Thermo Fisher Scientific PSG Corp. v. Arranta Bio MA, LLC

Court of Chancery of Delaware·Decided April 4, 2023·No. 2022-0608-NAC·Published

Opinion

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE

THERMO FISHER SCIENTIFIC ) PSG CORPORATION, ) ) Plaintiff and Counterclaim ) Defendant, ) ) v. ) C.A. No. 2022-0608-NAC ) ARRANTA BIO MA, LLC, ) ) Defendant and Counterclaim ) Plaintiff. )

MEMORANDUM OPINION

Date Submitted: February 10, 2023 Date Decided: April 4, 2023

Philip Trainer, Jr., Marie M. Degnan, ASHBY & GEDDES, Wilmington, Delaware; Michael Klisch, Joshua Siegel, Georgina Inglis, COOLEY LLP, Washington, DC; Robert Cahill, David A. Vogel, COOLEY LLP, Reston, VA; Counsel for Plaintiff and Counterclaim Defendant Thermo Fisher Scientific PSG Corporation.

Michael A. Barlow, ABRAMS & BAYLISS, LLP, Wilmington, Delaware; John B. Quinn, Jennifer J. Barrett, Rachel E. Epstein, Evan Hess, Michael Linneman, Neil T. Phillips, Phillip B. Jobe, QUINN EMANUEL URQUHART & SULLIVAN, LLP, New York, New York; Counsel for Defendant and Counterclaim Plaintiff Arranta Bio MA, LLC.

COOK, V.C. This is the first chapter in a dispute among leading contract development and

manufacturing organizations (“CDMOs”) that provide pharmaceutical and

biopharmaceutical services. At issue in this case is an agreement to develop

plasmids. A plasmid is a small circular DNA molecule found in bacterial cells.

Plasmids have at least one gene, such as genes associated with antibiotic resistance

or that provide genetic advantages to the host organism, that can be passed from one

cell to another. Because plasmids can be used as tools to clone, transfer, and

manipulate genes in ways that are beneficial to humans, they are a central component

to a growing number of next generation therapies and vaccines. Plasmids are a

subset of a broader category of drugs referred to as biologics, which are drugs

generally produced using living cells or organisms. This is in contrast to

conventional drugs, which are chemically synthesized and are sometimes referred to

as small-molecule drugs.

While the use of plasmids in drug development is growing rapidly, producing

plasmids that are compliant with Food and Drug Administration regulations is very

difficult and expensive. To develop and manufacture plasmids, a developer typically

starts with a bank of genetically engineered cells that are often proprietary. The

developer then must develop the specific processes to derive the plasmid from those

cells and to manufacture those plasmids on a commercially viable scale. CDMOs provide products and services related to the development and

manufacturing of drugs. Thermo Fisher Scientific PSG Corporation (“PSG”) and

Recipharm AB (“Recipharm”) are two of the largest CDMOs in the world. Arranta

Bio MA, LLC (“Arranta”) is also a CDMO and specializes in developing and

manufacturing complex biological drugs and advanced therapeutic medicinal

products.

In 2020, PSG and Arranta entered into an agreement under which Arranta

would manufacture plasmids for PSG. Because the manufacture of plasmids

involved the transfer of certain proprietary knowledge from PSG to Arranta, PSG

sought to restrict Arranta from transferring its plasmid development operations to or

being acquired by certain third parties. In such an event, the parties agreed that PSG

would obtain the right to prevent Arranta from engaging in plasmid development

and manufacturing services for 36 months (the “Non-Compete Obligation”), among

other rights. One of the conditions to PSG’s right to trigger the Non-Compete

Obligation was that the counterparty to a transfer of the plasmid operations be a

third-party that derived at least 50% of its revenue from performing contract

“biopharmaceutical” development or commercial manufacturing services.

In April 2022, Arranta’s grandparent entity was acquired by a wholly owned

subsidiary of Recipharm. It is undisputed that while Recipharm derived almost all

its revenue from performing CDMO services for small-molecule drugs, it derived

2 almost no revenue from such services for biologics. Shortly after the acquisition,

PSG sued Arranta in this Court seeking to enforce the Non-Compete Obligation.

The central issue in the parties’ dispute is whether “biopharmaceutical” means

only biologics or if it encompasses both biologics and small-molecule drugs. I

conclude that “biopharmaceutical” unambiguously means only biologics. Thus,

even assuming that Recipharm was the counterparty in the acquisition of Arranta’s

grandparent (a point Arranta contests), PSG had no right to trigger the Non-Compete

Obligation because Recipharm did not derive at least 50% of its revenue from

services associated with biologics.

I. FACTUAL BACKGROUND 1

A. Parties

Arranta is a Delaware limited liability company.2 Arranta is a CDMO

specializing in live biotherapeutic and mRNA products. 3 Mark Bamforth founded

Arranta in 2019.4

1 Joint trial exhibits are cited as “JTX ___,” trial testimony is cited as “TT___ (Name),” and depositions are cited as “[Name] Dep. ___.” 2 Thermo Fisher Scientific PSG Corp. v. Arranta Bio MA, LLC, C.A. No. 2022-0608-NAC, Docket (“Dkt.”) 180, Pretrial Stipulation and Proposed Order for Dec. 15–16, 2022 Trial (“Pretrial Stipulation”) ¶ 20. 3 JTX 208 (“Supply Agreement”), Recitals; JTX 314 at 3; see also TT135:9–138:9 (Bamforth). 4 TT135:9–138:1 (Bamforth).

3 PSG is a Delaware corporation. 5 PSG described itself in the Supply

Agreement as “a leading large and small molecule viral vector [CDMO].”6 PSG is

a part of Thermo Fisher Scientific Inc. (“Thermo”).7

B. Thermo’s Investments In Bamforth’s Companies

Before founding Arranta, Bamforth founded two other companies: Gallus

Pharmaceuticals, LLC and Brammer Bio.8 Gallus was merged into Patheon, Inc.,

which eventually became part of Thermo in 2017. Brammer Bio was acquired

directly by Thermo in 2019 for $1.7 billion. 9

Thermo was also an investor in Arranta Bio Holdings LLC (“Arranta

Holdings”), which is Arranta’s indirect grandparent company. 10 Prior to the merger

at issue, Thermo was the third largest investor in Arranta Holdings.11 Michel

Lagarde, who was President of PSG at the time of Thermo’s investment and is now

Thermo’s Chief Operating Officer, spearheaded Thermo’s investment in Arranta

5 Pretrial Stipulation ¶ 19. 6 Supply Agreement, Recitals. 7 Id. 8 TT130:12–22; TT133:5–11 (Bamforth). 9 JTX 74 at 1; Lagarde Dep. 98:17–101:24; TT134:6–17 (Bamforth). 10 JTX 247, Sch. A. 11 Id.; TT141:16–142:6 (Bamforth).

4 Holdings.12 Lagarde also led Thermo’s acquisitions of Gallus and Brammer Bio.13

Lagarde understood that Bamforth’s general business model was to develop new

ventures using private equity seed money and then sell or transfer the company to

monetize the investment.14

C. Supply Agreement15

Shortly after Thermo invested in Arranta Holdings, PSG and Arranta began

negotiating an agreement whereby Arranta would develop and manufacture

commercial-grade plasmids at Arranta’s Watertown, Massachusetts facility (the

“Watertown Facility”). 16 Plasmids are sometimes a component used to develop

large-molecule drugs derived from living organisms (sometimes referred to as

“biologics”). 17 Biologics are distinguished from traditional, small-molecule drugs

12 Lagarde Dep. 14:7–19, 96:9–103:4; TT142:7–143:21 (Bamforth). 13 Lagarde Dep. 96:9–103:4. 14 Lagarde Dep. 104:2–14.

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