definiens: means any reasonable costs and expenses incurred in filing, prosecuting, maintaining, defending and enforcing the Licensed Patents, including official filing, prosecution, maintenance and renewalfees, patent attorney, legal and other professional fees and expenses and costs and expenses associated withan opposition or interference action ; means an individual employed or otherwise appointed by each Party to review and consider allmatters relating to the filing and prosecution of Programme Patents ; means any patent applications, patents, author certificates, inventor certificates, utility models, andall foreign counterparts of them and includes all divisionals, renewals, continuations, continuations - in - part, extensions, reissues, substitutions, confirmations, registrations, revalidations and additions of or to them, aswell as any Supplementary Protection Certificate, or any like form of protection ( including any pediatric, orphandrug or other exclusivity granted by a Competent Authority beyond the expiry of the original patent expirationdate ) ; means a clinical trial in which a Licensed Product is administered to human subjects atmultiple dose levels with the primary purpose of determining safety, metabolism, and pharmacokinetic andpharmacodynamic properties of the Licensed Product, and consistent with 21 CFR § 312.21(a ) ; means a clinical trial of a Licensed Product in human patients, the principal purposes ofwhich are to make a preliminary determination that the Licensed Product is safe for its intended use, todetermine its optimal dose, and to obtain sufficient information about the Licensed Product ’s efficacy to permitthe design of Phase III Trials, and consistent with 21 CFR 312.21(b ) ; means a human clinical trial of a Licensed Product, which trial is designed : ( a ) to establishthat the Licensed Product is safe and efficacious for its intended use ; ( b ) to define warnings, precautions andadverse reactions that are associated with the Licensed Product in the dosage range to be prescribed ; and(c ) consistent with 21 CFR § 312.21(c ) . Any Phase II Trial that is adapted to be a larger scale trial andintended as a pivotal trial for the purpose of obtaining Regulatory Authorisation of a Licensed Product, shall bedeemed a Phase III Trial ; has the meaning given in the RCOA . For clarity, certain Pre - Clinical Candidatesidentified prior to the Effective Date have been listed in Schedule 3 Part A which may be updated from time totime in accordance with Clause 7.13 ; means, in those countries in the Territory where a Competent Authority may approve ordetermine pricing and/or pricing reimbursement for pharmaceutical products, such approval or determination ; has the meaning given in the RCOA ; 8 means a detailed written report produced by [COMPANY] in respect of : ( i ) the progress ofdevelopment of Licensed Products against the current Development Plan ; ( ii ) the progress of any applicationsfor Regulatory Authorisation and ( where relevant ) Price Approvals ; and ( iii ) the progress of and plans formarketing and sale of Licensed Products ; means any of the three - monthly periods commencing on the first day of any of the months ofJanuary, April, July, and October in any year and has a corresponding meaning ; means all authorisations, approvals, clearances, and licences of a CompetentAuthority ( including an NDA ) that may be required in any country of the Territory prior to commercial sale of therelevant Licensed Product in the Field, including any necessary variations thereto, but excluding any PriceApprovals ; has the meaning given in the RCOA . For clarity, certain Research Tools identified prior tothe Effective Date have been listed in Schedule 3 Part B ; means the non - refundable sum of [ * * * ] ; means any of the following in relation to a Pre - Clinical Candidate or Licensed Product : ( a ) [ * * * ] ; ( b ) [ * * * ] ; ( c ) [ * * * ] ; ( d ) [ * * * ] ; ( e ) [ * * * ] ; ( f ) [ * * * ] ; ( g ) [ * * * ] ; and ( h ) [ * * * ]