Health Care Authorizations. The Company and its subsidiaries have submitted and possesses, or qualify for applicable exemptions to, such valid and current registrations, listings, approvals, clearances, licenses, certificates, authorizations or permits and supplements or amendments thereto (collectively, “Health Care Authorizations”) issued or required by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their business as described in the Registration Statement, the General Disclosure Package and the Prospectus, including, without limitation, all such Health Care Authorizations required by the FDA, the EMA, the Department of Health and Human Services or any other state, federal or foreign agencies or bodies engaged in the regulation of medical devices, except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such Health Care Authorization, except where such revocation, modification or non-compliance would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
Appears in 5 contracts
Samples: Underwriting Agreement (Axonics, Inc.), Underwriting Agreement, Underwriting Agreement (Axonics Modulation Technologies, Inc.)