1.20 Good Manufacturing Practices or GMP means the regulatory requirements for current good manufacturing practices for pharmaceuticals promulgated by the FDA, as the same may be amended from time to time, and such standards of good manufacturing practice as are required by the Regulatory Authorities of the European Union and other organizations and Governmental Authorities in countries in which the applicable Licensed Product is intended to be manufactured or sold, to the extent such standards are not less stringent than United States GMP.
1.21 Governmental Authority shall mean any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, state or local authority or any political subdivision thereof, or any association of countries.
1.22 Government or Public Official means: (i) any official, officer, employee, representative, or anyone acting in an official capacity on behalf of: (a) any government or any department or agency thereof; (b) any public international organization (such as the United Nations, the International Monetary Fund, the International Red Cross, or the World Health Organization), or any department, agency, or institution thereof; or (c) any government-owned or controlled company, institution, or other entity, including a government-owned hospital or university; (ii) any political party or party official; and (iii) any candidate for political office.
1.23 IND means an Investigational New Drug application in the United States or, in any country other than the United States, a 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.
1.24 Know-How means any proprietary and confidential scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including any of the foregoing that are 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, manufacturing process and development information, results or data.
1.25 Lead Compound means Lillys Corticotropin-Releasing Hormone-1 (CRH-1) receptor antagonist (Lilly Id. No.: LY2371712) with the structure set forth on Exhibit C, including [***].
1.26 Licensed Compound means (a) the Lead Compound, (b) any other Corticotropin-Releasing Hormone-1 receptor antagonist covered by Patents Controlled by Lilly, (c) any [***], and (d) any [***].
1.27 Licensed Product means any product containing a Licensed Compound, including any Combination(s) (marketed or investigational).