A U.S. affiliate of a global video systems and games manufacturer retained CRA to investigate the royalty payments received from one of its distribution licensees. Pre-site analysis included preparation of document and information requests and verification of the mathematical accuracy of the royalty statements. On-site inspection and post-site analysis involved detailed reconciliation of the royalty statements with licensee documents, including sales invoices, inventory records, credit memos, and financial statements. Through the efforts described above, CRA identified and formally documented underreported royalties in excess of $600,000.
Biosimilars: Economic Issues for IP Litigation
In July 2021, the U.S. Food and Drug Administration granted a determination of interchangeability to a biosimilar drug for the first time. This approval has...