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Commitments and Contingencies
9 Months Ended
Sep. 30, 2018
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

13. Commitments and Contingencies

Future minimum payments under the non-cancelable operating leases consisted of the following as of September 30, 2018(in thousands):

 

Year ending December 31:

 

Minimum

payments

 

2018 (remaining three months)

 

$

712

 

2019

 

 

2,383

 

2020

 

 

2,247

 

2021

 

 

1,844

 

2022

 

 

1,802

 

Thereafter

 

 

4,672

 

 

 

$

13,660

 

 

Legal Proceedings

From time to time, the Company is subject to claims and litigation arising in the ordinary course of business. These claims may include assertions that the Company’s products infringe existing patents and claims that the use of its products has caused personal injuries. The Company intends to vigorously defend any such litigation that may arise under all defenses that would be available.

Vasopressin (Generic version of Vasostrict®)

On August 13, 2018, Athenex Pharma Solutions and Athenex Pharmaceutical Division, LLC, wholly-owned subsidiaries of the Company, filed a complaint for declaratory judgment against Par Pharmaceuticals, Inc., Par Sterile Products, LLC and Endo Par Innovation Company, LLC (together, “Par”) in the United States District Court for the Western District of New York (the “Court”). The Company is seeking a declaratory judgment from the Court that the Company’s compounded Vasopressin drug products in ready-to-use form do not infringe on patents that Par has with respect to its Vasostrict® product and that Par’s patents are invalid. On October 22, 2018, Par filed a motion to dismiss the complaint on the basis that the Court does not have subject matter jurisdiction and that motion is currently pending.

In addition, on August 13, 2018, Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC filed a motion to intervene and seek the dismissal of Par’s complaint against the FDA and certain governmental officials in the United States District Court for the District of Columbia. Par has sought declaratory and injunctive relief against the FDA and certain governmental officials that: (i) Vasopressin be delisted from Category 1 of the FDA’s list of bulk drug substances under evaluation pursuant to Section 503B of the Federal Food, Drug and Cosmetic Act (“FDCA”), (ii) the expansion of the FDA’s enforcement discretion to Category 1 substances, be enjoined; and (iii) that the FDA be enjoined from authorizing the compounding of Vasopressin under Section 503B of the FDCA.  Athenex’s motion to intervene was granted.  Par filed a preliminary injunction motion and Athenex and the FDA filed motions for judgment on the pleadings.  Prior to hearing those motions, the Court issued an order staying the litigation until the earlier of December 31, 2018 or when the FDA issues its final clinical need determination for Vasopressin. On August 14, 2018, the Company began selling compounded Vasopressin Injection in ready-to-use premix IV bags. The Company has sold and will continue to sell these products. Therefore, an adverse final determination that the patent is valid and infringed could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.