CERTAIN PORTIONS OF THIS EXHIBIT (INDICATED BY ***) HAVE BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K BECAUSE THEY ARE BOTH NOT MATERIAL AND ARE THE TYPE THAT THE COMPANY TREATS AS PRIVATE AND CONFIDENTIAL
FIRST AMENDMENT TO
COLLABORATION AND COMMERCIALIZATION AGREEMENT
This First Amendment (the “First Amendment”) to the Collaboration and Commercialization Agreement is entered into by and between Senseonics Incorporated (“Senseonics”) and Ascensia Diabetes Care Holdings AG (“Ascensia”) (each of Senseonics and Ascensia, a “Party”, and together, the “Parties”) and is effective as of March 31, 2021 (the “First Amendment Effective Date”).
WHEREAS, the Parties have entered into that certain Collaboration and Commercialization Agreement (the “Agreement”) dated as of August 9, 2020;
WHEREAS, under the Agreement, the Parties intended certain rights and obligations to arise upon FDA approval of the 180-day Product in the U.S.;
WHEREAS, due to general review delays at the FDA caused by the Covid-19 pandemic and the Parties’ shared desire to accelerate commercial activities in the U.S., the Parties mutually desire to make arrangements for an earlier transition of commercialization in the U.S. from Senseonics to Ascensia; and
WHEREAS, the Parties desire to amend and/or supplement the Agreement in accordance with Section 9.3 in order to provide for such earlier transition and to address other matters;
NOW THEREFORE, in consideration of the premises and mutual covenants contained in the First Amendment, the Parties agree as follows:
Transfer of Commercialization. Notwithstanding that the FDA has not approved the 180- day Product in the U.S. as of the date hereof, the Parties will coordinate to effect the transition of sales, marketing and commercialization activities from Senseonics to Ascensia on April 1, 2021. The Territory and Ascensia’s active commercialization efforts shall include the United States as of such date. As of April 1, 2021, except as set forth herein, the roles, responsibilities and revenue sharing arrangements which the Parties would have had with respect to marketing the 180-day Product will apply to the 90-day Product.
Roles and Responsibilities. Ascensia shall have the right to offer to sell and sell the 90-day Product to any customer within the United States and, from April 1, 2021 shall have primary responsibility for product commercialization during the Term. This shall include sales, sales management, sales operations, forecasting, marketing, billing, invoicing, contracting with and management of strategic fulfillment partners (“SFPs”), field support specialists (“FSSs”),