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Item
1.01
Entry into a Material Definitive Agreement.
On July 1, 2017, we entered into an Amendment No. 1 to Collaboration and License Agreement (the “Amendment”) with Sanofi-Aventis Deutschland GmbH (“Sanofi”), amending the terms of our Collaboration and License Agreement with Sanofi, dated November 5, 2015 (the “Agreement”).
Under the Amendment, the clinical development milestones under the Agreement were amended to reflect an amended development plan for type 2 diabetes. Under the amended clinical development milestones,
we are eligible to receive (a) up to an aggregate of $110 million upon the achievement of four development milestones relating to the results of certain Phase 3 clinical trials of sotagliflozin in type 2 diabetes patients and (b) $100 million upon the achievement of a milestone based on the results of either of two outcomes studies in type 2 diabetes patients, the completion of which would likely occur after initial regulatory approval of sotagliflozin in type 2 diabetes. We remain eligible to receive an aggregate of $210 million upon the achievement of the amended clinical development milestones, consistent with the aggregate amount subject to the original clinical development milestones. In addition, with respect to milestones that were not modified by the Amendment, we remain eligible to receive up to $220 million upon the achievement of specified regulatory milestones and up to $990 million upon the achievement of specified commercial milestones.
Also
under the Amendment, royalties payable by Sanofi with respect to net sales of sotagliflozin in certain member states of the European Union will be based on royalty rates applicable to the European Union even if such member states subsequently withdraw from the European Union.
The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, which we expect to file as an exhibit to our quarterly report on Form 10-Q for the three months ending September 30, 2017.
Signatures
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.