definiens: means a statement signed by a Qualified Person of the Supplierconfirming that at the time of issue of the statement the Product meets GMP, the Specification, theprocedures relating to the Product and the Quality Technical Agreement ; 1.8 means any day which is not a Saturday, a Sunday or a Dutch or Belgian public holidayand references to any time shall be to Dutch time ( GMT+ one hour ) ; 1.9 means a period of twelve ( 12 ) months commencing on 1 January and ending on 31December ; 1.10 when applied to any person will be deemed to have occurred on each occasion onwhich any person or persons other than those who Control such person at the Effective Datesubsequently acquire Control of it, whether directly or indirectly ; 1.11 means all information or material that has or could have commercial value orconstitutes sensitive information in the business or prospective business of a Party ’s company or itsAffiliates, whether or not such information is identified as Confidential Information ; 1.12 has the meaning as set out in Section 1.1 ; 1.13 has the meaning as set out in Section 16.1 ; 1.14 has the meaning as set out in Section 16.1 ; 1.15 has the meaning as set out in Section 16.1 ; 1.16 has the meaning as set out in Section 17.4 1.17 has the meaning as set out in Section 8.1 ; shall be construed accordingly ; 1.18 has the meaning as set out in Section 9.1 1.19 has the meaning as set out in Section 15.1 ; 1.20 has the meaning as set out in Section 10.4 ; 1.21 means 30 May 3014 ; 1.22 means the European Medicines Agency ; 1.23 means the countries currently belonging to the European Union as well as any newmember states thereof ; 1.24 means the manufacturing facility located at Urmonderbaan 20b, 6167RD Geleen, theNetherlands ; 1.25 has the meaning as set out in Section 18.1 ; [ * * * ] Certain information has been omitted and filed separately with the Commission . Confidential treatment has beenrequested with respect to omitted portions