General Terms and Conditions of Indivumed GmbH
- In addition to Indivumed’s Ethical Principles as made available under https://www.indivumed.com/ethical-principles, the following General Terms and Conditions (hereinafter the “Terms”) shall apply to any provision of biospecimen, patient-derived clinical and other data and / or laboratory services (jointly hereinafter the “Supplies”) by Indivumed GmbH (hereinafter referred to as “INDIVUMED”) to any contract partner (hereinafter referred to as the “Recipient”), unless INDIVUMED and the Recipient have expressly agreed otherwise in writing with regard to any specific or to all topics addressed herein, as the case may be. For the avoidance of doubt, these Terms shall not apply to any services offered by INDIVUMED relating to its global cancer platform IndivuType.
- These Terms shall apply to all current and future provision agreements on Supplies between INDIVUMED and the Recipient for as long as INDIVUMED does not publish a new version of its General Terms and Conditions.
- By entering into a binding order with INDIVUMED, irrespective of the form, the Recipient accepts these Terms and any additional provisions contained in INDIVUMED’s respective quotation to the full extent, unless INDIVUMED and the Recipient have expressly agreed otherwise in writing in such order with regard to any specific or to all topics addressed herein.
- All deviating terms proposed, introduced or referred to by the Recipient are rejected by INDIVUMED and shall not be applicable even if INDIVUMED, knowing of such terms of Recipient, does not explicitly object to them, and continues with the provision of Supplies, unless, and as far as, INDIVUMED has expressly agreed to any such deviating terms in written form.
- Unless explicitly stated otherwise in these Terms or a binding order, the term “in writing” shall also include electronic signatures in the meaning of § 126a BGB (German Civil Code), simple electronic signatures rendered through services generally recognized in the industry such as DocuSign and AdobeSign, and emails and other media of text form in the meaning of § 126b BGB (German Civil Code).
2. Quotation and Order; Subcontractors, Third-Party Involvement
- Unless otherwise agreed in writing, any quotation or other offer of INDIVUMED is subject to change; particularly, any stated number of samples is subject to availability at time of agreement on a binding order.
- Within the meaning of § 151 BGB (German Civil Code), the Recipient hereby dispenses with the receipt of an express order confirmation which shall be implied in the consignment of the ordered Supplies.
- Unless otherwise set forth in an INDIVUMED quotation, any advice given to Recipient shall be non-binding.
- Unless explicitly agreed otherwise by Recipient and INDIVUMED in writing, INDIVUMED shall be entitled to subcontract any or all of its obligations to perform the Supplies provided always that such subcontractors shall, in the reasonable opinion of INDIVUMED, be capable of performing the Supplies to the same standards as INDIVUMED. Where reasonable, INDIVUMED shall notify the Recipient of any subcontractors being used in the provision of the Supplies and the Recipient shall have the right to refuse or accept all subcontractors. When engaging subcontractors in accordance with this Section, INDIVUMED shall be permitted to disclose Confidential Information (as defined in Section 13) of the Recipient to such subcontractors. INDIVUMED shall have the right to make any changes to the Supplies which are necessary to comply with any applicable law or safety requirement, or which are otherwise necessary or expedient and do not materially affect the nature or quality of the Supplies, subject always to providing the Recipient with reasonable written notice of any such changes. For clarification purposes only, INDIVUMED’s sources from whom biospecimen and associated clinical data are being obtained shall not be considered subcontractors and consents or permissions from Recipient shall never be required with regard to the involvement of such sources.
- In the event that the Recipient requests INDIVUMED to transfer goods and / or data containing or constituting personal data directly to a third-party recipient located outside the EU (such as collaborators, CROs or service providers of the Recipient) and INDIVUMED agrees to such transfer, the Recipient acknowledges and accepts that the transfer may only take place after execution of the SCC (as defined in Section 8.8) between INDIVUMED and the third-party recipient. The Recipient is responsible for entering into any other contractual agreements required in connection with any transfers to such third-party recipients (irrespective of whether goods and / or data to be transferred by INDIVUMED to a third-party recipient contain or constitute personal data and whether the third-party recipient is located within or outside the EU) and disclosures of Confidential Information (as defined in Section 13) of the Recipient made by INDIVUMED in connection with third-party transfers as described in this Section 2.5 are hence exempted from INDIVUMED’S confidentiality obligations according to Section 13.
3. Packaging, Delivery and Date of Delivery
- Unless explicitly agreed otherwise by the Recipient and INDIVUMED, delivery shall be DAP delivery address specified in the applicable INDIVUMED quotation (Incoterms 2010). Shipping costs will be prepaid by INDIVUMED and added to the invoice.
- Unless otherwise agreed in writing, INDIVUMED may specify the transport route and means of transport for the Supplies to be provided at its sole discretion.
- Unless otherwise agreed in writing, delivery dates are not binding.
- The packaging is to be carried out in accordance with the applicable laws and industry standards. The packaging material can be returned to INDIVUMED, provided that the Recipient bears the costs for the return shipment to the full amount.
4. Compensation for Supplies
- Any compensation for Supplies shall correspond to the amounts indicated in the applicable INDIVUMED quotation or, if no amount was so indicated, the amount which is indicated by INDIVUMED in the general compensations scheme applicable at the time of the placement of the order, or the respective invoice provided.
- All amounts stated are exclusive of any applicable tax, customs duties and other charges which are to be borne by the Recipient, unless otherwise agreed in writing.
5. Payment Terms
- Unless it has been otherwise determined in writing, all amounts stated are given and to be paid in EUR and the Recipient shall pay the compensation as well as any invoiced shipment costs for the Supplies within 30 days of the invoice date being issued by INDIVUMED. Payment is to be made preferably by wire transfer into INDIVUMED’s bank account. Cheques are only accepted after the prior written consent of INDIVUMED. Bills of exchange and credit cards are not accepted and are not accepted as fulfilment of the obligation to pay.
- Upon INDIVUMED’s reasonable request, Recipient shall furnish a letter of credit issued by a recognized bank or insurance company. In this case the letter of credit must be issued in accordance with the current version of the Uniform Customs and Practices for Documentary Credits, ICC Publication No. 500.
- In the event that the Recipient falls into arrears with its payments, INDIVUMED is entitled to set the Recipient a final payment deadline at its own reasonable discretion, notwithstanding all other rights or means of legal redress that it may be entitled to, and terminate the concerned contract or a specific order after the fruitless expiry of the stipulated period, or to temporarily cease further deliveries to the Recipient, and charge the Recipient interest at 8 % p.a. above the LIBOR rate on the amount still outstanding until payment has been made in full.
6. Passing of the Risk
Passing of risk shall occur as defined in Sec. 3.1 of these Terms. By sole way of exception, if Recipient expressly wishes to have any goods ordered prior to the turn of the year being temporarily stored by INDIVUMED at INDIVUMED premises and be delivered after the turn of the year, the full risk of damage to or loss of such goods rests exclusively with Recipient as from the selection of such goods by INDIVUMED and their internal attribution to the Recipient.
7. Import Documents and Authorizations
The Recipient is obliged to obtain in due time all import documents and authorizations required under respective local law for the provision of any Supplies and to support INDIVUMED in providing all statements mandatorily to be made by INDIVUMED itself in this respect. INDIVUMED shall be entitled to terminate the respective order without any further obligation or liability towards the Recipient in case such documents are not duly provided.
8. Obligations of the Recipient, Restrictions on Use of Biospecimen and Data
- Recipient shall adhere to all bindingly applicable international and local laws and regulations when handling any biospecimens / and or clinical and other data provided by INDIVUMED and shall release and hold INDIVUMED harmless from and against any sanctions imposed on INDIVUMED due to Recipient and / or its collaborators or clients infringing upon any such law or regulation.
- The Recipient must use the biospecimen and / or clinical and other data as well as any other goods, if any, provided by INDIVUMED as part of Supplies in strict compliance with any accompanying written information provided by INDIVUMED and adhere strictly to all instructions and information which have been issued by INDIVUMED for the Supplies, irrespective of whether in verbal or written form; this applies among other things to all information regarding storage, handling and use of the Supplies.
- Any biospecimens provided by INDIVUMED are experimental by nature and shall for precaution be treated with due care and as being potentially infective. Any biospecimen and / or associated clinical data may only be used for legally permissible research and development purposes, unless set forth otherwise in the applicable INDIVUMED quotation, in the field of oncology.
- Any biospecimens provided by INDIVUMED must not be transplanted, infused, transferred into, or otherwise used in a human body or animals.
- Biospecimens provided by INDIVUMED must not be used for diagnostic and / or therapeutic purposes. Any accompanying information issued by INDIVUMED does not represent any medical, health care or other specialist recommendations.
- Any analytical data provided by INDIVUMED are supportive research data only and are not released for diagnostic and / or therapeutic purposes.
- Recipient must not make any attempts to identify or contact any patients donating biospecimen and / or associated clinical data provided by INDIVUMED. In the event that the Recipient inadvertently identifies any individual donor, it shall immediately notify INDIVUMED setting out, in reasonable clarity and detail, the circumstances by which this happened.
- Goods or data linked to a data subject through a code, for instance pseudonymized clinical data, constitute personal data. The Recipient shall comply with all bindingly applicable laws on data protection, including, but not limited to the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation, “GDPR”). For any transfers of personal data in the performance of Supplies to a country outside the EU for which the European Commission has not confirmed a suitable level of data protection on the basis of an adequacy decision, the prior execution of the Standard Contractual Clauses released by the European Commission (“SCC”) between a non-EU Recipient and INDIVUMED is mandatorily required. In addition, for mandatory compliance purposes, non-EU Recipients agree to execute such additional data protection agreements with INDIVUMED regarding such transfers of personal data as are required by bindingly applicable law, particularly GDPR, and / or to implement any other appropriate safeguards that have been pre-approved by the European Commission for such data transfers in the absence of an adequacy decision for the recipient country. If compliance with bindingly applicable law necessitates an amendment of the SCC executed between INDIVUMED and the Recipient, the parties shall in good faith collaborate in preparing and executing such amendment. Recipients located in the EU shall not transfer any goods and / or data provided by INDIVUMED containing or constituting personal data to a country outside the EU, in the absence of an adequacy decision, without the prior execution of the SCC with the respective recipient.
- Prior to transferring any biospecimen and / or clinical data provided by INDIVUMED, the Recipient shall require any third-party recipient to acknowledge and agree and to comply with the permitted use as contemplated by these Terms.
9. Requirements Regarding Material Provided by Either INDIVUMED or the Recipient
- INDIVUMED shall ensure that biospecimen and associated clinical data provided to Recipient as part of Supplies have either (i) been previously obtained and validly held in possession and are subject to a waiver of consent by the applicable Institutional Review Board or Ethical Committee, or otherwise by bindingly applicable law; or (ii) to the extent any consent or authorization is required by bindingly applicable law, or by applicable approval authority, to be obtained from an individual in connection with the collection, maintenance or transfer of the biospecimen and / or clinical data, such informed consent or authorization was or will be obtained as required.
- The Recipient shall ensure that the use of all materials provided by it or on its behalf to INDIVUMED, such as biological / chemical substances, biospecimen and / or (personal) data, to be used for the performance of laboratory services provided to Recipient under these Terms is legally permissible. If considered necessary by Recipient, the Recipient will provide INDIVUMED with information needed for the proper and safe handling, use, storage, and disposal of materials provided by it (e.g. by providing safety data sheets or equivalent documentation as applicable) and inform INDIVUMED in writing about any restrictions regarding the permissible use prior to the delivery of such materials to INDIVUMED.
- In case that the Recipient provides biospecimens and / or associated clinical data to INDIVUMED for the performance of laboratory services as part of the Supplies, the assurance obligation set forth in Section 9.1 shall apply accordingly to the Recipient.
- INDIVUMED will use any materials provided by the Recipient solely for the performance of the agreed Supplies, handle with due care and not transplant, infuse, or transfer any such materials into, or otherwise use them in a human body.
10. Ownership of Biospecimen, Intellectual Property Rights
- INDIVUMED acknowledges that any materials and / or biospecimen, as the case may be, provided to INDIVUMED by Recipient to perform services under a binding order which are the Recipient’s sole property remain the sole property of Recipient, unless explicitly agreed otherwise by Recipient and INDIVUMED.
- Subject to full payment of all applicable compensation due, all intellectual property without limitation that involves or relates to patentable know-how, designs, and / or copyrights directly being part of, or directly resulting from, any Supplies provided hereunder shall be the sole property of Recipient (the "Recipient IP"), and the filing of any such intellectual property shall be in the sole discretion of Recipient. Notwithstanding the foregoing, to any data provided by INDIVUMED the Recipient shall receive a non-exclusive usage right only and solely for the purpose covered by the respective order, unless agreed otherwise in writing by Recipient and INDIVUMED. Any intellectual property generated by INDIVUMED solely or with others other than the Recipient or by others on behalf of INDIVUMED that can be used without reference to Supplies provided to Recipient or Recipient biospecimen, know-how or Confidential Information shall be the sole property of INDIVUMED (the "INDIVUMED IP"), and the filing of any such intellectual property shall be in the sole discretion of INDIVUMED.
- For clarification purposes only, INDIVUMED shall be entitled to freely use and exploit any assays which are exclusively derived from generally commercially available third-party materials and have been generated without any use of Recipient’s Confidential Information and / or Recipient’s biospecimen.
11. Warranty and Liability
- INDIVUMED warrants within the meaning of § 434 BGB (German Civil Code) that all Supplies delivered within the scope of these Terms conform to the applicable and agreed specifications as set forth INDIVUMED’s respective quotation (“Agreed Specifications”). For clarification, it is expressly pointed out that the term “warranty” in these Terms is not to be construed as any guarantee and in particular – and this applies without restriction – not as a guarantee in accordance with § 443 BGB (German Civil Code). Furthermore, INDIVUMED does not give any further warranties or guarantees, either expressly or implicitly.
- The Recipient shall inspect the Supplies without undue delay after receipt and notify INDIVUMED in writing of any deviations from Agreed Specifications.
- Deviations from Agreed Specifications which were not apparent even during a proper inspection are to be notified in writing to INDIVUMED by the Recipient without delay upon their identification.
- In the event of a warranty claim, the subsequent performance (remedial work or delivery of new Supplies) is to be carried out at the discretion of INDIVUMED.
- The liability of INDIVUMED for intentional fault, for gross negligence on the part of the boards or senior executives, for claims on the basis of the German Product Liability Act for culpable injury to life, body and health as well as the fraudulent concealment of defects is governed by the German statutory provisions. In addition, the liability is limited as follows: a) INDIVUMED is only liable for willful intent and gross negligence. b) In the event of gross negligence, INDIVUMED is only liable for foreseeable damages which are typical for this type of contract. c) In the event of ordinary negligence, INDIVUMED is only liable in the event of a breach of a contractual obligation whose fulfilment only makes possible the proper performance of the contract concluded between INDIVUMED and the Recipient and whose breach would endanger the achievement of the contractual purpose and compliance with the terms of the contract and on which the Recipient may rely on (material contractual obligation), and in such case also only for foreseeable damages which are typical for this type of contract. d) All claims become statute-barred in one year from the passing of the risk.
- All information which is contained in publications, offered in print or electronic media, has been collected by INDIVUMED to the best of its knowledge. INDIVUMED accepts no liability whatsoever for any errors or misprints.
- INDIVUMED accepts no liability for damages caused by improper handling and / or use of Supplies and / or by improper storage of Supplies.
12. Acts of God
- In any case where either party hereto is required to do any act (other than the payment of money), delays caused by or resulting from Acts of God such as war, civil commotion, fire, flood or other casualty, labor difficulties, shortages of labor, materials or equipment, government regulations, unusually severe weather, endemics or pandemics, or other causes beyond such party’s reasonable control such party shall not be liable to the other for any damages directly resulting from any failure to perform is contractual obligations due to such causes.
- The non-performing party must notify the other party as soon as practically possible of such an obstacle and its consequences for its ability to fulfil the contract. If the reasons for the non-performance continue longer than six months, each party shall be entitled to terminate the respective order in writing.
Each party acknowledges that it may be given access to or knowledge of relevant business information proprietary to the other party (“Confidential Information” or “CI”) in the meaning of any information, regardless of its form or the manner of disclosure, which is not public at the time of such disclosure. All quotations and orders and – for the exclusion of doubts – all compensation amounts as well as Supplies and application specifications and manufacturing records shall be regarded as Confidential Information. Each party agrees that it will, (i) use such CI only for the purpose of evaluating and negotiating a deal as discussed between the parties and exercising rights and obligations in the performance of Supplies (“Purpose”), (ii) maintain in confidence such CI of the other party to the same extent it handles its own CI, but to no lesser extent than a reasonable one and (iii) not disclose, without prior written consent of the other party, such CI to any third party other than to any of its own directors, officers, advisors or its and / or its affiliates employees which have a need to know such CI for the Purpose and have been bound before to confidentiality obligations materially consistent with the ones set forth in this Section 13. This obligation to maintain secrecy shall continue to be binding for a period of three (3) years after the last provision of Supplies to the Recipient.
14. Processing of Personal Data
15. Applicable Law, Place of Jurisdiction
- All contracts concluded between INDIVUMED and the Recipient hereunder and these Terms shall be governed and interpreted in accordance with German law without recourse to its choice of law rules and under the exclusion of the United Nations Convention on Contracts for the International Sale of Goods (Vienna 1980).
- All disputes arising from or in connection with any contracts concluded between INDIVUMED and the Recipient or these Terms, including all disputes about the conclusion of a contract and its binding effect, amendment and termination, shall be settled in the law courts of the Free Hanseatic City of Hamburg, Germany.
- INDIVUMED is entitled to assert any claims in a court at the principal place of business of the Recipient.
The provisions of any contract including the Terms are severable. Should a provision of such contract or the Terms be or become invalid or unenforceable, the validity and enforceability of the remaining provisions remain unaffected. The invalid or unenforceable provision or the gap in the provisions shall be replaced or filled by INDIVUMED and the Recipient, insofar as this is legally possible and permissible, with a valid and enforceable provision which comes closest to the agreement which would have been reached between INDIVUMED and the Recipient at the time of conclusion of the contract if they would have known about the necessity of such an adaptation at the time of the conclusion of the contract.
17. Successors and Assigns
Neither party may assign its rights and obligations in respect of Supplies without the prior written consent of the other party; provided, however, that each party may assign its rights and obligations regarding Supplies without the other party’s consent in connection with the transfer or sale of all or substantially all of its assets or business to which such Supplies relate, whether by merger, sale of stock/shares, sale of assets or otherwise.
Version: January 23, 2023