General Terms and Conditions of Business (GTC)

of Kynelion Pharma Group (KPG)

Meissner Str. 191, Haus 1, 01445 Radebeul, GERMANY

1. Definition

1. 1. “Kynelion Pharma Group” or “KPG” refers to the joint venture between Cotectra GmbH, Schirmen Pharmaceuticals GmbH and Bio-Synergix International ltd.
   2. “Wholesaler” or “Supplier” refers to Schirmen Pharmaceuticals GmbH, an authorized pharmaceutical wholesaler and the entity providing pharmaceutical wholesale services.
   3. “Broker” refers to Cotectra GmbH, a registered pharmaceutical broker and the entity offering pharmaceutical services in name of the “Wholesaler”.
   4. “Regulatory Advisor” refers to Bio-Synergix International ltd., the entity in charge for regulatory affairs for the registration of pharmaceutical products.
   5. “Purchaser” or “Customer” refers to any entity purchasing pharmaceutical products from the Wholesaler.
   6. “Manufacturer” refers to any entity manufacturing and supplying pharmaceutical products for sale to the Wholesaler.
   7. “Goods” denote pharmaceutical products and related items offered for sale by the Wholesaler.
   8. “Licensing & supply agreement” or “LSA” means an agreement between KGP and Purchaser for the supply of Goods on separate specific terms and conditions, which may differ from this GTC.  
   9. “Regulatory Approval” means all approvals, including, where applicable, pricing approval, company and product registrations and renewals, authorizations, permits, licenses, filings, and certifications issued by any Regulatory Authorities necessary for the use, sale, offer for sale, distribution, handling, importation and Marketing of a Product in the Territory, including the Marketing Authorization.
   10. “Regulatory Authorities” shall mean the government or other entities charged with the regulation of pharmaceutical products in the Territory.
   11. “Territory” shall mean the country to where the Goods shall be sold and delivered by the Purchaser.

2. Scope of application

1. 1. The GTC set out below apply to all legal relationship contracted to one member of Kynelion Pharma Group, based on its defined business role.
   2. The GTC apply to all sales to Purchasers, if Purchasers is a business within the meaning of Section 14 German Civil Code (BGB).
   3. Deviating and conflicting terms and conditions from Purchaser which have not been previously accepted in writing shall not be recognized.
   4. Any individually negotiated agreements with Purchaser (including Licensing & supply agreement, side agreements, amendments and changes) as well as any terms in our offers and order confirmations conflicting with these GTC shall also take precedence over these GTC.
   5. Any amendment to these GTC will be announced on our homepage www.kynelion.com and will be effective on the date of publication on this homepage. 

3. Quotation and Order, Prices

1. 1. Unless otherwise specified in writing by KPG, any quotation submitted to Purchaser shall be binding and shall expire thirty (30) days after the date of issue.
   2. Price information can be subject to change and must be confirmed with a quotation or an order confirmation.
   3. The purchase order for Goods is only concluded by the written order confirmation of Wholesaler and can be refused by Wholesaler.
   4. Unless otherwise agreed all prices are deemed net prices FCA (Incoterms® 2020) plus packaging, costs of transportation/shipping and other logistics costs, and plus statutory value-added tax as applicable at the time of invoicing.
   5. Purchase orders for Goods can be placed only by authorized Purchasers. The Purchaser must submit in advance the certificate of authorization for Trade in Pharmaceutical Products. 

4. Terms of Payment

1. 1. Unless otherwise specified in the order confirmation or individual contracts, the Purchaser must pay the sales amount by up-front payment. 
   2. A deferred payment can be agreed in advance within thirty (30) days of the date of shipment by Letter of Credit issued by a first-class bank with rating equal or superior to BBB (as updated and issued by S&P, Moody’s, or Fitch), confirmed by the Wholesaler/Supplier.
   3. Purchaser may assert a right of retention against our claims only if it is based on claims from the same contractual relationship that are uncontested, ready for a decision or defined by final enforceable judgment. Any setoff is excluded except where the counterclaim is defined by final enforceable judgment, ready for a decision or uncontested.
   4. The Purchaser shall be responsible for all additional tariffs, charges, taxes and fees required by regulations or law (but not limited to, import taxes or fees for entry into the territory etc.) resulting from this Agreement and arising from its performance, with no right to any type of reimbursement.

5. Terms of Supply

1. 1. All delivery dates/deadlines are deemed nonbinding except where explicitly defined or agreed upon as binding.
   2. The Goods shall be supplied only following the written orders of the Purchaser.
   3. If we have not received at all or in due time supply of any goods ordered, we shall not be in default with the delivery to Purchaser unless we are responsible for having received such supply with delay or not at all. We are entitled to withdraw from the contract if it is established that we are not responsible for not having received supply of the goods ordered.

6. Obligations of Purchaser

1. 1. If the goods are intended to be placed on the market outside of Germany, the contract is concluded on the condition that the delivery does not conflict with any export control or other trade measures. 

The Purchaser has the following obligations:

1. 1. 1. Be liable for the legality of the Goods before Regulatory Authorities of the Territory. For the avoidance of doubt, the Wholesaler shall not be liable for the legal aspects related to the legality of the Goods in the Territory.
      2. Be liable for the transportation and storage of the finished Goods according to the Good Distribution Practices and the Supplier/Manufacturer specifications.
      3. If requested by local authority, perform the final quality controls of the Goods, withdrawing samples of each one of the batches received.
      4. Take full and exclusive liability for the finished, packed and commercialized Goods and such liability shall be reinforced before competent authorities as well as third parties.
      5. Be liable for the approval and clearance of the finished Goods for commercialization and distribution.

Allow any representative duly authorized by the Supplier/Manufacturer to visit the Purchaser annually in order to assess the good standing of the commercial relationship between both Parties.

7. Reservation of title

1. 1. All goods delivered by Supplier remain Supplier’s property under reservation of title (“Goods”) until all claims under the contract have been settled.
   2. Furthermore, the Goods remain Supplier’s property until all our other presently existing and future claims under the business relationship (including all unsettled balances based on current account) have been settled. In the event of a current account, the Goods serve to secure our unsettled balances. 
   3. The Purchaser shall not sell, transfer, pledge, or encumber the products in any manner until ownership is transferred by the Wholesaler after full payment is received.

8. Warranty and Return of Goods

1. 1. The Wholesaler warrants that all products delivered to the Purchaser shall meet the manufacturer’s specifications and be free from defects in material and workmanship at the time of delivery.
   2. The warranty period for pharmaceutical products shall be in accordance with the manufacturer’s stated expiration date or shelf life, whichever comes first. The warranty does not cover any damage resulting from improper storage, handling, or use of the products by the Customer. 
   3. The warranty is non-transferable and extends solely to the original Purchaser who purchased the products directly from Wholesaler.
   4. The Purchaser may request a return of products in the following circumstances:
      1. Receipt of damaged or defective products not caused by the Purchaser or products not saleable due to expiry date.
      2. Receipt of incorrect products not as per the original order.
   5. Any claims against the Wholesaler must be submitted in writing within 8 days from the date of delivery of the products. Failure to provide timely notice shall result in the waiver of the claim. The request of claim should include the order number, product details, and the reason for the claim.
   6. Returns due to shipping errors by Wholesaler or defective products will be accepted without additional charges to the Purchaser.

Return of Goods is excluded for legal reasons to return defect-free Goods. Any amount invoiced by Wholesaler must be paid in any case.

9. Limitation of liability

1. 1. The Wholesaler’s liability for any direct or indirect damages arising from the sale, use, or handling of products shall not exceed the purchase price of the affected products.
   2. The Wholesaler shall not be liable for any consequential, incidental, or punitive damages, including loss of profits, arising from the use or inability to use the products.
   3. The Wholesaler’s liability for any direct or indirect damages arising from the sale, distribution, or use of pharmaceutical products shall not exceed the total purchase price of the specific product(s) giving rise to the claim.
   4. The Wholesaler shall not be liable for any consequential, incidental, or punitive damages, including but not limited to loss of profits, business interruption, or reputational harm, arising from the use or inability to use the products supplied.
   5. The Wholesaler shall not be held liable for any damages or losses resulting from the improper storage, handling, or administration of the products after delivery to the Customer.
   6. The Wholesaler shall not be responsible for any delays, disruptions, or damages caused by events beyond its reasonable control, including but not limited to acts of nature, war, terrorism, labour disputes, government regulations, or transportation failures.
   7. The Purchaser agrees to indemnify and hold the Wholesaler harmless from and against any claims, liabilities, losses, or expenses arising from the Purchaser’s use or resale of the products or any breach of these Terms and Conditions.
   8. The limitations and exclusions in this clause shall apply to the fullest extent permitted by law, and if any part is deemed unenforceable, the remaining provisions shall remain in full force and effect.

10. Order Cancellation by the Customer

1. 1. The Customer agrees and accepts that all placed purchase orders that have been accepted by the Wholesaler are non-cancellable as they are purchase or production orders according to the Customer’s request. 
   2. In Force Majeure, the Customer may request the cancellation of an order by providing written notice to the Wholesaler before the order has been manufactured, shipped or processed for delivery. Depending on the order processing status the Customer has to assume the incurred costs by the Wholesaler up to the total order value.

11. Pharmaceutical Wholesaler’s Right to Cancel

1. 1. The Wholesaler reserves the right to cancel an order under the following circumstances:
      1. Non-payment: If the Customer fails to make payment as per the agreed-upon terms, the Wholesaler may cancel the order or contract.
      2. Non-compliance: If the Customer violates any terms and conditions of the contract or any applicable laws or regulations, the Wholesaler may cancel the contract.
      3. Force Majeure: If circumstances beyond the control of the Wholesaler, such as natural disasters, war, terrorism, or governmental actions, make it impossible or impractical to fulfil the order or contract, the wholesaler may cancel it.
   2. In the event of the Wholesaler exercising its right to cancel, the Wholesaler has to provide a written notice to the Customer and the Wholesaler has to refund the Customer. The amount of refund is calculated depending on the payments already made and the order processing status.  

12. Force Majeure

1. 1. In any event of force majeure or other unforeseen circumstances, such as disruption of business operations, lawful strike or employee lockout, import/export restrictions, official orders, epidemics, pandemics, etc., which temporarily prevent us, through no fault of our own or attributable to us, from delivering the goods by the date or within the time agreed, these delivery dates/times will be postponed and extended – including during the delay – by the duration of the interference caused by such circumstances. If performance is delayed by more than 4 months because of such interference, both parties may withdraw from the contract. If the delivery or part thereof becomes impossible or unacceptable because of these circumstances, we will to that extent be released of the obligation to make delivery and/or have the right to withdraw from the contract. 

13. Safety Data and Compliance

We refer to the information on our website www.kynelion.com

14. Arbitration

Any dispute linked to the agreement and its enforcement will be settled in accordance with the Rules of Conciliation and Arbitration of the International Chamber of Commerce in accordance with the rules.  German law shall apply to the exclusion of the UN Convention on Contracts for the International Sale of Goods. The place of jurisdiction is Dresden, Germany. 

GTC Version 1, August 20th, 2023