What changed in this filing

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Item 1. Legal Proceedings

2021-05-06 compared with 2020-11-10 · 47 added, 51 removed, 2 unchanged (98% of the section changed)

LEGAL PROCEEDINGS

On February 15, 2019, a purported shareholder

filed a shareholder derivative complaint in the Court of Chancery of the State of Delaware, John Wajda, derivatively on behalf

of Lipocine Inc.

Mahesh Patel, et al., against certain of our current and former officers and directors as well as the Company

as a nominal defendant.

The complaint asserts claims for alleged breaches of fiduciary duty and unjust enrichment arising

out of our dissemination of purportedly false and misleading statements relating to the filing of the New Drug Application (“NDA”)

The relief sought in the complaint includes unspecified damages, changes to our corporate governance procedures, equitable

and/or injunctive relief, restitution, and attorneys’ fees.

On August 16, 2019, defendants filed a motion to dismiss

the complaint.

In response, the plaintiff’s filed an amended stockholder derivative complaint.

Defendants’ motion to

dismiss the amended complaint was filed on December 12, 2019;

plaintiff’s response was filed on January 27, 2020 and defendants’

reply was filed on February 26, 2020.

Oral arguments on the motion to dismiss were held on July 28, 2020.

On July 30, 2020, the

court entered an order dismissing the complaint in its entirety.

On April 2, 2019, we filed a lawsuit against

Clarus in the United States District Court for the District of Delaware alleging that Clarus’s JATENZO®

product infringes

six of Lipocine’s issued U.S.

April 2, 2019, we filed a lawsuit against Clarus in the United States District Court for the District of Delaware alleging

that Clarus’s JATENZO®

product infringes six of Lipocine’s issued U.S.

and 6,923,988.

Clarus has answered

the complaint and asserted counterclaims of non-infringement and invalidity.

We answered Clarus’s counterclaims on

April 29, 2019.

The Court held a scheduling conference on August 15, 2019, a claim construction hearing on February 11, 2020 and

scheduled a five-day jury trial beginning on February 8, 2021.

On February 11, 2020, we voluntarily dismissed allegations of patent

infringement for expired U.S.

6,569,463 and 6,923,988 in an effort to streamline the issues and associated costs for

The parties are currently engaged in the fact discovery and expert testimony phase of the lawsuit.

On November 14, 2019, the Company

and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v.

et al ., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah.

The complaint alleges that the

defendants made false and/or misleading statements and/or failed to disclose that our filing of the NDA for TLANDO to the FDA contained

deficiencies and as a result the defendants’ statements about our business and operations were false and misleading and/or

lacked a reasonable basis in violation of federal securities laws.

The lawsuit seeks certification as a class action (for a purported

class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory damages in an

unspecified amount, and unspecified equitable or injunctive relief.

We have insurance that covers claims of this nature.

The retention

amount payable by us under our policy is $1.25 million.

We filed a motion to dismiss this class action lawsuit on July 24, 2020.

In response, the plaintiff’s filed their response to the motion to dismiss the class action lawsuit on September 22, 2020.

Further, we intend to vigorously defend ourselves and our current and former officers and directors against these allegations and

have not recorded a liability related to this shareholder class action lawsuit as the outcome is not probable nor can an estimate

be made of loss, if any.

However on February 11, 2020, we voluntarily dismissed allegations of patent infringement for expired U.S.

6,569,463 and 6,923,988 in an effort to streamline the issues and associated costs for dispute.

Clarus has answered the complaint

and asserted counterclaims of non-infringement and invalidity.

We answered Clarus’s counterclaims on April 29, 2019.

The Court held a scheduling conference on August 15, 2019, a claim construction hearing on February 11, 2020 and a summary judgment

hearing on January 15, 2021.

Originally the United States District Court for the District of Delaware had scheduled a five-day jury

trial to begin on February 8, 2021, however, on December 28, 2020, the District Court postponed the jury trial due to the ongoing

effects of the COVID-19 pandemic.

The jury trial will be rescheduled once it becomes clear when jury trials will resume in the District

On November 14, 2019, we and certain of our

officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v.

Lipocine Inc.

et al ., 2:19-cv-00906-PMW,

filed in the United District Court for the District of Utah.

The complaint alleges that the defendants made false and/or misleading statements

and/or failed to disclose that our filing of the NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’

statements about our business and operations were false and misleading and/or lacked a reasonable basis in violation of federal securities

The lawsuit seeks certification as a class action (for a purported class of purchasers of the Company’s securities from March 27,

2019 through November 8, 2019), compensatory damages in an unspecified amount, and unspecified equitable or injunctive relief.

have insurance that covers claims of this nature.

The retention amount payable by us under our policy is $1.25 million.

We filed a motion

to dismiss this class action lawsuit on July 24, 2020.

In response, the plaintiffs filed their response to the motion to dismiss

the class action lawsuit on September 22, 2020 and we filed our reply to our motion to dismiss on October 22, 2020.

to vigorously defend ourselves against these allegations and have not recorded a liability related to this shareholder class action lawsuit

as the outcome is not probable nor can an estimate be made of loss, if any.

On March 13, 2020, we filed U.S.

patent application serial number

16/818,779 (“the Lipocine ‘779 Application”) with the United States Patent and Trademark Office (“USPTO”).

On October 16 and November 3, 2020, we filed suggestions for interference with the USPTO requesting that a patent interference

be declared between the Lipocine ‘779 Application and US patent application serial number 16/656,178 to Clarus Therapeutics, Inc.

(“the Clarus ‘178 Application”).

Pursuant to our request, the Patent Trial and Appeal Board (“PTAB”)

at the USPTO declared the interference on January 4, 2021 to ultimately determine, as between us and Clarus, who is entitled to the

claimed subject matter.

The interference number is 106,128, and we were initially declared Senior Party.

A conference call

with the PTAB was held on January 25, 2021 to discuss proposed motions.

On February 1, 2021, the PTAB issued an order

authorizing certain motions and setting the schedule for the preliminary motions phase.

Briefing is presently ongoing.

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