GTC

ARTICLE 1 – Scope

In accordance with Article L 441-6 of the Commercial Code, these General Terms of Business form the foundation of the commercial relationship between the parties. Their purpose is to define the conditions under which ACM PHARMA provides its professional customers (‘the Customer(s) or the Instructing Party(ies)’), on making a written or direct request, with services and work, studies, analyses, dossiers and consulting, expertise or training initiatives (‘the Services’).

They apply unconditionally and without limitation to all Services provided by ACM PHARMA to Customers of the same category, notwithstanding any provisions that may be contained in the Customer’s documents, including its general terms and conditions of purchase. Under current regulations, these General Terms of Business are routinely made available to any Customer that so requests, allowing the Customer to place an order with ACM PHARMA.

Any order for Services implies, on the part of the Customer, acceptance of these General Terms of Business.

ARTICLE 2 – Orders

2.1. Sales of Services are only complete when a quotation has been prepared (‘the Quotation’), the Quotation has been accepted by the Customer, and the Customer’s order (‘the Order’) has been expressly accepted by ACM PHARMA in writing. The Customer is responsible for the accuracy of the information provided to ACM PHARMA for the preparation of the Quotation and the provision of the Services.

2.2. Any changes to the Order requested by the Customer will only be taken into account, to the extent that ACM PHARMA is able to do so, if they are notified in writing (email, amendment or purchase order) and any price adjustments are made.

2.3. If the Customer cancels the Order after it has been accepted by ACM PHARMA, for any reason whatsoever other than force majeure, ACM PHARMA will automatically be entitled to the payments set out in the ‘Payment Terms’ section of these General Terms of Business, without giving rise to any right of reimbursement.

ARTICLE 3 – Quotation

The period of validity of the Quotation drawn up by ACM PHARMA is indicated on the Quotation itself. Unless otherwise specified in the Quotation, it is valid for three (3) months from its issuance by ACM PHARMA.

The Services are provided at ACM PHARMA’s current rates on the day the Order is placed, as per the Quotation previously drawn up by ACM PHARMA and accepted by the Customer, in accordance with the section ‘Orders’ above.

Prices are given in euros and are net and undiscounted, exclusive of tax, with VAT applied at the applicable rate on the date of invoicing.

An invoice is issued by ACM PHARMA to the Customer for each provision of Services or, where appropriate, based on the progress made in the provision of the Services.

The conditions for determining the cost of the Services, the price of which can neither be known at the outset nor quoted precisely, as well as the method for calculating the price so that it can be verified, will be communicated to the Customer or will be the subject of a detailed Quotation, at the Customer’s request, pursuant to Article L 441-6, II of the Commercial Code.

ARTICLE 4 – Confidentiality – Safety

4.1. ACM PHARMA undertakes not to disclose, without the Customer’s prior consent, all or part of the information, documents or results obtained in connection with the work entrusted to it. ACM PHARMA shall ensure that its staff respect this commitment to confidentiality.

4.2. Unless otherwise specified by the Customer, the Customer agrees to appear on ACM PHARMA’s reference lists.

4.3. The Customer undertakes to provide ACM PHARMA with comprehensive written information about the risks involved in handling or storing the products sent to ACM PHARMA in connection with the provision of the Services, which may present a risk to the safety of its staff and the integrity of its equipment and premises.

ARTICLE 5 – Conditions for the Provision of Services

5.1. Upon receipt of the Order as described in Article 2 above, ACM PHARMA provides the Services according to industry standards and according to:

  • these general conditions of Business;
  • the specifications, research protocol or special instructions from the Customer;
  • the offer as stated in the purchase Order and, where applicable, in the signed Quotation serving as a purchase Order;
  • quality standards (GMP, ISO 17025), provided they are contractually defined;
  • the provisions contained in the ACM PHARMA Quality System, which may be consulted at ACM PHARMA’s head office.

5.2. Samples and products necessary for the provision of the Services will be sent at the Customer’s expense and risk. They must reach ACM PHARMA properly labelled and in a suitable container. Samples must be accompanied by a letter giving the information necessary for an inspection on receipt: type, quantity, batch number, storage conditions and, where appropriate, information on safety precautions. The Customer is responsible for the representativeness of the sampling submitted for the commissioned Services.

5.3. Deliveries should be made to ACM PHARMA’s address from Monday to Thursday from 8am to 6pm, Friday from 8am to 5pm and Saturday from 8am to 12pm. In the absence of written instructions from the Customer stipulating special storage conditions, the products will be kept at room temperature.

5.4. Unless otherwise instructed by the Customer in writing and subject to storage charges, ACM PHARMA will destroy the remaining samples and products after a storage period of one (1) month for products at room temperature and one (1) week if refrigerated, once the Services have been provided. The Customer will pay all costs arising from such destruction, including any additional destruction costs resulting from a change in the regulatory framework (e.g. on hazardous waste). However, at the express written request of the Customer, samples or products will be returned (‘the Returns’) to the address supplied by the Customer. Returns will be handed over at ACM PHARMA’s premises to a shipper or carrier, whereupon they will be transported at the Customer’s risk. The Customer, who should check their condition on delivery, acknowledges that the carrier is responsible for delivering the Returns. ACM PHARMA is deemed to have fulfilled its obligation to deliver the Returns as soon as the carrier has received and accepted them without reservation. The Customer cannot, therefore, bring a claim under the guarantee against ACM PHARMA for failure to deliver the Returns, nor for any damage occasioned during transit or unloading. Additional charges will be invoiced for the costs of preparing the return shipment and transport.

5.5. The results of the Services are communicated in the form of reports, analysis bulletins, minutes or files established on behalf of the Client on ACM PHARMA’s letterhead, in paper or electronic format. Only the original documents and certified copies are authentic with respect to third parties.

5.6. Additional costs :

5.6.1. The following addtional costs are listed in the Quote:

  • Waste management/destruction participation fee
  • Specific processing of samples (CMR-type toxicity or antimicrobial treatment)
  • Management of psychotropic drugs/narcotics
  • Sample return, cooler, room temperature probe
  • Retrieving an archived report for duplication
  • Sample pool and specific preparation

Any specific purchase necessary for the provision of the Services, such as: reference substances, microbial strains, specific reagents, additional insurance premiums, and so on, will give rise to additional charges, possibly increased by a minimum flat rate and administrative costs. This figure may be adjusted based on the nature of the provision and will, in such cases, be specified in the Quotation submitted for prior acceptance by the Customer.

5.6.2. Each copy of raw data supplied from a study, at the Customer’s request, will give rise to additional charges . The publication of extra reports translated into English will incur an additional charge.

5.6.3. GMP studies involve carrying out a basic investigation related to an OOS result (‘Routine Investigation’). Any additional and specific investigations carried out at the Customer’s request, which go beyond the Routine Investigation, will be subject to an additional flat-rate fee.

5.7. Archiving or Unarchiving: All documents, protocols, technical inspections, specifications, raw analytical data, study reports, amendments and deviations (the ‘Documentation’) will be retained by ACM PHARMA until the Services have been provided in full. Once the Services have been provided, the Customer will retrieve the Documentation at its own cost on the same terms as those described for Returns (see 5.4). Failing this, ACM PHARMA will be obliged to archive the Documentation as specified in the Quotation, on the understanding that any request from the Customer to supply the archived Documentation will be invoiced separately.

5.8. The Services requested by the Customer will be provided by the deadline set out on the duly signed Purchase Order that corresponds to the Quotation (‘the Deadline’). This is not a strict time limit and ACM PHARMA may not be held liable to the Customer for any delay in the provision of the Services. ACM PHARMA may not be held liable for any delay or suspension of the provision of the Services caused by the Customer, a third party (supplier or other) or in the case of force majeure.

5.9. Should the Customer make a special request to change the conditions for the provision of the Services, which is duly accepted in writing by ACM PHARMA, the associated costs will be invoiced separately on the basis of a Quotation or an amendment to the existing Quotation as accepted by the Customer.

5.10. In the course of providing the Services, ACM PHARMA reserves the right to adjust the prices indicated in the Quotation to take into account the impact of:

i) the discovery of unusual properties in the samples, which were unknown at the time of preparing the Quotation;

ii) the entry into force or amendment of any regulation or recommendation that is binding on ACM PHARMA;

iii) and, more generally, the occurrence of any event unforeseen at the time of preparing the Quotation that would affect ACM PHARMA.

In the cases referred to above, ACM PHARMA will send the Customer an amended Quotation with the relevant supporting documentation.

5.11. If ACM PHARMA is prevented from providing all or part of the Services for any reason beyond its control, including cancellation of the Order by the Customer or the Customer’s failure to perform any of its obligations, the Customer will pay ACM PHARMA the amount of any non-refundable expenses incurred, including any resource mobilisation, reservation of means or otherwise, increased by the percentage of the agreed price equal to the proportion of the Service(s) actually performed.

5.12. ACM PHARMA is entitled to subcontract part of the provision of the Services to other companies. For Services subject to GMP or ISO standards, such subcontracting will only be carried out with the prior written consent of the Customer. ACM PHARMA remains wholly responsible for the full and complete performance of the subcontracted obligations and compliance with the confidentiality clause.

ARTICLE 6 – Liability of ACM PHARMA – Guarantee

6.1. ACM PHARMA holds public liability insurance with a reputable and solvent company.

6.2. The Customer undertakes to subscribe to all the necessary insurance policies to cover its liability arising from the provision of the Services.

6.3. Under no circumstances will the actions of ACM PHARMA, or the results reported to the Customer during the provision of the Services, release the Customer from its obligations under the legal or regulatory requirements to which it is subject.

6.4. The results of the Services performed by ACM PHARMA are intended for the Customer’s exclusive use (unless explicitly or implicitly required by law or regulation). ACM PHARMA may not be held liable under any circumstances, except in the case of gross negligence as proven by the Customer, for any industrial or commercial consequences that may result therefrom.

6.5. In accordance with its legal duty to use reasonable efforts, ACM PHARMA guarantees the Customer against any non-conformity of the Services and any latent defect resulting from a fault in the design or supply of the Services, except insofar as the Customer is negligent or at fault.

6.6. Unless the Customer has explicitly made reservations or complaints on receipt of the Services, they will be deemed to conform to the Order, both in terms of quantity and quality. The Customer must submit any such reservations or complaints in writing, along with all the relevant documents, to ACM PHARMA within thirty (30) days of the provision of the Services, failing which any action relating thereto may be forfeited. If the Customer fails to comply with these procedures within the specified time limits, any complaints will be rejected.

6.7. ACM PHARMA may only be held liable in cases of proven fault or negligence and its obligation to indemnify is limited to direct losses and does not extend to indirect losses of any kind. Without exception, ACM PHARMA’s guarantee is limited to the amount paid by the Customer excluding VAT for the provision of the Services in dispute.

6.8. The Customer expressly waives any further claims against ACM PHARMA and warrants that its insurers will respect an equivalent waiver.

6.9. All actions against ACM PHARMA are time-barred after a period of one (1) year from the date of the invoice for the provision of the Services.

ARTICLE 7 – Terms of payment

7.1. Time limits for payment

The price is payable by cheque or bank transfer in full and in a single payment within thirty (30) days from the invoice date, unless otherwise agreed in the Quotation and confirmed in the Order.

7.2. Penalties for late payment

7.2.1. In the event of late payment and transfer of the sums owing by the Customer after the above-mentioned deadline, and beyond the date specified in the invoice addressed to the Customer, under Article L 441-6, paragraph 8 of the Commercial Code, late payment penalties calculated at the refinancing rate of the European Central Bank (ECB) increased by 10 points of the amount including tax of the price of the Services appearing on the said invoice, will be automatically acquired by ACM PHARMA as of right, without any formality or prior formal notice being required.

7.2.2. In addition to these late-payment penalties, there will be a fixed charge for collection costs of €40 excl. VAT, and any supplementary charges as necessary.

7.2.3. Late payment will result in all amounts owing to ACM PHARMA by the Customer becoming immediately due and payable, without prejudice to any other action that ACM PHARMA may be entitled to take against the Customer in this respect.

7.2.4. In the event of non-compliance with the payment terms set out above, ACM PHARMA also reserves the right to cancel the provision of the Services ordered by the Customer, to suspend the performance of its obligations and to cancel any discounts granted to the Customer.

7.2.5. By express agreement, it is understood that payment may not be delayed due to any dispute whatsoever concerning an Order after the thirty (30) day complaint period has elapsed.

7-3. No compensation

In accordance with Article L 442-6-I-8 of the Commercial Code, except with the express, prior and written consent of ACM PHARMA, and provided that the mutual claims and debts are in an available form, immediately payable and of a fixed amount, the Customer is not entitled to offset any penalties for a delay in the provision of the commissioned Services or non-compliance with the Order against the sums owed by the Customer to ACM PHARMA for the purchase of the said Services.

ARTICLE 8 – Intellectual property rights

8.1. Each Party retains full ownership of the rights it holds on the date the Quotation is issued by ACM PHARMA. ACM PHARMA retains ownership and control of all rights, patents, techniques, methods, know-how, tools, hardware and software that it owns, and which it may use, whether for a fee or free of charge, in connection with the provision of the Services. If the exploitation of the results of the Services provided would require the use of such techniques, patents, methods, know-how, tools, hardware and/or software, ACM PHARMA will grant the Customer a free, non-exclusive, non-transferable licence, which will be valid for the duration of the intellectual property rights attached thereto.

8.2. The Client will have absolute ownership of the results of the Services provided by ACM PHARMA (hereinafter referred to as the ‘Results’), as and when they are achieved. The Results include all deliverables, in particular the final Report if specified in the Quotation, studies, designs, inventions, whether patentable or not, processes, products, know-how, models, materials, tests, samples, prototypes, software, computer developments, specifications, databases, drawings, information, names, logos, of whatever nature, form and medium. As such, ACM PHARMA assigns to the Customer, on an exclusive basis, all industrial and/or intellectual property rights that it may hold over the Results. The rights thus assigned will include rights of reproduction, adaptation, translation, use and representation, for the whole world, in all forms, across all supports and media for the legal duration of the intellectual property rights of the country of use. When the above-mentioned rights are transferred to the Customer, the supporting documents or materials will become the property of the Customer and of any subsidiary company within the meaning of Article L 233-16 of the Commercial Code. As a result, the Customer will be entitled to use and exploit the Results without restriction. The Customer will have the exclusive right to register in its name any industrial property right capable of protecting the Results, in particular any patent and/or trademark application, whether they be French, Community or international applications. However, notwithstanding the transfer of ownership of the Results, the Customer grants ACM PHARMA a free and exclusive licence valid for the duration of the said intellectual property rights. Unless otherwise agreed between the Parties, use of the Results by the Parties will not be remunerated. If the rights relating to all or part of the Results, as described above, are not wholly owned by one of the Parties, the latter must obtain an assignment of these third-party rights for the benefit of the other Party.

ARTICLE 9 – Personal data privacy policy

Personal data is collected from the instructing party so that the service provided by ACM PHARMA can be properly performed. The legal basis is Article 6.1.b of the European General Data Protection Regulation on the protection of personal data (contract performance, or pre-contractual measures).

ACM PHARMA will also use the instructing party’s data for commercial purposes. The legal basis is Article 6.1.f of the European General Data Protection Regulation on the protection of personal data (legitimate interest: business development).

The recipients of the data, depending on their use, are the data controller, the quality department, the technical department, the administrative department, the sales department, the parcel reception/shipping department, and any person legally authorised to access the data (e.g. judicial services).

The data will be retained by ACM PHARMA for the duration of the service contract and up to 10 years after the last service has been provided.

The provision of such data is optional.

The data controller is ACM PHARMA 30-36 avenue du 21 août 1944, 45270 BELLEGARDE, rgpd@terangagroupe.com. The instructing party has the right to request from the data controller access to personal data, the correction or deletion of such data, a restriction on the processing concerning the data subject, the right to object to the processing and the right to data portability. The instructing party also has the right to lodge a complaint with a regulatory authority.

ARTICLE 10 – Conflict of Terms

In the event of a conflict or inconsistency between these General Terms of Business and the terms of any Special Agreements or Framework Contracts concluded with a customer, the terms of the latter will prevail.

If one or more provisions of these General Terms of Business should prove to be illegal or inapplicable for any reason whatsoever, the validity, legality and application of the other provisions shall in no way be affected.

ARTICLE 11 – Disputes

Any disputes to which this contract may give rise, concerning its validity, interpretation, execution, termination, impact and ramifications – which cannot be amicably resolved between the Parties within thirty (30) days of notification of the dispute by the most diligent party to the other party – will be referred to the courts of Orléans.

ARTICLE 12 – Language of the contract – Applicable law

The parties expressly agree that these General Terms of Business, and the resulting sales and purchase transactions, are governed by French law. Should they be translated into one or more languages, the French text alone will be deemed authoritative in the event of litigation.

ARTICLE 13 – Customer Acceptance

These General Terms of Business are expressly approved and accepted by the Customer, who declares and acknowledges having perfect knowledge of them, and therefore waives the right to rely on any conflicting document and, in particular, its own general terms of purchase, which may not be invoked against ACM PHARMA, even if ACM PHARMA is aware of them.