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Commitments and Contingencies
3 Months Ended
Mar. 31, 2023
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

3. Commitments and Contingencies

Leases

The Company’s operating lease for office space in Solana Beach, California was extended in February 2022 and had an expiration date of October 31, 2022, subject to the landlord’s option to cancel upon 30 days written notice. The Company extended this lease for an additional 12 months, effective November 1, 2022.

As of March 31, 2023, the Company has future minimum lease payments under its existing facility lease of approximately $94,000 payable in 2023. The remaining lease term is 0.58 years and the discount rate used was 10% for the office lease as of March 31, 2023.

The short-term lease expense of $24,854 and the operating lease expense of $11,471 are included in the general and administrative expense for the three months ended March 31, 2022. The operating lease expense of $37,372 was included in general and administrative expense for the three months ended on March 31, 2023. The cash paid for the operating lease liability was $40,112 and $37,281 for the three months ended on March 31, 2023 and 2022, respectively.

Legal Proceedings

On February 25, 2022, the Company received a letter notifying us that Teva submitted to FDA an ANDA for a generic version of Gimoti (metoclopramide hydrochloride) nasal spray eq. 15 mg base/spray that contains Paragraph IV certifications with respect to two of our patents covering Gimoti, U.S. Patent Nos. 8,334,281, expiration date May 16, 2030; and 11,020,361, expiration date December 22, 2029. These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for Gimoti. The certifications allege these patents are invalid or will not be infringed by the manufacture, use or sale of Teva’s metoclopramide hydrochloride nasal spray eq. 15 mg base/spray. In April 2022, the Company initiated litigation in the United States District Court for the District of New Jersey (Civil Action No. 1:22-cv-02019), alleging that Teva infringes the patents covering Gimoti. After the Company initiated litigation, Teva converted to a Paragraph III certification, which prevents the FDA from approving Teva’s ANDA until after the latest expiring patent expires in 2030. Consequently, the litigation against Teva was dismissed in January 2023.