definiens: shall mean more than one such authority ; means on a country by country basis that a Third Party under applicable laws concerning the application for and grant of Marketing Approvals having jurisdiction over that country at the relevant time ( i ) is precluded from submitting a Marketing Approval Application for any Competitive Product ; or ( ii ) in respect of any Competitive Product, is prohibited from relying upon Liverco ’s, or its Affiliates ’ or Sub -Licen see ’s product dossier or Regulatory Submission ( from which such party obtained a Marketing Approval ) concerning any Royalty Product, under any applicable abridged or streamlined procedure to obtain a Marketing Approval for such Competitive Product ; in respect of a Royalty Product, the package or packages of data, pre -clinical and clinical trial data and materials, information, results, materials and samples ( including any Test and Regulatory Data and/or the drug master file or part thereof ) submitted to a Regulatory Authority in support of a Marketing Approval Application or any other Regulatory Approval ; has the meaning set out in Clause 15.4.2 ; or has the meaning set out in Clause 12.1 ; has the meaning set out in Clause 12.6 ; shall mean any Original Royalty Products or any Additional Royalty Products, and shall be constructed to mean any combin ation of the foregoing ; has the meaning set out in Clause 12.13 ; means any product ( including an AAV product ) but not a Primary Product or Additional Royalty Product, where such product when sold in a country by Liverco or its Sub -Licensee, ( i ) would, were it not for the Licences granted hereunder in respect of the Original Licensed Patents, infringe any one or more Valid Claims of any of the Original Licensed Patents in such country ; or ( ii ) utilises in its manu facture ( a ) the [ * * ] as identified in Schedule 4 or a suspension cell line, as disclosed and licensed to Liverco 19 Certain confidential information contained in this document, marked by [ * * ], has been omitted because the information ( i ) is not mat erial and ( ii ) would likely cause competitive harm to the Company if publicly disclosed