Returned Goods

This Otsuka America Pharmaceutical, Inc. (“OAPI”) Returned Goods Policy (“Policy”) applies to all pharmaceutical products sold by OAPI (collectively referred to herein as (“Product(s)”). OAPI reserves the right to deny credit for returns sent to third party processors other than the OAPI designated third party returns processor. OAPI will only accept the return of Product for consideration of credit or refund, if applicable, under the conditions and limitations set out below. All products returned, whether eligible for credit or not, become the property of OAPI. This Return Goods Policy supersedes all previous policies and may be modified by OAPI. 

General Terms  

All Products purchased direct and indirect must be returned directly to the OAPI designated third party returns processor to be eligible for return credit or refund. OAPI reserves the right to refuse credit when returned through alternate channels. OAPI reserves the sole right to determine whether items qualify for return, credit, or refund. OAPI determination of the physical count of the returned Products will be final. By returning Product, you authorize OAPI and its designee as your agent to destroy, without payment or other recourse, any returned Product. All transportation charges are to be prepaid by the customer except when error is due to OAPI.

OAPI will not reimburse fees due to processing third par ty returns, destr uction charges, shipping costs, or processing. All returns are subject to review by OAPI. Issuance of return authorization does not guarantee credit. Credit issuance is dependent upon confirmed receipt/review of return goods. Unauthorized return goods will be destroyed, and credit will not be issued.

Returnable Items  

For purposes of this Policy, returns will only be accepted for credit as specified below:

• 1

  Product with shelf life six (6) months prior to expiration date, or up to twelve (12) months after expiration date which have a valid, legible NDC, lot number, expiry date, and serial number.

• 2

  Product must be in original, unaltered container, trade package.

OAPI contracts with PharmaLink to manage the return and destruction of outdated products. All Product must be returned to PharmaLink in accordance with the following procedures to be eligible for credit at the following address:

PharmaLink 
Receiving Department PLI- OAPI 
8285 Bryan Dairy Road, #160 
Largo, FL 33777

Prior Return Authorization (RA) is required for all returns. Request for Return Authorization (box RA Labels) from PharmaLink can be made as follows:

• 1 Access PharmaLink’s website at https://www.PharmaLinkinc.com and select Manufacturer Authorizations at the top of the webpage.
  • First Time users need to create a New User login.
• 2 Select “Start a new return” and choose Otsuka America Pharmaceutical from the Manufacturer dropdown menu.
  • Create Inventory: Allows you to enter an inventory of items in the shipment.
  • Upload Debit memo: Allows you to upload an inventory of items in the shipment.
• 3 The following information must be supplied, or the RA Request will be declined, and product will not be eligible for credit:
  • NDC Number, Product Description, Lot/Batch, Quantity, Customer’s Reference Number
  • Reason for return
  • Authorized Servicing Wholesaler
  • Debit Memo Number, Date, and Amount requested
  • Expiration Date (In the event the package expiration date is stated in month/year format, expiration date will default to the last day of the month)
  • Returning Facility details including
    • Facility Name, Address, City, State, and Zip code
    • Facility DEA Number
    • Facility State License

• 4

  The RA must be attached to the outside of the return shipment package.

• 5

  Additional information provided to OAPI if requested

All returns must be received by the OAPI Return Agent, PharmaLink, no later than sixty (60) days after RA Label issuance with the RA Label attached on the exterior of the box together with a copy of the Customer's Debit Memo for such return(s) enclosed in the shipment.

Product returned that does not meet the criteria listed above will be quarantined. If the above information cannot be obtained by the end of the requesting business day, the product will be denied and sent back to the returning entity.

Should you need assistance in returning your OAPI product to PharmaLink, contact CustomerSolutions@pharmalinkinc.com

Conditions for Credit  

• 1

  A valid Return Goods Authorization (RGA) Number must accompany all returns for proper credit. RGA Numbers are valid for 60 days from issuance. Expired RGA Numbers will be considered invalid, and no credit will be issued.

• 2

  All products must be returned to the designated OAPI returns processor, PharmaLink, within 60 days of RA to receive credit. Products that have been destroyed by customers or agents of customers will not receive credit.

• 3

  Each RGA must be in its own box. If multiple RGAs are in one box, they must be bagged separately.

• 4

  Only product from OAPI should be in the box.

• 5

  Product must be in original, unopened, unaltered container to receive credit.

• 6

  Product must be returned by the customer who purchased the product from OAPI. Proof of purchase may be required for credit issuance.

• 7

  It is the responsibility of the returning customer for all purchasing information.

• 8

  For ABILIFY MYCITE® (aripiprazole tablets with sensor)², ABILIFY MAINTENA® (aripiprazole) Injection³, ABILIFY ASIMTUFII® (aripiprazole) Injection⁴, IV BUSULFEX® (busulfan) Injection⁵, JYNARQUE® (tolvaptan) Tablets⁶, REXULTI® (brexpiprazole) Tablets⁷, SAMSCA® (tolvaptan) Tablets⁸, or VOYXACT® (sibeprenlimab-szsi) Injection⁹, credit will be issued at the highest lot acquisition cost or any applicable contract price, whichever is lower.

• 9

  For ABILIFY® (aripiprazole) Tablets¹ credit for returned product will be issued at current acquisition cost (where applicable, current contract price) as of the date the returned product is received at the designated return goods processor, less ten percent (10%).

• 10

  For NUEDEXTA® (dextromethorphan/quinidine) Capsules¹⁰ credit for returned product will be issued at the highest lot acquisition cost less 5% or the applicable contract price, whichever is lower.

• 11

  For opened packages of expired product otherwise eligible for reimbursement, the reimbursement value will be based upon exact count and not to exceed the original quantity on the label. For NUEDEXTA credit will be issued for full bottles only unless state law requires otherwise. For products that are packaged as vials or syringes credit will be issued if returned in the original, sealed, unopened containers.

• 12

  Any credit issued by OAPI pursuant to this policy will be issued to authorized distributors of record (ADR), such as wholesalers, distributors, and other direct accounts. Indirect customers, such as retail and hospital pharmacies, will be issued credit memos through their ADR for eligible returned products. Indirect customers must also list their ADR information on the RGA.

Non-Returnable Items 

OAPI will NOT accept the following for credit or refund:

• 1

  Product that was not purchased directly from OAPI and/or direct wholesale partners.

• 2

  Products damaged due to improper storage, handling, fire, or catastrophe.

• 3

  Products involved in salvage, bankruptcy, or insolvency proceedings.

• 4

  Private label, repackaged products, products not in the original container, non-legible lot/expiration-dated product, or altered original product containers (e.g., bearing a pharmacy label).

• 5

  Product with shelf life more than six (6) months prior to expiration date and product past twelve (12) months of the expiry date. 

• 6

  Product acquired or purchased outside the United States and its territories. 

• 7

  Product acquired as Free Goods.

• 8

  Items returned in other than the original retail trade packages. This includes, but is not limited to, items in packages marked “professional sample,” “professional package,” “clinical trial package,” or similar special labels. 

• 9

  Overages (containers overpacked for return). 

• 10

  Opened packages of the products that are packaged as vials or syringes, unless required by law. 

• 11

  Product for which proof of purchase cannot be verified. 

• 12

  Products purchased on a non-returnable basis. 

• 13

  Items for which OAPI cannot verify original proof of purchase. 

• 14

  If product is returned without an RA, it will be rejected and returned to the customer at their expense.

Other Terms of Policy  

• 15

  OAPI reserves the right to exclude products from this policy. In the event of product exclusion from this policy, a specific returned goods policy for that product will be communicated.

• 16

  Buyer is to prepay all transportation and insurance charges. OAPI is not obligated to pay all, or any charges incurred by the buyer in processing or returning goods.

• 17

  OAPI reserves the right to refuse returns shipped collect.

• 18

  OAPI is not responsible for lost returns or returns damaged in shipment.

All products are returned with the understanding that they are subject to final review and evaluation by OAPI and will be processed in accordance with the most recent returned goods policy at the time the return is received.

¹ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY®

² Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY MYCITE®

³ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY MAINTENA®

⁴ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY ASIMTUFII®

⁵ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for IV BUSULFEX®

⁶ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for JYNARQUE®

⁷ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for REXULTI®

⁸ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for SAMSCA®

⁹ Please see FULL PRESCRIBING INFORMATION for VOYXACT®

¹⁰ Please see FULL PRESCRIBING INFORMATION for NUEDEXTA®