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General Terms and Conditions

  1. General 

    1. All provisions of these GTC apply only insofar as they do not oppose mandatory law.

    2. If individual provisions of the contract or these conditions prove to be ineffective, the effectiveness of the remaining provisions remains unaffected. The ineffective provision is to be replaced by a valid one that comes closest to the objective pursued.

    3. No oral side agreements have been made. Subsequent amendments and supplements to a contract must be approved in writing by PRSG to be valid.

  2. Validity of the General Terms and Conditions

    1. The General Terms and Conditions (or "GTCs") of PRSG Pharmaceutical and Regulatory Services GmbH (or "PRSG" for short), Ragnitzstraße 55, 8047 Graz, apply to the entire business relationship between Client and PRSG (or "Partners" for short).

    2. Third-party terms of business and purchase apply only if they correspond to these GTC. Regulations that modify or override these conditions are valid only if PRSG has expressly confirmed this in writing.

    3. Amendments of the GTC become legally effective at the beginning of the next month but one following the month during which Client was notified. They will apply to any current and future business relationships between Client and PRSG unless a written objection from Client is received by PRSG before that date. Client can be notified in any form agreed upon within the context of the business relationship.

  3. Offer

    1. The offer made by PRSG is deemed non-binding and subject to change regarding all specified data, including the fee.

    2. All orders, whether awarded to PRSG directly or electronically, become legally effective only if PRSG confirms them in writing using an order confirmation. If the order confirmation does not match the order, Client shall object to it in writing within two days after the order confirmation has been issued, failing which the changes contained in the order confirmation which contradict the original order will be deemed accepted by Client.

    3. If PRSG is awarded orders in any form as part of a business relationship with a client, they are entitled to execute them for that client's account if PRSG is of the opinion (without fault) that they come from this party and cannot be attributed to PRSG.

    4. In the event of lacking or erroneous information from Client, PRSG reserves the right to alter the service content appropriately. Client shall bear any detriments incurred thereby, especially those due to costs or damages.

    5. PRSG is entitled to make necessary changes to the service, provided such changes are acceptable to Client.

    6. For tests to which certain measuring or regulatory values or other testing parameters apply, the appropriate testing methods must be determined before delivery begins and acknowledged by both Parties. If no such determination is made, the testing methods of PRSG will apply.

    7. Subsequent amendments and supplements to the contract must be approved in writing by PRSG to be valid.

    8. PRSG is entitled to make the rendering of services—even at a later time—contingent upon either a security deposit or prepayment in a reasonable amount, if it seems unlikely that Client will make the demanded payments on time.

  4. Rights and duties of the Contracting Parties

    1. PRSG shall execute the order awarded them in a proper manner and in accordance with the generally recognised rules of technology and the principles of sound financial management.

    2. PRSG is entitled to demand that Client provide all required information concerning their identity and legal and contractual capacity, by submitting official documents such as a photo ID and registration form, as well as proof of signatory or representative authorisation. Furthermore, at PRSG's request Client shall disclose a delivery address and a domestic paying agent, and show proof of a domestic bank connection.

    3. Declarations sent by non-registered letter are deemed delivered to companies within Austria on the second business day (Monday through Friday) after their delivery to the postal service, unless Client proves the delivery was sent later or not at all.

    4. If Client fails to disclose a change to his address or e-mail address, and if PRSG's legally relevant statements are therefore not served because they were sent to the last address he disclosed, the statements are deemed delivered nonetheless. Invoices and reminders from PRSG are deemed delivered under the same conditions it they are sent to the paying agent last disclosed by Client. If Client agrees, statements from PRSG—including legally relevant ones—can be transmitted using electronic media (such as e-mail). Electronic statements are deemed received if they are sent to the e-mail address last disclosed by Client.

    5. For contract execution, PRSG is entitled to make use of other third persons suited to this purpose and grant them contracts on behalf and for the account of Client. However, PRSG is obliged to grant Client the opportunity to object to such contract award to a third party within ten days, while specifying grounds. Exempt from this regulation are orders whose content typically necessitates the involvement of a third party through PRSG.

    6. If PRSG involves a suitable third party as a sub-planner, they must award such third party contracts on their own behalf and for their own account, by varying Item 3.5. In this case, PRSG shall notify Client in writing if they intend to have contracts executed by a sub-planner. If Client objects to the contract awarded to the sub-planner within seven days, and provides reasons, PRSG shall execute the contract themselves. On Client's request, PRSG shall assign to Client any existing claims against sub-planner.

  5. Scope of the contract

    1. The type and scope of the services owed by PRSG are based on the agreements that have been made, whereby the regulations applicable at the time of contract conclusion are to be taken into account, provided nothing else has been expressly agreed.

    2. If services are rendered by PRSG, PRSG shall owe such services, but not a successful outcome, unless otherwise agreed in writing.

    3. If changes are made to the regulations during the rendering of services—especially the technical code (e.g., cGMP (EU-GMP/AMWHV)), the service owed will not change thereby. However, while services are being rendered the Partners shall inform each other about changes that are intended or have been undertaken, to the best of their ability and knowledge. The Partners shall come to a mutual agreement regarding any expansion or alteration of the owed services that this will make necessary.

    4. Client shall promptly take all measures, make all statements, and provide all documents necessary for the contractual rendering of services by PRSG.

  6. Delivery periods and deadlines

    1. Delivery periods begin when Client receives PRSG's order confirmation, but not before all particulars of the order have been completely clarified and all information or documents to be delivered by Client have been received. The same applies to delivery deadlines.

    2. If changes to the contractual object have been mutually agreed, the delivery deadline expires and must be agreed again.

    3. All circumstances essential for the rendering of services must be completely clarified before the agreed delivery period can begin. Compliance with service obligations particularly requires the timely and proper fulfilment of the obligations of Client. Otherwise, the time limit will be extended accordingly.

    4. The delivery periods given are approximations, unless the delivery deadline was expressly agreed with binding effect.

  7. Warranty, responsibility for defects, liability

    1. If the agreed payment conditions are complied with, PRSG shall remedy any defect existing at the time of takeover which is based on faulty construction, materials or execution, according to the following provision.

    2. The warranty period amounts to six months, unless special warranty periods have been agreed for individual deliverables. The warranty period begins to run as soon as risk is transferred according to Item 7.3.

    3. Utilisation and risk are transferred as soon as PRSG's delivery departs on its way to Client.

    4. Objections must be made by registered letter within fourteen days from the takeover of the service or partial service at the latest, and must include exact information and descriptions of PRSG's defects and damage (notice of defect). This means that Client is not entitled to take unilateral measures. Notices of defect do not entitle Client to retain the agreed remuneration.

    5. If commercial EDP programmes are used to render services, PRSG will make no guarantee and assume no liability for consequential damages caused by programme or software errors.

    6. If one Partner realises he will be unable to fulfil an obligation incumbent upon him, either on time or at all, he shall notify the other Partner thereof without delay. PRSG shall render their services with the diligence expected of them as professionals (§ 1299 ABGB (Austrian Civil Code)).

    7. Any warranty claims presuppose that Client has made written notice of the defects according to Item 7.4. If a defect exists which is covered by the warranty, PRSG shall at his discretion repair the defective performance or component at the place of performance. Claims for rescission or price reduction are excluded. PRSG shall fulfil claims for improvement or replacement of missing parts within a reasonable period—generally a third of the period agreed for performing the service. Claims for damages caused by delay cannot be asserted during this period.

    8. If PRSG produces a service based on design details, drawings, models, other specifications, or documentation from Client, PRSG's liability extends only to their compliance with these instructions.

    9. The warranty will expire immediately if Client or a third party not authorised by PRSG makes changes or repairs to the delivered products without PRSG's written consent.

    10. Any liability for slight negligence (except personal injury), replacement of consequential damage and financial loss, unattained savings, loss of interest, loss of future profits, lost data and damages arising from third-party claims is excluded.

    11. Insofar as PRSG is not liable due to intent, gross negligence, culpable breach of essential contractual obligations, personal injury to life, limb or health, or in accordance with the Product Liability Act, any liability for damages which the service, deliverable, or performance object causes to Client's legal assets or legally protected rights (e.g., to other items, loss of future profits or other financial loss) is excluded.

    12. PRSG's obligation to compensate an individual injured party is limited for each damage-causing event (except personal injury) to the fee Client owes PRSG for the rendered service. If the total damages exceed the maximum limit, the compensation claims of the individual injured parties are reduced proportionately.

    13. If PRSG is prevented from providing the agreed service because of force majeure, whether in regard to deadlines, defects or in general, Client is not entitled to assert any claims for damage compensation therefrom.

    14. In their relationship to each other, the Parties make no guarantee that the work results or the information, documents and data provided within the framework of the contract have any general or agreed qualities or fulfil qualifications, are usable, complete, technically unobjectionable or marketable, or that they are free from defects of title.

  8. Withdrawal from the contract

    1. The prerequisite for Client to withdraw from the contract is a delay in delivery attributable to gross negligence on the part of PRSG and the fruitless expiry of a reasonable grace period (unless a special regulation has been agreed in this regard). Such withdrawal must be asserted by sending a registered letter to PRSG's company headquarters.

    2. Without prejudice to their other rights, PRSG is entitled to withdraw from the contract if

      1. the execution of the service, or beginning of the continuation of the service, is impossible or further delayed despite setting a reasonable grace period, due to reasons for which Client is responsible;

      2. doubts have arisen regarding Client's ability to pay, and Client fails to make a prepayment or provide adequate security before performance, despite PRSG's request to do so;

      3. Client defaults (even partially) in due payments despite being warned in writing or in electronic form, and threatened with contract termination, and despite the setting of a grace period of fourteen days;

      4. Client has applied for an out-of-court settlement, or settlement, bankruptcy or preliminary proceedings or total execution have been initiated or approved regarding Client's assets, or the initiation of such proceedings has been rejected due to lack of assets to cover costs;

      5. Client loses his legal or contractual capacity and submits no declaration of liability for his legal representative (trustee, etc.);

    3. In the event of withdrawal, services or partial services that have already been rendered must be invoiced and paid for according to the contract, without prejudice to PRSG's claim for damage compensation, including pre-trial costs.

    4. PRSG's claim to the entire agreed remuneration will not be affected by any cases of immediate contract termination for grounds attributable to Client's sphere of responsibility, even if contractual services were left incomplete because of the withdrawal. § 1168 ABGB (Austrian Civil Code) will not apply. If Client justifiably withdraws, they shall pay PRSG for rendered services.

  9. Remuneration

    1. The prices are listed in the contract or order in euros, unless otherwise expressly agreed. Unless otherwise expressly agreed in the order, the prices listed in the order do not include VAT or any shipping costs.

    2. The prices are based on the offer. PRSG services are based on the current service rates, whose tariffs can be requested from PRSG by Client.

    3. Besides the prices, Client shall bear the ancillary costs related to the service (e.g., travel costs, expenses for postal or telecommunication services, translations, notarial costs, etc.) and the legal VAT applicable at the time the service was rendered.

    4. PRSG is entitled to alter the agreed price within reason if changes arise before or during order execution because the information and documents Client provided were faulty, or if Client desired other changes.

    5. PRSG is entitled to demand a reasonable prepayment when the contract is concluded. Interest for this will not be compensated.

    6. If partial invoices are sent, the indicated partial payments will be due when such invoices are received. This also applies to invoiced amounts beyond the original contractual amount that are incurred through subsequent deliveries or other agreements, regardless of the payment conditions agreed for the main delivery.

    7. Client is entitled to offset payments to PRSG only against warranty claims or other counterclaims have been finally determined. Otherwise, Client is not entitled to retain payments or offset them due to warranty claims or other counterclaims.

    8. Invoices are due immediately on the invoice date. They must be paid in full, with no deductions. If they are not paid, Client is in default, with no further warning regarding the due payments being necessary. Rebates and discounts will not be granted.

    9. A payment is considered to have been made on the date when PRSG has access to it.

    10. In the event of payment default, PRSG is entitled to declare all outstanding claims from this or other transactions as due, and for these amounts may invoice the following, beginning on the due dates: dunning expenses amounting to 40 EUR; default interest in the amount of the legal default interest rate starting on the default date; and the legal VAT, unless PRSG can give evidence of costs beyond these amounts. In any case, PRSG is entitled to invoice for pre-trial costs—especially dunning costs and legal fees—provided they are necessary for expedient processing and recovery. PRSG reserves the right to assert further claims due to default in payment.

  10. Maintenance of Secrecy

    1. The additional non-disclosure agreement made between the Parties will apply.

    2. PRSG shall maintain secrecy regarding all information provided by Client.

    3. PRSG shall also keep their planning activities a secret, if and to the extent that Client has a legitimate interest in such discretion. For a time period of up to six months after the order has been executed, PRSG is entitled to publish the work forming the subject of the contract, in full or in part—by using reference links, for example—unless otherwise agreed.

    4. PRSG shall treat as confidential any documents, data from data storage devices or oral information they receive from third parties. They shall not transmit such information or documents, nor use them for purposes other than those allowed within the framework of the business relationship in question, or for commercial purposes.

  11. Industrial property rights and copyright

    1. All exploitation rights which arise in relation to PRSG's rendering of contractual services will be transferred to Client as soon as the entire agreed remuneration has been paid.

    2. If PRSG manufactures a product based on design details, drawings, models, other specifications, or documentation from Client, Client shall indemnify and hold harmless PRSG if any protective rights are breached.

    3. PRSG is entitled—and Client is obliged—to specify the name (both company name and business name) of PRSG in all publications and announcements regarding the respective contractual services.

  12. Legal bases, place of performance, place of jurisdiction

    1. The Parties expressly waive their rights to contest the contract due to error or laesio enormi.

    2. Neither Party is entitled to represent the other legally.

    3. The place of performance for all services is the registered office of PRSG.

    4. The court having jurisdiction ratione materiae at the registered office of PRSG is agreed as the exclusive place of jurisdiction for all legal disputes arising from existing contracts with PRSG. Client shall be subject to domestic jurisdiction. German law shall apply, under exclusion of the conflict of law rules. The application of the United Nations Convention on Contracts for the International Sale of Goods (CISG) is excluded.

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