Common use of Person in Plant Clause in Contracts

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 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 and telephone conferences of a proprietary nature), routine office supplies, parking, and cafeteria facilities; (ii) reasonable access to and use of high-speed internet (but not BI’s intranet) and photocopying services and (iii) such other reasonable and customary business accommodations as are necessary for such PIP to perform its activities as described above. HORIZON shall comply with all responsibilities under applicable laws concerning the employment or engagement of the PIP. In addition, HORIZON shall ensure that the PIP will be fully insured while working at the FACILITY. HORIZON acknowledges that according to local immigration and/or employment laws, BI may need to obtain a deployment authorization for the PIP from the local authorities before any scheduled visit of the PIP to the FACILITY. HORIZON and the respective PIP shall timely provide BI with the necessary information requested by BI, and BI shall timely process such information, to request a deployment authorization for the PIP from the local authorities. HORIZON further acknowledges that notwithstanding BI´s diligent processing of such a request, the six-week notification period set forth above may not be sufficient to secure a deployment authorization, if necessary, before the scheduled visit to the FACILITY. HORIZON shall bear its own costs with respect to the PIP’s presence at the FACILITY and BI shall not charge fees for any PIP’s presence.

Appears in 2 contracts

Samples: Global Supply Agreement (Horizon Pharma PLC), Global Supply Agreement (Horizon Pharma PLC)

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Person in Plant. During the term Nordion shall permit an employee of this AGREEMENT HORIZON may reasonably request that up to [*…***…] experienced technical or quality personnel of HORIZON, which may be employees or contractorsCorixa, (each, subject to execution of a “PIP”confidentiality agreement in the form attached hereto as Exhibit 5.12 (c)(vi) to be present at the FACILITY during manufacture under this AGREEMENTFacility as Corixa's PIP and the PIP shall have reasonable access to the Facility and related procedures as required to perform the functions set forth in Exhibit 5.12(c), subject to the following provisions: (i) All benefits, salary and other employment matters (including, without limitation, termination, workers compensation and health insurance and benefits) and employee liability related matters, shall be the sole and exclusive liability and responsibility of Corixa. (ii) Corixa shall be responsible for all acts or omissions by such PIP (including damages to persons or property to the extent set forth belowcaused by any such act or omission), for but only to the purpose extent the PIP is not acting or failing to act at the direction of observing manufacturing Nordion, while such person is on Nordion's Site and shall defend, indemnify and hold Nordion harmless therefrom. (iii) Work permits and ensuring that such PIP is permitted to remain in Canada shall be the sole responsibility of PRODUCT or DRUG SUBSTANCECorixa, participating provided that Nordion shall reasonably cooperate with Corixa in reviewsobtaining such permits and approvals, acting at Corixa's cost and expense. (iv) Such PIP shall observe and abide by all Nordion safety and security policies and protocols. (v) Corixa shall carry out such personal background checks on the PIP 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. are reasonably requested by Nordion. (vi) Such PIP shall be entitled required to make decisions on quality and/or technical matters related to execute a confidentiality agreement in substantially the PRODUCT and DRUG SUBSTANCE. HORIZON shall provide BI with […***…] notice of such visit by such form attached hereto as Exhibit 5.12(c)(vi). (vii) Such PIP specifying the function of the PIP. The role, rights and obligations of the PIP when present at the FACILITY shall be permitted to be present during normal working hours at Nordion's facility and at such other times as set forth below in this sectionneeded to support Labeled Drug. (viii) Any employee of Corixa, together with any additional responsibilities, authorities and obligations as may be set forth in the QAA. The PIP’s presence its Affiliates and representatives who visit or remain on site 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 Nordion's facilities shall at all times: • be accompanied by BI’s personnel for safety and confidentiality reasons; and CONFIDENTIAL XxxX: 151373 • observe BI’s house rules, regulations, confidentiality times comply with Nordion's rules and requirements, standard procedures, safety requirements and security procedures, regulations. Notwithstanding anything to the extent previously disclosed contrary in writing by BI to HORIZON; and • operate in a manner as not to adversely interfere with operations at the FACILITY or at the premisesthis Agreement, 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 and telephone conferences of a proprietary nature), routine office supplies, parking, and cafeteria facilities; (ii) reasonable access to and use of high-speed internet (but not BI’s intranet) and photocopying services and (iii) such other reasonable and customary business accommodations as are necessary for such PIP shall have no authority to perform its activities as described above. HORIZON shall comply with all responsibilities under applicable laws concerning the employment act on behalf of or engagement of the PIP. In addition, HORIZON shall ensure that the PIP will be fully insured while working at the FACILITY. HORIZON acknowledges that according to local immigration and/or employment laws, BI may need to obtain a deployment authorization for the PIP from the local authorities before any scheduled visit of the PIP to the FACILITY. HORIZON and the respective PIP shall timely provide BI with the necessary information requested by BI, and BI shall timely process such information, to request a deployment authorization for the PIP from the local authorities. HORIZON further acknowledges that notwithstanding BI´s diligent processing of such a request, the six-week notification period set forth above may not be sufficient to secure a deployment authorization, if necessary, before the scheduled visit to the FACILITY. HORIZON shall bear its own costs with respect to the PIP’s presence at the FACILITY and BI shall not charge fees for any PIP’s presenceotherwise bind Corixa.

Appears in 1 contract

Samples: Supply Agreement (Corixa Corp)

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Person in Plant. During the term of this AGREEMENT HORIZON may reasonably request that up MSA, for any PSA, Client shall have the right to [*…***…] have experienced technical or (i) technical, and (ii) quality personnel of HORIZONClient, which who may be employees or employees, contractors, or agents (each, a “PIP”) as the Parties may reasonably determine necessary to be present at the FACILITY Facility during manufacture any Manufacture and SBL’s Release under this AGREEMENTMSA, to the extent set forth below, for the purpose of observing manufacturing Manufacturing and SBL’s Release of PRODUCT or DRUG SUBSTANCEthe Product, participating in reviews, acting as liaison / single point of contact between HORIZON Client and BI SBL with respect to MANUFACTURING PROCESS Manufacturing Process related issues and performing such other actions set forth in the QAA. Client understands only [*] PIPs at any one time are allowed entry [*]. During Technology Transfer, Client shall have a right to have up to [*] people present at the Facility to facilitate the Technology Transfer process. Such PIP PIPs shall be entitled to make decisions on quality and/or technical matters related to the PRODUCT and DRUG SUBSTANCEProduct. HORIZON Client shall provide BI with […***…] SBL reasonable notice of such the timing and scope of the visits which shall, except in exceptional circumstances, be provided at least [*] prior to each visit by in order to provide adequate time to schedule the required activities and resources, provided, that Client shall have the right to have such PIP specifying the function of the PIPpresent during any and all Manufacturing and/or release Services provided hereunder by SBL. 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 SBL shall ensure that the PIP at the FACILITY Facility is kept reasonably informed of the relevant issues which may affect the PRODUCT and/or DRUG SUBSTANCE Product quality and will use the PIP to coordinate the performance of activities with respect thereto that are the responsibility of HORIZONClient. The PIP at the FACILITY shall at all times: • be accompanied by BI’s personnel for safety and confidentiality reasons; and 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 and telephone conferences of a proprietary nature), routine office supplies, parking, and cafeteria facilities; (ii) reasonable access to and use of high-speed internet (but not BI’s intranet) and photocopying services and (iii) such other reasonable and customary business accommodations as are necessary for such PIP to perform its activities as described above. HORIZON shall comply with all responsibilities under applicable laws concerning the employment or engagement of the PIP. In addition, HORIZON shall ensure that the PIP will be fully insured while working at the FACILITY. HORIZON acknowledges that according to local immigration and/or employment laws, BI may need to obtain a deployment authorization for the PIP from the local authorities before any scheduled visit of the PIP to the FACILITY. HORIZON and the respective PIP shall timely provide BI with the necessary information requested by BI, and BI shall timely process such information, to request a deployment authorization for the PIP from the local authorities. HORIZON further acknowledges that notwithstanding BI´s diligent processing of such a request, the six-week notification period set forth above may not be sufficient to secure a deployment authorization, if necessary, before the scheduled visit to the FACILITY. HORIZON Client shall bear its own costs with respect to the PIP’s presence at the FACILITY Facility, flight expenses, transportations, hotel accommodations, meals etc. While at the Facility, all such Client personnel shall have reasonable access to all areas as are relevant to SBL’s performance of the Services hereunder, provided that SBL may reasonably restrict Client personnel’s access to the Facility as it deems necessary to safeguard the information of third parties, and BI all such Client personnel shall not charge fees for any PIP’s presence.agree to and comply with confidentiality obligations to third REF: 00038830.0 25. Confidential /// Fibrogen - Samsung Master Services Agreement (38830.0) 2020

Appears in 1 contract

Samples: Master Services Agreement (Fibrogen Inc)

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