4 unchanged sentences
In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations.
−Removed: As of June 30, 2020, the Company had the following material ongoing litigation to which the Company was a party:
+Added: As of September 30, 2020, the Company had the following material ongoing litigation to which the Company was a party:
RELISTOR Subcutaneous Injection
−Removed: Between November 19, 2015 and September 18, 2017, Progenics, Salix, Valeant (now Bausch) and Wyeth filed multiple lawsuits against Mylan Pharmaceuticals and certain of its affiliates (collectively, “Mylan”) in the United States District Court for the District of New Jersey for infringement of certain U.S.
+Added: Between November 19, 2015 and September 18, 2017, Progenics, Salix, Valeant (now Bausch) and Wyeth filed multiple lawsuits against Mylan Pharmaceuticals and certain of its affiliates (collectively, “Mylan”) in the United States District Court for the District of New Jersey (the “Court”) for infringement of certain U.S.
patents based upon Mylan’s filing of multiple ANDAs seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of those patents expire.
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As a result, trial on the merits in the lead action was adjourned, allowing trial, if necessary, to be consolidated with the lagging, second action.
−Removed: Fact discovery has concluded in the lagging case, but deadlines for expert discovery have not yet been set.
+Added: On August 20, 2020, the parties agreed to dismiss all claims, affirmative defenses, and counterclaims in the lagging action and proceed to a full trial on the merits for the patents asserted in the lead action.
+Added: A date for trial has not yet been set.
On May 25, 2018, Mylan filed a Notice of Appeal to the United States Court of Appeals for the Federal Circuit (“CAFC”).
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Between December 6, 2016 and December 8, 2017, Progenics, Salix, Bausch, and Wyeth filed suit against Actavis, Actavis LLC, Teva Pharmaceuticals USA, Inc., and Teva Pharmaceuticals Industries Ltd.
−Removed: (collectively, “Actavis”) in the United States District Court for the District of New Jersey for infringement of certain U.S.
+Added: (collectively, “Actavis”) in the Court for infringement of certain U.S.
patents based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of those patents expire.
−Removed: The actions were later consolidated into a single action in the District of New Jersey.
+Added: The actions were later consolidated into a single action in the Court.
On May 6-9, 2019, a bench trial was held, and on July 17, 2019, the Court issued an Order finding the asserted claims of a certain U.S.
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Actavis’s opening brief was filed February 6, 2020.
−Removed: The deadline for Plaintiffs to file their responsive brief is currently September 15, 2020.
−Removed: On June 13, 2019, Progenics, Salix, Bausch, and Wyeth filed another suit against Actavis in the United States District Court for the District of New Jersey for infringement of a separate, and at that time, recently granted U.S.
+Added: The Plaintiffs filed their responsive brief on September 15, 2020.
+Added: Actavis’s reply brief is currently due on November 5, 2020.
+Added: On June 13, 2019, Progenics, Salix, Bausch, and Wyeth filed another suit against Actavis in the Court for infringement of a separate, and at that time, recently granted U.S.
patent based upon Actavis’s filing of an ANDA seeking to obtain approval to market a generic version of RELISTOR tablets before this patent expires.
−Removed: Litigation in this action is underway, and fact discovery has not yet begun.
+Added: Litigation in this action is underway, and fact discovery has begun.
RELISTOR European Opposition Proceedings
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Each of these matters are on appeal with the European Patent Office.
−Removed: Oral proceedings are set to occur on September 22, 2020, November 17, 2020 and November 18, 2020.
+Added: Oral proceedings for EP1615646 were held on September 22, 2020.
+Added: The decision under appeal was set aside and the case was remitted to the opposition division for further prosecution.
+Added: Oral proceedings are set to occur on November 17, 2020 and November 18, 2020 for EP2368553 and EP2368554, respectively.
For each of the above-described RELISTOR proceedings, Progenics 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 right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement.
−Removed: Because the outcome of litigation is uncertain
−Removed: and in these RELISTOR proceedings the Company does not control the enforcement of the intellectual property rights at issue, no assurance can be given as to how or when any of these RELISTOR proceedings will ultimately be resolved.
+Added: Because the outcome of litigation is uncertain and in these RELISTOR proceedings the Company does not control the enforcement of the intellectual property rights at issue, no assurance can be given as to how or when any of these RELISTOR proceedings will ultimately be resolved.
German PSMA-617 Litigation
−Removed: On November 8, 2018, Molecular Insight Pharmaceuticals, Inc., a subsidiary of Progenics (“MIP”), filed a complaint against the University of Heidelberg (the “University”) in the District Court of Mannheim in Germany.
+Added: On November 8, 2018, Molecular Insight Pharmaceuticals, Inc., a subsidiary of Progenics (“MIP”), filed a complaint against the University of Heidelberg (the “University”) in the District Court of Mannheim in Germany (the “German District Court”).
In this Complaint, MIP claimed that the discovery and development of PSMA-617 was related to work performed under a research collaboration sponsored by MIP.
−Removed: MIP alleged that the University breached certain contracts with MIP and that MIP is the co-owner of inventions embodied in certain worldwide patent filings related to PSMA-617 that were filed by the University in its own name.
+Added: MIP alleged that the University breached certain contracts with MIP and that MIP is the co-owner of inventions embodied in certain worldwide patent filings related to PSMA-617 that were filed by the University.
On February 27, 2019, Endocyte, Inc., a wholly owned subsidiary of Novartis AG, filed a motion to intervene in the German litigation.
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On March 6, 2020, MIP filed with the USPTO a notice stating that the Power of Attorney in certain pending US patent applications was signed by less than all applicants or owners of the applications.
−Removed: On February 27, 2019, the German District Court set € 0.4 million as the amount MIP must deposit with the Court as security in the event of an unfavorable final decision on the merits of the dispute.
−Removed: The Court held the first oral hearing in the case on August 6, 2019.
−Removed: The Court considered procedural matters and granted the parties the right to make further submissions.
−Removed: A further oral hearing occurred July 23, 2020, during which the Court heard live testimony from several witnesses.
−Removed: Progenics is vigorously enforcing its rights in this German proceeding.
−Removed: Because Progenics is the plaintiff, if unsuccessful in this proceeding, Progenics may also have liability for Court fees and fees and disbursements of defendant’s and intervenor’s counsel, such fees and disbursements to be at least partially covered by the aforementioned cash security deposited with the Court.
−Removed: Because the outcome of litigation is uncertain, no assurance can be given as to how or when this German proceeding will ultimately be resolved.
−Removed: Litigation Related to the Merger
−Removed: Nine purported stockholders of Progenics filed ten lawsuits alleging, among other things, that Progenics and the members of the Progenics Board of Directors violated Sections 14(a) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and 17 C.F.R.
−Removed: § 244.100 and Rule 14a-9 promulgated under the Exchange Act, by misstating or omitting certain allegedly material information in the S-4 Registration Statement filed with the Securities and Exchange Commission (“SEC”) on November 12, 2019, the amended S-4 Registration Statement filed with the SEC on March 16, 2020, and/or the Schedule 14A proxy statement filed with the SEC on March 19, 2020 related to the Merger.
−Removed: Two of the actions alleged that the Company and Plato Merger Sub, Inc.
−Removed: (“Merger Sub”) violated Section 14(a) and/or Section 20(a) of the Exchange Act.
−Removed: One of the actions further alleged that the members of the Progenics Board breached their fiduciary duties of care, loyalty and good faith to the stockholders of Progenics related to the Merger, that Progenics, the Company and Merger Sub aided and abetted such breaches of fiduciary duty, and that the Company and Merger Sub violated Section 14(a) of the Exchange Act.
−Removed: All such lawsuits have been voluntarily dismissed, with the last of the cases dismissed on June 23, 2020.
+Added: On February 27, 2019, the German District Court set €0.4 million as the amount MIP must deposit with the German District Court as security in the event of an unfavorable final decision on the merits of the dispute.
+Added: The German District Court held the first oral hearing in the case on August 6, 2019.
+Added: The German District Court considered procedural matters and granted the parties the right to make further submissions.
+Added: A further oral hearing occurred July 23, 2020, during which the German District Court heard live testimony from several witnesses, testifying on behalf of the defendants.
+Added: On August 24, 2020, the German District Court issued its decision dismissing MIP’s claims, stating that MIP failed to discharge its burden of proof in the matter.
+Added: On September 24, 2020, MIP filed a Notice of Appeal of the German District Court’s decision.
+Added: MIP is also considering its legal and procedural alternatives against the defendants in other jurisdictions and proceedings.
+Added: If MIP is not successful in its appeal, it will be responsible for German District Court fees and fees and disbursements of defendant’s and intervenor’s counsel, both at first instance and on appeal.
+Added: Most of such fees and disbursements at first instance are covered by the aforementioned cash security deposited with the German District Court.
+Added: Because the outcome of litigation is uncertain, we cannot predict how or when this matter will ultimately be resolved.
Whistleblower Complaint
7 unchanged sentences
The DOL action has been dismissed and the matter will proceed in federal district court.
−Removed: Progenics’ Answer to the Complaint is presently due by August 26, 2020.
+Added: Progenics filed an answer to Dr.
+Added: Mahmood’s complaint on August 26, 2020 and the initial pre-trial conference was held on September 16, 2020.
The Company believes the claims in this matter are without merit, and the Company has meritorious defenses to the claims.
1 unchanged sentence
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.