Client Access. 4.7.1 CLIENT’s employees and agents (including its independent contractors) (collectively, “CLIENT Personnel”) may participate in the production of the Product only in such capacities as agreed in the Quality Agreement and as may be approved in writing in advance by LWI. Such approval not to be unreasonably withheld or delayed. CLIENT Personnel working at the Facility are required to comply with LWI’s Operating Documents and any other applicable LWI facility and/or safety policies. For the avoidance of doubt, CLIENT Personnel may not physically participate in the production or manufacture of any Product that may be used in or on humans. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406 4.7.2 CLIENT Personnel working at the Facility will be and remain employees of CLIENT, and CLIENT will be solely responsible for the payment of compensation for such CLIENT Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits). CLIENT covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by applicable law with respect to all CLIENT Personnel working at the Facility. 4.7.3 CLIENT will pay for the actual cost of repairing or replacing to its previous status (to the extent that LWI determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of LWI damaged or destroyed by CLIENT Personnel (as shall be reasonably proven by LWI), provided CLIENT shall not be liable for repair or replacement costs resulting from ordinary wear and tear. 4.7.4 CLIENT Personnel visiting or having access to the Facility will abide by LWI standard policies, operating procedures and the security procedures established by LWI. CLIENT will be liable for any breaches of security by CLIENT Personnel. In addition, CLIENT will reimburse LWI for the cost of any lost security cards issued to CLIENT Personnel, at the rate of $50 per security card. All CLIENT Personnel will agree to abide by LWI policies and SOPs established by LWI and conveyed in writing to CLIENT, and will sign an appropriate confidentiality agreement. 4.7.5 CLIENT will indemnify and hold harmless LWI from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of any injuries suffered by CLIENT Personnel while at the Facility or elsewhere, except to the extent caused by the gross negligence or willful misconduct on the part of any LWI Party.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Gamida Cell Ltd.)
Client Access. 4.7.1 4.9.1 CLIENT’s employees and agents (including its independent Third Party contractors) (, collectively, “CLIENT Personnel”) may participate in the production of the Product only in such capacities as agreed in the Quality Agreement and as may be approved in writing in advance by LWI. Such approval not to be unreasonably withheld or delayedLONZA. CLIENT Personnel working at the Facility are required to comply with LWILONZA’s Operating Documents and any other applicable LWI LONZA facility and/or safety policies. For the avoidance of doubt, CLIENT Personnel may not physically participate in the production or manufacture of any Product that may be used in or on humans. [*] = Certain confidential information contained Notwithstanding anything to the contrary, a reasonable number of CLIENT Personnel shall have the right to be present in the Facility during cGMP activities, subject to the other provisions of this documentsection, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406for quality or technical reference purposes.
4.7.2 4.9.2 CLIENT Personnel working at the Facility will be and remain employees of CLIENT, and CLIENT will be solely responsible for the payment of [***] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and would be competitively harmful if publicly disclosed. compensation for such CLIENT Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits). CLIENT covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by applicable law Federal and state laws with respect to all CLIENT Personnel working at the Facility.
4.7.3 4.9.3 CLIENT will pay for the actual cost of repairing or replacing to its previous status (to the extent that LWI LONZA determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of LWI LONZA damaged or destroyed by CLIENT Personnel (as shall be reasonably proven by LWI)Personnel, provided CLIENT shall not be liable for repair or replacement costs resulting from ordinary wear and tear.
4.7.4 4.9.4 CLIENT Personnel visiting or having access to the Facility will abide by LWI LONZA standard policies, operating procedures and the security procedures established by LWILONZA. CLIENT will be liable for any breaches of security by CLIENT Personnel. In addition, CLIENT will reimburse LWI LONZA for the cost of any lost security cards issued to CLIENT Personnel, at the rate of $50 [***] per security card. All CLIENT Personnel will agree to abide by LWI LONZA policies and SOPs established by LWI and conveyed in writing to CLIENTLONZA, and will sign an appropriate confidentiality agreement.
4.7.5 4.9.5 CLIENT will indemnify and hold harmless LWI LONZA from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of any injuries suffered by CLIENT Personnel while at the Facility or elsewhereFacility, except to the extent caused by the gross negligence or willful misconduct on the part of any LWI LONZA Party.
Appears in 1 contract
Client Access. 4.7.1 CLIENT’s employees and agents (including its independent contractors) (collectively, “CLIENT Personnel”) may participate in the production of the Product only in such capacities as agreed in the Quality Agreement and as may be approved in writing in advance by LWI. Such approval not to be unreasonably withheld or delayed. CLIENT Personnel working at the Facility are required to comply with LWI’s Operating Documents and any other applicable LWI facility and/or safety policies. For the avoidance of doubt, CLIENT Personnel may not physically participate in the production or manufacture of any Product that may be used in or on humans. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406.
4.7.2 CLIENT Personnel working at the Facility will be and remain employees of CLIENT, and CLIENT will be solely responsible for the payment of compensation for such CLIENT Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits). CLIENT covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by applicable law with respect to all CLIENT Personnel working at the Facility.
4.7.3 CLIENT will pay for the actual cost of repairing or replacing to its previous status (to the extent that LWI determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of LWI damaged or destroyed by CLIENT Personnel (as shall be reasonably proven by LWI), provided CLIENT shall not be liable for repair or replacement costs resulting from ordinary wear and tear.
4.7.4 CLIENT Personnel visiting or having access to the Facility will abide by LWI standard policies, operating procedures and the security procedures established by LWI. CLIENT will be liable for any breaches of security by CLIENT Personnel. In addition, CLIENT will reimburse LWI for the cost of any lost security cards issued to CLIENT Personnel, at the rate of $50 per security card. All CLIENT Personnel will agree to abide by LWI policies and SOPs established by LWI and conveyed in writing to CLIENT, and will sign an appropriate confidentiality agreement.
4.7.5 CLIENT will indemnify and hold harmless LWI from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of any injuries suffered by CLIENT Personnel while at the Facility or elsewhere, except to the extent caused by the gross negligence or willful misconduct on the part of any LWI Party.. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(c) and 230.406
Appears in 1 contract
Samples: Manufacturing Services Agreement (Gamida Cell Ltd.)