Agreement to fund expansion of Rochester, MI facility to support fill-finish manufacturing of both mRNA and adenovirus vaccines
DUBLIN, Nov. 17, 2021 /CNW/ -- Endo International plc (NASDAQ: ENDP) (Endo) today announced that its subsidiary, Par Sterile Products, LLC (Par Sterile), has entered into a cooperative agreement to expand its sterile fill-finish manufacturing production capacity and capabilities at its Rochester, Michigan plant to support the U.S. government's national defense efforts regarding production of critical medicines advancing pandemic preparation.
Under the terms of the agreement, Par Sterile's Rochester facility will establish a new sterile fill-finish manufacturing asset capable of processing liquid or lyophilized products requiring Biosafety Level (BSL) 2 containment. It will also provide expanded product inspection and packaging capacity as well as sterile fill-finish manufacturing services to the U.S. Government. Under the terms of the agreement, the U.S. government will fund approximately $90 million of the program's total expected cost of approximately $120 million.
"Endo strives to be a force for good, and we are proud to partner with the U.S. government in its efforts to expand and accelerate domestic manufacturing in support of future pandemic preparedness," said Blaise Coleman, President and CEO of Endo. "This collaboration underscores our longstanding history as a U.S. manufacturer of high-quality medicines."
The agreement is a result of efforts defined under the Defense Production Act to address vulnerabilities in critical product supply chains and strengthen the advancement of manufacturing and on-shoring of domestic essential medicines production.
The Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Assisted Acquisition team in partnership with Army Contracting Command– Aberdeen Proving Ground (ACC - APG) – COVID Response are the awarding and administering acquisition offices. This work was supported by the ACC - APG – COVID Response, under the authority of 31 U.S.C. 6305 pursuant to Section 3101 of the American Rescue Plan Act (Public Law 117-2) and Title III of the Defense Production Act of 1950 (50 U.S.C. 4533) under Award No. W58P05-22-2-0001. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the JPEO-CBRND or ACC – APG – COVID Response.
Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statement
Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, the statements by Mr. Coleman and any statements relating to the manufacturing agreement, production capacity or capabilities, or the amount or timing of payments or costs. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this press release reflect Endo's current expectations of future events based on existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring; the timing, impact or results of any pending or future litigation, investigations or claims or actual or contingent liabilities, settlement discussions, negotiations or other adverse proceedings; our ability to satisfy judgments or settlements or pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes; our ability to refinance our indebtedness; a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs or repay indebtedness. The occurrence or possibility of any such result has caused us to engage, and may result in further engagement in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential corporate reorganization or restructuring involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives, corporate realignments or strategic partnerships. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission.
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