OncoDNA’s General Terms and Conditions

1. Definitions

In these OncoDNA & OncoSHARE General Terms and Conditions, the terms starting by a capital letter will have the meaning specified below or elsewhere in these OncoDNA & OncoSHARE General Terms and Conditions:

1. “Account” means the web account that the Client or the Patient needs to create on OncoSHARE 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. “Client” means either the hospital, 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 Medical Doctors under and in accordance with the provisions of the Agreement (as defined in clause 2.3 of these Terms and Conditions).

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 similar to 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 Test 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 Kit” means the package the Medical Doctor has to 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 Medical Doctor, a Patient or an Official Distributor, that is registered with OncoSHARE.

11. "Liquid Biopsy" shall mean the blood, urine and/or saliva sample procured from Patients wishing to have their DNA profiled by OncoDNA by means of OncoDEEP® Test, the OncoFOLLOW® Test, or OncoSELECT® Test (collectively with "Solid Biopsy", "Biopsies"; indifferently, "Biopsy");

12. “Medical Doctor” means a medical doctor 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. "Onco DNA Prior IP" shall have the meaning given to that term in clause 9 of these Terms and Conditions;

15. “OncoSHARE” means the OncoDNA web platform available at the address www.oncoshare.com (the “Website”), which is an online platform where Medical Doctors, Patients and Interested Third Parties may seek, collect and share information on cancer and oncology. OncoSHARE provide a link between all these parties. Through OncoSHARE sample Shipment box requests, analyses 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 or physicians. "Patients" access to the platform allows patients or their family to collect information in order to identify which is the best treatment for their specific condition. "Medical Doctors" access to the platform allows healthcare professionals to share their experiences, expertise and anonymous data with the aim of gathering more medical opinions and to get a comprehensive molecular profile of tumours that they have encountered to improve treatment prescription.

16. "Output Data" means 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 (i) the OncoDEEP theranostic report, containing personalized treatment options, taking into account the Patient’s tumor’s molecular characteristics (using tumor tissue). The OncoDEEP theranostic report includes a list of all mutations discovered, along with those which are actionable by therapies currently on the market, by therapies currently under development and a list of ongoing clinical trials; and/or (ii) the OncoFOLLOW Test cancer monitoring report of biomarkers specific to each Patient’s tumor, giving the Medical Doctor indicators of his/her Patient’s response to ongoing treatment (using blood samples); and/or (iii) the OncoSELECT Theranostic report containing the results of a cancer specific liquid biopsy and/or a Client specific report resulting from part of the Services. These Reports are drafted in English.

22. “Request” means the request made by the Medical Doctor directly, or through an Official Distributor, on OncoSHARE for the Test Services, in accordance with the provisions of Article 4 of these Terms and Conditions.

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:

a. the "OncoKDM Services" (Onco Knowledge Drive Medicine Services) consisting of (i) the integration of any type of data's, (ii) the structuration of them, (iii) the extraction of useful clinical information that can be presented via OncoSHARE and (iv) the delivery of a report organising and personalising Output Data in a reporting tool ("OncoKDM Report").

b. the OncoDEEP and/or the OncoFOLLOW Test and/or OncoSELECT services consisting in (i) the supply of an Information and/or Shipment Kit, (ii) the performance of the OncoDEEP and/or the OncoFOLLOW Test and/or OncoSELECT and (iii) the delivery of the Report(s) (the “Test Services”); and

c. the provision of OncoSHARE and related services to Medical Doctors, Patients, Official Distributors and Interested Third Parties (the “OncoSHARE Services”).

d. the “OncoDEEP Kit” (the “Kit”) which provides the End-User with the reagents to perform the NGS part of the OncoDEEP Test as described in Article 30.a.

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 in accordance with the protocol described on OncoSHARE (collectively with "Liquid Biopsy", "Biopsies"; indifferently, "Biopsy");

26. “Specimen” means Patient’s tumor tissue urine, saliva and/or blood samples collected and kept in the tubes provided in the Shipment Kit.

27. "Staff Members" means employees, officers, directors, agents, project managers and any other representatives of each Party (which, in the case of the Hospital includes, without limitation, nurses, OncologistMedical Doctor and surgeons);

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 Solution for his Patient and to provide him explanations and guidance in relation to the Theranostic Report

29. “Terms and Conditions” means these OncoDNA & OncoSHARE General 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 in accordance with Article 3.4., including without limitation sequencing and IHC tests for treatment recommendations and cancer monitoring. More particularly, the Tests include (all or part of) the:

a. “OncoDEEP Test”: aims at analyzing the molecular profile of the Patient’s tumor from a tumor tissue. OncoDNA integrates the results from high throughput DNA sequencing and 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”: it is currently possible to isolate DNA from tumor cells in the blood. This is called circulating tumor DNA (ctDNA) and it is precisely this tumor DNA present in the Patient’s blood that this Test analyzes and monitors. This Test 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 using blood samples. It will give the Medical Doctor indicators of his/her Patient’s response to ongoing treatment.

c. "OncoSELECT Test": (i) focuses on four cancers lung (NSCLC), colon, breast and prostate where targeted therapies associated with biomarkers of sensitivity or resistance are well published and accepted, (ii) analyzes and monitors tumor DNA present in the Patient’s blood and (iii) gives the Medical Doctor indicators of his/her Patient’s response to ongoing treatment.

For further information on the OncoDEEP Test, and/or OncoFOLLOW Test and/or OncoSELECT Test, 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.

2. Scope of application

2.1. 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 Client and/or Patient.

2.2. OncoDNA and Client or Patient are together referred to in these Terms and Conditions as the “Parties” and individually as a “Party”.

2.3. By registering with OncoSHARE or otherwise accepting these Terms and Conditions, the Client and/or Patient 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 the Distribution Agreement (with respect to Official Distributors only), as applicable (the “Agreement”).

2.4. 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 Client to OncoDNA.

2.5. Except as provided otherwise in these Terms and Conditions, the creation by the Patient and/or the Client of an Account pursuant to Article 3.1. shall be deemed to constitute unequivocal acceptance of these Terms and Conditions.

2.6. Any Services provided by OncoDNA are subject to these Terms and Conditions, the Privacy Policy and the ICF, as applicable.

2.7. OncoDNA expressly reserves the right to modify these Terms and Conditions, including but not limited to the Privacy Policy. The Client hereby undertakes to review periodically the Terms and Conditions as published and accessible on the Website. OncoDNA will take the Client’s legitimate interests into consideration when amending these Terms and Conditions. The Client 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.

2.8. 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.

3. Services

3.1. To access the Services, the Patient and/or the Client shall create an Account. The Patient and/or the Client 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 Client 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 Client to provide further data as reasonably necessary for authentication purposes. The Patient and/or the Client shall maintain and update the Account Data to keep it current, complete and accurate. The Patient and/or the Client shall be solely liable if the Patient and/or the Client allows any third party to use the Account Data.

3.2. The registration with OncoSHARE and the creation of an Account is free. Without prejudice to the foregoing, the Patient and/or the Client acknowledges and agrees that OncoDNA shall provide the OncoKDM Services and/or the Test Services to the Medical Doctor and/or to the Client, as applicable, against the payment of the Price as specified in Article 6.

3.3. With respect to Test Services, the Medical Doctor may, directly or through an Official Distributor, place a Request for Information and/or Shipment Kit through OncoSHARE. The Medical Doctor undertakes to use such requested Information and/or Shipment Kit exclusively in connection with the shipment of Specimens to OncoDNA. Title and ownership of the Information and/or Shipment Kit shall remain at all times with OncoDNA. The Medical Doctor shall use pre-printed waybill and shipment bag included in the Information and/or Shipment Kit to ship Specimens to OncoDNA.

3.4. OncoDNA shall provide the Services in accordance with these Terms and Conditions. Regarding the Test Services, the Medical Doctor, 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 (“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 Client that such work would be carried out at a specified laboratory.

3.5. As part of the Test Services, OncoDNA shall communicate to the Medical Doctor the Report.

3.6. The Report can be consulted by the Medical Doctor on OncoSHARE. The delivery times of the Report, if any, are indicative only, and delays shall under no circumstances give rise to any claims for compensation.

3.7. As part of the Services available to the Medical Doctor and in accordance with the Privacy Policy, the latter may choose to disclose or share, through OncoSHARE, 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 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, to discuss and exchange medical expertise/opinion about a specific case.

3.8. As part of the Services available to Patients and Interest Third Parties and subject to Articles 5.6. and 8.6.b., such Patients and Interested Third Parties may, without being charged any fee, (i) ask questions to OncoDNA related to the Services and/or more generally, to cancer and oncology, via the OncoDNA chat available on OncoSHARE; and (ii) publish; and (iii) consult other Patients/Interested Third Parties’ publication on OncoDNA moderated forum.

3.9. OncoDNA shall use reasonable efforts consistent with professional standards to carry out the Services and achieve their objectives, without guaranteeing any result.

3.10. Regarding OncoKDM Services, the Parties acknowledge that the Client generates and owns Raw Data and that the Client 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.

4. Request for Test Services

4.1. The Test Services may be ordered only by the Medical Doctor (the Patient cannot order directly the Test Services) from time to time by submitting to OncoDNA a Request, directly or through an Official Distributor. The Shipment Kit will then be sent to the Medical Doctor who shall exclusively use it to provide the appropriate Specimen to OncoDNA, in accordance with the instruction provided in the Shipment Kit and/or otherwise by OncoDNA.

4.2. 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; and (b) the payment of the Price.

5. Client Obligations

5.1. The Patient and/or the Client shall not use the Account of another Patient and/or Client without permission. The Patient and/or the Client is solely responsible for the activity that occurs on its Account, and the Patient and/or the Client must keep its Account password secure. OncoDNA encourages the Patient and/or the Client 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 Client must notify OncoDNA immediately of any breach of security or unauthorized use of its Account of which the Patient and/or the Client 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 Client’s negligence.

5.2. The Medical Doctor shall complete and submit the Request, on OncoSHARE directly or through an Official Distributor, and provide OncoDNA with undamaged Specimen in proper state, in accordance with policies and procedures specified by OncoDNA.

5.3. The Client, 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.

5.4. The Patient, or the Medical Doctor acting on behalf of his/her Patient, shall pay the Price in accordance with the provisions of Article 6. Unless otherwise specifically agreed, the Patient shall be responsible for the payment of all administration, insurance or patient billing and fee collections relating to the provision of the Test Services.

5.5. The Client shall immediately inform OncoDNA of any reports of irregularities, complaints or other adverse information received by the Client 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 Client shall not take any action with regard thereto, without first obtaining instructions in writing from OncoDNA.

5.6. The Patient and/or the Client shall not use the Services and OncoSHARE or allow the Services and OncoSHARE 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 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 the integrity of any data, system or program. The Patient and/or the Client 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 Client becomes aware of any infringement through the Services, of (intellectual) property rights or other rights, the Patient and/or the Client must alert OncoDNA immediately at the email address support@oncodna.com

5.7. The Medical Doctor and Patient shall not modify in any manner whatsoever the Reports, the Results or any disclaimers associated therewith.

5.8. The Client 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 Medical Doctor, the latter warrants that it has the legally required capacity, status and competence to request, interpret and use the Test 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.

5.9. The Client acknowledges and understands that OncoDNA relies upon the Client’s representations and warranties as set out in this Article 5.

6. Prices and Payment

6.1. In consideration of the performance of the OncoKDM Services and/or Test Services, the Patient (or his/her Medical Doctor, acting on the Patient’s behalf) and/or the Client will be required to pay the Price, the amount of which depends on the type of Test chosen, as agreed upon by OncoDNA and the Client.

6.2. 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, in accordance with Article 4.1. and shall be exclusive of VAT and any other applicable tax or duties which shall be borne by the Patient and/or the Client.The Price for the OncoKDM Services shall be as determined in the Agreement or the Schedules thereto.

6.3. 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.

6.4. In accordance with Article 4.2., OncoDNA reserves the right to suspend or delay the provision of the Test Services or OncoKDM Services as applicable, until complete payment of the Price or any other due amounts to OncoDNA under the Agreement.

6.5. In case the Medical Doctor or the Client 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.

6.6. By accepting these Terms and Conditions, by signing or otherwise consenting to the ICF and/or opening an Account, the Patient and/or the Client 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.

6.7. 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 Client for the cost of the OncoKDM Services and/or Test Services.

7. Patient Informed Consent and Additional Authorization

7.1. In accordance with Applicable Laws, the Patient’s informed consent is required to perform the Test(s) on the Patient’s Specimen(s) and to integrate the Results in OncoDNA's database for further secondary use. The Medical Doctor shall therefore place a Request for the Test Services in accordance with Article 4.1. after (i) having submitted and explained the ICF to his/her Patient and (ii) obtaining the completed and signed ICF by such Patient. As provided under Article 4.2., no Test shall be undertaken prior to the receipt of a copy of the duly completed and signed ICF.

7.2. 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 Client, 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 Client, 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 Client, 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 Client, the Medical Doctor and/or the Patient (as applicable).

8. Limitation of OncoDNA’s Liability and Warranties - Disclaimer

8.1. 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 OncoSHARE and/or the Services are, to the fullest extent permitted by applicable law, excluded.

8.2. To the extent that OncoDNA provides the OncoSHARE Services free of charge, (i) any liability of OncoDNA (including any of its subsidiaries or affiliates) for negligence or breach of these Terms and Conditions in that respect is excluded and (ii) notwithstanding anything else to the contrary contained in this Article 8 or elsewhere in these Terms and Conditions, in no event will OncoDNA’s (including any of its subsidiaries or affiliates) total cumulative liability to the Client – 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 the performance of its indemnification obligations arising from this Agreement, exceed an amount of EUR 1 (one euro).

8.3. With respect to the payable OncoKDM Services and Test Services, and notwithstanding anything else to the contrary contained in this Article 8 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 Client – 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 Client to OncoDNA under the Agreement during the period of twelve (12) months immediately preceding the date of the occurrence of the event giving rise to liability.

8.4. 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 Client’s, Medical Doctor's, Patient's and/or Interested Third Party's use of the Services is at the 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 CLIENT.

8.5. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ONCODNA (INCLUDING ANY OF ITS SUBSIDIARIES OR AFFILIATES) SHALL NOT BE LIABLE TO CLIENT, MEDICAL DOCTOR, PATIENT OR INTERESTED THIRD PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT OR SPECIAL 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.

8.6. REPORT DISCLAIMER:

a. THE BIOMARKER 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 CLIENT, 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 CLIENT, 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. Ownership, Intellectual Property and License

9.1. 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 – 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 Client, 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 Client 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 Client 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 Client and/or Medical Doctor, including by way of publication on the OncoSHARE® or OncoKDM platforms or elsewhere.

9.2. Should the aforementioned assignments require any further action or cooperation by the Client and/or Medical Doctor, the Client and Medical Doctor shall take such further actions and provide such further cooperation at the first request of OncoDNA.

9.3. The Client 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 Client shall also comply with all legal provisions concerning the validity and opposability of all agreements concluded in respect of the rights transferred hereby.

9.4. The Client 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 Client will provide all cooperation and assistance requested by OncoDNA in relation to such action. The Client will not challenge the assignment and validity of the OncoDNA Prior IP or Work Product.

9.5. In the framework of the Agreement and without prejudice to the generality of Article 9.1., OncoDNA grants to the Client 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.

9.6. 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 research and commercial purposes of OncoDNA.

9.7. With respect to the Reports and without prejudice to the generality of Article 9.1., OncoDNA grants to the Client 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 through which the Test Services were requested. The Client 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 Client and/or the Medical Doctor shall not infringe OncoDNA’s Intellectual Property Rights on said Reports in any manner whatsoever.

10. Termination

10.1. OncoDNA may terminate the Agreement and cease the provision of the Services subject to a thirty (30) days prior written notice to the Client if the Client is in breach of any material term or condition of these Terms and Conditions, and, to the extent such breach is remediable, the Client fails to remedy the same within thirty (30) days of the receipt of a written request from OncoDNA to do so.

10.2. With respect to the OncoKDM Services and Test Services, both OncoDNA and the Client have the right to terminate the Agreement in the event:

(a) Subject to derogatory mandatory provisions, including but not limited to the Belgian Business Continuity Act 2013, 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;

(d) When necessary in the interests of health and safety or as a result of any government authority or court of law.

10.3. 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 Client without further liability in the event of:

(a) An attitude, act, error or omission of Client which materially affects OncoDNA's reputation;

(b) Any use of the Test Services or OncoKDM Sevices by the Client or any Client staff member other than in accordance with this Agreement or OncoDNA's reasonable instructions;

(d) The Client is no longer properly licensed to perform its activities under Applicable Laws;

(e) any act, error or omission of Client which materially affects OncoDNA's reputation;

10.4. Given that the OncoSHARE Services are free of charge, OncoDNA has the right to terminate the Agreement in that respect at any time and without any reason.

10.5. 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 Client 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.

10.6. 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 Client, 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 Client in accordance with Article 6.

10.7. In any case of termination of this Agreement, OncoDNA shall be entitled to deactivate the Account of the Patient and/or the Client.

11. Data Protection and Privacy

11.1. In the framework of the provision of the Services, OncoDNA processes certain personal data relating to the Client and/or the Patients. Information and applicable provisions on how OncoDNA collects, protects, uses and shares the Client’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 Client 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.

11.2. Where expressly provided, some Services shall be subject to the application of the specific provisions of the Data Processing Agreement.

12. General

12.1. 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).

12.2. The Client 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. 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. 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.

12.3. 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 Client or any of its subsidiaries or affiliates) with respect to OncoSHARE and the provision of the Services.

12.4. Any failure or delay by any Party in exercising or insisting on the performance of any right under the Agreement, in whole or in part, or any reaction or absence of reaction by such Party in the event of violation by the other Party of one or more provisions of the Agreement, shall not operate or be construed as a waiver (whether express or implied, in whole or in part) of any of its rights under the Agreement or under said provisions, nor shall it preclude the further exercise of any such rights. Any waiver of a right must be express and in writing.

12.5. 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 Client hereby agrees that any dispute concerning the validity, interpretation, performance or termination of the Agreement, OncoSHARE and/or the Services shall be submitted to the exclusive jurisdiction of the courts of Charleroi, Belgium.

12.6. Force Majeure. OncoDNA will not be liable to the Client 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 Client 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.

12.7. 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.

12.8. 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).

Version: 17th May 2022