FDA Regulatory Compliance Clause Samples

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) The Concentrates Business products are being or have, since January 3, 2022, been manufactured, tested, packaged, labeled, distributed, and sold in compliance in all material respects with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FDCA”) and the regulations of the Food and Drug Administration (“FDA”) promulgated thereunder and all other applicable Laws. Seller holds all authorizations required by applicable Laws to operate the Concentrates Business, and all such authorizations are current and in full force and effect. Seller has made available to Purchaser true and complete copies of all material governmental correspondence (including copies of official notices, citations or decisions) in the files of Seller relating to such authorizations. Seller has made available to Purchaser true and 155815138v19 complete copies of all material governmental correspondence (including copies of official notices, citations or decisions) sent or received by Seller primarily related to the Concentrates Business since January 3, 2022. (b) All Permits required to be obtained from FDA for Seller to conduct the Concentrates Business as currently conducted or for the ownership and use of the Acquired Assets, in each case in all material respects, have been obtained by Seller and are valid and in full force and effect, and each of the Concentrates Business products has been cleared by the FDA, to the extent required by applicable Law. (c) Since January 3, 2022, to Seller’s Knowledge, all applications, notifications, submissions, information, claims, reports and filings utilized as the basis for or submitted in connection with any and all requests for an authorization relating to a Concentrates Business product were true, accurate and complete in all material respects as of the date of submission. Since January 3, 2022, to Seller’s Knowledge, any necessary or required updates, changes, corrections or modifications to such applications, notifications, submissions, information, claims, reports, filings and other data have been submitted to FDA or other Governmental Entity and as so updated, changed, corrected or modified remain true, accurate and complete in all material respects. (d) Since January 3, 2022, Seller has not received any written communication from FDA or any other Governmental Entity, including without limitation any warning letter or untitled letter that alleges or suggests that the Concentrates Business is not in compliance with ...

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. Except as otherwise set forth on the attached FDA Regulatory Schedule: (a) The Company and each of its Subsidiaries are in compliance in all material respects with all applicable FDA Laws administered or issued by the FDA or any applicable, comparable Governmental Entity (such as the Drug Enforcement Administration (the “DEA”)), including requirements related to development, clinical and non-clinical evaluation, 510(k) premarket notification, investigational new drug applications, new drug applications, abbreviated new drug applications, establishment registration and product listing, medical device reporting, adverse drug experience reporting, field alert reporting, corrections and removals, recalls, quality system regulation, good manufacturing practices, product warranties (with respect to medical devices), distribution, importation, exportation, use, handling, quality, sale, labeling, promotion, or advertising and other premarket and postmarket requirements or commitments of any drug or medical device or controlled substance subject to regulation by the Drug Enforcement Administration under the Controlled Substances Act. (b) During the past three (3) years neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any of the directors, officers, or employees of the Company or any of its Subsidiaries has been charged with, nor received any notice or other communication from the FDA or any other Governmental Entity alleging, any material violation of any FDA Laws by the Company or any of its Subsidiaries relating to its business. To the Company’s knowledge, the Company and its Subsidiaries, and the directors, officers, or employees of the Company and its Subsidiaries, are not the subject of any investigation that is pending, proposed, or threatened by the FDA or any comparable Governmental Entity. Neither the Company nor any of its Subsidiaries is subject to any obligation arising under any civil or criminal judicial, administrative, or regulatory action, FDA inspection, FDA warning letter, FDA untitled letter, FDA notice of violation letter, or other communication from the FDA or a comparable Governmental Entity, including the DEA, or other notice, response or commitment made to or with the FDA or a comparable Governmental Entity, including the DEA. During the past three (3) years, the Company and its Subsidiaries have not received any information regarding, nor have knowledge of, any facts or circumstances that furnish any re...

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.  In November 2016, LNE/G-Med (“G-Med”) suspended the CE M▇▇▇ certificate for the On-X ascending aortic prosthesis (“AAP”) in the European Economic Area (“EEA”) for various reasons with which CryoLife disagreed. CryoLife is currently seeking certification of the On-X AAP through another notified body. That new notified body has indicated that it may require reclassification of some On-X products from Class I to Class IIa. G-Med is still CryoLife’s/On-X’s notified body for other On-X products.  CryoLife is aware that the legacy Chinese distributor of On-X products failed to timely submit all vigilance reports.  On October 9, 2014, the FDA met with an advisory panel of external experts for guidance to consider a possible reclassification of "more than minimally manipulated" heart valves (which would include CryoLife's SynerGraft® pulmonary valve tissues) from "unclassified" to "Class III." At the meeting, a majority of the advisory committee panel recommended to the FDA that MMM allograft heart valves be classified as Class III. Pending any reclassification, CryoLife legally continues to process and ship CryoValve SGPV tissues. If the FDA ultimately reclassifies CryoLife’s CryoValve SGPV as Class III, CryoLife will evaluate its options at that time.

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. (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. (a) TAP and the TAP Subsidiaries have all material registrations and approvals for the VEP Products and the Split-off Products from the FDA or other Governmental Authorities required to conduct business as currently conducted. Each such Split-off Product and VEP Product registration and approval is valid and subsisting in full force and effect, and, subject to Applicable Law, may be assigned and transferred to Takeda or Newco in accordance with the provisions of this Agreement. The FDA has not informed TAP or the TAP Subsidiaries or any third parties in writing that it intends to limit, suspend, or revoke any such Split-off Product or VEP Product registration or approval or change the marketing classification or labeling of any Split-off Product or VEP Product. (b) The Split-off Products and the VEP Products that are subject to the jurisdiction of the FDA have been and are being developed, tested, manufactured, distributed and marketed by TAP and the TAP Subsidiaries in substantial compliance with all applicable FDA laws. (c) TAP and the TAP Subsidiaries, with respect to the Split-off Products and the VEP Products, are not subject to, and there exist no facts or circumstances reasonable 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.