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) Except as disclosed with respect to DESI Program Products or as disclosed in Schedule 4.26 or in public filings of the Parent with the SEC prior to the Closing Date and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) each Loan Party and each of their Subsidiaries has, and it and its Products are in conformance with, all Registrations, (ii) all Registrations are valid and in full force and effect; (iii) to the knowledge of each Loan Party, neither the FDA nor any comparable Governmental Authority is considering limiting, suspending, or revoking any such Registration; (iv) the Loan Parties and each of their Subsidiaries have fulfilled and performed their obligations under each Registration, 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 Registration; and (v) all reports, documents, claims, permits, adverse event reports, complaints, notices, registrations and applications required to be filed, maintained or furnished to the FDA or any other Regulatory Authority by a Loan Party or any of its Subsidiaries have been so filed, maintained or furnished.
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, 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. 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 marketed or distributed by the Credit Parties and their Subsidiaries.
FDA Regulatory Compliance. Except as would not reasonably be expected to have a Company Material Adverse Effect:
FDA Regulatory Compliance. (a) Each Loan Party and each of their Subsidiaries has, and it and its products are in conformance with, all registrations, listings, authorizations, approvals, licenses, permits, clearances, certificates and exemptions (including 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) issued or allowed by the FDA or any comparable Governmental Authority, including but not limited to Health Canada (hereinafter “Registrations”) that are required to conduct its business as currently conducted. To the knowledge of each Loan Party, neither the FDA nor any comparable Governmental Authority, including but not limited to Health Canada, is considering limiting, suspending, or revoking any such Registration. The Loan Parties and each of their Subsidiaries have fulfilled and performed their obligations under each Registration, 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 Registration.
FDA Regulatory Compliance. (a) Buyer is in compliance with the FDA Laws and, to the Knowledge of Buyer, the FTC Laws.
FDA Regulatory Compliance. (a) The Company has all Registrations from the FDA and any other Governmental Entity required to conduct their respective business as currently conducted, including any applicable Governmental Entity that regulates the development, import, marketing, promotion, manufacture, sale or distribution of the Company Products or the conduct of the business of the business of the Company, including valid 510(k) clearances or exemptions therefrom (as set forth in 21 C.F.R. Part 807), and Section 2.23(a) of the Company Disclosure Schedules sets forth a true and complete list of such Registrations. Each of the Registrations is valid and subsisting in full force and effect. To the Knowledge of the Company, neither the FDA nor any comparable Governmental Entity is considering limiting, suspending or revoking such Registrations or changing the marketing classification or labeling of the Company Products. There is no false or misleading information or significant omission in any product application or other submission to the FDA or any comparable Governmental Entity. The Company has fulfilled and performed its obligations in all material respects under each Registration, and, to the Company’s Knowledge, 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 the Company, any third party that is a manufacturer or contractor for the Company is in compliance in all material respects with all Registrations from the FDA or comparable Governmental Entity insofar as they pertain to the manufacture of product components for or of Company Products. No written notice of cancellation, default or any dispute concerning any Registration has been received by the Company. The Company is the sole and exclusive owner of the Registrations and the associated filings and applications with the FDA or any other applicable Governmental Entity, including any 510(k) submissions, comparable regulatory application or filing made or held by or issued to the Company, and holds all rights, title and interest in all such regulatory filings free and clear of any encumbrance. No consent from or notice to any Governmental Entity is necessary for the Registrations to continue in effect on and after the Closing. The Company has not granted any third party any right or license to use, access, or reference any of the regulatory filings or Registrations.
FDA Regulatory Compliance. (a) The Company is in compliance with all applicable Laws, rules, regulations and orders administered or issued by (i) the U.S. Food and Drug Administration (“FDA”) or any comparable Governmental Entity (“FDA Laws”) or (ii) to the Knowledge of the Company, the U.S. Federal Trade Commission (“FTC”) (“FTC Laws”).
FDA Regulatory Compliance. (i) 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.
