definiens: has the meaning specified in Section 11.1 ; means the FDA, EMA, and Health Canada and any other foreign regulatory agenciescompetent to grant marketing approvals for pharmaceutical products including the Products in the Territory ; means Radio Frequency Identification Devices which ( at present or in the future ) may be affixed toProducts or Materials to assist in inventory control, tracking, and identification ; has the meaning specified in Section 8.2(a ) ; means the exchange rate to convert one unit of the [COMPANY] Manufacturing Site localcurrency into one unit of the billing currency for each Year, calculated as the average daily interbank exchangerate for conversion of the [COMPANY] Manufacturing Site local currency into one unit of the billing currency duringthe full year period ( October 1st [ preceding year ] to September 30th ) as published by OANDA.com under the heading at www.OANDA.com/convert/fxhistory ; has the meaning specified in Section 2.2(b ) ; means any event occurring during the Manufacturing of the Product resulting in aDeviation that materially impacts the quality, performance, safety or reliability of the Product or intermediatesthereof . A confirmed Out of Specification result is a Significant Quality Event ; means the requirements, for each Material, Component, Active Material or Product, which isgiven by Client to [COMPANY] in accordance with the procedures listed in a Product Agreement on Schedule A andwhich contains documents or requirements relating to each Product, including, without limitation : - 7 -Master Manufacturing Services Agreement ( a)specifications for Active Materials and Components ; ( b)manufacturing specifications, directions, and processes ; ( c)storage requirements ; ( d)all environmental, health and safety information for each Product including material safety data sheets ; ( e)the in - process specifications ; and ( f)the finished Product specifications, packaging specifications and shipping requirements for each Product;all as updated, amended and revised from time to time by Client in accordance with the terms of this Agreement ; has the meaning specified in Section 2.2(a ) ; has the meaning specified in Section 2.2(a ) ; has the meaning specified in Section 12.2 ; means the transfer to Client or any Third Party designated by Client by [COMPANY] of allinformation relating to the process of manufacturing Product, all documents, manufacturing instructions, specifications, and any other relevant documentation, all relevant manufacturing know - how, licenses andmaterials ( including raw materials specifications ) related to Product that [COMPANY] or its Affiliates, as applicable, controls or has the right to license at any time during the Term and that is necessary to enable Client or itsdesignee to manufacture Product in accordance with the Specifications, and to comply with applicable regulatoryrequirements ( including obtaining any necessary regulatory approvals, conducting any required studies anddeveloping any other regulatory documentation ) and all Applicable Laws in connection with the transfer ; means any geographic area described in a Product Agreement where Products manufactured byPatheon will be distributed by Client ; means any party other than Client, [COMPANY] or their respective Affiliates ; means any Intellectual Property of any party other than Client or [COMPANY] or their respectiveAffiliates ; means the United States of America including its territories and possessions ; and means in the first year of this Agreement, the period from the Effective Date up to and includingDecember 31 of the same calendar year, and thereafter will mean a calendar year