On November 5, 2020, Regeneron Pharmaceuticals published a redacted version of the contract awarding the company $450 million taxpayers’ dollars for the large-scale manufacture of Regeneron’s investigational COVID-19 antibody treatment.
The contract uses Other Transactions Authority to weaken the U.S. government’s rights in data delivered under the agreement.
The agreement was awarded to Regeneron on behalf of the United States Department of Health and Human Services using an intermediary called Advanced Technology International. It is an Other Transaction Agreement (OTA), a type of government contract that federal agencies believe is exempt from federal laws and regulations establishing the government’s standard rights in data and intellectual property.
Under a standard government contract with a civilian agency, the government retains unlimited rights in data first delivered under the contract, regardless of how they were funded. 48 C.F.R. § 52.227-14. True to their name, these rights are virtually limitless and would allow the government to use the data in any manner, and to permit another company to do so, for any reason, including commercial purposes. As noted previously, these rights apply regardless of how the data were funded, including if the data were funded exclusively at private expense.
The data rights in this contract are located at section 7.3. For 10 years, the government retains narrower, government purpose rights in data delivered under the contract, only if the data were funded by the government. Not until 10 years have passed, probably long after the COVID-19 pandemic has been eradicated, does the government obtain unlimited rights in the data. For data funded exclusively by Regeneron, the government retains only limited rights, which are defined in the contract as the right to use the data “within the Government solely for research purposes for the Field.”
Section 7.3 b., Proprietary Manufacturing Data, stipulates that Regeneron retains “all rights in and to Data relating to or compromising Regeneron’s proprietary manufacturing technology and processes”, which include:
any trade secrets, Chemistry, Manufacturing and Controls information (CMC Data), and Data concerning or arising from test method development, device or delivery system development, assay development, formulation, quality assurance/quality control development, technology transfer, process development and scale-up and cell-line development[.]
The government cannot use this “Proprietary Manufacturing Data” outside of the contract and it cannot disclose the data to a third party.