Terms and Conditions, CRO Services - Biognosys

Terms and Conditions, CRO Services

Terms and Conditions for Procurement of Services

from

Biognosys AG

Wagistrasse 21

8952 Schlieren (Zurich)

Switzerland (“Provider”)

As of: 4 September 2024

 

1. Acceptance – ALL SERVICES ARE SUBJECT TO AND EXPRESSLY CONDITIONED UPON THE TERMS AND CONDITIONS CONTAINED HEREIN, AND UPON CLIENT’S ASSENT THERETO. NO VARIATION OF THESE TERMS AND CONDITIONS WILL BE BINDING UPON PROVIDER UNLESS AGREED TO IN WRITING AND SIGNED BY AN OFFICER OR OTHER AUTHORIZED REPRESENTATIVE OF PROVIDER.

These Terms and Conditions and the applicable Order, together with any and all attachments and appendices incorporated therein, issued or accepted by Provider and the Client as identified in such Order (collectively, the “Agreement“) govern the provision and purchase of the Services (each herein defined) described in such Order.

 

2. Definitions

2.1. “Affiliate” means any person, firm, association, organization, corporation, company, or other entity which: (i) is Controlled by a party hereto; (ii) Controls a party hereto; or (iii) is under common Control with a party hereto. “Control” is assumed when more than fifty percent (50%) of the controlled entity’s shares or ownership interest representing the right to make decisions for such entity are owned or controlled, directly or indirectly, by the controlling entity.
2.2. “Applicable Laws” means any country, federal, state, provincial, commonwealth, cantonal or local government law, statute, rule, requirement, code, regulation, permit, ordinance, authorization, order, judgment or similar governmental requirement, including any interpretation or guidance documents relating to any of the foregoing issued by a relevant governmental authority, in each case to the full extent applicable to any of the parties, this Agreement or Service to be provided hereunder. Applicable Laws includes without limitation Anti-Corruption Laws and Export Control Laws.
2.3. “Background IP” shall mean with respect to each party, any and all Intellectual Property Rights owned by such party upon placement and acceptance of the Order, including, without limitation, in any pre-existing technology and know-how, and in any further developments, improvements and modifications made thereto by such party during execution of Services under the applicable Order.
2.4. “BGS Platform” shall mean a proprietary platform, and associated protocols, methods and procedures, enabling protein profiling and data analysis thereof based on organic samples or other substances that was developed, is maintained, and owned by Provider and is used for protein profiling, data analysis and certain other services to third party customers.
2.5. “Change Order” means a written modification to an Order agreed between the Client and the Provider.
2.6. “Client” means the entity that signs the Order (together with its Affiliates and subsidiaries).
2.7. “Client Raw Data” means unaltered data collected by methods such as a mass spectrometer, spectrophotometer, or any other primary data collection method.
2.8. “Deliverables” means reports, data, information, documentation or other specific deliverables resulting from the Services if the applicable Order provides for Provider to deliver such results to Client.
2.9. “Good Clinical Practice” or “GCP” means (i) a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people, (ii) the laws, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in any relevant country, and refers (iii) to the European Medicines Agency (EMA) Reflection paper for laboratories that perform the
analysis or evaluation of clinical trial samples, February 2012.
2.10. “Good Laboratory Practices” or “GLP” means then-current standards, practices and procedures promulgated or endorsed by (i) the European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices as well as “The rules governing medicinal products in the European Union,” Volume 3, Scientific guidelines for medicinal products for human use (ex – OECD principles of GLP), (ii) the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and (iii) the equivalent laws in any relevant country, in each case, including all applicable rules, regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto.
2.11. “Intellectual Property Rights” shall mean (i) patents along with all reissues, continuations, continuations-in-part, revisions, divisions, extensions and re-examinations, supplementary protection certificates, any other rights to inventions, (ii) copyright and related rights, (iii) trademarks, trade names and domain names, rights in get-up, rights in goodwill or rights to sue for passing off, (iv) rights in designs, (v) rights in computer software and database, (vi) trade secrets, confidential technical knowledge and manufacturing processes, methods and procedures in the possession of a party or, as the case may be, to which a party has permitted access, (vi) and any other proprietary or intellectual property rights, in each case whether registered or unregistered and including all applications (and rights to apply) for, and renewals or extensions of, such rights and all similar or equivalent rights or forms of protection which subsist in any part of the world.
2.12. “Order” has the meaning set forth in Section 3.2. below.
2.13. “Quote(s)” means Provider’s written, itemized, descriptive list of Provider Services and the associated fees therefor.
2.14. “Record” means those specific records, notes, documents, data and the like that are specific to a business process (as opposed to any particular Order or Client’s Confidential Information) that are regularly kept in the ordinary course of the business and/or are required to be owned and maintained by Provider for legal or regulatory reasons, such as, but not limited to, medical records, source documents, written policies and procedures, standard operating procedures, time sheets, third party invoices, system validation, change management systems, quality control systems, maintenance tests of equipment, and financial reports. For the avoidance of doubt, Deliverables and Client Raw Data are excluded from the scope of this term.
2.15. “Representatives” means employees, directors, advisors, or agents of each respective party to the applicable Order.
2.16. “Services” means all necessary or required services, tasks, functions and other responsibilities and activities as set forth in, or reasonably inferable from, this Agreement or any Order issued hereunder to be governed by this Agreement, including the provision of Deliverables.
2.17. “Standard of Performance” means (i) meeting the professional standard of diligence, care, timeliness, trust, dependability, safety, oversight, efficiency, economy and skill exercised by members of Provider’s profession in the country where the Services are being performed with expertise in providing companies comparable to Client with first-class services substantially similar in size, scope, cost and complexity to those to be provided hereunder and (ii) exercising such professional standard by appropriate action or inaction.
2.18. “Statement of Work” means a detailed written description of the specific Services and/or Deliverables to be completed under an Order and may include the designation of partial invoices.

 

3. SCOPE OF WORK, ORDERING

3.1. Scope of Work. Provider will perform the Services ordered by Client and create and deliver any specified Deliverables, as detailed in the Order, including any Statement of Work attached thereto or incorporated therein by reference.

3.2. Ordering Process. With or without request of the Client, Provider will submit a Quote to Client, and such Quote will become an Order once Client submits a purchase order to Provider. Provider will not begin work under an Order until Provider receives the corresponding purchase order from the Client.

3.3. Quotes. Quotes are valid until the expiration date indicated on each Quote. Provider will provide an updated Quote if Client wishes to execute an order on an expired Quote.

3.4. Change Orders. After placement of an Order, should a Change Order be needed, such Change Order must be documented and agreed upon by Provider and Client. Client will ensure that each Change Order identifies all applicable changes. Provider will not perform any work that exceeds or differs from that specified in the Order until such change has been agreed in accordance with this Section 3.4.

3.5. Order Termination. Client may terminate an Order at any time (i) by giving at least six (6) months’ prior written notice to Provider, or (ii) immediately by giving written notice to Provider, if termination is for safety or regulatory reasons, including but not limited to a request from the FDA, EMA or other regulatory authority or breach (or threatened breach) of the governing confidentiality provisions. Upon the receipt of notice of termination of an Order from Client, Provider will immediately cease performance of the Order, and comply with all reasonable requests and instructions of Client to wind down the Order in an orderly and safe manner while minimizing additional costs to Client. Client will pay any monies due and owing for Services properly performed and all reasonable expenses properly incurred and/or committed to (which cannot be validly terminated without costs) in accordance with the applicable Order through the effective date of termination. Provider will deliver to Client within thirty (30) days from the effective date of termination all completed Deliverables, work in process, remaining Materials, results, information, data, reports, tables, graphs, programs, or other documents pertaining to the Order, unless otherwise directed by Client in writing.

3.6. Conflict. Except as otherwise expressly set forth herein, in the event of any conflict or inconsistency between the terms of these Terms and Conditions and any terms printed on the purchase order of the Client, the terms of these Terms and Conditions will prevail. Any additional or inconsistent terms in any Quote, acknowledgment or other documentation of any of the parties are hereby rejected and will not be part of the Agreement between the parties.

 

4. PERFORMANCE OF THE SERVICES.

4.1. Standards. Provider will perform Services in a thorough, timely and professional manner, consistent with prevailing scientific, professional and industry standards by individuals with the requisite training, background, experience, technical knowledge and skills to perform the Services, in accordance with the applicable Order and in compliance with all Applicable Laws and the Standard of Performance, including, to the extent applicable based on the Services specified in the applicable Order, Good Laboratory Practices or Good Clinical Practices. Provider represents and warrants that (i) it has facilities, computer systems, equipment, data and record management, and physical security measures in place that are compliant with Applicable Laws and prevailing industry practices to perform the Services outlined in the applicable Order; (ii) it has procedures in place to ship and receive Materials; (iii) it meets any and all safety regulations as required by Applicable Laws to perform the applicable Order; (iv) it has the appropriate licenses and approvals in place to perform the applicable Order; (v) it has the right and authority to perform the Services contemplated under the Agreement, including with respect to any third party technology used to perform such Services; and (vi) the performance of its obligations hereunder do not violate any third party rights.

4.2. Debarment, Disqualification, Exclusion. Neither Provider nor any of its personnel performing Services under the applicable Order have been (i) debarred, and to the best of Provider’s knowledge, are not under consideration to be debarred, by the United States Food and Drug Administration or any other governmental authority from working in or providing services to any pharmaceutical or biotechnology company under the Generic Drug Enforcement Act of 1992; (ii) the subject of a disqualification proceeding or disqualified as a clinical investigator pursuant to the Applicable Law, or otherwise disqualified or restricted by the FDA or any other regulatory authority; or (iii) the subject of an exclusion proceeding or excluded, suspended, or otherwise ineligible to participate in any government healthcare program or government procurement program.

4.3. Records. Provider will prepare and maintain complete and accurate Records relating to the performance of the Orders, the Services (but excluding Deliverables and any Client Raw Data), and all costs, liabilities, and obligations incurred hereunder, including without limitation those relating to the Order Fees, until the expiration of five (5) years after completion of the applicable Order, or such longer period as required by Applicable Laws. All Records and accounts relating to financial matters must be in a format consistent with U.S. Generally Accepted Accounting Principles (GAAP). If requested in writing by Client before expiration of the above retention period, Provider will continue to retain Records, provided that Client agrees to pay the associated costs of storage during such additional period, or Provider will forward the Records to the Client.

4.4. Deliverables and Acceptance. Any Deliverable is subject to acceptance by Client. Within ten (10) business days of receipt of a Deliverable, Client will assess the Deliverable with a view of confirming its compliance with the applicable Order. If Client does not refuse acceptance within such period by way of written notification to Provider, such Deliverable shall be deemed accepted.
Client may only refuse acceptance of a Deliverable if it detects a material non-compliance of a Deliverable with the specifications provided in the applicable Order (a “Defect”). Upon detecting a Defect, Client shall notify Provider accordingly in writing, providing all reasonable details to identify the Defect, and Provider shall rectify such Defect at its own cost and provide the rectified Deliverable within a reasonable period (which shall not exceed thirty (30) calendar days, unless a longer period is required to rectify the Deliverable in view of the work to be performed by Provider) of receipt of Client’s notification.
Unless the Order and Services are subject to GLP or GCP, Provider will store Deliverables and Client Raw Data provided for performance of Services for a period of three (3) months after completion of Services. Upon expiration of this period, Provider will destroy both Deliverables and Client Raw Data unless Client requests in writing for a longer storage period. In such case Client will be liable to compensate associated storage costs to Provider. For the avoidance of doubt, if the Order and Services are subject to GLP or GCP, the data storage period is regulated in accordance with the applicable rules.

4.5. Use of subcontractors. Except to the extent approved in writing in advance by Client or to the extent expressly provided otherwise in the Order, Provider will not subcontract all or any portion of Services under this Agreement. Any performance by a subcontractor in connection with this Agreement shall be pursuant to an appropriate written agreement between Provider and such subcontractor containing obligations consistent with the requirements of this Agreement. Any such subcontract agreement, together with such other relevant information as reasonably requested by Client, will be submitted to Client upon Client’s request.

 

5. MATERIALS.

5.1. Ownership of Materials. To the extent that any Order provides that Client supply (or has a third-party supply) Provider with certain Client Materials as described in the applicable Order in order to perform the Services under an Order, Client will retain all right, title, and interest to all Client Materials and any Intellectual Property Rights therein.

5.2. Transfer of Materials. To the extent required by an Order, Client will transfer to Provider the Client Materials required to perform the Services pursuant to such Order and pay or compensate Provider for all export/import duties associated with such transfer. Transfer of Client Materials will be in compliance with all Applicable Laws and in accordance with instructions in the applicable Order. Transferred Client Materials will be accompanied by the appropriate documentation including, as applicable, Material safety data sheets.

5.3. Client shall ensure that Client Materials delivered to Provider are correct, unaltered during transportation and suitable for processing and use by Provider in accordance with the applicable Order. Provider shall not be liable for any failure or delay in performing the Services that results from a delay or failure of Client to provide the Client Materials in accordance with the applicable Order and Client shall be responsible for all additional costs and expenses incurred by Provider arising out of such delay or failure.

5.4. Use of Materials. Provider shall use Client Materials only for the purpose of performing the Services in accordance with the applicable Order and not for any other purpose. Any specific storage and handling conditions to be observed by Provider when storing and handling Client Materials shall be specified in the applicable Order; absent such specification, Provider will store and handle Client Materials in accordance with its own standard processes and guidelines.

5.5. Disposal of Materials. Upon expiration of three (3) months after completion of the applicable Order and to the extent not consumed during performance of the Services, Provider will destroy Client Materials. If requested in writing by Client before expiration of the above three months period, Provider will (i) continue to store Client Materials, provided that Client agrees to pay the costs of storage during such additional period; or (ii) return the Materials to Client at Client’s full cost and expense (including applicable export/import duties and respective cost of the time spent by Provider’s employee on administrative arrangement of the return).

 

6. INTELLECTUAL PROPERTY.

6.1. Each party shall retain the full and exclusive ownership of its Background IP and execution of the Order shall not transfer or assign any Intellectual Property Right from a party to the other party.

6.2. Any and all Intellectual Property Rights in the BGS Platform, including, without limitation, in any further developments, improvements and modifications made by or on behalf of Provider in performing the Services or otherwise, shall be considered Background IP of Provider and owned exclusively by Provider (the “BGS Platform IP”).

6.3. Without limitation to Section 6.2, any and all Intellectual Property Rights in any Deliverables (the “Deliverables IP”) shall be owned by the Client exclusively; provided, however, that the parties agree that Deliverables IP shall not encompass any BGS Platform IP that may be embedded in, represented by or derived from any Deliverable and that Client shall not try to reverse engineer or derive from any Deliverable any of the BGS Platform IP. Provider agrees to assign and hereby assigns to Client upon payment of the Service Fee in full all Deliverables IP. Unless broader license or IP rights are granted to Provider under a separate agreement with the Client, Client grants to Provider a non-exclusive, non-sublicensable, non-transferrable, license to the know-how generated in the Deliverables IP for the sole purpose of improving Provider’s products and services and for no other purpose. All confidentiality obligations under this Agreement will continue to apply to said know-how at all times.

6.4. The parties shall, upon each party’s reasonable request at any time, execute or have executed all deeds, declarations, applications, filings and other documents necessary to give effect to the allocation of Intellectual Property Rights, assignment and transfer as set forth in this Article 6.

6.5. Limited License Grant. Each party agrees to grant and herewith grants to the other party a non-exclusive right and license to make use and have made use of Intellectual Property Rights owned or controlled by such granting party if and solely to the extent necessary for the performing the Services and providing the Deliverables under the applicable Order. The license grant under this shall expire upon completion or termination of the Order.
Notwithstanding the above, Provider agrees to grant and herewith grants to Client a perpetual, non-exclusive, fully paid-up, worldwide license (with the right to sublicense) to its Background IP only if and to the extent necessary and for the sole purpose to enable Client to use the Deliverables for their intended purpose. For the avoidance of doubt, the license grant under this Section 6.5 does not entitle Client to use the Background IP of Provider (i) to reverse engineer or derive from any Deliverable any of the BGS Platform IP, to use, or to create any derivative work of, the BGS Platform IP, (ii) to, directly or indirectly, offer the same or similar services as the Services to third parties, build or operate the same or a similar platform as the BGS Platform, or to otherwise offer, directly or indirectly, any products or services that compete with any of Provider’s business, own products or services to third parties, or (iii) for any other purpose other than as expressly set forth and permitted in this Section 6.5.
Except as expressly provided in this Article 6, the Order does not grant any right or license to a party under any of the Intellectual Property Rights of the other party or of any third party, and no other right or license is to be implied or inferred from any provision of this Agreement or by the conduct of the parties

 

7. WARRANTIES AND REPRESENTATIONS.

7.1. Mutual. Each party represents and warrants to the other that it has the full power, right and authority to make and accept the Order, to carry out its obligations under the applicable Order, and to assign and grant the rights pursuant to this Agreement. In addition, each party represents and warrants to the other that it will comply with Applicable Laws and it has not entered and will not enter into any agreements inconsistent with the provisions of this Agreement.

7.2. Services. Provider represents and warrants to Client that the Services performed and Deliverables provided under the applicable Order are in material compliance with the Applicable Laws and Standards of Performance. Client however acknowledges and agrees that the results of the performance of the Services, including, without limitation, the Deliverables and their quality, depends largely on the quality of the Client Materials provided and that Provider does not, notwithstanding any other provision of these Terms and Conditions, represent, warrant or covenant any specific result, outcome, benefit or other achievement from the performance of the Services.

 

8. INSPECTIONS.

8.1. Inspections. Upon reasonable notice, but not more than once annually, Client and its Representatives may visit and inspect Provider’s facilities at mutually agreeable times during normal business hours for the purpose of quality assurance inspections. Provider will make available to Client or its Representatives during normal business hours, data and records that Provider compiles in the course of the Services. During these visits, Client’s Representatives may examine the reports containing the results of all quality assurance inspections performed by Provider with respect to any Services and to examine the controls and procedures used by Provider in the performance of such quality assurance inspections. Client acknowledges and agrees that Provider may limit such access as reasonably required to safeguard Provider’s and its third-party customers’ confidentiality interests including without limitation pricing structure or the make-up and application of its indirect rates/costs. Client and its Representatives will at all times while present on Provider premises comply with all Provider rules, regulations, policies and standard operating procedures; failure to do so is grounds for immediate removal. Client may provide Provider with a written report summarizing its findings, and consequently, Provider will provide Client with a response to such findings, which will include a plan for corrective and preventative actions designed to address reasonable concerns and shortcomings documented in the audit report. Client agrees that in case such inspection requires any preparation of extensive questionnaires, Provider shall be entitled to charge a reasonable fee for its time spent on putting together the required information.

8.2. Regulatory Inspections. If any governmental or regulatory authority of appropriate jurisdiction conducts, or gives notice of intent to conduct, an inspection of the records of Provider related to an Order or any facility of Provider where Services are performed, to the extent legally permitted Provider will as soon as practicable, and in no event less than one (1) business day from receipt of notice from such authority, provide Client with notice thereof. If the inspection relates to or impacts Services performed for Client, to the extent legally permitted Provider will furnish Client with copies of any documents provided to such authority and copies of any written communications received from such authority pertinent to such inspection. Further, Client will have the right to be present at any such inspection, unless legally prohibited from attending. Provider will cause its Affiliates and Representatives involved in the performance of the Services which are subject of such governmental inspection or who are performing the Services at the facility that is the subject of such government inspection to cooperate with such inspection. Provider and its Affiliates will promptly take all steps necessary to correct any deficiencies noted by such inspecting authority during the inspection. Provider will give Client at least five (5) business days to review any response to a regulatory authority that is in response to a notice to inspect or other regulatory action or proposed regulatory action before it is forwarded to such regulatory authority.

 

9. INVOICING AND PAYMENTS.

9.1. In consideration for performing the Services, Client shall pay to Provider the service fee set forth in the applicable Order (the “Service Fee”). Unless clearly stated otherwise, all amounts of the Service Fee stated in the Order shall be exclusive of VAT and other taxes which shall be added to the Service Fee if applicable.

9.2. Except as agreed otherwise in the applicable Order, the costs for materials, consumables and third-party support used by Provider in performing the Services are included in the Service Fee. If the applicable Order provides for Client to reimburse Provider for costs and expenses of materials, consumables and/or services by third parties contracted by Provider, Client shall reimburse Provider such costs and expenses on an actually incurred basis as supported by documentary evidence. Service Fee is quoted as a lump sum, however, in case Client will require extensive support and/or Provider’s involvement in regular and multiple discussions with the Client, Provider reserves the right to charge the Client a reasonable fee for its time spent on such support or discussions.

9.3. Provider shall issue VAT correct invoices for Service Fees, costs and expenses, in accordance with the payment schedule specified in the applicable Order. If the Order does not specify a payment schedule, Provider may invoice fifty percent (50%) of the Service Fee at the acceptance of the Order and fifty percent (50%) of the Service Fee upon completion of the Services by Provider.

9.4. Client shall pay all invoiced amounts by wire transfer to the bank account of Provider indicated in the applicable Order or respective invoice within thirty (30) days of the receipt of the invoice. Client shall have no right to set-off or deduct any amounts from invoices issued by Provider in accordance with the applicable Order. Any payment that is not paid on or before the due date shall bear a ten (10) percent annual interest rate, calculated on the number of days the payment is late.

 

10. CONFIDENTIALITY.

10.1. Each party (the Receiving Party) shall keep confidential any and all information, data or know-how, whether technical or non­technical, oral or written, (Confidential Information) that is disclosed to it by or on behalf of the other party (the Disclosing Party), and it shall ensure that its officers and employees with access to Confidential Information are bound to confidentiality covenants duly protecting such Confidential Information of the other party. For the avoidance of doubt, (i) the terms of the applicable Order shall be Confidential Information of both parties, (ii) Client Materials shall be Confidential Information of Client, and (iii) BGS Platform IP shall be Confidential Information of Provider.

10.2. For the purpose of the applicable Order, information disclosed by any Affiliate of the Disclosing Party shall be deemed to have been disclosed by the Disclosing Party, and information received by an Affiliate of the Receiving Party shall be deemed to have been received by the Receiving Party.

10.3. The Receiving Party agrees (i) not to use Confidential Information of the Disclosing Party for any purpose other than the performance of its obligations and the exercise of its rights hereunder, and (ii) not to disclose Confidential Information of the Disclosing Party to any third party, except as expressly permitted under this Agreement or required under Applicable Law.

10.4. The Receiving Party may disclose or grant access to the Disclosing Party’s Confidential Information to its Affiliates without the prior written permission and without the obligation to enter into a separate confidentiality agreement if such Affiliate requires the Confidential Information in relation to this Agreement. The Receiving Party shall ensure and shall be fully responsible for ensuring that such Affiliate comply with the obligations of this Agreement.

10.5. In the event that a disclosure of Confidential Information to a third party becomes necessary or required, the Receiving Party shall give the Disclosing Party prompt prior written notice (unless prohibited under Applicable Law) to permit the latter to take all possible action to perfect and/or safeguard its rights in the Confidential Information.

10.6. The parties agree that Confidential Information shall not include any information, data or know-how that:

(i) as reasonably evidenced by the Receiving Party, was generally available to the public at the time of disclosure, or information that becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party;

(ii) can be evidenced by written records to have been already known to the Receiving Party prior to its receipt from the Disclosing Party;

(iii) is obtained at any time lawfully from a third party under circumstances permitting its use or disclosure, as reasonably evidenced by the Receiving Party;

(iv) is developed independently by the Receiving Party as evidenced by written records other than through knowledge of Confidential Information; or

(v) is approved in writing by the Disclosing Party for release by the Receiving Party.

In the event that Receiving Party believes that any information falls within Section 10.6 (i) to (iv) above, before using or disclosing such information outside the terms of this Agreement, they will provide 30 day written notice to Disclosing Party.

10.7. Except as expressly agreed otherwise in the applicable Order, upon completion or termination of the Order, each Receiving Party shall upon request of the Disclosing Party, return to the Disclosing Party at its cost and expense or destroy any and all Confidential Information of the Disclosing Party and all copies thereof, except for one copy, which may be retained in confidential files exclusively as archival record in accordance with applicable law or archived by its automatic security and/or disaster recovery systems. Any such retained copy shall remain subject to the confidentiality and non-use obligations set forth in this Article 10.

10.8. The obligations of the parties relating to Confidential Information under Article 10 shall expire five (5) years after completion or termination of the applicable Order.

 

11. INDEMNIFICATION.

11.1. Indemnification. Each party will, at its expense, indemnify, defend and hold harmless the other party, its officers, directors, employees, and Representatives, against any liabilities, losses, damages, judgements, expenses, fines, penalties, charges and fees (including reasonable attorneys’ fees) resulting from any claim, suit, action, demand or proceedings or allegations brought against an indemnitee by a third party (each a “Third Party Claim”) to the extent arising out of or attributable to: (i) any breach of these Terms and Conditions by the Indemnifying Party, (ii) any negligence, fraud or willful misconduct of the Indemnifying Party in the performance of the Services, (iii) where Provider is the Indemnifying Party, misappropriation or infringement of Intellectual Property Rights regarded as being caused by Provider-supplied designs or specifications, or Provider Confidential Information or Provider-supplied service offerings, or (iv) where Client is the Indemnifying Party, misappropriation or infringement of Intellectual Property Rights regarded as being caused by Client-supplied designs or specifications, or Client Materials or Client Confidential Information or Client instructions in an Order.

11.2. Indemnification Procedure

11.2.1 Notice. In the event of any Third Party Claim is made, or action initiated, the party seeking indemnification hereunder (the “Indemnified Party”) will promptly notify the other party (the “Indemnifying Party”) in writing of such actual or threatened Third Party Claim to enable the Indemnifying Party to arrange for the defence of such Third Party Claim, provided, however that failure to give prompt written notice will not limit the rights to indemnification hereunder except to the extent that the Indemnifying Party is materially prejudiced by such failure.

11.2.2 Cooperation. The Indemnified Party will cooperate with the Indemnifying Party in the investigation, defence and settlement of any Third Party Claims when the Indemnifying Party controls the defence of any such Third Party Claims. The Indemnifying Party will provide a diligent defence against and/or final settlement of any Third Party Claims brought or actions filed for the loss which is the subject of the foregoing indemnity.

11.2.3 Control of Defence. The Indemnifying Party will have sole control over the defence and the right to enter into a full and final monetary settlement of the Third Party Claims, at the Indemnifying Party’s sole expense and discretion, provided that the Indemnifying Party will not agree to any settlement which imposes injunctive relief on, requires an admission of fault by, or does not include a complete release of the Indemnified Party without the consent of the Indemnified Party. In any such proceeding, the Indemnified Party will have the right to retain its own counsel and participate in the defence of the Third Party Claims, at the Indemnified Party’s expense, provided that the Indemnified Party will not consent to the entry of any judgment or enter into any settlement with respect to the claims without the prior written consent of the Indemnifying Party, which consent must not be unreasonably withheld.

11.2.4 Non-exclusivity. The indemnification provided by these Terms and Conditions will not be deemed exclusive of any other rights to which the Indemnified Party may be entitled to under these Terms and Conditions and/or applicable Order, any other agreement, applicable law, or otherwise.

 

12. INSURANCE. Provider will maintain adequate levels and types of insurance coverage appropriate to its business and profession to cover its indemnity obligations hereunder, as required by applicable laws, and consistent with its performance hereunder with such coverage levels and types to include, at a minimum, and without limitation, the requirements set forth in this Article 12.

12.1. Insurance Requirements. Provider shall maintain adequate levels and types of insurance coverage appropriate to its business and profession to cover its indemnity obligations hereunder, as required by Applicable Laws, with such coverage levels and types to include at a minimum and without limitation insurance required by Applicable Laws with respect to Provider’s status as an employer, workers’ compensation, comprehensive general liability, employer’s liability, and automobile liability. All insurance coverage must be in full force and effect at all times during performance of Provider’s obligations hereunder.

12.2. Certificates of Insurance. Upon the written request of Client, Provider will provide Client with copies of the certificates of insurance and policy endorsements for all insurance coverage required by this Article.

 

13. LIMITATIONS OF LIABILITY.

13.1. Each party’s aggregate total liability under or in relation to this Agreement, whether in contract, tort or otherwise, shall be limited to lesser of (a) $1,000,000 or (b) the aggregate amount of Service Fees paid or to be paid to the Provider for the Services to which the liability relates during the six (6) month period immediately preceding the determination of such liability.

13.2. Except as expressly provided for under Section 11.1 above, neither party shall be liable to the other party for any indirect, special, punitive or consequential damages for any cause of action a party may have against the other party arising hereunder.

13.3. THE LIMITATIONS OF LIABILITY SET FORTH IN THIS ARTICLE 13 WILL NOT APPLY TO ANY DAMAGE OR LIABILITY RESULTING FROM A PARTY’S (A) BREACH OF ARTICLE 10 (CONFIDENTIALITY) HEREIN; (B) INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 11 HEREIN; (C) GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; (D) INFRINGEMENT OR MISAPPROPRIATION OF INTELLECTUAL PROPERTY RIGHTS; OR (E) OBLIGATION TO PAY SERVICE FEES HEREUNDER.

 

14. COMPLIANCE WITH LAWS.

14.1. Each party, on behalf of itself and its Representatives, represents and warrants that it will comply with all Applicable Laws in its performance of Services pursuant to this Agreement, including without limitation any of the more specifically referenced laws and regulations in this Article 14. Each party also agrees to make available to the other party, upon reasonable request, proof of its efforts to comply with this Article.

14.2 Anti-Bribery: Each party shall procure that its officers, workers, agents and any other persons who request or perform Services in connection with this Agreement shall:
(a) Not commit any act or omission which causes or could cause it or the other party to breach, or commit an offence under, any laws relating to anti-bribery and/or anti-corruption;
(b) Keep accurate and up to date records showing all payments made and received and all other advantages given and received by it in connection with this Agreement and the steps it takes to comply with this Section and permit the other party to inspect those records as required;
(c) Promptly notify the other party of: (i) any request or demand for any financial or other advantage received by it; and (ii) any financial or other advantage it gives or intends to give whether directly or indirectly in connection with this Agreement; and (iii) promptly notify the other party of any breach of this Section.

The non breaching party may terminate this Agreement immediately by giving written notice to that effect to the other party if such party is in breach of this Section 14.2.

14.3. Sanctions. Any of the parties will not perform any illegal transaction with any Blocked Entity.

14.4. Labor and Employment. Each party has implemented and maintains policies and procedures designed to facilitate compliance with all Applicable Laws regulating labour and employment. Each party will pay its employees fair compensation and provide safe working conditions. Each party agrees to support the policy of not discriminating on the basis of age, sex, race, religion, colour, national origin, physical or mental disability, or veteran status and abide by all laws, rules, and executive orders governing equal employment opportunity.

14.5. Human Rights. Each party hereto respects human rights as embodied by the Universal Declaration of Human Rights and will comply with all Applicable Laws protecting human rights. Each party has implemented and will maintain policies and procedures designed to facilitate compliance with all Applicable Laws prohibiting human trafficking, forced labour and child labour in all relevant jurisdictions, including without limitation the UK Modern Slavery Act, and Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims.

14.6. Export Control. With respect to all transactions pertaining to this Agreement, each party shall, and shall cause its Representatives to, comply with all applicable export control laws and regulations, including U.S. Export Administration Regulations.

14.7. Data Processing. The administration and management of this Agreement may include Client’s collection and processing of Provider’s Representatives’ personal information if needed to perform its obligations under this Agreement or by Applicable Law, including applicable regulatory guidance. Personal information includes non-sensitive information such as, but not limited to, name, contact details, field of expertise and the content of this Agreement. This information may be transferred to local regulatory authorities and therefore may become publicly available. This information may also be transferred to a third party for processing and/or processed and securely stored in countries outside of that in which it was collected, including non-EU/EEA countries. Regardless of the country where this information is processed, Client shall maintain and require its processors to maintain appropriate administrative, technical and physical safeguards to protect the information. Transfer of personal information follow applicable laws and are subject to safeguards such as Client’s Binding Corporate Rules (if issued) or EU Standard Contractual Clauses in a form currently available at https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc_en. Provider’s Representatives may access, correct or request deletion of its personal information, subject to certain restrictions imposed by law, by contacting Client’s data privacy office or as otherwise identified in Client’s privacy policy published on Client’s publicly available website.

 

15. MISCELLANEOUS

15.1. Contractual Relationship. Each party is engaged in an independent business and not as an agent, employee, partner or joint employer of the other party. The parties acknowledge and agree that neither party shall have responsibility or liability for treating the other party’s Representatives as employees for any purpose. Neither party nor any of its Representatives shall be eligible for coverage or to receive any benefit under the other party’s provided workers’ compensation, occupational health services, employee plans or programs or employee compensation arrangement, including without limitation any and all medical and dental plans, bonus or incentive plans, retirement benefit plans, stock plans, disability benefit plans, life insurance and any and all other such plans or benefits.

15.2. Modifications. Except to the extent expressly provided otherwise in this Agreement, no amendments or other modifications to this Agreement shall be binding unless in writing and signed by the parties.

15.3. No Exclusivity. Nothing contained herein shall (i) obligate Provider or its Affiliates to any exclusive relationship with Client or (ii) restrict or preclude Provider or any Provider Affiliate from contracting with any competitor of Client.

15.4. Assignment. This Agreement may not be assigned or otherwise transferred by any party without the prior written consent of the other party; provided, however, that either party may, without such consent, but upon prior written notice, assign its rights and obligations under this Agreement in connection with a merger, consolidation or sale of substantially all of the business to which this Agreement relates. Any purported assignment or transfer in violation of this Section shall be void. This Agreement shall be binding on the parties and their respective successors and permitted assigns.

15.5. Waiver. No action or inaction by either party shall be construed as a waiver of such party’s rights under this Agreement or as provided by law. The failure or delay of any party in enforcing any of its rights under this Agreement shall not be deemed a continuing waiver of such right. The waiver of one breach hereunder shall not constitute the waiver of any other or subsequent breach.

15.6. Severability. In the event any provision of this Agreement conflicts with the law under which this Agreement is to be construed or if any such provision is held illegal, invalid or unenforceable, in whole or in part, by a competent authority, such provision shall be deemed to be restated to reflect as nearly as possible the original intentions of the parties in accordance with Applicable Laws. The legality, validity and enforceability of the remaining provisions shall not be affected thereby and shall remain in full force and effect.

15.7. Survival. Representations, warranties and obligations under any provisions set forth in this Agreement related to proprietary rights, infringement, confidentiality, governing law, and provisions which contemplate performance or observance subsequent to termination or expiration of this Agreement shall survive such expiration or termination.

15.8. Third-party Beneficiaries. Except as expressly provided for in this Agreement, (i) this Agreement is entered into solely between, and may be enforced only by, Client and Provider and (ii) this Agreement shall not be deemed to create any rights in third parties, including without limitation subcontractors, or to create any obligations of a party to any such third parties.

15.9. Force Majeure. A party shall not be liable for any delay in the performance of its obligations under this Agreement if and to the extent such delay is caused, directly or indirectly, by acts of God, war, riots, terrorism, embargos, acts of public enemy, acts of military authority, pandemic, earthquake, fire or flood (“Force Majeure Event“); provided that a Party may not claim relief for a Force Majeure Event under this Section unless each of the following conditions has been satisfied: (i) the party claiming delay by Force Majeure Event (the “Delayed Party“) is without fault in causing such delay; (ii) such delay could not have been prevented by reasonable precautions taken by the Delayed Party, including, without limitation, the use of alternate sources, or workaround plans; (iii) the Delayed Party uses commercially reasonable efforts to recommence performance of such obligations whenever and to whatever extent possible following the Force Majeure Event; and (iv) the Delayed Party immediately notifies the other Party by the most expedient method possible (to be confirmed in writing) and describes at a reasonable level of detail the circumstances causing the delay. All obligations of both Parties shall return to being in full force and effect upon the passing of the Force Majeure Event.

15.10 Notices. Unless otherwise agreed in writing by both parties, all notices pursuant to this Agreement must be in writing, and delivered personally or sent by courier, certified mail (return receipt requested) addressed to the relevant party(ies) at their respective addresses set forth in the Order. Either party may specify a different address to receive notices by providing a notice in accordance with this Section. Notices sent by courier or certified mail are effective upon receipt or 5 working days after dispatch, whichever occurs first.

 

16. GOVERNING LAW. All disputes as to the legality, interpretation, application, or performance of this order or any of its terms and conditions shall be governed by the laws of Switzerland including its conflict of laws principles. Each party to this Agreement agrees that any dispute arising between them which results in either party instituting court proceedings shall be litigated in Zurich, Switzerland.

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