Common use of Manufacturing Documentation Clause in Contracts

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. SBL shall maintain in the English language, complete, Manufacturing Documentation to be true and accurate Manufacturing Documentationaccurate, 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. * SBL 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 LawQAG. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, Documentation 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. * 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 as otherwise may be set forth in an withhold Manufacturing Documentation provided pursuant to this MSA or any applicable PSAPSA 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, 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. SBL shall maintain in the English language, complete, Manufacturing Documentation to be true and accurate Manufacturing Documentationpursuant to the Data Integrity Requirements Electronic Records Requirements, 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. * SBL 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 LawQAG. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, Documentation at the Facility or through a secured/encrypted server (e.g. Sharepoint) 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. * 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. To the extent necessary, SBL may redact or as otherwise may be set forth in an withhold Manufacturing Documentation provided pursuant to this MSA or any applicable PSAPSA 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, source documents, quality control testing documentation, quality assurance records, and laboratory notebooks are the exclusive property of *SBL. Notwithstanding anything to the contrary, * SOPs SBL’s redacted version of general operating SOPs, not specific to the Client’s Products Products, may be provided to Client for on-site review or through a secured/encrypted server if deemed necessary by both * SBL and Client. Such SOPs cannot be removed from the * premisesSBL premises or the secured/encrypted server, 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. SBL shall maintain in the English language, complete, Manufacturing Documentation to be true and accurate Manufacturing Documentationaccurate, 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. * SBL 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 LawQAG. Upon written request of Client and at mutually agreeable times, Client shall have the right to review Manufacturing Documentation, including the Batch Records, Documentation 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. * 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. To the extent necessary, SBL may redact or as otherwise may be set forth in an withhold Manufacturing Documentation provided pursuant to this MDSA or any applicable PSAPSA 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, 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. SBL shall maintain in the English language, complete, Manufacturing Documentation to be true and accurate Manufacturing Documentationaccurate, and shall keep them in strict confidence and shall not use them Manufacturing Documentation for purposes other than providing or performing the Service Services or other obligations hereunder. * SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG Quality Agreement. SBL will upload such Manufacturing Documentation on [***] or such longer period as may other similar platform and Client will be required by Applicable Lawgiven 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, including the Batch Records, Documentation at the Facility as further defined in the applicable QAG; providedQuality Agreement. At Client’s request, however, * shall not delay any such request of Client for more than fifteen (15) Business Days. Client SBL may also request 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 records, data, documentation and other information Manufacturing Documentation in the language as so required in the applicable QAG 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 as otherwise may be set forth in an withhold Manufacturing Documentation provided pursuant to this MSA or any applicable PSAPSA 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 Client’s Products Facility or Services, may be provided to Client for on-site ​ review if deemed necessary reasonably requested by both * and Client. Such SOPs cannot be removed from the * SBL 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 referencereplicated without SBL's permission.

Manufacturing Documentation. SBL shall maintain in the English language, complete, Manufacturing Documentation to be true and accurate Manufacturing Documentationaccurate, 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. * SBL 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 LawQAG. 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. * SBL shall record record, maintain, and maintain disclose 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 LawLaws. To the extent necessary, SBL may redact those portions of the Manufacturing Documentation provided pursuant this MSA or as otherwise any applicable PSA to protect the confidential information of its other clients or third parties, unless such information is required to be disclosed by any applicable Regulatory Authority, in which case, SBL may be set forth in an submit such information directly to the applicable PSARegulatory Authority. 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 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, 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.