LEGAL PROCEEDINGS
+Added: May 2020 Letter from the Committee on Oversight and Reform of the U.S.
+Added: House of Representatives
+Added: On May 4, 2020, Jaguar Health, Inc.
+Added: received a letter from the Committee on Oversight and Reform of the U.S.
+Added: House of Representatives (the “Committee”) regarding the list price adjustment of Mytesi.
+Added: Among other things, the Committee expressed an interest in understanding whether the price adjustment was connected to the Company’s expectation that it could market crofelemer to treat coronavirus patients given the Company’s submission of a request to the U.S.
+Added: Food and Drug Administration for Emergency Use Authorization (“EUA”) for crofelemer for the symptomatic relief of diarrhea and other gastrointestinal symptoms in patients with COVID-19 and for patients with COVID-19 who have diarrhea associated with certain antiviral treatments, which submission was denied by the FDA on April 7, 2020 as previously disclosed.
+Added: The Company has cooperated with the Committee’s inquiry and has prepared a public statement regarding the price adjustment, which is available on the Company’s website at https://jaguarhealth.gcs-web.com/company-statement.
+Added: In its statement, the Company explains that the decision to adjust the price for crofelemer was made in December 2019 as part of expanding the Company’s comprehensive patient access program, and had the Company received EUA, it would have deferred the price adjustment until after the emergency use period ended.
July 2017 Complaint Relating to the Merger
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333 217364) declared effective by the Commission on July 6, 2017 related to the solicitation of votes from shareholders to approve the merger and certain transactions related thereto.
−Removed: The Company accepted service of the complaint and summons on behalf of itself and the United States-based director Defendants on November 1, 2017.
−Removed: The Company has not accepted service on behalf of, and Plaintiff has not yet served, the non-U.S.-based director Defendants.
−Removed: By order dated September 20, 2018, the court dismissed the lawsuit for failure to state a claim.
−Removed: Plaintiff was entitled to amend that complaint within 20 days from the date of dismissal.
−Removed: On October 10, 2018, Plaintiff filed a second amended complaint to focus on the Company’s commercial strategy in support of Equilevia and the related disclosure statements in the Form S-4 described above.
−Removed: On November 6, 2018, the Defendants moved to dismiss the second amended complaint.
−Removed: The court denied the Defendants’ motion to dismiss on June 28, 2019.
−Removed: The Company answered the second amended complaint on August 2, 2019;
−Removed: the answer denied the material allegations of the second
−Removed: amended complaint.
Following the completion of document discovery, the parties engaged in a mediation that resulted in an agreement in principle to settle the litigation on a class-wide basis for $2.6 million, subject to court approval.
−Removed: Plaintiff filed a motion for preliminary approval of the proposed settlement on December 30, 2020.
−Removed: The court preliminarily approved the proposed settlement, and authorized Plaintiff to provide settlement class members with notice of the proposed settlement, in an order dated February 2, 2021.
−Removed: The final settlement approval hearing is currently scheduled for May 27, 2021.
−Removed: Assuming that the court gives final approval to the proposed settlement following the final settlement approval hearing, the entire settlement consideration will be provided by the Company’s director and officer liability insurance carrier.
−Removed: May 2020 Letter from the Committee on Oversight and Reform of the U.S.
−Removed: House of Representatives
−Removed: On May 4, 2020, Jaguar Health, Inc.
−Removed: received a letter from the Committee on Oversight and Reform of the U.S.
−Removed: House of Representatives (the “Committee”) regarding the list price adjustment of Mytesi.
−Removed: Among other things, the Committee expressed an interest in understanding whether the price adjustment was connected to the Company’s
−Removed: expectation that it could market crofelemer to treat coronavirus patients given the Company’s submission of a request to the U.S.
−Removed: Food and Drug Administration for Emergency Use Authorization (“EUA”) for crofelemer for the symptomatic relief of diarrhea and other gastrointestinal symptoms in patients with COVID-19 and for patients with COVID-19 who have diarrhea associated with certain antiviral treatments, which submission was denied by the FDA on April 7, 2020 as previously disclosed.
−Removed: The Company intends to cooperate with the Committee’s inquiry and has prepared a public statement regarding the price adjustment, which is available on the Company’s website at https://jaguarhealth.gcs-web.com/company-statement.
−Removed: In its statement, the Company explains that the decision to adjust the price for crofelemer was made in December 2019 as part of expanding the Company’s comprehensive patient access program, and had the Company received EUA, it would have deferred the price adjustment until after the emergency use period ended.
+Added: On May 27, 2021, the court gave the final approval to the proposed settlement and the entire settlement consideration was provided by the Company’s director and officer liability insurance carrier.
+Added: Under the loss recovery model in ASC 450 and in reference to ASC 410, the ultimate net income effect of the recognized loss and the insurance proceeds directly related to the recognized loss is zero.
+Added: As of December 31, 2021 and 2020, the Company concluded not to record any loss contingency and insurance recovery.
Other than as described above, there are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition or cash flows.
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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.