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Supporting a $175B biopharmaceutical company in an IRS tax dispute

Case study

Keystone experts help global biotech company in transfer pricing dispute.

Overview
Challenge

A multinational biopharmaceutical company needed to defend a $10+ billion transfer pricing dispute brought by the IRS. The government challenged the structure of the company’s intercompany transactions between the company’s U.S. and international entities. The lawsuit stated that the biotech leader improperly allocated too much value to manufacturing operations abroad and not enough to the high-value activities conducted in the U.S. – namely R&D, IP development, regulatory strategy, and commercialization.

Client
Solution

Industry + scientific expertise

Keystone assembled a team of 10 leading experts from industry and academia to evaluate the key value drivers across the pharmaceutical supply chain - from R&D to the manufacturing, licensing, IP, and commercialization of biologics. The team’s analyses described the scientific foundations of biologics manufacturing, detailed the processes involved in commercializing a drug, and assessed arm’s-length terms for IP licensing and outsourcing.

Keystone experts
Charles L. Cooney
Charles L. Cooney
MIT School of Engineering
Academic expert, biochemical engineering, biologics manufacturing, MIT, 40+ years studying complexities of biologics manufacturing.
Prof. Chris Love
Prof. Chris Love
PhD
Academic expert, chemical engineering, process development, MIT, 20+ years studying integrated process development.
Prof. Steve Cramer
Prof. Steve Cramer
PhD
Academic expert, polymer engineering, downstream drug substance manufacturing, RPI, 35+ years studying bioprocessing with chromatography.
Prof. Ted Randolph
Prof. Ted Randolph
PhD
Academic expert, biological engineering, drug product manufacturing, CU-Boulder, 35+ years studying stabilization of proteins.
Prof. Kris Prather
Prof. Kris Prather
PhD
Academic expert, chemical engineering, upstream drug substance manufacturing, 20+ years studying bioprocess design.
David LaPré
David LaPré
Industry expert, technical operations and supply chain, 45+ years in technical and commercial engineering roles.
Nancy Miller-Rich
Nancy Miller-Rich
Former SVP Merck
25+ years leading Business Development & Licensing at MSD; described key considerations for dealmaking executives in the pharma industry and factors that influence arm's length negotiations.
Mark Levick
Mark Levick
MD/PhD
20+ years leading R&D functions at Sandoz and GSK; described the biopharma R&D process in general, and the division of R&D activities at Amgen specifically.
Riad El-Dada
Riad El-Dada
Former US President Merck
25+ years leading commercial functions at MSD; assessed the commercial functions at Amgen and their similarity to other biopharma companies in the industry.
Jim Coccia
Jim Coccia
Former Market Access VP
20+ years leading value & access at Takeda and Genzyme; evaluated and compared Amgen's value and access functions to other biopharma companies; described the standardization of payer negotiations.
Case Studies
Contact

To learn more about this case or Keystone’s expertise in Healthcare and Life Sciences litigation and strategy, contact science@keystone.com.

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