Business Agreements | 4. Business Agreements As noted above, in May 2016, the Company made the strategic decision to suspend the development of its prior lead program, BOW015, and will work to further evaluate strategic options for that program, which may include partnerships, divestitures and/or other value-generating alternatives. As the Company pursues this strategic review, it will also be reviewing its rights and obligations under the agreements described below. Sun Pharmaceutical Industries (formerly known as Ranbaxy Laboratories) In January 2014, the Company and Sun Pharmaceutical Industries Limited (formerly known as Ranbaxy Laboratories Limited) (“Sun”) executed a royalty-bearing and non-transferrable license agreement (“Sun License Agreement”) for BOW015 to Sun for a broad range of territories including India, selected Southeast Asian markets and North Africa. Under the terms of the Sun License Agreement, the Company and Sun agreed to pursue the commercialization of BOW015 in India and Sun received the right to sell BOW015 in the territories specified in the agreement. Sun does not have the right to manufacture BOW015. For the three months ended March 3 1 , 201 6 and 2015 , the Company recorded royalty revenue of $40 and $17 , respectively, related to commercial sales of the Company’s product, Infimab, which the Company launched with its commercialization partner Sun during the fourth quarter of 2014. As of March 31 , 20 16 , outstanding roy alty payments under the Sun agreement were $40 . Sun made an upfront payment of $500 upon the execution of the license agreement by and between the Company and Sun, dated as of January 3, 2014 and as amended from time to time (the “ Sun License Agreement”) and is obligated to pay the Company up to $1,000 if certain development and regulatory approval milestones are achieved and up to $10,000 if certain sales milestones are achieved. Under certain circumstances of uncured breach by the Company and termination of the Sun License Agreement by Sun, monetary damages of $500 would be due to Sun. The Company has invoiced Sun for a total of $ 1,375 in milestone payments, including the upfront payment, and received payments totaling $1,250 through March 31 , 201 6 . Mabxience, S.A. On May 13, 2015, the Company entered into an Exclusive License Agreement (the “MabX Agreement”) with mAbxience S.A., a company organized and existing under the laws of Uruguay and a wholly owned subsidiary of CHEMO Group (“Mabxience”), for the development, manufacturing and commercialization of BOW015. Under the MabX Agreement, the Company licensed to Mabxience an exclusive, royalty-bearing, non-transferable, sublicenseable license to develop, manufacture, commercialize and distribute BOW015 in the Mabxience territory. The Mabxience territory consists of Argentina, Chile, Ecuador, Paraguay, Uruguay and Venezuela. Pursuant to the MabX Agreement, Mabxience will be solely responsible, at its expense, for all aspects of commercialization of licensed product in the Mabxience territory. As consideration for the license granted to Mabxience, the Company is eligible to receive certain non-refundable, non-creditable milestone payments up to $1,500 upon the achievement of certain commercial sales in the Mabxience territory. Specifically, the Company will earn $250 upon the first commercial sale for each first commercial sale in each of the territory countries. In addition, the Company is eligible to receive certain royalty payments in the high teen percentages and distribution payments from Mabxience. These potential milestone and royalty payments have not been earned as of March 31, 2016. Unless terminated earlier in accordance with the terms of the agreement or extended by mutual agreement of the parties, the MabX Agreement expires 15 years following the first commercial sale of BOW015 in the Mabxience territory. Polpharma On July 13, 2015, the Company entered into a Collaboration Agreement (the “ Polpharma Collaboration Agreement”) with Swiss Pharma International AG, an affiliate of Pharmaceutical Works Polpharma S.A. (together with Swiss Pharma International AG, “Polpharma”), for the development and commercialization in certain designated territories of the Company’s product candidates, BOW015, BOW050 and BOW070. The designated territories include the European Union (with the exception of Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden, which are reserved for the Company), together with certain countries in the Middle East, Turkey, Russia, and other countries comprising the Commonwealth of Independent States, or CIS. The Company will also retain exclusive rights for the three products in North America and other markets outside of the designated territories, including Switzerland and Norway . Within the designated territories, the Polpharma Collaboration Agreement contains exclusivity provisions such that each of the Company and Polpharma agrees not to exploit any other biosimilar product based on reference product other than the three products licensed under the Polpharma Collaboration Agreement, subject to limited exceptions. The Polpharma Collaboration Agreement provides that Polpharma would bear 51% and the Company would bear 49% of total costs associated with the development programs for the three products in the designated territories. For clinical trial costs incurred in connection with global development, the cost sharing ratio is changed from 100% to 38% of total costs. As a result, under the agreement, Polpharma would bear 19% and the Company would bear 81% of total clinical trial costs incurred. Following commercial launch, profits and losses for the three products in the designated territories would be split 51% for Polpharma and 49% for the Company. For the three month period ended March 31, 2016, the Company recorded revenue of $570 related to this agreement. The Company invoiced and received a payment in the amount of $2,309 from Polpharma in January 2016. As of March 31, 2016, the Company had a deferred revenue balance of $2,263 related to the payment received for services that will be performed in future quarters of 2016. Livzon Mabpharm On September 24, 2015, the Company entered into a New Collaboration Compound Supplement to the Collaboration Agreement (the “Supplement Agreement”) with Livzon Mabpharm Inc. (“Livzon”). The Supplement Agreement amends the Exclusive License and Collaboration Agreement, dated as of September 24, 2014, by and between the Company and Livzon (the “ Livzon Collaboration Agreement”), to add the Company’s product candidate, BOW070, a biosimilar version of Actemra ® (tocilizumab), as one of the additional compounds to be developed and commercialized pursuant to the terms of the Livzon Collaboration Agreement. The Company will pay a total of $4,500 to Livzon to complete the pre-clinical development activities, consisting of: (i) an initial cash payment of $1,500 within 10 days of entry into the Livzon Supplement Agreement, which amount was paid on October 10, 2015, and (ii) three additional cash payments of $1,000 each upon the achievement of certain pre-clinical development milestones. The Company is expensing costs under the Supplement Agreement, as incurred, over the period that the work is performed (currently estimated at 18 months). For the three month period ended March 31, 2016, the Company recorded expense of $500 under the Livzon Supplement Agreement. Each of the parties is eligible to receive from t he other party royalty payments, based on gross margin of BOW070 in the other party’s territory, ranging from the low- to mid-single digit percentages. As of March 31, 2016, Livzon owned approximately 6% of the Company’s issued and outstanding common stock. |