1.21 Licensed Product means any product for use in the Field whose development, making, having made, use, sale, offer for sale, import, export and distribution would, in the absence of a license from AskBio, infringe one or more Valid Claims of the AskBio Patent Rights and/or use the AskBio Licensed Know-How.
1.22 Marketing Authorization means the requisite governmental approval for the marketing and sale of a Licensed Product in a given country.
1.23 Net Sales means the gross revenues invoiced by or on behalf of AveXis and any of its Sublicensees in connection with the sale, lease or other transfer for value of Licensed Product(s), in all cases after deduction of ****.
1.24 Patent Rights means patents and patent applications, whether domestic or foreign, including all continuations, continuations-in-part, divisions, provisionals and renewals, and letters of patent granted with respect to any of the foregoing, patents of addition, supplementary protection certificates, registration or confirmation patents and all reissues, re-examination and extensions thereof.
1.25 Quarter means the calendar quarterly periods ending March 31, June 30, September 30 and December 31.
1.26 Recipient means the Party receiving Confidential Information hereunder.
1.27 Regulatory Approval means with respect to a particular country in the Territory, receipt of all governmental approvals and authorizations necessary for the manufacture and commercial sale of the Licensed Product(s) in the applicable country, including, but not limited to, Marketing Authorization, pricing approval and reimbursement approval, as applicable.
1.28 Regulatory Authority means, with respect to any country, any and all governmental or regulatory bodies or authorities having the authority to approve the import, storage, export, transport, manufacture, sale and/or use of the Licensed Product(s), including the FDA.
1.29 Royalty Term means, with respect to each Licensed Product, on a country-by-country basis, the period beginning upon the Effective Date and ending upon expiration of all Valid Claims of the AskBio Patent Rights in such country that Cover such Licensed Product in such country.
1.30 Territory means worldwide.
1.31 Third Party means any entity other than AskBio or AveXis or their respective Affiliates.
****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.