On March 1, 2021, KEI obtained a copy of the binding term sheet between Pfizer/BioNTech and the Dominican Republic for the supply of their COVID-19 vaccine in the country. The document, requested via the freedom of information law in the Dominican Republic and released without redactions, is available here. It is available in English and Spanish.
Pfizer has asked some Latin American countries for “indemnity from civil cases, meaning that the company would not be held liable for rare adverse effects or for its own acts of negligence, fraud or malice,” according to a recent report from the Bureau of Investigative Journalism. “This includes those linked to company practices – say, if Pfizer sent the wrong vaccine or made errors during manufacturing.” In comments featured in the Bureau of Investigative Journalism report, Georgetown Law professor Lawrence Gostin explained that “[s]ome liability protection is warranted, but certainly not for fraud, gross negligence, mismanagement, failure to follow good manufacturing practices.”
Appendix A of the binding term sheet between Pfizer/BioNTech and the Dominican Republic includes provisions relating to the liability and indemnity, which the parties agreed to include in the definite agreement. The appendix states that the Dominican government will “indemnify, defend, and hold harmless” Pfizer, BioNTech, and their affiliates, “from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs, and expenses (including reasonable attorneys’ fees and other expenses of an investigation or litigation), whether sounding in contract, tort, intellectual property, or any other theory, and whether legal, statutory, equitable or otherwise (collectively, “Losses”) arising out of, relating to, or resulting from the Vaccine, including but not limited to any stage of design, development, investigation, formulation, testing, clinical testing, manufacture, labeling, packaging, transport, storage, distribution, marketing, promotion, sale, purchase, licensing, donation, dispensing, prescribing, administration, provision, or use of the vaccine.”
Put simply, the Dominican Republic will “indemnify, defend, and hold harmless” Pfizer even if the company makes a mistake in the “[…] manufacture, labeling, packaging, transport, storage, distribution, marketing, promotion, sale, purchase, licensing, donation, dispensing, prescribing, administration, provision, or use of the vaccine.” This includes, for instance, failures to keep the vaccines at the recommended temperatures during transportation to the country. The provision is yet another example of how Pfizer is using national governments to de-risk the commercialization of their vaccine.