General Terms and Conditions of Sale and Deliveries of Hänseler AG
valid from January 1st, 20223. Production and bottling for third parties
5. Minimum order quantities, conditions of delivery and terms of delivery
7. Authorization of purchase for ready-to-use drugs and medicines and raw materials (substances)
8. GMP/GDP delivery chain of active substances
9. Identification of excipients
10. Transfer of benefit and risk
1. Scope
All deliveries and sales and all services related therewith are based on these General Terms and Conditions for sales and deliveries (hereinafter: conditions of Sale). Individual agreements which are different from these Conditions of Sale are only valid if they are expressly confirmed by Hän- seler AG in writing. Contravening or differing conditions of the buyer are not accepted unless expressly confirmed by Hänseler AG in writing. These Conditions of Sale are even valid if the seller executes an order without reservation.2. Offer and accept
Offers of Hänseler AG are not binding; they are only an invitation to the buyer to submit an offer. The contract shall be binding on both parties upon receipt of the written confirmation of Hänseler AG that the order is accepted (Order Confirmation) or with the execution of the order without objection. There is no other way a binding contract can come into force, particularly not tacitly or implicitly. If an Order Confirmation differs from an order the Order Confirmation shall be deemed to constitute an offer of Hänseler AG which comes into force as binding contract on both parties unless the offer shall be refused within 14 days.3. Production and bottling for third parties
If Hänseler AG manufactures or bottles products by order of a third party such performance shall be based on the GMP guidelines (Ph.Helv 20.1 Rules of Good Manufacturing Practice for Medicines Produced in Small Quantities and EudraLex - Volume 4 Good Manufacturing Practice (GMP) Guidelines Part II). Such contracts shall only come into force with a specific written contract signed by both parties with an agreement concerning responsibilities and liabilities. In contracts under that clause the buyer shall accept quantities differing by +/- 10 % from the ordered quantity. Hänseler AG shall charge the quantity actu- ally delivered. Products correctly produced or bottled in accordance with the contract cannot be returned under any circumstances. Expenditures incurred in addition to the contract are charged to the buyer separately. As far as the contract or possible general conditions to the contract do not provide for a differing regulation or term these Conditions of Sale are applied correspondingly.4. Prices
List prices are standard values for standard packing sizes in the correspon- ding quantities only. Binding prices shall be those according to the order confirmation. Prices always are excluding Value added tax (VAT). Therefo- re, for products with the tax rate N, the full VAT will be charged in addition to the net prices, for products with the tax rate R, the reduced VAT will be charged in addition to the net prices. The currently applicable tax rate (N or R) is specified in the price list. For exports no VAT will be charged. For sales within Switzerland an eventual VOC-Duty is included in the price.5. Minimum order quantities, conditions of delivery and terms of delivery
Orders shall at least correspond to the following equivalents in Swiss francs:First order domestic:
CHF 300.00 for pharmacies and drugstores and hospitals (specialized trade orders)
CHF 1’000.00 for industry’s orders
Following orders domestic:
CHF 100.00 for pharmacies and drugstores (specialized trade orders)
CHF 5'000.00 for industry’s orders
First order and following orders export:
CHF 1’500.00 or equivalent in foreign currency
In the absence of any other provisions within these terms and conditions of sale, the following delivery conditions shall apply to all orders:
For specialized trade orders within Switzerland a GDP-surcharge of CHF 6.90 is charged per order. For specialist orders with an equivalent value of less than CHF 100.00, a processing fee of CHF 15.00 shall be applied to each shipment.
For Industry’s orders within Switzerland with a delivery value of at least CHF 500.00: DDP Swiss domicile by mail or truck. Orders of industry’s less than CHF 500.00 are subject to a processing surcharge of CHF 40.00 for each consignment.
For exports within Europe: DDP domicile. For exports outside Europe: EXW.
Hänseler AG does not grant any pick up or collection fees. Express deli- veries are offered at the current mail fares. Under no circumstances shall Hänseler AG be held responsible or liable for late delivery in time or for delivery delays.
6. Compliance with Laws
The buyer is responsible for and agrees to comply with all applicable legal and official laws and regulations whatsoever concerning import, transport, warehousing, distribution and use of the goods. If lack of space does not allow all warning and hazard information pursuant to the Swiss Chemicals Ordinance to be displayed on the goods, reference is made to the article- specific safety data sheet on the Hänseler AG homepage. For selected raw materials, which have a potential for abuse to produce explosives or anes- thetics, the customer is required to sign an end user statement on request before the goods can be purchased. These raw materials shall only be used for the production of drugs and medicines. The responsible person needs to consider the respective regulations.7. Authorization of purchase for ready-to-use drugs and medicines and raw materials (substances)
Deliveries of raw materials and ready-to-use medicines are executed according to the current legal regulations for example concerning the authorization of purchase for drugs and medicines under the classification A-E, concerning wholesale authorizations, alcohol licenses, anesthetics licenses or concerning other necessary authorizations or licenses.8. GMP/GDP delivery chain of active substances
Deliveries of active substances with a complete GMP/GDP delivery chain are identified in the certificate of analysis with the legally required GMP statement «We hereby certify that the above information is authentic and accurate. This batch has been fabricated/manufactured, including packaging and quality control at the above mentioned site in fully compliance with the EU-GMP requirements of the local Regulatory Authority. The batch processing, packaging and analysis records were reviewed and found to be in compliance with EU-GMP. This certificate is only valid for closed containers of this specific batch» The certificate of analysis of acti- ve substances with no complete GMP/GDP delivery chain does not contain such a GMP statement.9. Identification of excipients
The classification in active ingredients and excipients bases on the subs- tances list of Swissmedic as well as on the known intended purpose according to Hunnius (pharmaceutical dictionary). On the analysis certificates of the excipients a remark is stated, that the present raw material is an excipient.10. Transfer of benefit and risk
Unless otherwise agreed, benefit and risk concerning the object of purchase pass to the buyer as soon as the goods are loaded for shipping or picked up from the warehouse.11. Damages caused during transport
All consignments are at the consignee’s risk. Hänseler AG is responsible or liable for any damages caused during transportation. Insurance for damages of any kind is up to the buyer.12. Warranties and Liability
All warranties for defects are expressly waived as far as this is legally admissible under the applicable laws and replaced by the rules set forth in paragraphs 2 and 3 of this clause. Any other or further warranties, particularly, but not limited to those set forth by statute, or any liability for defects or damages of any kind is expressly excluded as far as this is admissible under the applicable law. Equally excluded is any compensation for damages caused by delivery delays. Furthermore, any liability is explicitly waived for consequential or other damages caused by defects whether they are directly or indirectly due to handling, treatment, or consumption of delivered products, as far as this is legally admissible under the appli- cable laws. The Exclusion of legal warranties according to this clause is expressly valid for goods delivered as substitution for defect goods either. The buyer has to examine deliveries and services immediately after receipt. Otherwise the delivery is deemed accepted. In case goods are defective and the defects have arisen after the transfer of benefits and risk the buyer has to return such goods to Hänseler AG within 30 days after receipt. Returns have to be made with the form designated by Hänseler AG for that purpose.If a return is made within the period of 30 days and with the required form Hänseler AG will at its own choice replace the defective goods with goods free from any defect or repay the purchase price. Hänseler AG will not take back goods individually labeled or especially obtained on the buyer’s order. Also excluded is the taking back of labeled goods which cannot be used again for any reason, and of opened bottles. Any raw material quantities consisting of bulk goods filled especially for you cannot be returned or reimbursed.
If a return is made within the period of 30 days and with the required form Hänseler AG will at its own choice replace the defective goods with goods free from any defect or repay the purchase price. Hänseler AG will not take back goods individually labeled or especially obtained on the buyer’s order. Also excluded is the taking back of labeled goods which cannot be used again for any reason, and of opened bottles. Any raw material quantities consisting of bulk goods filled especially for you cannot be returned or reimbursed.
Furthermore, items ordered in error will not be credited.