CRA was retained on behalf of a large biopharmaceutical firm defendant in a Diligent Efforts matter filed in the Southern District of New York.
Plaintiffs alleged that the defendant failed to exert Diligent Efforts to secure FDA approval of a set of CAR-T and small-molecule products, which terminated a CVR Agreement and made CVRs, potentially worth more than $6 billion, ineligible for payment. Dr. Annabelle Fowler submitted an expert report from the perspective of a healthcare economist that rebutted the opposing economic expert’s approach to assessing and characterizing Diligent Efforts. CRA’s analysis considered objective criteria by which to assess the defendant’s economic efforts, a critique of the opposing expert report’s comparable product analysis, and an assessment of the uncertainty of CVR payouts. Dr. Fowler was supported by Dr. Peter Rankin and Mr. Archan Ruparel.
