This Otsuka America Pharmaceutical, Inc. (“OAPI”) Returned Goods Policy (“Policy”) applies to product purchased either directly from OAPI or from an OAPI authorized distributor (collectively referred to herein as (“Product(s)”). OAPI reserves the right to deny credit for returns sent to third party processors other than an OAPI designated third party returns processor. OAPI will only accept the return of Product for consideration of credit, 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 at any time. 

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. OAPI reserves the right in its sole discretion, to refuse credit when returned through alternate channels. OAPI reserves the sole right to determine whether items qualify under this policy for return or credit. OAPI determination of the physical count of the returned Products will be final. By returning product, customer authorizes OAPI and its designee as customer’s 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 party returns, destruction 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. Non-returnable goods received by OAPI for return 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 no more than 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, and unopened container or trade package.

OAPI contracts with PharmaLink to manage the return and destruction of outdated products. To be eligible for return, all Product must be returned in accordance with the procedures set forth below to PharmaLink 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 RA under the Client Logins link 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 customers to enter an inventory of items in the shipment.
  • Upload Debit Memo
• 3 The following information must be supplied, or the RA Request will be declined, and product will not be eligible for return:
  • 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, and a request will be sent back to the returning entity for any missing information. If the above information cannot be obtained by the end of the requesting business day, the product will be denied for return and sent back to the returning entity.

Should further assistance be needed in returning OAPI product to PharmaLink, contact [email protected]

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, unaltered, and unopened container to receive full credit value as set forth herein. 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. This does not apply to vials or syringes and credit will be issued for vials and/or syringes only if returned in the sealed and unopened containers.

• 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)⁴, IV BUSULFEX® (busulfan) Injection⁵, JYNARQUE® (tolvaptan) Tablets⁶, REXULTI® (brexpiprazole) Tablets⁷ or SAMSCA® (tolvaptan) Tablets⁸, 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) Capsules⁹ credit for returned product will be issued at the highest lot acquisition cost less 5% or the applicable contract price, whichever is lower. Credit will be issued for full bottles only unless state law requires otherwise.

• 11

  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:

• 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  

• 1

  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.

• 2

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

• 3

  OAPI reserves the right to refuse returns shipped collect.

• 4

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

• 5

  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, and MEDICATION GUIDE, for ABILIFY®

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

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

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

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

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

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

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

⁹ Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for NUEDEXTA®

The California Transparency in Supply Chains Act requires large retailers and manufacturers conducting business in California to provide information to consumers regarding their efforts to eradicate slavery and human trafficking from their direct supply chains. 

Otsuka promotes ethical labor practices and the highest standards of business conduct both internally and within our direct supply chain.  Otsuka’s parent company, Otsuka Holdings, Ltd, is a signatory to the United Nations Global Compact, a voluntary initiative that unites companies in their commitment to create a sustainable and inclusive global economy.  By signing this compact, Otsuka has pledged to advance numerous human rights principles, including the elimination of all forms of forced and compulsory labor and the effective abolition of child labor.  These principles are consistent with Otsuka’s long-standing values and the expectations stipulated in our Code of Ethics and Professional Conduct, on which relevant Otsuka suppliers are trained and certified. 

Furthermore, all manufacturing of Otsuka pharmaceuticals approved for distribution in the United States complies with United States Food and Drug Administration (FDA) Current Good Manufacturing Practice (cGMP) regulations governing the methods, facilities, controls, and personnel qualifications necessary for the manufacturing, processing, and packing of a drug product.  These regulations not only set high quality thresholds for the work environment, but also impose stringent training requirements for the individuals working in these facilities. 

Verification 

All Otsuka employees are required to complete training and certify annually to our Code of Ethics and Professional Conduct.  The Code follows the principles set forth in the United Nations Declaration of Human Rights and prohibits any employment by Otsuka of underage children or forced labor, as well as any form of physical punishment or abuse.  Otsuka also maintains a Code for suppliers, which stipulates that all third parties with whom Otsuka does business are expected to provide a workplace free of human rights abuses, provide wages and benefits that comply with national laws and industry standards, and comply with all applicable labor and employment laws—including those that prohibit human trafficking and the employment of forced, bonded, enslaved, indentured, or involuntary prison labor.  Relevant suppliers must also train and certify annually to the Code. 

Additionally, the sourcing, manufacturing, and packaging of Otsuka pharmaceutical products for distribution in the United States is governed by FDA cGMP regulations, which include specific personnel and workplace qualifications.  Otsuka verifies manufacturing suppliers’ compliance with FDA cGMP regulations through regular audits and site inspections. 

Supplier Audits  

Otsuka conducts due diligence on all suppliers prior to their engagement, as well as throughout the period of their engagement.  This includes initial screening and audits if appropriate, as well as regular audits and site inspections of manufacturing and packaging suppliers to ensure compliance with our quality agreements.  Otsuka suppliers are also subject to ad hoc audits and inspection by government agencies, including FDA. 

While slavery and human trafficking are not specific targets of these audits, Otsuka personnel would be required to escalate any such observations or suspicions immediately. 

Supplier Certification 

All contractual arrangements between Otsuka and our suppliers stipulate compliance with local laws, rules, and regulations, which would include those concerning labor and employment in the region where the supplier operates. 

Where Otsuka third parties are also required to complete training on our Code of Ethics and Professional Conduct for suppliers based on their role and the services they provide, they must certify to their understanding and adherence.  Otsuka Ethics & Compliance monitors adherence to this requirement and third parties who fail to comply may be disengaged. 

Internal Accountability 

Otsuka requires all employees and suppliers to report, via our third party Integrity Line or directly to Otsuka Ethics & Compliance, any actual or suspected violations of the Code or any applicable law or policy in connection with the work done for us.  Reports to the Integrity Line can be made anonymously. 

Violations are escalated to a cross-functional investigations committee and handled through appropriate corrective and preventive actions such as procedural modifications, training, disciplinary measures or contract termination, and/or self-reporting if required by law.  

The following workplace standards apply: 

Code of Ethics and Professional Conduct for employees
Code of Ethics and Professional Conduct for suppliers

Training 

Otsuka employees at every level, relevant Otsuka suppliers, and our Board of Directors are required annually to review our Code of Ethics and Professional Conduct and certify to their understanding and adherence.  The Code outlines specific expectations and prohibitions concerning labor and human rights, including slavery and human trafficking. 

Otsuka Ethics & Compliance monitors adherence to this annual training and certification requirement, and noncompliance may result in disciplinary action or termination.  Our supplier contracts may also stipulate compliance training requirements or alternative training assurances, including audit rights.