XML 48 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Subsequent Events
6 Months Ended
Jun. 30, 2014
Subsequent Events

10. Subsequent Events

Commercial Supply Agreement

On July 1, 2014, we entered into a Commercial Supply Agreement (“the Agreement”) with CMC ICOS Biologics, Inc. (“CMC Biologics”), pursuant to which CMC Biologics will manufacture clinical and commercial supply of Andexanet alfa and perform pre-validation and validation work on our behalf.

Under the Agreement, we are required to purchase an aggregate fixed number of batches of Andexanet alfa from CMC Biologics from 2015 through 2021. Total batch commitments under the Agreement can be increased or decreased based on the achievement of milestones relating to the regulatory approval process for Andexanet alfa, expansion of existing manufacturing capacity and operational qualification of CMC Biologics’ manufacturing facilities. We made an upfront payment to CMC Biologics in the amount of $10.0 million in July 2014 and are required to make a reservation payment to CMC Biologics of $4.6 million in November 2014. Both payments will be credited against our future purchases of batches under the Agreement.

Total fixed commitments under the Agreement for the purchases of clinical and commercial batches, not taking into account possible price and batch adjustments, are approximately $294 million over the life of the Agreement from 2015 through 2021. We also committed to approximately $15 million worth of pre-validation and validation work which will be conducted pursuant to work orders under the arrangement.

The term of the Agreement is seven years and may be early terminated by either party for the other party’s uncured material breach or insolvency. We may also terminate the Agreement if CMC Biologics is unable to add additional manufacturing capacity on a timely basis, if certain manufacturing-related regulatory events do not occur before certain deadlines, or if the batch yield is below a certain threshold, in which case we are not obligated to pay CMC Biologics a termination payment and CMC Biologics will be obligated to refund the uncredited amounts of the upfront payment and reservation payment.

In addition, we may terminate the Agreement unilaterally if we discontinue the development and commercialization of Andexanet alfa for regulatory, safety, efficacy or other commercial reasons, or if the projected market demand or gross margin of Andexanet alfa is below a minimum threshold, in which case we will be obligated to pay CMC Biologics a termination payment ranging from between $5.0 million and $30.0 million, depending on the time of termination. Any remaining uncredited upfront payments or reservation payments at the time of termination will be credited towards the termination fee.

Collaboration with Daiichi Sankyo

In July 2014, we entered into a collaboration agreement with Daiichi Sankyo to include subjects dosed with edoxaban, their Factor Xa inhibitor product, in one of our Phase 3 studies of Andexanet alfa. We are responsible for the cost of conducting this clinical study. Daiichi Sankyo will work closely with us on both development and regulatory aspects of Andexanet alfa in connection with our Phase 3 study to the extent such matters relate to edoxaban. Pursuant to our agreement with Daiichi Sankyo we are obligated to provide research and development and regulatory approval services and participate on various committees.

 

The total consideration under this agreement of $40.0 million consists of a $15.0 million upfront payment and up to $25.0 million of payments due upon the achievement of certain milestones associated with the progress of our Phase 3 study.