Item 7.01. FD Regulation Disclosure.
As stated earlier, on
and its affiliates debtors under Chapter 11 of the Bankruptcy Code. Also, as mentioned earlier, on
Also, as mentioned earlier, on
The information contained in this Section 7.01, including Exhibit 99.1, is deemed to be “provided” and is not deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act 1934, as as amended (the “Stock Exchange Law”). , or otherwise subject to the responsibilities of this Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act 1933, as amended, or the Exchange Act.
Caution Regarding Forward-Looking Statements
Statements contained herein that are not strictly historical, including statements regarding future financial condition and results of operations, legal, economic, business, competitive and/or regulatory factors affecting Mallinckrodt’s business, and any other statement regarding events or developments which the company believes or anticipates or may occur in the future, may constitute “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on such forward-looking statements. These factors include risks and uncertainties relating to, among other things, the ability of Mallinckrodt and its subsidiaries to complete the plan, the effects of Chapter 11 matters, including increased professional expenses, liquidity, results operations and activities of Mallinckrodt and its subsidiaries; completion of the transactions contemplated by the Restructuring Support Agreement and the Plan, including settlements with OCC, UCC and holders of Mallinckrodt Second Lien Notes, financing required to fund certain distributions in under the plan and the ability of the parties to negotiate definitive agreements regarding matters covered by the related terms and conditions, whether related to such settlements, included in the restructuring support agreement, the plan or otherwise, the occurrence of events that may give rise to a right of either party to terminate the Restructuring Support Agreement, the Plan or any of the Settlements and to satisfy the other terms of the Restructuring Support Agreement , the plan and the regulations, including following the steps specified in the
restructuring support agreement; government inquiries and investigations, regulatory actions and lawsuits brought against Mallinckrodt by government agencies and private parties regarding its historical marketing of opioids, including the agreement set forth in the Plan for a comprehensive settlement to resolve all related claims opioids; potential delays in Mallinckrodt’s Chapter 11 process; the planned settlement with governmental parties to resolve certain disputes relating to Acthar Gel; the possibility that such settlement will not be consummated and the risks and uncertainties associated therewith, including the time and expense required to continue to litigate this dispute and the impact of this dispute on Mallinckrodt’s financial condition and performance expectations; the ability to maintain relationships with Mallinckrodt’s suppliers, customers, employees and other third parties as a result of Chapter 11 matters; the availability of working capital during the term of the Chapter 11 business, including events that could terminate Mallinckrodt’s right to continue to access cash collateral from Mallinckrodt’s lenders; the possibility that Mallinckrodt may not be able to achieve its business and strategic objectives even if the plan is successfully executed; the possibility of Mallinckrodt’s Chapter 11 cases being converted into Chapter 7 cases under the Bankruptcy Code; the potential termination of Mallinckrodt’s exclusive right to file a Chapter 11 plan; the non-discharge of certain claims against Mallinckrodt as part of the bankruptcy process; developing, funding and executing Mallinckrodt’s business plan and continuing to operate; Mallinckrodt’s post-bankruptcy capital structure; the ability and timing of satisfaction of the listing requirements of Mallinckrodt’s common stock on the NYSE and the NYSE’s approval of the listing application; scrutiny by governments, legislative bodies and law enforcement agencies regarding sales, marketing and pricing practices; pricing pressure on some of Mallinckrodt’s products due to legal changes or changes in insurers’ reimbursement practices resulting from recent heightened public scrutiny of healthcare and pharmaceutical costs; the impact of the COVID-19 coronavirus outbreak; the reimbursement practices of governmental health administration authorities, private insurers and other third-party payers; complex reporting and payment obligations under Medicare and Medicaid reimbursement programs and other government purchasing and reimbursement programs; cost containment efforts of customers, buying groups, third-party payers and governmental organizations; changes to or non-compliance with applicable laws and regulations; the ability of Mallinckrodt and its partners to successfully develop or commercialize new products or expand business opportunities; Mallinckrodt’s ability to manage price fluctuations; competition; the ability of Mallinckrodt and its partners to protect intellectual property rights; limited clinical trial data for Acthar Gel; clinical studies and related regulatory processes; losses related to product liability and other litigation liabilities; material health, safety and environmental responsibilities; potential indemnification liabilities to Covidien under the Separation and Distribution Agreement; business development activities; retention of key personnel; the effectiveness of the information technology infrastructure, including cybersecurity and data leakage risks; customer concentration; Mallinckrodt’s reliance on certain individual products that are material to its financial performance; Mallinckrodt’s ability to receive supply and production quotas granted by the
These and other factors are identified and further described in the “Risk Factors” section of Mallinckrodt’s most recent Annual Report on Form 10-K and other filings with the
Item 9.01. Financial statements and supporting documents.
Exhibit No. Description of Exhibit 99.1 Term Sheet, dated as of
May 20, 2022. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). 2
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