What changed in this filing

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Item 1. Legal Proceedings

2020-11-04 compared with 2020-08-04 · 51 added, 31 removed, 126 unchanged (39% of the section changed)

4 unchanged sentences

(now Actavis Laboratories, Inc.,

or “Actavis”), Par Pharmaceutical, Inc.(“Par”), Alvogen Pine Brook, Inc.

or “Actavis”), Par Pharmaceutical, Inc.

(“Par”), Alvogen Pine Brook, Inc.

(“Alvogen”), Teva Pharmaceuticals USA, Inc.

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District Judge McNulty on December 4, 2019, and DRL and Alvogen opposed the appeal.

The parties are awaiting further action from the New Jersey District Court on the appeal.

On January 17, 2020, we filed a motion to dismiss DRL’s and Alvogen’s

antitrust counterclaims for failure to state a claim and DRL and Alvogen opposed the motion.

The parties are awaiting further action from the New Jersey District Court on the motion to dismiss.

On June 3, 2020, the court issued an order setting a

schedule for ongoing fact discovery, expert discovery, and dispositive motions.

On January 17, 2020, we filed a motion to dismiss DRL’s and Alvogen’s antitrust counterclaims for failure to state a claim and DRL and Alvogen opposed the motion.

August 24, 2020, Judge McNulty issued an Opinion and Order denying both the appeal of the Magistrate’s decision and our Motion to Dismiss.

On June 3, 2020, the court issued an order setting a schedule for ongoing fact discovery, expert discovery, and

dispositive motions.

The schedule currently sets the close of fact discovery for October 20, 2020, with expert discovery continuing through the end of April 2021.

The schedule also sets the

deadline for filing dispositive motions for May 18, 2021.

The schedule also sets the deadline for filing dispositive motions for May 18, 2021.

No trial date has been set in those cases.

We are not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the

possible outcome or losses, is any, in this matter.

We are not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or losses, is any, in this matter.

On February 19, 2019, the Federal Circuit issued its mandate reversing the District of New Jersey’s preliminary injunction against Dr.

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On June 11, 2020, BDSI filed a petition for writ of certiorari at the Supreme Court of the United States.

The petition is scheduled for

consideration at the Court’s September 29, 2020 conference, at which time the Court will decide whether to accept BDSI’s petition for review of the Federal Circuit’s dismissal of BDSI’s appeal.

After the Federal Circuit denied BDSI’s

petition, on January 13, 2020, BDSI filed with the Eastern District of North Carolina Court a motion to dismiss the Complaint, and we opposed the motion on February 2, 2020.

The Eastern District of North Carolina Court denied BDSI’s motion

to dismiss and its motion to stay on April 1, 2020.

At the request of the Supreme

Court, we filed an opposition to BDSI’s petition on August 17, 2020, and BDSI filed a reply on August 27, 2010.

On October 5, 2020, the Supreme Court issued an order denying BDSI’s petition.

After the Federal Circuit denied BDSI’s petition,

on January 13, 2020, BDSI filed with the Eastern District of North Carolina Court a motion to dismiss the Complaint, and we opposed the motion on February 2, 2020.

The Eastern District of North Carolina Court denied BDSI’s motion to dismiss

and its motion to stay on April 1, 2020.

On April 16, 2020, BDSI filed an Answer to the Complaint, including counterclaims for non-infringement, invalidity, and unenforceability of the ’167 patent.

On May 7, 2020, Aquestive

filed a motion to dismiss BDSI’s unenforceability counterclaim and a motion to strike BDSI’s corresponding affirmative defenses for failure to state a claim for inequitable conduct under the heightened pleading standard applicable to such

claims and defenses.

On May 7, 2020, Aquestive filed a motion

to dismiss BDSI’s unenforceability counterclaim and a motion to strike BDSI’s corresponding affirmative defenses for failure to state a claim for inequitable conduct under the heightened pleading standard applicable to such claims and

Rather than oppose Aquestive’s Motion to Dismiss, on May 28, 2020, BDSI amended its counterclaims and filed an Answer and Amended Counterclaims, which included additional allegations in support of BDSI’s unenforceability

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Aquestive filed its Reply to BDSI’s Opposition on July 30, 2020.

The parties are awaiting further action

from the court on Aquestive’s motion.

Antitrust Litigation

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through August 1, 2019.

Daubert briefing is ongoing.

The remainder of the case schedule, including summary judgment briefing, is stayed

pending resolution of Indivior’s appeal of the District Court’s class certification ruling in a co-pending multi-district litigation to which we are not a party.

The remainder of the case schedule, including summary judgment briefing, is stayed pending resolution of Indivior’s appeal of the District Court’s class certification ruling in a co-pending multi-district litigation to

which we are not a party.

On July 28, 2020, the U.S.

Court of Appeals for the Third Circuit issued its

opinion affirming the District Court’s order certifying the class.

This ruling may result in a resumption of the pre-trial proceedings in this case.

We are not able to determine or predict the ultimate outcome of

this proceeding or provide a reasonable estimate, or range of estimate, of the possible outcome or loss, if any, in this matter.

Court of Appeals for the Third Circuit issued its opinion affirming the District Court’s order certifying the class.

On August 27, 2020, the district court issued a scheduling order,

setting the deadline for filing remaining Daubert challenges and summary judgment.

Under the scheduling order, the remaining Daubert motions were filed on September

28, 2020, and oppositions are due on October 19, 2020.

The court will set oral argument on the motions, but the date for oral argument is not yet known.

Summary judgment motions are due January 11, 2021, and responses to summary judgment motions

are due February 11, 2021.

No trial date has yet been set.

We are not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate, or range of estimate, of the possible

outcome or loss, if any, in this matter.

Humana and Centene Actions

On September 18, 2020, Humana, Inc., a health insurance payer, filed a suit against Aquestive and Indivior in the Eastern District of Pennsylvania relating to Suboxone.

Humana action, which alleges facts similar to those at issue in the Antitrust Case and the Suboxone MDL described above, was assigned to the same judge that is presiding over those actions.

Humana’s Complaint alleges five causes of action against

Aquestive, including conspiracy to violate the RICO Act, fraud under state law, unfair and deceptive trade practices under state law, insurance fraud, and unjust enrichment.

On September 21, 2020, Centene Corporation and other related insurance

payers filed a similar suit against Aquestive and Indivior in the Eastern District of Missouri.

The counsel representing Humana is also representing Centene.

On September 21, 2020, the Centene action was provisionally transferred to the Eastern

District of Pennsylvania by the United States Judicial Panel on Multidistrict Litigation.

No other proceedings have occurred, and the schedule is not yet known.

We are not able to determine or predict the ultimate outcome of this proceeding or

provide a reasonable estimate, or range of estimate, of the possible outcome or loss, if any, in this matter.

California Complaint

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Motion on July 13, 2020, and we filed our reply on July 17, 2020.

The parties are awaiting further action from the court regarding a new hearing date.

We are not able to determine or predict the ultimate outcome of this proceeding or provide a

reasonable estimate, or range of estimate, of the possible outcome or loss, if any, in this matter.

The court held a telephonic hearing on Aquestive’s anti-SLAPP motion on July 24, 2020.

On August 6, 2020, the Court issued an order granting in part and denying in part Aquestive’s

anti-SLAPP motion.

Aquestive filed a notice of appeal to the California Court of Appeal on September 1, 2020, and Neurelis filed a notice of cross-appeal on October 5, 2020.

We are not able to determine or predict the ultimate outcome of this

proceeding or provide a reasonable estimate, or range of estimate, of the possible outcome or loss, if any, in this matter.

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.

What changed 10-Q

Item 1. Legal Proceedings