Compliance with Applicable Product Laws; Product Authorizations Sample Clauses

Compliance with Applicable Product Laws; Product Authorizations. Except as described in the Exchange Act Documents, the Issuer and its Subsidiaries (a) are and at all times have been in compliance with all Laws applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Issuer (“Applicable Product Laws”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect, (b) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any Governmental Authority, self-regulatory organization or other non-governmental regulatory authority (including Nasdaq) or third party alleging or asserting non-compliance with any Applicable Product Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Product Laws (“Product Authorizations”), except for such non-compliance as would not, individually or in the aggregate, have a Material Adverse Effect, (c) possess all material Product Authorizations, and such Product Authorizations are valid and in full force and effect and are not in violation of any term of any such Product Authorizations, except for such violations as would not, individually or in the aggregate, have a Material Adverse Effect and as set forth on Schedule 5.20, (d) have not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority, self-regulatory organization, other non-governmental regulatory authority or third party alleging that any product operation or activity is in violation of any Applicable Product Laws or Product Authorizations, and, to the Issuer’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, (e) have not received written notice that any Governmental Authority, self-regulatory organization or other non-governmental regulatory authority has taken, is taking or intends to take action to materially limit, suspend, modify or revoke any Product Authorizations, and, to the Issuer’s knowledge, no such limitation, suspension, modification or revocation is threatened, and (f) have filed, obtained, maintained...