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Significant Contracts | 12 Months Ended
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Dec. 31, 2016
Significant Contracts Disclosure [Abstract] |
Significant Contracts | 3. Significant Contracts Distribution, Licensing and Research Agreements The Company has entered into licensing agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company is required to pay royalties on future sales of products employing the technology or falling under claims of patent applications. Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights for sapacitabine, its lead drug candidate, the Company is under an obligation to use reasonable endeavors to develop a product and obtain regulatory approval to sell a product and has agreed to pay Daiichi Sankyo an up-front fee, reimbursement for Daiichi Sankyo’s enumerated expenses, milestone payments and royalties on a country-by-country basis. The up-front fee, Phase 3 entry milestone, and certain past reimbursements have been paid. A further $10.0 million in aggregate milestone payments could be payable subject to achievement of all the specific contractual milestones which are primarily related to regulatory approval in various territories, and the Company’s decision to continue with these projects. Royalties are payable in each country for the term of patent protection in the country or for ten years following the first commercial sale of licensed products in the country, whichever is later. Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt losses. The agreement extends from its commencement date to the date on which no further amounts are owed under it. If the Company wishes to appoint a third party to develop or commercialize a sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified and given a right of first refusal, with the right of first refusal ending sixty days after notification, to develop and/or commercialize in Japan. In general, the license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial reasons on six months’ notice, or twelve months’ notice, if after a launch of a sapacitabine-based product, or by either party for material default. There were no milestones earned in 2015 or 2016. Collaboration, supply and licensing agreements In June 2015, the Company entered into a collaboration, licensing and supply agreement with ManRos Therapeutics SA (“ManRos”), for the exclusive development and commercialization of the Company’s oral seliciclib capsules by ManRos as a treatment for cystic fibrosis (“CF”). Among other terms of the agreement, ManRos licensed rights to the Company’s proprietary clinical data to enable clinical development of seliciclib for CF indications. The agreement provides for supply of seliciclib investigational product for initial and later stage clinical trials of seliciclib in CF and technical assistance related to the Company’s know-how to facilitate these trials. The Company received an up-front payment in July 2015 and reached a development milestone in September 2015. The Company will receive further milestone payments and tiered royalties, if seliciclib is commercialized for the treatment of CF. The upfront and milestone payments have been allocated to the separate deliverables within the arrangement and recognized over the period in which the deliverables are met. The significant deliverables within the arrangement are : (1) license to ManRos Company’s know-how (2), initial technical assistance, (3) further technical assistance during the CF trial, (4) supply of product and (5) Company know how to facilitate trials. The Company believes that each of these deliverables represent separate units of accounting with standalone values. The consideration has been allocated to the five deliverables/accounting units based on the Company’s best estimate of selling prices because the Company does not have vendor-specific objective evidence or readily available third party evidence of the standalone selling price. The consideration allocated to the Company’s know-how was determined based on a market approach using similar license deals for a Phase 1/2 asset. The Company reviewed various licensing transactions in the public domain in the CF area and similar stage of asset development. In the year ended December 31, 2015 and 2016, the Company recognized revenue of $250,000 and $0, respectively.

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- Definition The entire disclosure of significant contracts pursuant to distribution, licensing and research agreements entered by the reporting entity during the current period. + References No definition available. + Details
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