QSR

QSR. Shall mean the Quality System Regulation promulgated by the FDA under the Act or other applicable regulatory agencies of countries in which the Commercial Product will be sold as of the time of manufacture of the applicable Commercial Products; including ISO 13485, the European Union Council Medical Device Directives (the "EU Medical Device Directives"), and the Quality System Regulations as described in 21 CFR Part 820.

QSR. Means Quality System Regulations in the United States as promulgated by the FDA.

QSR. Means regulations set forth in FDA's Quality System Regulations at 21 C.F.R. Part 820. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. -4-

QSR. Shall mean all Law relating to quality system regulations for medical devices as promulgated by the FDA (as set forth in 21 CFR 820).

QSR. Means regulations set forth in FDA's Quality System Regulations at 21 C.F.R. Part 820.