Serialization. All Product delivered by Seller to Lannett shall meet serialization requirements, as outlined in the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act) signed into law on November 27, 2013 and provide data to support Product traceability as deemed necessary by Lannett. Requirements include, but are not limited to, the addition of unique Product identifiers Global Trade Item Number (“GTIN”), Serial Number (“SN”), Lot of batch number (“LOT”), expiration date (“EXP”) imprinted on each sellable unit, the same unique Product identifiers mentioned above and Quantity (“QTY”) are required on each homogeneous case and Serialized Shipping Container Code, 18-digit (“SSCC18”) on each pallet intended to be introduced in the US market. Serial numbers must be aggregated from unit to case and case to pallet. Reporting of serial number and aggregation data is required to coincide with finished goods shipment and must conform to data exchange format and connectivity specifications supported by TraceLink. 106569863.v1
Appears in 1 contract
Sources: Supply Agreement (Lannett Co Inc)
Serialization. All Product delivered by Seller to Lannett shall meet serialization requirements, as outlined in the Drug Supply Chain Security Act (Title II of the Drug Quality -3- 121181118.v1 and Security Act) signed into law on November 27, 2013 and provide data to support Product traceability as deemed necessary by Lannett. Requirements include, but are not limited to, the addition of unique Product identifiers Global Trade Item Number (“GTIN”), Serial Number (“SN”), Lot of batch number (“LOT”), expiration date (“EXP”) imprinted on each sellable unit, the same unique Product identifiers mentioned above and Quantity (“QTY”) are required on each homogeneous case and Serialized Shipping Container Code, 18-digit (“SSCC18”) on each pallet intended to be introduced in the US market. Serial numbers must be aggregated from unit to case and case to pallet. Reporting of serial number and aggregation data is required to coincide with finished goods shipment and must conform to data exchange format and connectivity specifications supported by TraceLink. 106569863.v1.
Appears in 1 contract
Sources: Supply Agreement (Lannett Co Inc)