| Item 1.01 | Entry into a Material Definitive Agreement. |
On September 17, 2018, a subsidiary of Horizon Pharma plc (the “Horizon Subsidiary”) entered into a Settlement and License Agreement (the “Settlement Agreement”) with Par Pharmaceutical, Inc. (“Par”) relating to RAVICTI® (glycerol phenylbutyrate) Oral Liquid, 1.1 gm/mL. Specifically, the Settlement Agreement pertains toon-going patent infringement litigation against Par in the U.S. District Court for the District of New Jersey and the District of Delaware (the “Litigation”) and petitions forinter partes review with the Patent Trial and Appeal Board with respect to certain U.S. patents covering RAVICTI (the “IPRs”). In the Litigation, the Horizon Subsidiary has alleged that a generic version of RAVICTI, for which Par is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (“ANDA”), infringes certain U.S. patents that are owned by the Horizon Subsidiary.
The parties have agreed to file stipulations of dismissal with the courts regarding the Litigation and a joint request for termination in the IPRs. The Settlement Agreement also provides for a full settlement and release by each party of all claims that relate to Par’s generic version of RAVICTI or the Litigation or the IPRs.
Under the Settlement Agreement, the Horizon Subsidiary granted Par anon-exclusive, perpetual, royalty-free license to manufacture and commercialize Par’s generic version of RAVICTI in the United States after the License Effective Date (as defined below) and to take steps necessary to develop inventory of, and prepare to commercialize, Par’s generic version of RAVICTI during certain limited periods prior to the License Effective Date.
Under the Settlement Agreement, the License Effective Date is July 1, 2025; however, Par may be able to enter the market earlier in certain circumstances.
The Horizon Subsidiary also agreed not to sue or assert any claim against Par for infringement of any patent or patent application owned or controlled by the Horizon Subsidiary during the term of the Settlement Agreement based on the manufacture, use, sale, offer for sale, or importation of Par’s generic version of RAVICTI in the United States. In turn, Par agreed not to challenge the validity or enforceability of the licensed patents.
The foregoing description of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the agreement, which will be filed, with confidential terms redacted, with the U.S. Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form10-Q for the quarter ending September 30, 2018.
Par was the first entity to file an ANDA with respect to RAVICTI. As previously disclosed, the Horizon Subsidiary entered into a Settlement and License Agreement with Lupin Ltd. and Lupin Pharmaceuticals, Inc., the other entities to file an ANDA with respect to RAVICTI, on June 27, 2018.
Forward-Looking Statements
This report contains forward-looking statements, including statements regarding the anticipated results and actions to be taken under the Settlement Agreement. These forward-looking statements are based on management’s expectations and assumptions as of the date of this report and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to risks regarding whether regulatory authorities challenge the enforceability of or seek to enjoin the entry into the Settlement Agreement, whether the courts will grant orders dismissing the Litigation, whether the IPRs will be terminated following the parties’ joint request for termination, whether additional third parties may seek to market generic versions of RAVICTI and the results of any litigation that Horizon Pharma plc files to defend and/or assert its patents against such third parties. For a further description of these and other risks facing Horizon Pharma plc, please see the risk factors described in Horizon Pharma plc’s filings with the U.S. Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this report and Horizon Pharma plc undertakes no obligation to update or revise these statements, except as may be required by law.
