1.110 “Regulatory Approval” means all approvals, including Pricing Approvals and MAAs, that are necessary for the commercial sale of a product in a given country or regulatory jurisdiction.
1.111 “Regulatory Authority” means any applicable Government Authority responsible for granting Regulatory Approvals for products, including the FDA, the EMA, the PMDA, and any corresponding national or regional regulatory authorities.
1.112 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.
1.113 “Regulatory Filings” means, with respect to a BioNTech Product orCo-Development Product, any submission to a Regulatory Authority of any appropriate regulatory application specific to BioNTech Product orCo-Development Product, and shall include any submission to a regulatory advisory board and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any IND, NDA, MAA or the corresponding application in any other country or jurisdiction.
1.114 “Remedial Action” means any recall, corrective action or other regulatory action with respect to BioNTech Product orCo-Development Product taken by virtue of Applicable Laws.
1.115 “Royalty Term” has the meaning set forth in Section 8.3(b) (Royalty Term).
1.116 “SEC” has the meaning set forth in Section 12.6(a) (Publicity/Use of Names - subsection (a)).
1.117 “Sole Inventions” means any Inventions made solely by a Party’s or its Affiliates’ employees, agents or independent contractors.
1.118 “Sublicense” means: (a) a license or sublicense to Develop, make, have made, use, distribute, sell, offer for sale, have sold, import, export or otherwise Commercialize any BioNTech Product and (b) a license or sublicense to Develop, make, use, distribute, sell, offer for sale, have sold, import, export or otherwise Commercialize anyCo-Development Product.
1.119 “Sublicensee” means a Third Party to whom BioNTech and/or Genevant has granted a Sublicense in accordance with the terms of this Agreement.
1.120 “Tax” or “Taxes” means any (a) federal, provincial, territorial, state, municipal, local, foreign or other taxes and other charges in the nature of a tax, including all income, excise, franchise, gains, capital, real property, goods and services, transfer, value added, gross receipts, windfall profits, severance, ad valorem, personal property, production, sales, use, license, stamp, documentary stamp, estimated or withholding taxes, and all customs and import duties; (b) any liability for the payment of any amounts of the type described in clause (a) as a result of being or having been a member of an affiliated, consolidated, combined or unitary group; and (c) any liability for the payment of any amounts as a result of being party to any tax sharing agreement or arrangement or as a result of any express or implied obligation to indemnify any other person with respect to the payment of any amounts of the type described in clause (a) or (b).
14