General Terms and Conditions of Sale

1. Scope

1.1 The services and deliveries based on contracts for the sale of pharmaceutical products of DENK PHARMA GmbH & Co. KG (hereinafter referred to as “DENK”) in business transactions with entrepreneurs, legal entities under public law or special funds under public law (hereinafter referred to as the “Purchaser”) are exclusively subject to the following General Terms and Conditions of Sale of DENK (hereinafter referred to as “Sales Conditions” or “GTCS”).

1.2 These Sales Conditions shall apply exclusively. Any other, deviating or conflicting conditions of the Purchaser will not be recognized. They will not become part of the contract even if reference was made to them in any order, unless DENK has expressly agreed in writing to the applicability of Purchaser’s conditions in advance.

1.3 These Sales Conditions shall also apply exclusively if DENK, being aware of any deviating conditions of Purchaser, supplies Purchaser.

1.4 These Sales Conditions shall also apply to future similar transactions between DENK and Purchaser, even if they are not expressly reconfirmed. If, at the time of the future transaction, these Sales Conditions have been amended and this is known or must be known to the Purchaser, these Sales Conditions shall apply as amended.

1.5 Individual agreements (in particular framework supply agreements, quality assurance agreements) and specifications in the order confirmation issued by DENK shall prevail over these GTCS. In case of doubt, any commercial terms shall be interpreted in accordance with the Incoterms issued by the International Chamber of Commerce (ICC) in Paris as amended at the time of the contract’s conclusion.

1.6 Legally relevant declarations and notifications by the Purchaser in relation to the contract (e.g., setting of deadlines, notification of defects, withdrawal or reduction) shall be made in writing. Written form within the meaning of these GTCS includes written and text form (e.g., letter, e-mail, fax). Statutory formal requirements and further evidence, in particular in the event of doubts about the declaring party’s legitimation, shall remain unaffected.

2. Conclusion of contract, offer, order and acceptance

2.1 Offers made by DENK shall be subject to change and non-binding. A contract shall only be concluded after acceptance in accordance with Section 2.3.

2.2 By placing an order, the Purchaser makes a binding declaration that it wishes to purchase the products specified in the order (hereinafter referred to as “Products”).

2.3 The offer contained in the order can be accepted by DENK within 30 days following receipt of the order. Acceptance shall be made in writing or implied by sending the products. DENK reserves the right not to confirm or deliver orders in whole or in part.

2.4 The period pursuant to Section 2.3 shall only commence when the Purchaser has provided all evidence that he is entitled to purchase the ordered products in addition to his order. This shall not require a separate request by DENK.

2.5 An order placed by a hospital pharmacy or a hospital-supplying pharmacy shall only be accepted subject to the further conditions set out in Section 3.

2.6 All correspondence must include the order number assigned by DENK, the office internally responsible on DENK’s part and the name of the contact person on DENK’s part.

3. Orders placed by hospital pharmacies or hospital-supplying pharmacies

3.1 In case of hospital pharmacies or hospital-supplying pharmacies, a purchase contract for products for the supply of hospitals shall only be concluded if the following requirements are met:

a) Delivery is made after conclusion of a separate supply contract and proof of compliance with the requirements of Art. 14 ApoG (German Pharmacy Act) in the form of a photocopy of a hospital pharmacy’s operating license or an official approval of the hospital supply contracts pursuant to Art. 14 (3) or Art. 14 (5) ApoG, indicating the term of the operating license or approval.

b) Purchaser shall be obliged to inform DENK immediately about the expiry of an operating license or the expiry of an official approval of the hospital supply contract.

c) The Purchaser may supply the Products purchased within the scope of this Section 3 to hospitals exclusively within the scope of its proven supply contracts. Any further delivery to other pharmacies, wholesalers or intermediaries is expressly prohibited.

3.2 The hospital pharmacy or hospital-supplying pharmacy shall be supplied with products for the inpatient area at the sales prices specified in the separate supply contract.

3.3 If Purchaser breaches an obligation pursuant to Section 3.1, DENK shall be free to demand the difference between the sales price and the pharmacy purchase price or to withdraw from the contract. Further statutory rights in favor of DENK shall remain unaffected.

3.4 If the conditions specified in Section 3.1a) cease to apply at a later date, the entitlement to supply shall lapse.

4. Prices, invoices and payment terms

4.1 The prices according to DENK’s price list at the time of delivery shall apply, generally EXW (Incoterms 2020), plus the applicable statutory value added tax.

4.2 Payment of the invoice amount shall be made exclusively to DENK’s account specified in the invoice.

4.3 Unless otherwise agreed in writing, the invoice amount is due for payment without deduction within 7 days (receipt of payment) from the invoice date.

4.4 If DENK becomes aware of circumstances that result in a significant deterioration in the liquidity or creditworthiness of the Purchaser, DENK shall be entitled to demand advance payment even for orders that have already been confirmed as binding.

4.5 Default interest shall be charged at a rate of 9 percentage points above the respective prime rate (as issued by the ECB) p.a. DENK reserves the right to claim higher specific damages caused by default. The Purchaser is entitled to prove that no or only minor damage has been caused by the delay in payment.

4.6 If the Purchaser is in default with a payment, DENK shall be free to withhold further deliveries or to deliver only in the event of advance payment. Further legal claims on the part of DENK shall remain unaffected.

5. Delivery, transfer of risk and packaging

5.1 The minimum net order value is EUR 1,000.00 net (plus VAT).

5.2 Delivery shall be made as standard shipment EXW (Incoterms 2020).

5.3 The Products are only supplied by DENK to wholesalers in bundles. Clinic packs shall be supplied by the piece exclusively to hospital pharmacies and hospital-supplying pharmacies subject to the further conditions set out in Section 3.

5.4 DENK shall enclose all legally required documents with the delivery of the Products. This includes in particular the documents and information required to be enclosed pursuant to Art. 17 (6) sentences 3 to 6 AMWHV (German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients).

5.5 Unless otherwise agreed, DENK shall be entitled to make partial deliveries. If DENK makes a partial delivery, DENK shall bear any additional shipping costs resulting therefrom.

5.6 If the Products are transported in special transport boxes, cool boxes or other loaned packaging, these shall remain the property of DENK and must be returned with the next delivery. Purchaser undertakes to treat such loaned packaging with care. If the Purchaser fails to return or damages any loaned packaging, it shall compensate DENK for the damage.

5.7 Any delivery shall be at the expense and risk of the Purchaser. Purchaser shall be free to take out transport insurance. The risk of accidental loss or accidental deterioration of the Products shall pass to the Purchaser upon dispatch of the order to the Purchaser or upon transfer to the transport company. The risk shall already be transferred upon notification of readiness for shipment by DENK if a delay in shipment occurs for reasons that are within the Purchaser’s sphere of risk. Any additional costs incurred for further storage after the transfer of risk shall be borne by the Purchaser.

5.8 The place of performance as well as the place of subsequent performance shall be DENK’s registered office.

5.9 Delivery dates specified by DENK are generally non-binding unless they have been confirmed in writing by DENK as “binding”. If a binding delivery date has been agreed, delivery shall be deemed to have been made on time if the order is made available for collection ex works or dispatched by DENK on the agreed date.

5.10 The prerequisite for compliance with any agreed delivery periods is the timely and proper fulfillment of the Purchaser’s obligations. This includes, in particular, the provision of necessary documents (such as permits) and, if an advance payment has been agreed, the receipt of such payment by DENK.

5.11 Delivery is subject to timely and correct delivery by DENK’s own suppliers. If DENK is unable to meet binding delivery dates for reasons beyond DENK’s control (non-availability of the service), DENK shall immediately inform Purchaser accordingly and at the same time inform the Purchaser of the expected new delivery date. If the service is also not available within the new delivery period, DENK shall be entitled to withdraw from the contract in whole or in part; DENK shall reimburse any consideration already provided by Purchaser without undue delay. A case of non-availability of the service in this sense includes in particular the delayed delivery by one of DENK’s suppliers if DENK has concluded a congruent hedging transaction and the delayed delivery is beyond DENK’s control or DENK is not obliged to procure in individual cases.

5.12 If a delivery date is not met for reasons for which DENK is responsible, Purchaser shall send DENK a written reminder and set DENK a reasonable grace period in writing. This shall not apply if the setting of a grace period is exceptionally dispensable.

5.13 In case of unforeseen events beyond DENK’s control (in particular force majeure, operational disruption, lawful strikes or lockouts at DENK or a supplier), which significantly affect the Products’ completion or delivery, the delivery period shall be extended by the duration of the hindrance. During this time, the Purchaser shall have no rights or claims against DENK due to delay. This shall also apply if such hindrances occur at a subcontractor. If DENK is in default at the time the event occurs, this shall not be deemed to be the sole reason for assuming a responsibility on the part of DENK.

5.14 If the Purchaser defaults on acceptance or fails to cooperate, the risk of accidental loss or accidental deterioration of the Products shall pass to the Purchaser at the time of default. DENK shall be entitled to demand compensation for any resulting damage plus any additional expenses.

5.15 If DENK is in default, DENK shall be liable for damages incurred by the Purchaser as a result only in case of intent or gross negligence for which DENK is responsible. This shall not affect claims based on injury to life, limb or health. Otherwise, claims due to delay in delivery shall be excluded. Other statutory claims of the Purchaser shall remain unaffected, unless otherwise stipulated in Section 8 or Section 9 of these GTCS.

6. Retention of title

6.1 Until receipt of all payments under the contract, DENK reserves title to the delivered Products pursuant to Art. 449 (1) BGB (German Civil Code) (“Reserved Products”). In the event of a breach of contract by the Purchaser, DENK shall be entitled to take back the Reserved Products without setting any deadline. In this case, Purchaser shall be obliged to surrender the Products. DENK’s taking back of the Reserved Products shall always constitute a withdrawal from the contract.

6.2 For the duration of the retention of title, Purchaser shall be obliged to treat the Reserved Products with care and to insure them at his own expense against all usual risks, in particular theft, fire and water damage in an amount equal to the replacement value.

6.3 The Reserved Products may not be pledged by the Purchaser or assigned as security to third parties. Purchaser must inform DENK immediately in writing if the Reserved Products are seized or if third parties intervene in the Reserved Products in any other way. Purchaser shall be liable to DENK for the loss incurred if the third party is unable to reimburse DENK for any judicial and extrajudicial costs.

6.4 Purchaser shall be revocably entitled to resell the Reserved Products in the ordinary course of business. Already upon conclusion of the delivery contract, Purchaser assigns to DENK its claim from the resale in an amount equal to the final invoice amount agreed with DENK, including VAT. DENK hereby accepts the assignment. Purchaser shall remain authorized to collect the claim even after assignment. DENK shall also remain authorized to collect the claim itself.

6.5 DENK shall not notify the third-party debtor of the assignment of claims and shall not collect the claims itself as long as the Purchaser meets its payment obligations and, in particular, no application for the opening of insolvency proceedings has been filed or there are reasonable indications that the Purchaser is insolvent or overindebted (cumulative “Standstill Conditions”). If the Standstill Conditions cease to apply, Purchaser shall be obliged to notify DENK of the assigned claims and the third-party debtors and to hand over all documents required to collect the claims and to disclose the assignment by way of security to the third-party debtors.

6.6 Payments made by the customer to the Purchaser in respect of the claim assigned to DENK shall be forwarded by the Purchaser to DENK without undue delay up to the amount of the assigned claim. If the Purchaser’s customer makes only partial payments on the assigned claim, the Purchaser shall first satisfy DENK’s claim from the partial payment received.

6.7 The processing or modification of the Reserved Products by the Purchaser shall always be made for DENK. If the Reserved Products are processed with other items not belonging to DENK, DENK shall acquire co-ownership of the new item in the ratio of the Reserved Products’ value to the other processed items at the time of processing. In all other respects, the item created by processing shall be subject to the same provisions as the Reserved Products.

6.8 If the Reserved Products are inseparably combined or mixed with other products that are not the property of DENK, DENK shall acquire co-ownership of the new item in the ratio of the Reserved Products’ value to the other combined or mixed items at the time of combination or mixing. If the items were combined or mixed in such a way that the Purchaser’s item is to be regarded as the main item, it is agreed that the Purchaser shall transfer co-ownership to DENK on a pro rata basis. Purchaser shall safeguard the sole ownership or co-ownership for DENK.

6.9 DENK shall release the securities to which DENK is entitled at the Purchaser’s request to the extent that their value exceeds the claims to be secured and not yet settled by more than 10%. In the case of various security interests, DENK shall be entitled to choose the securities to be released.

7. Liability for defects / warranty and obligation to give notice of defects

7.1 Purchaser’s claims due to a material defect require that the Purchaser has fulfilled its obligation under Art. 377 HGB (German Commercial Code) to immediately inspect the goods and report any defects. Purchaser must notify DENK in writing of recognizable defects within 5 days of receipt of the products. Concealed defects, i.e., all defects that cannot be recognized directly during the aforementioned inspection, must be reported to DENK by Purchaser within 5 days of their discovery. Such notification of defects within this period shall be deemed timely. The postmark of the notice of defects shall suffice for timeliness. The notice of defects shall include the number of the invoice and of the delivery bill.

7.2 If the parties disagree as to whether a defect exists, the dispute shall be submitted to the Zentrallaboratorium Deutscher Apotheker e.V., Carl-Mannich-Str. 20, 65760 Eschborn, Germany, or to another mutually agreed test laboratory as an independent expert. The decision of the independent expert shall be binding for the parties. If the laboratory comes to the conclusion that the product in question is defective, DENK shall bear the costs and expenses for the test. Otherwise, Purchaser shall bear the costs and expenses of the test. The parties undertake to grant the independent expert a maximum period of two (2) months to perform his task.

7.3 DENK shall not be responsible for any loss of quality, reduction in the Products’ effectiveness or other defects if the Products have not been stored properly by the Purchaser or have been stored beyond their shelf life.

7.4 In the event of a defect that has been notified in due time and that limits the Products’ value or usability not only insignificantly, DENK may, at its discretion, first provide subsequent performance by delivering a replacement or repairing the delivered Products.

7.5 If the supplementary performance has failed or if DENK has refused it, Purchaser may reduce the purchase price or withdraw from the contract. The right to claim damages shall remain unaffected.

8. Liability

8.1 DENK shall only be liable in accordance with the statutory provisions for damages that have been caused by DENK or its vicarious agents intentionally or due to gross negligence.

8.2 The limitation of liability pursuant to Section 9.1 shall not apply to the breach of material contractual obligations. However, in the event of a breach of material contractual obligations, liability shall be limited to the foreseeable damages typical for the contract that were foreseeable at the time the contract was concluded or at the latest when the breach of duty was committed.

8.3 Claims for damages under the Product Liability Act, under Art. 84 et seq. German Medicinal Products Act and for injury to life, limb and health shall remain unaffected in any case.

8.4 DENK shall not be liable for damages resulting from improper handling or improper use of the delivered Products.

9. Limitation

9.1 Notwithstanding Art. 438 (1) No. 3 BGB, the general limitation period for claims arising from material defects and defects of title is one year from delivery. If acceptance has been agreed, the limitation period shall commence upon acceptance.

9.2 The above limitation periods of Sales Law shall also apply to Purchaser’s contractual and non-contractual claims for damages which are based on a defect of the Products, unless the application of the regular statutory limitation period (Art. 195, Art. 199 BGB) would lead to a shorter limitation period in individual cases.

9.3 The reduction of the limitation period to one year shall not apply to Purchaser’s claims for damages within the meaning of Sections 8.1 and 8.2 of these GTCS. In this respect, the statutory limitation periods shall apply exclusively.

10. Set-off, right of retention and assignment

10.1 Purchaser may offset DENK’s claims only against legally established or undisputed claims.

10.2 Purchaser shall be entitled to exercise a right of retention only to the extent its counterclaim is based on the same contractual relationship.

10.3 Purchaser shall not be authorized to assign its contractual rights to any third party without DENK’s express written consent. Art. 354 a HGB shall remain unaffected.

11. Resale, supply of Products

11.1 The Purchaser may only sell or supply the Products to authorized customers within the scope of the legally permissible distribution channels.

11.2 DENK’s Products may only be sold or supplied in the unaltered original packaging. It is not permitted to change the original packaging or the package insert. In particular, it is not permitted to change or remove DENK’s trademarks or to repack the products in other packaging. The individual sale of partial quantities or the splitting of a clinic pack is not permitted.

12. Additional agreements, pharmacovigilance

Purchaser shall be obliged to enter, at DENK’s request, into such additional agreements as DENK, at its sole discretion, deems necessary in order to fulfill its obligations under applicable law. In particular, Purchaser shall be obliged to conclude a separate pharmacovigilance agreement at DENK’s request, which regulates the immediate reporting to DENK of any adverse drug reactions of which the Purchaser becomes aware.

13. Confidentiality, secrecy, reference and advertising

13.1 DENK shall reserve title and copyrights to all documents provided within the scope of the business relationship, irrespective of their form. Purchaser may only use them for the purposes of the business relationship. They must not be made available or accessible to any third party without DENK’s written consent. After termination of the business relationship or as soon as the documents are no longer required, they shall be returned unprompted or shall be destroyed with DENK’s consent.

13.2 Purchaser shall be obliged to keep confidential any business, operational or technical matters of which he becomes aware in connection with the business relationship even after the termination of the business relationship, unless such information has become publicly known or DENK has expressly waived confidentiality in writing. These obligations shall be unlimited in time.

13.3 Purchaser may only advertise with the business relationship, in particular with the company name or company name components or the company logo or logo components with DENK’s prior written consent.

14. Place of jurisdiction, choice of law

14.1 Alle legal relationships between DENK and Purchaser shall be exclusively governed by the laws of the Federal Republic of Germany to the exclusion of the conflict of laws provisions and CISG.

14.2 The place of jurisdiction for any legal action shall be Munich, Germany. DENK shall be entitled to also sue the Purchaser, at its own discretion, at its general place of jurisdiction.

15. Severability clause

If any provision of these Sales Conditions or other agreements should be or become invalid or unenforceable in whole or in part, or in case of a contractual gap, this shall not affect the validity of the remaining provisions. The parties shall replace any invalid provision with a valid provision which corresponds to the meaning and purpose of the invalid provision and which – to the extent permitted by law – achieves the intended economic purpose of the invalid provision.