definiens: means ( a ) in relation to disputes pursuant to Clauses 3.7 and 14.2.6, a suitably qualified independentexpert having expertise with the subject matter of the dispute and at least fifteen years of experience in thepharmaceutical and/or biotech industries, and appointed by agreement between the Parties, or if the Partiesare unable to reach agreement within twenty one ( 21 ) days of either Party seeking in writing to the other toappoint an expert, each Party shall submit two ( 2 ) names having the aforementioned expert qualifications 3to the President for the time being of the Association of the British Pharmaceutical Industry who shall beasked to select an individual from the four ( 4 ) names submitted ; and ( b ) in relation to a dispute concerningSub - Licence Revenue, or pursuant to Clause 6.3, a suitable qualified accountant having at least fifteen yearsof experience in the pharmaceutical and/or biotech industries, and appointed by agreement between theParties, or if the Parties are unable to reach agreement within twenty one ( 21 ) days of either Party seeking inwriting to the other to appoint an expert, each Party shall submit two ( 2 ) names having the aforementionedexpert qualifications to the President for the time being of Institute of Chartered Accountants in England & Wales who shall be asked to select an individual from the four ( 4 ) names submitted ; means the treatment of human diseases ; means, with respect to a Licensed Product, the first transfer or disposition to a thirdparty of such Licensed Product for which the corresponding consideration has been invoiced by [COMPANY], any ofits Affiliates or a Sub - Licensee, after all relevant Regulatory Authorisations for the transfer or disposition ofsuch Licensed Product have been obtained in respect of the relevant region or country ; means in relation to either Party any event or circumstance which is beyond the reasonablecontrol of that Party, which event or circumstance that Party could not reasonably be expected to have takeninto account at the Effective Date and which results in or causes the failure of that Party to perform any or allof its obligations under this Agreement including act of God, lightning, fire, storm, flood, earthquake, strike, lockout or other industrial disturbance, war, terrorist act, blockade, revolution, riot, insurrection, civilcommotion, public demonstration, sabotage, act of vandalism, explosion, provided that lack of funds shall notbe interpreted as a cause beyond the reasonable control of that Party ; means an investigational new drug application filed with the United States Food and Drug Administrationor any successor to it, or the equivalent application or filing filed with any equivalent Competent Authorityoutside the United States of America ( including any supranational agency such as the European MedicinesAgency ) necessary to commence human clinical trials in such jurisdiction ; means a disease classification as defined within the ‘ International Statistical Classification ofDiseases and Related Health Problems ’ as published from time to time by the World Health Organization ( e.g