PACKAGING AND DOCUMENTATION. (1) VPI shall cause that the Product be packaged as bulk cartridges, as set forth on Appendix 11. (2) With each delivery of Product, VPI shall cause to be submitted to NPS documents customarily required from a contract manufacturer for the applicable customs clearance in the Territory as set forth in the Quality Agreement. (3) VPI shall cause to be prepared a Batch Record for each Batch and VPI shall cause to be retained samples as provided in the Quality Agreement. VPI agrees to have maintained such Batch Record documentation [*] as may be permitted by GMP. VPI shall notify NPS [*] to destroying any Batch Record documentation and shall send to NPS, or cause it to be dispose of at NPS’ direction and cost. (4) For [*], NPS will receive [*]. Thereafter, for each Batch, VPI shall cause to be provided to NPS [*]. If NPS requires any additional documents or information, the cost thereof will be separately charged. If for any reason re-validation is required, VPI shall again cause to be provided [*].
Appears in 1 contract
Sources: Commercial Manufacturing Agreement (NPS Pharmaceuticals Inc)
PACKAGING AND DOCUMENTATION. (1) VPI shall cause that the Product be packaged as bulk cartridges, as set forth on Appendix 11.
(2) . With each delivery of Product, VPI shall cause to be submitted to NPS documents customarily required from a contract manufacturer for the applicable customs clearance in the Territory as set forth in the Quality Agreement.
(3) . VPI shall cause to be prepared a Batch Record for each Batch and VPI shall cause to be retained samples as provided in the Quality Agreement. VPI agrees to have maintained such Batch Record documentation [*] as may be permitted by GMP. VPI shall notify NPS [*] to destroying any Batch Record documentation and shall send to NPS, or cause it to be dispose of at NPS’ ' direction and cost.
(4) . For [*], NPS will receive [*]. Thereafter, for each Batch, VPI shall cause to be provided to NPS [*]. If NPS requires any additional documents or information, the cost thereof will be separately charged. If for any reason re-validation is required, VPI shall again cause to be provided [*].
Appears in 1 contract
Sources: Commercial Manufacturing Agreement (NPS Pharmaceuticals Inc)