and each of its Subsidiaries is and has been since January 1, 2014, in compliance in all material respects with (i) all Healthcare Laws and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, and all other Healthcare Regulatory Authorities, that are applicable to Amneal or its Subsidiaries, as applicable. As of the date hereof, neither Amneal nor any of its Subsidiaries, nor their respective officers, directors or employees, or agents authorized to appear before any Healthcare Regulatory Authority for or on behalf of Amneal or any of its Subsidiaries, is subject to, or has received written, or, to Amneal’s Knowledge, oral notice or other communication of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action alleging that any operation or activity of Amneal or its Subsidiaries is in violation of any Healthcare Laws or otherwise related to the business of Amneal or its Subsidiaries by or before any Healthcare Regulatory Authority, including any action (i) to suspend, revoke or withdraw a material Healthcare Regulatory Authorization or (ii) contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging, in each case, any material violation of Law with respect to, any product or product candidate manufactured, distributed or marketed by or on behalf of Amneal or its Subsidiaries.
(b) Amneal and each of its Subsidiaries, as applicable, has held, or has held contractual rights to, all material Healthcare Regulatory Authorizations required for the marketing and approval of all products marketed by or on behalf of Amneal or any of its Subsidiaries, and all such Healthcare Regulatory Authorizations are in full force and effect. As of the date hereof, neither Amneal nor any of its Subsidiaries, nor their respective officers, directors or employees, or agents authorized to appear before any Healthcare Regulatory Authority for or on behalf of Amneal or any of its Subsidiaries, as applicable, has received written or, to Amneal’s Knowledge, oral notice or other communication of any material inaccuracy or material insufficiency of, or of any termination, suspension, rejection or denial of, any filing or application for any material Healthcare Regulatory Authorization that was not corrected or otherwise addressed in a subsequent filing. To Amneal’s Knowledge, no event has occurred which allows, or after notice or lapse of ...
FDA Regulatory Matters. (a) Impax and each of its Subsidiaries is and has been since January 1, 2014, in compliance in all material respects with (i) all Healthcare Laws and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, and all other Healthcare Regulatory Authorities, that are applicable to Impax or its Subsidiaries, as applicable. The “Healthcare Laws” include: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) the Controlled Substances Act and the regulations promulgated thereunder (the “FFDCA”); (iii) the U.S. Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals; and (iv) all federal, state, local, and all foreign health care related fraud and abuse and physician sunshine act laws, including the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Sections 1320a-7, 1320a-7a, 1320a-7b and 1320a-7h of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; and (v) any other state or federal law, regulation, guidance document, manual provision, program memorandum, opinion letter, or other public issuance which regulates kickbacks, recordkeeping, claims process, documentation requirements, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, or any other aspect of manufacturing and distributing drugs, biologics, or medical devices. As of the date hereof, neither Impax nor any of its Subsidiaries, nor their respective officers, directors or employees, or agents authorized to appear before any Healthcare Regulatory Authority for or on behalf of Impax or any of its Subsidiaries, is subject to, or has received written, or, to Impax’s Knowledge, oral notice or other communication of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action alleging that any operation or activity of Impax or its Subsidiaries is in violation of any Healthcare Laws or otherwise related to the business of Impax or its Subsidiaries by or before...
FDA Regulatory Matters. (a) Except as set forth on Schedule 4.28(a), the Seller is in compliance with all applicable Laws, statutes (including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §321 et. seq.), rules, regulations, mandatory standards, and orders administered or issued by the U.S. Food and Drug Administration (the “FDA”) or any applicable, comparable foreign governmental regulatory authority, including requirements related to premarket clearance, exemption from premarket clearance, premarket approval, establishment registration and product listing, medical device reporting, corrections and removals, import and export requirements, product labeling, promotional materials and advertising, qualification, purchasing, controls, product testing, and good manufacturing practices, except for such noncompliance that would not, individually or in the aggregate, require payment by or a loss to the Seller of more than $10,000.
(b) The Seller has not been charged with, nor received any written notice or other written communication from the FDA or any comparable Governmental Entity alleging, any violation of any Laws by the Seller relating to the Business. The Seller is not the subject of any investigation that is pending or, to the Knowledge of the Seller, proposed or threatened by the FDA or any comparable Governmental Entity. The Seller is not subject to any obligation arising under any judicial, administrative, or regulatory action, FDA inspection, FDA warning letter, FDA untitled letter, FDA notice of violation letter or other written communication from the FDA or a comparable Governmental Entity or other written notice, response, or commitment made to or with the FDA or a comparable Governmental Entity. The Seller has not received any information regarding, nor has Knowledge of, any facts or circumstances that furnish any reasonable basis for any Form FDA-483 inspectional observations, untitled letter, notice of violation letter, warning letter, or similar communication from the FDA, or any comparable Governmental Entity.
(c) No seizure, denial, withdrawal, recall, detention, field notification, field correction, termination or suspension of manufacturing or marketing, import alert, or safety alert relating to any product manufactured or distributed by the Seller (the “Products”) has been initiated, proposed, requested, or threatened. The Seller has not received any information regarding, nor has any Knowledge of, any facts or circumstances reasonably likely to cause any ...
FDA Regulatory Matters. (a) Except as would not reasonably be expected to have a Material Adverse Effect, no seizure, denial, withdrawal, recall, detention, field notification, field correction, termination or suspension of manufacturing or marketing, import alert, or safety alert relating to any of the Company products or services has been initiated, or to the knowledge of the Company, proposed or requested. The Company has not received any information regarding, nor, to the knowledge of the Company, has any facts or circumstances reasonably likely to cause any such action.
(b) Part 3.26(b) of the Company Disclosure Schedule sets forth all inspections of the Company or any Subsidiary by the FDA or any comparable foreign Governmental Body having equivalent authority over medical devices.
(c) The Company or a Subsidiary, as applicable, is the sole and exclusive owner of the devices relating to the pending, cleared, and approved 510(k) premarket notifications, premarket approval applications, and investigational device exemption applications set forth on Part 3.26(c) of the Company Disclosure Schedule, each of which is valid and existing in full force and effect, and may be assigned to, transferred to, or assumed by Parent in accordance with this Agreement. To the knowledge of the Company, neither the FDA nor any other comparable Governmental Body is considering limiting, suspending or revoking any such FDA Permit or changing the regulatory classification or labeling of any of the Company products or services.
FDA Regulatory Matters. (a) For the period of one (1) year after the applicable date of transfer from Sellers to Buyers of each of the FDA Applications as specified in Sections 4.8 and 4.9, Sellers shall, and shall cause their affiliates to, assist Buyers, at Buyers expense, in: (i) disclosing and copying any relevant records and reports received by Sellers after the transfer to Buyers of any FDA/EU Application that are required to be made, maintained and reported pursuant to any applicable Law in connection with such FDA/EU Application; and (ii) processing and reporting complaints, service requests, adverse events, and device malfunctions related to the Products that are the subject of such FDA/EU Applications, to the extent required by applicable Laws.
(b) During the period between the date of this Agreement and the Closing Date, Sellers shall, and shall cause their affiliates to: (i) make commercially reasonable efforts to obtain the Initial FDA Approval and the Secondary FDA Approval, including the conduct and completion of any additional testing required by the FDA; (ii) take all actions necessary to continue the RESILIENT clinical study, in conformance with the study protocols in the RESILIENT IDE, and any additional requirements imposed by FDA or any relevant Institutional Review Boards (“IRBs”), and provide interim reports to Buyers, as requested by Buyers; (iii) take all actions necessary and obtain any documentation required to maintain the relevant FDA Applications and any amendments or supplements thereto, including the original premarket approval (“PMA”) application filed on May 25, 2007 for the “Lifestent FlexStar System” and
FDA Regulatory Matters. (a) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and each of its Subsidiaries is, and since January 1, 2019 has been, conducting their respective businesses in compliance with all applicable FDA Regulatory Laws.
(b) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2019, there have been no recalls ordered by any Governmental Authority, including the U.S. Food and Drug Administration (the “FDA”), or any seizures or warning letters or untitled letters issued (or, to the Knowledge of the Company, threatened), by the FDA or any other Governmental Authority with respect to any of the Company’s products.
(c) Except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent or distributor of the Company or any of its Subsidiaries, as the case may be, made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement, in each such case, related to the business of the Company and each of its Subsidiaries, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy.
