QUALITY AGREEMENT between Euroleki GK SP. Z o.o. Sp.k. Sw. Teresy od Dzieciątka Jezus 111, 91-222 Lodz, Poland (SUPPLIER / RECIPIENT) and ________________________________ ________________________________ ________________________________ (CUSTOMER / SUPPLIER) The Supplier and the Customer are also referred to as the “PARTY” or collectively as the “PARTIES”, as the case may be. The undersigned Parties intend to ensure product and patient safety in accordance with the European and national law and regulations. 1. WHOLESALER PERMIT (WHOLESALER LICENSE) a) The PARTIES assure to possess a valid wholesaler license. b) The PARTIES provide each other a translated copy in English, of his current wholesaler license. c) The PARTIES notify each other immediately about revocation, expiration or any other changes of the wholesaler license. 2. SOURCES OF THE ORDERED GOODS, COUNTERFEITS, RECALLS a) The SUPPLIER assures that he will only sell/deliver goods sourced from authorized companies to the CUSTOMER. b) The SUPPLIER assures the CUSTOMER that he will only sell/deliver goods which have been put on the market solely by the original pharmaceutical manufacturer within the EAA. c) The SUPPLIER assures the CUSTOMER that medical devices and diagnostics are of European Union origin and are intended for European Union market. d) The PARTIES immediately notify each other and the competent authorities of any occurrences of suspected counterfeited goods and recalls of goods. 3. GOOD DISTRIBUTION PRACTICE (GDP) a) The PARTIES assure to be familiar with the Good Distribution Practice guidelines of European Economic Area and assure to comply with the last updated version of the GDP guidelines. b) The PARTIES assure that they store the goods under the conditions specified by manufacturer in order to avoid any deterioration by light, moisture or temperature. Temperature must be monitored and recorded constantly. Records of temperature should be reviewed regularly. c) Storage and distribution of each batch of product must be carried out and recorded in a manner that allows easy traceability and reconciliation to facilitate a recall if necessary. 4. PACKAGING OF THE GOODS a) The SUPPLIER assures that he will not open, modify or remove the original packaging or the contents of the ordered goods and that he will not remove safety features or devices. b) The SUPPLIER delivers/sells the goods in their unopened original packaging to the CUSTOMER. c) The SUPPLIER is responsible that the goods are suitably protected in a manner that does not affect the quality of products. 1 5. RESPOSIBILITIES a) Both PARTIES agree to RESPOSIBILITIES provided in Annex 1 to this agreement. 6. DURATION a) This Quality Agreement expires at the end of the business relationship between the CUSTOMER and the SUPPLIER. b) Signatures on this agreement received by the way of Facsimile, Mail and/or e-mail shall be deemed to be an executed contract. 7. CONFIDENTIALITY a) The Parties shall treat the contents of this agreement as confidential, except to the extent that such disclosure is necessary to execute this agreement. 8. CHANGES TO THIS AGREEMENT a) Any changes to this agreement shall be made in writing. b) No collateral agreements to this agreement have been made. For and behalf of the CUSTOMER: For and behalf of the SUPPLIER: General Management Position: Name: Signature: Date: General Management Position: Name: Signature: Date: Position: Name: Signature: Date: Position: Name: Signature: Date: Responsible Person Position: Name: Signature: Date: Responsible Person Position: Name: Signature: Date: 2