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RETURN GOODS POLICY

This Return Goods Policy (“Return Policy”) for Mitsubishi Tanabe Pharma America, Inc. (“MTPA”) applies to any MTPA product (“Product”) sold in the United States and its territories. It applies to Product that is purchased from an In Network Distributor (“Distributor”) by a provider that is duly licensed to dispense or administer the Product (“Provider”). MTPA reserves the right to change its Return Goods Policy at any time.

Please click on Product Name Below for specific guidance related to the return of that product: 

Radicava IVRadicava ORSExservan

Radicava IV:

  1. Items Returnable for Credit: Product is eligible for credit from Providers where the Product satisfies the requirements in any of the sub-sections (A) through (G) below.
    1. Expired Product – Product that is returned no earlier than expiration of the Product and no later than six (6) months after the expiration of the Product, or as required by law. Expiration is the last day of the month indicated on the packaging. Contact MTPA’s Order/Returns Service at (844) 529-8990.
    2. Product Quality Complaint (“PQC”) Product that is unusable due to deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance. This includes reports of product, labeling, packaging or product container defects, or failure of the product to meet specifications or perform as expected. Contact MTPA Medical Information at (888)292-0058. This category excludes returns due to mishandling, which are outlined in Section 1.C below. 
    3. Mishandled Product – Product that is spoiled and unable to be administered if spoilage was due to one of the events below. Contact MTPA Medical Information at (888)292-0058.

      Examples: 

      1. Product was mishandled, dropped, or broken.
      2. Product was stored outside of specified temperature range. 
      3. Product was spiked incorrectly, (e.g. off-center, twist, angle, too deep)
      4. Oxygen sensor was purple/blue due to mishandling.

      Additional conditions for credit for mishandled Product:

      1. MTPA will issue credit upon receiving returned Product, until it is determined that Provider’s cap has been met or exceeded. The actual amount credited, not amount returned, will apply towards the annual cap.
      2. Providers that request credit in these circumstances may be asked or required to undergo product administration training as a condition of receiving the reimbursement, in the sole discretion of MTPA.
    4. Product Ordered by a Provider for Specific Patient That Could Not Be Used (Overstock) – Product not administered because Patient or Provider chose to discontinue therapy for any reason (exception: if discontinuation decision due to a potential adverse event; see Section F.) 
      1. If Provider is unable to use purchased Product on a different Patient within 4 months of invoice date, and cannot return product to the Specialty Distributor from which it was originally purchased for a credit, credit may be provided by MTPA, subject to a cap. Contact MTPA Medical Information at (888)292-0058 for more information or to report Product that cannot be used.
    5. Shipping errors/ Damaged Shipments – Product shipped from MTPA, or 3PL, to Distributor that is damaged in transit. Contact MTPA’s Order/Returns Service at (844)529-8990 within five (5) business days and returned Product is shipped FINAL – JANUARY 2023- v1.0 within thirty (30) calendar days of receipt of Product. Damaged Product must be returned to receive credit. Please have the transportation company note “damaged” on freight bill.
    6. For Product shipped from the Infusion Provider or Specialty Pharmacy to a patient that is damaged in transit, patients should contact the Infusion Provider or Specialty Pharmacy from which it was purchased.
    7. Potential Adverse Event – Contact MTPA Medical Information at (888)292-0058 or email mtpa@medinfodept.com no later than one (1) business day of receipt of the information. 
    8. Product Recall – Product that MTPA, in its sole discretion, has specified to be returned and authorized for credit. Return instructions will be provided with Product Recall notice. 
    9. Discontinued Product – Product discontinued by MTPA provided that the Product is returned to MTPA within six (6) months from the date of discontinuation. Return instructions will be provided with Product Discontinuation notice.
  2. Authorization Procedure – All returns must be accompanied by a Return Authorization (“RA”) 
    1. Contact the appropriate party as indicated in Section 1. 
    2. For product returns, MTPA will provide a Return Claim Form (“Form”) to the Provider to complete. 
    3. While an RA may be issued, it is not a guarantee of reimbursement. 
    4. The following items are required to be returned to the address listed on the RA for each individual product return:
      1. Original invoice
      2. RA
      3. The physical Product itself
    5. Provider must return Product within thirty (30) days of receiving the RA.
    6. MTPA reserves the right to inspect all authorized returns and a credit memo will be issued only for Product returned in accordance with the terms of this Return Policy and applicable law.
    7. MTPA will audit the quantities of return goods and final reimbursement will be based on MTPA’s counts.
  3. Basis of Credit 
    1. A credit memo will be issued at the wholesale acquisition cost (WAC) in effect at the time of purchase or contracted price paid, whichever is lower. 
    2. Reimbursements to Providers for returned Product will be issued as a credit through the Provider’s Distributor.
    3. Reimbursement will be determined by MTPA in its sole discretion.
  4. Return Shipments 
    1. MTPA incurs the cost for processing and destruction of Products that are returned properly and in accordance with this Return Policy.
    2. MTPA will not assume responsibility for charges incurred by customers using other means.
  5. Items Not Returnable for Credit
    1. If already billed or submitted to insurance, or a co-pay or co-insurance payment was received. 
    2. Shipping errors or Product damaged in transit from Distributor to Provider. Providers should contact their Distributor for reimbursement; MTPA is not responsible. 
    3. Shipping errors or Product damaged in transit from the Provider to Patient. Patients should contact their Provider for reimbursement; MTPA is not responsible. 
    4. Product not purchased directly from an MTPA Distributor. 
    5. Product destroyed or damaged from insurable causes (e.g., fire or catastrophe). 
    6. Product distributed at no charge. 
    7. Product that has been sold expressly on a non-refundable basis. 
    8. Product obtained illegally or via diverted means. 
    9. Product purchased on behalf of other manufacturers, institutions, contract research organizations, or others for use in clinical trials or studies, Phase IV studies, or for charitable donations. 
    10. Product not in original containers. 
    11. Product with labels removed or illegible.
    12. Product involved in salvage, bankruptcy or insolvency proceedings. Private label or repackaged Products. 
    13. Product for which proof of purchase cannot be verified. 
    14. Product that is returned in a manner that does not comply with applicable law. 
    15. Product more than six (6) months beyond its expiration date. Product may be returned for destruction, but no credit will be issued.
    16. No partial returns will be accepted for credit except for Product returns from those states that regulate partial returned goods, and Product returned for (1) PQCs, (2) mishandling, or (3) potential adverse events. Partial returns include broken safety seals either inside or outside of each container.
  6. Additional Conditions 
    1. MTPA will not be responsible for Product that is destroyed by any party other than MTPA’s Authorized Return Goods Vendor and proof of destruction will not be accepted in lieu of an actual return. All eligible Products shipped to MTPA must be shipped in a safe, secure, and reliable manner and in compliance with all applicable law. MTPA is not responsible for shipments lost and/or damaged in transit. MTPA recommends that all customers insure return goods shipments.
    2. MTPA reserves the right to audit the amounts reimbursed for return goods for a period of up to three (3) years from when the payment or credit was issued. If the audit determines that a customer was paid/credited in excess of the amounts specified per this Return Policy then MTPA will be allowed at its election to either: (i) withhold payments/credits for future return goods, or (ii) invoice the customer for the amount of the return goods overpayment and the customer must make payment within thirty (30) days upon receipt of invoice.

  7. Important Information

    PLEASE NEVER INFUSE PRODUCT FOR WHICH THE SPIKE HAS BEEN IMPROPERLY INSERTED INTO THE INFUSION BAG STOPPER. FOR OTHER IMPORTANT SAFETY INFORMATION, PLEASE REFER TO THE RADICAVA PACKAGE INSERT ENCLOSED WITH EACH UNIT OR AVAILABLE AT https://www.radicava.com/pdfs/radicava-prescribing-information.pdf

    MTPA has the right to modify or discontinue this Policy at any time without notice. Nothing in this Policy should be construed to be a guarantee of the safety or effectiveness of Product. The treating healthcare provider is solely responsible for ensuring that Product delivered to the patient is dosed and infused in a manner consistent with the FDA-approved labeling and sound medical judgment. 

Radicava ORS:

  1. Items Returnable for Credit: Product is eligible for credit from Providers where the Product satisfies the requirements in any of the sub-sections (A) through (G) below.
    1. Expired Product – Product that is returned no earlier than expiration of the Product and no later than six (6) months after the expiration of the Product, or as required by law. Expiration is the last day of the month indicated on the packaging. Contact MTPA’s Order/Returns Service at (844) 529-8990. 
    2. Product Quality Complaint (“PQC”) Product that is unusable due to deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance. This includes reports of product, labeling, packaging, bottle adapter, oral syringe, or product container defects, or failure of the product to meet specifications or perform as expected. Contact MTPA Medical Information at (888) 292-0058. This category excludes returns due to mishandling, which are outlined in Section 1.C below. 
      1. PQC Product must be returned to MTPA for credit to be given.
    3. Mishandled Product – Product that is spoiled and unable to be administered if spoilage was due to one of the events below. Contact MTPA Medical Information at (888)292-0058.

      Examples:

      1. Product was exposed to light.
      2. Product bottle adapter or oral syringe is inserted incorrectly and preventing administration of product.
      3. Product was mishandled, dropped, or broken.
      4. Product was stored outside of specified temperature range.

      Additional conditions for credit for mishandled Product:

      1. Request for credit must be submitted no more than 60 days from the date of Product dispense.
      2. Mishandled Product is not required to be returned for credit to be given.
      3. For patient/caregiver mishandling issues, Provider must follow their internal policies regarding replacement product for continuity of therapy for patient.
      4. Providers must confirm whether the patient’s insurance covers replacement Product. If patient’s insurance does not cover replacement Product, Provider may seek credit from MTPA to cover replacement Product at the purchase cost, subject to a cap. Provider is not required to purchase additional Product.
      5. Providers must provide the MTPA form invoice (includes lot #), purchase date, dispense date, and the patient ID if available. Documents should be emailed to customer_service@mt-pharma-us.com
      6. MTPA will issue credit upon receiving required documentation , until it is determined that the applicable cap has been met or exceeded. The actual amount credited, not amount returned, will apply towards the annual cap.
      7. Providers that request credit in these circumstances may be asked or required to undergo product administration training as a condition of receiving the reimbursement, in the sole.
    4. Product Ordered by a Provider for Specific Patient That Could Not Be Used (Overstock) – Product not administered because Patient or Provider chose to discontinue therapy for any reason (exception: if discontinuation decision due to a potential adverse event; see Section F.) 
      1. If Provider is unable to use purchased Product on a different Patient within 4 months of invoice date, and cannot return product to the Specialty Distributor from which it was originally purchased for a credit, credit may be provided by MTPA, subject to a cap. Contact MTPA Medical Information at (888)292-0058 for more information or to report Product that cannot be used.
    5. Shipping errors/ Damaged Shipments – Product shipped from MTPA, or 3PL, to Distributor that is damaged in transit. Contact MTPA’s Order/Returns Service at (844)529-8990 within five (5) business days and returned Product is shipped within thirty (30) calendar days of receipt of Product. Damaged Product must be returned to receive credit. Please have the transportation company note “damaged” on freight bill. 
      1. For Product shipped from the Specialty Pharmacy to a patient, that is damaged in transit, patient should contact the Specialty Pharmacy from which it was purchased.
    6. Potential Adverse Event – Contact MTPA Medical Information at (888) 292-0058 or email mtpa@medinfodept.com no later than one (1) business day of receipt of the information.
    7. Product Recall – Product that MTPA, in its sole discretion, has specified to be returned and authorized for credit. Return instructions will be provided with Product Recall notice. 
    8. Discontinued Product – Product discontinued by MTPA provided that the Product is returned to MTPA within six (6) months from the date of discontinuation. Return instructions will be provided with Product Discontinuation notice. 

  2. Authorization Procedure – All returns must be accompanied by a Return Authorization (“RA”) 

    1. Contact the appropriate party as indicated in Section 1. 
    2. For product returns, MTPA will provide a Return Claim Form (“Form”) to the Provider to complete. 
    3. While an RA may be issued, it is not a guarantee of reimbursement. 
    4. The following items are required to be returned to the address listed on the RA for each individual product return: 
      1. Original invoice
      2. RA
      3. The physical Product itself
    5. Provider must return Product within thirty (30) days of receiving the RA. 
    6. MTPA reserves the right to inspect all authorized returns and a credit memo will be issued only for Product returned in accordance with the terms of this Return Policy and applicable law.
    7. MTPA will audit the quantities of return goods and final reimbursement will be based on MTPA’s counts.

  3. Basis of Credit 

    1. A credit memo will be issued at the wholesale acquisition cost (WAC) in effect at the time of purchase or contracted price paid, whichever is lower. 
    2. Reimbursements to Providers for returned Product will be issued as a credit through the Provider’s Distributor. 
    3. Reimbursement will be determined by MTPA in its sole discretion.

  4. Return Shipments

    1. MTPA incurs the cost for processing and destruction of Products that are returned properly and in accordance with this Return Policy. 
    2. MTPA will not assume responsibility for charges incurred by customers using other means for processing returns and destruction.

  5. Items Not Returnable for Credit 

    1. If already billed or submitted to insurance, or a co-pay or co-insurance payment was received. 
    2. Shipping errors or Product damaged in transit from Distributor to Provider. Providers should contact their Distributor for reimbursement; MTPA is not responsible. 
    3. Shipping errors or Product damaged in transit from the Provider to Patient. Patients should contact their Provider for reimbursement; MTPA is not responsible. 
    4. Product not purchased directly from an MTPA Distributor. 
    5. Product destroyed or damaged from insurable causes (e.g., fire or catastrophe). 
    6. Product distributed at no charge. 
    7. Product that has been sold expressly on a non-refundable basis. 
    8. Product obtained illegally or via diverted means. 
    9. Product purchased on behalf of other manufacturers, institutions, contract research organizations, or others for use in clinical trials or studies, Phase IV studies, or for charitable donations. 
    10. Product not in original containers. 
    11. Product with labels removed or illegible. 
    12. Product involved in salvage, bankruptcy or insolvency proceedings. 
    13. Private label or repackaged Products. 
    14. Product for which proof of purchase cannot be verified. 
    15. Product that is returned in a manner that does not comply with applicable law. 
    16. Product more than six (6) months beyond its expiration date. Product may be returned for destruction, but no credit will be issued.
    17. No partial returns will be accepted for credit except for Product returns from those states that regulate partial returned goods, and Product returned for (1) PQCs, (2) mishandling, or (3) potential adverse events. Partial returns include broken safety seals either inside or outside of each container. Partial returns include broken safety seals either inside or outside of each container. 
    18. Product with illegible or missing lot number and/or expiration date. 

  6. Additional Conditions 

    1. MTPA will not be responsible for Product that is destroyed by any party other than MTPA’s Authorized Return Goods Vendor and proof of destruction will not be accepted in lieu of an actual return. All eligible Products shipped to MTPA must be shipped in a safe, secure, and reliable manner and in compliance with all applicable law. MTPA is not responsible for shipments lost and/or damaged in transit. MTPA recommends that all customers insure return goods shipments. 
    2. MTPA reserves the right to audit the amounts reimbursed for return goods for a period of up to three (3) years from when the payment or credit was issued. If the audit determines that a customer was paid/credited in excess of the amounts specified per this Return Policy then MTPA will be allowed at its election to either: (i) withhold payments/credits for future return goods, or (ii) invoice the customer for the amount of the return goods overpayment and the customer must make payment within thirty (30) days upon receipt of invoice.

  7. Important Information 

    PLEASE NEVER ADMINISTER PRODUCT THAT HAS BEEN STORED OR TRANSPORTED OUTSIDE OF THE APPROVED TEMPERATURE RANGES OR CONDITIONS. FOR OTHER IMPORTANT SAFETY INFORMATION, PLEASE REFER TO THE RADICAVA PACKAGE INSERT ENCLOSED WITH EACH UNIT OR AVAILABLE AT https://www.radicava.com/pdfs/radicava-prescribing-information.pdf

    MTPA has the right to modify or discontinue this Policy at any time without notice. Nothing in this Policy should be construed to be a guarantee of the safety or effectiveness of Product. The treating healthcare provider is solely responsible for ensuring that Product delivered to the patient is dosed and infused in a manner consistent with the FDA-approved labeling and sound medical judgment.

Exservan:

  1. Items Returnable for Credit: Product is eligible for credit from Providers where the Product satisfies the requirements in any of the sub-sections (A) through (G) below.
    1. Short-dated or Expired Product – Product that is returned within three (3) months of the expiration of the Product and no later than six (6) months after the expiration of the Product, or as required by law. Expiration is the last day of the month indicated on the packaging. Contact MTPA’s Order/Returns Service at (844) 529-8990. 
    2. Product Quality Complaint (“PQC”) Product that is unusable due to deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance. This includes reports of product, labeling, packaging, bottle adapter, oral syringe, or product container defects, or failure of the product to meet specifications or perform as expected. Contact MTPA Medical Information at (888)292-0058. This category excludes returns due to mishandling, which are outlined in Section 1.C below. 
    3. Mishandled Product – Product that is spoiled and unable to be administered if spoilage was due to one of the events below. Contact MTPA Medical Information at (888)292-0058.

      Examples:

      1. Product was mishandled, dropped, or broken.
      2. Product was stored outside of specified temperature range.
      3. Product was exposed to bright light.

      Additional conditions for credit for mishandled Product:

      1. MTPA will issue credit upon receiving returned Product, until it is determined that Provider’s cap has been met or exceeded. The actual amount credited, not amount returned, will apply towards the annual cap
      2. Providers that request credit in these circumstances may be asked or required to undergo product administration training as a condition of receiving the reimbursement, in the sole discretion of MTPA.
    4. Product Ordered by a Provider for Specific Patient That Could Not Be Used (Overstock)– Product not administered because Patient or Provider chose to discontinue therapy for any reason (exception: if discontinuation decision due to a potential adverse event; see Section F.) 
      1. If Provider is unable to use purchased Product on a different Patient within 4 months of invoice date, and cannot return product to the Specialty Distributor from which it was originally purchased for a credit, credit may be provided by MTPA, subject to a cap. Contact MTPA Medical Information at (888)292-0058 for more information or to report Product that cannot be used
    5. Shipping errors/ Damaged Shipments – Product shipped from MTPA, or 3PL, to Distributor that is damaged in transit. Contact MTPA’s Order/Returns Service at (844)529-8990 within five (5) business days and returned Product is shipped within thirty (30) calendar days of receipt of Product. Damaged Product must be returned to receive credit. Please have the transportation company note “damaged” on freight bill.
      1. For Product shipped from the Specialty Pharmacy to a patient, that is damaged in transit, patient should contact the Specialty Pharmacy from which it was purchased.
    6. Potential Adverse Event – Contact MTPA Medical Information at (888)292-0058 or email mtpa@medinfodept.com no later than one (1) business day of receipt of the information.
    7. Product Recall – Product that MTPA, in its sole discretion, has specified to be returned and authorized for credit. Return instructions will be provided with Product Recall notice.
    8. Discontinued Product – Product discontinued by MTPA provided that the Product is returned to MTPA within six (6) months from the date of discontinuation. Return instructions will be provided with Product Discontinuation notice.
  2. Authorization Procedure – All returns must be accompanied by a Return Authorization (“RA”)
    1. Contact the appropriate party as indicated in Section 1.
    2. For product returns, MTPA will provide a Return Claim Form (“Form”) to the Provider to complete.
    3. While an RA may be issued, it is not a guarantee of reimbursement.
    4. The following items are required to be returned to the address listed on the RA for each individual product return:
      1. Original invoice
      2. RA
      3. The physical Product itself
    5. Provider must return Product within thirty (30) days of receiving the RA.
    6. MTPA reserves the right to inspect all authorized returns and a credit memo will be issued only for Product returned in accordance with the terms of this Return Policy and applicable law.
    7. MTPA will audit the quantities of return goods and final reimbursement will be based on MTPA’s counts.
  3. Basis of Credit
    1. A credit memo will be issued at the wholesale acquisition cost (WAC) in effect at the time of purchase or contracted price paid, whichever is lower.
    2. Reimbursements to Providers for returned Product will be issued as a credit through the Provider’s Distributor.
    3. Reimbursement will be determined by MTPA in its sole discretion.
  4. Return Shipments
    1. MTPA incurs the cost for processing and destruction of Products that are returned properly and in accordance with this Return Policy.
    2. MTPA will not assume responsibility for charges incurred by customers using other means for processing returns and destruction.
  5. Items Not Returnable for Credit
    1. If already billed or submitted to insurance, or a co-pay or co-insurance payment was received.
    2. Shipping errors or Product damaged in transit from Distributor to Provider. Providers should contact their Distributor for reimbursement; MTPA is not responsible.
    3. Shipping errors or Product damaged in transit from the Provider to Patient. Patients should contact their Provider for reimbursement; MTPA is not responsible.
    4. Product not purchased directly from an MTPA Distributor.
    5. Product destroyed or damaged from insurable causes (e.g., fire or catastrophe).
    6. Product distributed at no charge.
    7. Product that has been sold expressly on a non-refundable basis.
    8. Product obtained illegally or via diverted means.
    9. Product purchased on behalf of other manufacturers, institutions, contract research organizations, or others for use in clinical trials or studies, Phase IV studies, or for charitable donations.
    10. Product not in original containers.
    11. Product with labels removed or illegible.
    12. Product with illegible or missing lot number and/or expiration date.
    13. Product involved in salvage, bankruptcy or insolvency proceedings.
    14. Private label or repackaged Products.
    15. Product for which proof of purchase cannot be verified.
    16. Product that is returned in a manner that does not comply with applicable law.
    17. Product returned more than three (3) months before its expiration date remaining, unless otherwise required by law.
    18. Product more than six (6) months beyond its expiration date. Product may be returned for destruction, but no credit will be issued.
    19. No partial returns will be accepted for credit except for those Product returns from those states that regulate partial returned goods, and Product returned for (1) PQCs, (2) mishandling, or (3) potential adverse events. Partial returns include broken safety seals either inside or outside of each container.
  6. Additional Conditions
    1. MTPA will not be responsible for Product that is destroyed by any party other than MTPA’s Authorized Return Goods Vendor and proof of destruction will not be accepted in lieu of an actual return. All eligible Products shipped to MTPA must be shipped in a safe, secure, and reliable manner and in compliance with all applicable law. MTPA is not responsible for shipments lost and/or damaged in transit. MTPA recommends that all customers insure return goods shipments.
    2. MTPA reserves the right to audit the amounts reimbursed for return goods for a period of up to three (3) years from when the payment or credit was issued. If the audit determines that a customer was paid/credited in excess of the amounts specified per this Return Policy then MTPA will be allowed at its election to either: (i) withhold payments/credits for future return goods, or (ii) invoice the customer for the amount of the return goods overpayment and the customer must make payment within thirty (30) days upon receipt of invoice.
  7. Important Information

    PLEASE NEVER ADMINISTER PRODUCT THAT HAS BEEN STORED OR TRANSPORTED OUTSIDE OF THE APPROVED TEMPERATURE RANGES OR CONDITIONS. FOR OTHER IMPORTANT SAFETY INFORMATION, PLEASE REFER TO THE RADICAVA PACKAGE INSERT ENCLOSED WITH EACH UNIT OR AVAILABLE AT https://www.exservan.com/pdf/exservan-prescribing-information.pdf

    MTPA has the right to modify or discontinue this Policy at any time without notice. Nothing in this Policy should be construed to be a guarantee of the safety or effectiveness of Product. The treating healthcare provider is solely responsible for ensuring that Product delivered to the patient is dosed and infused in a manner consistent with the FDA-approved labeling and sound medical judgment. 

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