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Collaboration and Licensing Agreements (Notes)
9 Months Ended
Sep. 30, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Collaborative Arrangement Disclosure [Text Block]
18.
Collaboration and Licensing Agreements
We periodically enter into collaboration and licensing agreements with other pharmaceutical companies for the development, manufacture, marketing and/or sale of pharmaceutical products. Our significant collaboration agreements are focused on the development, manufacturing, supply and commercialization of multiple, high-value generic biologic compounds, insulin analog products and respiratory products, among other complex products. Under these agreements, we have future potential milestone payments and co-development expenses payable to third parties as part of our licensing, development and co-development programs. Payments under these agreements generally become due and are payable upon the satisfaction or achievement of certain developmental, regulatory or commercial milestones or as development expenses are incurred on defined projects. Milestone payment obligations are uncertain, including the prediction of timing and the occurrence of events triggering a future obligation and are not reflected as liabilities in the Condensed Consolidated Balance Sheets, except for milestone and royalty obligations reflected as acquisition related contingent consideration. Refer to Note 11 Financial Instruments and Risk Management for contingent consideration amounts recorded. Our potential maximum development milestones not accrued for at September 30, 2018 totaled approximately $430 million, which includes the new agreements entered into as described in Note 4 Acquisitions and Other Transactions, and excludes potential milestone payments to Momenta Pharmaceuticals, Inc. (“Momenta”). We estimate the amounts that may be paid within the next year to be approximately $70 million. These agreements may also include potential sales-based milestones and call for us to pay a percentage of amounts earned from the sale of the product as a royalty or a profit share. The amounts disclosed do not include sales-based milestones or royalty obligations on future sales of product as the timing and amount of future sales levels and costs to produce products subject to these obligations is not reasonably estimable. These sales-based milestones or royalty obligations may be significant depending upon the level of commercial sales for each product.
On October 1, 2018, Momenta announced that it had initiated discussions with Mylan, to exit its participation in the development of five biosimilar programs including M834, a proposed biosimilar to ORENCIA®. Momenta also announced that it intends to continue the development of M710, a proposed biosimilar to EYLEA® (aflibercept) injection. While the Company is in the process of discussing the transition of collaboration activities with Momenta, it remains committed to invest strategically in biosimilar programs through the evaluation of regulatory data and market dynamics.
There have been no other significant changes to our collaboration and licensing agreements as disclosed in our 2017 Form 10-K.