Endo Announces Agreement to Resolve Federal Trade Commission Investigation and Litigation

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Jan 23, 2017, 13:17 ET

No Admission of Wrongdoing

No Monetary Payment by Endo

Covenants Relating to Patent Infringement Settlements Consistent with Current Endo and Industry Practices

DUBLIN, Jan. 23, 2017 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) and the U.S. Federal Trade Commission (FTC) today filed a joint motion in the U.S. District Court for the Northern District of California seeking the entry of a ten-year Stipulated Order for Permanent Injunction. The Stipulated Order resolves all disputes between the FTC and Endo relating to the patent infringement settlements Endo entered into in connection with its Opana® ER and Lidoderm® products. It also resolves the FTC's claims against Endo's subsidiary Par Pharmaceutical Companies, Inc. in the action FTC v. Actavis, Inc., et al. pending in the U.S. District Court for the Northern District of Georgia.

The FTC first asserted claims against Endo and certain generics manufacturers relating to the Opana® ER and Lidoderm® patent settlements in March 2016. The FTC's complaint, filed in the U.S. District Court for the Eastern District of Pennsylvania, alleged that certain aspects of the Opana® ER and Lidoderm® settlements constituted unfair methods of competition in violation of federal law and sought injunctive and declaratory relief, as well as other remedies including restitution and disgorgement. The FTC voluntarily dismissed its lawsuit in October 2016 but stated its intention to refile elsewhere. Endo subsequently filed declaratory judgment actions against the FTC in the U.S. District Court for the Eastern District of Pennsylvania seeking rulings on, among other things, whether the FTC has the statutory authority to initiate litigation against Endo in federal court with respect to the settlements and whether the FTC is able to seek disgorgement. The FTC today re-filed claims against Endo and other defendants in the U.S. District Court for the Northern District of California and also filed the Stipulated Order dismissing the claims against Endo.

Under the Stipulated Order, Endo will make no monetary payment to the FTC and will dismiss its claims in the declaratory judgment actions. The FTC has agreed that the prior dismissal of its claims against Endo in the U.S. District Court for the Eastern District of Pennsylvania will be treated as being with prejudice, that it will bring no other claims against Endo arising from the Opana® ER and Lidoderm® settlements and that it will also dismiss with prejudice its claims against Par in FTC v. Actavis, Inc., et al.

Endo made no admission of liability in the Stipulated Order and agreed to certain covenants relating to the future settlement of patent infringement litigation for a period of 10 years. These covenants, which are consistent with Endo's current practices in settling patent infringement cases, include a prohibition on agreements that prevent the marketing of authorized generic products or that involve payments to generics manufacturers in connection with delaying the market entry of their products. The Stipulated Order also requires the FTC to consider in good faith any requested modifications proposed by Endo in the event of a material change in the law governing the antitrust implications of patent infringement settlements.

"Endo is extremely pleased with the FTC settlement. We believe the absence from the Stipulated Order of any requirement that Endo make payment to the FTC, as well as the absence of any admissions of liability by Endo, are consistent with the Company's position that the Lidoderm® and Opana® ER settlements fully complied with the law both at the time they were executed and today," said Matthew J. Maletta, Executive Vice President, Chief Legal Officer, Endo. "We further believe that the covenants in the Stipulated Order relating to future patent infringement settlements align with how Endo currently approaches such settlements and with general pharmaceutical industry practices following the U.S. Supreme Court's 2013 decision in FTC v. Actavis."

About Endo International plc
Endo International plc (NASDAQ / TSX: ENDP) is a global specialty pharmaceutical company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements," including, but not limited to, the statements by Mr. Maletta, as well as Endo's expected, estimated or anticipated future results. Because forecasts are inherently estimates that cannot be made with precision, Endo's performance at times differs materially from its estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo. All forward-looking statements in this press release reflect Endo's current analysis of existing trends and information and represent Endo's judgment only as of the date of this press release. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations and projections. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Endo's periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval ("SEDAR"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. Additional information about Endo is available on the World Wide Web at www.endo.com or you can contact the Endo Investor Relations department by calling (484) 216-0000.

SOURCE Endo International plc