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Home»Marketing»Endo reaches settlement with U.S. Department of Justice regarding traditional marketing of Opana® ER
Marketing

Endo reaches settlement with U.S. Department of Justice regarding traditional marketing of Opana® ER

The Elite Times TeamBy The Elite Times TeamFebruary 29, 2024No Comments8 Mins Read
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With this resolution, Endo prepares to complete its financial restructuring Positioning for sustained success

dublin, February 29, 2024 /PRNewswire/ — Endo International plc (OTC: ENDPQ) (“Endo” or the “Company”) today announced that its subsidiary, Endo Health Solutions Inc. (“EHSI”) announced that they had agreed to resolve the issue. Department of Justice (“DOJ”) investigation into his EHSI and other Company subsidiaries related to certain legacy marketing of Opana;® E.R.We have voluntarily discontinued sales of Opana® In 2016, we offered ER directly to U.S. healthcare providers and discontinued sales of Opana® ER in 2017.

Payments made in connection with the Department of Justice resolution will be made in accordance with the previously disclosed in-principle Global Economic Settlement, which also resolves claims from the Internal Revenue Service. This is included in the company’s originally submitted proposed restructuring plan. December 19, 2023.

As part of the Department of Justice resolution, EHSI agreed to plead guilty to a single strict liability misdemeanor misrepresentation violation of the Federal Food, Drug, and Cosmetic Act related to certain Opana products.® ER marketing that occurs between April 2012 and May 2013. EHSI also agreed to resolve a Department of Justice civil investigation into Opana’s sales and marketing® E.R. The civil settlement does not include any admission of liability or wrongdoing by EHSI. We have cooperated with the Department of Justice’s investigations.

Since 2013, Endo has actively strengthened its U.S. compliance program by adopting new policies, enhancing other policies, and developing additional training and risk management procedures. Additionally, the Company agreed to a voluntary cease and desist order in April 2016 as part of the restructuring process. November 2022 it lasts forever August 2030. We remain committed to operating our business with integrity and maintaining a culture of compliance and ethics. The Department of Justice’s resolution does not impose any additional compliance-related or integrity obligations on post-emergence purchaser organizations.

Endo has submitted the Justice Department resolution to the bankruptcy court for approval, and Endo is seeking approval along with the proposed restructuring plan.A public hearing is currently scheduled to consider approval of the proposed rehabilitation plan. March 19, 2024. Endo’s financial restructuring documents can be accessed at https://restructuring.ra.kroll.com/endo.

About Endo International PLC

Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best lives through the delivery of high-quality, life-enhancing treatments. Our decades of proven success are driven by passionate team members around the world who work together to advance treatments. Together, we boldly transform insights into treatments that work when and for the people who need them. For more information, please visit www.endo.com or contact us on LinkedIn.

Notes on trading our securities

The Company continues to face certain risks and uncertainties that affect its business and operations, and these risks and uncertainties may affect the Company’s ability to enter into or propose a sale transaction. Our ability to complete our restructuring plans may be affected and our results of operations may be affected.Voluntary Petition for Relief Under Chapter 11 of the Bankruptcy Code US Southern District Bankruptcy Court new york (collectively, “Chapter 11 Filings”). Holders of our stock are likely to receive little or no recovery on their investments, and recovery to other interested parties cannot be determined at this time. The Company cautions that trading in the Company’s securities in light of its pending Chapter 11 filing is highly speculative and involves significant risks. The trading price of our securities may have little or no relationship to the value, if any, actually realized by the holders of our securities in our Chapter 11 filing. Accordingly, we urge you to exercise extreme caution in making existing and future investments in our securities.

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. This includes, but is not limited to, statements regarding Department of Justice resolutions. Chapter 11 Filings, Bankruptcy Court Reviews or Approvals, Continued Compliance Obligations, and Other Statements that Address Expectations, Estimates, or Expected Future Results or Relate to Not Only Historical Facts. “believe”, “expect”, “anticipate”, “intend”, “estimate”, “plan”, “will”, “may”, “look forward to”, “guide” Statements that include words or phrases such as “,” “future,” “potential,” or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect our current views as of the date of this communication regarding our plans, intentions, expectations, strategies and prospects and reflect currently available information and assumptions made by us. It is based on. Actual results could differ materially and adversely from current expectations based on a number of factors, including, among other things: the results of our restructuring activities; the timing, impact or outcome of pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust matters; Actual or Contingent Liabilities. Settlement discussions or negotiations. our liquidity, financial performance, cash position and business operations; risks and uncertainties associated with Chapter 11 proceedings; the adverse impact on our business as a result of filing for and operating under Chapter 11 protection; the time, conditions, or ability to obtain and complete the sale of our business under Section 363 of the U.S. Bankruptcy Code or the approval of any proposed plan of reorganization; the adequacy of capital resources for our business and the difficulty in predicting the liquidity needed to operate our business; the unpredictability of our financial results during the Chapter 11 proceeding; our ability to discharge claims in Chapter 11 proceedings; negotiations with holders of our debt, trade creditors and other significant creditors; risks and uncertainties in performing under restructuring support agreements and other arrangements with lenders or creditors during Chapter 11 proceedings; our ability to conduct business as usual; our ability to continue to provide our services at the high levels of service and performance that our customers, suppliers and other business partners expect from us; our ability to control costs during Chapter 11 proceedings; adverse litigation. the risk that a Chapter 11 action will be converted into a Chapter 7 action under the Bankruptcy Code; our ability to secure working capital; our ability to take advantage of opportunities to acquire assets with upside potential; the effects of competition, including loss of exclusivity and general competition; our ability to satisfy judgments and settlements or pursue appeals, including bond requirements; our ability to adapt to changing market conditions; our ability to attract and retain key personnel; inability to maintain compliance with financial covenants and operating obligations; our ability to incur additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions, general corporate or other purposes; Ability to refinance debt. A significant decrease in our short-term or long-term revenues could result in our inability to fund our operations or our liquidity needs or to service our debt. supply chain interruptions or difficulties; changes in competitive or market conditions; changes in laws or regulatory developments; our ability to obtain and maintain adequate protection of our intellectual property rights; the timing and uncertainty of the results of both research and development and regulatory processes, including regulatory decisions, product recalls, recalls and other unusual items; domestic and international health care and cost containment reforms, including government pricing, tax, and reimbursement policies; technological advances and patents obtained by competitors; performance, including the approval, introduction, consumer and physician acceptance of new products and the continued acceptance of currently marketed products; our ability to integrate newly acquired products into our portfolio and achieve our financial or commercial expectations; the impact of known and unknown side effects on market perceptions and consumer preferences for our products; the effectiveness of advertising and other promotional campaigns; Timely and successful implementation of strategic initiatives. Adverse publicity regarding opioid misuse. uncertainties related to the identification and success and execution of external corporate development initiatives and strategic alliance transactions; our ability to continue to advance our strategic priorities, develop our product pipeline and develop product markets; and our ability to obtain, manufacture, maintain and distribute products in sufficient quantities to meet market demand in a timely manner. In addition, the impact of U.S. and international economic conditions may have an impact. materially affect our results. Accordingly, readers are cautioned not to rely on these forward-looking statements. The Company expressly disclaims any intention or obligation to update these forward-looking statements, except as required by law.

Additional information regarding risk factors, including those referenced above, may be found in press releases issued by the Company and periodic filings the Company makes with the Securities and Exchange Commission (the “SEC”) and securities regulatory authorities. I am. CanadaThis includes discussions under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q or other filings with the SEC. will appear.

media contact

Daniel Junger / Richard Goldman / Ruth Pacman
Kext CNC
[email protected]

SOURCE Endo International plc

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