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donor directly or indirectly influences the identification or delineation of the specified diseases. the term "affiliate" of any donor includes, without limitation, any employee, agent, officer, shareholder, or contractor (including, without limitation, any wholesaler, distributor, or pharmacy benefits
this conclusion based on a combination of the following factors. first, no donor or affiliate of any donor would exert direct or indirect control over requestor or its program. requestor is an independent, nonprofit, tax-exempt charitable organization that operates with absolute, independent, and autonomous...
https://oig.hhs.gov/fraud/docs/advisoryopinions/2010/AdvOpn10-07.pdf