Common use of Regulatory Violations Clause in Contracts

Regulatory Violations. (a) SAFC represents and warrants that it does not and will not, and its Affiliates do not and will not, knowingly use in any capacity the services of any person or entity debarred under Section 306 of the Federal Food, Drug, and Cosmetic Act named on the FDA Debarment List (Drug Product Applications) (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/ora/compliance_ref/debar/), or otherwise debarred under the corresponding Laws of another jurisdiction. Where permissible by local Laws, notably regulation on personal data protection, SAFC will as soon as practically possible disclose in writing to Company any information which comes to its attention and indicates that the statement in the preceding sentence is or may be incorrect. SAFC shall notify Company in writing as soon as practically possible if any Violation (as defined below) occurs or comes to its attention at any time during the Term. If a Violation exists with respect to any of SAFC’s officers, directors, Key Employees, or Subcontractors, SAFC shall promptly remove such individual(s) or entities from performing any service, function or capacity related to this Agreement. Company shall also have the right, in its sole discretion, to terminate this Agreement immediately in the event of any such Violation, if such Violation (i) is not cured by SAFC within [***] after receipt of a notification of such Violation from Company or (ii) cannot be cured by SAFC. (b) SAFC represents and warrants that SAFC, its Affiliates and their respective officers and directors, and employees in the Manufacture of API, have not been, and will not be, in Violation. SAFC shall notify Company in writing as soon as practically possible if any such Violation occurs or comes to its attention. Company shall have the right, in its sole discretion, to terminate this Agreement and/or any purchase order immediately in the event of any such Violation. The term “Violation” shall mean that either SAFC or its Affiliates or, to SAFC’s knowledge any of their respective officers, directors, or employees Manufacturing API has been: (1) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/exclusions/authorities.asp ); (2) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/exclusions/authorities.asp ) or the U.S. General Services Administration's list of Parties Excluded from Federal Programs (▇▇▇▇://▇▇▇.▇▇▇.gov ); or (3) listed by any US Federal agency as being suspended, debarred, excluded, or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/ora/compliance_ref/debar/); or (4) listed on the SDN LIST (including owned by 50% or more by a person listed on the SDN List), the U.S. Commerce Department’s Denied Persons List (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇.▇▇▇/dpl/▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇) and Entity List (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇.▇▇▇/entities/default.htm), or the Consolidated List of Persons, Groups and Entities Subject to EU Financial Sanctions (▇▇▇▇://▇▇.▇▇▇▇▇▇.▇▇/external_relations/cfsp/sanctions/list/version4/global/e_ctlview.html).