As used in this part, unless the context otherwise requires:
(1)"Countermeasure" means a vaccine or the component parts used in the design, development, clinical testing or investigation or manufacture of a vaccine, including seed stocks, cell lines and plasmids, used to diagnose, mitigate, prevent, treat, cure or otherwise limit the harm of an infectious disease that is:
(A)Approved or cleared under Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § 351 et seq.), or licensed under § 351 of the federal Public Health Service Act ( 42 U.S.C. § 262 ); (B)The object of research for possible use as described in subdivision (1)(A) and is the subject of an exemption under § 505(i) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. § 355(i) ); or (C) Authorized for emergenc Free access — add to your briefcase to read the full text and ask questions with AI
As used in this part, unless the context otherwise requires: (1) "Countermeasure" means a vaccine or the component parts used in the design, development, clinical testing or investigation or manufacture of a vaccine, including seed stocks, cell lines and plasmids, used to diagnose, mitigate, prevent, treat, cure or otherwise limit the harm of an infectious disease that is: (A) Approved or cleared under Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § 351 et seq.), or licensed under § 351 of the federal Public Health Service Act ( 42 U.S.C. § 262 ); (B) The object of research for possible use as described in subdivision (1)(A) and is the subject of an exemption under § 505(i) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. § 355(i) ); or (C) Authorized for emergency use in accordance with § 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § 360bbb-3 ); (2) "Healthcare research institution" means any non-governmental, nonprofit research institution with its principal place of business in this state, that is, or that is affiliated with, a hospital or clinic for the treatment of pediatric patients, that does not seek payment for treatment provided to patients in the absence of insurance coverage for the treatment. "Healthcare research institution" includes any or all of the parents, subsidiaries, affiliates, successors and assigns of the institution, and any or all individual trustees, officers, directors, employees, and agents of the institution; and (3) "Willful misconduct" means an act or omission that is taken: (A) Intentionally to achieve a wrongful purpose; (B) Knowingly without legal or factual justification; and (C) In disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.