TSE Clause Samples

TSE. 15.1. NTP shall immediately provide written notification to LMI of the use or the planned use of any animal-derived raw materials, intermediates, or components to be manufactured in the Facility. Under no circumstance shall NTP use any animal-derived material unless proper documentation is accepted by LMI. 15.2. In addition, NTP shall take any and all precautions to prevent the transmission of Transmissible Spongiform Encephalopathy (TSE) in its Facility. TSE includes Bovine Spongiform Encephalopathy (BSE) and all other forms of animal or human spongiform encephalopathies. These precautions must extend to TSE-associated prior proteins, and any other material associated with TSE. 15.3. NTP shall on a periodic basis provide TSE compliance documentation to LMI stating that all of the raw materials and the products in its Facility are TSE-free, i.e., compliance documentation may include the completed LMI TSE Questionnaire, vendor declarations, certifications, and/or European Pharmacopoeia TSE Certificates of Suitability. NTP shall maintain all required TSE declarations and certifications for their starting materials, intermediates, cleaning agents, and product-contact materials, and these shall be subject to audit by LMI.