definiens: means any company, corporation ; firm, partnership or other entity w hich is directly or indirectly controlled by, or under the same control of any of the Parties, where control means the power, direct or indirect, to direct or cause the direction of the management and policies of such entity, whether by contract, through t he by - laws of the aforementioned entitles or otherwise ; means the present Agreement and all its Appendix(es ) including all Work Plans and Quality Agreements agreed between the Parties during the Term and any amendments to any of the foregoing made in accordance with this Agreement ; means the total quantity of Product obtained from one manufacturing run using the process at a specified scale, the purification of the Product, and the analytical activities as further described in the appl icable Work Plan ; means all of the documentation associated with the production and testing of a given Batch, including without limitation production records ( including -the master production record ) . Raw Materials certificates of release, sampling documentation, out of specification and deviation reports, test results, investigative and corrective action reports . all applicable manufacturing process data ( including any pertinent output from instrumentation ), facility cGMP compliance verific ations for the duration of the Batch ’s production ( including without limitation for Water For Injections ( WFI ) production system, Heating and Ventilation Air Conditioning ( ) system and clean room classification attainment at the time that the Batches are produced ), the Certificate of Analysis, the Certificate of Compliance and any additional quality review and approval documentation, If applicable . To the extent such documentation has been disclosed by CUSTOMER to NOVASEP, or includes CUSTOMER Backgro und Data, CUSTOMER Pre -Existing IPR, or constitutes CUSTOMER Foreground IPR, or has been developed specifically in relation to a Product, It shall be deemed to be CUSTOMER ’s Confidential Information disclosed to NOVASEP pursuant to this Agreement . Otherwis e such documentation ( other than where It relates to Jointly Owned Foreground IPR ) shall be deemed to be the Confidential information of the Party developing or generating the same . To the extent that such documentation relates to Jointly Owned Foreground IPR, it shall be deemed to be the Confidential Information of both Parties jointly In respect of which each Party shall be considered a Receiving Party and shall act in accordance with the confidentiality obligations on a Receiving Party as set out in this Agreement ; means a certificate of analysis listing in relation to each Batch the tests performed by NOVASEP or a sub -contractor of NOVASEP ( as permitted under this Agreement and agreed between the Parties ), the Specification and the test results and confirming that the Product meets the Specification and such other criteria as identified on the certificate of analysis ; means current Good Manufacturing Practices as promulgated in ICH Q7A ( Guideline on Good Manufacturing Pr actice for Active Pharmaceutical Ingredients ) as relevant to each stage of Product development and/or manufacture ; EU and US GMP requirements as defined In Eudralex Vol 4 and In EC Directives 2003/94 / EC and 2005/28 / EC, and in 21 CFR Parts 210, 211, 600 and 610 and Part 11 for activities directly related to final Drug Product manufacture and control as any of the foregoing may be amended from time to time ; and anything which replaces or supersedes the same from time to time ; means a Batch which is manufactured, or is stipulated in a Work Plan to be manufactured, according to cGMP ; 3 Certain confidential information contained in this document, marked by [ * * ], has been omitted because the information ( i ) is not material and ( ii ) would likely cause competitive harm to the Company if publicly disclosed