definiens: , or means ( a ) in the case of the Device for commercial sale in theUS, the manufacturing, quality control testing ( including in - process, release and stability testing ), assembling, releasing, labeling and packaging of the Devices as more fully described in the applicable MRD, ( b ) in the case of the Device forcommercial sale OUS ( other than Japan ), the manufacturing, quality control testing ( including in - process and release butexcluding stability testing ), assembling, releasing, labeling and packaging of the Devices as more fully described in theapplicable MRD, ( c ) in the case of the Device for commercial sale in Japan, the manufacturing, inspecting, quality controltesting ( including in - process and release ), assembling, releasing, labeling and packaging of the Devices as more fullydescribed in the applicable MRD, and ( d ) in the case of Finished EQW Product for OUS, the packaging, labeling and release(excluding stability testing ) and, in the case of Japan, inspection, of Finished EQW Product as more fully described in theapplicable MRD . For clarity, Manufacture excludes in all cases the manufacturing, quality control testing ( including in - process, release and stability testing ), and release of the Cartridges and Vials