definiens: means the manufacture, use or Commercialization of ~y product or service for the in vitro amplification, detection, qmintification, extraction or sequencing ofa nucleic acid in or from a human biological sample for the purpose of : ( a ) diagnosing, detecting or monitoring any disease, state, condition, trait or characteristic of a human being for medical management ; ( b ) exercising quality assurance and quality control testing of human blood or plasma from which biological therapeutic agents may be derived for resale ; ( c ) [ unless excluded by decision pursuant to Section 2.4, screening human blood or blood products for transfusion ] ; or ( d ) screening human . organs, tissues or cells for transplantation . The Alliance Field does not include the research, development, manufacture, use or Commercialization of any Carveout ; the internal · research by either Party for therapeutic development, including clinical trials ; or research, development, manufacture, use, Commercialization, or testing in Epidemiology or Biosecurity ( as each such term is defined below )