Commitments and Contingencies

3 Months Ended

Mar. 31, 2019

Commitments and Contingencies

Commitments and Contingencies

8. Commitments and Contingencies

The Company has a Research, Development and Commercialization Agreement with Hoffmann-La Roche (“Roche”) which grants the Company a sole and exclusive license to develop, use, sell, offer for sale and import any Licensed Product as defined by the agreement.

The agreement requires future milestone payments to Roche, the remainder of which total $10 million and are earned by achieving specified objectives related to Phase 3 clinical trials and future regulatory approval in the United States and Europe of a product developed from MGL-3196 (resmetirom). A single-digit royalty payment range is based on net sales of products developed from resmetirom, subject to certain reductions.  In October 2016, the Company commenced a Phase 2 study in Non-Alcoholic Steatohepatitis (NASH), which triggered a milestone payment under the agreement. Except as described above, the Company has not achieved any additional product development or regulatory milestones to date and had no Licensed Product sales for the three months ended March 31, 2019 and 2018.

The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of the Phase 2 and 3 clinical trials.