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Collaborations
3 Months Ended
Mar. 31, 2017
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Collaborations

 


7.

Collaborations

Pfizer

On August 20, 2013, the Company and Pfizer signed an amendment to the Factor VIIa collaboration agreement in which the companies agreed to provide specific mutual releases and covenants and modify certain milestone payment schedules in the agreement.

On April 2, 2015, Pfizer notified the Company that it was exercising its right to terminate the research and license agreement effective June 1, 2015. The termination became effective 60 days after the Company’s receipt of the termination notice. On June 1, 2015, the license and certain rights under the research and license agreement terminated and reverted to the Company.

On December 8, 2016, the Company signed an agreement with Pfizer pursuant to which the parties terminated the research and license agreement that was signed on June 29, 2009. Pursuant to the new agreement, Pfizer granted the Company an exclusive license to Pfizer’s proprietary rights for manufacturing and processes that apply to Factor VIIa variants, CB 813a (marzeptacog alfa (activated)). Pfizer has also transferred and will transfer to the Company documentation related to the development, manufacturing and testing of the Products, including the Investigational New Drug (“IND”) application as well as the orphan drug designation.

As part of the new agreement, the Company agreed to make contingent cash payments to Pfizer in an aggregate amount equal to up to $17.5 million, payable upon the achievement of clinical, regulatory and commercial milestones. Following commercialization of any covered product, Pfizer would also receive a single-digit royalty on net product sales on a country-by-country basis for a predefined royalty term. No amounts have been paid to date under this new agreement.

ISU Abxis

On June 16, 2013, the Company signed a license and collaboration agreement with ISU Abxis, whereby the Company licensed its proprietary human Factor IX products to ISU Abxis for initial development in South Korea. Under the terms of the agreement, ISU Abxis is responsible for manufacturing, preclinical development activities and clinical development through completion of a proof-of-concept Phase 1/2 study in individuals with hemophilia B. The Company has the sole rights and responsibility for worldwide development, manufacture, and commercialization of Factor IX products after Phase 1/2 development. ISU Abxis may exercise its right of first refusal to acquire commercialization rights in South Korea, in which case they would be entitled to profit sharing on worldwide sales. ISU’s rights will also terminate if the Company enters into a license agreement with another party to develop, manufacture and commercialize Factor IX products in at least two major market territories.

ISU Abxis paid the Company an up-front signing fee of $1.75 million and is obligated to pay to the Company contingent milestone-based payments on the occurrence of certain defined development events, and reimbursement for a portion of the Company’s costs relating to intellectual property filings and maintenance thereof on products. The Company is obligated to pay ISU Abxis a percentage of all net profits it receives from collaboration products.

Contract revenue of $0.3 million and $0.1 million for the three months ended March 31, 2017 and 2016, respectively, reflected (i) the amortization of the up-front fee over the estimated period of the Company’s performance obligations under the agreement, which was assessed to be four years beginning in September 2013 when the agreement was executed and (ii) $0.2 million recorded in March 2017 for a milestone payment earned by the Company. The deferred revenue balance related to the ISU Abxis collaboration was $0.3 million and $0.6 million as of March 31, 2017 and 2016, respectively.