CUSTOMER SERVICE AND PROCESSING AGREEMENT V2.4 (21.09.2021)

  

Entry in force date:

between 

The Customer

[Including name, institution and Registered Office Address]

and

The Health 2030 Genome Center

Fondation Campus Biotech Geneva

9 Chemin des Mines

CH-1202 I Geneva I Switzerland

 

each of the parties hereinafter also referred to as a “Party” and jointly as the “Parties”.

PREAMBLE

A. The Customer is and remains the owner and the controller of the provided biological samples and the produced data. The Genome Center will not analyze, publish, share or otherwise use any samples or data that is hosted or generated in the Genome Center environment, unless a specific task is mandated by the data owner.

B. The Health 2030 Genome Center is the genomic medicine arm of the Health 2030 initiative, whose partners include the EPFL, UNIGE, CHUV, HUG, UNIL, InselSpital and UNIBE, and is legally represented by the Fondation Campus Biotech Geneva. From now on the Health 2030 Genome Center is referred to as the Genome Center in the Agreement.

C. The Genome Center maintains an ISO15189 certified medical platform/laboratory for nucleic acid sequencing and analysis to support large-scale genetics and genomics research as well as clinical-grade diagnostic nucleic acid sequencing. Accreditation number SMTS 0050 granted by the Swiss Accreditation Society on 03.05.2021 (https://www.health2030genome.ch/accredited-sequencing-services).

D. The Customer wishes to benefit from the Services of the Genome Center as described in this Agreement to perform nucleic acid sequencing and/or data processing.

GENERAL TERMS OF SERVICES

1. Services
   • In accordance with the terms of this Agreement, the Genome Center undertakes to provide to the Customer the services specified in the paragraphs 1.2. and 1.3., as well as specified in Appendix 1, which forms an integral part of this Agreement, as a matter of best efforts using validated procedures, all available knowhow and following nationally and internationally accepted guidelines for handling biological samples and confidential data (the “Services”).
   • The standard Services include the following:
     1. When appropriate, confirming the acceptance criteria to qualify for ISO 15189 clinical grade sequencing (iso.org) are appropriately described and met for each sample (e.g. concentration and amount of material, nucleic acid degradation metrics, etc.);
     2. If necessary, controlling the quality of the nucleic acids provided by the Customer;
     3. Processing provided samples for both clinical-grade and non-clinical-grade sequencing and production of raw data (undemultiplexed reads) in the Genome Center DNA Sequencing Platform;
     4. Analyzing raw sequenced data and producing unaligned demultiplexed sequence data in the format of FASTQ files in the Genome Center Data Analysis and Interpretation Platform;
     5. Delivering FASTQ files and quality control reports to the Customer in accordance with paragraph 3 of this Agreement;
     6. Storage of the data in the Genome Center secure infrastructure for six (6) calendar months as of the closure date of the project (timestamped on the delivery report).
   • Processing of samples that do not meet the quality criteria for clinical-grade sequencing and other processing and data governance activities requested by the Customer are specified and priced in Appendix 1.
2. Financial Terms and Charges
   • The cost of the standard Service is recorded in Appendix 1 of the Agreement.
   • Other processing activities and non-standard Services requested by the Customer are recorded and invoiced according to the terms and conditions defined in Appendix 1.
   • Terms defining payment conditions, schedule and overdue charges are specified in the Appendix 1 or on a quote offered by the Genome Center and approved by the Customer. Specific details of the agreement are recorded in Appendix 1.
3. Data Transfer to the Customer
   • The signatory of the Customer designates the individuals (specified in Appendix 2) to whom all or part of the data shall be transferred.
   • Unless otherwise specified in Appendix 1, the standard service includes the organization of a one-time data delivery. Additional data delivery events can be organized for an associated fee.
   • Unless otherwise specified in Appendix 1, the data shall be transferred in an encrypted way by providing authorized remote secured access to the designated individuals. The Data delivery shall be compliant with the Swiss Personalized Health Network (SPHN) Information Security Policy (pdf).
   • According to the standard Service, the data will remain in the Genome Center secure infrastructure for six (6) calendar months as of the closure date of the project (timestamped on the delivery report). After this period, the data will be deleted upon approval by the Customer and in accordance with art. 3.
     1. The Genome Center informs the Customer in writing about the closure of the project and requests the Customer permission for data removal five (5) months after the closure of the project.
     2. The Customer is responsible to approve the data removal in writing by the end of the sixth calendar month as of the closure date of the project (timestamped on the project report).
     3. In case of absence of response, the Genome Center will activate data storage service for additional six (6) calendar months with the price of Twenty Swiss Francs per terabyte per month (CHF 20.-/TB/month), payable within thirty (30) calendar days following the receipt of the corresponding invoice.
   • Upon expiry of this Agreement (as defined in paragraph 8.2), the derived sequence data will be deleted from the Genome Center infrastructure. The Genome Center reserves the right to keep the quality metrics and metadata required for evaluating and improving the performance of its service.
   • Upon expiry of this Agreement (as defined in paragraph 8.2), the remaining aliquots (for example nucleic acid samples, sequencing libraries, etc.) will be returned to the Customer at their expense or will be destroyed irreversibly.

RESPONSIBILITIES

4. Responsibilities of the Genome Center
   • The Genome Center shall respect the laws and the best practices on processing confidential data to protect the autonomy, privacy and rights of the individuals whose samples will be sequenced.
   • The Genome Center is responsible for providing to the Customer detailed information about the primary sample requirement metrics and the Services, including sample concentration and volumes, instructions for transportation of samples, any needs for special handling or precautions, and quality values of derived sequence data as specified on the Genome Center website (https://www.health2030genome.ch/accredited-sequencing-services).
   • The Genome Center is responsible for securing integrity and security of the data, for protecting data against loss, unauthorized access, transmission and abuse of access rights in the Genome Center secure infrastructure during this Agreement.
   • In case of a data breach that affects the sensitive data of the Project, the Genome Center is responsible to inform the Customer within 36 hours after having learned about the potential occurrence of said data breach. The Parties must then agree on how they will manage the event, on who will bear the costs, and if they will provide an indemnity to the concerned data subjects. Moreover, the concerned Parties shall designate who will be responsible for notifying the competent authority(-ies) and, if required, the concerned data subjects. These actions will be carried out according to the Swiss Federal Act on Data Protection (FADP).
   • The Genome Center shall provide the estimated Service delivery time according to the indicative timeline defined by the Customer and by the Genome Center in Appendix 1.
5. Responsibilities of the Customer
   • The Customer is responsible for and shall confirm in Appendix 2 that it has the authority to process provided samples and that it has the right to transfer the samples to the Genome Center. If applicable, the signatory shall confirm that a relevant institutional ethics review board or ethics commission has approved high-throughput nucleic acid sequencing of the provided samples. In particular, the collection, storage, and use of the provided samples is based on the free and informed consent of the subjects.
   • The Customer and/or their designated associates have the competences and, if applicable, necessary certifications to process the biological samples according to the best laboratory practice protocols and to ensure accountable and lawful use of the obtained sequence data.
   • To protect individual autonomy and privacy, the Customer shall pseudonymize all sample names prior to sending them to the Genome Center and shall not reveal to the Genome Center any identifying personal information of the individuals from whom the samples are derived.
   • The Customer is responsible for following all precautions and instructions for sample quality, transportation of samples, as well as needs for special handling communicated to the Customer and/or their designated associates by the Genome Center as described on the Genome Center website (https://www.health2030genome.ch/accredited-sequencing-services).
   • The Customer is responsible to communicate with the subjects if they request information about the processing of their samples or personal data associated to it.

DATA OWNERSHIP AND INTELLECTUAL PROPERTY

6. Data and sample ownership
   • As stated in the Preamble, the Customer is the owner and the controller of the provided biological samples and the produced data.
7. Intellectual property
   • The Genome Center declares no ownership of the data or the intellectual property created using the data produced under this Agreement.

TERM OF THE AGREEMENT

8. Entry into Force and Term
   • This Agreement enters into force at the date specified on the front page of the Agreement.
   • The Agreement shall remain in effect for a fixed period of xxx months unless the execution of the Service defined in Appendix 1 cannot be accomplished in this period of time. In this case, the Agreement will continue until completion of the Service, and subject to the art. 3.4. and conditions defined in Appendix 1.
9. Termination
   • In the event the Parties breach or fail to comply with one or more of their obligations, the suffering party shall give to the non-compliant party written notice of such breach at any time thereafter. The non-compliant party shall remedy such breach within thirty (30) days from the date of such notice. In the event that the non-compliant party does not remedy the breach within the said 30 days, the suffering party shall, without incurring any liability whatsoever, have the right to immediately terminate this Agreement by giving written notice of termination to the non-compliant party to that effect.
   • In case of termination whatsoever, the Parties shall have no further obligations to each other under this Agreement, except for the payment of those accrued expenses for the work performed for the Services, up to the date of termination, as well as any reasonable expenses incurred prior to the receipt of the termination notice. Such expenses shall be paid by the debtor party to the creditor party within thirty (30) days of receipt of the invoices. Upon receipt of a termination notice, the Genome Center will stop the Service, and shall immediately deliver to the other party all written reports and all provided samples. The Parties are not precluded from claiming any other damages, compensation or relief that they may be entitled to upon such expiration or termination.

LIABILITY

10. Limitation of liability
    • Each Party’s liability does not extend to any consequential or indirect damages, such as in particular losses of profits, losses of opportunity or losses of clients.
    • The Genome center’s liability shall not exceed the total amount of its remuneration under the Agreement (see art. 2 and Appendix 1).
    • Each party’s liability shall not be limited in case of damages caused by serious misconduct. The indemnification of damages arising from the violation of intellectual property rights is also reserved.

GOVERNING LAW AND JURISDICTION

11. Applicable laws and jurisdiction
    • This Agreement shall be governed and construed in accordance with the laws of the Swiss Confederation.
    • Any disputes arising out or in connection with the conclusion, the interpretation or the execution of the Agreement shall be settled under the rules of the ordinary court of the canton of Geneva, without prejudice to an appeal before the Supreme Federal Court.

MISCELLANEOUS

12. Miscellaneous
    • The present Agreement represents all of the covenants and agreements between the Parties regarding the Services provided. It annuls all prior agreements between the Parties. The Agreement constitutes, with its Appendixes, if necessary, the entire and sole agreement between the Parties regarding the subject of the Agreement.
    • If any provision, term or condition contained in this Agreement or its Appendixes were to be declared invalid, void, illegal or unenforceable, the other terms, conditions and provisions shall stay in force and the Agreement shall be executed as if the invalid, void, illegal or unenforceable terms, conditions or provisions have never been part of the Agreement. In such cases, the Agreement shall be interpreted in order to maintain the will of the Parties.
    • The provisions of the Agreement shall not be modified without a written amendment duly signed by the Parties. Such written and signed amendment will integrally be part of the Agreement.
    • The words “execution”, “signature” and similar words in this Agreement shall be deemed to include unqualified electronic signatures (e.g. Docusign or any equivalent e-signature provider) which shall be of the same legal effect, validity or enforceability as a manually executed signature; while the term “written” and “in writing” shall include communications by email or other electronic forms.
13. Force majeure
    • Neither party will be liable to the other for any failure or delay in the execution of the Agreement if the performance of the Agreement is prevented or delayed by a Force Majeure event.
    • A Force Majeure event suspends the contractual obligation whose execution becomes impossible, as long as such Force Majeure event continues.
    • The Genome Center assumes no liability for any damages to the data or loss of the data, provided such damage or loss was not caused by a wilful intent or act of gross negligence.
14. Prohibition to disclose confidential information
    • Each of the Parties undertakes not to disclose any confidential information in relation with this Agreements and the Services provided to any third party without the prior written consent of the other Party and commits to cause its employees, agents, or subcontractors to respect the present confidentiality clause at all times.

 

[signature page]

 

APPENDIX 1

Terms of the Service agreed between the Customer and the Genome Center

The details of the services requested by the Customer and conditions agreed by the Parties are provided in the table at the end of Appendix 1.

A. Definitions

Data generation

Includes nucleic acid quality control (if necessary), library preparation and sequencing of samples provided by the Customer.

Data processing

Includes processing raw sequence data and producing unaligned demultiplexed sequence data; the output is in the format of FASTQ files.

Data analysis

Includes analysis of sequence data by the Genome Center standard pipelines, using a given set of references and standard parameters.

Data interpretation

Includes sequence data analyses according to custom parameters and all descriptive or non-conventional downstream data interpretation. 

B. Requested standard Service

Section B defines the details of standard data generation services requested by the Customer.

The Genome Center standard services are defined by the article 1.2. of the General Terms of Service.

Requested library type

For example: mRNA-sequencing; Total RNA sequencing; Whole-genome sequencing; Twist Whole-exome sequencing; Customer prepared libraries.

Requested sequencing run configuration

For example: 50PE; 100PE; 150PE; Other

Requested sequencing target cluster number or fold-coverage

For example: 10M clusters per library (average per library across the sample set), 10M clusters (minimum per library across sample set), 30x coverage (average per library across the sample set), 30x coverage (minimum per library across sample set)

Estimated sample number in sample set

The number of samples the customer expects to submit for the requested services. Note that the customer is not required to submit this exact number.

Other laboratory services

Services such as assessment of nucleic acid quantification (e.g. Qubit analysis) or nucleic acid integrity (e.g. Fragment Analyzer analysis).

 

C. Requested non-standard Services

Section C defines the details of non-standard services requested by the Customer.

Any additional processing of samples, analysis, interpretation or governance of the data shall be discussed, priced and agreed between the Customer and the Genome Center prior to signing the Agreement.

Data storage and governance

The standard period for data storage and governance provided by the Genome Center is 6 months after the closure date of the project. The Customer can opt to extend this period upon agreement of conditions (period, cost, etc.). These conditions shall be discussed, priced and agreed between the Customer and the Genome Center prior to signing the Agreement.

D. Requested file formats

Section D describes the file formats for data delivery.

The Genome Center standard delivery for each processed sample contains a FASTQ file and a delivery report with corresponding quality metrics. BAM/SAM and VCF formats can be delivered upon agreement and are subject to an additional fee. Delivery of any additional information or data formats (e.g. merged FASTQ files) shall be discussed, priced and agreed as non-standard service between the Customer and the Genome Center prior to signing the Agreement.

E. Data delivery protocol and project timeline

Section E describes the data delivery protocol as well as the estimated timeline for the project.

Data delivery protocol

The Customer can choose between two delivery options:

• Processing and delivery at specified intervals during the project;
• Processing and delivery by whole project with data delivery following completion of data generation. For this option, the WGS data deliveries have an upper limit of 300 samples.

The Genome Center standard protocol uses SSH File Transfer Protocol for transferring data in encrypted way. If the data transfer occurs via intermediate hosts, the data will be encrypted prior to transfer. The customer is responsible for providing to the Genome Center precise credentials and address of the server for the delivery of their data. Any variation from the standard protocol shall be discussed, priced and agreed between the Customer and the Genome Center prior to signing the Agreement.

Estimated project timeline

For planning purposes, an estimate of the project timeline is provided.  The Genome Center will endeavor to the best of its abilities to meet this timeline.

F. Charges and payment

Section F provides a summary of the charges for the requested services.

The summary includes charges for quality control and processing of samples, data analysis, transfer and governance requested by the Customer. The pricing and payment schedule shall be discussed and agreed between the Customer and the Genome Center prior to signing the Agreement.

 

Example of Appendix 1*: see example

 

Example of Appendix 2*: see example

Please note that this online form will be completed by the customer upon request.

*These appendices are provided for reference purposes only. Updated versions may be used when signing the final CSA.

For any inquiry on the CSA please refer to the Customer FAQs or contact us.