definiens: means current Good Manufacturing Practices as promulgated in EU Commission Directive2003/94 / EC ( EU GMP Guidelines ), EU Commission Directive 2001/20 / EC ( Clinical Trials ), EU RegulationEC 1394/2007 ( Advanced Therapy medicinal Products ( ATmP ) ), EU Directive 2001/83 / EC ( MedicinalProducts for Human Use ), and national implementation of the foregoing, and applicable InternationalConference on Harmonisation guidelines as well as any applicable regulatory guidelines issued byGovernment Competent Authorities in particular relevant guidance on good manufacturing practicescontained in Volume 4 of the Rules Governing Medicinal Products in the European Union and the nationalimplementations of these rules . For the avoidance of doubt, the Supplier ’s operational quality standardsare defined in internal GMP documents which shall always be coherent with and adequately reflect currentinternational applicable GMP guidelines and allow GMP manufacturing of investigationalbiopharmaceutical products and products for cellular therapies ; 1.27 means any applicable supra - national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or othergovernment entities regulating or otherwise exercising authority with respect to use, transport ( includingimport and export ), manufacturing or storage of the [COMPANY] Materials or the provision of the Services inany country ; 1.28 means the relevant Party together with its Affiliates ; 1.29 means all intellectual property rights, including ( without limitation ) patents, supplementary protection certificates, utility models, trade marks, database rights, rights in designs, copyrights and topography rights ( whether or not any of these rights are registered, and includingapplications and the right to apply for registration of any such rights ) and all inventions, know - how, tradesecrets, techniques and confidential information and other proprietary knowledge and information, and allrights 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 anycontinuations, continuations - in - part, divisionals, renewals, reissues or extensions ; 1.30 means [COMPANY] ’s Intellectual Property Rights in and to the Product and in and tothe Process as well as other processes and/or products necessary to produce the Product, as furtheridentified in Schedule 7 ; 1.31 means the marketing authorisation for ChondroCelect ® with numberEU/1/09/563/001 issued by the European Commission on 5 October 2009 ; 1.32 means a breach of any obligation or warranty contained in this Agreement which has oris in the near future likely to have a material effect on the interests of the other Party to this Agreement