1.36 FDCA has the meaning ascribed to it in Section 14.2.1.
1.37 Force Majeure Event has the meaning ascribed to it in Section 19.1.
1.38 Governmental Authority means any national, multi-national, regional, state or local regulatory agency, department, bureau, or other governmental entity.
1.39 Indemnitee has the meaning ascribed to it in Section 15.3.1.
1.40 Indemnitor has the meaning ascribed to it in Section 15.3.1.
1.41 Intellectual Property means all worldwide (i) Patents, (ii) copyright registrations and applications and all renewals and extensions thereof, (iii) discoveries, inventions, trade secrets, know-how, techniques, methodologies, modifications, improvements, works of authorship, designs and data (whether or not protectable under patent, copyright, trade secrecy or similar laws), and (iv) Confidential Information, including all applications and registrations with respect to the items identified in clauses (iii)-(iv) (if any), but excluding all trademarks, trade names, service marks, logos and other corporate identifiers.
1.42 Investigative and Corrective Action Reports or ICAR means the document that is used to record the investigation of, as well as the review and disposition of, a failure related to a cGMP manufacturing process or system.
1.43 Liabilities has the meaning ascribed to it in Section 15.1.
1.44 LONZA has the meaning ascribed to it in the Recitals.
1.45 LONZA Confidential Information means all technical and other information, whether patented or unpatented, relating to the LONZA Facility and/or LONZA processes, methods, operations, technologies, forecasts and business information that is disclosed or supplied to, or used on behalf of, PROTEON by LONZA pursuant to this Agreement, or of which PROTEON may become aware through the presence of its employees or agents at LONZA offices or at the LONZA Facility, including, without limitation, trade secrets, know-how, processes, concepts, experimental methods and results and business and scientific plans and information and facility layout and schematics.
1.46 LONZA Facility means the facility owned and operated by LONZA at Rottenstrasse 6, 3930 Visp, Switzerland or such other facility designated by LONZA and owned and operated by an Affiliate of LONZA.
1.47 LONZA Intellectual Property means all Intellectual Property owned or Controlled by LONZA that are conceived, discovered, developed, generated, created, made or reduced to practice or fixed in a tangible medium of expression at any time prior to the Effective Date or after the Effective Date if such Intellectual Property rights are not based upon or related to the performance of the Project.
* CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.