Common use of Absence of Certain Regulatory Actions Clause in Contracts

Absence of Certain Regulatory Actions. Except as described in the Exchange Act Documents or as would not, individually or in the aggregate, have a Material Adverse Effect, the Issuer has not (a) had any product or manufacturing site (whether Issuer-owned or that of a contract manufacturer for Issuer products or product candidates) subject to a Governmental Authority (including the FDA) shutdown or import or export prohibition or (b) received any FDA Form 483 or other Governmental Authority notice of inspectional observations, “warning letters”, “untitled letters”, requests to make changes to the Issuer products, processes or operations, or similar written correspondence or notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Laws. To the Issuer’s knowledge, neither the FDA nor any other Governmental Authority has threatened such action. The Issuer has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Regulatory Agency or other Governmental Authority alleging that any product operation or activity is in violation of any health care Laws, and, to the Issuer’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except where such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.

Absence of Certain Regulatory Actions. Except as described in the Exchange Act Documents Registration Statement and the Prospectus, or as would not, individually or in the aggregate, have a Material Adverse Effect, the Issuer Company has not (a) had any product or manufacturing site (whether IssuerCompany-owned or that of a contract manufacturer for Issuer Company products or product candidates) subject to a Governmental Authority governmental authority (including including, without limitation, the FDA) shutdown or import or export prohibition or (b) prohibition, nor received any FDA Form 483 or other Governmental Authority governmental authority notice of inspectional observations, “warning letters”, ,” “untitled letters”, ,” requests to make changes to the Issuer Company products, processes or operations, or similar written correspondence or notice from the FDA or other Governmental Authority governmental authority alleging or asserting material noncompliance with any applicable Lawslaws. To the IssuerCompany’s knowledge, neither the FDA nor any other Governmental Authority governmental authority has threatened such action. The Issuer Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, Regulatory Agency or other Governmental Authority governmental authority alleging that any product operation or activity is in violation of any health care Lawslaws, and, nor to the IssuerCompany’s knowledge, no is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except where such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.