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, the “Supplies”) by Indivumed Services GmbH (hereinafter referred to as “Provider”) to any contracting party (the “Client”). Any statement of work or quotation that is executed between Provider and Client for the provision of Supplies (individually, a “Work Order”) shall automatically be subject to the Terms and thereby incorporated therein by reference and made a part thereof. The Terms may be updated from time to time.
1. Work Order.
1.1. Work Order. Unless otherwise agreed in writing, any offer or quotation is subject to change; in particular, any stated number of samples is subject to availability at the time of agreement on a binding Work Order.
1.2. Changes to Study. Once signed, the Work Order is binding and may be changed or modified only in writing by both parties. Notwithstanding the foregoing, Provider shall have the right to make any changes to the Supplies in order to comply with applicable law or safety regulations, or if such changes are necessary or expedient and do not materially affect the nature or quality of the Supplies; Provider will send Client a written notice of any such change. Should there be any changes to the study design, prices will be adjusted accordingly to include additional costs. Urgent change requests made by Client within 48 hours cannot be guaranteed and Provider reserves the right to make such changes; if executable, such changes may incur additional costs that Client shall be responsible for.
1.3. Deviating Terms. All terms inconsistent with, contradictory to, different, deviating, and or ambiguous from the Terms are hereby rejected by Provider and shall not apply even if Provider does not explicitly object to them.
2. Subcontractor. Unless explicitly agreed otherwise by Client and Provider in writing, Provider shall be entitled to subcontract any or all of its obligations to perform the Supplies, provided that such subcontractors shall have a confidentiality obligation to Provider and Client. Provider shall use reasonable efforts to notify the Client of any subcontractors being used in the provision of the Supplies. When engaging subcontractors in accordance with this Section, Provider shall be permitted to disclose Confidential Information (as defined in Section 13) of the Client to such subcontractors. For clarification, Provider’ sources from whom biospecimen and associated clinical data are being obtained, and any supplier, shipper, storage provider or import/export agent shall not be considered subcontractors and consents or permissions from Client shall never be required with regard to the involvement of such sources.
3. Packaging, Delivery, and Shipping
3.1. Delivery. Unless explicitly agreed otherwise by the Client and Provider, delivery shall be DAP mdelivery address specified in the applicable Work Order (Incoterms 2010). Shipping costs will be prepaid by Provider and added to the invoice.
3.2. Packaging. The packaging will comply with applicable laws and industry standards. The packaging material can be returned to Provider, provided that the Client fully bears the costs for the return shipment.
3.3. Passing of Risk. Passing of risk shall occur as defined in Sec. 3.1 of these Terms. Notwithstanding the foregoing, if Client expressly wishes to have any ordered goods under the Work Order stored temporarily at Provider’s premises and delivered later, the full risk of damage to or loss of such goods rests exclusively with Client from the time such goods are selected by Provider and attributed to the Client. Such temporary storage is subject to Provider’s discretionary approval.
3.4. Import and Documentation. The Client shall promptly obtain all import documents and authorizations required under respective local law for the provision of any Supplies and shall provide Provider with any documentation or information necessary for such import. Provider shall be entitled to terminate the respective order without any further obligation or liability towards the Client in case such documents or information are not duly provided.
3.5. Inspection. The Client shall inspect the Supplies without undue delay after receipt and notify Provider in writing no later than five (5) business days upon receipt of Supplies of any deviations from Agreed Specifications (defined in 6.2.2). Deviations from Agreed Specifications which were not apparent even during a proper inspection are to be notified in writing to Provider by the Client within five (5) business days 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 Provider, subject to Section 8.2.4 .
3.6. Waiver of Order Confirmation. Within the meaning of § 151 BGB (German Civil Code), the Client hereby waives the receipt of an express order confirmation which shall be implied in the consignment of the ordered Supplies.
4. Payment Terms
4.1. Compensation. Any compensation for Supplies shall correspond to the amounts indicated in the applicable Work Order. All amounts stated in the Work Order are exclusive of any applicable tax, customs duties and other charges which are to be borne by the Client.
4.2. Invoice. Client shall pay each such invoice within the period as specified in the Work Order. All payments hereunder shall be in EUR or USD by wire transfer in immediately available funds to a bank account designated in writing by Provider or by check made payable to Provider.
4.3. Late payment. In the event that any payment due hereunder is not made when due, the payment shall accrue interest from the date due at the rate of 1.5% per month; provided, however, that in no event shall such rate exceed the maximum legal annual interest rate. The payment of such interest shall not limit Provider from exercising any other rights it may have because of the lateness of any payment.
5. Restrictions on Use of Provider Materials
5.1. Any biospecimens / and or clinical and other data provided by Provider (collectively "Provider Materials") are experimental in nature and shall for precaution be treated with due care and as being potentially infective.
5.2. Client must use the Provider Materials in strict compliance with any accompanying written information provided by Provider and adhere strictly to all instructions and information which have been issued by Provider for the Supplies, irrespective of whether in verbal or written form; this applies to all information regarding storage, handling, and use of the Supplies.
5.3. Client shall adhere to all applicable international and local laws and regulations when handling Provider Materials and shall release and hold Provider harmless from and against any liabilities imposed on Provider due to misuse, infringement or violation of any regulations or laws by Client and / or its collaborators.
5.4. Any Provider Materials may only be used for legally permissible research and development purposes, unless set forth otherwise in the applicable Work Order, in the field of oncology.
5.5. Any Provider Materials must not be used for diagnostic and / or therapeutic purposes.
5.6. Any accompanying information issued by Provider does not represent any medical, health care or other specialist recommendations.
5.7. Any Provider Materials must not be transplanted, infused, transferred into, or otherwise used in a human body or animals.
5.8. Client must not make any attempts to identify or contact any patients donating biospecimen and / or associated clinical data provided by Provider. In the event that Client inadvertently identifies any individual donor, it shall immediately notify Provider setting out, in reasonable clarity and detail, the circumstances by which this happened.
5.9. Client may not transfer any Provider Materials without Provider’'prior written consent. If consent is granted or is permitted as to the transfer of Provider Materials under these Terms, the Client shall require any third-party recipient to enter into a written agreement binding them to the non-use and data protection obligations under these Terms, including the execution of an SCC with any third-party recipients located in a non-EU country lacking an adequacy decision.
6. Representations and Warranties
6.1. Representations and Warranties by Both Parties.
6.1.1. Either party may provide biospecimen, clinical data, samples, and/or other materials under the Work Order to the other party (the "Material Recipient"). The party providing the materials (the "Material Transferor") hereby represents and warrants that if such Materials include biospecimen and / or clinical data, then such biospecimen and /or clinical data 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 equivalent authorities or (ii) to the extent any consent or authorization is required by applicable law or approval authority 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.
6.1.2. In addition, the Material Transferor further represents and warrants to the Material Recipient that (i) the Material Transferor has the right to provide all materials as contemplated by the Terms and the relevant Work Order; and (b) to the Material Transferor’s knowledge, the use of such materials does not infringe the intellectual property, proprietary, or other legally protected rights of any third party.
6.2. Other Warrants by Provider.
6.2.1. Provider shall use the Client's Materials solely for the performance of the agreed Supplies; Provider shall not transplant, infuse, or transfer any such materials into, or otherwise use the Client’s Materials in a human body.
6.2.2. Subject to Section 8.2.4 , Provider 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 Provider’s respective Work Order ("Agreed Specifications").
7. Ownership of Biospecimen, Intellectual Property Rights
7.1. Client Materials. Any Client's Materials remain the sole property of Client.
7.2. Ownership of Provider Materials. Upon full payment of all applicable compensation due, and subject to the Section 5 and other terms in the Terms and associated Work Order, Client shall (i) be the sole, exclusive user of the biospecimen provided by Provider; (ii) receive a non-exclusive, non-transferrable, and non-sublicensable license to use any clinical data provided by Provider; and (iii) own all right and interest in any discovery, invention, information, and results, including associated intellectual property rights, generated by Client from the use of the biospecimens provided by Provider. Notwithstanding the foregoing, Provider shall remain the sole and exclusive owner of any clinical data under the Supplies.
7.3. Intellectual Property Rights. Subject to full payment of all applicable compensation due, all intellectual property directly resulting from any Supplies provided hereunder shall be the sole property of Client (the "Client IP"), and the filing of any such intellectual property shall be in the sole discretion of Client. Any intellectual property generated by Provider solely or with other entities (other than Client) or by others on behalf of Provider that can be used without reference to Client’s materials, know-how or Confidential Information shall be the sole property of Provider (the "Provider IP"), and the filing of any such intellectual property shall be in the sole discretion of Provider.
7.4. No Implied License. Neither any provision of these Terms nor any disclosure of confidential or proprietary information by either party shall operate to confer any intellectual property rights upon the other party or be effective to license or transfer to the other party any right, title, or interest in the confidential or proprietary information of such party.
8. Disclaimer and Limitation of Liabilities
8.1.1. EXCEPT AS EXPRESSLY SET FORTH IN THE TERMS, PROVIDER DOES NOT MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGMENT, MERCHANTIBILITY, AND FITNESS FOR A PARTICULAR PURPOSE FOR ANY OF ITS SUPPLIES. Both parties hereto acknowledge and agree that Provider does not warrant or represent that any of its Supplies and/or the results of any study will be acceptable to any regulatory agency to which such results are presented or that the results of the study will enable Client to commercialize or otherwise exploit the Supplies or any product or technology.
8.1.2. All information which is contained in publications, offered in print or electronic media, has been collected by Provider to its best knowledge. THE PROVIDER ACCEPTS NO LIABILITY WHATSOEVER FOR ANY ERRORS OR MISPRINTS.
8.1.3. PROVIDER ACCEPTS NO LIABILITY FOR DAMAGES CAUSED BY IMPROPER HANDLING AND / OR USE OF SUPPLIES AND / OR BY IMPROPER STORAGE OF SUPPLIES.
8.1.4. The clinical collection of biospecimen is performed from a patient during a surgical procedure. The characteristics of biospecimen varies depending on the patient. Therefore, while Provider endeavors to collect the sample according to the Agreed Specifications, it cannot guarantee such. SAMPLES THAT PROVIDER DEEMS AS CONFORMING WITH SUCH SPECIFICATIONS AND DELIVERS TO CLIENT ARE NOT RETURNABLE AND WILL BE INVOICED IN ACCORDANCE WITH THE WORK ORDER.
8.2. Limitation of Liability. EXCEPT FOR LOSSES ARISING FROM INDEMNIFICATION OBLIGATION OR BREACH OF CONFIDENTIALITY OR INTELLECTUAL PROPERTY, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES IN CONNECTION WITH THE WORK ORDER. In no event shall Provider be responsible for damages, lost profits, or the cost of procurement of substitute goods and/or any materials used in the study, technology or services.
8.3. Indemnification. Each party ("Indemnifying Party") hereby agrees to save, defend, indemnify and hold harmless the other party, the other party's Affiliates (defined below) and their respective officers, directors, employees, consultants and agents (each, an "Indemnitee") from and against any and all losses, damages, liabilities, and costs, including reasonable legal expense and attorneys' fees ("Losses"), to which any Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any third party to the extent such Losses arise directly or indirectly out of the development, manufacture, use, handling, storage, sale or other disposition of any product by the Indemnifying Party, the gross negligence or willful misconduct of the Indemnifying Party or its personnel or the breach by the Indemnifying Party of any warranty, representation, covenant or agreement made by the Indemnifying Party in the respective Work Order, except to the extent such Losses result from the gross negligence or willful misconduct or breach of the respective Work Order by any Indemnitee.
9. Confidentiality. Each party acknowledges that it may be given access to or knowledge of relevant business information proprietary to the other party ("Confidential Information"), regardless of its form or the manner of disclosure, which is not public at the time of such disclosure. All Work Orders, payment, Supplies, application specifications, manufacturing records, among others, shall be regarded as Confidential Information. Confidential Information shall not include any information that the receiving party can prove by competent evidence: (a) was already known to the receiving party without any obligations of confidentiality prior to receipt from the other party; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving party; (c) becomes generally available to the public or otherwise part of the public domain after its disclosure, other than through any act or omission of the receiving party in breach of any obligation of confidentiality; (d) was disclosed to the receiving party, other than under an obligation of confidentiality, by a third party who had no obligation not to disclose such information to others; or (e) was independently discovered or developed by the receiving party without the use of Confidential Information of the other party. Each party agrees that it will: (i) use such Confidential Information 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 Confidential Information of the other party to the same extent it handles its own Confidential Information, but to no lesser extent than a reasonable one and (iii) not disclose, without prior written consent of the other party, such Confidential Information to any third party other than to any of its own directors, officers, advisors, subcontractors or its and / or its Affiliates employees which have a need to know such Confidential Information for the Purpose and have been bound before to confidentiality obligations materially consistent with the ones set forth in this Section. 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 Client. Notwithstanding the foregoing, a party may disclose Confidential Information of the other party, without violating the obligations herein, to the extent the disclosure is required by applicable law, or a valid order of a court or other governmental body having jurisdiction.
10. Processing of Personal Data.
10.2. Data Transfer outside the European Union. Client shall comply with all applicable laws on data protection, including the General Data Protection Regulation 2016/679) ("GDPR"). Any transfer of clinical data to recipients outside the EU countries may require both parties to sign Standard Contractual Clauses (SCC) as mandated by the European Commission.
11. Applicable Law, Place of Jurisdiction. All contracts concluded between Provider and the Client hereunder and the Terms shall be governed and interpreted in accordance with German law excluding its choice of law rules; in addition, application of the United Nations Convention on Contracts for the International Sale of Goods (Vienna 1980) is hereby excluded. All disputes arising from or in connection with any contracts concluded between Provider and the Client 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. Provider is entitled to assert any claims in a court at the principal place of business of the Client.
12. Successors and Assigns. The Terms shall inure to the benefit of and be binding upon the successors and assigns of both parties hereto; provided, however, that neither party shall transfer or assign the Terms without the prior written consent of the other party. Notwithstanding the foregoing, a party may assign the Terms and its rights and obligations hereunder without such consent to an Affiliate of the assigning party or in connection with the transfer or sale of all or substantially all of the business of the assigning party to which this Agreement relates, whether by merger, sale of stock, sale of assets or otherwise. "Affiliate" shall mean, with respect to an entity, any other entity that directly or indirectly controls, is controlled by, or is under common control with, the entity. For the purpose of this definition; "Control" means the ownership and voting control of more than fifty percent (50%) of the outstanding voting securities or interest in capital or profits of an entity, or the right to direct or control the management or affairs of such entity by contract or similar arrangement.
13.1. Termination of Agreement at Will. Either party may terminate the Work Order at any time upon thirty (30) calendar days' prior written notice to the other party. Notwithstanding the foregoing, if any Work Order are in progress on the date on which a party gives notice, then termination under this Section 13.1 shall not be effective until the later of (a) thirty (30) calendar days after the date on which the other party receives such notice of termination, or (b) when the Work Order have been completed.
13.2. Early Termination. Client's request to terminate the Work Order prior to the agreed end of Work Order must be received in writing, and Provider shall have no less than 30 days of notice of such early termination. Provider may terminate the respective binding order by providing 30-day written notice to Client upon Client's breach, including Client's failure of payment, if such breach has not been cured within such 30-day period. In the case of early termination, all costs incurred by Provider for Supplies rendered, materials purchased, committed contracted work, and other out-of-pocket expenses and non-cancellable commitments will be invoiced.
14. Miscellaneous. (A) Independent Contractor Relationship. Provider's relationship with Client will be that of an independent contractor and nothing in the Work Order should be construed to create a partnership, joint venture, or employer-employee relationship. Provider is not an agent of Client and is not authorized to make any representation, contract, or commitment on behalf of the Client. (B) Entire Agreement; The Work Orders constitutes the final, complete and exclusive agreement of the parties with respect to the subject matter hereof and supersedes all prior understandings and agreements relating to its subject matter. (C) Severability. If any provision of the Work Order should be held invalid or unenforceable, the remaining provisions shall be unaffected and shall remain in full force and effect, to the extent consistent with the intent of the parties as evidenced by the Work Order as a whole. (D) Force Majeure. In the event of a delay caused by inclement weather, fire, flood, strike or other labor dispute, pandemic, act of God, act of governmental officials or agencies, or any other cause beyond the control of the parties, the party or parties so affected shall be excused from performance hereunder for the period of time attributable to such delay, which may extend beyond the time lost due to one or more of the causes mentioned above. The affected party must notify the other party as soon as practically possible of such an obstacle and its consequences for its ability to fulfill 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. (E) Non-Waiver. No failure or delay of one of the parties to insist upon strict performance of any of its rights or powers under the Work Order shall operate as a waiver thereof, nor shall any other single or partial exercise of such right or power preclude any other further exercise of any rights or remedies provided by law.