Stipulated Penalties Review Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for Stipulated Penalties under this CIA shall be: (a) whether Good Shepherd was in full and timely compliance with the obligations of this CIA for which OIG demands payment; and (b) the period of noncompliance. Good Shepherd shall have the burden of proving its full and timely compliance and the steps taken to cure the noncompliance, if any. OIG shall not have the right to appeal to the DAB an adverse ALJ decision related to Stipulated Penalties. If the ALJ agrees with OIG with regard to a finding of a breach of this CIA and orders Good Shepherd to pay Stipulated Penalties, such Stipulated Penalties shall become due and payable 20 days after the ALJ issues such a decision unless Good Shepherd requests review of the ALJ decision by the DAB. If the ALJ decision is properly appealed to the DAB and the DAB upholds the determination of OIG, the Stipulated Penalties shall become due and payable 20 days after the DAB issues its decision.
Stipulated Penalties for Failure to Comply with Certain Obligations As a contractual remedy, Indivior and OIG hereby agree that failure to comply with certain obligations as set forth in this CIA may lead to the imposition of the following monetary penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the following provisions. 1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) per obligation for each day Indivior fails to establish, implement or comply with any of the following obligations as described in Section III: (a) a Compliance Officer; (b) a Compliance Committee; (c) the NGC compliance obligations and the engagement of a Compliance Expert, the performance of a Compliance Program Review, and the preparation of a Compliance Program Review Report, as required by Section III.A.3; (d) the management certification obligations and the development and implementation of a written process for Certifying Employees, as required by Section III.A.4; (e) written Policies and Procedures; (f) the development of a written training plan and the training and education of Covered Persons and NGC members; (g) a risk assessment and mitigation process; (h) a Disclosure Program; (i) Ineligible Persons screening and removal requirements; (j) the Incentive Compensation Restriction and Financial Recoupment Programs; (k) notification of Government investigations or legal proceedings; (l) reporting of Reportable Events; (m) notification of written communications with FDA; (n) the FFMP; (o) the NPMP; (p) notification to HCPs and HCIs; and (q) posting of any Payment-related information. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to engage and use an IRO as required by Section III.E and Appendix B. 3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to timely submit (a) a complete Implementation Report or Annual Report, (b) a certification to OIG in accordance with the requirements of Section V, or (c) a complete response to any request for information from OIG. 4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day Indivior fails to submit any IRO Review report in accordance with the requirements of Section III.E and Appendix B. 5. A Stipulated Penalty of $1,500 for each day Indivior fails to grant access as required in Section VII. (This Stipulated Penalty shall begin to accrue on the date Indivior fails to grant access.) 6. A Stipulated Penalty of $50,000 for each false certification submitted by or on behalf of Indivior as part of its Implementation Report, any Annual Report, additional documentation to a report (as requested by OIG), or otherwise required by this CIA. 7. A Stipulated Penalty of $2,500 for each day Indivior fails to grant the IRO access to all records and personnel necessary to complete the reviews required by Section III.E and for each day Indivior fails to furnish accurate and complete records to the IRO, as required by Section III.E and Appendix A; and 8. A Stipulated Penalty of $1,000 for each day Indivior fails to comply fully and adequately with any obligation of this CIA. OIG shall provide notice to Indivior stating the specific grounds for its determination that Indivior has failed to comply fully and adequately with the CIA obligation(s) at issue and steps Indivior shall take to comply with the CIA. (This Stipulated Penalty shall begin to accrue 10 business days after the date Indivior receives this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which OIG has sought a Stipulated Penalty under Subsections 1- 7 of this Section.
Judgments; Penalties One or more fines, penalties or final judgments, orders or decrees for the payment of money in an amount, individually or in the aggregate, of at least Two Hundred Fifty Thousand Dollars ($250,000.00) (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) shall be rendered against Borrower by any Governmental Authority, and the same are not, within ten (10) days after the entry, assessment or issuance thereof, discharged, satisfied, or paid, or after execution thereof, stayed or bonded pending appeal, or such judgments are not discharged prior to the expiration of any such stay (provided that no Credit Extensions will be made prior to the satisfaction, payment, discharge, stay, or bonding of such fine, penalty, judgment, order or decree);