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 Institution 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 or other third party. The Institution may not transfer any materials provided through this program, including rezafungin panels, to another party or laboratory. The Institution 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 Mundipharma products. Mundipharma reserves the right to disclose any transfer for value provided in connection with this program in accordance with state and federal transparency laws. This program may be discontinued at any time.

The Institution 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, Institution shall comply with the Investigational Review Boards (IRB), Good Clinical Practices (“GCP”), and Good Laboratory Practices (“GLC”). It is the sole digression of the Institution to inquire about the IRB needs for their site and submit the IRB application for the study, if needed. Institution certifies that neither they, nor any of their management or any other employees or independent contractors or agents who will have any involvement in the Services, are excluded from participation in any government healthcare program, debarred from or under any other federal program (including but not limited to debarment under the Generic Drug Enforcement Act), or have been convicted of any offense defined in 42 U.S.C. Section 1320a-7, and that neither they, nor any of their employees, independent contractors and agents are otherwise ineligible for participation in federal healthcare programs or federal procurement or non-procurement programs; further, Institution and Investigator each represent that it is not aware of any pending or potential action(s) (including criminal actions) against it or its employees or independent contractors or agents which would give rise to any such ineligibility. Your Institution shall notify Mundipharma immediately upon becoming aware of any pending or final action in any of these areas.