definiens: shall mean any entity that directly ( or indirectly through one or more intermediaries ) controls, is controlledby, or is under common control with a Party, and the term means control of ( i ) more than half of the votingpower or issued share capital, or ( ii ) the control directly or indirectly to direct or cause direction of the managementand policies of an entity ; and the terms and shall be construed accordingly ; shall have the meaning given in clause 16 ; shall mean this Supply and Exclusive License Agreement ; shall have the meaning given in clause 13 ; shall mean any claim, action, demand, proceeding, complaint or other similar action ( including, but not limitedto, any such claim, action, demand, proceeding, complaint or other similar action by a third party ) ; shall have the meaning given in clause 3 ; shall mean any and all competent and regulatory authorities in each of the countries in theTerritory : ( i ) that are responsible for the regulation of medicinal products intended for human use and responsible forgranting any Marketing Authorisation, including but not limited to the European Medicinal Agency ( EMA)/EuropeanCommission ; ( ii ) all local Medicinal Product Agencies ; and ( iii ) all pricing and reimbursement authorities ; shall mean in relation to a Party any secret or proprietary information ( whether written ororal and in whatever medium ) relating to a Party ’s business or of the business of their Affiliates, including IntellectualProperty Rights, the Trademark, Know - how, the Improvements, the Product and related developments, otherproducts, substances, customer lists, pricing policies, employment records and policies, operational methods, marketing and strategy plans and policies, product development techniques or plans, regulatory data, data, regulatoryapplications and dealings, methods of manufacture, technical processes, designs and design projects, inventions andresearch programmes, trade secrets and other business affairs, and any other information of a confidential nature ofthe Party or of its Affiliates ; or shall mean Good Distribution Practice as defined in all applicablelegislation and guidelines, including ( in respect of countries in the Territory in the EU ) directive 94 / C 63/03 andassociated guidelines ; or shall mean Good Manufacturing Practice for medicinalproducts as defined in all applicable legislation and guidelines, including ( in respect of countries in the Territory in theEU ) directive 2003/94 / EEC and associated guidelines ; shall mean any data protection, market exclusivity ( including but not limited to orphan andpaediatric ) or any similar protection granted to the Product according to the applicable rules and regulations in theTerritory ; shall mean the data privacy and data protection laws applicable to the Personal Data andactivities in relation to such Personal Data ; shall have the meaning given in clause 7 ; shall have the meaning given in clause 7 ; shall mean the signing date of this Agreement ; shall mean a period from the 1st January through December 31st in the same year ; shall mean human therapy ; shall mean the Product packaged, labelled and released by Licensor according to thespecifications approved by Competent Authorities for distribution and sale in each country of the Territory ; shall mean Patents in the Territory that are owned or controlled by Licensor and that relate tothe Product, including its uses and processes for manufacture ; shall mean ( a ) any change in, or development, improvement or derivative of, or modification to theLicensed Technology or the method of manufacture, processing or use in relation to or application of the LicensedTechnology ( whether patentable or not ), including improvements defined as aforesaid which ( i ) embody, use or areimprovements to or derivatives of Licensed Technology ; or ( ii ) which would infringe any patent or employ any Know - how included in Licensed Technology ; or ( iii ) otherwise relate to the Product ; and ( b ) improvements in or additions toKnow - how relating to the Product . shall always exclude data and Information falling within thedefinition of Regulatory or Clinical Data ; shall have the meaning given in clause 22.1.1 shall have the meaning given in clause 22.1.1 means any information, communications or data, in any form, including oral, written, graphic, electro - magnetic, in machine readable form, computerised, or otherwise stored in any media ; shall mean all intellectual property including all patents, trademarks, service marks, registereddesigns, utility models, design right, database rights, copyright, trade secrets and other confidential information, know - how, and all other intellectual and industrial property and rights of a similar or corresponding nature in any part ofthe world, whether registered or not or capable of registration or not and including the right to apply for and allapplications for any of the foregoing rights, right to claim priority, the right to sue for past infringements and commonlaw or equitable remedies in respect of any of the foregoing rights, and any renewals, extensions or restorations, anddivisional, continuation and reissued applications of the foregoing rights ( and meansrights, title and interest including all moral rights in such Intellectual Property ) ; shall mean any and all relevant Information, data and/or know - how, related to the Product ; shall mean collectively the Know - how and the Regulatory or Clinical Data owned orcontrolled by Licensor . ; shall mean losses of whatsoever nature, including damages, payments, penalties, interest, fines andcompensation, howsoever they might arise, whether as a result of a tort ( including negligence ), breach of contract, breach of statutory duty or misrepresentation and shall include all reasonable professional fees and expenses ; shall mean any and all marketing and other authorisations and approvals for uses in theField by Competent Authorities or a governmental or similar body necessary for the lawful importation, use, marketing, promotion, distribution, and sale ( whether to the public or the private sectors ) of the Product in each country in theTerritory including but not limited to regulatory approval and pricing and reimbursement . Distribution of the Product inthe Territory on a Named Patient basis is not considered a Marketing Authorisation ; shall in all text refer to Licensor