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License and Collaboration Agreements
9 Months Ended
Sep. 30, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
License and Collaboration Agreements
License and Collaboration Agreements
Otsuka Pharmaceutical Co. Ltd
In December 2014, the Company entered into a collaboration agreement (the “Collaboration Agreement”) with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) pursuant to which Otsuka will commercialize and further develop Iclusig in Japan, China, South Korea, Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand and Vietnam (the “Territory”).

In consideration for the licenses and other rights contained in the Collaboration Agreement, Otsuka paid the Company a non-refundable upfront payment of $77.5 million, less a refundable withholding tax in Japan of $15.8 million that was received in 2015. In addition, Otsuka has agreed to pay the Company up to $80.0 million in contingent milestone payments, consisting of three individual milestones for $10.0 million, $50.0 million and $20.0 million contingent upon various approvals of Japanese new drug applications. Payments received upon the completion of these milestones are based on the results of the Company's efforts and due to the level of effort required and risk of failure associated with the milestones, they are considered to be substantive in nature.

Otsuka will pay royalties based on a percentage of net sales in each country until the later of (i) the expiry date of the composition patent in each country, (ii) the expiration of any orphan drug exclusivity period or other statutory designation that provides similar exclusivity, or (iii) 10 years after the date of first commercial sale in such country. Otsuka will also pay for the supply of Iclusig purchased from the Company at a price based on a percentage of net sales in each country.
The Collaboration Agreement continues until the later of (x) the expiration of all royalty obligations in the Territory, (y) the last sale by Otsuka in the Territory, or (z) the last to expire patent in the Territory which is currently expected to be 2029. Under certain conditions, the Collaboration Agreement may be terminated by either party, in which case the Company would receive all rights to the regulatory filings related to Iclusig at our request, and the licenses granted to Otsuka would be terminated.

The nonrefundable upfront cash payment has been recorded as deferred revenue on the Company's balance sheet and is being recognized as revenue on a straight-line basis over the estimated term (currently estimated to extend through 2029), beginning at the point at which the Company began to provide all elements included in the Collaboration Agreement, which occurred in April 2015.
Medinol Ltd.
The Company entered into an agreement with Medinol Ltd. (“Medinol”) in 2005 pursuant to which the Company granted to Medinol a non-exclusive, world-wide, royalty-bearing license, under its patents and technology to develop, manufacture and sell stents and other medical devices to deliver the Company’s mTOR inhibitor, ridaforolimus, to prevent reblockage of injured vessels following stent-assisted angioplasty. The term of the license agreement extends to the later to occur of the expiration of the Company’s patents relating to the rights granted to Medinol under the license agreement or fifteen years after the first commercial sale of a product developed under the agreement.

The license agreement provides for the payment by Medinol to the Company of an upfront license fee, payments based on achievement of development, regulatory and commercial milestones and royalties based on commercial sale of products developed under the agreement. In January 2014, Medinol initiated two registration trials of its ridaforolimus-eluting stent system. The Company is eligible to receive additional regulatory, clinical and commercial milestone payments of up to $34.8 million under the agreement if two products are successfully developed and commercialized. During the third quarter of 2016, the Company recognized a $2.0 million milestone associated with the filing of the application to market and sell licensed products in the countries in the European Union. The Company expects to achieve and recognize an additional $2.5 million milestone during the fourth quarter of 2016.