1. General

(1) ABF Pharmaceutical Services ("ABF Pharma" or "we") concludes contracts exclusively under these General Terms and Conditions of Business (in the following: "GTC"). We do not accept any terms and conditions of the customer, unless we have explicitly agreed to their application in writing. Our GTC shall also apply, and customer's terms and conditions shall not apply, if we comply with, or carry out a customer order without explicitly accepting it, and even if we are aware that customer has proposed its own terms and conditions.

(2) Our GTC apply solely to contracts with traders (Unternehmer) within the meaning of § 1 (1) Austrian Consumer Protection Act (Konsumentenschutzgesetz), to public law entities and to funds created pursuant to public law.

(3) Any agreement concluded between us and the customer, any amendment thereof, and any agreement in performance of this contract shall be recorded in writing. This also applies to any supplements. The written form requirement can only be cancelled in writing for individual cases.

(4) Our GTC also apply to any future business relations with the customer, even if they are not explicitly referred to in a contract or offer.

(5) Our registered office is the exclusive place of venue; however, we are entitled to bring an action against the buyer at the court responsible for his registered office.

(6) Unless otherwise specified in the contract, our registered office shall be the place of performance for all goods supplied and all services performed under this contract.

2. Offer – Acceptance

(1) Unless explicitly specified otherwise in an individual offer, our offers are always non-binding.

(2) Documents made available by us prior to submission of the offer such as advertising brochures and similar documents are non-binding and subject to the specification of goods and services contained in our offer which shall have priority, unless and to the extent these documents are expressly defined as binding and prior-ranking. In case of contradictions between the specification of goods and services and the aforementioned documents, the specification of goods and services in the offer shall be prior-ranking.

(3) Unless explicitly otherwise specified by the customer, customer's orders are interpreted as an offer and can be accepted by us within two weeks, unless a shorter or a longer commitment period is agreed in writing. By issuing an order, the customer accepts these GTC.

(4) A customer order shall only be deemed to have been accepted by us, if it has been confirmed as binding by us in writing or if we start with the performance without reservation.

3. Confidentiality

Unless otherwise agreed in writing, both parties mutually commit to keep confidential any information they have received from the other party in connection with the performance of the agreed services and that are not proven to have been otherwise known to the receiving party, if and to the extent that a disclosure is not required by statutory or judicial obligation. In particular, both parties commit to use such information, which is to remain secret and shall be designated as “confidential”, exclusively by authorized persons for the indicated purpose, and to destroy or return it - subject to the applicable laws and regulations - on demand of the other party. For evidence purposes one archival copy can be kept. Press releases and scientific publications which contain confidential information are subject to the prior written approval by the other party.

4. Data Protection

(1) If personal data are processed in the course of the performance of an agreement concluded between us and the customer, both parties agree and warrant that the processing of personal data is carried out in accordance with the relevant and applicable data protection provisions. In this context, both parties agree and warrant especially:

.) to conclude a contract in accordance with Article 28 GDPR (if applicable) where such processing is to be carried out by a party as processor on behalf of a party as a controller;

.) that they have implemented appropriate technical and organisational measures to ensure an appropriate level of security for the rights and freedoms of the data subjects;

.) to ensure that persons authorised to process personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality;

.) that they have no reason to believe that the data protection legislation applicable to them prevents them from fulfilling their obligations under the respective agreement and that in the event of a change in that legislation which is likely to have substantial adverse effect on the performance of this agreement, will notify the change to the other party.

.) Both parties are responsible for the storage and deletion of personal data for their own area of responsibility.

.) Insofar as we are controller towards the customer, the customer has the following rights: If personal data is processed on the basis of customer’s consent, the right to withdraw consent, which has no effect on the lawfulness of processing based on consent before its withdrawal (Article 7 para 3 GDPR), Right of access (Article 15 GDPR), Right to rectification (Article 16 GDPR), Right to erasure (Article 17 GDPR), Right to restriction of processing (Article 18 GDPR), Right to data portability (Article 20 GDPR), Right to object (Article 21 GDPR), Right to lodge a complaint with a (data protection) supervisory authority.

5. Prices – Payment terms

(1) The Prices agreed in orders accepted by us shall apply to our services. Unless otherwise agreed in writing, all prices shall be understood as ex works (Incoterms 2020) our registered office exclusive of cost of transport and shipping. In addition to transport and shipping cost, the cost of express orders as well as special packaging must be paid separately. Our prices do not include the statutory value added tax; the value added tax is stated in the invoice separately at the applicable statutory rate at the date of the invoice. All prices are duty unpaid.

(2) By the time of its order at the latest, the customer shall fully inform us on all statutes, provisions, regulations and regulatory requirements in force at the place of destination that apply to the performance of the services, the use, the labelling, the packaging, the shipment and the health and safety provisions. If and to the extent additional costs are incurred beyond the customary provisions for services at our registered office, these shall be paid by the customer according to the corresponding disclosure in the invoice.

(3) Unless otherwise agreed, payment shall be made by the customer within 10 calendar days after receipt of our invoice without any deductions. In the event that the customer should be in default of payment, any money debt shall bear interest during the time of default. The default rate of interest per year is 9.2 percentage points above the basic rate of interest (Basiszinssatz) irrespective of customer's fault, while we reserve the right to demand compensation of damages exceeding such default interest. The customer bear reasonable reminder and enforcement costs. In any case, we are entitled to the payment of a flat amount of EUR 40.00 in case of delay of payment of the customer (§ 458 Commercial Code (Unternehmensgesetzbuch)). We reserve the right to assert further claims for damages.

(4) All our receivables shall be due with immediate effect if the customer does not comply with the terms and conditions of payment or in case of an adverse change of the creditworthiness of the customer. In this event, we are also entitled to provide still outstanding services only against payment in advance or to ask for reasonable securities and to withdraw from the contract following a reasonable period of grace and, if the customer is at fault, to demand damages in lieu of performance.

(5) The customer shall only be entitled to set-off against our claims those counterclaims which are confirmed by a final court order/award, or which have been explicitly acknowledged by us. The customer shall only be entitled to exercise a right of retention in accordance with the aforementioned conditions in so far as his counterclaim is based on the same contractual relationship.

6. Deadlines and dates

(1) Dates and deadlines are only binding if this has been explicitly agreed for the individual case. The deadline for the performance of the service begins at the earliest with the day of our acceptance of the order, however, not before all details of the performance have been clarified in full (test methods, specifications, reference substances, provided materials, etc.).

(2) Deadlines and dates shall be deemed to have been observed if we are ready to ship the goods and have notified the customer thereof within the agreed deadline / by the agreed due date, even if the shipment is impossible due to no fault of our own.

(3) The agreed deadline for the performance of our service is extended, and agreed due dates are postponed, by such time the customer is in default of fulfilment of his obligations arising from this or from another contract, or such longer time period of delay caused by its default. This shall apply without prejudice to our rights resulting from the customer’s default of fulfilment and our right to withdrawal according to the statutory provisions.

(4) If we are in default with the performance of a service, the customer shall set a reasonable grace period and shall be entitled to withdraw from the contract by the end of the period. No grace period shall be required if we have finally refused the performance of the service, or the setting of a grace period is unreasonable for the customer due to material circumstances.

(5) Claims for damages on the basis of a failure to observe binding deadlines and dates or on the basis of other delays are excluded, unless the damage was caused by us through willful intent or gross negligence. In Any case, we only assume liability for the foreseeable damages typical to the contract. The liability limitations set out in clause 11 hereof shall apply.

7. Force majeure

Incidents of force majeure shall entitle us to postpone the performance of the service for the duration of the hindrance plus a reasonable run-up time or to withdraw from that part of the contract not fulfilled. Strikes, lock-outs any other circumstances which, not due to our fault, either make it substantially more difficult or otherwise impossible for us to perform the service, e.g. as a fire, a machine breakdown, the lack of raw materials, an obstruction of the traffic routes, no difference whether such circumstances affect us or our supplier or our sub-contractors, shall be equivalent to force majeure. We will inform the customer as soon as reasonably possible after gaining knowledge of such circumstances. The customer can require us to state whether we will withdraw or perform within a reasonable deadline. The customer may withdraw from the contract if we fail to make such a declaration.

8. Damage claims due to unjustified non-acceptance

If Customer withdraws from the contract without reason or if he does not accept the performance within the deadline agreed or otherwise within the reasonable deadline set in the notice on the readiness to ship the goods, we can withdraw from the contract on our part and demand the payment of damages.

9. Rights and duties of the customer

(1) The customer shall specify the individual requirements for the packaging and the labelling of the IMP.

(2) The customer is responsible for the retention and archiving of findings and/or reports after the completion of the services rendered. Our duties concerning the retention and archiving conform to the respective statutory provisions applicable to us.

(3) We will cooperate with the customer on quality assurance and on the preparation and implementation of inspections by competent authorities at customer's cost. If the cooperation with the customer is regulated in an agreement on quality assurance, this shall prevail.

(4) Unless and to the extent otherwise agreed in writing, we reserve the right to delegate the performance of services to third parties or to engage sub-contractors which are correspondingly designated in our offer.

(5) We are committed towards the customer to perform the services carefully and professionally, consistent with industrial standards, the applicable professional standards and our quality management system. Upon demand of the customer, we inform about the respective official permits at the time of the conclusion of the contract; furthermore, we refer to the information provided on our website regarding the corresponding current permits.

(6) The customer may terminate a service contract at any time. If the customer gives notice of termination, we remain entitled to the remuneration after deduction of any savings on our part due to the termination, or in case of time based remuneration, to the remuneration for the services performed pro rata up to the date of receipt of the notification of termination. This also applies if the service contract is terminated either by us or by the customer for good reason without observing a notice period. Notifications of termination must be in writing to be valid.

10. Intellectual property

The customer acknowledges that we possess certain intellectual property, including inventions, processes, know-how, trade secrets, improvements, technology, copyright, trademarks or other intellectual properties and other assets, including procedures and techniques, procedure manuals, personnel data, computer technical expertise, computer programs or codes and software, which relate to our business or operation. The customer agrees that any of our intellectual property and improvements thereof which are used, improved, modified or developed by us during the performance of the services are our sole and exclusive property.

11. Warranties and liability

(1) If we are responsible for not providing the service in accordance with the contract and if we also fail to perform the service in accordance with the contract within the grace period set by the customer according to paragraph 6. (4) for reasons for which we bear responsibility, the customer is entitled to terminate the contract with immediate effect or to demand a corresponding reduction of the purchase price (reduction). In this event we are entitled to claim the remuneration corresponding to the services rendered up to the effective date of termination. We shall have no such claim in respect of services which are unusable and of no interest to the customer.

(2) If we are not responsible for not providing the service in accordance with the contract, we will offer to the customer, within the scope of our possibilities, the performance in accordance with the contract. If the customer accepts this offer, we are entitled to claim the reimbursement of necessary expenses associated therewith and of proven costs.

(3) Except as otherwise provided for below, paragraphs (1) and (2) above set out customer's only remedies, and further claims of the customer - irrespective of the legal grounds - are excluded.

(4) Except as otherwise required by mandatory law, and irrespective of the legal grounds, we are liable only in case of gross default and willful misconduct, and are not liable for indirect or consequential damages, loss of profit or other pecuniary losses, or damages resulting from third party claims. Our liability is capped by the lower of (i) the net contract remuneration and (ii) the amount of damages typical for the contract.

(5) The limitation period for claims of the customer for defaults of performance (Gewährleistung) is one year from handover of the results of the service to the customer. The limitation period for claims of the customer for damages (Schadenersatz) is of one year from the time the damage and damaging party are known. Claims shall be deemed to have been raised in time only if lodged with the competent court within the aforementioned limitation periods.

(6) Only ABF Pharma shall be liable to in connection with any contract. The liability of directors, statutory officers, employees and other representatives and agents of ABF Pharma is explicitly excluded, except to the extent resulting from mandatory law. In this case, the above limitations of liability, to the extent permitted, apply mutatis mutandis. The above limitations do not apply to damages affecting life, the body or health.

(7) The customer shall defend and hold us harmless against claims of third parties which are based on a breach of contractual or statutory duties of the customer or are otherwise attributable to him.

12. Place of Performance, Governing Law, Jurisdiction

(1) Unless otherwise specified in the contract, our registered place of business shall be the place of performance for all goods supplied and all services performed under this contract.

(2) Contracts shall be governed by the substantive laws of Austria excluding the provisions of the UN Convention on Contracts for the International Sale of Goods (CISG).

(3) For any disputes in connection with a contract, the court having subject matter jurisdiction for our registered office shall have exclusive jurisdiction. We are however also entitled to bring an action against the customer at the court having subject matter jurisdiction for his registered office.

13. Severability

Should any provision of this contract be or become invalid, the validity of the other provisions shall not be affected thereby. If and to the extent a provision in the individual contractual part is invalid, the parties to the contract commit to replace the invalid provision by a valid provision which purpose comes as close as possible to the purpose of the invalid provision. The same shall apply if the parties have, unintentionally, failed to address a certain matter in the contract.