definiens: shall mean all laws, statutes, rules, regulations, directives, decisions, ordinances and other requirements of any Governmental Authorit y in the United States or the EU applicable to the Services relating to the manufacture, testing, qual ity, storage and supply of investigational drugs ( including biologics ) ; including, without limitatio n : ( a ) in the case of cGMP Batches for investigatio nal clinical trials in the U.S., as expressly stated in the relevant Proposal or Quality Agreement, the FD & C Act and cGMPs ; and ( b ) all applicable regulations and g uidelines of the FDA, EMA and/or any other relevant Regulatory Authority in the United States and/or th e EU applicable to the manufacture, testing, qualit y, storage and supply of an investigational new drug ( including biologics ) ; in each case, together with a ny and all amendments thereto