definiens: has the meaning given in Clause 19.2 ; means, with respect to any Services or Technology Transfer, ( a ) any amounts paid to Third Parties ( including costs incurred by [COMPANY] or its Affiliates under Third Party contracts ) ; ( b ) shipping and transportation costs ( including the cost of any insurance related thereto ), duties and Taxes ; ( c ) travel - related costs from mut ually - agreed - upon travel ; ( d ) costs or expenses incurred by [COMPANY], its Affiliates or subcontr actors for the extraction, conversion and transfer of data ; ( e ) any costs and expenses described in a Ser vices SOW that are not included as Services Fees ; a nd ( f ) any other actual, reasonably incurred, document ed, out - of - pocket costs and expenses, in each case ( a ) through ( f ), directly incurred by [COMPANY] a nd its Affiliates in providing such Services or Technology Transfer ; and have the meanings given in the preamble hereto ; has the meaning given in Clause 8.2 ; means any individual, corporation, limited liabil ity company, partnership, firm, joint venture, association, joint - stock company, trust, unincorpor ated organization, Governmental Authority or other entity ; means the employees, officers, agents and contrac tors of a Party or ( where, the context requires, those of a Party ’s Affiliates ) ; means the pharmacovigilance agreement for the Sup plied Product to be mutually agreed upon between the Parties ; has the meaning given in the definition of ; means a written purchase order with a unique numb er issued by Viela for such quantities of the Products as Viela commits to purc hase from [COMPANY] for the period covered thereb y and specifying the required delivery dates and deli very locations therefor ; means, with respect to the Product and a particul ar country, any and all approvals ( including approvals of Biologics License Applications ), licenses, registrations or authorizations of any Regulatory Authority necessar y to develop, manufacture or commercialize the Product in such country ; means any applicable supra - national, federal, nat ional, regional, state, provincial or local regulatory agencies, department s, bureaus, commissions, councils or other government entities regulating or otherwise exercis ing authority with respect to the exploitation of Supplied Product anywhere in the world, including t he FDA in the United States ; means the release of Product for delivery pursuan t to the Commercial Quality Agreement