Galaxy Therapeutics, Inc.

Ensuring: i) the conformity of the devices is appropriately checked in accordance with the QMS under which the devices are manufactured, prior to release; ii) the technical files and the EU DoC are drawn up and kept up-to-date; iii) the PMS obligations are complied with; iv) the reporting obligations referred to in Articles 87 to 91 are fulfilled; v) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.