Manufacturing Documentation. SBL shall maintain Manufacturing Documentation to be true and accurate, and shall keep in strict confidence and shall not use Manufacturing Documentation for purposes other than providing or performing the Services or other obligations hereunder. SBL shall maintain all such Manufacturing Documentation for at least that period specified in the Quality Agreement. SBL will upload such Manufacturing Documentation on [***] or other similar platform and Client will be given access, including viewing and printing access. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation at the Facility as further defined in the Quality Agreement. At Client’s request, SBL may provide scanned or printed copies of such Manufacturing Documentation, but Client shall be responsible for reasonable costs associated therewith. SBL shall record and maintain such Manufacturing Documentation in the language as so required in the Quality Agreement or as so required by a Regulatory Authority and in compliance with Applicable Law, provided that SBL shall, at all times, maintain a copy in the English language, if such Manufacturing Documentation is not already in the English language. To the extent necessary, SBL may redact or withhold Manufacturing Documentation provided pursuant to this MSA or any applicable PSA to protect the confidential information of its other clients or third parties, provided that such redacted or withheld Manufacturing Documentation does not relate to the Services. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of SBL. Notwithstanding anything to the contrary, SBL’s SOPs not specific to Products, but related to the Facility or Services, may be provided to Client for on-site review if reasonably requested by Client. Such SOPs cannot be removed from the SBL premises, copied, photographed or otherwise replicated without SBL's permission.
Manufacturing Documentation. SBL shall maintain Manufacturing Documentation to be true and accurate, and shall keep in strict confidence and shall not use for purposes other than providing or performing the Service or other obligations hereunder. SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation at the Facility as further defined in the applicable QAG. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. SBL shall record and maintain such records, data, documentation and other information in the language as so required in the applicable QAG or as so required by a Regulatory Authority and in compliance with Applicable Law. SBL shall not provide Manufacturing Documentation provided pursuant to this MSA or any applicable PSA to any third party and shall protect such as the confidential information of Client. To the extent necessary, SBL may redact or withhold Manufacturing Documentation provided pursuant to this MSA or any applicable PSA to protect the confidential information of its other clients or third parties. The form and style of Batch documents, including, but not limited to, Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of SBL. Notwithstanding anything to the contrary, SBL’s SOPs not specific to the Client’s Products may be provided to Client for on-site review if deemed necessary by both SBL and Client. Such SOPs cannot be removed from the SBL premises, copied, photographed or otherwise replicated.
Manufacturing Documentation. All of Seller's right, title, and interest in all manufacturing documentation associated with the seismograph product lines listed on Schedule 1.
Manufacturing Documentation. Matricel will maintain original manufacturing documentation according to record retention procedure consistent with FDA requirements.
Manufacturing Documentation. 3.4.1 FRESENIUS KABI will maintain the batch identification system for the PRODUCT Manufactured by FRESENIUS KABI (i.e. batch number assignment) and ensure that unique batch numbers are used for each batch of the PRODUCT. X
3.4.2 FRESENIUS KABI will compile the BOM for PRODUCT Manufacturing with CSI’s final approval. X X
3.4.3 FRESENIUS KABI will maintain all batch records and associated PRODUCT documentation for a minimum of one year beyond expiry date of the PRODUCT. FRESENIUS KABI shall keep validation batch production and testing records permanently. X
3.4.4 FRESENIUS KABI will ensure executed batch records contain the following information to meet Device History Record (DHR) requirements. • Dates of manufacture; • Quantity manufactured; • Quantity released for distribution; • Acceptance records which demonstrate the device is manufactured in accordance with the DMR; • The primary identification label and labeling used for each production unit; and • Any identification(s) and control number(s) used. X
3.4.5 FRESENIUS KABI will draft and approve master Manufacturing batch records. X
3.4.6 FRESENIUS KABI shall Manufacture the PRODUCT in accordance with principles of cGMP as described by the Regulatory Authority appropriate for the type of PRODUCT. X
3.4.7 FRESENIUS KABI shall assure that the PRODUCT is Manufactured, Packaged, held, labeled, and tested according to FRESENIUS KABI’s procedures and batch records and fulfills the PRODUCT Specification. X
Manufacturing Documentation. The Manufacturing Documentation is complete, correct, and up-to-date and, together with the content of the documents and other items listed therein, describes the Seller Manufacturing Process in sufficient detail to enable reasonably trained and qualified personnel to operate the Seller Manufacturing Process as operated by Seller prior to the Closing Date (while redacting Excluded Technology).
Manufacturing Documentation. Formosa is responsible for the preparation and revision of Master Batch Records, Test Methods and Shipping Instructions for the Product. Formosa will provide these documents to NGX for review and approval before they are used in any manufacturing, testing or shipping operations. Editorial changes or changes in formatting that do not change the content of the document do not require NGX prior approval, however, copies of the revised documents will be provided to NGX immediately after the change has been implemented.
Manufacturing Documentation. Unless applicable Laws or GMP requires longer retention periods, VIFOR or its subcontractors shall retain Batch Manufacturing records for a period of (expiry date + 1 year) beyond the shelf-life of the applicable Batch of Product. Unless applicable Laws require a longer retention period, DISTRIBUTOR shall retain Product distribution records for a period of (expiry date + 1 year) beyond the shelf-life of the applicable Batch of Product.
Manufacturing Documentation. On or before [***] days from the Effective Date, Archemix shall provide Ophthotech with a copy of Item 7 (entitled “Chemistry, Manufacturing & Control”) of the IND application prepared by Archemix for ARC1905 dated December 15, 2005. Upon Ophthotech’s request, Archemix shall provide Ophthotech with copies of the supporting documents or records for such Item 7. Ophthotech shall be responsible for paying all costs including, without limitation, Archemix’s FTE Costs and any external expenses incurred by Archemix, associated with the transfer of any such documents or records to Ophthotech under this Section 3.5.4; provided, that, Archemix may redact any portion of such documentation and records as it reasonably determines contains Confidential Information of a Third Party.
Manufacturing Documentation. At the request of RMS, BEBIG agrees to provide RMS with copies of all manufacturing drawings, schematics and specifications 9 necessary or appropriate to permit manufacture of the Product and any improvements thereto. RMS shall reimburse BEBIG its reasonable reproduction and transport costs.
