Common use of Returns and Replacement Clause in Contracts

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 WIs. 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 [***]. 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 or 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 SOPs and Applicable Law. ESSDS will be responsible for covering any shipping costs associated with getting such 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

Samples: Master Services Agreement (Jazz Pharmaceuticals PLC)

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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 WIs. 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 Product. 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 or 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 SOPs SOP and Applicable Law. ESSDS will be responsible for covering any shipping costs associated with getting such 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

Samples: Master Services Agreement (Jazz Pharmaceuticals PLC)

Returns and Replacement. In the event that (aA) Xyrem or Xywav Product is damaged or destroyed after the product was dispensed and shipped title to the Patient such Product is transferred to ESSDS pursuant to Section 4.1(bSubsection 3.1(b) and (bB) such damage or destruction [***[ * ], ESSDS shall will 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 will monitor all reports of lost Product for the potential for abuse or diversion in compliance with relevant SOPs and WIsdiversion. CuraScript and 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 five (15) week business days from ESSDS’s conclusion of its investigationinvestigation for the purpose of allowing Jazz Pharmaceuticals to track the Product and satisfy its FDA reporting requirements. ESSDS will investigate the loss of Product by interviewing the Patient, and/or physician, report the loss to Jazz Pharmaceuticals and to the appropriate regulatory authorities, as required by law, and record the loss in the Patient’s file. Where there is suspicion of abuse or diversion, ESSDS will immediately contact the Jazz Pharmaceuticals designee identified to ESSDS as responsible for DEA issues, and lost Product will not be replaced without Jazz Pharmaceuticals’ written approval. 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 lost Product at no charge to the Patient once approved Patient; provided, however, Jazz Pharmaceuticals will reimburse ESSDS an amount equal to the replacement cost of such Product. All such return and replacement activities shall be reported to Jazz Pharmaceuticals by the pharmacy. Such replacement of Xyrem or Xywav shall be considered account director at ESSDS on 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 [***]. All Return or Replacement activities will be conducted in accordance with applicable SOPs, Work Instructions, and the REMS Documentsmonthly basis. Applicable fees will apply to the processing and shipping of replacement Xyrem another bottle and Xywav and the WAC price will be applied to the replacement Xyrem or Xywav, bottle and record of the shipment will be kept in the Patient file. For damaged Product, ESSDS will make a good faith effort to arrange for the damaged Product to be returned to ESSDS at its expense except [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as amended. if such damage or destruction is not the result of defects not reasonably susceptible to discovery upon receipt of the Product by ESSDS. Upon receipt of damaged Product, ESSDS will keep the damaged Product in a secure locked area in compliance with applicable SOPsarea, and will dispose of it using Jazz Pharmaceuticals’ reverse distributor vendor at ESSDS’s cost in compliance with the applicable SOPs and Applicable Law. ESSDS will be responsible SOP for covering any shipping costs associated with getting such Product to the reverse distributor for destruction. All other costs associated with the utilization destruction of Jazz Pharmaceuticals’ reverse distributor vendor will be covered by Jazz PharmaceuticalsProduct.

Appears in 1 contract

Samples: Master Services Agreement (Jazz Pharmaceuticals Inc)

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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 WIsWork 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 or 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 SOPs SOP and Applicable Law. ESSDS will be responsible for covering any shipping costs associated with getting such 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

Samples: Master Services Agreement (Jazz Pharmaceuticals PLC)

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