Collaboration Agreements | 4. Collaboration Agreements (a) Genentech, Inc. In June 2003, the Company licensed its proprietary Hedgehog pathway technologies to Genentech for human therapeutic use. The primary focus of the collaborative research plan has been to develop molecules that inhibit the Hedgehog pathway for the treatment of various cancers. The collaboration is currently focused on the development of Erivedge, which is being commercialized by Genentech in the United States and by Genentech’s parent company, Roche, in several other countries for the treatment of advanced BCC. Roche is also conducting additional exploratory clinical studies in patients with less severe forms of BCC. Pursuant to the agreement, the Company is eligible to receive up to an aggregate of $115,000 in contingent cash milestone payments, exclusive of royalty payments, in connection with the development of Erivedge or another small molecule Hedgehog pathway inhibitor, assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives. Of this amount, the Company has received $59,000 as of June 30, 2016. In addition to these payments and pursuant to the agreement, the Company is entitled to a royalty on net sales of Erivedge that ranges from 5% to 7.5%. The royalty rate applicable to Erivedge may be decreased by 2% on a country-by-country basis in certain specified circumstances, including when a competing product that binds to the same molecular target as Erivedge is approved by the applicable regulatory authority in another country, and is being sold in such country, by a third party for use in the same indication as Erivedge, or, when there is no issued intellectual property covering Erivedge in a territory in which sales are recorded. In 2015, the FDA and the European Medicine Agency’s Committee for Medicinal Products for Human Use, or CHMP, approved another Hedgehog signaling pathway inhibitor, sonidegib, which is marketed by Novartis, for use in locally advanced BCC. Beginning in the fourth quarter of 2015, Genentech applied the 2% royalty reduction on United States sales of Erivedge as a result of the first commercial sale of sonidegib in the United States. In December 2012, Curis formed a wholly owned subsidiary, Curis Royalty, which received a $30,000 loan at an annual interest rate of 12.25% pursuant to a credit agreement between Curis Royalty and BioPharma-II (Note 7). In connection with the loan, Curis transferred to Curis Royalty its right to receive royalty and royalty-related payments on the commercial sales of Erivedge that it receives from Genentech. The loan and accrued interest is being repaid by Curis Royalty using such royalty and royalty-related payments. The loan constitutes an obligation of Curis Royalty and is non-recourse to Curis. The Company recognized $1,842 and $2,034 in royalty revenue under the Genentech collaboration during the three months ended June 30, 2016 and 2015, respectively, and $3,586 and $3,705 during the six months ended June 30, 2016 and 2015, respectively. The Company recorded costs of royalty revenues within the costs and expenses section of its condensed consolidated statements of operations and comprehensive loss of $95 and $103 during the three months ended June 30, 2016 and 2015, respectively, and $184 and $187 during the six months ended June 30, 2016 and 2015, respectively. For each of these periods, these amounts are comprised of 5% of the royalties earned by Curis Royalty that the Company is obligated to pay to university licensors. As further discussed in Note 7, the Company expects that all royalty revenues received by Curis Royalty from Genentech on net sales of Erivedge will be used by Curis Royalty to pay principal and interest under the loan that Curis Royalty received from BioPharma-II, subject to specified quarterly caps, until such time as the loan is fully repaid. The Company recorded research and development revenue of $56 and $84 during the three months ended June 30, 2016 and 2015, respectively, and research and development revenue of $109 and $140 during the six months ended June 30, 2016 and 2015, respectively, related to expenses incurred by the Company on behalf of Genentech that were paid by the Company and for which Genentech is obligated to reimburse the Company. Genentech incurred expenses of $218 and $46 during the three months ended June 30, 2016 and 2015, respectively, and expenses of $289 and $114 during the six months ended June 30, 2016 and 2015, respectively, under this collaboration, for which the Company is obligated to reimburse to Genentech, and which the Company has recorded as contra-revenues in its condensed consolidated statements of operations and comprehensive loss. b) Aurigene Agreement In January 2015, the Company entered into an exclusive collaboration agreement with Aurigene for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and selected precision oncology targets. Under the collaboration agreement, Aurigene granted the Company an option to obtain exclusive, royalty-bearing licenses to relevant Aurigene technology to develop, manufacture and commercialize products containing certain of such compounds. For each program, Aurigene has granted the Company an exclusive option, exercisable within 90 days after Aurigene delivers the relevant data regarding a development candidate, to obtain an exclusive, royalty-bearing license to develop, manufacture and commercialize compounds from such program, including the development candidate and products containing such compounds, anywhere in the world, except for India and Russia. For the development, manufacture, and commercialization of compounds from a particular program and products containing such compounds in India and Russia, Aurigene will grant the Company the royalty-bearing license described above for such program, and the Company will grant Aurigene an exclusive, royalty-free, fully paid license under the Company’s relevant technology upon exercise of the relevant option. During 2015, the Company exercised options to license the first two programs under this collaboration, resulting in an aggregate one-time payment of $6,000 (comprised of a $3,000 option exercise fee for each program) by the Company to Aurigene. Effective October 2015, the Company agreed to make additional payments to Aurigene totaling up to $2,000 for supplemental research, development and/or manufacturing activities in support of these two programs. The Company incurred and recognized $1,000 of such costs in the three months ended December 31, 2015, which was paid in the three months ended March 31, 2016. The remaining $1,000 was incurred and recognized in the three months ended March 31, 2016 and paid in the three months ended June 30, 2016. Also in 2015, the Company selected a preclinical program for potential further development within the immuno-oncology part of the collaboration, as described in Note 1. The Company has not yet exercised its option to license this third program under the collaboration. The Company anticipates that it will select additional programs under this collaboration in the future, and the Company intends to have the collaboration’s steering committee recommend such additional programs in order for Aurigene to initiate or continue the relevant preclinical activities described in each program’s written plan. For each option to license (as described above) exercised by the Company, the Company is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one product in each of the United States, specified countries in the European Union, and Japan, and Aurigene is obligated to use commercially reasonable efforts to perform its obligations under the development plan for such licensed program in an expeditious manner. Subject to specified exceptions, Aurigene and the Company have agreed to collaborate exclusively with each other on the discovery, research, development and commercialization of programs and compounds within immuno-oncology for an initial period of approximately two years from the effective date of the collaboration agreement. At the Company’s option, and subject to specified conditions, it may extend such exclusivity for up to three additional one-year periods by paying to Aurigene exclusivity option fees on an annual basis. The first of such option fees will be $7,500, and the Company currently estimates that this payment will be due in the first quarter of 2017. In addition, beyond the up-to five years of exclusivity described above, and subject to specified exceptions and payment by the Company of an annual exclusivity fee on a program-by-program basis, Aurigene and the Company have agreed to collaborate exclusively with each other on each program for which there are ongoing activities in research or development, or for which the Company has exercised its option to acquire an exclusive license (as described above) and the Company or its affiliates or sublicensees are actively developing or commercializing a compound or product from such program in a major market. For each product that may be commercialized, the Company has granted Aurigene the right, subject to certain conditions, to nominate one global drug substance or drug product supplier to provide up to 50% of the total requirements in the Company’s territory. Research Payments, Option Exercise Fees and Milestone Payments. • for the PD-1/VISTA and IRAK4 programs: up to $52,500 per program, comprised of: $3,000 for each option exercise, $3,000 upon acceptance of each IND filing, $4,000 upon dosing of the fifth patient in the Company’s first Phase 1 clinical trial in each program, as well as specified approval and commercial milestones, plus specified additional payments for approvals for additional indications, if any. Effective October 2015, the Company agreed to make additional payments to Aurigene totaling up to $2,000 for supplemental research, development and/or manufacturing activities in support of these two programs. During the three months ended June 30, 2016, the Company recognized and paid $3,000 to Aurigene upon the acceptance of the IND filing for CA-170, a PD-L1/VISTA antagonist. Since the inception of the agreement through June 30, 2016, the Company has incurred costs totaling $11,000 related to these programs under the collaboration; • for the third and fourth programs: up to $50,000 per program, comprised of: $2,000 for a program selection fee, $3,000 for an option exercise, $2,500 upon acceptance of an IND filing, as well as development, approval and commercial milestones, plus specified additional payments for approvals for additional indications, if any. Since the inception of the agreement through June 30, 2016, the Company has made payments to Aurigene totaling $2,000 related to the third program under this collaboration; and • for any program thereafter: up to $140,500 per program, comprised of: up to a total of $53,000 for research fees, an option exercise fee, a preclinical milestone and development milestones, as well as specified filing, approval and commercial milestones, plus specified additional payments for approvals for additional indications, if any. As of June 30, 2016, no payments have been made to Aurigene related to such programs under the collaboration. |