In an American Arbitration Association (AAA) dispute over early-stage drug candidates in a development agreement between two pharmaceutical companies, CRA consultants were retained to assist in expert reports regarding industry practices regarding exclusivity of drug product candidates. A key issue was whether exclusivity was limited to individual antibodies and who had the right to select the antibodies for development. The reports addressed the scope and breadth of exclusivity in the industry and whether the payments in the contract were consistent with broad or narrow exclusivity.
Strategic implications for the 340B Rebate Model Pilot Program
These entities receive discounts on all eligible covered outpatient drugs. The program has expanded substantially over the years, with the number of covered...