General terms and conditions of sale and clinical trial services – Centre D’Études Cliniques Ltée
Scope of application – Enforceability
The following general terms and conditions (hereinafter referred to as “GTC”) apply exclusively to all business relations between Centre D’Études Cliniques Ltée (CEC), its customers (hereinafter referred to as “Customers”) and other interested parties. These GTC apply to Customers who are considered promoters within the meaning of applicable legal requirements.
When an order is placed with CEC by a promoter or a registration is made by a “volunteer”, these GTC are considered approved, unless an objection to their application is expressly formulated in writing.
Any other condition contrary to the CEC’s GTCs will only become part of the agreement if the CEC expressly accepts it in writing, depending on the case. Otherwise, any proposal by the interested party, at any time and in any form, which deviates from these GTC, will not be accepted and will therefore be considered null and void.
Offers and orders
Offers and/or orders received from customers are accepted in accordance with these terms and conditions. All offers for clinical trial services (hereinafter referred to as “the offer”) must be made in writing by the Company either on paper (fax or courier) or on an electronic medium to which these GTC are attached. Once an offer has been sent to the customer, acceptance of the offer implies acceptance of the GTC.#
Current offers concerning specific conditions are not spontaneously postponed. CEC’s offers to a customer based on its requirements and agreed conditions, to provide specific clinical trial services, will not be automatically applied to other orders, but must be accepted in reverse by both parties.
However, CEC proposals are not binding, unless they are valid only for a specific period or for a specific study. In this case, the proposal may become null and void on expiry of the time limit. The periods for which the proposal may be accepted by the customer or volunteers will be specified by CEC in the respective proposal. Customer acceptances received after this date will only be considered as offers and must be expressly accepted by the CEC.
Objections to the content of an order confirmation (submission of final reports) must be made in writing no later than the days specified in the study protocols, otherwise the order confirmation (approval of final clinical trial reports) will be deemed approved.
CEC provides its services in accordance with the agreed proposal, study protocol and order confirmation via quotations. All agreements, including amendments, modifications and subsidiary agreements, must be in writing. CEC reserves the right to confirm orders verbally.
CEC handles customer orders in a professional manner and with due diligence, common in this sector and in accordance with the legal provisions applicable in our local and international context, but which are not limited to:
– Data Protection Act 2017 (DPA 2017)
– Good clinical practice
– General Data Protection Regulation (GDPR)
– Companies Act 2001
In general, a confirmed order from a customer is essentially because of the performance of the agreed services (in particular, the performance of a clinical study including the preparation of the final report), with the aim of obtaining a successful and specific result, insofar as this arises from the purpose and intention of the agreement. However, a customer’s order does not include the obtaining of a specific test result.
CEC assumes responsibility for informing the customer, at short notice, in the event of conditions unforeseeable at the time the order was placed; consequently, requiring additional services to the existing order in order to efficiently process the customer’s order. Conversely, the agreed agreement for the service to be provided does not confirm the additional offer nor the additional costs that will result and will need to be agreed with the customer prior to the performance of the additional services.
Any additional services not included in the scope of the service, but agreed to by the customer, such as translation of reports, modification of report format or creation of presentations, etc., by CEC, will be carried out only at CEC’s usual rate or for an additional charge to be agreed between the two parties.
The customer assumes responsibility for inspecting and reporting any defects in the investigational product to ensure the safety of clinical trials.
Delivery of experimental products (IP) by the customer
It is the customer’s responsibility to assume the cost and risk of delivery of experimental products, also known as “samples”, for the conduct of the study, unless both parties have agreed on a pickup at the CEC’s risk. Prior to shipment, samples of products to be tested must be properly packaged and clearly labeled in accordance with the guidelines provided by the CEC.
The customer assumes responsibility for any damage resulting from the hazardous nature of the materials to be tested. The customer undertakes to disclose in writing all known hazards and handling instructions (a text will suffice). Unless otherwise stipulated in the order, samples will be stored only to the extent that their condition allows testing in accordance with the latest technological standards, but only until the pre-emption date indicated.
CEC reserves the right to check samples and their storage conditions before using them. In the event of any anomaly on samples during verification, this must be reported immediately to customers, and all processes must be carried out in accordance with established procedures.
If samples are returned by the CEC, all transport, insurance and packaging costs will be borne by the customer. The company will not be liable for any damage to the sample during transit.
Responsibility for sample destruction would be carried out as agreed in writing by both parties. However, if the CEC were to assume this responsibility, sample destruction would be carried out in accordance with the procedure in force locally and should be carried out after receipt of the study report by the customer without prior notice, unless the organization and the customer have agreed in writing on the conditions of sample retention by the organization.
In the event of an adverse product reaction, customers will be informed by the CEC and appropriate action will be taken in accordance with the established study protocol. However, it is the customer’s responsibility to ensure that product rights are hereby guaranteed and that no samples are dangerous to volunteers, including transport of products to the CEC, or to other Company premises, instruments, personnel or representatives. Consequently, it is the customer’s duty to ensure compliance with applicable legal requirements at all times, and to inform CEC personnel or their representatives of any health and safety issues, including any known or suspected contaminants or other contaminants that may be present in the sample and its likely level of contamination, as well as the risks to the Company’s premises, instruments, personnel and representatives associated with contamination.
The customer is responsible for all costs, damages, liabilities and injuries that may be caused to CEC, its personnel or its representatives during the transportation and handling of the products on CEC’s premises. In addition, all additional costs associated with the disposal of hazardous waste resulting from the products will be borne by the customer.
Customer property : Rights and protection of the investigational product
The customer retains ownership rights to the investigational product sent to the CEC for a clinical study. Consequently, the customer only authorizes the CEC to use the product for the provision of the service required by the CEC. The customer reserves the right to decide, after completion of the study, whether the investigational product is to be returned to the customer or destroyed in accordance with the procedure established by the CEC. Consequently, the CEC will not be responsible for any deterioration of the sample.
If the customer decides that the experimental product must be returned, once the study has been completed, all transport, insurance, packaging and related costs, as well as the associated risks, are to be borne by the customer. Under no circumstances can CEC be held responsible for damage/loss in transit.
Prices, Additional Charges, Terms of Payment
The price to be paid for each order is based on the respective valid CEC service specifications, to which the respective order refers. Information concerning the amount for the clinical trial service indicated in quotations and unspecified services is therefore not contractual. The price to be paid for a specific clinical trial service generally depends on customer requirements and the conditions associated with the provision of the service.
CEC reserves the right to increase its prices accordingly, whenever a contractual agreement has been reached or even a binding proposal has been submitted, any cost increase not resulting from CEC. All prices may fluctuate, and price revisions for a particular service are made on a case-by-case basis, and the final price to be charged must be communicated to customers before the service is provided.
Packaging and transport costs, i.e. the return of samples for testing, will be invoiced separately. Receipts for these costs will be provided at the customer’s request. An exception to the above are express flat-rate agreements.
The amounts agreed for the service to be provided are net and subject to the applicable taxes in force on the date of invoicing.
Insofar as no due date has been agreed, invoices are due and payable within the number of days stipulated on the invoice. Any formal or substantive discrepancies on invoices must be notified in writing within seven days, otherwise the invoice will be deemed officially accepted.
The method of payment for a particular service must be made in accordance with CEC requirements (e.g. by bank transfer or direct debit). It is therefore the customer’s responsibility to make payment by the agreed method. The statutory provisions apply in the event of late payment.
CEC will not be in a position to provide the customer with a discount for any discrepancies in payment.
In the event of cancellation or postponement of a study within 2 weeks of the start of the study, the customer will be charged 30% of the cost of the study. However, if cancellation occurs after the start of the study, a charge of at least 50% of the cost of the study will be applied. Fees are essentially calculated according to the progress of the study at the time of cancellation.
If the customer intends to dispute the ECC for specified and justified reasons, he/she is required to send notification to the organization by post no later than 30 days after the invoice date.
The customer is not authorized to offset amounts owed to the Company for the analysis performed against amounts owed to him by the Company, without the Company’s written agreement.
Delivery dates and force majeure
Delivery dates are approximate and do not constitute a commitment on the part of CEC. However, any discrepancy in the estimated date should be communicated by both parties and an alternative date agreed.
Once the analysis of the study results has been completed, the results are generally sent by e-mail, or other electronic means, to the attention of the persons indicated by the customer.
Additional advice, related information and consequences are also provided, as required, in the study analysis report in accordance with the conclusions and analysis provided. Conversely, the customer has the right to make his or her own decisions based on the information provided or on the results obtained from the study. However, the customer remains responsible for actions taken after the submission of findings and reports.
In the event that the analysis has been undertaken by a subcontracting company appointed by the CEC, the customer retains the right to formally request the CEC to submit the subcontracting company’s original report.
With regard to interruptions, inaccuracies, damage and/or other related problems caused by force majeure beyond the reasonable control of CEC or government obligations, CEC cannot therefore be held responsible for reasons beyond the organization’s control.
As a general rule, reported difficulties, transportation problems related to intellectual property, operational disruptions and other disruptions not attributable to CEC, its suppliers or cooperation partners, as well as their consequences, release CEC from its obligation to operate for the duration of the disruption and within the scope of the consequences.
In addition, such incidents will entitle the CEC not to perform contractual services, to the exclusion of any obligation to pay damages. If services cannot be performed, CEC will inform the customer without delay.
The agreed due date for completion of the assignment and execution must be extended by the duration of the delay if operations are disrupted by force majeure and, in addition, by the preparation time that now becomes essential.
However, CEC undertakes to take the necessary steps to inform the customer of the expected delay, as far as is possible and reasonable.
Unless otherwise indicated, the material published on the CEC website is the property of CEC. Except for these specific uses, no part of this site may be reproduced, in whole or in part, without the express prior written permission of CEC. In general, CEC is willing to permit a “reasonable portion” of the content of this site to be reproduced and communicated for educational or non-commercial purposes, provided that:
Express permission is sought and granted in advance and
The source of the material so used is duly acknowledged.
Persons wishing to obtain permission to use the contents of the site in this way should first address their request to the CEC Quality Assurance Controller, Mr Ravi Peenith.
Transfer of ownership
CEC will retain the rights to the final results (final report) of the study and other associated services to be provided to the customer, until full payment has been made in accordance with the declared invoice for the agreed service. Otherwise, the customer will not retain ownership rights to use the results of the report.
If the customer intends to review documented information or supporting documents when validating the study report, a formal request must be sent to CEC management. However, the organization has no obligation as such towards the customer to accept the request, and the decision to accept/refuse the customer’s request to send documented information remains with CEC’s top management. In the event of the request being accepted by the organization, the submission of this documented information for reference purposes must be carried out in compliance with established procedures, in accordance with the quality management system in place.
Regardless of the likelihood of acceptance of the request, the Customer indemnifies the organization against all consequences, of whatever nature, of the results of the analysis report.
CEC reserves the right to retain an electronic copy of the study report, even though full payment has been made by the customer. However, both parties must demonstrate compliance with the confidentiality agreement for non-disclosure of confidential material.
Limited warranties and liabilities
The CEC ensures that all customer orders are processed efficiently and effectively, with due care and effort, in accordance with current procedures and legal requirements for clinical trials. The CEC assumes responsibility for putting in place the approaches, procedures and systems needed to provide the final report on clinical trial services, while ensuring compliance with the organization’s procedures.
The CEC assures all its customers that specific orders will be processed in a unique manner, and that the clinical trial report submitted to the customer will relate exclusively to the test product supplied by the customer when the trial is carried out. When submitting the final clinical trial report, it is the customer’s responsibility to demonstrate compliance with the recommendations provided, or to reject the recommendations. However, the CEC accepts no responsibility for the consequences of actions taken by customers which prove to be inadequate or absurd.
The CEC must demonstrate compliance with the study protocol in the provision of clinical trial services. Thus, if a preliminary report is to be submitted in accordance with the study protocol, it must be submitted by the CEC. Conversely, should a preliminary report not be submitted in accordance with the study protocol, the CEC will not be held legally responsible for the non-delivery. All customer requests must of course be addressed to the CEC, and the confirmation for the same service must be retained as proof.
The customer is responsible for packaging and shipping the investigational product to the CEC for the clinical trial. Agreement must be reached on how the product to be tested is to be shipped, and responsibilities must be clearly assigned for collection of the product once shipment has been completed. In general, the established product shipment procedure must be properly communicated to the customer by the CEC, and all associated documents must also be properly cleared through customs. Unless otherwise agreed in writing, CEC cannot be held responsible for damage to or loss of products. It is the customer’s responsibility to ensure that products are delivered securely to the CEC. However, upon receipt of the products, CEC must demonstrate compliance with the customer’s property protection procedure. Consequently, it is CEC’s responsibility to store the products in a secure area and in accordance with the stipulated conditions.
The customer must send all documents relating to the product, and guarantees that the products sent to the CEC for clinical trial study are safe and in stable condition and undertakes to indemnify the CEC for any losses, injuries, claims and costs which have been incurred by the CEC as a result of the weak and unsafe product.
Unless explicitly agreed in writing by both parties, the contractual relationship is exclusively between the customer and CEC. However, the CEC will inform the customer of the subcontracting company responsible for collecting the investigational product and sending it to the CEC for the clinical trials service.
In the above-mentioned scenario, the customer indemnifies CEC against any claim emanating from CEC but on behalf of the third party related to the customer or its order in any respect whatsoever, for any cause whatsoever, and undertakes to fully indemnify CEC for any compensation that would require payment to the third party.
Limitation of professional liability by the CEC
CEC has taken out professional liability insurance, which essentially covers the organization for any malpractice or any type of serious side-effect related to clinical trials. However, CEC is only liable if the persons concerned (as such the customer and the volunteers) have proved that the aforementioned clinical trial errors have been committed. The customer waives any further claims against CEC and will oblige its insurers to do the same.
CEC shall not be liable to customers or third parties for significant or unforeseen, unintended, or even substantial losses, such as loss of business, profits, goodwill, commercial opportunities, etc., or for any other loss or damage of any kind.
Conditions for any reworking
The customer has the right to object to the raw results, preliminary report within the time allotted in the study protocol, for review and validation of the results and preliminary report. However, any objection concerning the final study report must be addressed in writing to the CEC within thirty (30) days of the date on which the customer receives the final report. Unless it appears that the results of the final report do not correspond to the raw results and/or the validated preliminary report, the customer will assume the costs of reworking the study. Similarly, modifications to the study will be made after agreement between the two parties, taking into account the suitability of the products to be tested. Otherwise, the customer will have to absorb all costs, including product transport, analysis and payment of volunteers for the new study.
CEC’s senior management will retain the right to consider the reworking of any study claim by the customer by means of valid justifications. Any agreement between the customer and CEC must be set out in writing in the study protocol or in any other document.
Disclaimer for website information
CEC makes every effort to ensure that the information contained on this website is accurate and up-to-date. However, the CEC makes no warranties, representations or undertakings, express or implied, and assumes no legal liability, direct or indirect, as to the accuracy, completeness or usefulness of such information.
The CEC assumes no responsibility for any loss or damage that may be suffered by third parties as a direct or indirect result of using this site or relying on the information contained therein.
The information contained on this website, including course information, may be changed from time to time without notice. If in doubt as to whether particular information is up to date, users should consult the relevant CEC department to confirm the accuracy of the information.
The CEC attaches great importance to confidentiality in all its activities. The organization also demonstrates its commitment through a confidentiality agreement signed with its clients to retain the study report. Under no circumstances will it be authorized to use it or to disclose confidential information to third parties for any reason whatsoever, except for the purpose of proving the implementation of the task entrusted to it, or following receipt of an official request from the authorities or enforcement of a court order.
The CEC will ensure the confidentiality of all documents relating to the technical and financial aspects of the study that the client must disclose to the organization in order to enable it to carry out the assignment.
Conditions of abstention – partial insufficiency
Unless the court of law annuls, binds or obliges any part of the general terms and conditions to be invalid, all remaining parts of these general terms and conditions will still have to demonstrate the commitment of the users of the websites. However, the responsible party undertakes to make the correction for the part that the court has declared invalid.
Thus, any website user who fails to comply with the current terms and conditions, for whatever reason, constitutes a forfeiture and is legally liable.
Links to external sites
Hypertext links to sites external to CEC are provided for the convenience of users. CEC has no control over, and is not responsible for, the content of any information provided by external sites through these links. The provision of these links does not imply any association between CEC and the various external organizations or individuals, and CEC does not endorse any information, products or services available from or promoted by these sites.
It is the responsibility of each 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 downloading any linked material and/or for any costs incurred in downloading such material. Downloading images and/or text without the permission of the copyright holder may constitute a violation of Mauritian and international copyright laws.
Applicable law and jurisdiction
From a legal point of view, the applicable jurisdictions for any binding agreement between CEC and the customer or even volunteers (in the case of registration as volunteers), are governed by the laws of Mauritius.
However, any legal action relating to the legitimacy, interpretation and conclusion of the contractual agreement between CEC and the customer will be governed by the Commercial Court, for which the registered office of the organization, having accepted the order in question, will enjoy exclusive jurisdiction.