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Commitments and Contingencies
6 Months Ended
Jun. 30, 2022
Leases [Abstract]  
Commitments and Contingencies

8.  Commitments and Contingencies

Lease Commitments

In December 2020, the Company entered into a sublease agreement for office space in Waltham, Massachusetts (the “Waltham Sublease”). The Waltham Sublease commenced on December 21, 2020 and expires on November 30, 2023. In addition to rent of approximately $15,000 per month, the Waltham Sublease requires the Company to pay certain taxes, insurance and operating costs relating to the leased premises (collectively, “Lease Operating Costs”). The Waltham Sublease contains customary default provisions, representations, warranties and covenants. The Waltham Sublease is classified as an operating lease. The Company recognizes the Waltham Sublease expense in the condensed consolidated statements of operations and records a lease liability and right-of-use asset for this lease. The option to extend the Waltham Sublease was not recognized as part of the Company’s lease liabilities and right-of-use lease assets. 

Future minimum lease payments, excluding Lease Operating Costs, as of June 30, 2022 are as follows (in thousands):

2022

 

$

91

 

2023

 

 

166

 

Thereafter

 

 

-

 

Total future minimum lease payments

 

 

257

 

Less: discount

 

 

(25

)

Total lease liabilities

 

$

232

 

Lease expense under current leases was approximately $45,000 and $0.1 million for the three and six months ended June 30, 2022, respectively. Lease expense under current and former leases was approximately $0.1 million and $0.2 million for the three and six months ended June 30, 2021, respectively. Cash paid for amounts included in the measurement of lease liabilities was $45,000 and $0.1 million for the three and six months ended June 30, 2022, respectively. Cash paid for amounts included in the measurement of lease liabilities was $0.1 million for the three and six months ended June 30, 2021. As of June 30, 2022, the weighted-average remaining lease term and the weighted-average discount rate for the Company’s only operating lease, the Waltham Sublease, was 1.4 years and 3.3%, respectively.

Legal Proceedings

On February 15, 2022, the Company 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 Nos.: 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, the Company 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 the Company 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. The Company intends to vigorously enforce its intellectual property rights relating to GIAPREZA.

Following the announcement of the Agreement and Plan of Merger (the “Merger Agreement”) with Innoviva, Inc., a Delaware corporation (the “Parent”) and Innoviva Acquisition Sub, Inc., a Delaware corporation and a wholly owned subsidiary of the Parent (the “Purchaser”), and through August 12, 2022, the Company is aware of six complaints that have been filed in United States District Courts and five demand letters that were sent to the Company by purported stockholders of the Company related to the transaction (collectively, the “Complaints”).

On July 27, 2022, Richard Gole, a purported stockholder of the Company, filed a complaint in the United States District Court for the Southern District of New York, Case No. 1:22-cv-06395. On August 1, 2022, Denise Redfield, a purported stockholder of the Company, filed a complaint in the United States District Court for the Southern District of New York, Case No. 1:22-cv-06528. On August 2, 2022, Marc Waterman, a purported stockholder of the Company, filed a complaint in the United States District Court for the Southern District of New York, Case No. 1:22-cv-06534. On August 2, 2022, the Company received a demand letter from Miriam Nathan, a purported stockholder of the Company. On August 2, 2022, the Company received a demand letter from Raymond Tomo, a purported stockholder of the Company. On August 4, 2022, Richard Lawrence, a purported stockholder of the Company, filed a complaint in the United States District Court for the District of Delaware, Case No.1:22-cv-01032-UNA. On August 4, 2022, Katherine Finger, a purported stockholder of the Company, filed a complaint in the United States District Court for the Southern District of New York, Case 1:22-cv-06640. On August 5, 2022, Brian Jones, a purported stockholder of the Company filed a complaint in the United States District Court for the Southern District of New York, Case No. 1:22-cv-06681. On August 7, 2022, the Company received a demand letter from Christopher Taylor, a purported stockholder of the Company. On August 8, 2022, the Company received a demand letter to inspect books and records pursuant to 8 Del. §220 from James Gyldenvand, a purported stockholder of the Company. On August 11, 2022, the Company received a demand letter to inspect books and records pursuant to 8 Del. § 220 from Ramin Hatam, a purported stockholder of the Company.

The Complaints name the Company and each of the Company’s directors as defendants (“Defendants”) and generally allege violations of Sections 14(e), 14(d), and 20(a) of the Securities and Exchange Act of 1934 (“Exchange Act”) as a result of Defendants’ efforts to sell the Company to the Parent through a cash tender offer (“Offer”) by the Purchaser. The Complaints generally contend that the Recommendation Statement on Schedule 14D-9 filed on July 25, 2022 (“Recommendation Statement”) has omitted or misrepresented material information regarding the Merger.

The Complaints seek generally to enjoin the transactions contemplated by the Merger Agreement or, in the event the transactions are consummated, an order rescinding consummation or an award of rescissory damages, to direct Defendants to disseminate a Recommendation Statement that does not contain any untrue statements of material fact, award of costs, including reasonable attorneys’ and experts’ fees and other relief the court may deem just and proper. Company management believes it has strong factual and legal defenses to all actions and intends to defend itself vigorously. Other similar cases or cases based on similar facts may be filed in the future.