General terms and conditions of sale and clinical testing services – Centre D’Études Clinique Ltée

  1. Scope of Application – Enforceability

The following general terms and conditions (referred to hereinafter as “GTC“) shall have exclusive application to all business relations between Centre D’Études Clinique Ltée (CEC), its customers (referred to hereinafter as “customers”) and other related Interested Parties. These GTC apply to customers deemed as sponsors as understood under applicable legal requirements.

Whenever any order is placed with CEC as being a sponsor or registration being made as ‘Volunteers’ these terms and conditions shall be considered approved, unless an objections was expressly demonstrated to their application in writing.

Any other terms and conditions that contradict CEC’s GTC shall only become part of the agreement if CEC expressly agrees to them in writing in a case to case basis. Otherwise, any kind of proposal by the interested party at whatever moment and under whichever form, that would deviate from this GTC will not be entertained and therefore, ponder to be null and void.

  1. Offers and Orders

Offers and/ or orders receive from the customers shall be accepted as per this GTC. Any offers for Clinical Trial Services shall be done in writing by the Company (hereafter referred to as « the Offer») either on paper (fax or courier), or on an electronic support, to which are attached the present GTC. Once, an offer has been sent to the customer, the return of acceptance of the offer entailing acceptance of the GTC.

Any prevailing offers that pertain to certain specific conditions are not spontaneously carried forward. CEC offers to a customer based on the requirements of the customer and the agreed conditions to provide specific clinical trial services will not be applied automatically to other orders but should be agreed conversely by both parties.

However, CEC’s proposals are non-binding to anyone, unless the proposal’s validity was limited to a certain time period or for any specific study. In that event, the proposal is subject to become void upon expiry of this time period. The durations for which the proposal can be accepted by the client or volunteers will be specified by CEC in writing in the respective proposal. Acceptances by the client received after this specified date shall only be considered offers and shall be subject to express acceptance by CEC.

Objections against the content of an order confirmation (submission of final reports) shall be made in writing no later than the specified days as per the protocols of study otherwise, the order confirmation (approval of final clinical trial reports) shall be considered approved.

CEC’s provides its services in line with the agreed proposal, the study protocol, and the order confirmation through the quotations. All agreements, including amendments, modifications, and subsidiary agreements, shall be in writing. CEC reserves the right to confirm an order verbally.

CEC shall process the customer orders in a professional manner and with due professional care common in this sector and in accordance with the following applicable legal requirements in our local and international context, but which are not limited to:

– Data Protection Act 2017

– Good Clinical Practices

– General Data Protection Regulation (GDPR)

– Companies Act 2001

Generally Speaking, a confirm order from a customer is basically is the performance of the agreed services (in particular, conducting a clinical trial study including preparation of the final report), with the aims to achieving a specific successful result, in as much as this arises from the purpose and intention of the agreement. However, the order from any customer does not include achieving a specific test result.

CEC own the responsibility to inform the customer, in a short lap of time, if conditions that were unforeseeable when the order was placed which; therefore, require any additional services to the existing order in light to efficaciously process the customer order. Conversely,  the agreed agreement for the service to be provided do not uphold the supplemental offer and additional costs that will incur and shall be agreed upon with customer prior to execute the additional services.

Any supplementary services that are not included in the service scope, but accepted by the customers, as such it can be related to translations of reports, changing formats of reports, or creating presentations and the like, by CEC, will be solely performed at the usual CEC hourly rates or for an extra charge to be agreed from both parties.

The customer shall assume the duties to inspect and to notify of any defect set forth in the Investigational Product in the light to ensure safe clinical trial practices.

  1. Delivery of Investigational Products (IP) by the Customer

It relies on the responsibility of the customer to absorb the cost as well as risk of delivering the Investigational Products (IP) also known as ‘samples’ for the conduct of study, unless both parties reached an agreement on pickup at the risk of CEC. Prior to the shipment of IP by the customer, the samples products to be tested shall be packaged properly and clearly labelled as per the directives provided by CEC.

The customer shall assume liability for any damages that are attributable to the dangerous nature of the materials to be tested. The customer shall undertake to disclose any known dangers and handling instructions in writing (text form is sufficient). Unless otherwise agreed in the order, the samples shall only be stored as long as their condition allows testing according to the latest technological standards, but only until expiration of the deadlines stated below.

CEC upholds the authority to verify the samples to check for their usage and storage conditions prior to make use of the samples. Any discrepancy on the samples, during the check, this should be immediately reported to the customers and all these processes shall be done as per the established procedures.

If the samples are returned by CEC, all transport, insurance and packaging costs will be borne by the Customer. The Company will not be liable in case of deterioration of the sample during transport.

The responsibility for destruction of the samples would be conducted as agreed by both party in writing. However, if CEC should uphold such responsibility, the destruction of the sample would be performed as per the established procedure in place and it should be done after the reception by the Customer of the study report without further notice, unless the organisation and the Customer have agreed in writing on the terms of the organisation’s retention of the samples.

In the event of any undesired effect of the products, the customers shall be informed by CEC and appropriate actions should be initiated as per the established protocol of Study. However, it relies on the customer to ensure that the IP are hereby warrants and no samples poses any danger to the volunteers including transportation of the IP to CEC or otherwise the Company premises, instruments, personnel or representatives. Therefore, the customer has a duty of care towards to ensure compliance with applicable legal requirements at all times and also to and to inform the CEC personnel or representatives about sample health and safety concerns, including any known or suspected toxic or other contaminant that may be present in the sample and its likely level of contamination as well as the risks to the Company premises, instruments, personnel and representatives related to the contamination.

The customer shall be responsible for, and indemnifies CEC against, all costs, damages, liabilities and injuries that may be caused to or incurred by CEC or its personnel or representatives during the transportation to CEC premises and handling of the IP. Moreover, any additional costs for disposal of the hazardous waste resulting from the IP shall be borne by the customer.

  1. Customer Property: Rights on the IP and Safeguarding the IP

The customer retains the rights as ownership of the IP send to CEC for Clinical trial study. Therefore, the customer only authorise CEC to make use of the IP in the provision of the required service by CEC and the customer reserve the rights to decide, after completion of the study, whether the IP should be returned to the customers or destroyed as per the established procedure in place at CEC. Henceforth, CEC shall not be liable to any deterioration of the sample.

In the event, that the customer decide that the IP should be returned , following completion of study, all the transport, insurance, packaging and related costs as well as associated risks shall be borne by the customer and CEC shall not be accountable to any damages/ loss during transportation.

  1. Price, Supplementary Costs, Payment Terms

The price to be payable for each order is based on the respective valid service specifications by CEC, to which the respective order refers. Information concerning the amount for the clinical trial service indicated in the quotations and services not specified are therefore non-binding. The price to be paid for a specific clinical trial service is usually based on the requirements of the customers and the conditions associated with the provision of the service.

CEC shall uphold the right to increase its prices accordingly, whenever a contractual agreement has been agreed or even though a binding proposal has been submitted, any cost increases occur that are not attributable to CEC. All prices may fluctuate and revision of price for a particular service is effected on a case to case basis and the final price to be charged should be communicated to the customers prior to deliver the service.

The cost of packaging and transportation, i.e., for returning test samples or sample materials, will be billed separately. Receipts for these costs will be provided upon request by the client. Express fixed-price agreements shall be an exception to the above.

The agreed amounts for service to be provided are net and subject to the respective applicable taxes into force at the date of invoicing. Payment should be effected within 60 days from the date of invoice.

In as much as a due date was not agreed, invoices are due and payable within the stipulated number of days as per the Invoice. Any formal or content discrepancies found in the invoices must be notified in writing within seven days, otherwise the invoice will be considered formally accepted.

The mode of payment for a particular service should be done as per the CEC’s requirements (by bank transfer or direct debit for example). Therefore, it relies on the responsibility of the customer to effect the payment as per the agreed payment method. The statutory provisions shall be applicable in cases of payment default.

CEC shall not be in a position to be obliged to provide any reduction/ discount to the customer for any discrepancy occurred while effecting the payment.

Regarding cancellation or postponement of the study in the 2 weeks preceding the start of the study, an amount of 30% of the cost of the study will be applied on the customer. However, if the cancellation occurs after the start of the study, a fee of at least 50% of the cost of the study will be applied, the fees is basically calculated according to the state of progress of the study at the time of the cancellation.

In the event that the customer intends to challenge CEC for specified and justified reasons, the customer is bound to send a notification to the organisation by registered mail not later than 30 days as from the date of invoice.

The Customer shall not be allowed to make any compensation between the amounts due to the Company for the analysis carried out and the amounts whatsoever due to him by the Company, without any upfront written agreement of the Company.

 

  1. Delivery Dates and Force Majeure

Delivery dates are approximate and do not constitute a commitment by the CEC. However, any divergence in the estimate d date should be communicated by both parties and alternative date should be agreed upon.

Subsequent to completion of the analysis of the findings of the study, the results are usually sent or by email, or via other electronic means, to the attention of the persons as indicated by the customer.

Supplementary guidance, related information and consequences are also provided, as and when require, within the analysis report of the study in line with the given findings and analysis of the study. Conversely, the customer has the rights to make its own decisions based on the information provided or else base on the results obtained from the study. Yet, the customer remain own responsible for the actions initiated following submission of the findings and reports.

In the event that the analysis has been undertaken by an outsourcing firm appointed by CEC, the customer retain the rights to formally request CEC to submit the original report of the outsourcing firm.

Regarding, interruptions, inaccuracies, damages and/or other related issues caused from force majeure that are beyond CEC’s reasonable controls or any obligations from the government, therefore, CEC shall not be held accountable for reasons that are beyond the organisations control.

In general submission of reports difficulties, transportation problems of the IP, operational and other disturbances not attributable to CEC, its suppliers, or cooperation partners, and consequences thereof shall release CEC from its obligation to perform for the duration of the disturbance and within the scope of the consequences.

Furthermore, such incidents will entitle CEC not to perform contractual services under the exclusion of any liability to pay damages. In case the services cannot be performed, CEC will notify the client without delay.

The agreed due date for completion of assignment and performance shall be prolonged by the duration of the delay if operations are disturbed due to force majeure and in addition the preparation time that now becomes essential.

However, CEC shall undertake to appropriate disposition to notify the client about the anticipated delay, in as much as this is possible and reasonable.

 

  1. Copyright Statement

Unless otherwise stated, the material published on CEC website is the copyright of CEC. Aside from these specific uses, no part of this site may be reproduced, in whole or in part, without the specific written permission of CEC first-hand and obtained. Generally speaking, CEC is disposed to allow a “reasonable portion” of the material on this site to be reproduced and communicated for educational or non-commercial purposes, provided that:

  • express permission is sought and granted beforehand and
  • due acknowledgement is given as to the source of the material so used.

Persons wishing to obtain permission to use material from the site in this way should address their request in the first instance to CEC Quality Assurance Officer, Mr. Ravi Peenith.

  1. Transfer of Property

CEC shall retain the rights on the end results (Final Report) of the study and other related service to be delivered to the customer, until the full payment effected as per the claimed invoice for the agreed service to be delivered. Otherwise, the customer will not retain the property rights to make use of the results from the report.

In the event that the customer intend to review any documented information or support documents while validating the study report, a formal request should be sent to the top management of CEC. However, the organisation has no as such obligation towards to customer to accept the request and decision to accept/ reject the request of the customer to send documented information remains to the top management of CEC.  If ever the request has been accepted by the organisation, submission of such documented information as reference should be performed within the boundary of established procedures as per the Quality Management System in place.

Regardless of the likelihood that the request has been accepted, the Customer guarantees the organisation against all consequences, of any nature whatsoever, of a results of the analysis report.

CEC retain the right to keep the softcopy of the study report, although full payment effected by the customers. However, both parties should demonstrate compliance with the confidential agreement for non-disclosure of confidential matters.

 

  1. Limited Warranties and Responsibilities

CEC ensures that all the orders from customers will be processed effectively and efficiently while exerting the effort and care judiciously as per the applicable procedures and legal requirement in the clinical trial field. CEC assume the responsibilities for establishing the approaches, proceedings and systems to deliver the end report of the clinical trial services while ensuring compliance with the procedures within the organisation.

CEC reassure all its customers that the specific orders will be treated uniquely and the clinical trial report submitted to the customer will relate exclusively to the IP provided by the customers in the conduct of the clinical trial study. Upon submission the final clinical trial report, it relies on the responsibilities of the customer to either demonstrate compliance with the recommendations provided or reject the recommendations. However, CEC disclaim all the responsibilities for the impacts of the actions initiated by the customers which proved to be inadequate or absurd.

CEC shall demonstrate compliance with the protocol of study in the delivery of clinical trial services. As such if a preliminary report should be delivered, as per the protocol of study, then same shall be delivered by CEC. Conversely, assuming that a preliminary report not to be delivered, as per the protocol of the study, therefore CEC shall not be hold legally responsible for not none delivery. Any request from the customer shall be send evidently to CEC and confirmation for the same service shall be retained as evidence.

It is on the responsibility of the customer for packaging and shipping the Investigational Product to CEC for the conduct of Clinical Trial Study. An agreement shall be reached over how the IP should be despatched and responsibilities should be well assigned for collecting the IP once shipping completed. Generally speaking, the established procedure for shipping of IP should be well communicated to the customer by CEC and also all associated documents shall be well provided for clearance at the custom office.  Unless otherwise precisely agreed in writing, CEC accepts no responsibility for any damage or loss of IP. It relies on the responsibility of the customer to ensure that the IP are securely delivered to CEC. However, upon receipt of the IP, CEC shall demonstrate compliance with the procedure for safeguarding the customer property. Therefore, the responsibility of CEC to retained the IP in a safe area and shall be kept as per the stipulated conditions.

The customer shall sent all the documents related to the IP, and warrants that the IP sent to CEC for clinical trial study are safe and in stable condition and undertakes to indemnify CEC for any losses, injuries, claims and costs that have been suffered by CEC as a results of poor and unsafe IP.

Unless explicitly agreed in writing by both parties, the contractual relationship shall be exclusively between the customer and CEC. However, CEC shall informed the customer about the outsourcing firm, responsible for collection of the IP and despatch to CEC for clinical trial service.

In the above mentioned scenario, the Customer shall warrant CEC against any claim coming from CEC but on behalf of the Third party that are related to the Customers or its order at any respect whatsoever,  for any cause whatsoever and commits to entirely indemnify CEC for any indemnity that would require to pay the third party.

  1. Limitation of the Professional Liability by CEC

CEC uphold a professional liability insurance that basically covers the organisation from any malpractice or any kind of serious side effects in relation to the clinical trial doings. However, CEC shall only be liable if the aforesaid clinical trial malpractices have been proved by the concern persons (as such the customer and volunteers). The Customer waives any other claim against CEC and will cause its insurers to do the same.

CEC shall not be accountable to the customers or any third party for any thru or unintended or even any substantial loss or impairment, such as loss of business, profits, goodwill, business opportunities and amongst others.

  1. Conditions for any Re-work

The customer has the right to make an objection to the results of raw results, preliminary report as per the time allocated in the protocol of study, for review and validation of results and preliminary report. However, any objection with regards to the final report of study shall be made in writing to CEC within thirty (30) days after the date the customer receive the final report. Unless it would appear that the results of the final report do not match the validated raw results and/ or preliminary report, the customer will swallow the costs of the rework for the study. Likewise, the rework for the study will be effected upon agreement between both parties while consideration for the sufficient IP for the rework will be taken into consideration. Else, the customer will be required to absorb the all the costs, including IP transportation, analytical and payment of volunteers for the repeat Study.

The top management of CEC will retain the right for considering the rework for any study claim by the customer through valid justifications. All agreement between the customer and CEC need to be writing within either the protocol of study or in any other documented information.

  1. Disclaimer Notice for Information on Website

CEC uses its best endeavours to ensure that the information contained within this website is accurate and up to date. However, CEC makes no warranty, representation or undertaking, whether expressed or implied, nor does it assume any responsibility or legal liability, whether direct or indirect, for the accuracy, completeness, or usefulness of such information.

CEC accepts no liability for any loss or damage which may be suffered by other parties as a direct or indirect result of using this site, or reliance on the information that it contains.

Information within this website, including information relating to course offerings, may be subject to change from time to time without notice. If in doubt about whether particular information is up-to-date, users should refer to the appropriate CEC department to confirm the accuracy of the material.

  1. Confidentiality

CEC highly values confidentiality in its entire doings. The organisation also demonstrates the commitment through signed confidentiality agreement with its delighted customers for retaining the study report and in no means will be allowed to use it or to disclose confidential information to any third party for any reason whatsoever, apart from with a view to proving the implementation of the task assigned or else upon receipt of a formal request from the authority or to execute a court decision.

CEC ascertain to retain confidentiality with all the documents related to technical as well as financial aspects with regards to the study that the customer shall disclose to the organisation in order to enable the organisation perform the assignment.

  1. Conditions for Forbearance – Partial inadequacy

Unless the court of justice renounce, bound or clutch any part of the Terms and Conditions to be invalid, all the remaining parts of this Terms and Conditions shall still be demonstrated commitment by users of the websites. However, the responsible party shall engage in effecting the correction on the part mentioned by the court to be invalid.

Thus, any users of the website not committed to the valid terms and conditions, with whatsoever reasons, shall constitute forfeiture and legally shall be liable.

  1. Links to External Sites

Hypertext links to sites outside CEC are provided as a convenience to users. CEC has no control over, and is not responsible for, the contents of any information provided by outside sites through these links. The provision of these links does not imply any association between CEC and the various external organisations or individuals, nor does CEC endorse any information, products, or services available from or promoted by such sites.

It is the responsibility of the individual user to make decisions regarding the relevance, accuracy, currency and/or reliability of information found on linked external sites.

The user of the links remains responsible for the downloading of any linked material and/or any fees or charges incurred by the downloading of this material. Downloading of images and/or text without the permission of the copyright owner may breach Mauritian and international copyright laws.

  1. Applicable Laws and Jurisdictions

Legally speaking, the applicable jurisdictions, for any binding agreement between the CEC and the customer or even volunteers (in the event of registration being made as volunteers) shall be in Mauritian Law.

However, in the rise of any lawsuit with regards to the legitimacy, interpretation and conclusion of the contractual agreement between CEC and the customer shall be governed by the Commercial Court for which the legal seat of the organisation having accepted the order in question is located, which shall have exclusive jurisdiction.