FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations from FDA or other Governmental Authority required to conduct their respective businesses as currently conducted. Each of the Registrations is valid and subsisting in full force and effect. To the knowledge of the Credit Parties and their Subsidiaries, the FDA is not considering limiting, suspending, or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiaries. To the knowledge of the Credit Parties and their Subsidiaries, there is no false or misleading information or significant omission in any product application or other submission to FDA or any comparable Governmental Authority. The Credit Parties and their Subsidiaries have fulfilled and performed their obligations under each Registration in all material respects, and 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 that could reasonably be expected to result in a Material Adverse Effect. To the knowledge of the Credit Parties and their Subsidiaries, any third party that is a manufacturer or contractor for the Credit Parties and their Subsidiaries is in compliance with all Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product components or products for the Credit Parties and their Subsidiaries.
(b) All products developed, manufactured, tested, distributed or marketed by or on behalf of the Credit Parties and their Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority have been and are being developed, tested, manufactured, distributed and marketed in compliance with the FDA Laws or any other applicable Requirement of Law, including, without limitation, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, and adverse event reporting, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect, and have been and are being tested, investigated, distributed, marketed, and sold in compliance in all material respects with FDA Laws or any other applicable Requirement of Law, except where a failure to be in compliance could not reasonably be expected to result in a Material Adverse Effect.
(c) The Credit Parties and their Subsidiarie...
FDA Regulatory Compliance. (a) Since January 1, 2009, the Company and its Subsidiaries have complied in all material respects with all applicable provisions of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. § 301 et. seq., as amended from time to time, and all applicable regulations promulgated thereunder by the FDA (collectively, “FDA Law and Regulation”), and analogous provisions of foreign Law governing the conduct of the Business.
(b) In the past five (5) years, neither the Company nor any Subsidiary nor to the Company’s Knowledge, any manufacturer of the Company’s products has received any written (or, to the Company’s Knowledge, oral) notice or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation, or any notice from any other Governmental Authority with respect to analogous provision of foreign Law governing the regulation of the Company’s products or the Business. The Company and its Subsidiaries are not now subject (and have not been subject at any time during the previous five (5) years) to any civil, criminal or administrative action, suit, claim, complaint, hearing, demand letter, warning letter, untitled letter, proceeding, inspection, finding, recall, investigation, penalty assessment, audit or other compliance or enforcement, regulatory or administrative proceedings by the FDA, and to the Company’s Knowledge, no review or investigation has been Threatened against the Company or any Subsidiary or any of the manufacturers of the Company’s products for failure to comply with any FDA Law and Regulation or analogous provision of foreign Law governing the regulation of the Company’s products or the Business. None of the Company or any Subsidiary or any of their respective officers or directors, or, to the Company’s Knowledge, any of their respective employees, has been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a.
(c) The Company and its Subsidiaries have obtained all necessary clearances and authorizations from the FDA and other Governmental Authorities for their current and past Business activities, including the commercial distribution of any products that are regulated by the FDA or other Governmental Authorities. Schedule 3.22(c) sets forth a list of all material regulatory registrations, clearances, and approvals issued under the FD&C Act (“FD&C Permits”) and held by the Company or any of its Subsidiaries. Each such FD&C Permit is in full f...
FDA Regulatory Compliance. 1
(i) Since January 1, 2019, CRH and all CRH products have been in material compliance with all applicable FDA Laws.
(ii) Except as disclosed in Schedule 4.1(bb)(ii) to the CRH Disclosure Letter, since January 1, 2019, CRH has not received any written notice from any Governmental Authority asserting noncompliance with any FDA Law, including any warning or untitled letter, notice of violation, notice of inspectional observations, Form FDA-483, or similar letter or written notice. Since January 1, 2019, CRH has not been subject to any enforcement, regulatory or administrative proceedings initiated by any Governmental Authority and, to CRH’s knowledge, no such enforcement, regulatory or administrative proceeding has been threatened. 1 Subject to ongoing review by regulatory specialists.
(iii) Except as disclosed in Schedule 4.1(bb)(iii) to the CRH Disclosure Letter, since January 1, 2019, no product distributed or sold by or on behalf of CRH has been seized, detained, withdrawn, voluntarily or involuntarily recalled, or subject to a suspension of manufacturing, and there are no facts or circumstances reasonably likely to cause a market withdrawal, recall, seizure, detention, or suspension of the manufacturing, marketing or distribution, of any such product.
(iv) Since January 1, 2019, all preclinical and clinical investigations sponsored or conducted by or on behalf of CRH have been and are being conducted in material compliance with all applicable FDA Laws, applicable research protocols, institutional review board or other ethics committee requirements, and federal and state Laws relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. CRH has not received any written notice that any Governmental Authority or institutional review board or independent ethics committee has initiated, or threatened to initiate, any action to suspend, terminate, delay, or otherwise restrict any clinical trial sponsored or conducted by or on behalf of CRH.
(v) Since January 1, 2019, neither CRH, nor to CRH’s knowledge, any officer, director employee or agent of CRH has (i) made any materially false statement on, or material omission from, any notifications, applications, approvals, reports and other submission to any Governmental Authority; or (ii) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “...
FDA Regulatory Compliance. (a) Abbott has all material Registrations from the FDA or other Governmental Authority required to conduct the Business as currently conducted. To the Knowledge of Abbott, each of such Registrations is valid and subsisting in full force and effect, and, subject to applicable Law, may be assigned and transferred to GE in accordance with the provisions of this Agreement. The FDA has not informed Abbott in writing that it intends to limit, suspend or revoke such Registrations or change the marketing classification or labeling of any Abbott Products.
(b) The Abbott Products that are subject to the jurisdiction of the FDA have been and are being developed, tested, manufactured, distributed and marketed in substantial compliance with all applicable FDA Laws.
(c) Abbott, with respect to the Business, is not subject to, and does not have Knowledge of facts or circumstance reasonably likely to cause, any material obligation arising under an administrative or regulatory action status, FDA warning letter, FDA notice of violation letter, or other notice from the FDA or any comparable Governmental Authority except for the Consent Decree.
FDA Regulatory Compliance. (a) Each of the Borrower, Holdings, and their Subsidiaries (i) are, and for the past five (5) years have been, in material compliance with applicable FDA Laws; and (ii) hold and are in, and for the past five (5) years have held and have been in, material compliance with all required FDA Permits.
(b) No products of the Borrower, Holdings, or their Subsidiaries are or have been: (i) adulterated within the meaning of section 501 of the FDCA, 21 U.S.C. § 351; (ii) misbranded within the meaning of section 502 of the FDCA, 21 U.S.C. § 352; (iii) in violation of any provision of section 301 of the FDCA, 21 U.S.C. § 331, or section 351 of the Public Health Service Act, 42 U.S.C. § 262; (iii) subject to violations of any FDA Law or Requirements of Law similar to the foregoing under any applicable state, federal, or foreign Governmental Authority’s jurisdiction; or (iv) subject to any seizure, detention, recall or suspension of manufacturing or distribution, whether voluntarily or ordered or requested by a Governmental Authority.
(c) All non-clinical and clinical investigations conducted, sponsored, or otherwise relied upon by the Borrower, Holdings, and their Subsidiaries are being conducted, and have been conducted, in compliance in all material respects with all applicable FDA Laws, including (i) FDA standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and for human subjects protection contained in 21 C.F.R. Parts 50, 54, 56, 312 and 812, (iii) applicable Requirements of Law related to registration and disclosure of clinical trials and trial-related information, and (iv) any other applicable state, federal, or foreign FDA Laws or other Requirements of Law regulating the conduct of non-clinical and clinical investigations comparable to the foregoing.
(d) All products of the Borrower, Holdings, and their Subsidiaries are, and for the past five (5) years have been, in compliance in all material respects with all applicable FDA Laws regarding the manufacturing, compounding, processing, storing, labeling or packaging, advertising, distributing, selling, or marketing of drugs and devices, including Requirements of Law concerning (i) testing, current good manufacturing practices contained in 21 C.F.R. Parts 210, 211, and 820, (ii) reporting adverse events contained in 21 C.F.R. Parts 312, 600 and 803; (ii...
FDA Regulatory Compliance. (a) The Companies are, and have been at all times during the four (4) year period prior to the date hereof, in compliance with all applicable statutes, rules, regulations, standards, guidelines, policies, and orders administered or issued by FDA (“FDA Laws”) or any comparable Governmental Body, except where non-compliance has not been and would not be (individually or in the aggregate) material to the Companies or their businesses.
(b) To Seller’s knowledge, the Companies’ genetic screening and diagnostic testing activities are currently subject to the FDA’s exercise of enforcement discretion with respect to so-called “home brew” tests developed and utilized in clinical laboratories certified pursuant to the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), and, therefore, are not subject to active FDA regulation as of the date of this Agreement.
(c) The Companies have had no written communications with the FDA regarding regulatory non-compliance of their businesses, and are not subject to (i) any written notice or communication from the FDA or from any comparable Governmental Body alleging non-compliance with any FDA Laws, or (ii) any FDA inspection, FDA warning letter, FDA notice of violation letter, or response or commitment made to or with the FDA or with any comparable Governmental Body, and, to Seller’s knowledge, no such proceedings have been initiated.
FDA Regulatory Compliance. The Company shall maintain, and cause each Subsidiary to maintain, such permits, licenses, franchises, authorizations and clearances (“Permits”) of Governmental Entities, including FDA and/or any committee thereof, as are necessary to own, lease and operate its properties and to conduct its business as now conducted and as currently proposed to be conducted; the Company shall fulfill and perform, and cause each Subsidiary to fulfill and perform, all such material obligations with respect to the Permits, and the Company shall cause each Subsidiary to conduct or sponsor feasibility, pre-clinical, clinical and other studies and tests in accordance with standard medical and scientific research procedures.
FDA Regulatory Compliance. Since January 1, 2019, CRH and all CRH products have been in material compliance with all applicable FDA Laws.
FDA Regulatory Compliance. 101103 Section 6.34 Accounts 102104 Section 6.35 Ground Lease 102104 Section 6.36 Labor Matters 102104 Section 6.37 Single Purpose Entity/Separateness 103105 Section 6.38 Holding Companies 105106 Section 6.39 Michigan Lessees 105106 SECTION 7. AFFIRMATIVE COVENANTS 105107 iii US_Active\120558968\V-3 US_ACTIVE\122519032\V-4 TABLE OF CONTENTS (continued) Page Section 7.1 Punctual Payment 105107 Section 7.2 Maintenance of Office 105107 Section 7.3
FDA Regulatory Compliance. Following the Closing, Purchaser will timely register as a manufacturing facility as required by applicable Law. From and after the Closing Date, Purchaser shall be responsible for compliance with the FDA Quality System Regulations, 21 C.F.R. Part 820, for the all products manufactured at the Facility following Closing and all Inventory.
