General
These Standard Terms and Conditions for the Sale of Services (“Terms”) will govern all orders accepted by the Companies of the Research Group listed below. Company means either:
- Innovative Environmental Services Ltd located Benkenstrasse 260, 4108 Witterswil Switzerland.
- or Mambo-Tox Limited located 2 Venture Road, University Science Park Southampton SO16 7NP in UK.
- or i2L Research Ltd. located Capital Business Park, Wentloog, Cardiff, CF3 2PX, UK .
- or i2L Research Europe s.r.o. located Lipová 1789/9, České Budějovice 2, 370 05 Czech Republic,
- or i2L Research USA Inc. 1430 Joh Ave, Baltimore, MD 21227, United States.
- or i2LResearch Spain S.L, C/Mare de Déu de Montserrat, 30 17844 Girona, Cornellà del Terri, Spain.
The Company defined in the Quotation if the one engaged legally with the Sponsor.
These Terms apply to a single study, several studies performed for the same company or sponsor, written and online orders, orders place by telephone which have not been confirmed in writing, and orders made by a delivery of samples. All offers and tenders for services, including any resulting contracts and agreements, will be governed by these Terms.
These Terms supersede and replace all prior verbal or written price quotations and, unless specifically indicated in writing, take precedence over all conflicting or inconsistent provisions of subsequent written agreements between the parties. No employee, agent or subcontractor, other than an authorized officer of THE COMPANY, has the authority to alter or waive any of these Terms or to make any representation which conflicts with or purports to override any of these Terms; and no such alteration, waiver or representation is binding upon THE COMPANY, unless it is in writing and signed by an authorized officer of THE COMPANY. If any of the provisions of these Terms proves to be invalid or illegal, that will not in any way affect, impair or invalidate any other provisions and all other provisions of these Terms will remain in full force and effect.
Acceptance of Order
An order for services will be valid only if it contains all required information and the Company agrees to provide the services. The Company is not obligated to start any work unless the order is clearly communicated, accepted by the Company, and the Company is provided with all required information. Unless specifically accepted in writing and signed by an authorized officer of the Company, any additional terms proposed or submitted at any time (including, but not limited to, terms or provisions in a purchase order) which differ from these Terms are rejected as a material alteration of these Terms and will be of no force or effect.
Study Plan
The Company will perform a study or studies according to a detailed written study plan. Each study plan will specify the plan sponsor (“Sponsor”), study design, information desired, estimated duration of the study and all other matters pertinent to completion of the study. The study plan will appoint a study director (“Study Director”) to be responsible for the completion of the study and a representative of Sponsor or Sponsor’s study monitor. If not otherwise agreed in the study plan all communications between Sponsor or Sponsor’s study monitor and the Company regarding the conduct of the study shall be addressed to or routed through the Study Director and Sponsor or Sponsor’s representative.
A study plan becomes valid only after signature by Company’s Study Director. Afterwards, a representative of Company’s management, the Sponsor or Sponsor’s study monitor, and the Quality Assurance Unit (QAU) will sign it.
The study plan will be prepared either by the Company solely or in consultation with and/or assistance of the Sponsor or Sponsor’s study monitor. the Company does not warrant that the study design and/or the study results will satisfy the requirements of any regulatory agencies at the time of submission of study results to such agencies.
The study plan may be modified or amended at the discretion of the Study Director and/or in consultation with the Sponsor or Sponsor’s study monitor. Detailed descriptions of all amendments must be in writing and signed by Company’s Study Director, a representative of Company’s management, the Sponsor or Sponsor’s study monitor, and the QAU.
Study Performance
The Company will use its best efforts according to the present state of science and technology to provide facilities, technical equipment, and staff to complete the study as described in the study plan and study plan amendments in accordance with these Terms.
The Company may employ external consultants and laboratory or field capacity for specific needs of the project. The Company will be responsible for the work of its external resources in the same way as for its own work.
Study Materials
Study Materials are included but not limited to test items, the Safety Data sheet, COA, information about the test items, study equipment and materials which are agreed by Sponsor that Sponsor will be responsible for preparing and providing to the Company.
The Sponsor or Sponsor’s study monitor will provide the Company free of charge with sufficient amounts of test items, materials, or other substances with which the study shall be performed, as well as the necessary data to enable the Company to safely and appropriately handle the material, including but not limited to all necessary identification, stability, storage and safety requirements.
If delays in the agreed commencement or performance of the study occur because of Sponsor’s or Sponsor’s study monitor’s inability to supply the Company with sufficient test materials or sufficient information required to begin or perform the study, the Company may reallocate resources being held for performance of the study without incurring liability to Sponsor or Sponsor’s study monitor. Rescheduling of studies due to lack of materials from Sponsor may be subject to additional cost.
Reports
The Company will prepare the results of all studies in the Company’s standard report format, unless otherwise specified in the study plan. The Company will provide a draft report on completion of the project. On receipt of Sponsor’s or Sponsor’s study monitor’s approval or four weeks after dispatch of the draft, whichever is sooner, the Company will provide the final report.
Additional copies of reports and interim reports not specified in the study plan and/or copies of or original raw data will be provided in due time after the Sponsor’s or Sponsor’s study monitor’s respective request and expense.
The Company will not publish any report or data prepared by the Company for Sponsor without prior written consent of the Sponsor.
Pricing and Payment Terms
Financial Terms are reflected in the Quotation. In case a Contract is established the Contract overrides the Quotation in terms of pricing and payment terms.
Confidentiality
Each party shall undertake to keep confidential any and all business and trade secrets and all other confidential or proprietary information (“Confidential Information”) obtained within the contractual relationships hereunder and shall not disclose them to third parties except as required for the purpose of the contractual relationship hereunder, without the prior written consent of the other party. Confidential Information shall not include information that is: (i) publicly known or accessible, (ii) already known or disclosed to the receiving party by a third party without breach of any obligation of secrecy, (iii) required to be disclosed to accreditation bodies for the purpose of assessments or pursuant to any legal or regulatory requirement to which Sponsor or the Company is subject. In the event that either party is required to disclose any Confidential Information pursuant to a subpoena, mandatory reporting obligation, or other legal process, such party shall provide the other party with prompt notice of such request, unless otherwise prohibited. the Company may disclose Confidential Information to affiliates, agents, or subcontractors for the purposes of performing its obligations related to other service orders from the same Sponsor.
All Confidential Information supplied by a disclosing party will remain the property of the disclosing party. Except as specifically provided in these Terms, the receiving party does not receive any right or license, express or implied, under any patents, copyrights, trade secrets, or other intellectual property rights of the disclosing party.
Visits
With prior notice of at least ten (10) business days, Sponsor’s or Sponsor’s Study Monitor’s representative may visit the Company at reasonable times during normal business hours to observe the progress of the study. The Company will assist in scheduling such visits.
Retention of Data and Material
The Company will retain raw data and/or samples of the test material and/or copies or originals of the study plan, amendments, and report as appropriate and necessary in compliance with regulatory and GLP requirements applicable in Company’s country of origin. Upon expiration of any regulatory requirements to maintain such data or material Sponsor or Sponsor’s study monitor will be asked and shall direct whether to destroy such data or material, to retain for a standard storage fee, or to transfer to any address specified by the Sponsor or Sponsor’s study monitor at Sponsor’s expense.
Study Samples
Samples collected during the study will be stored at no additional cost for one month after study finalization, unless no finalization could be achieved 12 months after issuance of the draft report, in which case a storage contract might be issued. After study completion, a Sample Elimination Statement will be sent to the Sponsor to agree on the handling of the samples. The samples may either be disposed of, stored further at THE COMPANY for an additional cost, or shipped to the Sponsor at their expense.
Radiolabelled Test Item
Radiolabelled test items will be automatically discarded three months after the issue of the finalized study report if less than 1 MBq of the test item(s) remain. A Substance Elimination Statement will be provided akin to the Sample Elimination Sheet to agree on the handling of the remaining radiolabelled substance(s). The substances may either be disposed of, stored further at THE COMPANY for an additional cost, or shipped to the Sponsor at their expense.
Termination of Studies
Sponsor or Sponsor’s study monitor may terminate any running study prior to completion by giving written notice not less than thirty (30) days to the Company. In such an event, the Company shall immediately comply with such notice to terminate work on the study and use its best effort to reduce cost to Sponsor or Sponsor’s study monitor. Sponsor or Sponsor’s study monitor shall pay the Company all its cost incurred or irrevocably obligated, plus a pro rata portion of applicable profits determined in accordance with the Company’s ordinary accounting System computed to the date of termination.
Either party may terminate this agreement in writing in the event of breach of a material obligation of the other if such breach remains uncured after thirty (30) days written notice.
The termination of this agreement shall not relieve either party of its obligations to the other in respect of confidentiality of information, indemnification and/or compensation for services performed.
Sponsor or Sponsor’s study monitor may cancel any study prior to initiation by giving written notice to the Company. Studies terminated prior to the initiation date are subject to cancellation fee in accordance with the Company ‘s ordinary accounting System computed to the date of termination. The cancellation fees depend on the type of study and are included in the Quotation and/or in the Contract.
Limited Warranties and Responsibilities
The Company does not guarantee, either express or imply, that the results of any services provided will meet the acceptance or other criteria set out by Sponsor, and the Company does not accept responsibility for failure to meet any acceptance or other criteria.
Sponsor is responsible for the proper delivery of test item sent to the Company for examination and/or analyses. Unless otherwise agreed in writing, the Company accepts no responsibility for any loss or damage which may occur to any test item in transit or to any facility or site where services are being delivered. Sponsor will be liable for the security, packaging, and insurance of the test item from its dispatch until it is delivered to the offices or the laboratories of the Company. the Company will use reasonable care in handling and storing test item respecting the information provided in the MSDS or any other document provided by the sponsor.
EXCEPT AS EXPRESSLY SET FORTH IN THESE TERMS, IES MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN CONNECTION WITH ITS PERFORMANCE OF SERVICES AND, TO THE MAXIMUM EXTENT PERMITTED BY LAW, IES SPECIFICALLY DISCLAIMS ANY AND ALL OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF SUITABILITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Liability and Indemnification
The Company undertakes to exercise due care and skill in the performance of its services and accepts responsibility for non-fulfilment of its obligations only where skill and care is not exercised and negligence by the Company is proven. The Company cannot be held liable for delays, errors, damages or other problems caused by events or circumstances which are unforeseen or beyond the Company’s reasonable control, or which result from compliance with governmental requests, laws and regulations.
Company’s liability for breach of these Terms, or for any negligence or other wrongdoing in the performance of services, is limited, at Company’s option, to either: (1) re-performing the services ordered or (2) refunding the total fee paid for the particular services at issue.
Under no circumstances will IES be liable for any indirect, SPECIAL, INcidental, punitive or consequential DAMAGES.
The Company agrees to defend, indemnify, and hold harmless Sponsor, its directors, officers, representatives, agents, employees and contractors from and against any and all claims, demands, costs, or other causes of action (collectively “Claims”) which are the proven direct result of the Company’s willful misconduct or fraud in connection with the performance of services.
Except to the extent of any required indemnity by the Company pursuant to these Terms, Sponsor agrees to defend, indemnify and hold harmless the Company, its affiliates and their respective officers, directors, agents, employees, representatives and contractors from and against any and all Claims arising out of or relating to: (i) the performance of services in accordance with these Terms; (ii) Sponsor’s use of any products reviewed or analyzed by the Company; or (iii) the use of any results or reports or any other data or analysis provided by the Company hereunder.
Compliance with Law
Both parties agree to comply with all applicable laws including, but not limited to, the UK Antibribery Act, Foreign Corrupt Practices Act (FCPA), EU’s General Data Protection Regulation (GDPR), UK’s Data Protection Act, and all other laws and regulations applicable to the parties.
Force Majeure
Either party shall be excused from performing its obligations under this agreement if its performance is delayed or prevented by any event beyond such party’s reasonable control, including but not limited to fire, explosion, weather, disease, pandemic, war, insurrection, civil strife, riot, government action, or power failure, provided that such performance will be excused only to the extent of and during such delay. Any time specified for completion of performance in the study plan shall be automatically extended for a period of time equal to the period of such force majeure delay. The Company will promptly notify Sponsor or Sponsor’s study monitor if, by reason of any events referred to herein, the Company is unable to meet any such time for performance specified in the study plan. If any part of the study is invalid as result of a force majeure delay, the Company will, upon written request of Sponsor or Sponsor’s study monitor and at Sponsor’s sole cost and expense, repeat that part of the study affected by the delay.
Assignment
This agreement and relationship shall not be assigned in whole or in part by either party without the prior written consent of the other, which consent shall not be unreasonably withheld. Any attempt to assign this agreement without consent shall be void and of no effect.
Applicable Law
These Terms shall be construed and enforced in accordance with the laws of Switzerland.
These Terms and Conditions were last updated on: 18/05/2023.
