SYSTEM STATUS: FDA ACTIVE ISO 13485 Valid MDR Ready
Establishment SinoTitanium
Metals
FEI No. 3033849259
Status Valid
[ISO 13485:2016 VERIFIED] // VDS- PROTOCOL ACTIVE
Commercial Agreement Protocol Active
VDS-LEGAL-2025 // DOCUMENT ID: VT-LEGAL-TERMS-2025

Supply Terms & Conditions

Standard terms governing the supply of medical-grade titanium materials by Valid Industrial Systems Ltd. Buyer acknowledges these materials are regulated medical device components subject to MDR/FDA requirements.

Effective Date 2025-01-01
Governing Law Hong Kong SAR
Framework MDR + FDA QSR
REGULATORY RESTRICTION: ValidTi materials are EXCLUSIVELY for use in the manufacture of Class I/IIa/IIb medical devices (dental prosthetics, implants). Sales to non-regulated sectors are prohibited.
01

Definitions

[Terminology Framework]

"Supplier": Valid Industrial Systems Ltd (HK Company Registry: 3012XXX), trading as ValidTi™.

"Buyer": The purchasing entity identified in the Purchase Order or Quotation.

"Materials": Medical-grade titanium alloys (ASTM F136 Grade 23 ELI, ASTM F67 Grade 5) supplied in disc, rod, or plate form, manufactured by SinoTi (Xi'an) per ValidTi specifications.

"Technical File": Material Test Certificates (MTC), Certificates of Analysis (CoA), ISO 10993 Biocompatibility Reports, and Declaration of Conformity per EU MDR Annex I.

02

Order & Acceptance

[Contract Formation Protocol]

2.1 Quotation Validity: All quotations expire 30 days from issue date unless explicitly extended.

2.2 Minimum Order Quantity (MOQ):

  • Annealed Discs (PRO Series): 10 units per SKU
  • Precision Rods (ULTRA Series): 5 bars (15m cumulative length)
  • Frame Plates: 20 units per SKU

2.3 Contract Formation: A binding contract is formed when Supplier issues a written Order Confirmation. Purchase Orders from Buyer constitute offers only, not acceptance.

03

Pricing & Payment

[Financial Terms]

Currency & Incoterms

All prices quoted in USD. Standard terms: EXW Xi'an or CIF [Destination Port] as specified in quotation.

3.1 Payment Terms:

Order Value (USD) Payment Structure
< $5,000 100% Prepayment
$5,000 - $20,000 50% Deposit + 50% Before Shipment
> $20,000 30% Deposit + Net 30 (Subject to Credit Approval)

3.2 Late Payment: Overdue invoices accrue interest at 2% per month (24% APR). Supplier reserves the right to suspend shipments for accounts >15 days overdue.

04

Delivery & Lead Time

[Logistics Framework]

4.1 Standard Lead Times (from Order Confirmation):

  • Stock Items: 5-7 business days
  • Made-to-Order: 30-45 business days
  • Custom Tolerances: 60-90 business days

4.2 Force Majeure: Supplier is not liable for delays caused by regulatory shutdowns, export restrictions, natural disasters, or supply chain disruptions beyond reasonable control.

4.3 Partial Shipments: Supplier may fulfill orders in multiple shipments. Each shipment constitutes a separate transaction for invoice and acceptance purposes.

05

Quality Assurance & Conformity

[Compliance Guarantee]

5.1 Certification Delivery: All shipments include:

  • EN 10204-3.1 Material Test Certificate (MTC)
  • ASTM F136 / F67 Compliance Statement
  • ISO 10993-5 & 10993-10 Biocompatibility Summary (on request)
  • Declaration of Conformity per EU MDR Annex IV

5.2 Manufacturing Standards: Materials are produced in ISO 13485:2016 certified facility (NQA Certificate: VT-ISO13485-2024-001).

Traceability Guarantee

Every batch is assigned a unique LOT number linking to full metallurgical records, retained for 10 years per EU MDR Article 10.8.

06

Returns & Defects

[Non-Conformance Protocol]

6.1 Inspection Period: Buyer must inspect materials within 14 days of delivery. Failure to report defects within this period constitutes acceptance.

6.2 Eligible Defects:

  • Chemical composition outside ASTM F136/F67 specification limits
  • Dimensional variance exceeding ±0.5mm (or specified tolerance)
  • Visible surface contamination or corrosion

6.3 Return Process: Written notice to qa@sinotimetal.com with photos and batch LOT number. Approved returns receive replacement or credit. Return shipping costs borne by Supplier.

Non-Returnable Items: Materials that have been machined, heat-treated, or altered in any way are NOT eligible for return.

07

Limitation of Liability

[Risk Allocation Framework]

7.1 Liability Cap: Supplier's total liability under this agreement is limited to the purchase price of the specific defective materials. Supplier is NOT liable for:

  • Consequential damages (lost profits, production downtime)
  • Third-party claims from end-users/patients
  • Regulatory penalties incurred by Buyer

7.2 Buyer's Responsibility: Buyer is solely responsible for:

  • Post-Market Surveillance per MDR Article 10.10
  • Clinical evaluation of finished devices (Annex XIV)
  • Product liability insurance for manufactured devices

Critical Disclaimer

Supplier provides RAW MATERIALS only. Buyer is the manufacturer of record for the finished medical device and bears all regulatory and liability obligations under EU MDR, FDA QSR 820, or applicable local law.

08

Intellectual Property

[Brand Protection]

8.1 ValidTi™ Trademark: "ValidTi" and associated marks are owned by Valid Industrial Systems Ltd. Buyer may NOT use the ValidTi name in marketing unless under a separate Private Label Agreement.

8.2 Technical Data: All Technical Files, CAM strategies, and process protocols remain Supplier's proprietary information. Buyer receives a non-exclusive, non-transferable license for internal use only.

09

Governing Law & Disputes

[Legal Jurisdiction]

9.1 Governing Law: This agreement is governed by the laws of the Hong Kong Special Administrative Region, without regard to conflict of law principles.

9.2 Dispute Resolution: Parties agree to resolve disputes through:

  1. Good-faith negotiation (30 days)
  2. Mediation via HKIAC (Hong Kong International Arbitration Centre)
  3. Binding arbitration in Hong Kong (English language proceedings)

9.3 Exclusive Venue: If litigation is unavoidable, parties consent to the exclusive jurisdiction of Hong Kong courts.

Legal & Commercial Contact

RFQ & Quotations: rfq@validti.com

Orders (Existing Customers): orders@validti.com

Quality Issues: qa@sinotimetal.com

General Info: info@validti.com

Legal/Compliance: compliance@validti.com

Response Time: < 48 hours (Business Days, GMT+8)

Ready to Establish Supply Agreement?

Initiate Procurement Process

Request Quotation

Direct Secure Access // Commercial Team