definiens: means current good manufacturing practices and regulations applicable to theManufacture of Cell Therapy products that are promulgated by any Regulatory Authority, including as promulgated under and in accordance with ( a ) the US Federal Food, Drug andCosmetic Act, Title 21 of the US Code of Federal Regulations, Parts 210, 211, 600, 601 and610, ( b ) relevant EU legislation, including European Directive 2003/94 / EC or nationalimplementations of that Directive, ( c ) relevant guidelines, including the EU Guidelines for GoodManufacturing Practices for Medicinal Products ( Eudralex Vol . 4 and Annexes thereto ), ( d)International Conference on Harmonisation Good Manufacturing Practice Guide for ActivePharmaceuticals Ingredients, applicable US FDA guidance documents, and ( e ) any analogousset of regulations, guidelines or standards as deﬁned, from time to time, by any relevantRegulatory Authority applicable to any Party ’s Development, Manufacture or Commercializationof Cell Therapy products in each case as in eﬀect as of the date such manufacturing for suchCell Therapy product are or were conducted