and any other filings required by the Regulatory Authorities relating to the manufacture, testing, sale or distribution of the Product.
1.74 Replacement Drug Substance has the meaning ascribed to it in Section 10.3.
1.75 Resin means all chromatographic media intended to refine or purify the Drug Substance, as specified in the Master Production Record.
1.76 Rules has the meaning ascribed to it in Section 20.3.
1.77 Run means a single complete operation of all, or a discreet portion of, the Manufacturing Process at the LONZA Facility.
1.78 Shipping Guidelines means LONZAs written procedures, as approved by PROTEON in writing, that describe the methods of packaging, preserving, monitoring and shipping any and all PROTEON property, including the Drug Substance.
1.79 [ ]*
1.80 Subcontractor means any independent entity that LONZA contracts with to perform any services or meet any obligations that are required under the terms and conditions of this Agreement.
1.81 Suite Activation Date has the meaning ascribed to it in Section 18.2.
1.82 Term has the meaning ascribed to it in Section 18.1.
1.83 Third Party means any party other than PROTEON, LONZA and their respective Affiliates.
1.84 Transfer Batch means a Batch produced from a Transfer Run.
1.85 Transfer Run means a Run used to demonstrate and transfer in to LONZA the Manufacturing Process.
1.86 Waste shall mean any hazardous substance and/or hazardous material as provided under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), any hazardous waste as provided under the Resource Conservation and Recovery Act (RCRA), and/or any other waste material, pollutant and/or contaminant of any kind including, without limitation, any routine process waste or any by-product arising from any activities conducted pursuant to this Agreement.
1.87 Wearables means any coverings or protective gear used by LONZA employees or agents in the course of the performing the development and manufacturing services hereunder, including without limitation gloves, coveralls, booties, eye shields and the like.
* 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.