Product Replacement Program Terms & Conditions

Eligibility

A replacement request may be considered when a Valorum product becomes unusable due to an eligible circumstance, including:

• Accidental breakage, dropping, or damage during storage, preparation, or administration.
• Refrigerator malfunction, power outage, or other storage event resulting in product exposure outside the conditions specified in the Prescribing Information.
• Accidental handling or preparation error that compromises product sterility or usability.
• Product prepared for administration that cannot be administered to the intended patient due to an unforeseen circumstance.
• A suspected product quality issue, packaging defect, or device-related issue requiring evaluation as a product complaint.
• Other documented circumstances determined by Valorum Biologics, in its sole discretion, to warrant replacement.

Replacement Requests

Authorization is required for each unit of ARMLUPEG requested for replacement.

Requests related to wastage, breakage, handling issues, or potential product complaints should be submitted to ValorumPRO within one week of the occurrence.

The healthcare provider may be required to provide supporting information, including:

• Date and description of the occurrence.
• Quantity of product affected.
• Product lot number and expiration date.
• Description of storage, preparation, or administration circumstances.
• Additional information reasonably requested by Valorum Biologics.

Approved replacement requests are generally processed within 2 to 5 business days.

Product Complaints

Events involving a suspected product defect, quality concern, damaged packaging, or device malfunction may be evaluated as a product complaint and may require additional documentation.

Billing and Reimbursement

Replacement product is provided solely to replace ARMLUPEG determined to be eligible under this program and may not be used to obtain duplicate payment or reimbursement.

Healthcare providers are responsible for ensuring that billing and reimbursement associated with the original and replacement product comply with applicable payer requirements and all federal and state laws and regulations.

Replacement product may not be sold, transferred, or exchanged for cash or other consideration and has no cash value.

Limitations

Replacement is limited to the quantity approved by Valorum Biologics based on the circumstances of the request.

Valorum Biologics may deny a replacement request if:

• Required information or documentation is incomplete.
• The request is submitted outside the applicable reporting timeframe.
• The product was used or administered.
• The circumstances do not meet program requirements.
• Replacement would result in duplicate reimbursement or otherwise conflict with applicable law or payer requirements.

Approval of a prior replacement request does not guarantee approval of any future request.

Program Administration

Valorum Biologics reserves the right to interpret these Terms & Conditions and to modify, suspend, or discontinue the ARMLUPEG Product Replacement Program at any time, with or without notice, subject to applicable law.