Inotiv, announced that Envigo entered a settlement with the US Department of Justice (DOJ) and the US Department of Agriculture (USDA) that resolves an extensive civil and administrative investigation into Envigo’s facility in Cumberland, VA.
The settlement, which was mutually entered into by all parties involved and approved by the court on July 15, does not require that Envigo pay any fines or penalties to governmental agencies. In addition, it is expressly stated that the settlement is not an admission of liability or wrongdoing by Envigo with regard to its past operation of the Cumberland Facility.
The resolution incorporates the transfer plan that was mutually agreed to by the DOJ and Envigo on July 1, 2022 (the “Transfer Plan”), and it concludes all related civil and administrative complaints related to the Cumberland Facility. In addition, the settlement requires that the DOJ and USDA move to dismiss the civil and administrative complaints with prejudice seven days after all the canines vacate the Cumberland Facility pursuant to the Transfer Plan.
This resolution follows Inotiv’s press release on June 13, in which Inotiv’s President and Chief Executive Officer, Robert Leasure, Jr., commented, “Since the Envigo acquisition in November 2021, the Cumberland Facility was recognized as needing improvements and investments,” and that “the required investments to improve such facility and the lead time to achieve these improvements had recently increased.” In the same press release, Inotiv announced its decision to discontinue investment in the Cumberland Facility and shut it down, considering that the sales derived from the site comprise less than 1% of Inotiv total sales and have not contributed to profits in the Company’s Research Models and Services segment since its acquisition.
This settlement confirms the orderly closure plan of the Cumberland Facility as previously announced in court filings. Inotiv expects that it will take approximately 60 days to close the Cumberland Facility. Following the closure, Envigo will not engage in any activity that requires a USDA license at the site.
Mr. Leasure concluded, “As a leading contract research organization and supplier of models for research, Inotiv has the important responsibility and honor of contributing to the future of medicine. Our work and the work of our clients is essential to saving human lives. Without critical drug discovery and development efforts, millions of people around the world would continue their lives devoid of any hope for treatments and cures to life-threatening diseases. Our top priority continues to be ensuring proper animal welfare and regulatory compliant practices at all of our facilities.”
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