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COMMITMENTS AND CONTINGENCIES
6 Months Ended
Jun. 30, 2018
COMMITMENTS AND CONTINGENCIES  
COMMITMENTS AND CONTINGENCIES

NOTE 12.  COMMITMENTS AND CONTINGENCIES

 

Leases

 

The Company has non-cancelable operating leases for our office buildings and is obligated to make payments under non-cancelable operating leases for automobiles used by our sales force. Future minimum lease payments under our non-cancelable operating leases at June 30, 2018 were as follows (in thousands):

 

 

 

 

 

 

Year Ending December 31,

    

Lease Payments

 

2018 (remainder)

 

$

1,367

 

2019

 

 

2,687

 

2020

 

 

2,545

 

2021

 

 

2,371

 

2022

 

 

2,188

 

Thereafter

 

 

633

 

Total

 

$

11,791

 

 

In April 2012, the Company entered into an office and laboratory lease agreement to lease approximately 52,500 rentable square feet in Newark, California (Newark Lease) commencing on December 1, 2012. The Company occupied approximately 8,000 additional rentable square feet commencing in July 2015.  The lease is due to expire on November 30, 2022.

 

The Company is relocating its corporate headquarters from Newark, California to Lake Forest, Illinois in the third quarter of 2018. The Company began preliminary discussions with the Newark Lease Landlord in the first quarter of 2018 and discussed our options to exit the premises by either subleasing the space or negotiating an exit.

 

Effective February 28, 2018, the Company entered into an Office Lease, in Lake Forest, Illinois (Lake Forest Lease) for its corporate headquarters, where the Company will lease approximately 31,000 rentable square feet of space. The Company’s initial tenant improvements in the space are expected to be completed in August 2018 and until such time, the Company has the right to use temporary space in the building containing approximately 6,700 rentable square feet.  The Lake Forest Lease term is for five years and six months. The Company has the right to renew the term of the Lease for one period of five years, provided that written notice is made to the Landlord no later than twelve months prior to the expiration of the initial term of the Lease. 

 

The Lake Forest Lease initial annual base rent will be $18.00 per rentable square foot and will increase annually by $0.50 per rentable square foot. The lease is a triple net lease, with the Company required to pay its pro rata share of real estate taxes and operating expenses. The Landlord will make available to the Company a tenant improvement allowance of $28.00 per square rentable square foot, which the Company may use towards the initial build-out or apply to the payment of rent. 

 

As of June 30, 2018, the aggregate rent payable over the remaining term of the lease agreements was approximately $7.2 million on the Newark Lease and $3.3 million on the Lake Forest Lease, including the Company’s option to renew. Deferred rent was approximately $1.6 million as of June 30, 2018 and $1.4 million as of December 31, 2017.

 

Gross rent expense relating to the office lease agreements for the three and six months ended June 30, 2018, was $0.5 million and $0.9 million, respectively. Gross rent expense relating to the office lease agreements for the three and six months ended June 30, 2017, was $0.1 million and $0.3 million, respectively.

 

The Company has an operating lease agreement with Enterprise FM Trust (Enterprise) for the lease of vehicles to be used by the Company's sales force, with the lease terms ranging from 18 to 48 months. As of June 30, 2018, the aggregate rent payable over the remaining lease term of the vehicle lease agreement was approximately $1.3 million. Rent expense relating to the lease of cars for the three and six months ended June 30, 2018 was $0.2 million and $0.7 million, respectively.  Rent expense relating to the lease of cars for the three and six months ended June 30, 2017 was $0.8 million and $1.6 million, respectively. 

 

Legal Matters

 

Depomed v. NUCYNTA and NUCYNTA ER ANDA Filers

 

Actavis & Alkem:  In July 2013, Janssen Pharma filed patent infringement lawsuits in the U.S. District Court for the District of New Jersey (D.N.J.) against Actavis Elizabeth LLC, Actavis Inc. and Actavis LLC (collectively, Actavis), as well as Alkem Laboratories Limited and Ascend Laboratories, LLC (collectively, Alkem). The patent infringement claims against Actavis and Alkem relate to their respective ANDAs seeking approval to market generic versions of NUCYNTA and NUCYNTA ER before the expiration of U.S. Reissue Patent No. 39,593 (the ’593 Patent), U.S. Patent No. 7,994,364 (the ’364 Patent) and, as to Actavis only, U.S. Patent No. 8,309,060 (the  ’060 Patent). In December 2013, Janssen Pharma filed an additional complaint in the D.N.J. against Alkem asserting that newly issued U.S. Patent No. 8,536,130 (the ’130 Patent) was also infringed by Alkem’s ANDA seeking approval to market a generic version of NUCYNTA ER. In August 2014, Janssen Pharma amended the complaint against Alkem to add additional dosage strengths.

Sandoz & Roxane:  In October 2013, Janssen Pharma received a Paragraph IV Notice from Sandoz, Inc. (Sandoz) with respect to NUCYNTA related to the ’364 Patent, and a Paragraph IV Notice from Roxane Laboratories, Inc. (Roxane) with respect to NUCYNTA related to the ’364 and ’593 Patents. In response to those notices, Janssen Pharma filed an additional complaint in the D.N.J. against Roxane and Sandoz asserting the ’364 Patent against Sandoz and the ’364 and ’593 Patents against Roxane. In April 2014, Janssen Pharma and Sandoz entered into a joint stipulation of dismissal of the case against Sandoz, based on Sandoz's agreement not to market a generic version of NUCYNTA products prior to the expiration of the asserted patents. In June 2014, in response to a new Paragraph IV Notice from Roxane with respect to NUCYNTA ER, Janssen Pharma filed an additional complaint in the D.N.J. asserting the ’364, ’593, and ’130 Patents against Roxane.

Watson:  In July 2014, in response to a Paragraph IV Notice from Watson Laboratories, Inc. (Watson) with respect to the NUCYNTA oral solution product and the ’364 and ’593 Patents, Janssen Pharma filed a lawsuit in the D.N.J. asserting the ’364 and ’593 Patents against Watson.

In each of the foregoing actions, the ANDA filers counterclaimed for declaratory relief of non-infringement and patent invalidity. At the time that the actions were commenced, Janssen Pharma was the exclusive U.S. licensee of the patents referred to above. On April 2, 2015, the Company acquired the U.S. rights to NUCYNTA ER and NUCYNTA from Janssen Pharma. As part of the acquisition, the Company became the exclusive U.S. licensee of the patents referred to above. The Company was added as a plaintiff to the pending cases and is actively litigating them.

In September 2015, the Company filed an additional complaint in the D.N.J. asserting the ’130 Patent against Actavis. The ’130 Patent issued in September 2013 and was timely listed in the Orange Book for NUCYNTA ER, but Actavis did not file a Paragraph IV Notice with respect to this patent.  In its new lawsuit, the Company claimed that Actavis would infringe or induce infringement of the ’130 Patent if its proposed generic products were approved. In response, Actavis counterclaimed for declaratory relief of non-infringement and patent invalidity, as well as an order requiring the Company to change the corrected use code listed in the Orange Book for the ’130 Patent.

In February 2016, Actavis, Actavis UT, Roxane and Alkem each stipulated to infringement of the ’593 and ’364 patents.  On March 9, 2016, a two-week bench trial on the validity of the three asserted patents and infringement of the ’130 patent commenced.  Closing arguments took place on April 27, 2016.  On September 30, 2016, the Court issued its final decision.  The Court found that the ’593, ’364 patent, and ’130 patents are all valid and enforceable, that Alkem will induce infringement of the ’130 patent, but that Roxane and Actavis will not infringe the ’130 patent.

On April 11, 2017, the Court entered final judgment in favor of the Company on the validity and enforceability of all three patents, on infringement of the ’593 and ’364 Patents by all defendants, and on infringement of the ’130 Patent against Alkem. The judgment includes an injunction enjoining all three defendants from engaging in certain activities with regard to tapentadol (the active ingredient in NUCYNTA), and ordering the effective date of any approval of Actavis, Actavis UT, and Roxane’s ANDAs, and Alkem’s ANDA for NUCYNTA IR to be no earlier than the expiry of the ’364 Patent (June 27, 2025), and the effective date of any approval of Alkem’s ANDA for NUCYNTA ER to be no early than the expiry of the ’130 Patent (September 22, 2028). The period of exclusivity with respect to all four defendants may in the future be extended with the award of pediatric exclusivity.

Notices of appeal were filed by defendants Alkem and Roxane concerning the validity of the ’364 and ’130 patents. The Company filed its own cross-appeal with regard to the Court’s finding that Roxane and Actavis will not infringe the claims of the ’130 Patent. The appeals have been consolidated at the Federal Circuit.  Briefing concluded in March 2018 and oral arguments are scheduled for September 4, 2018.  It is estimated that the Federal Circuit will issue a written decision in late 2018 or in the first quarter of 2019.  The ‘593 patent is not the subject of any appeals.

Depomed v. Purdue

 

The Company has sued Purdue Pharma L.P (Purdue) for patent infringement  in a lawsuit filed  in January 2013  in the  U.S. District Court for the District  of New Jersey. The lawsuit arises from Purdue’s commercialization  of reformulated OxyContin® (oxycodone hydrochloride controlled-release)  in the U.S. and alleges infringement  of U.S. Patent Nos. 6,340,475 (the ‘475 Patent) and 6,635,280 (the ‘280 Patent), which expired  in September 2016.

On September 28, 2015, the district court stayed the Purdue lawsuit pending the decision  of the U.S. Court  of Appeals for the Federal Circuit (CAFC)  in Purdue’s appeal  of the  PTAB’s Final Written Decisions described below.    On June 30, 2016, the district court lifted the stay based  on the CAFC’s opinion and judgment affirming the  PTAB’s Final Written Decisions confirming the patentability  of the patent claims  of the ‘475 and ‘280 Patents Purdue had challenged.    On June 10, 2016, the Company filed a motion for leave  to file a second amended Complaint  to plead willful infringement.  On June 21, 2016, Purdue filed  an opposition  to the Company’s motion for leave  to plead willful infringement.  On January 31, 2017, the Court granted the Company’s motion for leave  to plead willful infringement.

On February  1, 2017, the Company filed a Second Amended Complaint pleading willful infringement.  On July 10, 2017, the case was reassigned  to Judge Wolfson.    On February 15, 2017, Purdue answered the Company’s Second Amended Complaint and pled counterclaims  of non-infringement, invalidity, unenforceability and certain affirmative defenses.  On September 26, 2017, the case was reassigned  to Judge Martinotti.    On December 22, 2017, the Court set the close  of expert discovery for March 30, 2018.    On January  5, 2018, the Court vacated the January 25, 2018 pretrial conference.    

On July 9, 2018, the Court issued an order administratively terminating the case pending the outcome of settlement discussions between the parties. The Court’s order does not constitute a dismissal with prejudice of the case under the Federal Rules of Civil Procedure and if a settlement cannot be consummated, either party may request that the action be reopened.  

In response  to petitions filed  by Purdue, the  PTAB instituted IPRs  of certain  of the claims asserted  in the Company’s lawsuit against Purdue.  In the IPRs initiated  by Purdue,  in July 2014, the  PTAB declined  to institute  an IPR  as  to two claims  of  the ‘475 patent and two claims  of  the ‘280 Patent. The  PTAB instituted  an IPR  as  to the other 15 claims  of the ‘475 Patent and  as  to the other ten claims  of the ‘280 Patent asserted against Purdue.    In July 2015, the  PTAB issued Final Written Decisions confirming the patentability  of all claims  at issue.  In March 2016, following Purdue’s appeal  of the  PTAB’s decisions, the CAFC affirmed the  PTAB’s Final Written Decisions.

 

Securities Class Action Lawsuit

 

On August 23, 2017, the Company, its current chief executive officer and president, its former chief executive officer and president, and its former chief financial officer were named  as defendants  in a purported federal securities law class action filed  in the United States District Court for the Northern District  of California (Huang  v. Depomed  et al., No. 3:17-cv- 04830-JST, N.D. Cal.).   The action alleges violations  of Sections 10(b) and 20(a)  of the Securities Exchange Act  of 1934,  as amended, and Rule 10b-5 relating  to certain prior disclosures  of the Company about its business, compliance, and operational policies; and practices concerning the sales and marketing  of its opioid products.   The plaintiff, who seeks  to represent a class consisting  of all purchasers  of Company common stock between February 26, 2015 and August  7, 2017, contends that the conduct supporting the alleged violations affected the value  of Company common stock and  is seeking damages and other relief.  On December  8, 2017, the “Depomed Investor Group” was appointed lead plaintiff.    On February  6, 2018, the lead plaintiff filed  an amended complaint that asserted the same claims arising out  of the same and similar disclosures against the Company and the same individuals  as were involved  in the original complaint.   The Company and  the individuals filed a motion  to dismiss the amended complaint  on April  9, 2018.   The lead plaintiff filed an opposition to the motion on June  8, 2018.   The Company and the individuals filed a reply  in support  of  their motion  to dismiss on July 23, 2018.  The Company believes that the action  is without merit and intends  to contest  it vigorously.

In addition, three shareholder derivative actions were filed on behalf of the Company and purport to assert claims by the Company against its officers and directors for breach of fiduciary duty, arising out of the same factual allegations as the class action.  Two of these actions were filed in the Northern District of California, the first on November 10, 2017 (Solak v. Higgins et al., No. 3:17-cv-06546-JST) and the second on November 15, 2017 (Ross v. Fogarty et al., No. 3:17-cv-06592- JST).  The third derivative action was filed in the Superior Court of California, Alameda County (Singh v. Higgins, et al., RG17877280) on September 29, 2017.  On December 7, 2017, the plaintiffs in Solak v. Higgins, et al. voluntarily dismissed the first federal derivative action.  And, on January 18, 2018 and January 23, 2018, respectively, the remaining federal and state derivative actions were stayed pending the resolution of the motion to dismiss in the securities class action. The Company believes that these actions are without merit and intends to contest them vigorously.

Opioid-Related Requests and Subpoenas

 

As a result of the greater public awareness of the public health issue of opioid abuse, there has been increased scrutiny of, and investigation into, the commercial practices of opioid manufacturers generally by federal, state, and local regulatory and governmental agencies.  The Company received a letter from Senator Claire McCaskill (D-MO), the Ranking Member on the U.S. Senate Committee on Homeland Security and Governmental Affairs, requesting certain information from the Company regarding its prior commercialization of opioid products.  The Company voluntarily furnished information responsive to Sen. McCaskill’s request.  The Company has also received subpoenas or civil investigative demands focused on historical promotion and sales of Lazanda, NUCYNTA, and NUCYNTA ER from various State Attorneys General seeking documents and information regarding our prior sales and marketing of opioid products.  In addition, the State of California Department of Insurance (CDI) has issued a subpoena to the Company seeking information relating to our prior sales and marketing of Lazanda.  The CDI subpoena also seeks information on Gralise, a non-opioid product in our portfolio.  The Company received subpoenas from the U.S. Department of Justice (“DOJ”) seeking documents and information regarding our prior sales and marketing of opioid products.  The Company also from time to time receive and comply with subpoenas from governmental authorities related to investigations primarily directed at third parties, including health care practitioners, pursuant to which our records related to agreements with and payments made to those third parties, among other items, are produced.  As a general matter, the Company is cooperating with all of the requests from and investigations by regulators described above.

Multidistrict Opioid Litigation

 

A number of pharmaceutical manufacturers, distributors and other industry participants have been named in numerous lawsuits around the country brought by various groups of plaintiffs, including city and county governments, hospitals and others.  In general, the lawsuits assert claims arising from defendants’ manufacturing, distributing, marketing and promoting of FDA-approved opioid drugs.  The specific legal theories asserted vary from case to case, but most of the lawsuits include federal and state statutory claims as well as claims arising under state common law.  Plaintiffs seek various forms of damages, injunctive and other relief and attorneys’ fees and costs.

For such cases filed in or removed to federal court, the Judicial Panel on Multi-District Litigation issued an order in December 2017, establishing a Multi-District Litigation court (MDL Court) in the Northern District of Ohio (In re National Prescription Opiate Litigation, Case No. 1:17-MD-2804).  Since that time, more than 600 such cases that were originally filed in U.S. District Courts, or removed to federal court from state court, have been transferred to the MDL Court.  The Company is currently involved in 11 lawsuits that have been transferred to the MDL Court and two additional federal lawsuits, one each in the Northern District of New York and the Eastern District of Kentucky.  Plaintiffs may file additional lawsuits in which the Company may be named. Plaintiffs in these cases include county and municipal governmental entities, employee benefit plans, health clinics and health insurance providers who assert federal and state statutory claims and state common law claims, such as conspiracy, nuisance, fraud, negligence or deceptive trade practices.  In these cases, plaintiffs seek a variety of forms of relief, including actual damages to compensate for alleged past and future costs such as to provide care and services to persons with opioid-related addiction or related conditions, injunctive relief to prohibit alleged deceptive marketing practices and abate an alleged nuisance, establishment of a compensation fund, disgorgement of profits, punitive and statutory treble damages, and attorneys’ fees and costs.  These lawsuits are in the earliest stages of proceedings, and the Company intends to defend itself vigorously in these matters.

State Opioid Litigation

 

Related to the cases in the MDL Court noted above, there have been numerous similar lawsuits filed in state courts around the country, in which various groups of plaintiffs assert opioid-drug related claims against similar groups of defendants.  The Company is named in eight such cases -- three filed in Texas, two in Pennsylvania, and one each in Missouri,  Nevada and Arkansas. Plaintiffs may file additional lawsuits in which the Company may be named. In these cases, plaintiffs are asserting state common law and statutory claims against the defendants similar in nature to the claims asserted in the MDL cases.  Plaintiffs are seeking past and future damages, disgorgement of profits, injunctive relief, punitive and statutory treble damages, and attorneys’ fees and costs.  These lawsuits are likewise in their earliest stages, and the Company intends to defend itself vigorously in these matters.

General

 

The Company cannot reasonably predict the outcome of the legal proceedings described above, nor can the Company estimate the amount of loss, range of loss or other adverse consequence, if any, that may result from these proceedings or the amount of any gain in the event the Company prevails in litigation involving a claim for damages. As such the Company is not currently able to estimate the impact of the above litigation on its financial position or results of operations.

The Company may from time to time become party to actions, claims, suits, investigations or proceedings arising from the ordinary course of our business, including actions with respect to intellectual property claims, breach of contract claims, labor and employment claims and other matters. The Company may also become party to further litigation in federal and state courts relating to opioid drugs. Although actions, claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, other than the matters set forth above, the Company is not currently involved in any matters that the Company believes may have a material adverse effect on its business, results of operations or financial condition. However, regardless of the outcome, litigation can have an adverse impact on the Company because of associated cost and diversion of management time.