General Terms and Conditions of PharmGenetix GmbH

1. Applicability and Acceptance

The General Terms and Conditions (“GTC“) shall become part of all contracts for transactions between PharmGenetix GmbH (“PhGx“), Porzellangasse 33a/III/19-20, 1090 Vienna, and its customers with immediate effect. The GTC shall be accepted by the customers by placing their orders, unless a customer expressly objects to application of the same when placing an order. The GTC shall apply throughout the duration of the business relationship. Any terms and conditions of the customer’s conflicting with or deviating from these GTC shall become part of the contract only if PhGx agrees to applicability of the same in writing. This shall also apply in the case that PhGx renders its service unconditionally even though it is aware of conflicting or deviating regulations.

2. Customer; Placing orders; Accepting orders; Contractual relationship

a. Customer

For the purposes of these GTC “Customer” means the owner of the biospecimen (blood, secretion, tissue material, etc.).

b. Placing orders

For an order to be valid we require a signed statement of consent from the Customer, i.e. from the person whose biospecimen (e.g. secretions, blood and/or tissue) is to be analysed. The physician will take the biospecimen from the Customer and confirm by his/her signature that the biospecimen (e.g. secretions, blood and/or tissue) is the Customer’s and that he/she has taken the same from the Customer. Minor persons or persons who have been assigned a trustee cannot be accepted. In this case a statement of consent must be obtained from the parent or guardian or from the trustee.

The Customer can place orders only by means of an order form which he or she has duly completed together with the treating physician and the Customer shall be liable for accuracy and completeness of the details. Orders not fulfilling these formal requirements will not be accepted or processed.

c. Accepting orders

All orders will be checked for their completeness and feasibility upon receipt. After the check an order will either be accepted or rejected. An acknowledgement of receipt will not necessarily be followed by an acceptance of the order.

Orders will be accepted either by letter or implicitly by execution. If an order is rejected following a check, the Customer will be informed thereof immediately.

 

d. Contractual relationship

The contractual relationship shall be based on the order which has been specified by the Customer jointly with the physician plus the patient information leaflet, the statement of consent, an excerpt from the Austrian Genetic Engineering Act [Gentechnikgesetz – “GTG”], the Data Protection Agreement and these GTC.

The Customer will become PhGx’s contracting party, provided that they are themselves capable of understanding their actions and of acting accordingly (diskretions- und dispositionsfähig). For all other Customers (e.g. minors, persons having a trustee, etc.) their legal representatives (parent or guardian, trustee, etc.) will become the contracting party.

The contractual relationship will come into existence by receipt of the order and the biospecimen by the relevant PhGx partner laboratory and acceptance of the order by PhGx.

“PhGx Partner Laboratories” means certified laboratories that fulfil all requirements for Good Laboratory Practice (“GLP“) and possess all necessary accreditation from the relevant national ministries and/or agencies (drug agency, etc.). Austrian orders will primarily be processed by PhGx’s own laboratory in Niederalm-Anif, Salzburg.

e. Liability for intended use

PhGx assumes no liability for any purpose which the Customer wishes to achieve by means of the report. PhGx shall not be liable either for any disadvantages suffered or damages incurred in the event that the Customer is not the person mentioned in the relevant orders.

As to the merits the contractual relationship will exhaustively be limited by the Customer’s order. PhGx is not obliged to conduct tests other than those requested in the order. Subsequent requests for analyses regarding an order which already exists or has already been concluded will be treated as a new order. If the Customer has agreed to his/her biospecimen being retained, no other taking of a specimen will be necessary.

3. Statement of Consent

By signing the Statement of Consent the Customer confirms that he/she agrees that a biological sample (secretions, blood and/or tissue) will be taken and that any pharmacogenetically (“PGx”) relevant, genetic and metabolic changes will be analysed.

In addition, by signing the Statement of Consent the Customer confirms that the following points were explained to him/her by the treating physician and that he/she has understood the same:

  • the analyses/tests have been specifically designed for PGx-relevant, genetic and metabolic changes;
  • the analysis/analyses/test(s) to be conducted in no way guarantee the Customer’s health or that of his/her family members;
  • a positive test result may be an indication of a changed effect of medication; other tests may be necessary to support the diagnosis;
  • despite a negative test result there may be a PGx-relevant mutation/metabolic condition;
  • due to technical limitations of the procedures used and incomplete knowledge of the underlying genes and of the function of their products it may not be possible to prove certain changes in the DNA sequence/metabolic analytes which may cause/explain a changed response to medication;
  • situations may occur where it is not possible to interpret test results; in rare cases test results may also indicate conditions or predispositions that are not pharmacogenetically relevant;
  • the tests mostly reveal changes; the chosen testing procedures identify changes (mutations) in the DNA due to missing, additionally inserted and/or changed nucleotides; biochemical tests are used to identify gene products and/or their functional analytes;
  • most of the tests used are highly specific and sensitive;
  • if no direct test can be conducted, a so-called linkage analysis may be used. That procedure is much less specific but is able to clarify potential genetic links.
  • due to technical limitations that procedure may not deliver usable results;
  • the accuracy of the procedures used depends on the exactness of the information provided about the family history/genealogy;
  • the procedures used may show a biological genealogy that is different (from the one stated in the medical history), i.e. a non-biological mother/father;
  • the tests used are state of the art but faulty results may occur despite the use of complex and highly sophisticated procedures;
  • due to the complexity of the analysis/testing procedures used and the possible consequences results of analyses or tests may only be delivered and explained by a physician;
  • participation in the analyses/tests to be conducted is absolutely voluntary;
  • unless otherwise instructed by the Customer, PhGx will retain material which has not been used (secretions, blood and/or tissue) after the testing procedure and use it for other analyses, tests or anonymised clinical studies.
  • All information on PhGx is available to Customers via the online portal pharmgenetix.com.

4. Execution of orders; Delivery periods

PhGx shall execute orders with conscientious care and in line with the state of the art. Delivery periods are only estimated periods or expected dates that are stated to the best of our knowledge and belief. PhGx is committed to processing all orders as quickly as possible; in the case of temporarily increased demand delays cannot be excluded. Accordingly, Customers have no claim to exact observance of delivery periods.

5. Handling of specimen material

Upon receipt by the relevant PhGx Partner Laboratory all incoming biospecimens shall pass into the possession of PhGx. Unless otherwise agreed with the Customer, PhGx shall be under no obligation to create retention samples but reserves the right to create any retention samples for its own purposes, provided that the Customer has not expressly prohibited PhGx from doing so in the order form.

The terms “purposes” or “research purposes” also include proficiency tests in line with international standards (IEC) and ring tests.

6. Right of rescission; Return of PhGx Box

There shall be a right of rescission only as long as the biospecimen has not arrived at the PhGx Partner Laboratory yet. The right of rescission granted herein shall expire not later than upon registration of the biospecimen in the relevant PhGx Partner Laboratory. Despite rescission PhGx shall have the right to invoice the services ordered from the time of registration of the biospecimen.

Due to strictest statutory hygiene regulations PhGx is not permitted to take back PhGx Boxes that have been dispatched.

7. Damage

PhGx assumes no liability for any damage to biospecimens or analyses/tests or reports caused by force majeure (e.g. acts of God or traffic disruptions), network or server failure, blackouts, line or transmission failure, viruses or disruption of the mail.

8. Confidentiality; Data protection

PhGx undertakes to treat as confidential all information concerning the Customer, the order and the biospecimen. This obligation shall survive termination of the contractual relationship. Consequently, information may be given to third parties who are not mentioned in the order by name only subject to the Customer’s express consent.

a. Confidentiality of the Customer’s data; Location of the Customer’s data

To PhGx individual medicine also means individual responsibility in handling health data. That is why all data, results of analyses as well as the report (all together the “Customer Data“) are owned by the Customer. He/She is the only one who has the power to dispose of the same and who can determine who may see the data.

PhGx collaborates with an Austrian data security specialist, namely the company “A-Trust Gesellschaft für Sicherheitssysteme im elektronischen Datenverkehr GmbH” (“A-Trust“, DPR: 1065181, FN [Business Register Number] 195738a) to warrant utmost electronic data security for the Customer. A-Trust is an Austrian company offering services in the field of secure communication in a digital and mobile world. It offers maximum security standards which comply with all EU Directives, Regulations and laws. The focus is on confidentiality, integrity and comfort as well as on generating secure digital signatures. A-Trust operates on the basis of the Austrian Signature Act [Signaturgesetz/SigG] and European Directives and is an accredited certification provider of reliable certificates in Austria and Liechtenstein. A-Trust is subject to regular audits by Rundfunk und Telekom Regulierungs-GmbH (RTR). For more information on A-Trust please go to: www.a-trust.at.

b. Account/Location of Customer Data

Customer Data will be anonymised in the relevant PhGx Partner Laboratory by means of coding. The medical report concerning the anonymised customer will be stored in an encrypted form in the relevant “e-Tresor” [e-vault] of the Customer on servers in the high-security computing centre of A-Trust in Austria. The “e-Tresor” is a web application which is certified according to ÖNORM [Austrian Standard] A 7700. For more information please go to the A-Trust website https://www.a-trust.at.

In the relevant PhGx Partner Laboratory all results of analyses are stored in an anonymised form only and there is no connection between the result of an analysis and the Customer.

E-vaults are managed and encrypted by A-Trust’s data protection system. Customer Data may only be decrypted and read by entering the identification code stated on the PhGx customer card and the TAN into the web portal (website) of PhGx.

Access to the Customer Data can be gained only via a TAN which the Customer will be sent to his/her mobile phone. Validity of the TAN will be limited in time and restricted to one use only. After logout the Customer Data will neither be stored on the physician’s computer nor with PhGx but only in the e-vault of the Customer concerned.

To inspect the Customer Data again the Customer must ask for a new TAN, which again will only be sent to the Customer.

By deleting the Customer’s profile from PhGx’s portal the Customer Data in the e-vault will not be deleted automatically. To delete Customer Data from the Customer’s e-vault the Customer must contact A-Trust himself/herself. As PhGx is not the owner of the Customer’s accounts with A-Trust and because they belong to the Customers themselves, PhGx cannot ask for deletion of all data.

Even though by using the services of A-Trust PhGx has engaged an expert in data security, PhGx cannot exclude that, in particular in the case of electronic transmission of data, unauthorised third parties will gain unlawful access to Customer Data and therefore assumes no liability for any data leaks of the e-vault.

c. Data protection

The Customer agrees that PhGx stores and processes personal data of the Customer’s in a machine-readable form and uses the company HubSpot, Inc. to facilitate the process of ordering, contacting Customers and facilitating downloads of information material. Use of such data and processing of the same is subject to strict compliance with the Austrian Data Protection Act as amended from time to time.

 

PhGx may anonymise the data obtained from execution of orders in line with international standards (IEC), for ring tests and for its own proficiency tests.

Personal and sensitive (health) data which you enter into the order form when visiting your physician will exclusively be used for analysis in the relevant PhGx Partner Laboratory and is subject to the physician’s duty to maintain secrecy. Such data will not be transmitted to PhGx at any time and will therefore never be stored by PhGx.

The data protection policy (www.pharmgenetix.com/datenschutz) regulates collection, preparation, use as well as deletion of data. If you use our website, our blogs or our registration service, you agree to the data protection policy.

 

9. Terms of payment; Late payment

 

The statutory value added tax applicable at the time of conclusion of the contract will be added to all prices stated. If regular services are being owed, the VAT rate applicable at the time the relevant amount is due shall be decisive.

The due date shall be the date agreed from time to time and shall be within 10 days of invoicing. Payments shall be made when due to an account advised by PhGx without deductions.

Even if the Customer has instructed otherwise, PhGx may first of all set off the Customer’s payments against his/her oldest debt. If costs and interest have accrued already, PhGx shall be entitled to first of all use the payment to cover the costs, then the interest and finally the principal payment.

Claims may be offset against counterclaims of the Customer and payments may be withheld only if the counterclaim has been recognised by PhGx or ascertained by a court in a non-appealable manner; this shall not affect a statutory right of reduction that may exist. Under this contractual relationship the Customer may not claim any rights of retention under other contractual relationships with PhGx.

PhGx is entitled to refuse to accept bills of exchange or cheques. Cheques or bills of exchange shall only be accepted on account of payment. Discount or bill charges shall be borne by the Customer and shall be due immediately. Services becoming necessary because of incomplete or incorrect information provided by the Customer and any resulting costs of special services shall be borne by the Customer.

For express orders or special orders we will charge the surcharges for the extra work necessary which we have advised beforehand.

To the extent that the list of prices and services provides for monthly billing the calendar months will be the relevant measure of time.

PhGx is entitled to assign trade receivables for financing purposes.

In the case of late payment PhGx is entitled to claim interest of 9.2 percentage points above the applicable base interest rate of the European Central Bank for entrepreneurs and of at least 5 percentage points above the applicable base interest rate of the European Central Bank plus the applicable statutory VAT for consumers. Any interest accrued shall be due immediately. Claiming of other damages shall remain unaffected thereby.

If the Customer is late in paying or if there are concrete indications of the Customer’s imminent insolvency, PhGx shall be entitled to discontinue work on all of the Customer’s orders. PhGx may demand immediate advance payment of all receivables, including bills of exchange and amounts for which it has granted a respite, or ask for appropriate collateral security.

In the case of a delay in acceptance the risk of incidental loss or accidental deterioration shall pass to the Customer.

 

10. Reservation of title

Despite delivery to the Customer PhGx shall reserve title until the service has been fully paid for. Services under the contract shall remain the property of PhGx until all claims under this contract and the entire business relationship with the Customer, including future ones, have been settled.

11. Bearing of risk

PhGx shall not bear the risk of loss of mail. From receipt of the biospecimen by the relevant PhGx Partner Laboratory the same shall be liable for loss of that specimen.

If, after acceptance of the order, the biospecimen turns out to be unusable, PhGx shall be released from execution of the order. If the fact that the specimen is unusable is due to reasons for which PhGx is not responsible (e.g. climatic impacts or other damage during transport, improper shipping by the Customer/physician, wrong name of specimen, insufficient quantity), PhGx shall be entitled to charge services that have already been rendered according to the actual costs incurred or work done (including return shipping, disposal, etc.).

Upon proper delivery of the report including analysis results and an optional PhGx customer card to a carrier (courier, Post AG, etc.) the risk shall pass to the Customer. After that time PhGx shall not be liable, in particular not for the risk of delay, loss or deterioration.

12. Liability

PhGx shall only be liable for gross negligence or wilful intent and for the fact that material contractual duties possess properties that have been warranted in detail. Liability for slight negligence shall be excluded.

The Customer shall be liable for accuracy and completeness of the information given to PhGx.

PhGx shall not be liable for any consequential damage based on whatever legal ground, i.e. damage that has occurred other than to the subject matter of the contract itself.

a. Medication check disclaimer

PhGx assumes no liability and does not warrant that the information provided in the medication check is up to date, accurate or complete. Liability claims against PhGx that are based on damage of a tangible or intangible nature caused by use of or failure to use information offered and/or by use of faulty or incomplete information shall be excluded as a matter of principle, unless there is wilful or grossly negligent fault on the part of PhGx that can be proved.

The medication check does in no case replace the experience or knowledge of the prescribing physician and does not serve the purpose of diagnosing or setting up a therapy plan. Dispensing or prescribing medication or an agent requires the most careful clinical monitoring, independent of the information gained from the medication check.

PhGx expressly reserves the right to change, amend or delete the entire or parts of the medication check without separate notice or to discontinue publication temporarily or for good.

b. Pocket Guide disclaimer

PhGx assumes no liability and does not warrant that the information provided in the Pocket Guide is up to date, accurate or complete. Liability claims against PhGx that are based on damage of a tangible or intangible nature caused by use of or failure to use information offered and/or by use of faulty or incomplete information shall be excluded as a matter of principle, unless there is wilful or grossly negligent fault on the part of PhGx that can be proved.

The Pocket Guide is merely a source of information for treating physicians and does not replace the experience or knowledge of the prescribing physician. The Pocket Guide does not serve the purpose of diagnosing or setting up a therapy plan. Dispensing or prescribing medication or an agent requires the most careful clinical monitoring, independent of the information contained in the Pocket Guide.

PhGx expressly reserves the right to change, amend or delete the entire or parts of the Pocket Guide without separate notice or to discontinue publication temporarily or for good.

13. References and links

Direct or indirect references to academic writing or other sources of information (Austria Codex, manufacturers’ information, links to webpages of PhGx partners, etc.) are beyond the area of responsibility of PhGx and PhGx assumes no liability for the fact that such information is up to date, accurate or complete.

14. Copyright

PhGx is committed to observing the copyrights to pictures, graphs, audio documents, video sequences and texts used in all publications, to using pictures, graphs, audio documents, video sequences and texts created by PhGx itself or to making use of licence-free graphs, audio documents, video sequences and texts.

All trademarks mentioned in PhGx publications that may be proprietary to third parties are without limitation subject to the provisions of the copyright law applicable from time to time and to the ownership rights of the authors/owners registered from time to time.

PhGx alone holds the copyright to contents produced by PhGx (graphs, audio documents, texts, video sequences, etc.). Any reproduction or use of contents (graphs, audio documents, video sequences, texts, etc.) in other electronic or printed publications shall be permitted only subject to PhGx’s express approval and shall be subject to legal action.

15. Severability clause

If any provision of these GTC is or becomes ineffective or is incomplete, this shall not automatically affect the validity of the remaining provisions. The parties shall cooperate in order to find an agreement which comes as close as possible to the intended provisions.

16. Online dispute resolution

New online dispute resolution pursuant to Art. 14(1) of the ODR Regulation: In future the European Commission will provide a platform for online dispute resolution, which will be available at http://ec.europa.eu/consumers/odr/ .

17. Place of performance; Place of jurisdiction

The place of performance for all contractual services shall be the registered office of the treating physician. In the case of disputes between the parties Austrian law shall apply exclusively and the conflict of laws rules shall be excluded.

For entrepreneurs (as defined by Section 1 of the Austrian Business Code [Unternehmensgesetzbuch/ UGB] and foreign Customers the legal venue shall be the court in Vienna having jurisdiction over the subject matter. For Customers as defined by the Austrian Consumer Protection Act [Konsumentenschutzgesetz – KSchG] the legal venue shall be the court at the Customer’s domicile having jurisdiction over the subject matter.

18. Information pursuant to the duty to provide information as defined in Section 5 E-Commerce Act [E-Commerce-Gesetz/ECG]

Company name: PharmGenetix GmbH

Registered office: Porzellangasse 33a/III/19-20, 1090 Vienna, Austria

Phone: +43 (0) 50 10 15

Fax: +43 (0) 50 10 15 – 50

Information, data requests and complaints to:

Web:    http://www.pharmgenetix.com

Email:  office@pharmgenetix.com

Legal form: GmbH [Austrian limited liability company]

FN [Business Register Number]: 433838y, Commercial Court Vienna

VAT No.: ATU69820269

Description of business (by the business itself): Innovation transfer of scientific research results from medicine and medical technology via market analysis, market and product development.

Competent authority according to the ECG (E-Commerce Act): Municipal District Office for the 9th  District

Media owner (editor): PharmGenetix GmbH, Porzellangasse 33 a/III/19-20, 1090 Vienna