definiens: means, with respect to each party, any corporation or other business entity that ( a ) directly or indirectly controls, is owned by or is under common ownership with a party to this Agreement to the extent of at least fifty percent ( 50 % ) of the equity ( or such lesser percentage which is the maximum allowed to be owned by a foreign organisation in a particular jurisdiction ) having the power to vote or direct the affairs or such entity, or ( b ) directly or indirectly Controls, is Controlled by or is under common Control with such party ; 1.1.2 means any company which is either the parent undertaking or a subsidiary undertaking of the party in question or a subsidiary undertaking of such party 's parent undertaking and an undertaking in which the party in question has a participating interest ( as defined in section 260 Companies Act 1985 ) and which is not a subsidiary undertaking of the party in question . and shall have the meanings attributed thereto in section 258 Companies Act 1985 ; 1.1.3 means a day ( other than a Saturday, Sunday or Bank Holiday ) on which banks are open for the transaction of normal business in the City of London ; 1.1.4 means each successive period of three calendar months commencing in each Calendar Year on 1st January, 1st April, 1st July and 1st October and referred to as Q1, Q2, Q3 and Q4 respectively ; 1.1.5 means each successive period of twelve calendar months commencing on 1 st January ; 1.1.6 means the certificate of analysis to accompany all Product delivered to [COMPANY] in the agreed format ; 1.1.7 means from 1 st January 2QQQ to the date of termination of this Agreement ; 1.1.8 means storage, checking and testing of both incoming materials and outgoing Product, processing and blister packing of tablets with overprinted lidding into pre - formed strips of multiples of 6 or 2 tablets per strip which are then bulk packed in an agreed container ready for shipment . It is agreed between the parties that this definition complies with the description ' bulk unlabelled and unpacked blisters ' in Exhibit I of the Development and Licence Agreement as far as pricing is concerned .In such description it is acknowledged that unlabelled allows for provision of certain variable Product information and packing instructions and that if [COMPANY] wishes CIMA to provide Product in non standard packaging ( cassettes ) prior to bulk packing, additional costs shall be incurred ; 1.1.9 means the calendar quarter in which product or placebo is manufactured but which is cleared for delivery within the 15 days following that calendar quarter ; 1.1.10 means formulations made using CIMA 's DuraSolv ™ Technology but without the inclusion of API . Manufacture of Placebos shall mean the same as manufacture of Product but in addition Placebos are to be supplied packed in cartons prior to being packed into an agreed container ready for shipment . It is agreed between the parties that this definition complies with the description for ' Finished Packaged Product ' in Exhibit 1 of the Development and Licence Agreement in relation to pricing ; 1.1.11 mean the quality assurance agreement signed by the parties and dated 23rd April 1999 and the US quality assurance agreement signed by the parties dated April 11, 2000 ; 1.1.12 means any pharmaceutical dosage form which is formulated using the DuraSolv ™ Technology and which contains Zolmitrifitan as its active ingredient, whether taste masked ( in any flavour ) or untreated ; 1.1.13 means the specification for the Product as specified in Schedule 1 and as amended from time to time by agreement in writing between the parties ; 1.1.14 means forming and lidding foil purchased by CIMA for exclusive use in the manufacture of particular market variants of Product ; 1.1.15 means the specification for Placebo and Product ready for delivery to [COMPANY] ; 1.2 Definitions Unless expressly stated otherwise in clause 1.1 above, capitalised terms shall bear the meaning ascribed to them in the Licence Agreement