definiens: means the Amended and Restated Capital Expenditur e and Equipment Agreement between the parties effective M ay 28, 2019 as may be amended that addresses the rights and responsibilities of the parties rega rding capital equipment and facility modifications that are required to perform the Manufacturing Services under this Agreement ; means, as applicable, current good manufacturing practices as described in : ( a ) Parts 210 and 211 of Title 21 of the United States ' Code of Federal Regulations ; ( b ) Commission Directive ( EU ) 2017/1572 ( art . 2 ) ; and ( c ) Division 2 of Part C of the Food and Drug Regulatio ns ( Canada ) ; together with current final industry - accepted Healt h Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control pra ctice, all as updated, amended and revised from tim e to time ; means Intellectual Property generated or derived by Client before or after entering into this Agreement, or by [COMPANY] w hile performing any Manufacturing Services which Intellectual Property is specific to, or dependent upon, the Product or Client ’s technology, including, without limitation, the controlled or modified rele ase drug delivery systems and technology used in connection with Client ’s Product ( which, for the pu rposes of this Agreement, will include variations a nd modifications of these systems and technology ) ; means, collectively, all packaging components, ra w materials, ingredients, and other materials ( including labels, product inserts and ot her labelling for the Products ) required to manufac ture or package Product in accordance with the Processin g Instructions, including the API ; has the meaning specified in Section 11.1 ; means the Drug Enforcement Administration of the United States Department of Justice ; has the meaning specified in Section 6.1(a ) ; has the meaning specified in Section 11.1 ; means the European Medicines Agency ; means the United States Food and Drug Administrat ion ; has the meaning specified in Section 5.1(d ) ; June 28, 2019 Confidential Manufacturing Services Agreement between [COMPANY] and PLx Page 5 of 38 17 CFR 240.24b-2, confidential information has been omitted in places marked and has been file d separately with the Securities and Exchange Commiss ion pursuant to a Confidential Treatment Applicatio n filed with the Commission