Commitments and Contingencies Disclosure [Text Block] | Note 8 . Commitments and Contingencies We are or may not one Abbreviated New Drug Application Litigations R ELISTOR Subcutaneous Injection - Mylan and Actavis Paragraph IV Certifications On or about October 6, 2015, November 20, 2015, December 22, 2015, December 23, 2015, four On or about October 27, 2015, January 5, 2016, January 8, 2016, three District Court Actions Progenics, Salix, Valeant (now Bausch Health Companies Inc., “Bausch”), and Wyeth filed suit against Mylan Pharmaceuticals, Inc. and Mylan Inc. in the District of New Jersey on November 19, 2015 ( 2:15 8180 8,247,425, 8,420,663, 8,552,025, 8,822,490 February 4, 2016, No. 9,180,125. January 4, 2016 ( 2:16 00035 8,247,425, 8,420,663, 8,552,025, 8,822,490 January 25, 2016, No. 9,180,125. September 1, 2017 ( 2:17 06714 No. 9,669,096 September 18, 2017, No. 9,492,445. Progenics, Salix, Bausch, and Wyeth filed suit against Actavis LLC, Actavis, Inc., Actavis Elizabeth LLC, and Allergan PLC fka Actavis PLC in the District of New Jersey on November 30, 2015 ( 2:15 08353 8,247,425, 8,420,663, 8,552,025, 8,822,490 February 18, 2016, No. 9,180,125. February 18, 2016 ( 2:16 00889 8,247,425, 8,420,663, 8,552,025, 8,822,490, 8,822,490 August 18, 2017 ( 2:17 07206 9,669,096 9,492,445 The 2:15 8180 2:16 00035 2:15 08353 2:16 00889 2:15 08180 May 1, 2018, 8 No. 8,552,025. May 23, 2018, 54 8 ’025 The 2:17 06714 2:17 07206 2:17 06714 2:15 8180 Settlement Agreement (Actavis) On May 25, 2018, No. 2:15 08180 No. 2:17 06714. 30 Under the Agreement, Plaintiffs grant Actavis a non-exclusive, royalty-free, non-transferable, non-sublicensable, limited license under the Patents-In-Suit to make, import, and sell each of the Actavis Products in the U.S. (the “License”) beginning on the earliest of (a) January 1, 2028; ( 21. 355 5 not 180 180 not not 180 181 third ® third not 180 first third ® 505 2 first No. 021964 ® ® first third Federal Circuit Appeal On May 25, 2018, On July 9, 2018, July 17, 2018, September 12, 2018. R ELISTOR Subcutaneous Injection - Par Paragraph IV Certification On or about July 15, 2017, District Court Actions Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, LLC, Par Pharmaceutical, Inc., and Endo International plc in the District of New Jersey on August 25, 2017 ( 2:17 06449 8,247,425, 8,420,663, 8,552,025, 8,822,490, 9,180,125, 9,669,096 Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, LLC, Par Pharmaceutical, Inc., and Endo International plc in the Southern District of New York on August 25, 2017 ( 1:17 06557 8,247,425, 8,420,663, 8,552,025, 8,822,490, 9,180,125, 9,669,096 November 30, 2017. Settlement Agreement On May 10, 2018, No. 17 06449 The Agreement provides for a full settlement and release by both Plaintiffs and Par of all claims that were or could have been asserted in the District Court Case and all resulting damages or other remedies. Plaintiffs and Par have agreed to and, in fact, filed a Stipulated Consent Judgment and Injunction after the execution of the Agreement. Plaintiffs and Par have further acknowledged and agreed that the 30 Under the Agreement, Plaintiffs grant Par a non-exclusive, royalty-free, non-transferable, non-sublicensable, limited license under the Patents-In-Suit to make, import, and sell the Par Products in the U.S., or make outside the U.S. solely for importation into the U.S. (the “License”) beginning on the earliest of (i) September 30, 2030; ( one hundred eighty-one 181 third 21. 355 5 ® third ® ® third not 180 first not one hundred fifty 150 R ELISTOR Tablets - Actavis Paragraph IV Certifications On or about October 24, 2016 October 24, 2017, two District Court Actions Progenics, Salix, Bausch, and Wyeth filed suit against Actavis Laboratories FL, Inc., Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on December 6, 2016 ( 2:16 09038 8,420,663, 8,524,276, 8,956,651, 9,180,125, 9,314,461 Progenics, Salix, Bausch, and Wyeth filed suit against Actavis Laboratories FL, Inc., Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on December 8, 2017 ( 2:17 12857 9,724,343 9,492,445 The 2:16 09038 2:17 12857 2:16 09038 European Opposition Proceedings In addition to the above described ANDA notifications, in October 2015, three EP1615646 September 24, 2015 EP2368553 September 29, 2015 September 30, 2015 EP2368554 September 24, 2015 On May 11, 2017, EP2368553 June 28, 2017, EP1615646 July 4, 2017, EP2368554 Progenics and Salix continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between Progenics and Salix, Salix has the first |