Manufacturing Documentation shall maintain in the English language, complete, true and accurate Manufacturing Documentation, and shall keep them in strict confidence and shall not use them for purposes other than providing or performing the Service or other obligations hereunder. * shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG or such longer period as may be required by Applicable Law. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, at the Facility as further defined in the applicable QAG; provided, however, * shall not delay any such request of Client for more than fifteen (15) Business Days. Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith. * 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, or as otherwise may be set forth in an applicable PSA. 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 *. Notwithstanding anything to the contrary, * SOPs not specific to the Client’s Products may be provided to Client for on-site review if deemed necessary by both * and Client. Such SOPs cannot be removed from the * premises, copied, photographed or otherwise replicated, but to the extent required for filing in connection with any Regulatory Approval related to a Product including, but not limited to, an IND, BLA or MAA, * will file, maintain and update such SOPs with appropriate Regulatory Authorities by means of a Drug Master File, Common Technical Document or other means by which such SOPs may remain confidential, but available by reference to Client to effect Regulatory Approvals, and * shall formally authorize such reference.
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. 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. Distribution Documentation and other related documents: Temperature records, Complaints, AEs etc. 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. Matricel will maintain original manufacturing documentation according to record retention procedure consistent with FDA requirements.
Manufacturing Documentation. In accordance with the terms of the Tech Transfer Agreement, Genentech shall, by the relevant date that is set forth in the Tech Transfer Agreement as such date may be modified by the JPT, provide to Lonza the Manufacturing Documentation listed within exhibits and schedules to the Tech Transfer Agreement, and shall, thereafter, from time to time and in accordance with the timeline set forth in the Tech Transfer Agreement, provide to Lonza such additional Manufacturing Documentation as Lonza shall reasonably require in order to implement the Tech Transfer Agreement and the Manufacturing Process and otherwise perform its obligations under this Agreement. In accordance with the terms of the Quality Agreement and cGMP, Lonza shall maintain a process notebook which maintains a record of the Manufacturing Process as implemented at the Lonza Facility, including, without limitation, the process trend and variability data (the “Process Notebook”). Genentech shall have the right to review and copy any information in such Process Notebook at any time during the Term. Genentech’s obligations under this Section 4.8 shall be subject to obligations to Third Parties as set forth in written agreements in effect prior to the Effective Date of this Agreement. In the event an obligation to a Third Party prohibits Genentech from rendering such assistance, Genentech shall promptly seek from such Third Party permission to render such assistance. Such Manufacturing Documentation and Process Notebook shall be the sole property of Genentech, and shall be treated in all respects as Genentech Confidential Information. The Process Notebook, including any copies or any portion thereof, shall be delivered to Genentech upon expiration or termination of this Agreement.
Manufacturing Documentation. Manufacturing Documentation includes all written information which P-Com retains after production release of a product. This will vary based upon the type and complexity of each particular assembly, but will at a minimum include all documentation required by P-Com's ISO certified process. Typical Manufacturing Documentation consists of: