definiens: shall mean, in eve ry case, costs ( including Allocable Overhead ) incurred by a Party, and not re imbursed, as required to develop and/or obtain the authorization and/or abil ity to manufacture, formulate, fill, ship and/or sell a Licensed Produc t in commercial quantities in the Territory . shall include, w ithout limitation, the cost of studies on the toxicological, pharmacokinetic, m etabolic or clinical aspects of a Licensed Product conducted internally, or by i ndividual investigators, contract research organizations or consultants nece ssary for the purpose of obtaining and/or maintaining approval of a Licensed Product by a government authority in a country in the Territory, and costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a governmental authority to obtain and/or maintain ap proval of a Licensed Product in a country in the Territory, as well as the costs of process development scale - up and recovery ( including plant costs ) . shall also include, without limitation, the cost of research a nd development of Vaccine Variants ( as defined in Section 1.5 above ) as poten tial Licensed Products, including, without limitation, research relating to the immunologic and serologic properties of Vaccine Variants, cloning a nd expression, and research and development of processes for expression and man ufacture of Clinical Vaccine(s ) and/or Commercial Vaccine(s ) including o r consisting of Vaccine Variants . shall also include, w ithout limitation, the cost of post - approval studies in support of a Licensed P roduct in the Field in the Territory, and the expenses for compensation, benef its and travel and other employee - related expenses, data management, statist ical designs and studies, document preparation, and other expenses associated with the clinical testing of a Licensed Product . in any case shall not include any costs or expenses which are reimbursed by the other Party or any third party