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Commitments and Contingencies | 6 Months Ended
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Jun. 30, 2018
Commitments And Contingencies Disclosure [Abstract] |
Commitments and Contingencies |
(6) | Commitments and Contingencies
Litigation In the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. “Item 3. Legal Proceedings” of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and “Item 1. Legal Proceedings” of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 include discussions of the Company’s current legal proceedings. There have been no material changes to the matters described in those disclosures as of the date of this filing, other than as set forth below. On May 24, 2018, the Company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. (“Teva”) that resolves its previously reported abbreviated new drug application (“ANDA”) patent litigation as it relates to Teva’s ANDA seeking FDA approval of generic forms of both the 1-gram and 0.5-gram dose strengths of Vascepa. As part of this settlement agreement, Teva may first begin selling its generic version of Vascepa in the United States on August 9, 2029, or earlier under certain customary circumstances, including commercial launch by another generic manufacturer under certain circumstances, in which event Teva would pay the Company certain royalties on its generic Vascepa products. Under the agreement, the Company paid Teva $2.0 million in recognition of the savings to the Company in the avoidance of costs, expenditure of time and resources, disruption and burden associated with continued litigation with Teva. This patent litigation continues in the United States District Court for the District of Nevada with parties West-Ward Pharmaceuticals Corp. and Dr. Reddy’s Laboratories, Inc. and their affiliated entities as it relates to such parties’ ANDAs seeking FDA approval of generic forms of Vascepa. Milestone and Supply Purchase Obligations The Company entered into long-term supply agreements with multiple FDA-approved API suppliers and encapsulators. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls, as detailed below. The Company entered into its initial Vascepa API supply agreement with Nisshin Pharma, Inc. (“Nisshin”) in 2010. In 2011, the Company entered into agreements with two additional suppliers, Chemport, Inc. (“Chemport”) and BASF (formerly Equateq Limited), for the supply of API. In 2012, the Company agreed to terms with a fourth API supplier, a consortium of companies led by Slanmhor Pharmaceutical, Inc. (“Slanmhor”). The API supply agreement with BASF terminated in February 2014. In July 2014, the Company terminated the supply agreement with Slanmhor and subsequently, in June 2015, entered into a new supply agreement with Finorga SAS (“Novasep”). These agreements included requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities including the FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers as described below. Nisshin, Chemport and Novasep are currently the three manufacturers from which the Company purchases API. As of June 30, 2018, the Company has no royalty, milestone or minimum purchase commitments with Nisshin. Chemport was approved by the FDA to manufacture API for commercial sale in April 2013 and the Company began purchasing commercial supply from Chemport in 2013. The agreement with Chemport contains a provision requiring the Company to pay Chemport in cash for any shortfall in the minimum purchase obligations. The Company began purchasing commercial supply from Novasep in 2015. API manufactured by Novasep was previously approved by the FDA in July 2014. The 2015 supply agreement with Novasep contains a provision requiring the Company to pay Novasep a certain cash remedy for any shortfall in the minimum purchase obligations. The Company continues to meet its contractual purchase obligations. Under the 2004 share repurchase agreement with Laxdale Limited (“Laxdale”), upon receipt of marketing approval in Europe for the first indication for Vascepa (or first indication of any product containing Amarin Neuroscience Limited intellectual property acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of £7.5 million (approximately $9.9 million as of June 30, 2018). Also under the Laxdale agreement, upon receipt of a marketing approval in the United States or Europe for a further indication of Vascepa (or further indication of any other product using Amarin Neuroscience Limited intellectual property), the Company must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $6.6 million as of June 30, 2018) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $13.2 million as of June 30, 2018). The Company has no provision for any of the obligations above since the amounts are either not probable or able to be estimated as of June 30, 2018.

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