PURCHASING TERMS AND CONDITIONS
By accepting this Purchase Order (“PO”), the Supplier agrees to the following:
1. Prices and Payment
Prices are fixed and include all costs unless otherwise agreed in writing. Payment terms shall be as specified in the Offer. Any
advance payment shall not constitute acceptance of the Products, which remains subject to inspection and approval by Elixi.
2. Delivery and Incoterms
Delivery shall strictly comply with the agreed timelines, Incoterms® 2020, and all specified transport conditions (including
temperature control, where applicable).
3. Delays
In case of delay, the Elixi may cancel the PO (in whole or in part), refuse delivery, and/or claim damages.
4. Compliance
The Supplier shall comply with all applicable laws and regulations, including GMP/GDP, as well as anti-corruption and trade compliance laws.
5. Quality and Warranties
The Supplier warrants that Products:
• conform to specifications and regulatory requirements
• are manufactured and handled in accordance with GMP/GDP
• are free from defects and counterfeit risk
• are fully traceable
• have adequate remaining shelf-life upon delivery.
6. Packaging and Transport
• Products must be packaged appropriately to withstand transport and storage conditions.
• Special requirements for cold chain, hazardous materials, or sensitive goods must be strictly adhered to.
7. Inspection and Acceptance
Products are subject to inspection. Elixi may reject non-conforming Products. Payment does not constitute acceptance.
8. Documentation
Each delivery must include all required documentation (including CoA, certificates of origin, and invoice). Missing documentation may result in rejection.
9. Non-Conformity and Recall
Elixi may reject, request replacement, or obtain a refund for any Products that do not comply with the agreed specifications,
applicable GDP/GMP requirements, or regulatory standards (“Non-Conforming Products”).
The Supplier shall notify Elixi in writing within 24 hours upon becoming aware of any actual or potential quality defect or non-
conformity and shall provide timely updates, including investigation results and CAPA measures.
The Supplier shall fully cooperate in any recall, withdrawal, or field safety action in accordance with applicable GDP requirements
and regulatory obligations.
Where the non-conformity is attributable to the Supplier, the Supplier shall bear all reasonable and documented costs related to the
recall, including but not limited to logistics, storage, destruction, replacement, and regulatory compliance activities.
10. Pharmacovigilance and Safety
The Supplier shall report to Elixi any Adverse Events (including Serious Adverse Events), Product Quality Complaints with potential
safety impact, medication errors, and any other safety-related information within 24 hours of becoming aware of such information.
Reports shall be submitted to Elixi’s designated pharmacovigilance contact point and shall include, at a minimum, an identifiable
patient, identifiable reporter, suspected product, and description of the event.
The Supplier shall promptly provide any follow-up information and cooperate with Elixi in the investigation, assessment, and
reporting of safety information to competent authorities.
The Supplier acknowledges that pharmacovigilance obligations, including regulatory reporting, remain the responsibility of the
applicable Marketing Authorization Holder. The Buyer, acting solely as a GDP-authorised distributor, shall ensure the timely
collection and transmission of safety information to the Supplier and/or the relevant Marketing Authorization Holder and shall
cooperate in any related investigations or regulatory activities.
The Supplier shall maintain appropriate procedures and training to ensure compliance with applicable pharmacovigilance regulations
and shall allow audits by Elixi or relevant authorities.
All personal data shall be processed in compliance with applicable data protection laws.
11. Liability and Insurance
The Supplier is liable for defects, non-compliance, and resulting damages, and shall indemnify Elixi. Adequate product liability
insurance must be maintained.
12. Audit and Subcontracting
The Elixi may audit the Supplier with 14 (fourteen) days prior written notice. Subcontracting requires prior written approval, and the
Supplier remains fully responsible.
13. Confidentiality and IP
All information is confidential and may be used only for the PO. Elixi’s specifications and materials remain Elixi’s property.
14. Force Majeure and Termination
Force majeure events must be promptly notified. Elixi may terminate the PO for convenience or in case of breach or prolonged force
majeure.
15. Governing Law
Swiss law applies, excluding the CISG. Place of jurisdiction: Lugano, Switzerland.
