The Uppsala-based pharmaceutical company says it is in the final stages of concluding a definitive settlement agreement, though there is no assurance that a final deal will be reached on the terms outlined.

Under the agreement in principle, Orexo would pay USD 4 million in installments over several years, along with a capped contingent payment based on 5% of net sales, conditioned on certain sales thresholds being met in 2030 and 2031.

The settlement would take the form of a Non-Prosecution Agreement (NPA) alongside a separate civil settlement, with no admission of wrongdoing by Orexo or any current or former employees. Once finalized, the NPA and civil settlement would resolve the DOJ investigation and close out Orexo’s exposure related to the matter.

Two former Orexo US employees have also reached agreements in principle with the DOJ to resolve civil claims. The company intends to seek insurance coverage for the full settlement amount on their behalf.

“The investigation by the Department of Justice has been ongoing for more than six years. I am pleased that we are close to concluding it,” says Nikolaj Sørensen, President and CEO of Orexo. “The decision to pursue a settlement is not an admission of any wrongdoing, but is based on the significant costs of a continued process and the need to focus on the continued development of Orexo and its important research.”

As a result of the progress with the DOJ, Orexo expects to recognize a provision for the estimated liability of USD 4 million. Further details on the financial impact will be disclosed separately once a final settlement agreement is signed.