United States v. Vaxima, Inc.

Court of Appeals for the Fourth Circuit·Decided February 28, 2022·No. 17-4277·Unpublished

Opinion

UNPUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 17-4277

UNITED STATES OF AMERICA, Plaintiff – Appellee,

v. VAXIMA, INC., Defendant – Appellant.

No. 17-4278

UNITED STATES OF AMERICA, Plaintiff – Appellee,

v. GENPHAR, INC., Defendant – Appellant.

Appeal from the United States District Court for the District of South Carolina, at Charleston. Bruce H. Hendricks, District Judge. (2:11-cr-00511-BHH-2; 2:11-cr-00511- BHH-3)

Argued: January 27, 2022 Decided: February 28, 2022

Before WILKINSON and AGEE, Circuit Judges, and FLOYD, Senior Circuit Judge.

Affirmed by unpublished per curiam opinion.

ARGUED: Linda S. Sheffield, Marietta, Georgia, for Appellants. Nathan S. Williams, Assistant United States Attorney, OFFICE OF THE UNITED STATES ATTORNEY, Charleston, South Carolina, for Appellee. ON BRIEF: Peter M. McCoy, Jr., United States Attorney, OFFICE OF THE UNITED STATES ATTORNEY, Columbia, South Carolina, for Appellee.

Unpublished opinions are not binding precedent in this circuit.

PER CURIAM:

Vaxima, Inc. and GenPhar, Inc. (“Corporate Defendants”) were convicted of over twenty criminal offenses, including wire fraud, theft of government property, and conspiracy to defraud the United States. Each conviction arose from the fraudulent retention of federal funds that were awarded pursuant to three Cooperative Research and Development Agreements (“CRADAs”) the Corporate Defendants held with federal agencies. They raise myriad pretrial-, trial-, and sentencing-related challenges on appeal. For the reasons that follow, we affirm.

I.

In April 2011, Dr. Jian-Yun “John” Dong, Dr. Danher Wang, GenPhar, and Vaxima were indicted by a federal grand jury for thirty-four violations of federal law. Dr. Wang later entered into a plea agreement with the Government, under which she agreed to cooperate with the Government and testify against Dr. Dong and the corporations.

GenPhar was established as a for-profit corporation in 1999 for the purpose of performing pharmaceutical and vaccine research. Dr. Dong was GenPhar’s President and Chief Executive Officer, and also served on its Board of Directors. Dr. Wang––Dr. Dong’s then-wife––was GenPhar’s Vice President of Research and Development.

Vaxima “is [a] small subsidiary company” “under GenPhar” that “solely belong[s]

to Dr. Dong.” Gov’t Supp. J.A. 34–35. 1 It provides vaccine production services to GenPhar ostensibly as a cost-saving mechanism. Vaxima paid its employees with money that GenPhar provided to it. But Vaxima paid GenPhar rent for the space in which it performed its work, and it also paid for Dr. Dong’s “corporate car[] [and] expenses.” Gov’t Supp. J.A. 751.

When GenPhar was first founded, it was funded almost exclusively by investors. 2 Indeed, over the course of its existence, GenPhar received nearly $13 million in investor funds. Eventually, those funds ran low, and GenPhar began to operate primarily (and after 2009, exclusively) on funds it obtained from CRADAs.

The CRADAs at issue here are different from a typical governmental grant. Under the terms of a standard grant, an agency provides the grantee with a lump sum of money and the grantee has discretion to use that money as it deems fit in pursuing the ultimate goal described in the grant application. CRADAs, however, are different. A federal agency and a private entity “enter into a collaborative effort to use” congressionally-earmarked funds for a specific function—in this case, vaccine research. Gov’t Supp. J.A. 1176. Unlike standard grants, CRADAs entail “substantial Federal scientific or programmatic

1 The parties filed four different appendices. Herein, we reference three of them: the initial Joint Appendix (“J.A.”), the Government’s supplemental appendix (“Gov’t Supp. J.A.”), and Defendants’ second supplemental appendix (“Defs.’ 2d Supp. J.A.”).

2 The record does not reflect the shareholders of GenPhar or Vaxima or in what percentages or capacities shares were held. Similarly, the record does not reflect whether GenPhar’s “investors” received equity shares or debt instruments for their investments.

involvement,” which “means that, after award, scientific or program staff” from the agency “will assist, guide, coordinate[,] and participate in project activities.” Gov’t Supp. J.A. 344.

Another notable difference between typical grants and CRADAs is that under a CRADA, the awardee does not have total discretionary spending power. Instead, a CRADA awardee is paid in accordance with achieving certain scientific “milestones” enumerated in the award. To receive a CRADA payment, the awardee must submit to the federal agency “progress reports” indicating which milestone(s) the awardee has achieved. Upon satisfactory review, the agency will release the money associated with that milestone to the awardee.

Relevant here, GenPhar was awarded three different CRADAs for vaccine research and production: one by the Army Medical Research Institute of Infectious Diseases (“the Army”) that ran from 2002 to 2007; one by the Navy Medical Research Center that ran from 2005 to 2008; and one by the National Institutes of Health (“NIH”) that ran from 2006 to 2011. These CRADAs collectively provided GenPhar approximately $15 million. Each federal agency was initially satisfied with the work that was performed.

Federal officials later testified at trial that if GenPhar saved some money on CRADA-funded work, then GenPhar was not required to refund the agencies that money, but only if it put those funds towards other proposed work specified in the CRADA. None of the CRADAs GenPhar held authorized it, or any other defendant, to use funds for lobbying political officials or to construct a new, freestanding research facility.

In 2009, Special Agent Larry Leonard of the Defense Criminal Investigative Service (“DCIS”)––an investigative arm of the U.S. Department of Defense’s Office of Inspector

General––began investigating whistleblower allegations made in a qui tam civil suit that GenPhar was committing fraud under its CRADA with the NIH. His investigation revealed evidence that GenPhar had submitted, and continued to submit, claims for payment and progress reports under all three CRADAs containing false statements. These false statements, which Dr. Dong approved and signed, certified that the Corporate Defendants had incurred certain costs in performing, or subcontracting, work that was required under any given CRADA. In fact, however, the work either had not been performed, or an undisclosed party performed it at a much lower cost. In the Government’s view, this allowed the Corporate Defendants to unlawfully “profit” from the CRADAs. Special Agent Leonard discovered evidence that the Corporate Defendants were using these unlawful “profits” to build a brand-new research facility for GenPhar and Vaxima and to lobby certain political officials.

The evidence adduced at trial tracked Special Agent Leonard’s findings. For example, GenPhar’s CRADA with the NIH required GenPhar to hire a quality control director and provided GenPhar $70,000 per year for that position’s salary. Though GenPhar certified to the NIH that it filled that position, it actually used two existing employees (including Dr. Wang) to conduct those duties, and retained the $70,000. Similarly, GenPhar’s CRADA with the Army provided approximately $1 million for GenPhar to outsource two vaccine studies: one to the Medical University of South Carolina, to be performed on rabbits; and a second to an Army laboratory, to be performed on monkeys. GenPhar certified to the Army that it had outsourced both studies. Instead, Dr. Dong directed Dr. Wang to conduct the rabbit study in-house, which ended up costing less than

$15,000. And while GenPhar outsourced the monkey study, it never paid the Army laboratory the $614,250 it was owed for that work. GenPhar kept those funds.

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