Person in Plant. Customer shall be permitted to have, [***], [***] at the Facility as reasonably requested by Customer, [***] for the purpose of observing, reporting on, and consulting as to the performance of the Services. Such [***] shall be subject to and agree to abide by confidentiality obligations to Third Parties and Lonza’s customary practices and operating procedures regarding persons in plant, and such [***] agrees to comply with all instructions of Lonza’s employees at the Facility.
Person in Plant. Licensee may designate at its discretion up to *** representatives to be present in the applicable Facility during normal working hours to coordinate, expedite and guide manufacturing.
Person in Plant. During manufacturing of 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”), 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 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 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.
Person in Plant. If reasonably requested by Magenta, at a mutually agreed day and time, Bachem will permit and provide working space for Magenta to staff one person on location at Bachem’s premises, limited to no more than [***] days, during preparation for manufacturing and packaging of the Product. Such person shall be given reasonable access to all records, facilities and personnel working on any Services or Project Plans for the purpose or providing advice, coordinating reviews, approvals or any other actions required to ensure compliance with this Agreement to the extent that it does not compromise the confidentiality of other customers.
Person in Plant. Forty Seven shall be permitted to have, at no additional cost, [*] at the Facility as reasonably requested by Forty Seven, at any time during the Manufacturing Process for the purpose of observing, reporting on, and consulting as to the performance of the Services. Such employee shall be subject to and agree to abide by confidentiality obligations to Third Parties and Lonza’s customary practices and operating procedures regarding persons in plant, and such employee agrees to comply with all instructions of Lonza’s employees at the Facility. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Person in Plant. With seven (7) days advance notice to the Contractor in writing from the CO, the Government may place a man-in-plant in the Contractor’ or Subcontractor’s facility, who shall be subject to the Contractor’s or Subcontractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s or Subcontractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, of the production areas being utilized in performance on the Contract. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor or subcontractor plant. An article substantially similar to this Person-in-Plant article shall be incorporated into any subcontract for experimental or manufacturing work.
Person in Plant. During the term of this AGREEMENT HORIZON may reasonably request that up to [*…***…] experienced technical or quality personnel of HORIZON, which may be employees or contractors, (each, a “PIP”) be present at the FACILITY during manufacture under this AGREEMENT, to the extent set forth below, for the purpose of observing manufacturing of PRODUCT or DRUG SUBSTANCE, participating in reviews, acting as liaison / single point of contact between HORIZON and BI with respect to MANUFACTURING PROCESS related issues and performing such other actions set forth in the QAA. Such PIP shall be entitled to make decisions on quality and/or technical matters related to the PRODUCT and DRUG SUBSTANCE. HORIZON shall provide BI with […***…] notice of such visit by such PIP specifying the function of the PIP. The role, rights and obligations of the PIP when present at the FACILITY shall be as set forth below in this section, together with any additional responsibilities, authorities and obligations as may be set forth in the QAA. The PIP’s presence at the FACILITY shall be limited to the active manufacturing operational hours of the PRODUCT and DRUG SUBSTANCE and the PIP’s access to the FACILITY shall be limited to MANUFACTURING PROCESS steps in accordance with a mutually agreed schedule. BI shall ensure that the PIP at the FACILITY is kept reasonably informed of the relevant issues which may affect the PRODUCT and/or DRUG SUBSTANCE quality and will use the PIP to coordinate the performance of activities with respect thereto that are the responsibility of HORIZON. The PIP at the FACILITY shall at all times: • be accompanied by BI’s personnel for safety and confidentiality reasons; and ***Confidential Treatment Requested CONFIDENTIAL XxxX: 151373 • observe BI’s house rules, regulations, confidentiality rules and requirements, standard procedures, safety requirements and security procedures, to the extent previously disclosed in writing by BI to HORIZON; and • operate in a manner as not to adversely interfere with operations at the FACILITY or at the premises, and not give any instruction to BI or personnel; and • respect any instructions provided by BI regarding presence in the FACILITY and overall use of BI’s premises and EQUIPMENT at the FACILITY. With respect to any PIP present at the FACILITY during the term of this AGREEMENT, BI shall provide, at no cost to HORIZON, (i) space in an on-site office along with reasonable access to conference rooms (as necessary for meetings a...
Person in Plant. In addition to the access provided for in Section 6.1(a), Patheon shall permit one Zogenix employee to be permanently located within the Facility during the term of the Agreement ( the “PIP”). Patheon will provide the PIP with reasonable office space within the Facility and the PIP shall have access to such office space during regular working hours throughout the term of the Agreement. The PIP shall comply with any and all confidentiality, security, safety, quality or similar guidelines that apply to persons present in the Facility and that are communicated by Patheon. The cost of this provision is included in the rental fee.
Person in Plant. Bioverativ shall have the right but not the obligation to establish its employees or up to three (3) outside consultants, in each case under strict confidentiality and non-use provisions at least as stringent as those applicable to Bioverativ employees with respect to Confidential Information of Biogen, as resident in Biogen’s Drug Substance manufacturing facility in order to observe operations relevant to products and to facilitate communications between the Parties regarding same. For avoidance of doubt, any such resident employee or consultant shall not have authority to direct or interfere with the operations at such facility and Biogen shall have the right to exclude any such employee or consultant from areas of the facility deemed in Biogen’s reasonable judgment to be particularly commercially sensitive or as reasonably required by any agreement with a Third Party having a bona fide interest in confidentiality at the facility. Bioverativ shall in all cases remain responsible for any equipment, salary, benefits and insurance associated with any such employee or consultant, who shall under no circumstances be deemed in the employment of or under contract to Biogen. Biogen’s sole obligation with respect to any such employee or consultant shall be to provide reasonable working space at or near the facility and to grant the agreed access to the facility to such employee or consultant.
Person in Plant. In addition to the inspection and audit rights set forth in Section 4.2 and the Quality Agreement, Customer shall be permitted to have, at no additional cost, [***] at the Facility as reasonably requested by Customer, [***] the Manufacturing Process for the purpose of observing, reporting on, and consulting as to the performance of the Services. Such [***] shall be subject to and agree to abide by confidentiality obligations of this Agreement and Lonza’s customary practices and operating procedures regarding persons in plant, and such [***] agrees to comply with all instructions of Lonza’s employees at the Facility.
