Collaborative Arrangements and Revenue Recognition | 5. Collaborative Arrangements and Revenue Recognition Chugai In February 2015, we entered into an exclusive license agreement (the “Chugai Agreement”) with Chugai Pharmaceutical Co., Ltd. (“Chugai”) to develop and commercialize MultiStem for the treatment of ischemic stroke in Japan. Chugai has the exclusive rights for the development, regulatory activities and commercialization of MultiStem for ischemic stroke in Japan and will pay us for supplying clinical and commercial product. Chugai will pay us royalties on net sales, starting in the low double digits and increasing incrementally to the high teens depending on net sales levels. We received a non-refundable, up-front cash payment of $10 million from Chugai, of which $2.0 million was temporarily withheld by Japan taxing authorities. The withholdings are expected to be refunded to us in August 2015 and were recorded as a receivable at June 30, 2015. Under the terms of the Chugai Agreement, we may terminate the Chugai Agreement in the event that Chugai does not pay us a $7 million milestone payment following its review of the interim results from our Phase 2 ischemic stroke study. In the event that Chugai does not make the $7 million milestone payment within the required time and we terminate the Chugai Agreement, all rights would revert to us and we would retain the up-front $10 million cash payment. Under the Chugai Agreement, the payment is due during the third quarter of 2015. To determine the appropriate accounting for the Chugai Agreement, we evaluated its terms, considering our specific facts and circumstances, to assess the rights and obligations and determined that our obligations under the Chugai Agreement represent multiple deliverables. In the period prior to Chugai’s decision to continue the collaboration and make the $7 million payment to us, the deliverables include the license grant and access to our technology, and importantly, the interim results of our stroke Phase 2 clinical study. For deliverables with standalone value, our policy is to account for these as separate units of accounting We allocate the overall consideration of the arrangement that is fixed and determinable, excluding consideration that is contingent upon future deliverables, to the separate units of accounting based on estimated selling prices (as defined in ASC 605-25) of each deliverable. We considered the deliverables and concluded that the license grant, for example, did not have standalone value (as defined in ASC 605-25) at the inception of the arrangement. At the time, the Phase 2 ischemic stroke study results were not yet available to Chugai and, once available, Chugai has several months to review the results before making the $7 million milestone payment required for it to retain its license. Thus, the effective use of the license by Chugai would not take place until after Chugai makes the $7 million payment to us. Accordingly, we have recorded the $10 million up-front payment as deferred revenue at June 30, 2015. Pfizer In 2009, we entered into a collaboration with Pfizer Inc. (“Pfizer”) to develop and commercialize our MultiStem product candidate to treat inflammatory bowel disease (“IBD”) for the worldwide market on an exclusive basis. Under the terms of the agreement, we received a $6 million non-refundable, up-front payment from Pfizer and research funding and support, totaling $6.25 million, through June 2012. In addition, Pfizer conducted a Phase 2 clinical study exploring the potential of MultiStem cell therapy to treat advanced and severe ulcerative colitis, and would be responsible for any subsequent development. Overall, the study results were disappointing, even though a single administration of the cell therapy may have had some short-term effects. Taking these results into account, following an internal portfolio review, Pfizer determined that it would not invest further in this program targeting IBD, as would be required by the collaboration, and in May 2015, notified us of this decision and its intent to terminate the license agreement effective in the third quarter of 2015. In connection with the termination, all rights that Pfizer had to the program revert to us, and intellectual property generated through the collaboration will be owned by us. Pfizer will transfer to us all preclinical and clinical data relating to the program in its possession, all reports, records and other information relating to preclinical and clinical development, and ownership of all investigator brochures, regulatory filings and approvals related to the program. We will be free to use such information, data, filings and approvals for subsequent analyses and development in this area, and such research findings to support development in other areas, including immunology and inflammatory conditions. RTI Surgical, Inc. In 2010, we entered into an agreement with RTI Surgical, Inc. (“RTI”) to develop and commercialize biologic implants using our technology for certain orthopedic applications in the bone graft substitutes market on an exclusive basis. Under the terms of the agreement, we received a non-refundable license fee in installments and performed certain services that were concluded in 2012. We are eligible to receive cash payments upon the successful achievement of certain commercial milestones. We evaluated the nature of the events triggering these contingent payments and concluded that these events are substantive and that revenue will be recognized in the period in which each underlying triggering event occurs. No milestone revenue has been recognized to date. In addition, we began receiving in 2014 tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single digits and increasing into the mid-teens. Any royalties may be subject to a reduction if third-party payments for intellectual property rights are necessary or commercially desirable to permit the manufacture or sale of the product. |