Direct Biologics, LLC v. McQueen

CourtDistrict Court, W.D. Texas
DecidedMay 4, 2022
Docket1:22-cv-00381
StatusUnknown

This text of Direct Biologics, LLC v. McQueen (Direct Biologics, LLC v. McQueen) is published on Counsel Stack Legal Research, covering District Court, W.D. Texas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Direct Biologics, LLC v. McQueen, (W.D. Tex. 2022).

Opinion

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF TEXAS AUSTIN DIVISION

DIRECT BIOLOGICS, LLC, § Plaintiff § § v. § § Case No. 1:22-CV-381-SH ADAM MCQUEEN, § VIVEX BIOLOGICS, INC. AND § VIVEX BIOLOGICS GROUP, INC. § Defendants §

ORDER

Before the Court are Direct Biologics Direct Biologics, LLC’s Opposed Application for Temporary Restraining Order and a Preliminary Injunction (Dkt. 6), filed April 25, 2022; Direct Biologics Direct Biologics, LLC’s Opposed Motion for Expedited Discovery (Dkt. 7), filed April 25, 2022; and Adam McQueen’s Opposition to Plaintiff’s Application for Temporary Restraining Order and a Preliminary Injunction (Dkt. 21), filed May 3, 2022. On April 29, 2022, after the parties consented to the exercise of jurisdiction by a United States Magistrate Judge, the District Court reassigned this case to the undersigned to conduct all proceedings and order the entry of judgment in accordance with Section 636(c) of Title 28 of the United States Code and Federal Rule of Civil Procedure 73. Dkt. 15. I. Background Direct Biologics, LLC brings this breach of contract and misappropriation of trade secrets lawsuit against former employee Adam McQueen and McQueen’s new employer, Vivex Biologics, Inc. and Vivex, Biologics Group, Inc. (“Vivex”) (collectively, “Defendants”).1

1 Direct Biologics is a Wyoming limited liability company with its principal place of business in Austin, Texas. Complaint (Dkt. 5) ¶ 5. Defendant McQueen is a resident of Dallas, Georgia. Id. ¶ 6. Vivex Biologics Group, Inc. is a Delaware corporation with its principal place of business is in Marietta, Georgia. Id. ¶ 8. A. Facts2 Direct Biologics is a biotechnology company that focuses on cellular and regenerative therapies. Complaint (Dkt. 5) ¶ 16. Direct Biologics has two main product lines: AmnioWrap and ExoFlo. Id. ¶¶ 17-18. The AmnioWrap product line is a skin substitute for slow-healing wounds, while the ExoFlo product line uses a proprietary extracellular vesicle (“EV”) technology to

stimulate tissue healing processes. Id. In 2019, Direct Biologics launched ExoFlo, which initially did not require a license or approval from the Federal Drug Administration (“FDA”). Id. ¶ 18. In 2021, the FDA announced that EV products would be regulated under the Public Health Service Act as “drugs and biological products,” and thus could not be marketed or sold in the United States without securing formal FDA approval. Id. ¶ 19. Direct Biologics alleges that this change forced ExoFlo and all its competitors to leave the market and started “a race among Direct Biologics and its competitors to secure the FDA approval required to bring (or return) their EV products to the market.” Id. ¶ 21. On March 11, 2022, the FDA granted Direct Biologics a regenerative medicine advanced

therapy designation (“RMAT”) for ExoFlo’s use to treat severe or critical COVID-19. Id. ¶ 25. On March 24, 2022, the FDA approved ExoFlo to enter Phase III clinical trials for Exit COVID-19, which is the final stage before Direct Biologics can submit its Biologics License Application (“BLA”) to offer this treatment to the consumer market. Id. ¶ 26. Direct Biologics alleges that if it is successful in Phase III, ExoFlo will be the first purely biologics EV drug ever to receive FDA

Vivex Biologics, Inc. is a Georgia corporation with its principal place of business is in Marietta, Georgia. Id. ¶ 9. 2The factual background is based on the allegations in the Complaint (Dkt. 5) and evidence and testimony presented at the hearing on Direct Biologics’ Application for Temporary Restraining Order. approval and “would make Direct Biologics the only company authorized to commercialize and sell a purely biologics EV drug in the United States.” Id. Defendant McQueen was a high-level sales and marketing executive for four years, until March 28, 2022. Direct Biologics alleges that: For the past four years, Defendant Adam McQueen has had a front- row seat as Direct Biologics has developed its innovative technologies, refined its manufacturing and logistics systems, contracted several key contract manufacturing organizations (“CMOs”), and navigated the FDA approval process at an extraordinary pace. As the company’s third-hired employee, an equity-holding Member of the LLC, and until just recently a member of its C-level strategy and operations teams, McQueen knows all Direct Biologics’ secrets. He is one of the only people in the company to have been intimately involved with both the AmnioWrap and EV product lines, and he is one of handful of individuals who knows the company’s most closely guarded secret: the formula and production specifications for its flagship technology, ExoFlo.

Id. ¶ 28. McQueen also served on the company’s Intellectual Property Steering Committee and attended the Direct Biologics Intellectual Property Summit in Las Vegas in September 2020. Id. ¶ 36. Direct Biologics alleges that McQueen attended presentations from high-level employees and Direct Biologics’ outside intellectual property lawyers that revealed sensitive details of the company’s research and business strategies, including the details of all Direct Biologics’ current trade secrets, patents and planned patent filings, its legal and regulatory strategy, specific plans for testing at various investigational review board studies and clinical trials for different ExoFlo lines, and the new EV product lines it is pursuing. Id. Direct Biologics further alleges that McQueen regularly attended the weekly R&D and Manufacturing calls that addressed the company’s entire manufacturing and distribution operation in granular detail, and illuminated its broader product development strategy. Id. ¶ 37. Direct Biologics alleges that McQueen was privy to “every detail of Direct Biologics’ successful effort to fast-track an EV treatment from the starting block to the brink of the finish line, empowering him to bestow an extraordinary, unearned advantage on a competitor like Vivex that seeks to undercut Direct Biologics’ market advantage,” and that “McQueen carries with him knowledge possessed by only a handful of people anywhere: all the information Vivex needs to

exactly replicate Direct Biologics’ flagship product.” Id. ¶ 39. Direct Biologics alleges that it received ExoFlo’s Phase III FDA approval on Friday, March 24, 2022. Id. ¶ 40. The following Monday, March 28, 2022, McQueen resigned. Id. Direct Biologics alleges that by week’s end, McQueen accepted a job as a senior executive with one of its direct competitors, Vivex, “in direct breach of his contractual covenants.” Id. Direct Biologics contends that Vivex is a direct competitor with its key AmnioWrap product line and in the emerging EV field. Id. Direct Biologics further alleges that Vivex is one of only a few companies with the resources, infrastructure, and commercial motive to immediately and wrongfully exploit the Direct Biologics’ confidential information McQueen is privy to. Id. Direct

Biologics further alleges that as a senior manager at Vivex, McQueen is positioned to help Vivex compete with Direct Biologics’ AmnioWrap product line and guide Vivex through accelerated development and FDA approval of new EV products. Id. ¶ 75. Direct Biologics alleges that it was planning to terminate McQueen for cause before he tendered his resignation. Id. ¶ 60. Regardless, Direct Biologics sent him a termination letter on March 29, 2022. Id. ¶ 62. The termination letter specifically reminded McQueen of his contractual noncompete, non-solicit, and confidentiality obligations, and demanded return of any property, documents, or materials in his possession, including the company’s Confidential Information. Id. ¶ 63.

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Direct Biologics, LLC v. McQueen, Counsel Stack Legal Research, https://law.counselstack.com/opinion/direct-biologics-llc-v-mcqueen-txwd-2022.