definiens: means any corporation or other entity that controls, is controlled by, or is under common controlwith, a Party . A corporation or other entity shall be regarded as in control of another corporation or entity if itowns or directly or indirectly controls more than 50 % of the voting securities or other ownership interests ofthe other corporation or entity, or if it possesses, directly or indirectly, the power to direct or cause thedirection of the management and policies of the corporation or other entity ; ‘ Applicable Laws ’ means all relevant statutes, laws, directives, regulations, ordinances guidance notes andcodes that apply to the Services in the country where such Services are performed, and those specifically setout below, applicable to a Project or the Services in force from time to time during this Agreement includingapplicable : ( i ) FDA Guidance Documents on current cGMP and compliance, including the Guidelines on thePreparation of Investigational New Drug Products ( Human and Animal ) and the Draft Guidance for Industry : Investigating Out - of - Specification ( OOS ) Test Results for Pharmaceutical Production ; ( ii ) ApplicableEuropean, US and ICH cGMP and cGLP ; and ( iii ) all other regulations specified in the relevant ProjectAgreement ) ; ‘ Arising Intellectual Property ’ shall have the meaning given in clause 6.1 ; ‘ Background Intellectual Property ’ shall have the meaning given in clause 6.4 ; EXECUTION COPYPage 2 of 24 ‘ Business Day(s ) ’ means a day other than a Saturday, Sunday or a day on which banks are not open forbusiness in France or the Country where the Services will be performed under this Agreement and the relatedProject Agreement ; ‘ Certificate of Analysis ’ means SUPPLIER ’s standard form certificate of analysis confirming the results oftests conducted on Service Materials ; ‘ cGMP ’ means the current good manufacturing practice requirements as applicable : ( i ) in the European Union;(ii ) in the United States of America ; and ( iii ) in accordance with ICH requirements . As in force from time totime during the term of this Agreement ; ‘ Competent Authority/(ies ) ’ means a national or supra - national authority responsible for the control ofmedicinal products ; is defined in preamble of the Agreement ; ‘ External Costs ’ means the amount paid by SUPPLIER or the SUPPLIER Affiliate for any Service specificmaterials, goods, supplies, and equipment of any nature for providing the Service under the related ProjectAgreement when SUPPLIER or the related SUPPLIER Affiliate shall have not the resources, capacity orability to provide such part of the Service whatever this Person is deemed to be a subcontractor or not, andany tax to be invoiced to CUSTOMER under Applicable Laws and Regulations ; “ Force Majeure Event ’ means, in relation to either Party, any circumstances beyond the reasonable controlof that Party ( including, without limitation, fire, floods, embargoes, shortages, epidemics, quarantines, war, acts of God, acts, omissions or delays in acting by any governmental authorities and any strike, lock - out orother form of industrial action or other form of action with respect to employment relationships ) ; ‘ cGLP ’ means the current Good Laboratory Practice being a set of principles that provides a framework withinwhich laboratory studies are planned, performed, monitored, recorded, reported and archived as applicable : ( i)in the European Union ; ( ii ) in the United States of America ; and ( iii ) in accordance with ICH requirements . Asin force from time to time during the term of this Agreement ; ‘ Intellectual Property ’ means all intellectual property rights, including ( without limitation ) patents, supplementary protection certificates, petty patents, utility models, trademarks, database rights, rights indesigns, copyrights ( whether or not any of these are registered or capable of being registered ) and includingall applications and the right to apply for registered protection of the foregoing and all inventions, tradesecrets, know - how, techniques and confidential information and other proprietary knowledge and information, and all rights and forms of protection of a similar nature or having equivalent or similar effect to any of thesewhich may subsist anywhere in the world, in each case for their full term and together with any renewals orextensions ; ‘ Internal Costs ’ means ( i ) fully allocated cost of a full time equivalent ( ) for providing the Service underthe related Project Agreement, such fully allocated costs comprises direct costs incurred directly for theprovision of the Services by SUPPLIER or the SUPPLIER Affiliate under the related Project Agreement(including but not limited to labour, materials, goods and supplies ) and indirect costs specifically allocable tothe provision of Services by Supplier or the SUPPLIER Affiliate under the related Project Agreement(including but not limited to administrative labour costs, maintenance, insurance the part of depreciationallocated to assets used in the provision of the related Services ) ; such calculation being based uponaccepted contract manufacturing industry standards and generally accepted accounting principles ; EXECUTION COPYPage 3 of 24 ‘ Master Agreement ’ means the agreement entered into by and between the Parties on Effective Date wherethe Parties have agreed upon, among other things, overall conditions for providing the Services ; ‘ Materials ’ means all compounds, materials and other substances supplied by CUSTOMER to SUPPLIER foruse under a Project Agreement ; ‘ Parties ’ means CUSTOMER and SUPPLIER ; ‘ Party ’ means CUSTOMER or SUPPLIER as appropriate ; ‘ Permitted Recipients ’ means those employees or contractors of the receiving Party who would reasonablyrequire access of the Relevant Information for the proper enjoyment or performance by that Party of its rightsand obligations under this Agreement or a Project Agreement ; ‘ Project ’ means a specific project related to pharmaceutical development activities and the manufacturing ofdrug products for clinical use which CUSTOMER and SUPPLIER agree to enter into under the terms of thisAgreement and the relevant Project Agreement ; ‘ Project Agreement ’ means each agreement made under this Agreement in accordance with clause 2relating to a Project in the form set out in Appendix 1 to this Agreement ; ‘ Quality Agreement ’ means a quality agreement setting out the Parties responsibilities for quality assuranceunder Applicable Laws ; ‘ Relevant Information ’ means any data or information ( whether or not recorded in a document, and whetheror not marked as confidential ), which is disclosed by one Party to the other or is obtained by either Party fromany information so disclosed or from any materials which are made available by or on behalf of one Party tothe other Party or is otherwise obtained by one Party, which are not publicly known . Relevant Informationshall include without limitation information relating to the business of either Party, including clinical andproduct development plans, strategies, patent disclosures, patent applications, structures, models, techniques, know - how, trade secrets, processes, compositions, formulations, compounds and apparatusrelating to the same and proprietary information related to the current, future, and proposed products orservices of the disclosing Party, including for the avoidance of doubt Service Data which shall be RelevantInformation of CUSTOMER ; ‘ Service Data ’ means all data and information produced as a result of the performance of the Services ; ‘ Service Materials ’ means all materials produced as a result of the performance of the Services ; ‘ Services ’ means the services to be performed by SUPPLIER pursuant to the relevant Project Agreement ; ‘ SOPs ’ means the relevant standard operating procedures to be used by SUPPLIER during the performanceof the Services that have been approved in writing by CUSTOMER ; and EXECUTION COPYPage 4 of 24 ‘ Starting Fee ’ means any applicable starting fee paid as a deposit for initiation of a Project as stated in theProject Agreement