General Terms and Conditions of Purchase

1. Scope

1.1 These General Terms and Conditions of Purchase (hereinafter “Purchase Conditions” or “GTCP”), as amended, shall apply to all business relations and contracts (and their performance) under which any third party (hereinafter referred to as “Supplier”) provides benefits in kind, services or other benefits for DENK PHARMA GmbH & Co. KG (hereinafter “DENK”).

1.2 These Purchase Conditions shall apply exclusively. Any deviating conditions of the Supplier or additional or even conflicting conditions of the Supplier shall only become part of the contract if and to the extent DENK has expressly agreed to them in writing or if this has expressly been agreed upon in writing. Such consent requirement shall apply in any case, for example, also if the Supplier, in his order confirmation, refers to his GTC and this has not been expressly objected to by DENK.

1.3 These Purchase Conditions shall also apply exclusively if DENK, being aware of any deviating conditions, accepts Supplier’s performance without reservation.

1.4 Individual agreements between Supplier and DENK (in particular framework agreements, quality assurance agreements) and specifications in the order placed by DENK shall prevail over these GTCP. 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.

1.5 Legally relevant declarations and notifications by the Supplier 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 GTCP 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.

1.6 These Purchase Conditions shall apply exclusively to entrepreneurs within the meaning of Art. 14 of the German Civil Code (BGB), legal entities under public law or special funds under public law.

1.7 These Purchase Conditions shall generally also apply to future transactions with the Supplier, even if they are not expressly reconfirmed. If, at the time of the future transaction, these Purchase Conditions have been amended and this is known or must be known to the Supplier, these Purchase Conditions shall apply as amended.

1.8 If, due to the nature of the Supplier’s performance or a corresponding agreement, the result of the performance is subject to acceptance, acceptance shall take the place of delivery in these Purchase Conditions.

2. Conclusion of contract, offers and cost estimates

2.1 All offers and cost estimates of the Supplier shall be prepared by the Supplier at its own expense. Supplier’s offers shall be binding for 90 calendar days.

2.2 Supplier shall be required to confirm any order placed by DENK within five (5) days from receipt. If such confirmation is not provided within the aforementioned period, DENK shall no longer be bound by the order placed. Late acceptance shall be deemed a new offer and shall require express acceptance by DENK.

2.3 Any conditions contained in the Supplier’s order confirmation that deviate from the order shall not become part of the contract.

2.4 By accepting the order, the Supplier confirms that it has taken note of these Purchase Conditions and agrees to them.

2.5 All correspondence, in particular the confirmation of dispatch, delivery bill and invoice, 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. Prices, invoices and payment terms

3.1 Unless expressly agreed otherwise, all prices stated in the order are in EUROS.

3.2 All agreed prices are generally binding and fixed. They generally include all of Supplier’s services, in particular including packaging, transport costs, insurance premiums, customs duties and any excise duties. Any additional remuneration or reimbursement of costs shall require the prior separate written commissioning of the corresponding service not covered by the performance by DENK with an express declaration of assumption of costs by DENK.

3.3 Prices are to be quoted without statutory value added tax (VAT). VAT must be shown separately.

3.4 Supplier shall issue the invoices by indicating the respective order number. Invoices are to be sent by e-mail to invoice@denkpharma.de. Each invoice may only relate to services from one order. DENK shall not be responsible for any delays due to non-compliance with these requirements. Supplier shall be liable for any damage arising for DENK due to the fact that Supplier’s invoices do not meet statutory requirements, in particular the requirements pursuant to Art. 14 (4) UStG (German VAT Act).

3.5 The remuneration or payment by DENK shall be due no earlier than sixty (60) calendar days following the proper delivery to the place of delivery pursuant to Section 4.1 of these GTCP and invoicing. In case of payment within fourteen (14) days, DENK shall be entitled to a discount of three (3) percent. Neither party shall owe any interest on maturity pursuant to Art. 353 sentence 1 HGB.

3.6 The following also applies to the remuneration for the granting of rights of use and any deduction of withholding taxes and surcharges: DENK shall be entitled to withhold, if required, any withholding taxes for which DENK is liable, include any surcharges. Within the scope of the business relationship, any such withheld tax shall be deemed to be a payment made by DENK to the Supplier. DENK shall provide the Supplier with a certificate of the withheld and paid amounts. Withholding tax shall not be deducted or shall be reduced if the Supplier provides DENK with a corresponding exemption certificate from the Federal Central Tax Office together with the invoice.

4. Contract manufacturing, raw materials

4.1 If Supplier and DENK have agreed upon the delivery of products which are manufactured by Supplier for DENK according to DENK’s specifications (“Contract Manufacturing”) and, according to this agreement, DENK is expressly required to provide raw materials, the following shall apply:

4.2 To the extent DENK provides raw materials that DENK purchases from third parties and which are directly delivered by them to the Supplier, Supplier undertakes to perform, on behalf of DENK, a proper and customary incoming goods inspection and to immediately inform DENK about any obvious defects identified in the process and to immediately notify the third party accordingly. Any defects which are detected later, and which were initially concealed must also be reported to DENK and notified to the third party immediately upon detection.

4.3 Supplier shall be obliged to store the provided raw materials in compliance with GMP and in compliance with all instructions issued by DENK.

4.4 Unless expressly agreed otherwise, Supplier shall procure all raw materials required for the product. Any costs for procuring the raw materials to be procured by Supplier shall be compensated by the payment of the remuneration pursuant to Section 3.

4.5 With regard to all raw materials, Supplier shall take appropriate precautions in order to ensure sufficient stock to fulfill the delivery obligation entered into.

5. Delivery, transfer of risk and packaging

5.1 The Supplier is generally not entitled to make partial deliveries. Partial deliveries shall only be permitted in exceptional cases with DENK’s prior written consent. Such consent shall neither affect the overall scope of the delivery obligation nor the conditions in other respects.

5.2 Supplier shall deliver the goods in accordance with DENK’s currently valid delivery and logistics instructions, which DENK shall provide to the Supplier at least in text form and which shall be valid from receipt in each case. Unless otherwise agreed in individual cases, delivery of the products shall always be DDP (Incoterms 2020) DENK’s premises. The place of performance for services requiring acceptance shall generally be DENK’s registered office or the place of delivery specified by DENK in the individual case. In such case, the transfer of risk shall take place upon acceptance.

5.3 The agreed delivery date or the agreed delivery period shall be binding in the sense of a fixed date – unless expressly agreed otherwise in writing.

a) If the Supplier fails to deliver within the respective delivery period or on the confirmed delivery date, DENK shall be entitled to claim liquidated damages. If Supplier exceeds the agreed delivery date, DENK shall additionally be entitled to liquidated damages in the amount of zero point three (0.3) percent of the net order value per working day up to a maximum total of five (5) percent of the net order value, unless the delay is beyond Supplier’s control. DENK retains the right to liquidated damages, even if it does not reserve this right when accepting fulfillment. Further claims for damages, in particular the assertion of actual higher damages and other statutory rights shall remain unaffected by this. Payment of the liquidated damages shall not release the Supplier from its contractual obligations.

b) Supplier shall be obliged to inform DENK immediately in writing if it becomes apparent to the Supplier that the deadline for the service cannot be met.

c) If the delivery is made earlier than agreed, DENK shall be entitled to refuse acceptance, to store the goods temporarily at the Supplier’s expense and risk, to arrange a return shipment at the Supplier’s expense and risk or to accept the premature delivery. This shall not affect the agreed conditions. In the event of a justified refusal of acceptance or return of the prematurely delivered goods, DENK shall retain the right to punctual delivery.

5.4 Delivered goods must be regularly packed by the Supplier in such a way that damage during transportation is avoided. The packaging material used must be environmentally friendly and shall only be used to the extent necessary. Ownership of the packaging shall pass to DENK. At DENK’s request, Supplier shall take back the packaging or DENK shall dispose of the packaging at the Supplier’s expense. If DENK places special requirements on the packaging beyond the above requirements, in particular with regard to size, packaging materials and artwork, the Supplier shall also implement these.

6. Retention of title

The delivered goods shall become the property of DENK upon delivery. The agreement of a simple, extended or prolonged retention of title by the Supplier is hereby excluded. In any case, DENK shall be entitled without further ado, in particular without approval or notification, to process the delivered goods or to dispose of them in any other way.

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

7.1 Supplier warrants that the services rendered are free from any defects.

7.2 Supplier shall generally provide its services free from any material defects and defects of title and, in particular, in accordance with the legal provisions and applicable laws applicable to Supplier and to DENK and – unless otherwise specifically agreed – in any case in accordance with the current state of the art in science and technology as well as current industry standards.

7.3 Furthermore, in addition to Section 7.1, the Supplier shall be obliged to manufacture products in accordance with (i) GMP, (ii) applicable laws and regulations, (ii) any manufacturing and testing instructions approved by DENK, (iv) any technical agreements on responsibilities in the manufacturing process (“VAV”), (v) any specifications, and (vi) the respective contract or order (collectively “Specification-conforming Product”).

7.4 To the extent the Supplier is a pharmaceutical entrepreneur or distributor of a product, Supplier guarantees, with regard to the products delivered to DENK, in addition to the warranty according to Section 7.2, (i) the therapeutic or pharmacological effects and side effects and (ii) the marketability or suitability for the respective intended purpose.

7.5 If a certain specification within the meaning of Section 7.3 has been agreed between DENK and the Supplier or has been specified by DENK within the scope of the order that has become binding, Supplier guarantees, in addition to the warranty under Section 7.2, that each product delivered is a “Specification-conforming Product” within the meaning of Section 7.3 at the time of delivery.

7.6 The statutory regulations for defective services shall generally apply, unless otherwise permissibly regulated in these GTCP.

7.7 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, the Supplier shall bear the costs and expenses for the test. Otherwise, DENK 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.

7.8 If the Supplier has delivered defective products, the Supplier shall, at DENK’s discretion, immediately rectify the defect or make a replacement delivery. If requested by DENK, subsequent performance shall also include any necessary removal and transportation of the defective item as well as the proper installation of the replacement delivery. This shall not affect DENK’s claim to reimbursement of corresponding expenses.

7.9 The place of performance for subsequent performance is the location of the item.

7.10 The Supplier shall bear the costs of subsequent performance as well as any costs of returning, sorting and disposing of defective products. DENK shall be entitled to the statutory rights of recourse in the supply chain (Art. 445 a, Art. 445 b and Art. 478 BGB) without restriction. The rights of recourse shall also apply if the delivered goods have been processed by DENK or a third party.

7.11 If the supplementary performance by the Supplier has failed, DENK shall have the right to withdraw from the relevant order or to a price reduction. DENK shall also be entitled to remedy the defect itself at the Supplier’s expense if the Supplier is in default or if a request for subsequent performance by the Supplier is unreasonable for DENK. DENK may demand an advance payment from the Supplier for the expenses required to remedy the defect.

7.12 The limitation period for claims for defects within the meaning of the warranty period shall be thirty-six (36) months from the transfer of risk, unless the law provides for a longer limitation period. The limitation period shall be suspended for the period between the notification of defects by DENK and the rectification of the defect.

7.13 The assertion of further or more extensive claims on the part of DENK shall not be affected by these GTCP.

7.14 DENK shall only inspect the incoming goods for obvious defects, completeness and identity of the delivered goods, to the extent this is directly apparent from an external inspection of the products’ transport packaging or from the shipping documents. Such defects shall be notified to the Supplier within 15 days of delivery. Concealed defects, i.e., all defects that are not directly visible during the aforementioned, limited incoming goods inspection, shall be notified to the supplier within 15 days of their discovery. Such notification of defects within this period shall be deemed timely. A notification of defects shall in no way lead to a restriction of any rights on the part of DENK. In the case of services that are subject to acceptance, there is no obligation to inspect incoming goods.

8. Liability / product liability and insurance

8.1 The Supplier shall indemnify DENK against third-party claims for damages, costs, expenses and other disadvantages resulting from product defects to the extent the cause lies within its sphere of control and organization and it is liable itself in relation to third parties.

8.2 Within the scope of these indemnification obligations, Supplier shall also be obliged to reimburse any expenses incurred by DENK and to compensate for any damage resulting from a product defect or a field measure taken in connection with a product defect. The field measures include, in particular, product recalls and warnings. As far as possible and reasonable, DENK shall inform the Supplier of the content and scope of such field measures and give it the opportunity to comment within twenty-four (24) hours.

8.3 Furthermore, Supplier shall be responsible for ensuring that neither the provision of the service nor the result of the service infringes any third-party property rights. In this respect, too, Supplier shall indemnify DENK against all claims asserted by third parties due to any infringements of industrial property rights and the associated costs.

8.4 The Supplier shall be obliged to maintain general and appropriate liability insurance, including product liability and recall cost insurance, with a reputable insurance company. Furthermore, Supplier shall be obliged to maintain business, property and transport insurance with appropriate and suitable conditions and premiums with a reputable insurance company. The aforementioned insurances must also extend to any companies affiliated with the Supplier, to the extent these are involved in the provision of services to DENK. Supplier shall maintain the aforementioned insurance policies for the duration of the contractual relationship and for as long as possible claims on the part of DENK against the Supplier may arise and these have not yet become time-barred. At DENK’s request, the Supplier must immediately and at any time provide written proof of the existence of the aforementioned insurance cover.

8.5 Any further claims on the part of DENK shall remain unaffected.

9. Set-off and rights of retention

Any set-off and the assertion of rights of retention shall only be permitted if the Supplier’s counterclaim is undisputed or has been legally established. The defense of non-performance of the contract shall remain unaffected.

10. Subcontracting

Supplier shall generally provide the service itself. Supplier shall only be entitled to subcontract or use subcontractors with DENK’s prior written consent. In any case, the Supplier shall remain fully responsible to DENK for the provision of the service.

11. Rights of use

11.1 The Supplier transfers to DENK the exclusive, perpetual and irrevocable right to the comprehensive use, publication, distribution, duplication, processing and other exploitation of all ideas, concepts, drafts, inventions, works, documents and designs provided by the Supplier and commissioned by DENK. The rights granted above shall extend to all types of use. The granting of rights under this provision expressly includes the right to transfer rights to third parties.

11.2 The aforementioned granting of rights shall be compensated by the price paid by DENK.

12. Compliance

12.1 Supplier shall be obliged to act in compliance with all legal provisions applicable to him, in particular the regulations on data protection, competition law, anti-corruption and money laundering.

12.2 If there is reasonable suspicion or if it is certain that the Supplier has violated the legal provisions applicable to it, DENK shall be entitled to withdraw from the contract or to terminate the contract if DENK can no longer be reasonably expected to adhere to the contract. Other rights on the part of DENK, in particular to compensation for damages, shall remain unaffected.

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. Supplier 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 Supplier 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 If a separate confidentiality agreement between the Supplier and the Purchaser applies, its provisions shall take precedence over this Section 13 and its subsections.

13.4 Unless expressly permitted in writing by DENK, the Supplier may not – in whatever form – refer to the business relationship with DENK or advertise with the business relationship. The requirement of consent also applies in particular to the use of the company name or company name components or the company logo or logo components as well as to any other reference.

14. Place of jurisdiction, choice of law

14.1 Alle legal relationships between Supplier and DENK 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 Supplier, at its own discretion, at its general place of jurisdiction.

15. Severability clause

If any provision of these Purchase 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.