definiens: means, with respect to a country in the Territory, any and all approvals ( including approvals of Drug Approval App lications ), licenses, registrations or authorizatio ns of any Regulatory Authority necessary to commercially dist ribute, sell and market a Licensed Product in such country, including, where applicable, ( a ) commercially reaso nable pricing or reimbursement approval in such cou ntry, ( b ) pre- and post - approval marketing authorizations ( including any prerequisite Manufacturing approval or authorization related thereto ), and ( c ) labeling ap proval ; it being understood and agreed that if aggr egate, cumulative Net Sales for a Licensed Product in the [ * * * ] exceed [ * * * ], then such 17 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [ * * * ], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOU LD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED