exhibit 10. 12. 8 exhibit 10. 12. 8 amendment no. 8 to the agreement dated 6th september 2017 between lonza sales ag and lonza ag and denali therapeutics inc. with respect to : quality agreement 19jul22 / mm / ep ( fa ) / b26647page 1 of 7 19jul22 / mm / ep ( fa ) / b26647page 1 of 7 page 1 of 7 a. lonza and the customer entered into a development and manufacturing service agreement dated 06 september 2017 ( “ agreement ” ) pursuant to which lonza agreed to provide services to the customer as so defined in the agreement ; and lonza and the customer entered into a development and manufacturing service agreement dated 06 september 2017 ( “ agreement ” ) pursuant to which lonza agreed to provide services to the customer as so defined in the agreement ; and b. the agreement has been previously amended ; and the agreement has been previously amended ; and c. the parties now wish to further amend the agreement to further define the cgmp responsibilities of each party for the manufacture, testing and release of product in accordance with current good manufacturing practices and general biologics products standards as promulgated under the european commission directives 2001 / 83 / ec, as amended, and 2001 / 20 / ec ; the european commission guidelines of good manufacturing practices for medicinal products as promulgated under european directive 2003 / 94 / ec ( eudralex – volume 4 ) ; the us fda 21 cfr 210 / 211 / 600 and 21 cfr part 11 and 610 ; the rules governing medicinal products in the european union, volume iv part i ( for drug products ) and / or part ii ( for apis ) and other agency regulations as applicable to api or drug product manufacture on the occasion that lonza manufactures and tests product for customer for further manufacturing use in the preparation of human drug products for clinical trial supply or that lonza manufactures the final drug product for clinical trial supply ; and the parties now wish to further amend the agreement to further define the cgmp responsibilities of each party for the manufacture, testing and release of product in accordance with current good manufacturing practices and 19jul22 / mm / ep ( fa ) / b26647page 2 of 7 19jul22 / mm / ep ( fa ) / b26647page 2 of 7 page 2 of 7 d. the parties wish that lonza ’ s affiliates, having particular expertise in the