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Commitments and Contingencies | 9 Months Ended
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Sep. 30, 2016
Commitments and Contingencies |
(7) | Commitments and Contingencies
Litigation and Other Legal Matters 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, 2015, and “Item 1. Legal Proceedings” of the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016 and June 30, 2016 include discussions of the Company’s current legal proceedings. There have been no material changes to those disclosures as of the date of this filing other than as set forth below. In September and October 2016, the Company received paragraph IV certification notices from four companies contending to varying degrees that certain of its patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of Vascepa as described in those companies’ abbreviated new drug applications, or ANDAs. The Company filed or is in the process of filing patent infringement lawsuits against each of these ANDA applicants. In October 2016, Amarin filed a lawsuit against Roxane Laboratories, Inc. and related entities, or Roxane, in the U.S. District Court for the District of Nevada. The case against Roxane is captioned Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc. et al, Civ. A. No. 2:16-cv-02525 (D. Nev.). In the Roxane lawsuit, Amarin is seeking, among other remedies, an order enjoining Roxane from marketing generic versions of Vascepa before the last to expire of the asserted patents in 2030. The Company intends to vigorously enforce its intellectual property rights relating to Vascepa, but cannot predict the outcome of the Roxane lawsuit or any subsequently filed lawsuits. 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 July 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. 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 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 $9.7 million as of September 30, 2016). 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 $6.5 million as of September 30, 2016) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $13.0 million as of September 30, 2016). 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 September 30, 2016.

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