Collaboration Agreements | 4. Collaboration Agreements (a) Genentech 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 Roche in several other countries for the treatment of advanced basal cell carcinoma. Genentech’s parent company, Roche, is also conducting additional exploratory Phase 2 studies in patients with less severe forms of basal cell carcinoma. Pursuant to the agreement, the Company is eligible to receive up to an aggregate of $115,000,000 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 $59,000,000 as of June 30, 2015. In June 2014, Roche filed an investigational new drug application for the use of Erivedge in patients with idiopathic pulmonary fibrosis, a non-oncology indication, resulting in a milestone payment of $3,000,000 to the Company. As a result of this milestone payment, the Company recognized revenue of $3,000,000 during the three and six months ended June 30, 2014. No such payments were received during the three and six months ended June 30, 2015. Pursuant to agreements by and between the Company and two university licensors, the Company has made certain payments to such licensors in connection with its receipt of milestone payments from Genentech. The Company recorded research and development expenses of $150,000 during the three and six months ended June 30, 2014, related to the payments the Company made to its licensors upon the Company’s receipt of this milestone payment from Genentech. In addition to the contingent cash milestone payments, the Company’s wholly-owned subsidiary, Curis Royalty, is entitled to a royalty on net sales of Erivedge that ranges from 5% to 7.5% based upon global Erivedge sales by Roche and Genentech, subject to reduction under specified circumstances. Future royalty payments related to Erivedge will service the outstanding debt and accrued interest to BioPharma-II, up to the quarterly caps for 2015, and until the debt is fully repaid thereafter (see Note 7). The Company recognized royalty revenues from Genentech’s net sales of Erivedge of $2,033,836 and $1,823,935 during the three months ended June 30, 2015 and 2014, respectively, and $3,704,906 and $3,112,183 during the six months ended June 30, 2015 and 2014, respectively. The Company recorded cost of royalty revenues within the costs and expenses section of its Condensed Consolidated Statements of Operations and Comprehensive Loss of $102,972 and $91,837 during the three months ended June 30, 2015 and 2014, respectively, and $187,064 and $156,985 during the six months ended June 30, 2015 and 2014, respectively. For each of these periods, these amounts are comprised of 5% of the Erivedge 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 the specified quarterly cap, until such time as the loan is fully repaid. The Company recorded research and development revenue of $80,938 and $31,376 during the three months ended June 30, 2015 and 2014, respectively, and research and development revenue of $136,724 and $71,237 during the six months ended June 30, 2015 and 2014, 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 $45,630 and $54,153 during the three months ended June 30, 2015 and 2014, respectively, and expenses of $114,405 and $139,583 during the six months ended June 30, 2015 and 2014, 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 Collaboration Overview. The collaboration agreement specifies that the first two programs will be directed at developing orally available small molecules that will target the modulation of IRAK4 and PD-1 pathway, respectively. The Company anticipates that at least two additional programs will be selected within two years of the effective date of the collaboration agreement, and the Company’s goal is to have the collaboration’s steering committee recommend as many additional programs as feasible, in order for Aurigene to initiate or continue the relevant preclinical activities as described in a written plan for each program. In April 2015, the Company selected a third program under this collaboration which is directed at antagonizing an immune checkpoint target. Under the terms of its agreement with Aurigene, Curis made a $2,000,000 milestone payment to Aurigene as a result of this selection. 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, excluding India and Russia. Upon exercise of the option for a particular program, 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 to develop, manufacture and commercialize compounds from such program and products containing such compounds in India and Russia. For each program with respect to which the Company exercises the option to license (as described above), it is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one product in each of the U.S., 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. In addition, beyond the up-to five years of exclusivity described above, and subject to specified exceptions, 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 exclusively 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, subject to the Company’s payment of an annual exclusivity fee on a program-by-program basis. For each product that may be commercialized, the Company has granted Aurigene the right, subject to certain conditions, to nominate one global supplier of drug substance or drug product to provide up to 50% of the total requirements in the Company’s territory. Up-front Equity Issuance. Research Payments, Option Exercise Fees and Milestone Payments. • for the first two programs: up to $52,500,000 per program, including up to $10,000,000 for an option exercise fee, a preclinical milestone and development milestones, as well as specified approval and commercial milestones, plus specified additional payments for approvals for additional indications, if any; • for the third and fourth programs: up to $50,000,000 per program, including up to $7,500,000 for research fees, an option exercise fee, a preclinical milestone and development milestones, as well as specified approval and commercial milestones, plus specified additional payments for approvals for additional indications, if any; and • for any program thereafter: up to $140,500,000 per program, including up to a total of $53,000,000 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. Royalties on Net Sales by the Company. Amounts that the Company Receives from Sublicensees. • with respect to amounts that the Company and its affiliates receive from sublicensees with respect to the grant of a sublicense of a licensed program in the U.S. or the European Union, a declining percentage of non-royalty sublicense revenues that is dependent on the stage of the most advanced product for such licensed program at the time the sublicense is granted, including for example 25% of such amounts following the Company’s initiation of Phase 2 clinical study and 15% of such amounts after initiation of the first pivotal study. This sharing will also extend to royalties that the Company receives from sublicensees, subject to minimum royalty percentage rates that the Company is obligated to pay to Aurigene, which generally range from mid-to-high single-digit royalty percentage rates up to 10%; • with respect to sublicensing revenues the Company and its affiliates receive from sublicensees with respect to the grant of a sublicense of a licensed program in Asia, 50% of such sublicensing revenues, including both non-royalty sublicensee revenues and royalties that the Company receives from sublicensees; and • with respect to non-royalty sublicensing revenues the Company and its affiliates receive from sublicensees with respect to the grant of a sublicense of a licensed program outside of the U.S., the European Union and Asia, a percentage of such non-royalty sublicense revenues ranging from 30% to 50%. The Company is also obligated to share 50% of royalties that the Company receives from sublicensees that it receives in these territories. The Company’s royalty payment obligations (including with respect to royalties on sales by sublicensees) under the collaboration agreement with respect to a product in a country will expire on a product-by-product and country-by-country basis on the later of (i) expiration of the last-to-expire valid claim of the Aurigene patents covering the manufacture, use or sale of such product in such country and (ii) 10 years from the first commercial sale of such product in such country. Term and Termination. The collaboration agreement may be terminated, either in its entirety or with respect to a particular program, by either Aurigene or the Company for uncured material breach by the other party, other than an uncured material breach by the other party of its diligence obligations with respect to a program or licensed program. If an uncured material breach other than a diligence breach relates to a particular program or licensed program, the non-breaching party may terminate the collaboration agreement only with respect to that program or licensed program. However, after initiation of the first pivotal clinical trial of a product for a licensed program, Aurigene may not terminate the collaboration agreement with respect to such licensed program for an uncured non diligence breach by the Company, except in the case of the Company’s uncured material breach of its payment obligations with respect to such licensed program, but Aurigene may pursue any and all remedies that may be available to it at law or in equity as a result of such breach. Similarly, after initiation of the first pivotal clinical trial of a product for a licensed program, the Company may not terminate the collaboration agreement with respect to the license the Company has granted Aurigene for the its territory or India and Russia for such licensed program for an uncured non diligence breach by Aurigene, but the Company may pursue any and all remedies that may be available at law or in equity as a result of such breach. On a program-by-program basis, the Company may terminate the collaboration agreement as it relates to a program or licensed program for an uncured diligence breach by Aurigene with respect to such program or licensed program, and Aurigene may terminate the collaboration agreement as it relates to a licensed program for an uncured diligence breach by the Company with respect to such licensed program. In addition, the Company may terminate the collaboration agreement in its entirety or as it relates to a particular program or licensed program or on a country-by-country basis, for any reason or for no reason at any time upon 60 days’ prior written notice to Aurigene. In the event of termination of the collaboration agreement in its entirety before the Company has exercised the option for any program, or termination of the collaboration agreement as it relates to any program prior to exercise of the option for such program, all rights and licenses granted by either Aurigene or the Company to the other party with respect to such program under the collaboration agreement (including the option for such program) will automatically terminate. If the royalty term with respect to a product for any licensed program in any country has expired on or before any termination of the collaboration agreement in its entirety or as to such licensed program, the license granted by Aurigene to the Company with respect to such product in such country, as well as the corresponding license granted to Aurigene in its territory, shall survive such termination of the collaboration agreement. Solely in the event of termination of the collaboration agreement by Aurigene for the Company’s uncured breach, or the Company’s termination of the collaboration agreement for convenience, the following will apply to any program that was a licensed program immediately prior to such termination: • the Company’s license with respect to any licensed program that is not a terminated program (defined below), either in the Company’s entire territory or in countries within our territory outside of the terminated region (defined below), as applicable, shall continue in full force and effect, subject to all terms and conditions of the collaboration agreement, including the Company’s payment obligations; • the Company’s license with respect to any terminated program, either in the Company’s entire territory or in the terminated region, as applicable, shall terminate and revert to Aurigene; • the Company will grant Aurigene a perpetual, royalty-free (except for pass-through royalties and milestone payments payable by the Company under licenses to third party patent rights with respect to products developed or commercialized by or on behalf of Aurigene) license, with the right to sublicense, under the Company’s relevant patent rights and other technology solely to develop, manufacture and commercialize compounds and products for any terminated program, either in the Company’s entire territory or in the terminated region, as applicable. The foregoing license will be non-exclusive with respect to the Company’s patent rights and exclusive with respect to its other technology; • the Company will grant to Aurigene a right of first negotiation, exercisable within 90 days after termination, to obtain an exclusive, royalty-bearing license, with the right to sublicense, under our relevant patent rights solely to develop, manufacture and commercialize compounds and products for any terminated program, either in the Company’s entire territory or in the terminated region, as applicable, upon commercially reasonable terms and conditions to be negotiated in good faith by the parties; • the Company will perform other specified activities and actions reasonably necessary for Aurigene to develop, manufacture and commercialize compounds and products for any terminated program, either in the Company’s entire territory or in the terminated region, as applicable; and • the applicable license to Aurigene will survive termination. For purposes of the foregoing, “terminated program” means: (i) in the case of termination of the collaboration agreement in its entirety by Aurigene for our uncured non diligence breach, any program that was a licensed program immediately prior to such termination, but excluding, except in the case of our uncured material breach of the Company’s payment obligations with respect to such licensed program, any such licensed program for which initiation of the first pivotal clinical trial of a product has occurred prior to such termination; (ii) in the case of any termination of the collaboration agreement as to a particular licensed program by Aurigene either for the Company’s uncured non diligence breach (to the extent termination as to such licensed program is permitted) or our uncured diligence breach, such licensed program; (iii) in the case of the Company’s termination of the collaboration agreement in its entirety for convenience, any program that was a licensed program immediately prior to such termination; or (iv) in the case of the Company’s termination of the collaboration agreement as to a particular licensed program for convenience, such licensed program; provided, however, that, in the case of the preceding clauses (iii) and (iv), if the Company’s termination of the collaboration agreement in its entirety or as to a particular licensed program for convenience was with respect only to a particular country or subset of countries within the entire territory (as applicable, a “terminated region”), the applicable licensed program(s) shall be considered “terminated program(s)” only in the terminated region but shall remain licensed program(s) in the rest of the Company’s territory. Accounting Summary. In April 2015, the Company selected a third program under this collaboration which triggered a payment of $2,000,000 to Aurigene. As a result, the Company recognized $2,000,000 as research and development expenses within its Consolidated Statement of Operations and Comprehensive Loss for the three and six months ended June 30, 2015. (c) Debiopharm International S.A. Termination and Transition Agreement In February 2015, the Company entered into a termination and transition agreement with Debiopharm International S.A., or Debiopharm to terminate the August 5, 2009 license agreement between the Company and Debiopharm, under which the Company granted Debiopharm an exclusive, worldwide license to Debio 0932, a small molecule inhibitor of heat shock protein 90, or HSP90, as amended. Under the terms of the termination and transition agreement, the licenses and all other rights granted by the Company related to Debio 0932 have been terminated and reverted to the Company effective as of the termination date. Debiopharm ceased enrollment in all clinical trials as of the termination date. In addition, the Company exercised its right, pursuant to the license agreement, to obtain a non-exclusive, worldwide, royalty-bearing license, with the right to sublicense, under intellectual property rights of Debiopharm to develop, make, have made, use, sell, offer for sale, have sold and import Debio 0932 and any product containing Debio 0932, and Debiopharm will transfer to the Company the U.S. investigational new drug application related to Debio 0932. Debiopharm also assigned its sole patent application related to Debio 0932 to the Company. Under the terms of the transition agreement, Debiopharm will transition ongoing Debio 0932 development and manufacturing activities to the Company and will transfer the manufacturing technology necessary for the manufacture of Debio 0932 and all data generated by or on behalf of Debiopharm relating to Debio 0932 to the Company. In February 2015, the Company agreed to make the following payments to Debiopharm under the terms of the termination and transition agreement: Up-front drug product payment. Milestone payments. (i) $3,000,000 within 30 days after the first dosing of the first patient in the first Phase 3 clinical trial of Debio 0932; and (ii) $10,000,000 within 30 days after receipt of the first marketing approval for Debio 0932 in the United States of America or any specified major European market (whichever occurs first). Royalties on the Company’s net sales. Amounts that the Company receives from sublicensees. • 10% of any royalties that the Company receives from third party sublicensees based on such sublicensees’ net sales of products containing Debio 0932; and • 15% of any non-royalty sublicense payments that the Company receives from third party sublicensees, provided that the maximum aggregate amount payable by the Company to Debiopharm with respect to non-royalty sublicense payments is $20,000,000, unless such sublicense payments are attributable to the Company’s grant to a third party sublicensee of a license or sublicense to develop or commercialize a topical formulation of Debio 0932 for local, non-systemic delivery for the treatment of psoriasis, in which case there is no such maximum aggregate. (d) The Leukemia & Lymphoma Society Agreement November 2011 Agreement. In August 2015, the Company entered into an amendment of the November 2011 agreement with LLS. Under this amendment, LLS has agreed to provide advisory services to the Company regarding CUDC-907 as well as its IRAK4 program under the Company’s collaboration with Aurigene, and LLS will no longer be obligated to make further milestone payments related to the Company’s ongoing clinical development of CUDC-907. The Company has agreed to make up to $1,650,000 in future payments to LLS pursuant to certain objectives, including a licensing, sale or other similar transaction, as well as regulatory and commercial objectives, in each case related to the CUDC-907 |