Financial Commitments and Contingencies and License Agreements | FINANCIAL COMMITMENTS & CONTINGENCIES AND LICENSE AGREEMENTS (a) Facility Leases We lease our principal executive office in Henderson, Nevada under a non-cancelable operating lease expiring October 31, 2021 . We also lease our research and development facility in Irvine, California under a non-cancelable operating lease expiring July 31, 2022 , in addition to several other administrative office leases. Each lease agreement contains scheduled rent increases which are accounted for on a straight-line basis. Our total rental expense in 2018 , 2017 , and 2016 was $1.6 million , $1.6 million , and $1.5 million , respectively. Adoption of New Lease Accounting Standard, Effective January 1, 2019 In February 2016, the FASB issued ASU 2016-02 , which amends the FASB Accounting Standards Codification and creates Topic 842 , Leases ( “Topic 842” ). Topic 842 will become effective for us beginning January 1, 2019, and requires us (as a lessee) to recognize a "right-of-use asset" and a "lease liability" on our balance sheet for all leases (with the exception of leases less than 12 months) at the lease commencement date. The lease liability will be measured as the present value of the unpaid lease payments and the right-of-use asset will be derived from the calculation of the lease liability, adjusted for any prepayments or incentives. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842) Targeted Improvements , amending certain aspects of this new accounting standard. The amendment allows an additional optional transition method whereby an entity records a cumulative effect adjustment to the opening retained earnings balance in the year of adoption, without restating prior periods. We plan to elect the package of practical expedients available under the transition provisions of the new guidance, including (i) not reassessing whether expired or existing contracts contain leases, (ii) lease classification, and (iii) not revaluing initial direct costs for existing leases. Additionally, we plan to elect the practical expedient which allows for the aggregation of lease and non-lease components of underlying asset classes, as well as the short-term lease exemption. We will elect the optional transition approach to not apply the new lease standard in the comparative periods presented and the package of practical expedients available under the transition provisions in ASU 2018-11 . Under the new lease classification criterion, we currently do not have any finance or embedded leases. Our operating leases solely relate to (1) our executive, administrative, and research and development office facilities and (2) certain office equipment. Our January 1, 2019 adoption of Topic 842 will result in the initial reporting of "right-of-use assets" and "lease liabilities" on our Consolidated Balance Sheets of approximately $4.4 million and $4.4 million , respectively. Our future minimum operating lease payments are as follows: Year ending December 31, Operating Lease 2019 $ 1,486 2020 1,441 2021 1,465 2022 828 2023 and thereafter 87 $ 5,308 (b) In/Out Licensing Agreements and Co-Development Arrangements The in-license agreements for our commercialized and development-stage drug products provide us with territory-specific rights to their manufacture and distribution (including further sub-licensing/out-licensing rights). We are generally responsible for all related clinical development costs, patent filings and maintenance costs, marketing costs, and liability insurance costs. We are also obligated to make specified milestone payments to our licensors upon the achievement of certain regulatory and sales milestones, and to pay royalties based on our net sales of all in-licensed products. We also enter into out-license agreements for territory-specific rights to our drug products which include one or more of: upfront license fees, royalties from our licensees’ sales, and/or milestone payments from our licensees’ sales or regulatory achievements. For certain development-stage drug products, we may enter into cost-sharing arrangements with our licensees and licensors. Our most significant of these agreements, and the key financial terms and our accounting for each, are summarized below: (i) ZEVALIN U.S.: In-Licensing and development in the U.S. In December 2008, we acquired rights to commercialize and develop ZEVALIN in the United States as the result of a transaction with Cell Therapeutics, Inc. (“CTI”) through our wholly-owned subsidiary, RIT Oncology LLC (“RIT”). In accordance with the terms of assumed contracts, we were required to meet specified payment obligations, including a milestone payment to Corixa Corporation of $5 million based on ZEVALIN sales in the United States. As of December 31, 2018 all the patents licensed from Corixa had expired under the terms of the agreement. Under the terms of the agreement, we are no longer obligated to pay United States net sales-based royalties in the low to mid-single digits to Genentech, Inc. and mid-teens to Biogen Inc. (ii) ZEVALIN Ex-U.S.: In-License and Asset Purchase Agreement with Bayer Pharma In April 2012, through our wholly-owned subsidiary, Spectrum Pharmaceuticals Cayman, L.P., we completed a €19 million acquisition of licensing rights to market ZEVALIN outside of the United States from Bayer. ZEVALIN is currently approved in approximately 40 countries outside the United States for the treatment of B-cell NHL, including countries in Europe, Latin America, and Asia. We amended the agreement in February 2016, which adjusted our tiered royalty to Bayer from the single-digits to 20% . The term of the agreement, as amended, continues until the expiration of the last-to-expire ZEVALIN patent in the relevant country, or 15 years from the date of the first commercial sale of ZEVALIN in such country, whichever is longer. (iii) ZEVALIN Ex-U.S.: Out-License Agreement with Dr. Reddy’s In June 2014, we executed an exclusive License Agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) for ZEVALIN distribution rights within India. The agreement term is 15 years from the receipt of pending approval of ZEVALIN from the Drug Controller General of India. In December 2014, upon our execution of a drug supply agreement, an upfront and non-refundable payment of $0.5 million was triggered and paid to us in February 2015. The recognition of the applicable portion of this upfront receipt is no longer reported on a straight line basis, within “license fees and service revenue” on our accompanying Consolidated Statements of Operations, due to the adoption of Topic 606 as of January 1, 2018 (see Note 2(i) ). Additionally, sales and regulatory milestones, each aggregating $1.5 million (for a total of $3 million if both are achieved), are due to us upon Dr. Reddy’s achievement of such milestones, as well as a 20% royalty on its net sales of ZEVALIN in India. (iv) ZEVALIN Ex-U.S.: Out-License Agreement with Mundipharma In November 2015, we entered into an out-license agreement with Mundipharma for its commercialization of ZEVALIN in Asia (excluding India and Greater China), Australia, New Zealand, Africa, the Middle East, and Latin America (including the Caribbean). In return, we received $18 million (comprised of $15 million received in December 2015 and $3 million received in January 2016). Of these proceeds, $15 million was recognized within "license fees and service revenue" in the fourth quarter of 2015, and the remaining $3 million payment was recognized in full by June 30, 2017. Mundipharma is required to reimburse us for our payment of royalties due to Bayer from its Zevalin sales (see Note 17(b)(ii) ). In March 2018, Mundipharma achieved a specified sales milestone, resulting in a receipt of $2 million recorded within "license fees and service revenue" on our accompanying Consolidated Statements of Operations for the year ended December 31, 2018 (see Note 5 ). (v) FUSILEV: In-License Agreement with Merck & Cie AG In May 2006, we amended and restated a license agreement with Merck & Cie AG (“Merck”), which we assumed in connection with our March 2006 acquisition of the assets of Targent, Inc. This provided us with an exclusive license to use regulatory filings related to FUSILEV, and a non-exclusive license under certain patents and know-how to develop, manufacture, and sell FUSILEV in the field of oncology in North America. The contractual royalty percentage on our FUSILEV net sales due to Merck is set at the mid-single digits; however, in September 2017, we paid Merck $2.6 million in full settlement of all royalty obligations under the agreement. As a result, we are no longer contractually obligated to pay any royalties or milestones for our net sales of FUSILEV. (vi) FOLOTYN: In-License Agreement with Sloan-Kettering Institute, SRI International and Southern Research Institute In December 2002, Allos entered into an in-license agreement for the drug now marketed as FOLOTYN with Sloan-Kettering Institute for Cancer Research, SRI International (SRI), and Southern Research Institute. We assumed this agreement when we acquired Allos in September 2012. The agreement provides for our exclusive worldwide rights to a portfolio of patents and patent applications related to FOLOTYN, though we are required to fund certain drug development programs. In addition, we pay graduated royalties to our licensors based on our worldwide annual net sales of FOLOTYN (including our sub-licensees). These royalties are 8% of annual worldwide net sales up to $150 million ; 9% of annual worldwide net sales of $150 million through $300 million ; and 11% of annual worldwide net sales in excess of $300 million . We are also obligated to remit a $3.5 million payment to SRI upon approval of FOLOTYN by the European Medicines Agency (“EMA”) approval of FOLOTYN. This regulatory milestone has not been met, and no amounts have been accrued in our accompanying Consolidated Balance Sheets for its potential achievement. (vii) FOLOTYN: Out-License Agreement with Mundipharma As a result of our acquisition of Allos (see Note 10(c) ), we assumed “the Mundipharma Collaboration Agreement” as well as certain FOLOTYN clinical development obligations. Under the Mundipharma Collaboration Agreement, (see Note 16 ), we retained full commercialization rights for FOLOTYN in the United States and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in all other countries in the world, except in Europe and Turkey. We are contractually entitled to receive regulatory and sales milestone payments from Mundipharma upon its achievement of such milestones, which aggregate $16 million and $107 million , respectively, as well as tiered double-digit royalties on Mundipharma's net sales. In July 2017, FOLOTYN was approved in Japan for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma ("PTCL"). Consequently, we received $3 million from Mundipharma in August 2017 for this milestone achievement. This amount was recognized within "license fees and service revenue" on our accompanying Consolidated Statements of Operations for the year ended December 31, 2017. In August 2017, FOLOTYN was commercially launched in Japan. This triggered a contractual milestone of $2 million from Mundipharma. This amount was recorded within "license fees and service revenue" on our accompanying Consolidated Statements of Operations for the year ended December 31, 2017. (viii) EVOMELA: In-License Agreement with Cydex Pharmaceuticals, Inc. In March 2013, we completed the acquisition of exclusive global development rights to EVOMELA from CyDex, a wholly-owned subsidiary of Ligand (see Note 10(b) ), and assumed responsibility for its then-ongoing clinical and regulatory development program. We filed a New Drug Application ("NDA") with the FDA in December 2015 for its use as a conditioning treatment prior to autologous stem cell transplant for patients with MM, and in March 2016, the FDA communicated its approval. Consequently, we made a $6 million contractual milestone payment to Ligand in April 2016. We reclassified $7.7 million from "EVOMELA IPR&D rights" to "EVOMELA distribution rights" which is presented within "intangible assets, net of accumulated amortization" (see Note 3(g) ) within our accompanying Consolidated Balance Sheets as of December 31, 2018 . We are required to pay Ligand amounts of up to $60 million (exclusive of the $6 million milestone paid in April 2016), upon our achievement of specified net sales thresholds. We are also responsible to pay Ligand royalties of 20% on our net sales of EVOMELA in all territories. (ix) MARQIBO: Acquisition of Talon Therapeutics, Inc. and Related Contingent Consideration Agreement In July 2013, we completed the acquisition of Talon, through which we obtained exclusive global development and commercialization rights to MARQIBO (see Note 10(a) ). As part of this acquisition, the former Talon stockholders have contingent financial rights that we have valued and presented on our accompanying Consolidated Balance Sheets as a $4.3 million and $6.2 million liability within “acquisition-related contingent obligations” as of December 31, 2018 and December 31, 2017 , respectively. The maximum payout value of these contingent financial rights to the former Talon shareholders is $195 million , assuming we achieve all sales and regulatory approval milestones. In addition, we are contractually obligated to pay royalties in the single digits on our net sales of MARQIBO and a portion of sublicensing revenue may be due upon our receipt of such revenue for MARQIBO. (x) QAPZOLA : License Agreements with Allergan, Inc. and NDDO Research Foundation In October 2008, we entered into an exclusive development and commercialization collaboration agreement with Allergan, Inc. ("Allergan") for QAPZOLA pursuant to which Allergan paid us an up-front non-refundable fee of $41.5 million at execution (which we have recognized in full within “license fees and service revenue” by December 31, 2013). Concurrently we also entered into a letter agreement with NDDO Research Foundation (“NDDO”), pursuant to which we agreed to pay NDDO the following in relation to QAPZOLA milestones: (a) upon FDA acceptance of our NDA, the issuance of 25,000 of our common shares (which occurred in March 2016 and the $0.1 million value of these shares was included in "research and development" expense for the year ended December 31, 2016), and (b) upon FDA approval, a one-time payment of $0.3 million (which has not yet been met, and no amounts have been accrued in our accompanying Consolidated Balance Sheets for its potential achievement). In January 2013, we entered into a second amendment to the license, development, supply, and distribution agreement with Allergan. This amendment relieved Allergan of its development and commercialization obligations and resulted in our acquisition of its rights in the United States, Europe, and other territories, in exchange for our agreement to pay a tiered single-digit royalty on our sales of certain products containing QAPZOLA. (xi) QAPZOLA: Collaboration Agreement with Nippon Kayaku Co. LTD. In November 2009, we entered into a collaboration agreement with Nippon Kayaku Co., LTD. (“Nippon Kayaku”) for the development and commercialization of QAPZOLA in Asia, except North and South Korea (the “Nippon Kayaku Territory”). In addition, Nippon Kayaku received exclusive rights to QAPZOLA for the treatment of Non-Muscle Invasive Bladder Cancer in the Nippon Kayaku Territory, including Japan and China. Nippon Kayaku will conduct QAPZOLA clinical trials in the Nippon Kayaku Territory pursuant to a development plan. Further, Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of QAPZOLA in the Nippon Kayaku Territory. Under the terms of this agreement, Nippon Kayaku paid us an upfront fee of $15 million (which we recognized within “license fees and service revenue” in full by December 31, 2013). Under the terms of the agreement, we are entitled to receive $10 million and $126 million from Nippon Kayaku upon the achievement of certain regulatory and commercialization milestones, respectively (some of which are our responsibility to achieve). Nippon Kayaku is also obligated to pay us royalties on its net sales of QAPZOLA in the mid-teen digits. (xii) BELEODAQ: In-License and Collaboration Agreement with Onxeo In February 2010, we entered into an in-license and collaboration agreement with TopoTarget A/S (now Onxeo DK) (“Onxeo”), for the development and commercialization of BELEODAQ, as amended in October 2013. We paid Onxeo an upfront fee of $30 million (and agreed to additional payments described below) for rights in North America and India, with an option for China. We are contractually obligated to pay royalties in the mid-teen digits on our net sales of BELEODAQ. All development and studies of BELEODAQ are conducted under a joint development plan (of which we fund 70% and Onxeo funds 30% ). We have the final decision-making authority for all developmental activities in North America and India (and China upon exercise of our option). Onxeo has final decision-making authority for all developmental activities in all other jurisdictions. In February 2014, upon FDA acceptance of our NDA, we were contractually obligated to issue Onxeo one million shares of our common stock and to make a $10 million milestone payment. The aggregate value of this milestone at achievement was $17.8 million , and was recognized within “research and development” expense in the first quarter of 2014. In July 2014, we received approval from the FDA for BELEODAQ’s use for injection and treatment of relapsed or refractory PTCL. As a result, we made a second milestone payment to Onxeo of $25 million in November 2014. This amount was capitalized as "BELEODAQ distribution rights" and is presented within "intangible assets, net of accumulated amortization" (see Note 3(g) ). We are also contractually obligated to pay Onxeo upon our achievements of other regulatory events and sales thresholds, up to $88 million and $190 million , respectively. These milestone amounts are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. (xiii) ROLONTIS: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Co. Ltd In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi Pharmaceutical Co. Ltd., or Hanmi, for ROLONTIS (formerly known as “LAPS-G-CSF" or "SPI-2012”), a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of this agreement, as amended, we have primary financial responsibility for the ROLONTIS development plan and hold its worldwide rights (except for Korea, China, and Japan). We are contractually obligated to pay Hanmi tiered royalties that range from the low double-digits to mid-teens on our net sales of ROLONTIS. In January 2016, the first patient was dosed with ROLONTIS in a clinical trial. This triggered our contractual milestone payment to Hanmi, and in April 2016, we (i) issued Hanmi 318,750 shares of our common stock, then valued at $2.3 million , and (ii) remitted a $0.4 million payment to the Internal Revenue Service (IRS) on their behalf for related tax obligations. This aggregate $2.7 million was recognized within "research and development" expense in our accompanying Consolidated Statements of Operations for the year ended December 31, 2016. We are responsible for further contractual payments upon our achievement of regulatory and sales milestones, up to $13 million and $225 million , respectively. These amounts are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. (xiv) Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials (which has also shown single agent activity in the treatment of various cancer types during Phase 1 studies, including breast, gastric, colorectal, and lung cancers), and made an upfront payment for these rights. Under the terms of this agreement, we received the exclusive rights to commercialize poziotinib, excluding Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. We are contractually obligated to make payments to Hanmi upon our achievement of certain regulatory and sales milestones, aggregating $33 million and $325 million , respectively, which are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. We will pay Hanmi royalties in the low to mid-teen digits on our net sales of poziotinib, potentially reduced by royalties due to other third parties. These amounts are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. In April 2018, we executed an exclusive patent and technology agreement for poziotinib’s use in treating patients with EGFR and HER2 exon 20 mutations in cancer and HER2 exon 19 mutations in cancer with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”) that had discovered its use in treating these patient-types (“Exon 19/20 Patients”). We made an upfront payment of $0.5 million upon this agreement’s execution that was recognized within “research and development” expense in the accompanying Consolidated Statements of Operations for the year ended December 31, 2018 . We will also pay MD Anderson royalties in the low single-digits on our net sales of poziotinib that relate to the treatment of Exon 19/20 Patients. We are contractually obligated to make fixed payments to MD Anderson upon our achievement of certain regulatory and sales milestones, aggregating $11 million and $23 million , respectively, which are not included within “total liabilities” in our accompanying Consolidated Balance Sheets. (xv) ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO: Out-License Agreement with Servier in Canada In January 2016, we out-licensed ZEVALIN, FOLOTYN, BELEODAQ, and MARQIBO to Servier (see Note 13 ). We received an aggregate $6 million of upfront proceeds in the first quarter of 2016, which was recognized within "license fees and service revenue" in our accompanying Consolidated Statements of Operations for the year ended December 31, 2016. In November 2018, we received a $1 million milestone receipt from Servier upon the approval of FOLOTYN in Canada (see Note 13 ). We are entitled to additional milestone receipts (aggregating $1.0 million ) upon Servier's achievement of specific regulatory approvals, and a high single-digit royalty on its sales of these products. (xvi) KHAPZORY: Data Sharing License Agreement with Medac Pharma, Inc. In March 2013, we executed a Data Sharing License Agreement with Medac Pharma, Inc, ("Medac") for certain data relating to the manufacture, testing and use of KHAPZORY (previously referred to as sodium levoleucovorin) and levofolinic acid for pharmaceutical applications. Our access to Medac's data will be used to obtain regulatory approval, and commercialize our products containing sodium levoleucovorin in the United States and Canada. In March 2015, we entered into a first amendment to the data sharing license agreement with Medac. We filed an NDA with the FDA for KHAPZORY and the FDA communicated its approval in October 2018. Consequently, we made milestone payments to Medac including (i) $0.3 million upon FDA acceptance of our NDA filing, which was recognized within "research and development" expense in our Consolidated Statements of Operations for the year ended December 31, 2017, and (ii) $2.7 million upon FDA approval for commercial sale of KHAPZORY. We capitalized the $2.7 million to "KHAPZORY distribution rights" which is presented within "intangible assets, net of accumulated amortization" (see Note 3(g) ) within our accompanying Consolidated Balance Sheets as of December 31, 2018 . (c) Service Agreements for our Research and Development Activities We have entered into various contracts with numerous third-party service providers for the execution of our research and development initiatives (to which we assign discreet project codes in order to compile and monitor such expenses). These vendors include raw material suppliers and contract manufacturers for drug products not yet FDA approved, clinical trial sites, clinical research organizations, and data monitoring centers, among others. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on the achievement of certain events specified in the agreements - such as contract execution, progress of service completion, delivery of drug supply, and the dosing of patients in clinical studies. We recognize these “research and development” expenses and corresponding “accounts payable and other accrued liabilities” in the accompanying financial statements based on estimates of our vendors’ progress of performed services, patient enrollments and dosing, completion of clinical studies, and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would typically be limited to the extent of the work completed, as we are generally able to terminate these contracts with adequate notice. (d) Supply and Service Agreements for our Commercial Products We have entered into various supply and service agreements, and/or have issued purchase orders, which obligate us to complete agreed-upon raw material purchases from certain vendors for the production of our commercialized drug products through designated contract manufacturers. These commitments do not exceed our planned commercial requirements, and the contracted prices do not exceed current fair market value. (e) Employment Agreement We previously entered into an employment agreement with our former Chief Executive Officer, Rajesh C. Shrotriya, M.D., under which cash compensation and benefits would become payable to him in the event of termination by us for any reason other than cause, his resignation for good reason, or upon a change in control of our Company. Effective December 17, 2017, Dr. Shrotriya’s employment was terminated without cause. As of December 31, 2017, we accrued for all contractual cash amounts due and unpaid to him within “accrued payroll and benefits” on the accompanying Consolidated Balance Sheets. We entered into new employment agreements with each of our named executive officers (chief executive officer, chief operating officer, chief financial officer, and chief legal officer) in April and June 2018, which supersede any prior Change in Control Severance Agreements with such individuals. These new agreements provide for the payment of certain benefits to each executive upon his separation of employment under specified circumstances. These arrangements are designed to encourage each to act in the best interests of our stockholders at all times during the course of a change in control event or other significant transaction. (f) Deferred Compensation Plan The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended. The DC Plan is maintained to provide deferred compensation benefits for a select group of our employees (the “DC Participants”). DC Participants make annual elections to defer a portion of their eligible cash compensation which is then placed into their DC Plan accounts. We match a fixed percentage of these deferrals, and may make additional discretionary contributions. At December 31, 2018 and December 31, 2017 , the aggregate value of this DC Plan liability totaled $6.2 million and $11.0 million , respectively, and is included within “accounts payable and other accrued liabilities” and "other long-term liabilities" in the accompanying Consolidated Balance Sheets. (g) Litigation We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We may also be subject to derivative lawsuits from time to time. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition. Shareholder Litigation Olutayo Ayeni v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 21, 2016 in the United States District Court, Central District of California; Case No. 2:16-cv-07074) (the “Ayeni Action”) and Glen Hartsock v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 28, 2016 in the United States District Court, District Court of Nevada Case; No. 2:16-cv-02279-RFB-GWF) (the “Hartsock Action”). On November 15, 2016, the Ayeni Action was transferred to the United States District Court for the District of Nevada. The parties have stipulated to a consolidation of the Ayeni Action with the Hartsock Action. These class action lawsuits allege that we and certain of our executive officers made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our NDA to the FDA for QAPZOLA in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended. The plaintiffs seek damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. We believe that these claims are without merit, and intend to vigorously defend against these claims. Furthermore, as of December 31, 2018 , the value of a potential settlement cannot be reasonably estimated given its highly uncertain nature. EVOMELA Litigation We obtained global development and commercialization rights to EVOMELA from CyDex Pharmaceuticals, Inc., a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated, or CyDex, in March 2013. We thereafter assumed responsibility for completing its clinical trials and were responsible for filing the New Drug Application. Under our license agreement with CyDex, CyDex received a license fee and is eligible to receive milestone payments and royalties. On December 20, 2017, CyDex filed an action against Teva Pharmaceuticals USA, Inc., TEVA Pharmaceuticals Industries Ltd., and Actavis, LLC, together Teva, in the U.S. District Court for the District of Delaware, alleging patent infringement with respect to a paragraph IV certification, or an Abbreviated New Drug Application (“ANDA”), filed with the FDA seeking approval to market a generic version of EVOMELA. CyDex brought suit against Teva to protect its intellectual property rights, for which we have a direct financial interest by virtue of our distribution rights for EVOMELA. Intellectual Property Litigation We and Onxeo received a Paragraph IV Notice Letter dated August 21, 2018, notifying us that Fresenius Kabi USA, LLC (“Fresenius”) has submitted to the FDA, an ANDA seeking approval from the FDA to manufacture and market a generic version of BELEODAQ (belinostat) for injection in the U.S. On October 3, 2018, we and Onxeo have filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware, alleging patent infringement with respect to a paragraph IV certification, or an Abbreviated New Drug Application ("ANDA"), against Fresenius which triggered an automatic stay of this ANDA for 30 months . In addition, BELOEDAQ is protected from competition in the U.S. by an Orphan Drug Exclusivity indication until July 3, 2021. |