General Terms and Conditions of ATRC Aurigon Toxicological Research Center Ltd
These terms of business are valid from 1st of January 2015. They replace all previous versions.
1. Scope of Validity
(1) The terms and conditions herein shall apply to all services and offers from ATRC Aurigon Toxicological Research Center Ltd (hereafter named “ATRC”).The terms and conditions according to the § 6:77 sect. 1 Nr. 5 from 2013 are an integral part of all contracts that are concluded between ATRC and our contract partners (hereafter named “PARTNER”) for our services. This is valid for orders confirmed by telephone, fax or email.
(2) Should a Master Service Agreement for preclinical development of a medicinal substance or a galenics preparation be concluded with PARTNER or a cooperation partner, the conditions in the master service agreement prevail when the conditions differ from those in these general terms and conditions. The validity of all other points in the general terms and conditions remain unchanged.
(3) Specific business terms and conditions that differ from these general terms and conditions of business agreed upon with PARTNER or a third party will remain unbinding unless they are specifically agreed upon in writing. A specific acknowledgement of other general terms and conditions of business is especially not given when another document is referred to when it contains or refers to the general terms and conditions of PARTNER or of a third party.
(4) These terms and conditions apply to all future business relations with PARTNER, as well as when they are not separately agreed upon. They replace any previous general terms and conditions that were in place with PARTNER.
2. Object of Agreement, Termination
(1) The subject matter of the development projects and the exact scope of the services to be provided by or to ATRC are determined in the confirmation of order, descriptions of services, experimental plans, trial plans or study plans.
(2) Before the execution of the services agreed upon, the document(s) mentioned in §2 point (1), must be confirmed in writing to ATRC and by a person authorised from PARTNER, vis- à-vis ATRC.
(3) An extraordinary termination of the contract due to important breach of duty is reserved. Precondition for the legitimacy of the termination is that the party having caused the damages be entitled to a reasonable time period to discontinue the violation of the contract, or to reverse the consequences thereof. This does not apply, when the violation of the contract is so serious that further maintenance of the contract would be at any rate unacceptable. The termination must be given in writing and state the reason. The date of termination will be the fifth day after dispatch of termination by post to the addressee.
(4) In the case where regulations of any provisions of these general terms of business exceed the term of the contract in time, these general terms and conditions remain valid, even after the term of the contract has been exceeded or expired. This specifically applies to § 8.
3. Delivery Times for Services
(1) Respites and time lines for the implementation of the services, including the final date and those for each phase are detailed in the pertaining confirmations of orders, descriptions of services, experimental plans, trial plans or study plans. They are unbinding and only approximate, unless binding respites and deadlines are explicitly agreed upon in writing, but material changes from the approximations must be agreed upon in writing.
(2) If circumstances beyond the reasonable control of ATRC, hinder the services or render the completion of services impossible, ATRC reserves the right to withdraw from the contract, when these circumstances are not of a temporary nature. When the circumstances are of a temporary nature, then the delivery time will be extended by the duration of these circumstances plus an adequate time period.
(3) If the acceptance of the services is unreasonable for PARTNER due to circumstances cited in §3 Para. 2, PARTNER may withdraw from the contract by immediate notification to ATRC in writing. In this case, damage claims against ATRC are excluded.
4. Payment
(1) The payment schedule for services will be made according to the regulations agreed upon by individual contracts, service descriptions or quotations.
(2) Unless nothing else is agreed - referred to the §4. Par. 1- , the §4 3-8 shall apply.
(3) Projects are divided as follows:
- First partial order is placement of order and/or starting of project activities (for example preparing study plan, ordering study materials, obtaining approvals etc.)
- Second partial order is end of in-life phase (exclusive eventual recovery-groups)
- Third partial order is delivery of draft report to prepare the final report (Draft report)
- Fourth partial order is delivery of the final report. (Final report) If no complain are submitted by PARTNER within 6 weeks after delivery of the draft report, the draft report will be finalized and a final report will be issued.
(4) Invoice will be issued after the performance of the partial order.
(5) In general the first partial order is 50 % of the project volume, the second partial order 30 % of the project volume, the third partial order 15 % of the project volume and the fourth partial order 5 % of the project volume.
(6) Payments are due within 14 days after receipt of invoice.
(7) Complaints and claims referring to invoices can be accepted within 2 weeks after receipt of invoice.
(8) Any changes in the study design or postponement of the study after order by the sponsor may generate additional costs that will be invoiced separately.
5. Property Rights
All material, data (such as study records, study protocols, study plans, reports), rights to project-related data and research results of ATRC shall remain the sole and untransferrable property of ATRC and shall not be transferred to anyone and shall be returned or destroyed at ATRC’s request. Material transferred by PARTNER shall remain the sole and untransferrable property of PARTNER and shall not be transferred to anyone and shall be returned or destroyed at PARTNER’s request.
All property rights related to the results of services will be transferred to PARTNER after PARTNER has fulfilled all payment obligations against ATRC.
6. Transport and Transfer of Perils
The risk for material or samples sent lies with PARTNER from the moment of hand- over to a courier or a transport company. This shall be the case regardless of which party pays the transport costs.
7. Warranty and Liability
(1) Contract for Work and Labour:
The services are only subjected to law of contract for work and labour if explicitly the creation of a product defined in advance is agreed upon.
(2) Liability Limitation:
In so far as hereinafter nothing else is specified, further claims of PARTNER are excluded, regardless of the legal grounds on which they are based. In particular, ATRC is not liable for PARTNER’s profit losses or other financial losses. This liability limitation for damages will not apply for contracts for work and labour if the damages are caused by the absence of a property that ATRC has guaranteed. If ATRC neglects a cardinal obligation or an essential contractual duty, the liability is limited to the obligation of replacement and the predictable damages. As far as legally permitted, ATRC takes no liability for damages for breach of the rules in § 9, in particular concerning accidents or damages to property or physical injury to PARTNER’s personnel during a visit to ATRC’s premises. The time periods stated in §7 1) and 2) are limitations; they are not valid for claims resulting from unlawful acts.
(3) PARTNER’s Liability:
Damages to ATRC’s premises, facilities, machines that are caused by the acts of the PARTNER’s employees will be repaired or replaced by PARTNER.
8. Confidentiality, access to data, information and documents
(1) PARTNER will forward to ATRC in a timely manner, all information and documents that are necessary for the implementation of the service. They are to be used exclusively for the service. At the end of the service, all tangible items must be returned to PARTNER.
(2) PARTNER and ATRC will maintain confidentiality over business or company secrets, technical information, in particular intentions, experiences, expertise and designs, as well as financial information such as calculation basis, costs and financial structures that will be entrusted to either party or that become known during the collaboration. They will be used exclusively for the implementation of the services and not communicated to any third party, nor used in PARTNER´s own interest. These obligations will survive for the following five (5) years after the end of the contractual period. These confidentiality obligations are also applicable according to the § 8:2 Civil Code when dealing with companies that are affiliates of PARTNER. These obligations do not apply to information:
a. which was demonstrably already known prior to signature of contract or placing the order, or which was generally known prior to signature of contract or placing the order, or which became generally known after signature of the contract through no breach of the confidentiality obligations by one of the contracting parties
b. which is demonstrably lawfully acquired from third parties who have a right to disclose such information;
c. which was already known to the contracting parties at the time of disclosure
(3) Data and research results obtained during the implementation of services shall be considered as business/work secrets, and handled as such. Data and research results obtained by ATRC which are obtained independently and have no reference to information or materials received from PARTNER or the project shall be handled as ATRC’s business/work secrets.
(4) Records, documents and data, which are required to remain with ATRC due to legal requirements or guidelines (such as Chemical law, GLP, ICH, EMA, OECD, ISO) are excluded from the rules stated in § 8 Para. 1.
9. Animal housing, work procedures in the establishments of ATRC
(1) PARTNER and his personnel recognize ATRC’s regulations concerning occupational health and safety, animal protection and hygiene. Within the establishments of ATRC, PARTNER’s personnel will follow the directives of ATRC’s personnel concerning dispositions for work procedures for animal protection or safety and hygiene.
(2) PARTNER’s personnel may not enter ATRC’s facilities or laboratories without the prior knowledge of the responsible representative of ATRC, nor leave the area agreed upon, once entered.
(3) Only PARTNER ’s personnel who have been previously identified to ATRC by name, and who have been briefed on ATRC’s rules and SOP’ s are allowed to enter the facilities or laboratories.
(4) When entering ATRC’s facilities or laboratories PARTNER ’s personnel is responsible and ensures, that all pertaining regulations are adhered to (e.g. regulations concerning occupational safety, genetic engineering law, radiation safety) for the protection of the personnel and facilities of both the PARTNER and ATRC.
(5) ATRC reserves the right to refuse the PARTNER’s personnel entry to the establishment if the rules in § 9 Para. 1 – 5 are not adhered to.
10. Other Provisions
(1) Place of fulfilment is Dunakeszi, unless nothing else is agreed upon. The place of jurisdiction is the Pest Megyei Biróság Hungarian law is applicable; the UN sales convention does not apply.
(2) In the event that any clause hereof should be invalid or non compliant to the law, this shall not affect the validity of the remaining terms. Instead of the invalid or non compliant clause the parties shall endeavour to find a clause that is compliant to the law, and which comes closest to the intention of the parties.
(3) For everything that is not regulated in these general terms and conditions the latest version of the Hungarian Civil Code (2013 évi V. törvény) shall apply.