Person in Plant. During manufacturing of a Technical Batch, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the Manufacturing Process for the purpose of observing, reporting on, and consulting as to the performance of the Services. During manufacturing of the GMP Batches, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the GMP Manufacturing Process for the purpose of observing and reporting on the performance of the Services. Furthermore, unless otherwise agreed to by the Parties, if Lonza does not have suitable space at Lonza’s Services site for drug product (“Drug Product Services Site”), CONFIDENTIAL Customer shall [***]. In addition, Customer shall be permitted [***] within the Drug Product Services Site as visitor(s), for visits over periods to be determined by mutual agreement to (a) facilitate real-time (same time-zone) communications between Customer technical drug product team and the Lonza drug product team, (b) facilitate transfer of process and analytical technology between the companies; (c) facilitate master batch record review and approval process; (d) perform technical review of manufacturing batch data; and/or (e) augment program management by providing local input. Each such Customer employee or authorized representative shall be subject to and agree to abide by confidentiality obligations to Third Parties and Lonza's customary practices, and such employee agrees to comply with all instructions of Lonza’s employees at the drug product manufacturing Facility and/or Drug Product Services Site.
Appears in 2 contracts
Samples: Master Services Agreement (Vaxcyte, Inc.), Master Services Agreement (Vaxcyte, Inc.)
Person in Plant. During manufacturing of a the first Technical Batch, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the Manufacturing Process for the purpose of observing, reporting on, and consulting as to the performance of the Services. During manufacturing of the GMP Batches, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the GMP Manufacturing Process for the purpose of observing and reporting on the performance of the Services. Furthermore, unless otherwise agreed to by the Parties, if Lonza does not have suitable space at Lonza’s Services site for drug product (“Drug Product Services Site”), CONFIDENTIAL Customer shall [***]. In addition, Customer shall be permitted to [***] within the Drug Product Services Site as visitor(s), for visits over periods to be determined by mutual agreement to (a) facilitate real-time (same time-zone) communications between Customer SutroVax technical drug product team and the Lonza drug product team, (b) facilitate transfer of process and analytical technology between the companies; (c) facilitate master batch record review and approval process; (d) perform technical review of manufacturing batch data; and/or (e) augment program management by providing local input. Each such Customer employee or authorized representative shall be subject to and agree to abide by confidentiality obligations to Third Parties and Lonza's ’s customary practices, and such employee agrees to comply with all instructions of Lonza’s employees at the drug product manufacturing Facility and/or Drug Product Services Site.
Appears in 2 contracts
Samples: Development and Manufacturing Services Agreement (Vaxcyte, Inc.), Development and Manufacturing Services Agreement (SutroVax, Inc.)