Collaboration and License Agreements | Collaboration and License Agreements Eureka Therapeutics, Inc. and Memorial Sloan Kettering Cancer Center In August 2016, the Company entered into a license agreement with Memorial Sloan Kettering Cancer Center ("MSK") and Eureka Therapeutics, Inc. pursuant to which the Company obtained an exclusive license pertaining to a fully-human binding domain targeting B-cell maturation antigen ("BCMA"), as well as binding domains against two additional undisclosed multiple myeloma targets to be used for the potential development and commercialization of CAR cell therapies for patients with multiple myeloma. The Company made an upfront cash payment and agreed to pay additional amounts upon achievement of specified clinical, regulatory, and commercial milestones, as well as royalties on net sales of licensed products and services by us or our affiliates and sublicensees. Celgene The Company is party to a Master Research and Collaboration Agreement (“Celgene Collaboration Agreement”) with Celgene Corporation and one of its wholly owned subsidiaries (together, “Celgene”) pursuant to which the Company and Celgene agreed to collaborate on researching, developing, and commercializing novel cellular therapy product candidates and other immuno-oncology and immunology therapeutics, including, in particular, CAR and TCR product candidates. The Company is also party to a Share Purchase Agreement (the “Celgene Share Purchase Agreement”) with Celgene. The Celgene Collaboration Agreement and Celgene Share Purchase Agreement, and the Company’s accounting analysis pertaining to these agreements, are described in Note 4 of the financial statements included in the 2015 Annual Report. In March 2016, Celgene exercised its annual right to purchase additional shares of the Company’s common stock to “top-up” its ownership interest in the Company. Celgene purchased 1,137,593 shares at a price of $41.32 per share, for an aggregate cash purchase price of $47.0 million . As Celgene did not exercise the top-up right in full to reach 10% ownership that would have been permitted by the top-up right, the top-up right that will be triggered by the filing of the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2016 will only permit Celgene to top-up its ownership stake of the Company’s common stock to 9.76% . In April 2016, Celgene exercised its opt-in right to develop and commercialize product candidates from the Company’s CD19 program outside North America and China. As a result, the Company and Celgene entered into a license agreement (the “Celgene CD19 License”) pursuant to which Celgene received an exclusive, royalty-bearing license to develop and commercialize therapeutic CAR product candidates from the Company’s CD19 program in all territories outside of North America and China (the “Celgene Territory”). The Company retains all rights to develop further and commercialize such product candidates in North America and China (the “Juno Territory”). The Company and Celgene will generally share worldwide research and development costs, while the Company will be responsible for commercialization costs in the Juno Territory and Celgene will be responsible for commercialization costs in the Celgene Territory. The Company has the right to participate in specified commercialization activities for licensed products arising from the CD19 program in certain major European markets. Celgene has the right to participate in specified commercialization activities in North America for licensed products for certain indications under the CD19 program. The Company received a $50.0 million option exercise fee from Celgene upon the exercise of Celgene’s option to license CAR product candidates from the CD19 program. The Company will also receive royalties from Celgene for CAR product candidates arising from the CD19 program at a percentage in the mid-teens of net sales of such product candidates in the Celgene Territory. The Celgene CD19 License agreement contains the following deliverables: (1) an exclusive license with respect to intellectual property, (2) transfer of certain clinical and manufacturing knowledge and related support, and (3) participation on various collaboration committees during the technology transfer period. The Company has accounted for these deliverables as a single unit of accounting because they do not have standalone value and the obligations will be delivered throughout the estimated period of performance. The $50.0 million option exercise fee was recorded in deferred revenue and is being recognized ratably over the period in which the Company expects to fulfill these performance obligations, which was initially determined to be approximately two years . To the extent the Company’s research and development costs for the CD19 program exceed Celgene’s research and development costs for the CD19 program for a given quarter, Celgene is required to provide partial reimbursement to the Company for such costs. The Company recognizes the reimbursement by Celgene as revenue in the period the services are performed. To the extent Celgene’s research and development costs for the CD19 program exceed the Company’s research and development costs for the CD19 program for a given quarter, the Company is required to provide Celgene partial reimbursement for such costs. The Company recognizes the reimbursement to Celgene as additional research and development expense in the period the services are provided. The Company recognized revenue of $20.7 million and $43.4 million in the three and nine months ended September 30, 2016 , respectively, in connection with the Celgene Collaboration Agreement and the Celgene CD19 License. The Company recognized $1.3 million in revenue for the three and nine months ended September 30, 2015 in connection with the Celgene Collaboration Agreement. Fred Hutchinson Cancer Research Center In October 2013, the Company entered into a collaboration agreement with the Fred Hutchinson Cancer Research Center (“FHCRC”) focused on research and development of cancer immunotherapy products and a license agreement pertaining to certain patent rights. The Company also granted FHCRC rights to certain share-based success payments. The collaboration agreement, license agreement, the share-based success payments, and the Company’s accounting analysis pertaining to these agreements and share-based success payments, are described in Note 4 of the financial statements included in the 2015 Annual Report. In December 2015, the Company entered into an agreement with FHCRC to support the establishment of a clinical immunotherapy trial unit. Excluding the expense or gain related to success payment obligations, the Company recognized $3.2 million and $3.1 million of research and development expenses in connection with its collaboration and funding agreements with FHCRC for the three months ended September 30, 2016 and 2015 , respectively, and $11.9 million and $7.5 million for the nine months ended September 30, 2016 and 2015 , respectively. The estimated fair value of the total success payment obligation to FHCRC, after giving effect to the success payments achieved and paid in December 2015, was approximately $37.2 million and $67.3 million as of September 30, 2016 and December 31, 2015 , respectively. With respect to the FHCRC success payment obligations, the Company recognized a gain of $10.5 million and $15.3 million in the three months ended September 30, 2016 and 2015 , respectively. The Company recognized a gain of $13.3 million in the nine months ended September 30, 2016 compared to an expense of $14.6 million in the nine months ended September 30, 2015 . The expense and gain are recorded in research and development expense in the condensed consolidated statements of operations, and represent the change in the FHCRC success payment liability during such periods and the respective months of accrued expenses. The FHCRC success payment liabilities on the condensed consolidated balance sheets as of September 30, 2016 and December 31, 2015 were $20.5 million and $33.8 million , respectively. The Company’s liability for share-based success payments under the FHCRC collaboration is carried at fair value and recognized as expense over the term of the six -year collaboration agreement. To determine the estimated fair value of the success payment liability, the Company uses a Monte Carlo simulation methodology which models the future movement of stock prices based on several key variables. The following variables were incorporated in the calculation of the estimated fair value of the success payment liability as of the following balance sheet dates: Assumptions September 30, 2016 December 31, 2015 Fair value of common stock $ 30.01 $ 43.97 Risk free interest rate 1.15% - 1.48% 1.89% - 2.20% Expected volatility 70% 70% Expected term (years) 5.04 - 8.04 5.79 - 8.79 The computation of expected volatility was estimated using a combination of available information about the historical volatility of stocks of similar publicly-traded companies for a period matching the expected term assumption and the Company’s historical and implied volatility. The risk free interest rate and expected term assumptions depend on the estimated timing of U.S. Food & Drug Administration (“FDA”) approval. In addition, the Company incorporated the estimated number and timing of valuation measurement dates in the calculation of the success payment liability. Memorial Sloan Kettering Cancer Center In November 2013, the Company entered into a sponsored research agreement with MSK focused on research and development relating to CAR T cell technology and a license agreement pertaining to certain patent rights and intellectual property rights related to certain know-how. The Company also granted MSK rights to certain share-based success payments. The sponsored research agreement, license agreement, the share-based success payments, and the Company’s accounting analysis pertaining to these agreements and share-based success payments, are described in Note 4 of the financial statements included in the 2015 Annual Report. The Company is also party to clinical study agreements with MSK. Excluding the expense or gain related to success payment obligations, the Company recognized $0.9 million and $1.0 million of research and development expenses in connection with its research and clinical agreements with MSK for the three months ended September 30, 2016 and 2015 , respectively, and $1.7 million and $3.8 million for the nine months ended September 30, 2016 and 2015 , respectively. The estimated fair value of the total success payment obligation to MSK, after giving effect to the success payment achieved in December 2015 and paid in March 2016, was approximately $22.7 million and $48.9 million as of September 30, 2016 and December 31, 2015 , respectively. With respect to the MSK success payment obligations, the Company recognized a gain of $7.2 million and $10.3 million in the three months ended September 30, 2016 and 2015 . The Company recognized a gain of $7.5 million in the nine months ended September 30, 2016 compared to an expense of $2.7 million in the nine months ended September 30, 2015 . The expense and gain are recorded in research and development expense in the condensed consolidated statements of operations, and represent the change in the MSK success payment liability during such periods and the respective months of accrued expense. The MSK success payment liabilities on the condensed consolidated balance sheets as of September 30, 2016 and December 31, 2015 were $14.0 million and $31.0 million , respectively. The Company’s liability for share-based success payments under the MSK collaboration is carried at fair value and recognized as expense over the term of the five-year collaboration agreement. To determine the estimated fair value of the success payment liability, the Company uses a Monte Carlo simulation methodology which models the future movement of stock prices based on several key variables. The following variables were incorporated in the calculation of the estimated fair value of the success payment liability as of the following balance sheet dates: Assumptions September 30, 2016 December 31, 2015 Fair value of common stock $ 30.01 $ 43.97 Risk free interest rate 1.16% - 1.49% 1.91% - 2.20% Expected volatility 70% 70% Expected term (years) 5.14 - 8.14 5.89 - 8.89 The computation of expected volatility was estimated using a combination of available information about the historical volatility of stocks of similar publicly-traded companies for a period matching the expected term assumption and the Company’s historical and implied volatility. The risk free interest rate and expected term assumptions depend on the estimated timing of FDA approval. In addition, the Company incorporated the estimated number and timing of valuation measurement dates in the calculation of the success payment liability. St. Jude Children’s Research Hospital/Novartis The Company is party to a license agreement with St. Jude (“St. Jude License Agreement”) pertaining to certain patent rights owned by St. Jude. In connection with the April 2015 settlement of Trustees of the University of Pennsylvania v. St. Jude Children’s Research Hospital, Civil Action No. 2:13-cv-01502-SD (E.D. Penn.), in which the Company was a party (the “Penn Litigation”), the Company entered into a sublicense agreement (the “Penn/Novartis Sublicense Agreement”) with the Trustees of the University of Pennsylvania and an affiliate of Novartis pursuant to which the Company granted to Novartis a sublicense pertaining to patent rights licensed to the Company under the St. Jude License Agreement. The St. Jude License Agreement and the Penn/Novartis Sublicense Agreement are described in Note 4 of the financial statements included in the 2015 Annual Report. In January 2016, a clinical milestone was met under both the Penn/Novartis Sublicense Agreement and the St. Jude License Agreement, pursuant to which the Company received a payment of $5.8 million from Novartis, and the Company made a corresponding payment to St. Jude of $5.0 million . A second clinical milestone was met in June 2016, in connection with which the Company received a payment of $8.5 million from Novartis, and the Company made a corresponding payment to St. Jude of $7.5 million . Seattle Children’s Research Institute In February 2014, the Company entered into a sponsored research agreement with Seattle Children’s Research Institute (“SCRI”) and a license agreement with SCRI pertaining to certain patent rights. The Company is also party to clinical support and manufacturing services agreements with SCRI related to the Company’s JCAR017 trials. The sponsored research agreement, license agreement, and clinical support agreement with SCRI are described in Note 4 of the financial statements included in the 2015 Annual Report. The Company recognized $1.1 million of research and development expense in connection with its sponsored research, clinical support and manufacturing services agreements with SCRI for the three months ended September 30, 2016 and 2015 . The Company recognized $3.5 million and $1.4 million of research and development expense in connection with its sponsored research, clinical support and manufacturing services agreements with SCRI for the nine months ended September 30, 2016 and 2015 , respectively. Opus Bio The Company is party to a license agreement with Opus Bio, Inc. (“Opus Bio”) pertaining to certain patent rights and data. The license agreement is described in Note 4 of the financial statements included in the 2015 Annual Report. Two milestones under the license agreement were achieved in the first quarter of 2016 , for which the Company issued a total of 603,364 shares of its common stock as payment and recorded research and development expense of $23.2 million based on the fair value of the common stock on the date the milestones were achieved. After giving effect to the achievement of these milestones, as of September 30, 2016 , one milestone required to be paid in equity in the amount of $25.0 million remains to be achieved, along with up to $215.0 million in milestones payable in cash. Fate Therapeutics In May 2015, the Company entered into a collaboration and license agreement with Fate Therapeutics, Inc. (“Fate Therapeutics”), to identify and utilize small molecules to modulate the Company’s genetically-engineered T cell product candidates to improve their therapeutic potential for cancer patients. The collaboration and license agreement is described in Note 4 of the financial statements included in the 2015 Annual Report. The Company recognized $0.5 million of research and development expense in connection with its collaboration agreement with Fate Therapeutics for the three months ended September 30, 2016 and 2015 . The Company recognized $1.5 million and $0.8 million of research and development expense in the nine months ended September 30, 2016 and 2015 , respectively. Editas Medicine In May 2015, the Company entered into a collaboration and license agreement with Editas Medicine, Inc. (“Editas”), to pursue research programs utilizing Editas’ genome editing technologies with Juno’s CAR and TCR technologies. The collaboration and license agreement is described in Note 4 of the financial statements included in the 2015 Annual Report. The Company recognized $0.9 million and $0.8 million of research and development expense in connection with its collaboration agreement with Editas for the three months ended September 30, 2016 and 2015 , respectively. The Company recognized $2.9 million and $1.0 million of research and development expense in the nine months ended September 30, 2016 and 2015 , respectively. |