Artesunate is produced under GMP (§14 AMG) conditions (content 96%-102%).
The quality control of artesunate is carried out in the quality control department, where regular quality inspections of pharmaceutical raw materials and finished medicinal products are carried out at the highest level.
Each batch of Artesunat is produced according to established and validated manufacturing instructions, analytical methods and pharmaceutical regulations and is checked for purity and content. Only the most modern, regularly maintained and qualified, state-of-the-art equipment is used to manufacture and test the products, in order to ensure the reliability of the data collected. The highly qualified employees are continuously trained by internal and external courses and further education. Regular GMP inspections certify that it complies with the GMP guidelines.
Regular quality control ensures that only artesunate that meets the highest quality standards is released. Artesunat is therefore suitable as an active ingredient for all conceivable application sites; from topical, through oral to parenteral - Artesunat is available for a wide range of therapy options.
§ 1 Scope of application
1. Our offers, sales are made exclusively on the basis of the following terms and conditions.
2. They apply to all business relationships with clients concerning the production/delivery of active ingredients.
3. Contradictory or conflicting terms and conditions of the Customer shall not bind the Supplier, even if the Supplier is aware of them.
4. Deviating terms and conditions of business shall only become binding if the supplier has expressly agreed to them in writing and thereby acknowledged them.
5. The general terms and conditions can be settled by individual contract and replaced by other regulations.
§ 2 Prices
1. Offers of the supplier are limited in time. They contain the concrete services offered, prices and expected implementation periods. The prices are net prices. Not included in the prices are the shipping costs themselves. These will be communicated on request.
2. Offers can be individually agreed between the parties.
3. The client's order must be made in writing. Upon written confirmation by the supplier, the order is concluded under the specified conditions.
4. The supplier reserves the right to change the prices after conclusion of the contract if considerable cost increases or reductions (especially in the case of changes in the price of materials) occur. The supplier bears the burden of proof in this respect.
5. Invoices are to be paid in advance, unless otherwise stated in the offer. The delivery will only take place after receipt of payment.
§ 3 Retention of title
1. The delivery item remains the property of the supplier until the purchase price claims have been met.
§ 4 Audits
1. If the customer himself, or a domestic or a foreign authority, carries out a quality audit at PharmBioTec in connection with delivery items to be supplied or provided, the customer shall bear the costs incurred by the supplier as a result.
§ 5 Quality, specifications
2. The delivery is carried out according to the specifications offered. Other specifications can be agreed upon in individual contracts.
§ 6 Delivery, place of performance
1. Unless otherwise stated in the order confirmation, the place of performance is the registered office of the contractor. The transport risk is borne by the client.
2. Insurance and transport costs shall be borne by the customer and shall be shown separately on the invoice.
§ 7 Delivery periods
1. Compliance with the agreed delivery deadlines requires the documents to be supplied by the customer and the written confirmation of the order received by the supplier. If these prerequisites are not met, the delivery period shall be extended accordingly. This shall not apply if the Supplier is responsible for the delay.
2. Fulfilment of the order is subject to the proviso that this does not conflict with any international or national legal regulations.
3. Information within the offer about the period of time during which the service is to be provided is not binding, unless a fixed date is agreed in writing by which the service must be provided.
4. If the failure to comply with the delivery deadlines is due to force majeure and therefore not the responsibility of the supplier, the deadline shall be extended accordingly.
§ 8 Default of acceptance
1. If there is a case of default of acceptance at the time of delivery, the supplier is entitled to claim the damage caused by default.
2. If the Supplier is in default, the Supplier shall be liable in cases of intent or gross negligence on the part of the Supplier or a representative of the Supplier in accordance with the statutory provisions. In cases of simple negligence, the liability of the supplier is limited to the foreseeable damage typical for the contract.
3. If the Supplier is in default with the performance incumbent upon it under the contract and if it is able to provide the contractually agreed performance later than at the originally agreed time, the Supplier may, after setting a reasonable deadline, request the Customer to declare to it in a binding manner whether it accepts the contractual performance despite the default in performance or whether it declares its withdrawal from the contract instead. In the request, the supplier must state in the request with a deadline setting whether the withdrawal from the contract or the continuation of the contract will take effect upon expiry of the deadline if the purchaser does not declare his withdrawal within the set deadline. Other claims and rights of the purchaser remain unaffected.
§ 9 Non-delivery, impossibility
1. In cases of general impossibility of performance and inability of the Supplier to perform, the statutory provisions (in particular §§ 275, 323, 326 BGB) shall apply to the Customer's rights of withdrawal and rights to damages. No. 7.5 shall apply accordingly.
§ 10 Liability, withdrawal
1. Customer may only withdraw from the contract within the framework of the statutory provisions insofar as Supplier is responsible for the delay in performance.
2. Warranty claims of the customer presuppose that the customer has properly fulfilled his obligations to examine the goods and make a complaint in accordance with § 377 HGB.
3. If there is a defect in the delivered item, the supplier is entitled to choose between subsequent performance in the form of rectification of the defect or delivery of a new defect-free item.
4. If the supplementary performance fails, the customer is entitled to demand rescission or reduction of the purchase price at his discretion.
5. The warranty does not extend to damage that occurs after the transfer of risk as a result of faulty or negligent handling, or that arises due to special external influences.
6. Insignificant deviations from the agreed quality do not constitute defects of the delivered item.
7. The Supplier shall be liable in accordance with the statutory provisions if the Purchaser asserts claims for damages based on intent or gross negligence. In cases of simple negligence, the liability of the supplier is limited to the foreseeable damage typical for the contract.
8. Outside the cases of sentence 7, the Supplier shall be liable in accordance with the statutory provisions if the Supplier culpably breaches a material contractual obligation; however, even in this case the liability for damages shall be limited to the foreseeable, typically occurring damage. Liability for culpable injury to life, body or health remains unaffected; this also applies to mandatory liability under the Product Liability Act.
§ 12 Limitation period
1. Any claims of the customer for breach of contract shall become statute-barred within 12 months from the transfer of risk. The Supplier's liability shall be limited to any lack of conformity that occurs within this period.
2. The statutory limitation period due to intentional or fraudulent conduct and due to mandatory legal claims remains unaffected.
§ 13 Place of jurisdiction
1. German law shall apply to the legal relations between the parties.
2. Place of jurisdiction is Saarbrücken.
§ 14 Data protection
1. The Supplier is entitled to process or store the data about the Customer received in connection with the business relationship in compliance with the statutory provisions insofar as this is necessary for the purpose of the contract or to safeguard the legitimate interests of the Supplier and there is no reason to assume that an overriding interest of the Customer worthy of protection prohibits this. Between the parties, only the German version of the General Terms and Conditions of Delivery shall apply. The English version is a non-binding translation.
§ 15 Severability Clause
1. Should one of the above provisions be or become invalid, this shall not affect the validity of the remaining provisions. In such a case the client and the supplier will agree on a legally permissible regulation.