United States v. Vaxima, Inc.

CourtCourt of Appeals for the Fourth Circuit
DecidedFebruary 28, 2022
Docket17-4277
StatusUnpublished

This text of United States v. Vaxima, Inc. (United States v. Vaxima, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Vaxima, Inc., (4th Cir. 2022).

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UNPUBLISHED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

GENPHAR, INC.,

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Affirmed by unpublished per curiam opinion.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Unpublished opinions are not binding precedent in this circuit.

2 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.

3 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.

4 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

5 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

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