Legal Documentation

Terms of Service &
Manufacturing Agreement

These terms govern the manufacturing, supply, and OEM/ODM services provided by Aura Medical for B2B commercial transactions. Please review carefully before placing purchase orders.

Effective Date: 01/01/2026January 17, 2026 Version 2.4
01

Acceptance of Terms

These Terms of Service ("Terms") constitute a legally binding agreement between Aura Medical ("Manufacturer", "We", "Us") and the entity purchasing products or services ("Buyer", "Distributor"). By submitting a Purchase Order (PO), paying a deposit, or authorizing production samples, the Buyer acknowledges and agrees to be bound by these Terms.

These Terms apply specifically to B2B commercial transactions, including OEM (Original Equipment Manufacturer) and ODM (Original Design Manufacturer) services. Any conflicting terms in the Buyer's Purchase Order shall be void unless expressly agreed to in writing by an authorized officer of Aura Medical.

02

Orders, MOQ & Production

2.1 Minimum Order Quantity (MOQ)

Standard MOQs apply as follows unless otherwise negotiated:

  • Standard White Label (Nasal Strips): 5,000 pieces per SKU.
  • Custom Packaging (Private Label): 10,000 units per design.
  • Custom Formula/Shape (ODM): 50,000 units + Mold Fees.

2.2 Sample Approval

For all OEM/ODM orders, the Manufacturer will provide a Pre-Production Sample (PPS). Production will strictly commence only after the Buyer provides written approval (via email or signed form) of the PPS. The Manufacturer is not liable for delays caused by the Buyer's delayed approval.

2.3 Lead Times

Estimated lead times (e.g., 15-25 business days) are estimates only and commence upon receipt of the deposit AND final artwork/sample approval. Force majeure events (raw material shortages, regulatory changes, acts of God) may extend lead times.

03

Pricing & Payment Terms

Standard Payment Terms

30% Deposit due upon order confirmation.
70% Balance due before shipment (EXW/FOB) or upon arrival at port (DDP, for qualified buyers).

All prices are quoted in US Dollars (USD) unless otherwise stated. Prices are valid for 30 days from the quotation date. We reserve the right to adjust prices due to significant raw material cost fluctuations (e.g., medical-grade adhesive, non-woven fabrics) with prior notice.

04

Shipping & Incoterms

Unless otherwise specified in the Purchase Order, standard shipping terms are FOB Shenzhen or EXW Factory (Guangzhou).

  • DDP Service: For Amazon FBA sellers or DDP requests, we act as the shipper of record to clear customs and pay duties. However, the Buyer is responsible for providing valid Tax IDs (EIN/VAT) where required.
  • Risk of Loss: Risk passes to the Buyer according to the specified Incoterm (Incoterms 2020).
  • Customs Clearance: For non-DDP shipments, the Buyer is solely responsible for import clearance, duties, and taxes in the destination country.
05

Quality Assurance & Returns

We manufacture under ISO 13485:2016 quality management systems.

5.1 Inspection Period

The Buyer must inspect goods within 7 business days of receipt. Any claims for shortages, visible defects, or non-conformity must be made in writing within this period.

5.2 Defect Tolerance

Due to the nature of mass manufacturing, a defect rate of up to 1.5% is considered acceptable industry standard. Claims exceeding this rate will be compensated via replacement stock or credit on future orders.

06

Regulatory Compliance

Aura Medical guarantees that products are manufactured in compliance with declared standards (CE, FDA requirements).

Buyer Responsibility: The Buyer is responsible for compliance with local laws regarding the sale, marketing, and labeling of the products in their specific jurisdiction (e.g., FDA 510(k) ownership if applicable for specific custom devices, EU MDR Authorized Representative).

07

Intellectual Property (OEM/ODM)

Buyer's IP: The Buyer retains all rights to their artwork, brand names, and custom packaging designs. We agree not to sell, display, or distribute Buyer-branded products to third parties without permission.

Manufacturer's IP: Unless a separate "Transfer of Ownership" agreement is signed, all molds, tooling, and proprietary adhesive formulas developed by the Manufacturer remain the property of Aura Medical.

08

Limitation of Liability

In no event shall Aura Medical be liable for any indirect, incidental, special, consequential, or punitive damages, including loss of profits, revenue, or business opportunity, arising out of or related to this agreement. Our total liability shall not exceed the total purchase price of the specific order giving rise to the claim.

Questions regarding these terms?

Our compliance team is available to clarify any points regarding international trade terms or regulatory requirements.

Contact Sales