definiens: shall mean the technical, medical and scientific licenses, registrations, authorizations and / orapprovals of a Product ( including any prerequisite manufacturing approvals or authorizations related thereto ) that arerequired or deemed necessary by any national, supra - national ( e.g., the European Commission or the Council of theEuropean Union ), regional, state or local regulatory agency, department, bureau or other governmental entity, and anypricing, third party reimbursement approvals and labeling approvals required or deemed necessary for themanufacture, means any good or product ( or any part of a good or product ) which applies or is made according to, allor any part of the University Patent or Generated Intellectual Property means a claim of an issued and unexpired patent or patent application included within the scope ofprotection afforded by University Patent or Generated Intellectual Property that has not lapsed, been revoked orabandoned or held unenforceable or invalid by a final decision of a court or other appropriate body of competentjurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been disclaimed, deniedor admitted to be invalid or unenforceable through reissue, re - examination, disclaimer or otherwise