Registration

All testing materials are for in vitro evaluation use only. Use of any testing materials to determine therapeutic options for patient treatment or any other diagnostic purpose is prohibited. The User (user of the RUO AST devices) is prohibited from charging any patient or third-party payer for any testing materials or including the value of the testing materials on any cost report submitted to any government agency, patients or other third party. The User may not transfer any materials provided through this program, including Blujepa (gepotidacin) gradient diffusion strips and/or Blujepa (gepotidacin) disks, to another party or laboratory. The User acknowledges that the provision of testing materials through this program are not contingent on, nor intended to serve as an inducement or reward for, any past or future purchases of GSK products. In furtherance of the scientific objectives of this program, it is requested that the User submit their testing results to IHMA to permit further analysis related to laboratory susceptibility. GSK reserves the right to disclose any transfer of value provided in connection with this program in accordance with state and federal transparency laws. This program may be discontinued at any time.
The User shall comply with all then applicable laws, regulations, and rules promulgated to law including but not limited to, the federal Anti-Kickback statute, 42 U.S.C. § 1320a-7b(b) and similar State laws; Federal Food, Drug and Cosmetic Act and relevant regulations; the Food and Drug Administration’s Guidance on Industry-Supported Scientific and Educational Activities (1997); and American Medical Association ethics rules and opinions, if applicable. Further, User shall comply with the Investigational Review Boards (IRB), Good Clinical Practices (“GCP”), and Good Laboratory Practices (“GLC”).