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- ilnd;;1:03-cv-06495_de156 RegisterActionDate "2005-04-27" @default.
- ilnd;;1:03-cv-06495_de156 RegisterActionDescriptionText "MINUTE entry before Judge James F. Holderman : Genendo Pharmaceutical N.V.'s motion in limine regarding the amended complaint allegations pertaining exclusively to the Phil & Kathy's Group defendants 133 is granted. The United States is correct that Genendo has put at issue whether its agreement with Phil & Kathy's meets the requirements necessary to qualify for an exemption under 21 U.S.C. Section 353(a) and 21 C.F.R. Section 201.150. However, the government is incorrect in arguing that the actual practices at Phil & Kathy's are relevant to whether the agreement satisfies the exemption. 21 C.F.R. Section 201.250 requires a "written agreement...containing such specifications... as will insure, if such specifications are followed, that such drug will not be adulterated or misbranded." (emphasis added). Thus, in regard to the issue presented in this case, it is the written agreement (Joint Exhibit 12) between Genendo and Phil & Kathy's that is relevant, not the actual unilateral practices of Phil & Kathy's. (jmp, ) (Entered: 04/28/2005)" @default.
- ilnd;;1:03-cv-06495_de156 AdministrativeID "147" @default.
- ilnd;;1:03-cv-06495_de156 OntologyLabel minute_entry @default.
- ilnd;;1:03-cv-06495_de156 hasReferenceToOtherEntry ilnd;;1:03-cv-06495_de143 @default.