Legal Proceedings
+Added: From time to time we are subject to litigation and claims arising in the ordinary course of business including intellectual property and product liability litigation, but, except as stated below, we are not currently a party to any material legal proceedings and we are not aware of any other pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
Securities Class Action
2 unchanged sentences
District Court for the Southern District of New York against us and certain of our executive officers.
−Removed: The complaint alleges that the defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA and find that the materials minimized the risks or overstated the efficacy of the product.
+Added: The complaint alleges that the defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA (hydrogen peroxide) topical solution, 40% (w/w), or ESKATA, our non-marketed FDA-approved product, and find that the materials minimized the risks or overstated the efficacy of the product.
The complaint seeks unspecified compensatory damages on behalf of Rosi and all other persons and entities that purchased or otherwise acquired our securities between May 8, 2018 and June 20, 2019.
2 unchanged sentences
in the same court against the same defendants.
−Removed: On November 6, 2019, the court consolidated the Rosi and Fulcher actions, or together, the Consolidated Securities Action, and appointed Fulcher “lead plaintiff”
−Removed: for the putative class.
−Removed: On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming two additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness.
−Removed: The defendants’
−Removed: deadline to answer, move against or otherwise respond to the consolidated amended complaint is March 27, 2020.
−Removed: We and the other defendants dispute plaintiffs’
−Removed: claims in the Consolidated Securities Action and intend to defend the matter vigorously.
+Added: On November 6, 2019, the court consolidated the Rosi and Fulcher actions, or together, the Consolidated Securities Action, and appointed Fulcher “lead plaintiff” for the putative class.
+Added: On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming two additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness.
+Added: The defendants filed a motion to dismiss the consolidated amended complaint on April 17, 2020.
+Added: Fulcher filed an opposition to the defendants’ motion on June 15, 2020, and the defendants filed a reply to such opposition on August 4, 2020.
+Added: Oral argument on the pending motion to dismiss is scheduled for February 25, 2021.
+Added: The motion remains under judicial consideration.
+Added: We and the other defendants dispute plaintiffs’ claims in the Consolidated Securities Action and intend to defend the matter vigorously.
Stockholder Derivative Action
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Walker et al.
−Removed: District Court for the Southern District of New York against certain of our directors and executive officers.
+Added: District Court for the Southern District of New York against certain of our
+Added: directors and executive officers.
The complaint alleges that the defendants, among other things, breached their fiduciary duties as directors and/or officers in connection with the claims alleged in the Consolidated Securities Action.
5 unchanged sentences
Derivative Litigation , or the Consolidated Derivative Action, and directed that future derivative cases filed in or transferred to the court arising out of substantially the same transactions or events be similarly consolidated.
−Removed: Thereafter, on January 11, 2020, the court stayed –
−Removed: subject to certain conditions –
−Removed: all deadlines in the Consolidated Derivative Action pending resolution of the defendants’
−Removed: anticipated motion to dismiss the Consolidated Securities Action.
−Removed: The defendants dispute plaintiffs’
−Removed: claims in the Consolidated Derivative Action and intend to defend the matter vigorously.
−Removed: Patent Infringement
−Removed: On October 8, 2019, we, together with Allergan, Inc., filed a patent infringement lawsuit in the U.S.
−Removed: District Court for the District of Delaware against Taro Pharmaceuticals, Inc., or Taro, related to an ANDA that Taro filed with the FDA to market a generic version of RHOFADE.
−Removed: The lawsuit claims infringement of U.S.
−Removed: 7,812,049, 8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for RHOFADE.
−Removed: We received a Paragraph IV Notice Letter from Taro dated August 28, 2019, advising that Taro had submitted an ANDA to the FDA seeking approval from the FDA to manufacture and market a generic version of RHOFADE prior to the expiration of the Orange Book-listed patents.
−Removed: Under our agreement with EPI Health for the purchase of RHOFADE, EPI Health agreed to file a motion to be substituted for us as a plaintiff party and has agreed to reimburse us for our reasonable fees and expenses so long as we remained a plaintiff party.
−Removed: On December 3, 2019, EPI Health was substituted for us as a plaintiff party.
−Removed: In addition, from time to time, we are subject to litigation and claims arising in the ordinary course of business but, except as stated above, we are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
+Added: Thereafter, on January 11, 2020, the court stayed – subject to certain conditions – all deadlines in the Consolidated Derivative Action pending resolution of the defendants’ then-anticipated motion to dismiss the Consolidated Securities Action.
+Added: The defendants dispute plaintiffs’ claims in the Consolidated Derivative Action and intend to defend the matter vigorously.
Mine Safety Disclosures
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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.