Commitments and Contingencies Disclosure [Text Block] | Note 8 . Commitments and Contingencies Consulting Agreement On March 4, 2020, March 27, 2020 May 15, 2020 July 1, 2020, $180,000 not Legal Proceedings We are or may not one Abbreviate d New Drug App lication Litigations RELISTOR Subcutaneous Injection Paragraph IV Certifications - Mylan On or about October 6, 2015, November 20, 2015, December 22, 2015, December 23, 2015, four Paragraph IV Certification – Actavis 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 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 May 16, 2018, 15 8180 17 6714 The 2:17 06714 2:17 07206 2:17 06714 2:17 06714 not 2:15 8180 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 ® first No. 021964 ® ® first third 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. February 4, 2020. April 8, 2020, May 8, 2020. April 22, 2020, June 22, 2020. 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 Federal Circuit Appeal Actavis filed an appeal of the District Court decision with the Court of Appeals for the Federal Circuit on August 13, 2019. February 6, 2020. July 17, 2020. 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. EP2368554 EP2368553, March 9 March 10, 2020, March 9, 2020, November 18, 2020 EP2368554 November 17, 2020 EP2368553. 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, 3038996 A1 14799340.6 18172716.5, 18184296.4, 18203547.7 December 10, 2018, November 27, 2018. December 20, 2018, 15/131,118; 15/805,900; 16/038,729 16/114,988 November 12, 2019, February 21, 2020, December 20, 2018, 16/551,198 16/510,495. March 6, 2020, 16/551,198 16/510,495 On February 27, 2019, €416,000 February 28, 2019, August 6, 2019 first October 1, 2019 January 31, 2020 April 8, 2020. 2020. Third Party Patents Post-Grant Review of U.S. Patent No. 10,112,974 On July 29, 2019 No. 10,112,974 ‘974 ‘974 1 15 31 On August 13, 2019, three 3 not January 29, 2020, ‘974 April 22, 2020 March 13, 2020, 1 5, 7, 9, 13 15 31. April 27, 2020, 6, 8, 10 12 not Litigation Related to the Merger Six lawsuits - four two November 12, 2019 no March 16, 2020 March 19, 2020. On November 22, 2019, Johnson v. Progenics Pharmaceuticals, Inc., et al. No. 1:19 02183, 10 Johnson I March 5, 2020, Johnson I November 25, 2019, second Thompson v. Progenics Pharmaceuticals, Inc., et al. No. 1:19 02194, 10 Thompson March 10, 2020, Thompson November 26, 2019, third Wang v. Progenics Pharmaceuticals, Inc., et al. No. 1:19 10936, 10 Wang December 9, 2019, fourth Michael A. Bernstein IRA v. Progenics Pharmaceuticals, Inc. et al. No. 2:19 21200, 10 Bernstein IRA April 21, 2020 Bernstein IRA May 6, 2020, Bernstein IRA No. 1:20 03521. December 12, 2019, fifth Pill v. Progenics Pharmaceuticals, Inc., et al. No. 1:19 02268, March 10, 2020. December 20, 2019, sixth Hess v. Progenics Pharmaceuticals, Inc., et al. No. 1:19 11683, 10 Hess April 8, 2020, Hess On April 2, 2020, seventh Goldstone v. Progenics Pharmaceuticals, Inc., et al. No. 1:20 02750, 10 Goldstone April 6, 2020, Johnson Johnson v. Progenics Pharmaceuticals, Inc., et al. No. 1:20 02847, 10 Johnson II April 8, 2020, eighth Krueger v. Progenics Pharmaceuticals, Inc., et al. No. 1:20 02913, 10 Krueger The complaints in the Wang Bernstein IRA Hess Goldstone Johnson II Krueger 14 20 17 244.100 14a 9 November 12, 2019 March 16, 2020, March 19, 2020. Goldstone In addition, by letter dated October 14, 2019, 220 may Whistleblower Complaint In July 2019, 806 2002 March 2020, not 180 May 26, 2020. |