Commitments and Contingencies Disclosure [Text Block] | Note 8 . Commitments and Contingencies We are or may not one Abbreviated New Drug Application Litigations RELISTOR Subcutaneous Injection Paragraph IV Certifications - Mylan On or about October 6, 2015, November 20, 2015, December 22, 2015, December 23, 2015, four 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. 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 Litigation in the 2:17 06714 not 2:15 8180 Federal Circuit Appeal On May 25, 2018, On July 9, 2018, July 17, 2018, September 12, 2018. February 8, 2019, April 9, 2019. July 2, 2019. August 6, 2019. Paragraph IV Certification – Actavis On or about October 27, 2015, January 5, 2016, January 8, 2016, three Settlement Agreement - Actavis On May 25, 2018, No. 2:15 08180 No. 2:17 06714. 30 Under the Actavis 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. 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 Paragraph IV Certification - Par On or about July 15, 2017, District Court Actions Progenics, Salix, Bausch, and Wyeth filed suit against Par Sterile Products, Par Pharmaceutical, Inc. (“Par Pharmaceutical” and, together with Par Sterile, “Par”), 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, Par Pharmaceutical, 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 - Par On May 10, 2018, No. 17 06449 The Par 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 Par Agreement. Plaintiffs and Par have further acknowledged and agreed that the 30 Under the Par 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 “Par 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 RELISTOR 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, 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, 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 four May 6, 2019 May 9, 2019. July 17, 2019, No. 8,524,276 No. 209615 may not No. 8,524,276. Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd. in the District of New Jersey on June 13, 2019 ( 2:19 13722 No. 10,307,417 2:19 13722 not 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 May 11, 2017, EP2368553 June 28, 2017, EP1615646 July 4, 2017, EP2368554 EP1615646 September 22, 2020. not EP2368553 EP2368554. For each of the above-described proceedings, we and Bausch continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between Progenics and Bausch, Bausch has the first We are or may PSMA- 617 German District Court Litigation We announced a lawsuit and associated worldwide patent ownership dispute based on our claims to certain inventions related to PSMA- 617, On November 8, 2018, 617 617, February 27, 2019, On November 27, 2018, 3 038 996 A1 14 799 340.6 18 172 716.5, EP18 184 296.4, 18 203 547.7 December 10, 2018, November 27, 2018. December 20, 2018, 15/131,118; 16/038,729 16/114988 On February 27, 2019, two €416, 000 August 6, 2019 August 6, first |