Returns and Replacement. In the event that (a) Xyrem or Xywav is damaged or destroyed after the product was dispensed and shipped to the Patient pursuant to Section 4.1(b) and (b) such damage or destruction [***], ESSDS shall replace the Xyrem or Xywav to the Patient free of charge once the damaged Xyrem or Xywav is returned to ESSDS. ESSDS shall monitor all reports of lost Product for the potential for abuse or diversion in compliance with relevant SOPs and Work Instructions. ESSDS will cooperate with state and federal authorities fully in any investigations of lost Product, and will promptly provide reports of such loss to Jazz Pharmaceuticals within one (1) week from ESSDS’ conclusion of its investigation. Where abuse or diversion is not suspected and the damage or destruction is the direct result of a defect [***], ESSDS will promptly replace the Xyrem or Xywav at no charge to the Patient once approved by the pharmacy. Such replacement of Xyrem or Xywav shall be considered a Non-PAP order and title to such product shall pass to ESSDS and ESSDS shall be deemed to have purchased such product from Jazz Pharmaceuticals upon removal of the consigned product to fulfill the product replacement Jazz Pharmaceuticals shall reimburse ESSDS for an amount equal to the replacement cost of such Xyrem or Xywav. All Return or Replacement activities will be conducted in accordance with applicable SOPs, Work Instructions, and the REMS Documents. Applicable fees will apply to the processing and shipping of replacement Xyrem and Xywav and WAC price will be applied to the replacement Xyrem and Xywav, and record of the shipment will be kept in the Patient file. Upon receipt of damaged Product, ESSDS will keep damaged Product in a secure locked area in compliance with applicable SOPs, and will dispose of it using Jazz Pharmaceuticals’ reverse distributor vendor in compliance with applicable SOP and Applicable Law. ESSDS will be responsible for covering any shipping costs associated with getting Product to the reverse distributor for destruction. All other costs associated with the utilization of Jazz Pharmaceuticals’ reverse distributor vendor will be covered by Jazz Pharmaceuticals.
Appears in 1 contract
Sources: Pharmacy Master Services Agreement (Jazz Pharmaceuticals PLC)
Returns and Replacement. In the event that (a) Xyrem or Xywav Product is damaged or destroyed after the product was dispensed and shipped to the Patient transfer of title pursuant to Section 4.1(b3.1(a) and (b) such damage or destruction [***], ] ESSDS shall replace the Xyrem or Xywav Product to the Patient free of charge once the damaged Xyrem or Xywav Product is returned to ESSDS. ESSDS shall monitor all reports of lost Product for the potential for abuse or diversion in compliance with relevant SOPs and Work InstructionsWIs. ESSDS will cooperate with state and federal authorities fully in any investigations of lost Product, and will promptly provide reports of such loss to Jazz Pharmaceuticals within one (1) week from ESSDS’ conclusion of its investigation. Where abuse or diversion is not suspected and the damage or destruction is the direct result of a defect [***], ] ESSDS will promptly replace the Xyrem or Xywav Product at no charge to the Patient once approved by the pharmacy. Such replacement of Xyrem or Xywav shall be considered a Non-PAP order and title to such product shall pass to ESSDS and ESSDS shall be deemed to have purchased such product from Jazz Pharmaceuticals upon removal of the consigned product to fulfill the product replacement Jazz Pharmaceuticals shall reimburse ESSDS for an amount equal to the replacement cost of such Xyrem or XywavProduct. All Return or Replacement activities will be conducted in accordance with applicable SOPs, Work Instructions, and the REMS Documents. Applicable fees will apply to the processing and shipping of replacement Xyrem and Xywav Product and WAC price will be applied to the replacement Xyrem and XywavProduct, and record of the shipment will be kept in the Patient file. Upon receipt of damaged Product, ESSDS will keep damaged Product in a secure locked area in compliance with applicable SOPs, and will dispose of it using Jazz Pharmaceuticals’ reverse distributor vendor in compliance with applicable SOP and Applicable Law. ESSDS will be responsible for covering any shipping costs associated with getting the Product to the reverse distributor for destruction. All other costs associated with the utilization of Jazz Pharmaceuticals’ reverse distributor vendor will be covered by Jazz Pharmaceuticals.. Pharmacy Master Services Agreement
Appears in 1 contract
Sources: Pharmacy Services Agreement (Jazz Pharmaceuticals PLC)