1.28“Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, region, state or local authority or any political subdivision thereof, or any association of countries.
1.29“IND” means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.30“Know-How” means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.
1.31“Licensed IP” means Licensed Know-How and Licensed Patents.
1.32“Licensed Know-How” means all Know-How Controlled by MIST or its Affiliates as of the Effective Date or at any time during the Term that is necessary or reasonably useful for the Development, Manufacture or Commercialization of the Product in the Field in the Territory; provided, however, that Licensed Know-How shall exclude [*].
1.33“Licensed Patents” means all Patents in the Territory Controlled by MIST or its Affiliates as of the Effective Date or at any time during the Term that are necessary or reasonably useful for the Development, Manufacture or Commercialization of the Product in the Field in the Territory; provided, however, that Licensed Patents shall exclude [*]. Licensed Patents existing as of the Effective Date are set forth in Exhibit B.
1.34“Manufacture” and “Manufacturing” mean activities directed to manufacturing, processing, filling, finishing, packaging, labeling, quality control, quality assurance testing and release, post-marketing validation testing, inventory control and management, storing and transporting the Product.
1.35“Manufacturing Cost” means, with respect to the Compound, Device or Product supplied by MIST to Ji Xing hereunder:
(a)if the Compound, Device or Product [*]; and
(b)if the Compound, Device or Product [*].
1.36“MIST Licensees” means any and all licensees and sublicensees of MIST or a MIST’s Affiliate for the Product (other than Ji Xing, Ji Xing’s Affiliates and sublicensees).