The following definitions apply to these General Terms and Conditions:
1.1. Client: the party commissioning the engagement by accepting, signing or approving otherwise the proposed Contract by the Contractor
1.2. Contractor: The Regulatory Company, the party providing services.
1.3. Proposal: a Contract that is proposed by the Contractor to the Client
1.4. Contract: a set of documents consisting of the Service Agreement, one of more Service Descriptions, and these General Terms and Conditions of services under which the Contractor carries out the work for the Client.
1.5. Service Agreement: document in which Client and Contractor confirm Client specific details of the services provided by the Contractor
1.6. Service Description: description of the standard service that will be provided by the Contractor to the Client, including the service specific terms and conditions, and the (PIF / product dossier) data and documentation requirements that apply.
2.1. These General Terms and Conditions are applicable to any provision of services to the Client by the Contractor, except where provided otherwise in the Service Agreement or Proposal for services.
2.2. The Contractor explicitly rejects the applicability of the Client’s General Terms and Conditions, Procurement Terms and Conditions, and/or comparable conditions unless otherwise agreed in writing.
3.1. The Contract is concluded as soon as the Contractor has received the Service Agreement or accepted Proposal for services duly signed by the Client and the Contractor. As long as the Contractor is not in possession of the Service Agreement or accepted Proposal for services, it reserves the right to deploy its staff elsewhere. The Service Agreement is based on the information provided by the Client to the Contractor at the same time the Service Agreement was drafted.
3.2. If the engagement was commissioned orally or the Contractor has not yet received the signed Service Agreement, the Contract is deemed to have been concluded under the Service Description(s) and these General Terms and Conditions as soon as the Contractor has initiated the Contract at the Client’s request.
3.3. The Contract supersedes and replaces any previous proposals, correspondence, agreements or other communications, whether orally or in writing.
3.4. The Contract is concluded for an indefinite period unless its contents imply that it was concluded for a definite period.
4.1. The Client undertakes to provide the Contractor with all information and documents which the latter believes to be required for the timely and proper execution of the Contract, and to do so on time and in the desired form and manner.
4.2. The Client undertakes to inform the Contractor without delay of any facts and circumstances that might be relevant to the proper execution of the Contract.
4.3. The Client is responsible for the accuracy, completeness and reliability of the information and documentation provided to the Contractor, even if they originate with or are acquired from third parties.
4.4. The Client will deploy the staff deemed required by the Contractor or have this staff deployed in order to allow the Contractor to carry out the engagement. If specific staff members are required, this will be laid down in the Service Agreement. The Client undertakes to ensure that its staff is sufficiently skilled and experienced at the work to be carried out under the engagement.
4.5. Any additional costs and extra fees due to a delay in the execution of the Contract resulting from failure to make the requested information, documents, facilities and/or staff available, or to do so on time or in the proper fashion are for the Client’s account.
5.1. Unless expressly stipulated otherwise, the Contractor will carry out all activities to the best of its knowledge and ability and in accordance with professional standards.
5.2. The Contractor determines the manner in which the Contract will be executed and by whom, with due observance of the wishes expressed by the Client where possible.
5.3. The Contractor cannot carry out any activities in addition to those commissioned and bill these to the Client until the Client has given its prior consent.
5.4. The Contractor cannot involve third parties in the execution of the Contract unless it has reached agreement with the Client about such involvement.
5.5. The Contractor keeps working documents in relation to the Contract on file. This file, which contains (copies of) relevant documents, is in the possession of the Contractor.
6.1. If the Client is required to make an advance payment or to make information and/or materials available for the purposes of executing the Contract, then the term taken for completion of the work will not take effect until the Contractor receives payment in full and/or until all information and/or materials have been made available to the Contractor respectively.
6.2. As the duration of the Contract is subject to many factors, such as the quality of the information provided by the Client and the cooperation extended, the due dates for completion of the work should be regarded as deadlines only where this has been agreed in writing.
6.3. Unless execution of the Contract proves to be permanently impossible, the Client cannot terminate the Contract on account of overdue performance, unless the Contractor does not perform the Contract, either partially or in full, within a reasonable period of which it was notified in writing after expiry of the agreed delivery period.
7.1. The fee charged by the Contractor is exclusive of out-of-pocket expenses and expense claims filed by third parties commissioned by the Contractor. The Contractor will inform the Client to the best of its ability of these expenses in a timely and concise manner.
7.2. All fees are exclusive of turnover tax and other government levies, if any.
7.3. All fees may be subject to annual indexation according to the EUROSTAT Service Producer Price Index (SPPI).Indexation is based on the EUROSTAT SPPI for the Netherlands in the 3rd quarter of the previous year.
8.1. The Client is required to pay the fee charged without any deduction, discount or debt settlement no later than 30 days after the invoice date. Payments must be made by means of money transfer to the bank account mentioned on the invoice. Objections to the amounts charged do not exempt the Client from its obligation to pay.
8.2. If the Client fails to pay within the period referred to in 8.1 above, it is in default by operation of law after having been reminded by the Contractor at least once that payment is due. In that case, the Client is liable to pay statutory interest on the credit balance with effect from the date on which the payment became due until the date of payment. In addition, all collection costs incurred after the Client’s default, both judicial and extrajudicial, are for the Client’s account.
8.3. If the Contractor believes that the Client’s financial position and/or payment performance justifies such action, the Contractor has the right to demand that the Client immediately furnish security or additional security in a form to be determined by the Contractor and/or make an advance payment. If the Client fails to furnish the desired security, the Contractor has the right, without prejudice to its other rights, to immediately suspend the further execution of the Contract, and that which the Client owes to the Contractor for whatever reason will become immediately due and payable.
9.1. Unless the requirements of reasonableness and fairness dictate otherwise, the Client and the Contractor have the right to terminate the Contract in writing with due observance of the contract duration, and notice period stated in the Service Agreement. If not stated in the Service Agreement the Contract shall commence upon the date it is signed and shall continue for a minimum period of 3 years. After the minimum duration period of 3 years, this Contract will automatically be renewed for a period of 1 year. Both parties can terminate the Contract with a minimum notice period of 3 months before the end of the (renewed) contract duration period.
9.2. Either party may terminate the Contract, whether prematurely or not, in writing without due observance of a notice period if the opposite party fails to pay its debts or if a bankruptcy trustee, administrator or liquidator has been appointed, the opposite party is subject to debt rescheduling, or ceases its operations for any other reason or if the opposite party considers it to be likely, within reason, that one of the above circumstances will apply to the opposite party or if a situation has arisen that justifies immediate termination in the interest of the party terminating the Contract.
9.3. If the Client terminates the Contract prematurely, the Contractor is entitled to compensation in full and in line with the agreed contract duration, prolongation, and notice period for termination in article 9.1. or agreed otherwise in the Service Agreement. As well as for additional costs that must reasonably be incurred as a result of the premature termination of the Contract, unless the termination was motivated by facts and circumstances that can be attributed to the Contractor. If the Contractor terminates the Contract prematurely, the Client is entitled to assistance from the Contractor in transferring the work to third parties, unless the termination was motivated by facts and circumstances that can be attributed to the Client. In all cases of termination, whether premature or not, the Contractor retains the right to payment of the expense claims for the work carried out including expense claims by 3rdparties for the work carried out.
9.4. If the Contract is terminated, both parties will immediately make available to the opposite party all goods, objects and documents belonging to the opposite party that it has in its possession.
10.1. The provisions of this Contract, which are intended, either expressly or tacitly, to remain in effect even after termination of this Contract, will remain in effect after the Contract has been terminated and continue to bind both parties.
11.1. Confidential information shall include all the information disclosed to TRC while dealing with TRC and shall include but is not limited to formulas, product formulations, business contacts, product details, designs, drawings, artworks and any other information disclosed of confidential nature. Where TRC obtains Confidential Information of the Client in connection with this Agreement it shall:
11.1.1. keep that Confidential Information confidential, by applying the standard of care that it uses for its own Confidential Information;
11.1.2. use that Confidential Information only for the purposes of performing obligations under this Agreement; and shall
11.1.3. not disclose the Confidential Information to any third party without the prior written consent of the Client.
11.2. Except where a statutory provision, regulation or other professional obligation to disclose information is in effect, the Contractor and its staff undertake to maintain confidentiality vis-à-vis third parties in respect of confidential information acquired from the Client.
11.3. The Contractor cannot use the information provided by the Client for any purpose other than for which it was obtained without the Client’s written consent.
11.4. Except where a statutory provision, regulation or professional obligation to disclose information is in effect, the Client will not disclose to third parties the contents of reports, opinions or any other written or oral statements issued by the Contractor.
11.5. The Contractor and the Client have the right to refer in general terms to the nature of their contractual relation and the activities performed, provided that this only serves as a description of the Contractor’s experience and the Client’s regulatory management. This is not deemed contrary to the provisions of this article 11.
11.6. Information is not considered to be Confidential Information when:
11.6.1. it is or has become public knowledge other than by breach of this article 11;
11.6.2. it is or has been received by TRC from a third party who lawfully acquired it and who is under no obligation restricting its disclosure; or
11.6.3. it is independently developed by TRC without access to the relevant Confidential Information.
11.7. The Contractor and the Client will impose their obligations under this Article on any of its outside contractors.
11.8. All Intellectual Property Rights belonging to the Client shall remain vested with the Client. Nothing in this Agreement is intended to transfer any Intellectual Property Rights from the Client to TRC.
12.1. During the execution of the Contract, the Client and the Contractor will be able to communicate and exchange data via electronic means such as email, (cloud) databases, and (web) interfaces at either party’s request. Both the Client and the Contractor recognize the risks associated with electronic communication and data exchange, including, but not limited to, distortion, delays, viruses, and security breaches. The Client and the Contractor hereby declare that they will not hold each other liable for any losses incurred either of them as a result of the use of electronic communication and data exchange.
12.2. Both the Client and the Contractor will do or not do all that can reasonably be expected from them to avoid such risks. If the Client or Contractor is in doubt as to the correctness or the security of the electronic communication and data exchange they have received, they will inform each other immediately. In case of distortion, the contents of the message or data originating with the sender is decisive.
13.1. The Contractor must be notified in writing of complaints relating to the work carried out and/or the invoiced amount within 30 days of the date of dispatch of the documents or information in respect of which the Client is filing a complaint, or within 30 days of the discovery of the shortcoming, if the Client proves that the shortcoming could not have reasonably been discovered previously.
13.2. Complaints as referred to in the first paragraph do not exempt the Client from its obligation to pay.
13.3. If the Client filed a legitimate complaint, it has the option of adjusting the fee charged, having the rejected work rectified or repeated free of charge or terminating the Contract (or remaining work) in exchange for a refund proportionate to the fee already paid by the Client.
14.1. The Contractor will carry out its work to the best of its ability, while exercising the due care that may be expected of a Contractor. If an error is made as a result of the Client providing incorrect or incomplete information, the Contractor is not liable for any resulting loss. If the Client proves that it has suffered a loss due to an error by the Contractor that could have been prevented if proper care had been taken, the Contractor is liable for that loss limited to the total fee received within the scope of the applicable Contract. If the (consulting) Contract runs for more than six months, the Contractor liability is limited to the total fee received within the scope of the applicable Contract for the last six months.
14.2. The limitation of liability laid down in paragraph 14.1 above also applies to third parties commissioned by the Contractor to execute the Contract.
14.3. The Client indemnifies the Contractor against third-party claims for losses incurred as a result of the Client supplying incorrect or incomplete information to the Contractor, unless the Client proves that the loss does not relate to imputable faults or negligence on its part or was caused by an intentional act or omission, or similar intentional recklessness on the part of the Contractor.
15.1. Neither party shall be liable to the other for any delay in performing or failure to perform any obligation under this Agreement to the extent that such delay or failure to perform is a result of:
15.1.1. war (whether declared or not), civil war, riots, revolution, acts of terrorism, military action, sabotage and/or piracy;
15.1.2. natural disasters such as violent storms, earthquakes, tidal waves, floods and/or lighting; explosions and fires;
15.1.3. strikes and labour disputes, other than by any one or more employees of the affected party or of any Supplier or agent of the affected party; or
15.2. A party whose performance is affected by a Force Majeure Event (as described in 15.1) shall:
15.2.1. promptly notify the other party in writing of the Force Majeure Event and the cause and the likely duration of any consequential delay or non-performance of its obligations;
15.2.2. use all reasonable endeavours to avoid or mitigate the effect of the Force Majeure Event and continue to perform or resume performance of its affected obligations as soon as reasonably possible; and
15.2.3. continue to provide Services that remain unaffected by the Force Majeure Event.
15.3. If the Force Majeure Event continues for more than 60 days after the day on which it started, the non-affected party may terminate this Agreement by giving at least 10 days' written notice to the affected party.
16.1. Except where otherwise provided in the Contract, rights of action and other powers enjoyed by the Client for whatever reason vis-à-vis the Contractor will lapse in any event one year after an occurrence leading to the Client’s entitlement to invoke these rights vis-à-vis the Contractor.
17.1. The rights or powers enjoyed by the Contractor under this Contract will not be affected or limited by the Contractor’s failure to directly enforce any rights or powers. Any right or authority laid down in or ensuing from any provision or condition of this Contract can only be renounced in writing.
18.1. Unless the other party has given its express consent, to which it is entitled to attach conditions, a party is not permitted to assign any obligation laid down in this Contract to third parties. This provision excludes the transferability within the meaning of article 3:83 (2) of the Dutch Civil Code (sluit de overdraagbaarheid uit). The transferring party commits to impose all relevant (payment) obligations laid down in the Contract on the third party. Unless the Client and the Contractor explicitly agree otherwise, transferring party and/or the third party, will continue to be liable for the obligations laid down in the Service Agreement and the General Terms and Conditions.
18.2. The Client indemnifies the Contractor against all third-party claims arising from the Client’s non-performance or incorrect performance of any obligation laid down in the Service Agreement and/or these General Terms and Conditions, unless any imperative national or international rule or law dictates otherwise.
19.1. If and to the extent that, in all reasonableness and fairness or by virtue of its unreasonably onerous nature, any of the provisions of the Contract cannot be invoked, the provision in question will in any event be accorded a meaning corresponding as closely as possible to the original contents and tenor so that this provision can nevertheless be invoked.
20.1. Nothing in this Agreement and no action taken by the parties under this Agreement shall constitute a partnership, association, joint venture or other co-operative entity between the parties or constitute any party the partner, agent or legal representative of the other.
21.1. In case the contract documents contain conflicting terms and conditions, the conditions contained in the documents will prevail in the following order: Service Agreement, Service Description(s), and these General Terms and Conditions.
22.1. All Contracts between the Client and the Contractor are governed by the laws of the Netherlands. Unless the parties expressly agree otherwise in writing, all disputes between the Client and the Contractor relating to this Contract will be referred to the competent District Court of The Hague.