province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, provincial, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal); (d) multi-national or supranational organization or body; or (e) individual, entity, or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.
1.54“
IND”
means an Investigational New Drug Application as defined in the FD&C Act and the regulations promulgated thereunder, or the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, including a Clinical Trial Authorization to the European Medicines Agency, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
1.55“
Indemnified Party”
has the meaning set forth in
Section 10.3.1.
1.56“Indemnifying Party” has the meaning set forth in Section 10.3.1.
1.57“Indication” means Metachromatic leukodystrophy through [*].
1.58“Know-How” means any proprietary or confidential scientific or technical information, inventions, discoveries, results and data of any type whatsoever, in any tangible or intangible form, including inventions, discoveries, databases, safety information, practices, methods, instructions, techniques, processes, drawings, documentation, specifications, formulations, formulae, knowledge, know-how, trade secrets, skill, experience, test data and other information and technology applicable to formulations, compositions or products or to their manufacture, development, registration, use, marketing or sale or to methods of assaying or testing them, including pharmacological, pharmaceutical, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, physical and analytical, safety, quality control data, manufacturing, and stability data, studies and procedures, and manufacturing process and development information, results and data. Know-How excludes Materials and Patent Rights.
1.59“
Krabbe License Agreement” has the meaning set forth in the recitals.
1.60“Law” or “Laws” means all applicable laws, statutes, rules, regulations, ordinances, and other pronouncements having the binding effect of law of any Governmental Body.
1.61“
License” has the meaning set forth in
Section 2.1.
1.62“
Licensed Compound” means PBML04, as more fully described in
Schedule 1.62.
1.63“Licensed Know-How” means the Licensed UPenn Know-How and Passage Know-How.
1.64“Licensed Product(s)” means any (a) process, service or method covered by a Valid Claim of a UPenn Patent or whose use or practice would, absent the License, constitute an