Common use of FDA Regulatory Compliance Clause in Contracts

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) Except as disclosed with respect to DESI Program Products or as disclosed in Schedule 4.26 4.25 or in public filings of the Parent Borrower 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 and, to the knowledge of each Loan Party, 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) to the knowledge of each Loan Party, 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) Except as disclosed with respect to DESI Program Products or as disclosed in Schedule 4.26 Annex IV or in public filings of the Parent with the Holdings’ SEC prior to the Closing Date Filings and (2) as would not reasonably be expected to result in a Material Adverse Effect, (i) each Loan Credit 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 Credit Party, neither the FDA nor any comparable Governmental Authority is considering limiting, suspending, or revoking any such Registration; (iv) the Loan Credit 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 Credit Party or any of its Subsidiaries have been so filed, maintained or furnished.