definiens: means the speciﬁcations for Bulk Drug Product supplied under this Agreement along with the set of analytical tests, methods and acceptance criteria applicable ( schedule A ) thereto, as such speciﬁcations may be amended and revised from time to time uponmutual agreement of the Parties in accordance with the terms of this Agreement to obtain or maintain approval of the Finished Product fromany Regulatory Authority, including, without any limitation : ( a)Manufacturing specifications, directions, instructions and packaging processes for the API, Components and Bulk Drug Product ; ( b)Storage requirements for API, Components and Bulk Drug Product ; ( c)All environmental, health and safety information for the API, Components and Bulk Drug Product, including material safety datasheets ; ( d)The drug product composition packaging specifications and shipping requirements for the Bulk Drug Product ; and ( e)The Specifications will include regulatory compliance obligations, as provided in this Agreement and in the Quality Agreement