Updated 13 March 2025
1. Background
These General Terms and Conditions cover all the Services provided by OncoDNA except if mutually agreed by the Parties.
2. Definitions
In these OncoDNA General Terms and Conditions, the terms starting by a capital letter will have the meaning specified below or elsewhere in the document:
1. “Account” means the web account that the Customer or the Patient needs to create on the related platform to access the Services.
2. "Applicable Laws" shall mean all applicable laws, enactments, regulations, regulatory policies, regulatory guidelines, industry codes, regulatory permits, in each case which are in force from time to time in any jurisdiction where these Terms and Conditions apply.
3. “Customer” means either the hospital, laboratory, Medical Doctor, Official Distributor or Interested Third Party.
4. "Data Protection Laws" means
a) The General Data Protection Regulation 2016/679 adopted on 27 April 2016 and enforceable since 25 May 2018 and;
b) all other relevant existing or new applicable laws relating to or impacting on the processing of information of a living person and privacy.
5. "Feedback" means feedback provided by the Customer under and in accordance with the provisions of the Agreement.
6. "Intellectual Property Rights" means all rights in models, designs, trademarks, copyrights, database rights, rights on know-how, patents, supplementary protection certificates and other intellectual property rights (whether registered or unregistered), as well as all applications and the right to apply for such rights (and renewals or extensions of such rights), and all other rights aiming for a protection or effect like one of the above-mentioned rights throughout the world.
7. “Official Distributor” means the individual, company, corporation, organization, or other legal entity that resells and distributes the Services, for the account of OncoDNA, in the framework of a distribution agreement entered into with OncoDNA (the “Distribution Agreement”).
8. “Information and/or Shipment box” means the box the Medical Doctor must use to ship Specimens to OncoDNA.
9. “Informed Consent Form” or “ICF” means the informed consent form to be filled out and signed or otherwise consented to by the Patient prior to the performance of the Test.
10. “Interested Third Party” means any individual that is not a hospital, laboratory, Medical Doctor or an Official Distributor.
11. "Liquid Biopsy" shall mean the blood, urine and/or saliva sample procured from Patients.
12. “Medical Doctor” means a physician specialized or not in the diagnosis and treatment of cancer.
13. “OncoDNA” means the limited liability company OncoDNA, incorporated under Belgian law, having its registered office at Avenue Louis Breguet, 1, 6041 Gosselies, Belgium, registered with the Crossroads bank for enterprises under company number 0501.631.837.
14. "OncoDNA Prior IP" shall have the meaning given to that term in clause 9 of these Terms and Conditions.
15. “OncoSHARE platform” available at the address www.oncoshare.com, which is an online platform where Medical Doctors, Patients and Interested Third Parties can order the Tests, seek, collect and share information on oncology. OncoSHARE provide a link between all these parties. Through OncoSHARE, sample Shipment box requests, Test ordering, process follow-up, data analysis and data sharing is facilitated. OncoSHARE also provides access to the results of Test Services to Patients, registered healthcare professionals. Medical Doctors access to the platform allows them to share their experiences, expertise and anonymous data with the aim of gathering more medical opinions and to get a comprehensive molecular profile of tumors that they have encountered to improve treatment prescription.
16. "Output Data" means the information obtained from an analysis delivered based upon the interpretation of Raw Data and OncoDNA proprietary know-how and technology.
17. “Patient” means for the purposes of these Terms and Conditions the individual diagnosed with a tumor.
18. “Price” means the price payable, according to the given situation, for the OncoKDM Services and/or the Test Services.
19. “Privacy Policy” means the OncoSHARE Privacy Policy available at https://login.oncokdm.com/static/privacy_policy.pdf which constitutes an integral part of these Terms and Conditions.
20. "Raw Data" means different types or formats of genetic, biological, or clinical datasets (genomic, molecular pathology, IHC, tests results and clinical data, in different digital formats).
21. “Report” or "Theranostic Report" means the theranostic report drafted in English and resulting from the performance of (i) one of the Tests, or (ii) from the OncoKDM Service.
22. “Request” means the request made by the Medical Doctor directly, or through an Official Distributor, on the OncoSHARE platform for a Test.
23. “Result” means any results or output resulting from the implementation of the Services, including but not limited to any data, information, creative ideas, inventions, know-how, discoveries, developments, whether patentable or not, discovered, conceived or reduced to practice during and in connection with any of the Services and its use in the treatment of Patients in connection with these Terms and Conditions. For the avoidance of doubt, the Results include, without limitation, sequencing raw files and sequencing data resulting from the Tests, Theranostic Reports, Feedback and any use thereof by OncoDNA.
24. “Services” means including but not limited to:
a. “OncoDEEP Test”: which aims at analyzing the molecular profile of the Patient’s tumor from a tumor tissue. OncoDNA integrates the results from high throughput DNA and RNA sequencing and, if ordered, molecular pathology analyses (such as immunohistochemistry tests) in order to get the most complete molecular characterization possible of the tumor tissue. Those genetic findings are then integrated with data present in the most recent scientific literature.
b. “OncoFOLLOW Test”: which is the personalized solution for the monitoring of biomarkers specific to each Patient’s tumor. This Test makes it possible to monitor the Patient’s cancer by analyzing the circulating tumor DNA (ctDNA) from blood samples. It will give the Medical Doctor indicators of his/her Patient’s response to ongoing treatment.
c. "OncoSELECT Test": which (i) focuses on four cancer types (NSCLC, colorectal, breast and prostate) where targeted therapies associated with biomarkers of sensitivity or resistance are well published and accepted, (ii) analyzes and monitors ctDNA from blood samples and (iii) gives the Medical Doctor indicators of his/her Patient’s response to ongoing treatment.
d. “OncoDEEP KIT”: which provides the End-User with the reagents to perform the NGS part of the OncoDEEP Test.
e. “OncoSELECT KIT ” which provides the End-User with the reagents to perform the NGS part of the OncoSELECT Test.
f. "OncoKDM Service" (Onco Knowledge Drive Medicine Services) and related services available at the address login.oncokdm.com, which is an online platform intended for Healthcare Professionals and that allows (i) the integration of any type of data's, (ii) the structuration of them, (iii) the extraction of useful clinical information and (iv) the delivery of a Report organizing and personalizing Output Data.
25. "Solid Biopsy" shall mean the solid biopsy consisting of a small piece of the primary tumor or of metastasis, inserted in FFPE block and/or slides.
26. “Specimen” means any kind of Patient’s samples obtained from Solid and/or Liquid Biopsy.
27. "Staff Members" means any members and representatives of each Party.
28. "Support" shall mean the free upstream and downstream scientific support provided by OncoDNA under this Agreement in order to guide the Medical Doctor in choosing the most adapted OncoDNA Service for their Patients and to provide them with explanations and guidance in relation to the Theranostic Report.
29. “Terms and Conditions” means these OncoDNA fGeneral Terms and Conditions as may be amended and/or updated by OncoDNA from time to time.
30. “Tests” means the laboratory testing Services provided by OncoDNA, including without limitation sequencing and IHC tests for treatment recommendations and cancer monitoring. More particularly, the Tests include (all or part of) the “OncoDEEP Test”, the “OncoFOLLOW Test” and the "OncoSELECT Test. For further information on these Tests, please consult www.oncodna.com.
31. "Third Party" shall mean each person which is not a party to this Agreement.
32. "Work Product" shall have the meaning given to that term in clause 9 of the Terms and Conditions.
3. Scope of application
3.1. Subject to any other specific written arrangement with OncoDNA, these Terms and Conditions shall govern the Services provided by or on behalf of OncoDNA to any Customer.
3.2. OncoDNA and Customer are together referred to in these Terms and Conditions as the “Parties” and individually as a “Party”.
3.3. By accepting these Terms and Conditions, the Customer acknowledges and agrees that it enters into an agreement with OncoDNA with respect to the provision of the Services by or on behalf of OncoDNA, such agreement being made of these Terms and Conditions, the Privacy Policy, the ICF (with respect to Patients only) and if applicable, the Distribution Agreement (with respect to Official Distributors only), as applicable (the “Agreement”).
3.4. These Terms and Conditions shall apply in place of and prevail over any terms or conditions or warranties contained or referred to in any document provided by the Customer to OncoDNA.
3.5. Except as provided otherwise in these Terms and Conditions, the creation by the Customer of an Account on OncoSHARE and/or OncoKDM platform shall be deemed to constitute unequivocal acceptance of these Terms and Conditions.
3.6. Any Services provided by OncoDNA are subject to these Terms and Conditions, the Privacy Policy and the ICF, as applicable. OncoDNA expressly reserves the right to modify these Terms and Conditions, including but not limited to the Privacy Policy. The Customer hereby undertakes to review periodically the Terms and Conditions as published and accessible on the Website.
3.7. OncoDNA will take the Customer’s legitimate interests into consideration when amending these Terms and Conditions. The Customer will be notified in case of modification of these Terms and Conditions and will then have to accept these modifications to keep on using the Services.
3.8. The provisions of these Terms and Conditions are severable. The invalidity, unlawfulness or unenforceability of any term or provisions thereof shall in no way affect the validity, lawfulness or enforceability of any other terms or provisions of these Terms and Conditions.
4.1. To access the Services, the Patient and/or the Customer shall create an Account on OncoSHARE or OncoKDM The Patient and/or the Customer agrees to provide such contact details and other related information as may be requested by OncoDNA for the purpose of creating the Account and other registration process (thereafter the “Account Data”). The Patient and/or the Customer represents and warrants that the Account Data it provides to OncoDNA is true and accurate. OncoDNA may verify the accuracy of the Account Data, as it deems appropriate. OncoDNA may request the Patient and/or the Customer to provide further data as reasonably necessary for authentication purposes. The Patient and/or the Customer shall maintain and update the Account Data to keep it current, complete and accurate. The Patient and/or the Customer shall be solely liable if the Patient and/or the Customer allow any third party to use the Account Data.
4.2. The creation of an Account is free. Without prejudice to the foregoing, the Patient and/or the Customer acknowledges and agrees that OncoDNA shall provide the Test Services against the payment of the Price.
4.3. Request of a Test Service:
4.3.1. With respect to Services, the Medical Doctor or the Customer may, directly or through an Official Distributor, place a Request for Information and/or shipment box through OncoSHARE platform. The Medical Doctor or the Customer undertakes to use such requested Information and/or shipment bit exclusively in connection with the shipment of Specimens to OncoDNA.
4.3.2. The shipment box will then be sent to the Medical Doctor or to the Customer who shall exclusively use it to provide the appropriate Specimen to OncoDNA, in accordance with the instruction provided in the shipment box and/or otherwise by OncoDNA.
4.3.3. Title and ownership of the Information and/or shipment box shall remain at all times with OncoDNA. The Medical Doctor or to the Customer shall use pre-printed waybill and shipment bag included in the Information and/or shipment bit to ship Specimens to OncoDNA.
4.3.4. The Tests shall be performed after OncoDNA receives (a) the Request, the Specimen(s) and a related diagnosis or pathology report, a copy of the ICF duly completed and signed by the Patient; and (b) the payment of the Price.
4.4. Patient Informed Consent and Additional Authorization:
4.4.1. In accordance with Applicable Laws, the Patient’s informed consent is required to perform the Test(s) on the Patient’s Specimen(s) and for further secondary use (including the reuse of the pseudonymized remaining Specimen for scientific purposes such as the participation to clinical trials and/or for validation purposes of the Tests). The Medical Doctor or the Customer shall therefore place a Request for the Test Services after (i) having submitted and explained the ICF to his/her Patient and (ii) obtaining the completed and signed ICF by such Patient. No Test shall be undertaken prior to the receipt of a copy of the duly completed and signed ICF.
4.4.2. In the event that any license or authorization of any competent government or authority is required for the performance of the Test Services, the collection, carriage or handling of any Specimens to be sent to OncoDNA for the performance of the Tests (“Additional Authorization”), the Customer, the Medical Doctor and/or the Patient (as applicable) shall obtain the Additional Authorization at its and/or their own expense. Upon OncoDNA’s request, the Customer, the Medical Doctor and/or the Patient (as applicable) shall provide evidence of the same to OncoDNA. Failure to obtain any Additional Authorization shall not entitle the Customer, the Medical Doctor and/or the Patient to withhold or delay payment of the Price for Test Services already provided in good faith by OncoDNA. Any additional expenses or charges incurred by OncoDNA resulting from such failure shall be borne by the Customer, the Medical Doctor and/or the Patient (as applicable).
4.5. OncoDNA shall provide the Services in accordance with these Terms and Conditions. Regarding the Test Services, the Medical Doctor, the Customer or the Patient and the Official Distributor acknowledge and agree that the Tests may be subcontracted to OncoDNA’s then current service provider with respect thereto, i.e. BIO.be SA, having its registered offices at Avenue Georges Lemaitre 25, 6041 Charleroi, registered with the Crossroads bank for enterprises under company number 0861.738.595 (“BIO”) – or any other selected service provider, provided that when selecting said provider OncoDNA complies with Data Protection Laws. (In the case of BIO, the Tests shall be performed, on behalf of BIO, by BIO’s mother company, the Institute of Pathology and Genetics ASBL, having its registered offices at Avenue Georges Lemaitre 25, 6041 Charleroi, registered with the Crossroads bank for enterprises under company number 0408.333.871, namely the IPG). Unless otherwise provided under Data Protection Laws, OncoDNA may subcontract the provision of the Tests Services to any third party at its discretion and notwithstanding any representations made to the Customer that such work would be carried out at a specified laboratory.
4.6. As part of the Test Services, OncoDNA shall communicate to the Medical Doctor or to the Customer the Report drafted in English.
4.8. As part of the Services available to the Medical Doctor or the Customer and in accordance with the Privacy Policy, the latter may choose to disclose or share, through OncoSHARE platform, any generated Report in relation to his/her Patients, to (i) the relevant Patient (as may, in some cases, be mandatory under Applicable Law) and/or (ii) specialized Medical Doctors collaborating with OncoDNA (the “Expert Advisors”), for advising purposes or in case the Medical Doctor or the Customer has peculiar questions pertaining to such Expert Advisors’ specialties with respect to a Patient’s condition. In addition, the Medical Doctor may disclose anonymized Reports to other Medical Doctors registered with OncoSHARE platform, to discuss and exchange medical expertise/opinion about a specific case.
4.9. OncoDNA shall use its best efforts consistent with professional standards to carry out the Services and achieve their objectives.
4.10. Request for Kit Services
4.11. With respect to Kit Services, the Customer may, directly or through an Official Distributor, upload the Raw data on the OncoKDM platform after the approval of the Purchase Order.
4.12. As part of the Kit Services OncoDNA shall communicate through the Customer the Report drafted in English.
4.13. The Report can be consulted by the Customer on OncoKDM platform. The delivery times of the Report, if any, are indicative only, and delays shall under no circumstances give rise to any claims for compensation.
4.14. As part of the Services available to the Customer and in accordance with the Privacy Policy, the latter may choose to disclose or share, through OncoKDM platform, any generated Report in relation to his/her data.
4.15. OncoDNA shall use its best efforts consistent with professional standards to carry out the Services and achieve their objectives.
5. Customer Obligations:
5.1. The Medical Doctor and Patient shall not modify in any manner whatsoever the Reports, the Results or any disclaimers associated therewith.
5.2. Specific customer obligations for the Tests Services:
a) The Patient and/or the Customer shall not use the Account of another Patient and/or Customer without permission. The Patient and/or the Customer is solely responsible for the activity that occurs on its Account, and the Patient and/or the Customer must keep its Account password secure. OncoDNA encourages the Patient and/or the Customer to use “strong” passwords (passwords that use a combination of upper and lower case letters, numbers and symbols) for its Account. The Patient and/or the Customer must notify OncoDNA immediately of any breach of security or unauthorized use of its Account of which the Patient and/or the Customer becomes aware. OncoDNA will not be liable for any damage and/or loss caused by any unauthorized use of the Account which is due to the Patient’s and/or Customer’s negligence.
b) The Medical Doctor shall complete and submit the Request, on OncoSHARE platform directly or through an Official Distributor, and provide OncoDNA with undamaged Specimen in proper state, in accordance with policies and procedures specified by OncoDNA.
c) The Customer, Medical Doctor, Official Distributor and/or the Patient, as the case may be, shall notify OncoDNA in writing of any matter which is likely to materially affect the performance or delivery of the Test Services.
Kit Service:
5.3. The Parties acknowledge that the Customer generates and owns Raw Data and that the Customer needs OncoDNA’s OncoKDM Services (i) to integrate Raw Data, (ii) to deliver Output Data, and (iii) to produce OncoKDM Reports, presented via a customized OncoKDM platform powered by OncoDNA. The Customer is responsible for collecting the ‘Informed Consent Form’ signed by the patient, which includes authorizing OncoDNA to process the data resulting from the sequencing of his/her samples.
5.4. The Customer represents and warrants that it:
a. has all the necessary rights and authorities to enter into this Agreement and to perform the obligations herein contained. In addition, with respect to the Customer, the latter warrants that it has the legally required capacity, status and competence to request, interpret and use the Services;
b. obtained and maintains, where applicable, all government licenses, approvals and permissions necessary in connection with its obligations pursuant to the Agreement;
c. complies with all laws, rules, regulations and the like applicable to its activities.
5.5. The Customer acknowledges and understands that OncoDNA relies upon the Customer’s representations and warranties.
5.6. The Customer shall immediately inform OncoDNA of any reports of irregularities, complaints or other adverse information received by the Customer relating to the Services, including any Medical Doctor’s, Patient’s, Official Distributor’s and/or Interested Third Party’s use of the Services, the quality or the performance of Services. The Customer shall not take any action with regard thereto, without first obtaining instructions in writing from OncoDNA.
5.7. The Patient and/or the Customer shall not use the Services or allow the Services to be used for:
a) illegal activities of any form, including criminal acts;
b) any form of communication of an improper, obscene, indecent, libelous, defamatory, menacing, offensive, undesired or unsolicited nature or which causes annoyance, distress or needless anxiety, or is contrary to public order and/or public decency or any Applicable Laws, including concerning racial hatred;
c) deceptive, misleading, unethical or unlawful business practices, including but not limited to, disparagement of OncoDNA or the Services, and disparagement of any third party’s competitive products or services;
d) any activity which may violate the privacy or data protection rights of other users or third parties;
e) any unlawful and/or criminal dissemination of secret or confidential information;
f) distributing in purpose viruses or other malware or in any way disrupting communications or data storage or otherwise causing damage or destruction to the Services or restricting or impairing the use or capacity of the Services for other users or third parties, including by causing unnecessary overloading of the internet through large, unwarranted data traffic flows (flooding, spamming, etc.);
g) committing data theft or acquiring access to data or systems through the use of false keys, false codes and/or false properties or in any other illegal manner;
h) impeding, damaging or destroying in purpose the integrity of any data, system or program. The Patient and/or the Customer undertake to respect the Intellectual Property Rights (including without restriction, the copyrights, trademarks, patent rights and rights to databases) belonging to OncoDNA, other users of the Services and third parties. Without limiting the generality of Article 5.5., in the event that the Patient and/or the Customer becomes aware of any infringement through the Services, of (intellectual) property rights or other rights, the Patient and/or the Customer must alert OncoDNA immediately at the email address support@oncodna.com
6.1. Invoices may be contested within a maximum of ten (10) days of receipt. After this term, invoices are deemed to have been accepted by the customer. Except agreed otherwise by the Parties, the Customer shall pay all invoiced amounts due to OncoDNA within thirty (30) days from the date of OncoDNA's invoice.
6.2. All payments are made in euros.
6.3. The Customer shall pay interest on all late payments at the rate foreseen in the law of 2 August 2002 on combating late payment in commercial transactions. The Customer shall reimburse OncoDNA for all costs incurred in collecting any late payments that have not been disputed in good faith within the thirty (30) day payment period, including without limitation, costs of reasonable attorneys' fees.
6.4. In addition to all other remedies available under the Agreements contracted upon the Parties or at law, if the Customer fails to pay any amounts when due hereunder and such failure continues for fifteen (15) days following written notice thereof; or becomes insolvent, or any proceedings are commenced under any bankruptcy or similar laws for the Customer's reorganization or other debt adjustment; then OncoDNA shall be entitled to suspend the delivery of any Services and/or reject any of the Customer's future orders.
6.5. The Customer shall not withhold payment of any amounts due and payable by reason of any set-off of any claim or dispute with OncoDNA.
6.6. OncoDNA reserves the right to suspend or delay the provision of the Services as applicable, until complete payment of the Price or any other due amounts to OncoDNA under the Agreement.
7. Services related to the Tests:
a) By accepting these Terms and Conditions, by signing or otherwise consenting to the ICF and/or opening an Account, the Patient and/or the Customer acknowledges and agrees (i) that the Test Services constitute payable services and (ii) to pay the Price, plus VAT and any other applicable tax or duties, either indirectly to his/her Medical Doctor or an Official Distributor or directly to OncoDNA.
b) The Price for the Test Services shall be that effective at the time of the Request placed by the Medical Doctor, directly or through the intermediary of an Official Distributor, on OncoSHARE platform, and shall be exclusive of VAT and any other applicable tax or duties which shall be borne by the Patient and/or the Customer.
c) Subject to other instructions provided by OncoDNA, and unless expressly agreed otherwise, any payment shall be made by credit card or wire transfer, in accordance with the instructions provided on OncoSHARE platform.
d) In case the Medical Doctor or the Customer pays the Price to OncoDNA or an Official Distributor on his/her Patient’s behalf, such Price, plus VAT and any other applicable tax or duties, will be invoiced to such Patient.
e) No Guarantee of Reimbursement: OncoDNA makes no promises or guarantees that a healthcare provider, insurer or other third-party payor, whether private or governmental, will reimburse the Patient and/or the Customer for the cost of the Services.
8. Services related to OncoDEEP KIT:
The Price for the OncoDEEP KIT shall be as determined in the Agreement or the Schedules thereto or quotations.
9. Services related to OncoKDM:
a) The Price for the OncoKDM Service shall be as determined in the Agreement or the Schedules thereto or quotations.
b) No Guarantee of Reimbursement: OncoDNA makes no promises or guarantees that a healthcare provider, insurer or other third-party payor, whether private or governmental, will reimburse the Patient and/or the Customer for the cost of the Services.
10. Limitation of OncoDNA’s Liability and Warranties - Disclaimer
10.1. Except where expressly stated otherwise in these Terms and Conditions, all warranties, conditions, representations, obligations and liabilities on OncoDNA’s part, whether express or implied by statute or law, in connection with the Services are, to the fullest extent permitted by applicable law, excluded.
10.2. With respect to the payable Services , and notwithstanding anything else to the contrary contained in this Article or elsewhere in these Terms and Conditions, in no event shall OncoDNA’s total aggregate liability (including any of its subsidiaries or affiliates) to the Patient and/or the Medical Doctor and/or the Customer – whether in contract or in tort or however otherwise arising – including any direct damages and all liabilities, costs, and expenses incurred by OncoDNA (including any of its subsidiaries or affiliates) in performance of its indemnification obligations arising from this Agreement, exceed an amount corresponding to the aggregate amounts paid by or on behalf of the Patient and/or the Customer to OncoDNA under the Agreement during the period of twenty four(24) months immediately preceding the date of the occurrence of the event giving rise to liability.
10.3. Although OncoDNA attempts to provide accurate information with respect to the Services, OncoDNA (including any of its subsidiaries or affiliates) assumes no liability for the accuracy or completeness of the information provided except in the case of intentional or gross negligence by OncoDNA and/or by any of its subsidiaries or affiliates. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, THE SERVICES ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT, AND ONCODNA DISCLAIMS ANY AND ALL SUCH WARRANTIES. The Customer’s, Medical Doctor's, Patient's and/or Interested Third Party's use of the Services is at their own risk. OncoDNA (including any of its subsidiaries or affiliates) does not make any warranty as to the results that may be obtained from the use of the Services or the data obtained through the Services. ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES OR AFFILIATES) DOES NOT WARRANT THAT THE SERVICES WILL BE UNINTERRUPTED, TIMELY OR ERROR FREE. IN PARTICULAR, THEIR OPERATION MAY BE MOMENTARILY INTERRUPTED DUE TO MAINTENANCE, UPDATES OR TECHNICAL IMPROVEMENTS. FURTHERMORE, ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES OR AFFILIATES) MAY REFUSE WITHOUT INCURING ANY LIABILITY, TO PROVIDE THE SERVICES ON SPECIMENS THAT IT RECEIVES AND THAT DO NOT MEET ONCODNA’S REQUIREMENTS FOR THE PERFORMANCE OF THE TEST SERVICES. THIS LIMITATION AND EXCLUSION OF WARRANTIES SHALL SURVIVE TERMINATION OR EXPIRATION OF THE AGREEMENT, INCLUDING ONCODNA CEASING TO PROVIDE SERVICES TO CUSTOMER.
10.4. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES OR AFFILIATES) SHALL NOT BE LIABLE TO CUSTOMER, MEDICAL DOCTOR, PATIENT OR INTERESTED THIRD PARTY FOR ANY INDIRECT DAMAGES (INCLUDING LOST PROFITS, LOST REVENUE OR SALES, LOSS OF USE, DIMINUTION OF GOODWILL, BUSINESS INTERRUPTION OR THE LIKE) EVEN IF ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES OR AFFILIATES) WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
a. THE TEST PERFORMED FOR THE PROVISION OF THIS SERVICE IS A LABORATORY DEVELOPED TEST DESIGNED BY ONCODNA. IT HAS NOT BEEN CLEARED OR APPROVED BY THE US FOOD AND DRUG ADMINISTRATION (FDA). THE FDA DOES NOT REQUIRE THIS TEST TO GO THROUGH PREMARKET FDA REVIEW. THIS TEST IS USED FOR CLINICAL PURPOSES. IT SHOULD NOT BE REGARDED AS INVESTIGATIONAL OR FOR RESEARCH. THE CLINICAL DECISION SUPPORT TOOL USED FOR THE INTERPRETATION (TERTIARY ANALYSIS) IS A MEDICAL DEVICE SOFTWARE CE-MARKED AND ISO13485:2016 CERTIFIED BY SGS.
b. THIS REPORT HAS BEEN REVIEWED AND APPROVED BY THE QUALIFIED EXPERTS OF ONCODNA (PRIOR TO ITS FINAL VALIDATION BY THE HEALTHCARE PROFESSIONNALS WHEN APPLICABLE).
c. THE CONTENT OF THIS REPORT IS INTENDED FOR USE BY A MEDICAL DOCTOR. ALTHOUGH THIS REPORT CAN BE KEPT IN THE PATIENT’S MEDICAL FILE, THE REPORT DOES NOT CONSTITUTE AND IS NOT INTENDED TO REPLACE INDEPENDENT MEDICAL JUDGMENT AND ADVICE. THE INFORMATION AND DRUG RECOMMANDATIONS CONTAINED IN THE REPORT ARE INTENDED SOLELY FOR THE GENERAL INFORMATION OF THE MEDICAL DOCTOR. THE REPORT IS NOT TO BE USED “AS IS” FOR TREATMENT PURPOSES. THE INFORMATION PRESENTED IN THE REPORT IS NOT INTENDED TO REPLACE PROFESSIONAL MEDICAL CARE. THE INFORMATION CONTAINED IN THE REPORT IS NEITHER INTENDED TO DICTATE WHAT CONSTITUTES REASONABLE, APPROPRIATE OR BEST CARE FOR ANY GIVEN HEALTH ISSUE, NOR IS IT INTENDED TO BE USED AS A SUBSTITUTE FOR THE INDEPENDENT JUDGMENT OF THE MEDICAL DOCTOR FOR ANY GIVEN HEALTH ISSUE. THE REPORT MERELY CONSTITUTES PART OFTHE INFORMATION CONCERNING THE PATIENT’S CONDITION (SUCH AS PATIENT AND FAMILY HISTORY, PHYSICAL EXAMINATIONS, INFORMATION FROM OTHER DIAGNOSTIC TESTS, AND PATIENT PREFERENCES) TO ASSIST MEDICAL DOCTORS IN THE DETERMINATION OR ADAPTATION OF THE PATIENTS’ MEDICAL TREATMENT. TREATMENT DECISIONS REMAIN THE EXCLUSIVE RESPONSIBILITY OF THE MEDICAL DOCTOR. THE MEDICAL DOCTOR SOLELY AND EXCLUSIVELY DECIDES WHETHER (AND TO WHAT EXTENT) TO TAKE INTO CONSIDERATION THE REPORT WITH RESPECT TO HIS/HER PATIENT’S TREATMENT.
d. CONSEQUENTLY, ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES, AFFILIATES OR SUBCONTRACTOR) IS SOLELY RESPONSIBLE FOR THE PERFORMANCE OF THE BIOMARKER TEST AND FOR PROVIDING THE RESULTS OF SUCH TEST IN THE PRESENT REPORT BUT ASSUMES NO LIABILITY WHATSOEVER AS TO THE POSSIBLE CONSEQUENCES OF THE DECISION OF THE MEDICAL DOCTOR TO FOLLOW OR NOT THE (CONTENT OF) THIS REPORT. BY ACCEPTING THE TERMS AND CONDITIONS OF THIS SERVICE AND – WHERE APPLICABLE - BY SIGNING OR OTHERWISE CONSENTING TO THE INFORMED CONSENT FORM, THE CUSTOMER, THE MEDICAL DOCTOR AND PATIENT EXPRESSLY DECLARE AND ACKNOWLEDGE HAVING UNDERSTOOD AND AGREED TO ONCODNA’S LIMITED LIABILITY.
e. MOREOVER, ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES, AFFILIATES OR SUBCONTRACTOR) ASSUMES NO LIABILITY, EXCEPT IN CASE OF INTENTIONAL OR SERIOUS ERROR BY ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES, AFFILIATES OR SUBCONTRACTOR), AS TO THE DECISION OF:
- THE MEDICAL DOCTOR TO ORDER THE SERVICE WHILE IT IS NOT INDICATED OR RECOMMENDED FOR THE HEALTH ISSUE OF HIS/HER PATIENT.
- THE MEDICAL DOCTOR TO ORDER THE SERVICE FROM A SAMPLE THAT DOES NOT FULLY COMPLY WITH THE SPECIFICATIONS DEFINED TO ENSURE THE INFORMATION OF THE REPORT IS AS REPRESENTATIVE AS POSSIBLE OF THE PATIENT’S HEALTH ISSUE.
- THE CUSTOMER, THE MEDICAL DOCTOR AND PATIENT TO REQUEST A PRELIMINARY REPORT WHICH ONLY CONTAINS A PARTIAL INFORMATION. ONCODNA RESERVES THE RIGHT TO REFUSE TO PROVIDE A PRELIMINARY REPORT WHEN THE BENEFIT/RISK RATIO OF THE PARTIAL AND AVAILABLE INFORMATION PRESENTED IN THE REPORT IS NOT FAVOURABLE FOR THE PATIENT SAFETY.
f. THIS REPORT MAY INCLUDE INFORMATION ON GENETIC ANOMALIES LIKELY TO BE INHERITED. SHOULD AN INCIDENTAL FINDING RELATED TO A HEREDITARY DISEASE BE DISCOVERED FROM THE SAMPLE SO THAT IT CANNOT BE CONFIRMED WHETHER IT HAS BEEN TRIGGERED BY THE HEALTH ISSUE OR IT HAS BEEN PRESENT IN GERMINAL CELLS, ONCODNA WILL PROPERLY INFORM AND ADVISE THE MEDICAL DOCTOR VIA THE REPORT TO CONSULT A GENETICIST TO CONFIRM THE ORIGIN OF THE FINDING AND ITS POTENTIAL IMPACT ON THE PATIENT’S RELATIVES.
g. THIS REPORT IS INTENDED AND PROVIDED BY ONCODNA TO MEDICAL DOCTORS ONLY. IN COMPLIANCE WITH THE APPLICABLE LAWS, THE PATIENT MAY HAVE THE RIGHT TO REQUEST ACCESS TO INFORMATION RELATING TO HIS/HER HEALTH, INCLUDING THE REPORT TO HIS/HER MEDICAL DOCTOR WHO IS RESPONSIBLE AND ACCOUNTABLE FOR PROVIDING CLEAR INFORMATION. THEREFORE, THE RESPONSIBILITY AND ACCOUNTABILITY OF THE EXERCISE OF THAT RIGHT DO NOT REST ON ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES, AFFILIATES OR SUBCONTRACTORS) WHO ASSUMES NO LIABILITY WHATSOEVER AS TO THE DECISION OF THE MEDICAL DOCTOR WHETHER OR NOT TO PROVIDE SUCH ACCESS.
9.6. Warranty : OncoDNA warrants that all products delivered will meet OncoDNA’s standard specifications. If an OncoDNA product fails to meet its specifications, OncoDNA must be notified within 48 hours of receiving the product. Upon receiving the defective item, OncoDNA will replace it with a new product at no additional cost. OncoDNA’s responsibility for defective products is limited to replacement only. Should a product replacement again not meet OncoDNA’s standard specifications, the Patient and/or the Customer will be credited the purchase price. All disputes or claims must be submitted within 6 month of time. OncoDNA reserves the right not to handle any disputes after 6 months from the date that the goods were received.
11. Ownership, Intellectual Property and License
11.1. All Intellectual Property Rights belonging to OncoDNA shall remain vested in OncoDNA. This includes, but is not limited to, all Intellectual Property Rights in the Services, the customization of OncoKDM platform and the OncoSHARE platform, the Reports, the process of obtaining or creating the Output Data, the Output Data itself and their respective content, the bed files – including, without limitation, the texts, comments, software, graphics, illustrations, images, logos, icons, OncoDNA brand and product names – which shall remain vested exclusively in OncoDNA and its licensors ("OncoDNA Prior IP"). Nothing in this Agreement shall be intended or construed as to confer any rights, titles, authorizations or licenses with respect to OncoDNA Prior IP, to the Customer, Medical Doctor, Patient or Interested Third Party, except were expressly provided otherwise. The OncoDNA Prior IP may not be copied, reproduced, distributed, used, adapted or translated, in whole or in part, except with the express and written authorization of OncoDNA. Subject to the provisions of Articles 9.5. and 9.7., the Agreement does not grant to the Customer any license under any Intellectual Property Right. All Intellectual Property Rights in services, other products or materials created by OncoDNA or any subcontractor during the course of the provision of any Services, the development and manufacturing of any of these products, in any Results, including Theranostic Reports, Output Data and Feedback (together "Work Product") and the content of the OncoSHARE platform shall vest in OncoDNA unconditionally and immediately on their creation and shall be the exclusive property of OncoDNA. To the extent that all rights, title, and interest in Intellectual Property Rights in and to Work Product may not, by operation of law or equity, vest in OncoDNA, the Customer and Medical Doctor hereby irrevocably assign such Intellectual Property Rights (including by way of future assignment) to OncoDNA for the entire world, which assignment OncoDNA hereby accepts, together with all causes of action for infringement, misappropriation, or otherwise relating to any Intellectual Property Rights in the Work Product. As a result, subject to compliance with Applicable Laws, including but not limited to Data Protection Laws, OncoDNA shall be exclusively entitled to make available, reproduce, distribute, process or otherwise exploit all or part of the Work Product, including, without limitation, the Results, the Output Data, the Feedbacks or any other observations made by the Customer and/or Medical Doctor, including by way of publication on the OncoSHARE or OncoKDM platforms or elsewhere.
11.2. Should the aforementioned assignments require any further action or cooperation by the Customer and/or Medical Doctor, the Customer and Medical Doctor shall take such further actions and provide such further cooperation at the first request of OncoDNA.
11.3. The Customer represents and agrees that it shall (and shall procure that all Staff Members shall) (i) assign to OncoDNA any and all right, title and interest in Intellectual Property Rights in and to the Work Product; (ii) assist OncoDNA in all proceedings for obtaining or preserving the rights transferred or assigned under this clause; and (iii) execute all necessary documents so that all Intellectual Property Rights vest in OncoDNA absolutely and as sole beneficial owner. The Customer shall also comply with all legal provisions concerning the validity and opposability of all agreements concluded in respect of the rights transferred hereby.
11.4. The Customer shall promptly inform OncoDNA in writing of any third party infringement of OncoDNA Prior IP or Work Product and of any use of OncoDNA Prior IP or Work Product by a third party. OncoDNA shall have the sole right to take such action as it deems necessary against such infringements. The Customer will provide all cooperation and assistance requested by OncoDNA in relation to such action. The Customer will not challenge the assignment and validity of the OncoDNA Prior IP or Work Product.
11.5. In the framework of the Agreement and without prejudice to the generality of Article 9.1., OncoDNA grants to the Customer that have registered with OncoDNA a personal, free of charge, non-exclusive, non-assignable and non-transferrable license (revocable and without the right to grant a sublicense) to use OncoSHARE and OncoKDM Services and the customized OncoKDM platform, for their own internal purposes, and in accordance with the conditions provided in these Terms and Conditions, during the entire duration of the Agreement.
11.6. OncoDNA shall retain all exclusive rights to use and exploit the Output Data (the Patient's personal information remaining strictly anonymous) and the anonymised Feedback and OncoKDM Reports for the enhancement and enrichment of OncoDNA Prior IP, including, without limitation, the right to exploit the Output Data without hindrance of any kind, for the own researchlegitimate.
11.7. With respect to the Reports and without prejudice to the generality of Article 9.1., OncoDNA grants to the Customer and/or the Medical Doctor a limited, non-exclusive, non-assignable and non-transferrable license, subject to the payment of the Price, to use the Reports solely in relation to and to the extent necessary for the treatment of his/her Patients concerned by such Reports. In accordance with Article 3.7., the Medical Doctor may share the Reports with Expert Advisors and other Medical Doctors registered with OncoSHARE platform through which the Test Services were requested. The Customer and/or the Medical Doctor hereby acknowledges and agrees that (i) the content of the Reports is generated on the basis of OncoDNA’s aggregate know-how in the field of cancer and oncology and is the property of OncoDNA and (ii) the Customer and/or the Medical Doctor shall not infringe OncoDNA’s Intellectual Property Rights on said Reports in any manner whatsoever.
12. Termination
12.1. OncoDNA may terminate the Agreement and cease the provision of the Services subject to a thirty (30) days prior written notice to the Customer if the Customer is in breach of any material term or condition of these Terms and Conditions, and, to the extent such breach is remediable, the Customer fails to remedy the same within thirty (30) days of the receipt of a written request from OncoDNA to do so.
12.2. With respect to the Services , both OncoDNA and the Customer have the right to terminate the Agreement in the event:
a) Subject to derogatory mandatory provisions, , the other Party becomes insolvent, or if voluntary or involuntary proceedings under any bankruptcy or insolvency laws are instituted concerning the other Party, a receiver is appointed of the whole or any part of the assets or undertaking or the other Party, or the other party presents a petition or has a petition presented by a creditor for its winding up or calls a meeting of creditors or an administration order is presented or a liquidator is appointed or a resolution passed for its winding up (except for the purpose of amalgamation or reconstruction);
b) A substantial part of the assets of the other Party are encumbered or seized and such encumbrance or seizure is not lifted within thirty (30) days;
c) The other Party liquidates or dissolves its company or (otherwise) ceases to carry on its business; or
d) When necessary in the interests of health and safety or as a result of any government authority or court of law.
12.3. With respect to the OncoKDM Services as well as the Test Services, respectively, OncoDNA is also entitled to terminate the Agreement with immediate effect upon written notice to Customer without further liability in the event of:
a) An attitude, act, error or omission of Customer which materially affects OncoDNA's reputation;
b) Any use of the Test Services or OncoKDM Services by the Customer or any Customer staff member other than in accordance with this Agreement or OncoDNA's reasonable instructions;
c) OncoDNA ceases to produce or market Test Services or OncoKDM Services for any reason; or
d) The Customer is no longer properly licensed to perform its activities under Applicable Laws;
e) any act, error or omission of Customer which materially affects OncoDNA's reputation;
12.4. The termination of the Agreement shall be without prejudice to the rights and duties of either Party accrued prior to such termination. The provisions of these Terms and Conditions which expressly or impliedly have effect after termination shall continue to be enforceable notwithstanding termination. The Patient and/or the Customer shall pay any amounts due in respect of any OncoKDM Services and/or Test Services (or part thereof) provided prior to termination of the Agreement, regardless of the reason for termination.
12.5. In the event of termination of the Agreement, the Parties agree that, subject to payment of all amounts owed by the Patient and/or the Customer, OncoDNA will perform the OncoKDM Services and/or Test Services with respect to Specimen(s) shipped in good faith prior to termination. Any payment obligations accruing prior to the effective date of termination or with respect to Specimens referred to in the previous sentence shall be payable by the Patient and/or the Customer in accordance with Article 6.
12.6. In any case of termination of this Agreement, OncoDNA shall be entitled to deactivate the Account of the Patient and/or the Customer.
13. Data Protection and Privacy and Data Retention Policy
13.1. In the framework of the provision of the Services, OncoDNA processes certain personal data relating to the Customer and/or the Patients. Information and applicable provisions on how OncoDNA collects, protects, uses and shares the Customer’s and/or the Patient's personal data are contained in the Privacy Policy which is available at www.oncoshare.com/legaldocs/oncoshare-privacypolicy.pdf. The Privacy Policy constitutes an integral part of the Agreement. The Customer and/or the Patient is therefore strongly invited to read the Privacy Policy which must be accepted prior and in order to access and use the Services.
13.2. Where expressly provided, some Services shall be subject to the application of the specific provisions of the Data Processing Agreement.
13.3. OncoDNA retention policy is designed in compliance with the guidelines provided by the Belgian Personalised Medicine Commission (Compermed). The following provisions apply:
a) Input Data: FASTQ files will be retained for a period of 1 year.
b) Results Files: VCF, CSV files (including LOH, TMB, etc.) will be retained for a period of 4 years.
c) Intermediate Files: Pipeline intermediate files will be retained for a period of 1 month.
d) Full BAM Files: Aligned input FASTQ files merged into a single BAM for visualization within OncoKDM will be retained for a period of 1 year.
e) SFTP Server Files: Files uploaded to the SFTP server will be deleted two weeks after the date of upload.
This policy ensures effective data management and compliance with regulatory requirements. Should the customer have any specific needs or require exceptions to this policy, he can contact his sales representative to discuss tailored solutions.
The Party transmitting personal data to OncoDNA undertakes to have previously obtained the Informed Consent Form from the patient and to comply with all the Data Protection Laws and Regulations applicable to the processing of personal data including the GDPR.
14. General
14.1. Any notice to be given under these Terms and Conditions shall be in writing and delivered or sent (i) in person through a reputable courier service, (ii) by fax with a confirmation slip, (iii) by registered mail (with acknowledgement of receipt) or by email (with acknowledgement of receipt).
14.2. The Customer may not assign, transfer, charge or license the whole or any part of its rights and/or obligations under this Agreement to any third party without the express written consent of OncoDNA. To the extent permitted under Applicable Laws (including Data Protection Laws), OncoDNA may at any time assign, transfer, charge, sub-contract or deal in any other manner with all or any of its rights or obligations under the Agreement, subject to obtaining the prior and express consent of the Customer. Without limiting the generality of the preceding sentence, OncoDNA is free to assign or transfer the Agreement as a whole or any of its rights and/or obligations under the Agreement, whether to its affiliates or to third parties, in the form and under the structure OncoDNA deems appropriate, subject to obtaining the prior and express consent of the Customer. The foregoing is applicable to any type of transfer of rights or obligations under the Agreement, be it as an individual asset or as part of a transfer of universality or of a branch of activities, and notably, without limitation, in the event of merger, scission, contribution of universality or of branch of activities, winding up, bankruptcy or transformation of OncoDNA. Subject to any restrictions on assignment herein contained, the provisions of the Agreement shall inure to the benefit of and shall be binding upon the Parties hereto and their respective heirs, legal representatives, successors and permitted assigns.
14.3. Subject to any other specific written arrangement, these Terms and Conditions, the Privacy Policy, the ICF and the Distribution Agreement, as applicable, constitute the entire agreement between the Parties with respect to the subject matter hereof and supersede any and all other agreements, either oral or written, between the Parties (including, without limitation, any prior agreement between OncoDNA and Customer or any of its subsidiaries or affiliates) with respect to the provision of the Services.
14.5. The Agreement shall be governed by and construed in accordance with the laws of Belgium, and no effect shall be given to any other choice of law or any conflict-of-laws rules or provisions (Belgian, foreign or international) that could cause the laws of any jurisdiction other than Belgium to be applicable. The Customer hereby agrees that any dispute concerning the validity, interpretation, performance or termination of the Agreement, the Services shall be submitted to the exclusive jurisdiction of the Courts of Charleroi, Belgium, unless otherwise expressly agreed by the Parties.
14.6. Force Majeure. OncoDNA will not be liable to the Customer for failure to perform or delay in the performance of any of its duty or obligation under the Agreement where such failure or delay is due to any acts, events, omissions or accidents beyond its reasonable control, including, without limitation, strikes, lock-outs or other industrial disputes (whether involving the workforce of OncoDNA or any other party), failure of a utility service or transport or telecommunications network, act of God, war, riot, civil commotion, malicious damage, act of terrorism, embargo or governmental order, rule, regulation or direction, accident, breakdown of plant or machinery, fire, flood, storm, hacking, failures of suppliers or subcontractors (“Force Majeure Event”), provided that the Customer is promptly notified of such Force Majeure Event, its severity and its likely impact on OncoDNA’s ability to perform its obligations under the Agreement after becoming aware of the commencement of the relevant Force Majeure Event. Notwithstanding the foregoing, OncoDNA shall use all reasonable endeavors to continue to perform its obligations under the Agreement for the duration of such Force Majeure Event.
14.7. The headings in these Terms and Conditions are for convenience and reference only, and are not intended to, and shall not, define or limit the scope of the provisions to which they relate.
14.8. None of the provisions of the Agreement are intended to create, nor shall be deemed or construed to create, any relationship between the Parties other than that of independent entities. Nothing in the Agreement and these Terms and Conditions shall be deemed to create any partnership, joint venture, legal association, or other operating relationship between the Parties other than as independent contractors. Neither Party shall have the authority to act in the name or on behalf of or otherwise to bind the other in any way (including, but not limited to, the making of any representation or warranty, the assumption of any obligation or liability and the exercise of any right or power).
15. Additional conditions relating to the Kits : (These conditions supersede the conditions set out above).
15.1. Twist is the company providing certain parts of the OncoDNA Kits, especially the reagents for the NGS part of the Tests.
15.2. Twist is a third-party beneficiary to the contractual relationship between OncoDNA and the End-User defined by OncoDNA General Terms and Conditions and OncoDNA Kits General Terms and Conditions. Twist shall not be bound by or subject to such conditions towards the End-Users.
15.3. Warranties.
15.4. Twist Limited Warranties.
15.5. All Products are provided by Twist “AS-IS.”
15.6. OncoDNA represents and warrants that OncoDNA is an authorized distributor of Twist to supply the Products.
15.7. ONCODNA AND TWIST MAKE NO, AND HEREBY DISCLAIMS ALL, REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS OR ANY OTHER SUBJECT MATTER OF THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT AS WELL AS WARRANTIES REGARDING SECURITY, RESULTS OBTAINED THROUGH THE USE OF ANY PRODUCT AND ANY WARRANTY ARISING FROM A STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF PERFORMANCE, DEALING OR USAGE OF TRADE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED. IN NO EVENT WILL TWIST’S TOTAL LIABILITY FOR BREACH OF ANY WARRANTY EXPRESSLY PROVIDED HEREUNDER EXCEED THE PURCHASE PRICE OF THE PRODUCT AT ISSUE. IN NO EVENT WILL ONCODNA’S OR TWIST’S TOTAL LIABILITY FOR BREACH OF ANY WARRANTY EXPRESSLY PROVIDED HEREUNDER EXCEED THE PURCHASE PRICE OF THE PRODUCT AT ISSUE.
15.8. End-User Warranties.
15.9. In the event that End-User must provide sequence information required for the manufacture and/or supply of the Products, and any other related documentation or materials (together “Sequence Information”), End-User warrants that a) End-User has all rights, licenses, consents and permissions to provide the Sequence Information to OncoDNA and Twist and for Twist to use such Sequence Information to manufacture and supply the Products; (b) End-User has the right to have the Product embodied by the Sequence Information manufactured by Twist; (c) Twist’s possession and use of the Sequence Information to manufacture, possess and sell the Product, and Twist’s OncoDNA’s possession and use of the Sequence Information to possess and sell the Product, shall not violate any applicable laws or End-User agreement, require registration or other action under Federal Select Agent Program regulations or other biosecurity requirements (collectively, “Biosecurity Requirements”), or infringe or misappropriate the intellectual property rights of any third-party; and (d) End-User shall not provide any personally identifiable information, Personal Health Information as defined in 45 C.F.R section 164.501, or Personal Data as defined by GDPR, each pertaining to Sequence Information, to OncoDNA or Twist. End-User warrants the accuracy of any information pertaining to the Sequence Information provided by End-User to OncoDNA or Twist.
15.10. Limitations on Use of Products.
15.11. Products have not been approved, cleared, authorized or licensed by the United States Food and Drug Administration (“FDA”) or any other applicable governmental agency, within or outside the United States, for any use. End-User shall not use any Product in humans to treat or diagnose any condition nor for any other diagnostic or therapeutic purposes, for investigational use in foods, drugs, devices or cosmetics of any kind, or for consumption by or use in connection with or administration or application to humans or animals unless End-User first obtains all necessary and/or appropriate approvals, clearances, authorizations and/or licenses from the FDA or other applicable governmental agency within or outside the United States. End-User shall use all Products in accordance with applicable laws, rules, regulations and governmental policies and in accordance with the terms and conditions of this End-User Agreement. Neither OncoDNA nor Twist will not be responsible or liable for any losses, damages, costs, expenses, or any other forms of liability arising out of End-User’s use of the Products. End-User shall not sell, resell, transfer or distribute any Products to any third party. End-User shall not to (and not to authorize or permit others to) reverse engineer, deconstruct or disassemble any Products.
15.12. Infringement Indemnification.
15.13. End-User shall indemnify OncoDNA and Twist, and their respective affiliates, directors, officers, employees, and agents (together, “Indemnitees”) from and against any and all costs, expenses, liabilities, damages and losses (including reasonable legal expenses and attorneys’ fees) (collectively, “Losses”) arising out of any third party suits, claims, actions, or proceedings (collectively, “Claims”) brought against Indemnitees to the extent resulting from or caused by: (a) the gross negligence, recklessness or willful misconduct of the End-user or its affiliates, directors, officers, employees or agents; (b) End-User’s use of any Product; (c) the infringement of any third-party intellectual property rights by an Indemnitee’s receipt, possession or use of any Sequence Information or other information or instructions provided by End-User, prior to or after issuance of a Purchase Order, in connection with the assessment, development, manufacture, possession, sale or use of a Product; and (d) End-User’s breach of its obligations, warranties or representations under this Agreement; except in each case to the extent that a Claim arises out of or results from the gross negligence, recklessness or willful misconduct of the Indemnitee.
15.14. Indemnification for a Claim shall consist of the following: End-User shall (a) defend or settle the Claim at its own expense, (b) pay any judgments finally awarded against Indemnitees under a Claim or any amounts assessed against Indemnitees in any settlements of a Claim, and (c) reimburse the Indemnitees for the reasonable administrative costs or expenses, including without limitation reasonable attorneys’ fees, it necessarily incurs in responding to the Claim. End-User’s obligations under this Infringement Indemnification Section are conditioned upon the Indemnitee (i) giving prompt written notice of the Claim to End-User, (ii) permitting End-User to retain sole control of the investigation, defense or settlement of the Claim, except that the Indemnitee may cooperate in the defense at its own expense using its own counsel and (iii) providing End-User with such cooperation and assistance as End-User may reasonably request from time to time in connection with the investigation, defense or settlement of the Claim. Notwithstanding the foregoing, End-User shall not settle any Claim on any terms or in any manner that would (i) require an Indemnitee to make a payment which End-User is not obligated by this End-User Agreement to pay on behalf of such Indemnitee, (ii) require an Indemnitee to make any admission against its interest or, (iii) impose an unreasonable commercial or operational burden on an Indemnitee without such Indemnitee’s express written consent.
15.15. Limitation of Liability. IN NO EVENT SHALL ONCODNA OR TWIST BE LIABLE TO END-USER FOR ANY LOSS OF USE, REVENUE OR PROFIT, LOSS OF DATA OR DIMINUTION IN VALUE, OR FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE AND WHETHER OR NOT ONCODNA OR TWIST HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE. IN NO EVENT SHALL ONCO'S OR TWIST’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS END-USER AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EXCEED THE FEES PAID OR PAYABLE BY END-USER TO ONCO HEREUNDER DURING THE TWELVE (12) MONTHS PRECEDING THE CLAIM UNDER WHICH SUCH LIABILITY AROSE. The afore mentioned limitation of liability shall not apply to liability resulting from ONCO's or Twist’s gross negligence or willful misconduct.
Version: 13 March 2025