definiens: means any applicable supra - national, federal, nat ional, regional, state, provincial or localregulatory agency, department, bureau, commission, council or other government entity regulating or ot herwiseexercising authority with respect to the Exploitati on of Agreement Compounds or Licensed Products in t heTerritory1.49 . means, with respect to a country in the Territory, any and all approvals, licenses, registrations or authorisations of any Health Autho rity necessary to commercially distribute, sell or market aLicensed Product in such country, including, where applicable, ( a ) pricing and reimbursement approval in suchcountry, ( b ) pre- and post - approval marketing autho risations ( including any prerequisite Manufacturing approvalor authorisation related thereto ), ( c ) labelling ap proval and ( d ) technical, medical and scientific li censes