Common use of FDA Regulatory Compliance Clause in Contracts

FDA Regulatory Compliance. (a) Each of the Credit Parties and their Subsidiaries have all Registrations, or are pursuing such Registrations, from the FDA or other Governmental Authority required to conduct their respective businesses as currently conducted (other than the portion of such business conducted by distributors). With respect to jurisdictions in which Registrations are held by distributors, to the knowledge of the Credit Parties, each of the distributors has all Registrations, or is pursuing such Registrations, from the FDA or other Governmental Authority required to conduct its respective business as currently conducted. Each of the Registrations is, in all material respects, valid and subsisting in full force and effect. Except as set forth on Schedule 4.23 attached hereto, to the knowledge of the Credit Parties and their Subsidiaries, as of the Closing Date, 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 existing 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 in all material respects 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.

FDA Regulatory Compliance. (a) Each of BSC and the Credit Parties and their Subsidiaries Sellers have all Registrations, or are pursuing such Registrations, material Registrations from the FDA or United States Food and Drug Administration (the “FDA”) and any other comparable Governmental Authority required to conduct their respective businesses as currently conducted (other than the portion of such business conducted by distributors). With respect to jurisdictions in which Registrations are held by distributors, to the knowledge of the Credit Parties, each of the distributors has all Registrations, or is pursuing such Registrations, from the FDA or other Governmental Authority required to conduct its respective business Business as currently conducted, and Section 3.17 of the Disclosure Schedule sets forth a true and complete list of such Registrations. Each of the Registrations is, in all material respects, such Registration is valid and subsisting in full force and effect. Except as set forth on Schedule 4.23 attached heretoTo the Knowledge of BSC, to neither BSC nor the knowledge of the Credit Parties and their Subsidiaries, as of the Closing Date, Sellers have received any written notice from the FDA or any comparable Governmental Authority that the FDA or such comparable Governmental Authority is not considering limiting, suspending, suspending or revoking such Registrations or changing the marketing classification or labeling of the products of the Credit Parties and their Subsidiariesrelated Products. To the knowledge Knowledge of the Credit Parties and their SubsidiariesBSC, 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 Credit Parties BSC and their Subsidiaries have the Sellers have, in all material respects, fulfilled and performed their obligations under each existing Registration in all material respectssuch Registration, and no event has occurred or condition or state of facts exists which would constitute a material breach or material default or would cause revocation or termination of any such Registration that could reasonably be expected to result in a Material Adverse EffectRegistration. To the knowledge Knowledge of the Credit Parties and their SubsidiariesBSC, any third party that is a manufacturer or contractor for with respect to the Credit Parties and their Subsidiaries Products is in material compliance in all material respects with all such Registrations from the FDA or comparable Governmental Authority insofar as they pertain to the manufacture of product Products or components or products for the Credit Parties Products for BSC or the Sellers. Each Product that is subject to the jurisdiction of the FDA or any comparable Governmental Authority has been and their Subsidiariesis being developed, tested, investigated, manufactured, distributed, marketed, and sold in material compliance with all applicable statutes, rules, regulations, standards, guidelines, policies and orders administered or issued by the FDA or any comparable Governmental Authority and any other applicable requirement of Law, including those regarding clinical research, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, adverse event reporting and reporting of corrections and removals.