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Commitments and Contingencies
9 Months Ended
Sep. 30, 2022
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

11. Commitments and Contingencies

Operating Lease

We have operating leases for our corporate headquarters, office spaces and laboratory facilities.

The components of lease cost are as follows:

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

(In thousands)

 

2022

 

 

2022

 

Straight line operating lease costs

 

$

640

 

 

$

1,101

 

Variable lease costs

 

 

35

 

 

 

110

 

Total lease costs

 

$

675

 

 

$

1,211

 

 

Supplemental cash flow information related to leases are as follows:

 

 

 

Nine Months Ended September 30,

 

(In thousands)

 

2022

 

Cash paid for amounts included in the measurement of operating lease liabilities:

 

$

540

 

Operating lease right-of-use assets obtained in exchange for operating lease obligations

 

 

3,323

 

Right-of-use assets obtained through acquisitions

 

 

1,185

 

 

As of September 30, 2022, our operating leases have weighted-average remaining term of approximately three years and the weighted average discount rate on our operating lease liabilities was 7.5%.

 

We have not presented the comparative information above as our operating lease in 2021 was not material.

 

The following table summarizes our operating leases as presented in the unaudited condensed consolidated balance sheets:

 

 

 

September 30,

 

 

December 31,

 

(In thousands)

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Right-of-use assets

 

$

3,679

 

 

$

97

 

Liabilities

 

 

 

 

 

 

Current portion of lease liabilities

 

$

1,170

 

 

$

106

 

Long-term portion of lease liabilities

 

 

2,703

 

 

 

 

Total lease liabilities

 

$

3,873

 

 

$

106

 

 

Future minimum payments on our operating leases as of September 30, 2022 were as follows:

 

(In thousands)

 

September 30, 2022

 

Years ending December 31:

 

 

 

Remainder of 2022

 

$

250

 

2023

 

 

1,542

 

2024

 

 

1,269

 

2025

 

 

1,289

 

Total undiscounted lease payments

 

 

4,350

 

Less: imputed interest

 

 

(477

)

      Total operating lease liabilities

 

$

3,873

 

 

Legal Proceedings

From time to time, the Company is involved in legal proceedings in the ordinary course of its business. We are not currently a party to any material legal proceedings except as discussed below.

As previously disclosed in the Quarterly Report on Form 10-Q filed by La Jolla on August 15, 2022, on February 15, 2022, La Jolla received a paragraph IV notice of certification (the “Notice Letter”) from Gland Pharma Limited (“Gland”) advising that Gland had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use or sell a generic version of GIAPREZA® in the U.S. prior to the expiration of U.S. Patent No.s.: 9,220,745; 9,572,856; 9,867,863; 10,028,995; 10,335,451; 10,493,124; 10,500,247; 10,548,943; 11,096,983; and 11,219,662 (the “GIAPREZA® Patents”), which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). The Notice Letter alleges that the GIAPREZA® Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Gland’s ANDA.

On March 29, 2022, La Jolla filed a complaint for patent infringement of the GIAPREZA® Patents against Gland and certain related entities in the United States District Court for the District of New Jersey in response to Gland’s ANDA filing. In accordance with the Hatch-Waxman Act, because GIAPREZA® is a new chemical entity and La Jolla filed a complaint for patent infringement within 45 days of receipt of the Notice Letter, the FDA cannot approve Gland’s ANDA any earlier than 7.5 years from the approval of the GIAPREZA® NDA unless the District Court finds that all of the asserted claims of the patents-in-suit are invalid, unenforceable and/or not infringed. We intend to vigorously enforce our intellectual property rights relating to GIAPREZA®.

Indemnification

 

In the ordinary course of business, we may provide indemnifications of varying scope and terms to vendors, directors, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by us, our negligence or willful misconduct, violations of law, or intellectual property infringement claims made by third parties. In addition, we have entered into indemnification agreements with directors and certain officers and employees that will require us, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers, or employees. No material demands have been made upon us to provide indemnification under such agreements, and thus, there are no claims that we are aware of that could have a material effect on our unaudited condensed consolidated financial statements. We also maintain director and officer insurance, which may cover certain liabilities arising from our obligation to indemnify our directors. To date, we have not incurred any material costs and have not accrued any material liabilities in the condensed consolidated financial statements as a result of these provisions.