definiens: shall mean the prevention, diagnosis, control or treatment of any human or animal disease or conditi on by the Systemic Use of a Covered Product(s ), either as a single agent or in combination with any other therapy . The Field may be modified from time to tim e as provided in Section 7.7First Commercial Sale " shall mean, with respect to any Covered Product, the first sale for use or consumption by t he general public of such Covered Product in a country in the Territory after all required marketing and pricing approvals have been granted, or otherwise p ermitted, by the governing health authority of such country . shall not include the sale of any Covered Product for use in clinical tri als or for compassionate use prior to the approval of an NDA ; provided, however, that if and to the extent that [COMPANY] receives remuneration for any such compass ionate use or named patient sales, [COMPANY] shall pay royalties thereon in accordanc e with Section 9.5