Major European Market Countries. Major European Market Countries shall mean [####].
Manufacture, Manufactured or Manufacturing. Manufacture, Manufactured or Manufacturing shall mean all activities undertaken by or on behalf of Cardiokine or its Affiliates or sublicensees that are involved in the production of a Licensed Compound or a Licensed Product.
NDA. NDA shall mean a United States New Drug Application.
Net Sales. Net Sales shall mean the gross amount invoiced by Cardiokine or its Affiliates or sublicensees in respect of sales of Licensed Compound or Licensed Products to Third Parties in the Territory, less returns and less the following amounts (a) customary quantity, trade and/or cash discounts, refunds, chargebacks, allowances, rebates (including any and all federal, state or local government rebates, e.g., Medicaid rebates) and any price adjustments allowed or given; (b) sales and other excise taxes and duties directly related to the sale, to the extent such items are included in the gross invoice price; (c) credits for returned goods; (d) transportation charges to the extent included in the gross invoice price; and (e) agents commissions. Sales of Licensed Product(s) by Cardiokine, or an Affiliate or sublicense of Cardiokine, to any Affiliate or sublicensee which is a reseller thereof shall be excluded, and only the subsequent sale of such Licensed Product(s) by Affiliates or sublicensees of Cardiokine to Third Parties shall be deemed Net Sales hereunder. Any transfer of Licensed Produces) by Cardiokine, or an Affiliate or sublicensee of Cardiokine, to any party in connection with the development, testing, marketing or promotion of any Licensed Produces) shall also be excluded from Net Sales.
Patents. Patents shall mean (a) patents, patent applications and patents issuing from any such applications, and (b) any continuation, continuation-in-part, division, renewal, substitute, re-issue, extension, re-examination, revival or revalidation of any of the items in clause (a)/
Person. Person shall mean an individual, a corporation, a limited liability company, a partnership, an association, a trust or other entity or organization, including a governmental entity.
Regulatory Approval. Regulatory Approval shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals of any national (e.g., the FDA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the Research, Development, Manufacture and Commercialization of Licensed Product(s) in the Territory, including, without limitation, INDs and other submissions and approvals necessary to conduct clinical studies, approvals of ND As, supplements and amendments, pre- and post- approvals, and labeling approvals.
Regulatory Approval Application. Regulatory Approval Application shall mean an application submitted to a Regulatory Authority seeking Regulatory Approval for a Licensed Product.
Regulatory Authority. Regulatory Authority shall mean any national (e.g., the FDA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in the Territory involved in the granting of Regulatory Approval for a Licensed Product.