definiens: shall mean International Conference of Harmonizatio n ; 1.11 shall mean an investigational new drug application or any equivalent of it issued by any of the Regulatory Authorities ; 1.12 shall mean Patent Rights and Know - How ; 1.13 shall mean a Joint Development Committee to be form ed in accordance with Article 2.1 ; 1.14 shall mean the meeting(s ) of JDC held by the repres entatives of the Parties as defined in Article 2.2 ; 1.15 shall mean the task force to be formed by the Parti es pursuant to Article 2.5 ; 1.16 shall mean all information relating to the Product not in the public domain of whatsoever nature, including without limitations an y information regarding the manufacturing process, any non - clinical and clinical data ; 2 1.17 shall mean the date of first Commercial Launch by P HARMAENIGINE of the Licensed Product in a country within the Territory ; 1.18 shall mean any Product which is covered, in whole o r in part, by a Valid Claim or Know How ; made by a process covered, in whole or in part, by a Valid Claim or Know - How ; or whose use is covered, in whole or in part, by a Val i d Claim or Know - How