MEDICAL DEVICE DISTRIBUTION CONTRACTS
Between the undersigned
|1||The company [[name of the Distributor]]|
|[[owner society form]] with a capital of [[share capital of the owner]], with its registered office at [[head office owner]] registered in [[TCR city owner]] Trade and Companies Register under number [[TCR number owner]] Represented by [[rep name owner]] in his/her capacity as [[rep capacity owner]] Hereinafter referred to as “the Distributor”|
|Of the first part,|
|2||The company [[name of the Manufacturer]]|
|[[transferee society form]] with a capital of [[share capital of the transferee]], with its registered office at [[head office transferee]] registered in [[TCR city transferee]] Trade and Companies Register under number [[TCR number transferee]] Represented by [[rep name transferee]] in his/her capacity as [[rep capacity transferee]] Hereinafter referred to as “the Manufacturer”|
|Of the second part|
Hereinafter referred to as “the Parties”
The Manufacturer [[or its Affiliates (companies belonging to the Manufacturer’s group)]] has different manufacturing sites: [[where the different manufacturing sites are located]] and the equipment suitable for the manufacture of the Product according to the requirements of the regulations in force, as well as the necessary administrative authorisations.
The Manufacturer will manufacture the Product at its site in [[where the manufacturer will manufacture the Product]] [[or may subcontract its manufacture to]] [[to whom the Manufacturer may subcontract the manufacture of the Product]] .
The Manufacturer or its Affiliates has developed the Product defined in Appendix [[product description]] (hereinafter “the Product”), for which the Manufacturer has obtained the necessary Certifications.
The Distributor declares that it is familiar with the Product and that it has the commercial, technical and regulatory skills and resources to effectively market the Product in accordance with the regulations.
The Distributor therefore wishes to distribute the Product in the territories defined in Appendix F [[list of territories]] of this agreement.
The Manufacturer declares its willingness to allow the Distributor to distribute the Product in the Territories under its own brand name.
The Products are medical devices and are therefore subject to the provisions of the European Regulation (EU) 2017/745, amended by the European Regulation (EU) 2020/561 as regards the dates of application of certain of its provisions (hereinafter the “MD Regulation”).
THE FOLLOWING HAS BEEN AGREED AND STIPULATED
ARTICLE 1 – DEFINITIONS
“Year” means: the period of twelve (12) months from the date of signature for the first year, or the anniversary of the contract for subsequent years.
“Certification(s)”: means the necessary Product certificate(s) as defined in particular by EU Regulation 2017/745.
“File” means all the documents and results necessary to constitute the technical documentation drawn up with a view to obtaining the CE certification of the Product in accordance with Regulation (EU) 2017/745. The list of elements constituting the Dossier is provided in Annex [[list of elements constituting the Dossier]].
“Product” means the finished product consisting of the medical device manufactured in accordance with the Dossier, its packaging, ready to be marketed under the Distributor’s brand. The Product is a Medical Device within the meaning of the MD Regulations.
“Guaranteed Minimum” means the number of orders (excluding VAT) guaranteed by the Distributor in the first Year.
“Territories” means all the countries covered by this distribution agreement and listed in Appendix F [[list of territories]].
ARTICLE 2 – CONTRACTUAL DOCUMENTS
The contractual documents are in the following order of priority:
- These general provisions of the contract and its annexes, namely
- Summary of the Distributor / Manufacturer commitmentsSchedule A: Product Description
- Annex B: [[Certification(s) of the Product]]
- Annex C: [[Packaging and wrapping]]
- Annex D :
- Annex E: [[Financial conditions]]
- Annex F: [[List of territories covered by this distribution agreement]]
- Annex G: [[List of elements of the File]]
- Annex H: [[Minimum Order Quantity (MOQ) and indicative forecast volumes over 3 years]]
- Annex I: [[Confidentiality Agreement]]
- Separately signed Contract Documents
Hereinafter together referred to as the “Contract”.
The Agreement prevails over any other previous document of any kind and in particular over any quotation, Manufacturer’s general terms and conditions of sale or Distributor’s general terms and conditions of purchase or any communication exchanged between the Parties prior to and during their execution so that this Agreement alone governs the business relationship between the Parties, unless expressly agreed otherwise in writing by the Parties.
In addition, any changes that may be made to the provisions of the Contract must be made in writing and be the subject of an amendment signed by duly authorised representatives of the Parties.
ARTICLE 3 – PURPOSE OF THE AGREEMENT
For the duration of this Agreement, the Manufacturer grants the Distributor, who accepts it, the non-exclusive right to distribute the Product in the Territories under the name that the Distributor will have freely chosen, and for which it will be fully responsible, whether it is registered as a trademark or not.
It should be noted that the Manufacturer retains all the obligations associated with its status as a manufacturer under the MDR. As a reminder, the MDR defines a manufacturer as “‘a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;” (art. 2, 30, MDR).
ARTICLE 4 – OBLIGATIONS OF THE DISTRIBUTOR
The Distributor undertakes to comply with all regulations applicable in the Territory(ies) in which the Product is to be marketed, relating to the distribution of the Product, in particular, but not exclusively, with regard to advertising, promotion and material surveillance.
The Distributor and its affiliates undertake to ensure that all their distributors comply with these same distribution obligations.
4.1 In accordance with the provisions of the MDR, the Distributor undertakes, in particular, to comply with the following obligations.
1. Compliance by the distributor with the obligations of his distribution chain
It is recalled that a distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market, up to the stage of putting it into service. Consequently, it is the Distributor’s responsibility to respect and ensure that its entire distribution chain respects the obligations imposed on it by the MD Regulation.
In addition, the Distributor will fulfil the obligations incumbent on manufacturers if it carries out any of the following tasks :
(a) make a device available on the market under its own name, trade name or registered trade mark, unless a distributor or importer concludes an agreement with the manufacturer whereby the latter is mentioned as such on the label and remains responsible for compliance with the requirements imposed on manufacturers by the MD Regulation
(b) change the purpose of a device already placed on the market or put into service
(c) change the purpose of a device already placed on the market or put into service in such a way that it may affect compliance with the applicable requirements.
4.1.2. General obligations of distributors
The Distributor undertakes to act with due diligence to meet the applicable requirements when making the device available on the market.
Before making a device available on the market, the Distributor shall ensure that the following conditions are met.
188.8.131.52 The distributor must verify the conformity of the products it makes available and the manufacturer’s compliance with certain regulatory requirements, in particular:
🗸 The device bears the CE marking
🗸 The EU declaration of conformity has been drawn up by the manufacturer
🗸 The instructions for use and labelling comply with the requirements of the DM Regulation (see Annex [[confidentiality agreement]] Chapter III on the requirements for information supplied with the device)
🗸 The UDI (Unique Device Identifier) has been assigned by the manufacturer
🗸 For imported devices: the importer has clearly identified himself on the device and/or accompanying documents
🗸 Storage and transport conditions are specified and the distributor is able to respect them
[[is this something you want to add]]
184.108.40.206 Record keeping and traceability
The Distributor is required to maintain records to document the following events:
- Device non-conformities (including adulterated devices)
- User complaints
- Recalls by the manufacturer
- Recalls by the manufacturer
- Do you want to add more docs?
These records are available for consultation, on request, by the competent authority (ANSM in France) and the Manufacturer. The Distributor must implement a traceability of the devices made available, in order to – if necessary – be able to collaborate with the Manufacturer during surveillance and vigilance actions.
220.127.116.11 Treatment of Non-Compliant devices
The Distributor is required to take action in the event of suspected non-compliance with safety and performance requirements.
Where the Distributor considers or has reason to believe that the device does not comply with the requirements of the MD Regulations, he shall inform the Manufacturer and shall not make the device available on the market until it has been brought into compliance. Where the Distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, he shall also inform the competent authority of the Member State in which he is established.
If the Distributor considers or has reason to believe that a device he has made available on the market is not in conformity with the MD Regulation, he shall immediately inform the Manufacturer. The distributor shall cooperate with the manufacturer and the competent authorities to ensure that the necessary corrective measures are taken to bring the device into conformity, withdraw it or recall it, as appropriate. Where the distributor considers or has reason to believe that the device presents a serious risk, he shall also immediately inform the competent authorities of the Member States in which he has made the device available and shall specify, in particular, the case of non-compliance and the corrective measures taken, if any.
The treatment of non-conformities is the responsibility of the Manufacturer, the Distributor must warn him and implement any corrective action.
18.104.22.168 Complaints and reports
The Distributor undertakes to report to the Manufacturer any information and complaint from a user, after marketing.
By complaint, we mean any information related to a user’s dissatisfaction, in order to determine whether the complaint concerns a non-conformity, problems of use or points that do not call into question the conformity of the MD.
22.214.171.124 Management of traceability and the UDI (Unique Identifier for Medical Devices)
The Distributor undertakes to implement a traceability system, in order to present upon request from the Manufacturer all the quality records provided for in the post-market surveillance plan and providing proof of the conformity of the product delivered.
The Distributor agrees to undertake all necessary steps to obtain the IUD-ID I part (GTIN code GS one) for the Products that will be made available on the market under its brand. The Distributor authorizes the Manufacturer to use the IUD-ID I part (GTIN GS one), in particular in order to proceed with the compulsory declarations to EUDAMED. The Manufacturer undertakes to provide the Distributor with any document or declaration that it may need and that would be required by the competent attribution entity in order to obtain the attribution of the IUD-ID part.
126.96.36.199 Cooperation with the authorities and the manufacturer
The Distributor undertakes to co-operate with the Manufacturer and the authorities for vigilance and compliance actions, particularly in the following situations
- Implementation of corrective measures in the event of non-compliance, recall or withdrawal
In addition, at the request of the competent authorities, the Distributor :
- Communicate the information and documents available to it and necessary to demonstrate the conformity of a device;
Provide free samples or access to the device;
- Implement any measures adopted to eliminate the risks presented by devices that it has made available on the market.
188.8.131.52 Patient information / communication
The Distributor shall comply with the following provisions:
In the labelling, instructions for use, availability and use of the Products, as well as in the advertising of the Products, it is prohibited to use text, names, trademarks, images and figurative or other signs that are likely to mislead the user or the patient with regard to the purpose, safety and performance of the Product:
a) by attributing to the Product functions and properties that it does not have;
b) giving a misleading impression of treatment or diagnosis, or of functions or properties which are not those of the Product in question
c) failing to inform the user or patient of a likely risk in using the Product as intended
d) suggesting uses of the Product other than those declared to be within the scope of the purpose for which the conformity assessment was carried out.
4.3- Informing the Manufacturer
4.3.1 The Distributor agrees to inform the Manufacturer of
a) any incident that has or has not yet given rise to a report to the ANSM for France or to any other competent authority depending on the Territory, in accordance with the provisions of the Specifications. This information must be transmitted in accordance with the deadlines mentioned in the Contract Documents from the time of the occurrence of the said incident.
b) any misuse or use of the Product that does not comply with the instructions for use of which it is aware, within the period mentioned in the Contract Documents from the day on which it is informed.
More generally, the Distributor will take all necessary steps to ensure that the Manufacturer is informed of any useful or compulsory feedback from the field and/or from material vigilance in the Territory.
4.4.2 The Distributor agrees to do its best to inform the Manufacturer of any situation observed in the Territory that may affect the Manufacturer’s commercial interests (e.g. parallel distribution channels, counterfeit products, marketing of new competing products).
4.5 – Transfer of ownership
Ownership of the Product will be fully transferred to the Distributor after full payment of the Product price by the Distributor to the Manufacturer.
4.6 – Storage and transport
Storage and transport conditions are defined in the specifications and its annexes.
They are a prerequisite for maintaining the characteristics of the Product over time as defined in the appendix [[product description]]. The Distributor declares that it has quality assurance procedures in place to ensure compliance with storage and transport conditions.
4.7 -Audits and inspections
Except in the case of a particular need justified by a public health risk, the Distributor accepts a maximum of one audit of its procedures and one inspection of its site(s), [[define maximum audit frequency accepted by the Distributor]] except in the case of an audit for cause (audit possible within 7 days). The details of these audits are specified in the specifications.
The Manufacturer will also accept the principle of auditing under the same conditions as those mentioned above and in the Specifications.
As part of the collaboration between the Manufacturer and the Distributor, inspections by health authorities, and audits by notified bodies carried out by the Manufacturer may extend to the Distributor, as part of the activities defined in this agreement.
The Distributor agrees to submit to all unannounced inspections of its site by the Manufacturer’s competent authorities. Refusal by the Distributor to do so may result in the Manufacturer’s prohibition to sell and the loss of Certifications.
4.8 – Quality, quality assurance system and complaint handling
The Distributor declares that it has a quality assurance system that guarantees traceability, appropriate handling of complaints, and product recall in accordance with the regulations applicable in the Territory. In particular, the Distributor undertakes to comply with the provisions set out in the “Complaints Handling” section of the Contract Documents. The Distributor also agrees to collaborate with the Manufacturer in maintaining a risk management system adapted to the Medical Device concerned.
Option: if the Manufacturer wishes the distributor to buy exclusively from him for the duration of the contract
4.9 – Exclusive supply
The Distributor agrees to purchase the Product exclusively from the Manufacturer for the duration of the Agreement (including the Initial Term and any subsequent renewal periods of the Agreement).
ARTICLE 5 – OBLIGATIONS OF THE MANUFACTURER
As the manufacturer, the Manufacturer guarantees that the device complies with the MDR at the time it is duly supplied and when it is correctly installed, maintained and used in accordance with its intended purpose.
The Products must comply with the general safety and performance requirements set out in Annex [[confidentiality agreement]] of the MDR that are applicable to them given their intended purpose.
As a manufacturer, the Manufacturer has the following obligations under the MDR, which the Distributor shall provide all reasonable assistance to fulfil.
5.1 The Manufacturer undertakes to comply with the following principles of the MDR:
5.1.1. When placing its devices on the market or putting them into service, the Manufacturer ensures that they have been designed and manufactured in accordance with the requirements of the MDR.
5.1.2. The Manufacturer establishes, documents, implements and maintains a risk management system as described in Annex [[confidentiality agreement]], section 3 of the MDR
5.1.3. Manufacturers shall carry out a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV of the MDR, including post-market clinical follow-up (PMCS).
5.1.4. Manufacturers of devices other than custom-made devices shall establish and maintain technical documentation for such devices. The technical documentation shall be such as to enable the conformity of the device with the requirements of the MD Regulation to be assessed. This technical documentation shall contain the elements provided for in Annexes II and III of the MDR.
5.1.5. Where conformity with the applicable requirements is demonstrated following the applicable conformity assessment procedure, manufacturers of devices other than custom-made devices or devices under investigation shall draw up an EU declaration of conformity in accordance with Article 19 and affix the CE conformity marking in accordance with Article 20 of the MD Regulation.
5.1.6. Manufacturers shall comply with the obligations concerning the IUD system referred to in Article 27 and the registration obligations referred to in Articles 29 and 31 of the MDR.
5.1.7. Manufacturers shall keep the technical documentation, the EU Declaration of Conformity and, where applicable, a copy of any applicable certificate issued in accordance with Article 56, including any amendments and supplementary documents, at the disposal of the competent authorities for a period of at least 10 years after the last device covered by the EU Declaration of Conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
On request from a competent authority, the manufacturer shall provide, as specified in that request, the full technical documentation or a summary thereof.
5.1.8. Manufacturers shall ensure that procedures exist to maintain series production in accordance with the requirements of the MDR. Due account shall be taken, in a timely manner, of changes in the design or characteristics of the device and of changes in the harmonised standards or common specifications on the basis of which the conformity of a device is declared. Manufacturers of devices, other than devices under investigation, shall establish, document, implement, maintain, update and continuously improve a quality management system that ensures compliance with the provisions of the MDR in the most effective manner possible and in a manner commensurate with the class of risk and type of device.
5.1.9. Device manufacturers implement and update the post-market surveillance system in accordance with Article 83 of the MDR.
5.1.10. Manufacturers shall ensure that the device is accompanied by the information given in Annex [[confidentiality agreement]], Section 23, in an official language or languages of the Union as defined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly understandable to the patient or user for whom the device is intended.
5.1.11. Manufacturers who consider or have reason to believe that a device they have placed on the market or put into service is not in conformity with the MD Regulations shall immediately take the necessary corrective measures to bring it into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors of the device in question and, where appropriate, the authorised representative and importers accordingly.
Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where appropriate, the notified body that issued a certificate in accordance with Article 56, in particular, of the case of non-compliance and of any corrective measures taken.
5.1.12. Manufacturers shall have a system for recording and reporting safety incidents and corrective actions as described in Articles 87 and 88.
5.1.13. At the request of a competent authority, manufacturers shall provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official language of the Union defined by the Member State concerned. The competent authority of the Member State in which the manufacturer has his registered place of business may request that the manufacturer provide samples of the device free of charge or, if this is not possible, give access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if this is not possible, to mitigate the risks posed by devices which they have placed on the market or put into service.
5.2 The Manufacturer agrees to manufacture and deliver the Product to the Distributor in accordance with the provisions of this Agreement and in compliance with the specifications of the File, the regulations applicable to the Product in the Territory, the provisions of Annex [[Packaging and Packing]] to this Agreement relating to packaging and packing (“Packaging and Packing”), the provisions of Annex [[Logistics Requirements]] to the Specifications, as well as with the order formulated by the Distributor.
5.3 The Manufacturer agrees to inform the Distributor as soon as possible of any change in the certification of the Product and to provide the Distributor with the corresponding documents. In the event of suspension or prohibition of marketing, the provisions of article 12 will apply.
5.4 The Manufacturer agrees to inform the distributor as soon as possible and at the latest with the first order following the modification, in case of modification of the transport and storage conditions of the Products mentioned in the appendix [[List of products and storage conditions ]] of the specifications.
5.5 The Manufacturer shall provide the Distributor with the corresponding certificates of conformity for each batch delivered. The storage of the sample library will be carried out by the Manufacturer.
5.6 The conformity of the Products delivered and the respect of the delivery deadlines are fundamental requirements of the Distributor that the Manufacturer commits to respect.
In the event that the Manufacturer fails to comply with these requirements, which could lead to a change in the manufacturing start date, a change in the packaging or a non-conformity of a Product, the Manufacturer will immediately inform the Distributor (by telephone and then in writing).
The Distributor will provide the Manufacturer with a monthly forecast of orders for the following months, including the current month, in order to establish a manufacturing plan.
It is specified that the order forecasts for the first [[specify number of months]], including the current month, will be firm orders, the forecasts for the following [[specify number of months]] months will be variable and will not be firm orders.
Except for the cases of force majeure referred to in the article “force majeure” below, in the event of a delay in delivery of more than [[define delay time penalty]] weeks (or in the event of non-conformity resulting in a delay in delivery of conforming Products of more than [[define delay time penalty]] weeks), the Distributor reserves the right to apply penalties to the Manufacturer calculated as follows:
- Penalty of 1 (one) % of the total amount of the order concerned, excluding VAT, per working day of delay between D+1 and D+7;
- Penalty of 2 (two) % of the total amount of the order concerned per working day of delay from D+8;
The total penalty per order may not, however, exceed 10% of the total amount excluding VAT of the order concerned.
After one year of collaboration, if the service rate is less than [[percentage service rate]] %, the Parties undertake to discuss these penalties in good faith with a view to increasing them. The service rate shall be calculated on the quantities delivered in accordance with the specifications of the File, the regulations applicable to the Product in the Territory, the Annex [[packaging and wrapping]] and the order and deadlines over a year in relation to the total quantities ordered over the year.
It is also agreed that the Distributor reserves the right to cancel an order without compensation to the Manufacturer in the event of a delay in delivery of more than [[delay in delivery]] weeks.
ARTICLE 6 – ORDER FORECAST AND DELIVERY
6.1 – Order forecast
The Distributor will send to the Manufacturer, each month of [[from which month the order forecasts are sent]] and upon written request of the Manufacturer, in order to allow the establishment of a manufacturing plan, its order forecasts established for the months of [[period concerned by the order forecast XXX to XXX]] of the following year.
The Manufacturer guarantees the Distributor a production and delivery capacity for the year N+1 corresponding to its orders for the year N plus 10%.
The Distributor will update monthly the order forecasts for the months to M+[[define for which period the order forecast majors are made]] to M+[[XXX]].
In the month in which the Distributor makes its order firm, it may vary the quantities in relation to the latest forecasts:
- downwards and/or
- by shifting part of the quantities to subsequent months and/or
- upwards, provided that the Manufacturer confirms the feasibility of the higher quantity. The Manufacturer will use its best efforts to respond favourably to the Distributor’s request but will not be obliged to deliver the higher quantity of differential in time.
6.2 – Order confirmation procedure
All firm requirements will be ordered by the Distributor and confirmed in writing by the Manufacturer as follows:
The Distributor will send its firm orders at the latest [[deadline for transmission of orders]] months before the desired delivery date. The Distributor will send his orders by e-mail to the e-mail address mentioned in the “contacts” appendix of the specifications, indicating the desired delivery date; this date cannot be less than [[order transmission deadline]] months.
The Manufacturer agrees to communicate to the Distributor, at the latest within seven (7) calendar days following the date of receipt of the order, the confirmation of the latter.
In exceptional cases, the Customer may request a shorter delivery time, which must be accepted by the Manufacturer, provided that the Manufacturer’s availability allows it.
Orders will be considered firm and irrevocable and will bind the Parties as soon as they have been accepted and confirmed by the Manufacturer.
In the event of cancellation of an order by the Manufacturer after the Manufacturer has confirmed the order, the Manufacturer will be liable to the Distributor for compensation equal to :
- A) In the event of cancellation within one month of confirmation: actual costs incurred and supported by documentary evidence;
- B) In the event of cancellation after more than one month following confirmation: actual costs incurred and proven by supporting documents + [[define penalty for cancellation in %]] of the price corresponding to the cancelled order
The minimum volume of orders is defined in Annex [[minimum orders]].
6.4 – Delivery
The delivery of the Products will be carried out by the Manufacturer in [[define the incoterm applicable to the delivery]].
The delivery time indicated on the order will be calculated from the date the order is placed by the Distributor.
ARTICLE 7 – PRODUCT DISTRIBUTION METHODS
7.1 The Distributor may use the name/sign of its choice, whether or not it is registered as a trademark, on all packaging in which the Products are marketed and market them under this name/sign.
7.2 The Manufacturer agrees to send the Distributor the cutting diagrams and the texts that will allow the Distributor to make the proofs. The Distributor will send the proofs to the Manufacturer for validation.
This process will apply to all new packaging and all modifications of packaging. A more detailed description of this process is available in the specifications.
7.3 Each packaged Product shall contain instructions for use of the Product in the language(s) most commonly used in the Territory.
The instructions for use of the Product are written by the Manufacturer in French. The Distributor will provide the Manufacturer with certified translations of the instructions necessary for the packaging of the Product. The Manufacturer will remain solely responsible and liable for the conformity of these translations and the resulting labelling and will bear the consequences of any non-conforming translation of the instructions for use or of any other element of the packaging. All translation and swearing costs shall be borne by the Distributor.
7.4. Promotion of the Product
7.4.1 The Distributor may promote the Products in the Territory in the same manner as it promotes its other catalogue products. It shall maintain the positioning of the Products in accordance with the Dossier.
7.4.2 The Distributor shall provide samples of the Products to health professionals in accordance with the regulations applicable in the Territory.
ARTICLE 8 – ENTRY INTO FORCE – DURATION OF THE CONTRACT
8.1 This Contract shall come into force on the date of the last signature of the Parties for an initial term of [[what is the initial term, must be minimum 1 year]] years (“Initial Term”).
8.2 Upon expiry of this period, this contract shall be tacitly renewed for successive periods of [[define the renewal period]] on the same terms and conditions, unless terminated by either Party by registered letter with acknowledgement of receipt [[deadline in months for termination of the contract]] one month prior to the end of the current contractual period and without any compensation being due from either Party. In any event, the contract shall end at the latest [[time limit in years for the end of the contract]] years after its date of signature. Any renewal after that date shall be the subject of a document signed by both Parties.
8.3 In any event, the Contract may be terminated by either of the Parties in the event of non-performance by one of them of its obligations, under the conditions set out in Article 15 of this Contract.
ARTICLE 9 – PROHIBITION OF ACTIVE SALES OUTSIDE THE TERRITORY
The Distributor undertakes not to pursue an active policy of selling the Product outside the Territory, in particular by promoting it to health professionals or establishments, canvassing direct customers, seeking marketing in any form whatsoever, or developing advertising or promotional activities.
ARTICLE 10 – FINANCIAL CONDITIONS
10.1 – Purchase price of the Products
The price of the Products is set out in Appendix [[financial conditions]] to this Contract and is fixed for the entire duration of the Contract, subject to the provisions below.
10.2 – Possible revision of the purchase price of the Products
The Manufacturer may, during the entire term of the Agreement, revise the prices, under the following conditions and terms:
- In the event of cumulative inflation in France since the date of entry into force of this Agreement greater than or equal to [[inflation percentage]] %: [[percentage of product price]] % of the product price will be revised by the value of the percentage of inflation greater than [[percentage of inflation]] %.
- In the event of a change of [[percentage change in purchase price MP]] % or more in the purchase price of the raw material of the Product used, either upwards or downwards: the price of the Product shall be revised in proportion to the share of the raw material of the Product in the total price ([[define % of the share of the PM in the total price]] %).
The revised price will be applied with a notice period of [[notice period]] months from the date of transmission by the Manufacturer of the new price to the Distributor, together with all the necessary supporting information.
In the event of disagreement with the new prices, either party may terminate the agreement by giving [[notice period]] months’ notice and the old prices will remain in effect.
The price applied will be the one in force at the time the order is issued.
10.3 – Payment terms
10.3.1 The Distributor agrees to pay the Manufacturer within [[distributor’s payment term]], starting from the date of the invoice.
10.3.2 If an invoice is not paid on time, even partially, a late payment penalty of an amount equivalent to that which would result from the application of a rate equal to the legal interest rate plus five points will be due by the Distributor.
10.3.3 This penalty will be payable by operation of law, without the need for a reminder or formal notice, on the day following the payment date indicated on the invoice.
10.3.4 The Manufacturer may also suspend all orders and/or deliveries in the event of non-payment of a single invoice until all outstanding invoices have been paid in full.
10.4 Reservation of ownership
The Manufacturer reserves the ownership of the Products sold until full payment of the invoiced price, the applicable VAT and all related accessories, in particular any late payment interest that may be due.
The delivery of bills of exchange or other securities creating an obligation to pay does not constitute a payment within the meaning of this provision. Payment will only be deemed to have been made when the Manufacturer has actually received payment.
The Distributor undertakes to identify and insure the Products under retention of title in his premises, to include the Manufacturer as a beneficiary of the said insurance during the retention of title and, in the event of a claim, to subrogate the Manufacturer in his rights vis-à-vis the insurer.
The Distributor is obliged to inform the Manufacturer immediately of any seizure of the Products delivered under the retention of title to the benefit of a third party. The Distributor is allowed to resell the delivered Products in the normal course of business but cannot use them as a guarantee. In the event that the Products are resold before full payment has been made, the sale price is deemed to be assigned to the Manufacturer until full payment has been made. The authorisation to resell in the absence of full payment is automatically withdrawn in the event of the Distributor’s receivership or liquidation.
ARTICLE 11 – NON-CONFORMITY OF THE PRODUCT OR A DELIVERY
11.1 The Manufacturer guarantees that the Products delivered comply with the characteristics specified in the Appendix [[product description]] and in the separately signed Product Definition Sheet, with the specifications of the File, with the regulations applicable to the Product in the Territory, and with the Appendix [[packaging and packing]] and are delivered in accordance with the order and with the provisions of this Agreement.
11.2 Any complaints after receipt of the Product about the conformity of the Product or a delivery to the order must be notified to the Manufacturer by e-mail within [[time limit for raising a complaint after receipt of the Product]] working days following the date of delivery of the Product. After this period, the Manufacturer will be released from its obligation to replace the Product in question, provided that it cannot be held liable for any hidden defect.
11.3 The Customer agrees to provide the Manufacturer with all the information required to substantiate the claim so that the Manufacturer can assess the validity of the claim.
11.4 In the event that the Manufacturer deems the claim to be well-founded, the Manufacturer will inform the Customer without delay so that the Customer can return the Product or have it destroyed and the Manufacturer can replace it as soon as possible, all at the Manufacturer’s expense. The Distributor may also decide to cancel the order.
11.5 In the event of disagreement, the Parties shall each submit the information they have concerning the claim to an expert chosen by mutual agreement. The expert shall determine whether or not the Product or the delivery complies with the specifications of the File and the order. The conclusions of this expert shall be binding on the Parties. The costs incurred shall be borne by the Party whose conclusions are not confirmed by those of the expert. In the event that the Parties are unable to agree on the joint appointment of an expert within [[time limit for the appointment of an expert]] following receipt of the letter referred to in 11.2, the procedure referred to in Article 21 of this Contract shall be implemented at the initiative of the most diligent Party.
ARTICLE 12 – BATCH RECALL – SUSPENSION OR PROHIBITION OF MARKETING
12.1 – Batch recall
The Distributor is required to inform the Manufacturer immediately of any anomaly that he has or has been made aware of on the Product.
The responsibility for the decision to recall a batch lies with the Manufacturer.
When a product shipped to the Distributor is found to have a defect that may require immediate recall, the following actions will be taken by the Manufacturer:
- the Manufacturer’s Quality Manager or in his absence, his delegate, will inform the Distributor by phone of the detected anomaly.
- A letter, written by the Quality Manager or his delegate, is sent to the Distributor by e-mail specifying:
- the name of the product, the batch number, the expiry date,
- the date of manufacture of the product,
- the nature of the anomaly.
- the quantity of the batch affected
The Distributor must in turn inform and recover the batches from the wholesalers, retailers, hospital pharmacists or dispensaries. He must then return them to the Manufacturer.
The Distributor must have a batch recall procedure in accordance with the legislation of the country in which he distributes the Product.
It is the responsibility of the Distributor to carry out the steps required, for its distributor part, by the Competent Authority of the country in which it distributes the Product. Any declaration related to material safety must be made by the Manufacturer of the Product within the meaning of the MD Regulation.
Returned Products are quarantined by the Manufacturer; the Quality Manager, his delegate or any other authorised person decides on the destruction of the Products. For the closure of the recall, a reconciliation of the number of units shipped and the number of units recovered is performed by the Manufacturer.
After closure of the recall, a final report is written by the Manufacturer, indicating the cause of the Product anomaly and the corrective and preventive actions taken.
A copy of this report is sent to the Distributor. The Manufacturer will forward the report to the Competent Authority of the country(ies) of distribution if necessary.
All costs related to the recall of the Products will be borne exclusively by the Manufacturer by way of reimbursement or credit to the Distributor. However, the Distributor will reimburse the Manufacturer for the full cost of the Product recalls if the defect is the result of the Distributor’s disregard of the rules and instructions given by the Manufacturer for the storage and delivery of the Products.
12.2 – Suspension or prohibition of marketing
12.2.1 Suspension or prohibition of marketing not producing direct effects in the Territory
In the event that the decision to suspend or prohibit marketing is not directly applicable in the Territory, the Distributor will decide on the notifications to be made, notably to the Competent Authority of the country(ies) of distribution concerned.
The Manufacturer will be informed without delay, as well as of any follow-up action that may be taken.
12.2.2 Suspension or prohibition of marketing with direct effects in the Territory
In the event that the decision to suspend or prohibit the sale of the Product is directly applicable in the Territory, the Parties will consult in good faith to examine the conditions for the continuation of the Agreement or decide to terminate it.
In the latter case, the Contract shall be terminated without compensation on either side, except in the event of gross negligence on the part of one of the Parties which would justify compensation from the other Party.
In the event of a definitive ban on marketing, each Party shall destroy the Products concerned at its own expense, except in the event of proven fault on the part of one of the Parties, which shall then bear the cost of destroying the said Products at its own expense.
ARTICLE 13 – LIABILITY
13.1 Limitation of liability
It is expressly agreed that the total amount of compensation that may be payable by the Manufacturer to the Distributor under the Agreement shall in no event exceed the total amount payable by the Distributor for the calendar year in which the claim is notified, provided that such amount shall in no event exceed EUR [[maximum amount of compensation claimed]]. EUR.
This limitation of liability shall not apply in the following cases:
- Deliberate, gross negligence or gross negligence on the part of the Manufacturer in the performance of the Agreement;
- Gross negligence and/or repeated negligence of the Manufacturer in the safety of the Products;
- The Manufacturer’s liability towards the Distributor for personal injury caused to a third party.
In any case, each of the Parties will be liable to the other only for direct damages that it may cause in the context of the Agreement and excludes the compensation of indirect damages.
By express agreement between the Parties, any financial or commercial loss or disturbance, loss of profit, loss of turnover, operating profit, orders or customers, data or damage to image, as well as any action directed against the Parties by a third party, with the exception, however, of an action by a third party involving the implementation of the tort liability of one of the Parties, shall be considered as indirect damage that cannot give rise to compensation.
This clause shall not prevent either party from being held liable for personal injury.
The Manufacturer’s liability is excluded for any damage resulting from force majeure, defective storage conditions of the Products, inappropriate use of the Products and/or use of the Products not in accordance with the instructions, as well as for damage due to the fault or negligence of the Distributor and the latter’s customers. Similarly, the Manufacturer will not be held responsible for the consequences of the failure of the Distributor and the Distributor’s customers to comply with the legislation in force regulating the use, sale and or promotion of the Products.
The Distributor agrees to indemnify and hold harmless the Manufacturer from and against any claims, costs or damages arising from the abnormal, improper or non-conforming use of the Products, negligence, breach of this agreement or any fault of the Distributor, including, but not limited to, storage of the Products in inappropriate conditions, use of the Products in conditions or for purposes other than those for which they are intended.
13.2 Social and environmental responsibility
The Manufacturer declares and guarantees that it (1) complies with its national laws and regulations regarding social and labour law, in particular those concerning remuneration and the various social benefits as well as working hours and (2) that its employees are regularly employed and declared, in accordance with the rules in force. It undertakes to respect and ensure respect for the prohibition of child labour, the prohibition of forced labour in any form and the prohibition of discrimination on any grounds whatsoever. It also undertakes to provide its workers with a clean, safe and healthy working environment.
The Manufacturer also represents and warrants that it will comply with its national laws and regulations relating to environmental law, including the management of waste, chemicals and any hazardous substances. It undertakes to (1) use and promote environmentally friendly manufacturing methods (energy efficiency, recycling, no pollution, etc.) and (2) apply a precautionary approach to environmental issues.
The Manufacturer undertakes to communicate, upon request from the Distributor, all relevant information concerning its production sites and the respect of the above-mentioned commitments. The Manufacturer will ensure that its suppliers, subcontractors and partners comply with equivalent social and environmental obligations.
13.3 Regulatory compliance
The Manufacturer and its affiliates, including its shareholders, legal representatives/agents and senior management (collectively the “MANUFACTURER”), hereby declare to the Distributor and/or its affiliates, including its shareholders, representatives/agents and senior management (collectively, The Distributor shall ensure that its activities are in compliance with all applicable national and international regulations, including anti-corruption regulations (such as the Sapin II Act, US FCPA, UK Bribery Act, etc.), anti-money laundering regulations, export control regulations and in particular the export control regulations of the European Union, the United States of America (OFAC regulations) and/or the United Nations.
The Distributor will ensure that its customers, suppliers, subcontractors and all persons with whom the Distributor does business (the “Partners”) comply with the above regulations.
The Manufacturer shall indemnify the Distributor against all costs and damages arising from a breach of the foregoing to the extent that such breach causes the Manufacturer to suffer loss or damage which it shall be required to prove.
The Parties undertake to take out an insurance policy covering their respective professional civil liability for all activities and obligations arising from this Contract.
Likewise, the Parties undertake to maintain this policy throughout the duration of this Contract and to provide proof thereof on request by the other Party, by providing it with a certificate from its insurers, listing the cover taken out, the amount thereof and the period of validity thereof.
Any modification, suspension, resolution or termination of the insurance policy of a Party, for whatever reason, must be notified to the other Party as soon as possible.
ARTICLE 14 – INTELLECTUAL PROPERTY
14.1 This Agreement shall not be construed as transferring any rights in the Product to the Distributor. In particular, all intellectual and/or industrial property rights and/or know-how attached to the Product shall remain the property of the Manufacturer.
The Manufacturer undertakes to offer and sell to the Distributor only Products that are free of any intellectual property rights belonging to third parties.
The Manufacturer guarantees the Distributor against any action of any nature whatsoever or any request from a third party who would be or would claim to be the owner of any intellectual property right on the Products and undertakes to reimburse the Distributor for damages, fees and expenses incurred by this action.
In the event that a third party brings an action against the Distributor for infringement and/or unfair competition of the Product or any of its components, all damages, fees and expenses (including attorneys’ fees) incurred or paid by the Distributor shall be paid in full by the Manufacturer, provided that the Manufacturer has been notified within a reasonable period of time and that a final decision has been rendered finding the Product to be infringing and/or unfairly competitive.
14.2 Nothing in this Agreement shall be construed as transferring any rights in the name, packaging or labelling of the Product to the Manufacturer. All intellectual property rights and/or industrial property rights and/or know-how relating to the aforementioned elements shall remain the property of the Distributor.
In the event that a lawsuit is filed by a third party against the Manufacturer involving the above mentioned elements on the basis of infringement and/or unfair competition, all damages, fees and expenses (including legal fees) that the Manufacturer may incur or pay, will be entirely paid by the Distributor, provided that the Distributor has been notified within a reasonable time and that a final decision has recognized the elements in whole or in part as infringing or prejudicial to competition.
ARTICLE 15 – NON-PERFORMANCE – TERMINATION – NON-RENEWAL
15.1 This Contract shall be terminated by operation of law in the following cases:
Option: If the Parties provide for a resolution for unforeseen circumstances
15.1.1 – Resolution for unforeseen circumstances
Without prejudice to the provisions of Article 15 below, termination for impossibility of performance of an obligation that has become excessively onerous may not, notwithstanding the clause Termination for failure by a Party to fulfil its obligations set out below, take place, in the absence of or in the event of failure of renegotiations, until thirty (30) days after the sending of a formal notice declaring the intention to apply this clause, notified by registered letter with acknowledgement of receipt or by any other extra-judicial act.
15.1.2 – Termination for non-performance of a sufficiently serious obligation
Notwithstanding the termination clause for failure by a Party to fulfil its obligations set out below, in the event of sufficiently serious non-performance of any of the obligations incumbent on the other Party, the Party suffering the default may notify the defaulting Party by registered letter with acknowledgement of receipt of the termination of the present agreement, thirty (30) days after receipt of an unsuccessful formal notice to perform, in application of the provisions of article 1224 of the Civil Code.
15.1.3 – Termination for force majeure
Termination by operation of law for reasons of force majeure, notwithstanding the clause Termination for failure by a party to fulfil its obligations set out below, may only take place thirty (30) days after formal notice has been sent by registered letter with acknowledgement of receipt or by any extrajudicial act.
Option: If the Parties provide for termination for failure by a Party to fulfil its obligations
15.1.4 – Termination for failure of a party to fulfil its obligations
In the event of a breach by either Party of the following obligations:
– [[List each of the breached obligations referred to in the Articles of this Agreement, this Agreement may be terminated at the option of the aggrieved party.]]
It is expressly understood that such termination for failure by a Party to comply with its obligations shall take place ipso jure thirty (30) days after receipt of a formal notice to perform, which has remained, in whole or in part, without effect. The formal notice may be served by registered letter with acknowledgement of receipt or any extrajudicial act.
15.1.5 Other cases of termination
- if the Parties fail to agree on the price, as defined in Article 10 of this Contract, by giving [[notice period for notification of termination]] months’ notice of termination by registered letter with acknowledgement of receipt.
- by giving [[notice period for manufacturer]] months’ notice of termination by registered letter with acknowledgement of receipt if the Manufacturer decides to stop manufacturing the Product for a reason beyond its control.
- by giving [[notice period for distributor]] months’ notice of termination by registered letter with acknowledgement of receipt if the Distributor decides to stop distributing the Product for reasons beyond its control.
15.2 In the event of termination or non-renewal of this Agreement, the Distributor and the Manufacturer shall return, free of charge, all items and documents provided by the other Party to enable them to perform this Agreement.
15.3 Except in the event that this Agreement has been terminated due to a breach by the Distributor, the Distributor is authorised to continue to sell the Products beyond the date of termination or expiry of this Agreement until its stock is exhausted.
– Consequences of termination of the Agreement
At the end of this Agreement, the Distributor may dispose of its remaining stocks of Products (“Sell-Off Period”) except in the event of termination for fault on its part.
The Distributor undertakes during the Sell-Off Period, if applicable, to continue to market the Products under good conditions and in accordance with the obligations stipulated in the Agreement.
In the event of a breach of the Agreement by the Distributor, the Distributor will be obliged to repurchase from the Manufacturer the excipients, whether processed or not, ordered for the manufacture of the Products as well as the packaging materials then held by the Manufacturer.
ARTICLE 16 – FORCE MAJEURE
16.1 Force majeure
The Parties shall not be held liable if the non-performance or delay in the performance of any of their obligations, as described herein, results from a case of force majeure, within the meaning of Article 1218 of the Civil Code.
Option: If the Parties agree to determine a particular event as force majeure:
By express agreement, force majeure includes, but is not limited to, catastrophic storms and floods, lightning, earthquakes and other typical natural events, wars, riots, sabotage, trade embargoes, fires, explosions, intervention of governmental authority, changes in applicable laws that prevent the Manufacturer from performing its duties and obligations.
Also included as force majeure events are: [[wish to add events]] lister events
The Party that observes the event shall immediately inform the other Party of its inability to perform its obligations and justify this to the other Party. The suspension of obligations shall in no case be a cause of liability for non-performance of the obligation in question, nor shall it lead to the payment of damages or penalties for delay.
The performance of the obligation shall be suspended for the duration of the force majeure if it is temporary and does not exceed a period of [[time limit for a force majeure to be temporary]]. Consequently, as soon as the cause of the suspension of their mutual obligations disappears, the Parties shall make every effort to resume normal performance of their contractual obligations as soon as possible. To this end, the Party prevented shall notify the other of the resumption of its obligation by registered letter with acknowledgement of receipt or any extrajudicial act.
If the impediment is definitive or exceeds a duration of [[time limit for a case of force majeure to be temporary]], the present contract shall be purely and simply terminated in accordance with the terms and conditions defined in Article 15. 1..3.
During this suspension, the Parties agree that the costs of the contract generated by the situation shall be shared equally.
ARTICLE 17 – HARDSHIP
In the event that one of the Parties wishes to raise a case of unforeseeability as defined by Article 1195 of the Civil Code, i.e. a change in circumstances unforeseeable at the time of the conclusion of the contract which renders performance excessively onerous for a Party who had not agreed to assume the risk, the latter may request renegotiation of the contract from its co-contractor. It continues to perform its obligations during the renegotiation.
This conciliation will take place in the following way:
The Party wishing to avail itself of the situation of unforeseeability shall notify its intention to renegotiate to the other Party by registered letter with acknowledgement of receipt;
As from the receipt of this notification and within a period of one (1) month, the Parties shall meet in order firstly to establish the situation of unforeseeability and secondly to renegotiate, in good faith, the stipulations of the present Contract with the aim of recovering the contractual balance initially desired. If they so wish, each of the Parties may be assisted by a third party during this meeting
Each Party shall be responsible for its own costs, disbursements and fees necessary for the conciliation.
If no agreement is reached within two (2) months of the implementation of this clause, the contract may be terminated by either Party in accordance with Article 15.1.1.
Option 2: if the parties do not wish to provide for unforeseen circumstances:
ARTICLE 17 – HARDSHIP
The Parties shall rely on the legal regime of unforeseeability.
ARTICLE 18 – CONFIDENTIALITY
18.1 The parties have signed a confidentiality agreement as an annex [[annex conf agreement]] to this contract. They confirm their commitment to this agreement which shall apply for the duration of this Agreement and for a period of [[duration after expiry of the cover agreement]] after its expiry for any reason whatsoever.
Option: If the Parties prohibit themselves from advertising this contract
They shall likewise refrain from disclosing to third parties the existence of this contract and of all or part of the service entrusted to them without the prior written consent of the other Party.
Option: If there is a penalty clause
In the event that one of the parties does not respect its commitment, it shall automatically be liable to the other party for a fixed indemnity of an amount equal to [[Amount of fixed indemnity]] euros.
18.2 – Security of personal data
Option: If the data controller is identified within the meaning of the GDPR
In accordance with Article 24 of the RGPD (Regulation on the protection of personal data) which came into force on 25 May 2018, the data controller [[Name and surname of the data controller]] undertakes to put in place appropriate technical and organisational measures to guarantee the security of personal data and the rights of the persons whose data has been collected (the right to information, the right of access, the right to rectification and the right to erasure, the right to limitation of processing, the right to portability.
Similarly, the data controller must define a retention period for documents containing personal data, established according to their purpose.
The data controller or its subcontractor in charge of archiving must present sufficient guarantees in terms of security and confidentiality of the data entrusted to it.
Option: If the use of personal data is limited to the performance of the contract
Personal data will only be used for the purposes of the Contract and not for any other purpose, in accordance with the GDPR (General Data Protection Regulation) which came into force on 25 May 2018.
ARTICLE 19 – MISCELLANEOUS
19.1 – Non-assignability
This Agreement may not be transferred or assigned, in whole or in part, by either Party without the prior written consent of the other Party, except in the case of a transfer to a subsidiary of the Manufacturer or an Affiliate. It is expressly agreed between the Parties that the transferee of all rights under this Agreement shall remain liable for the rights and obligations under this Agreement. Any transfer in violation of the provisions of this section shall be deemed null and void.
19.2 This Agreement is entered into intuitu personae by reason of the person and skills of the Parties. Consequently, it may not be transferred, assigned or contributed to any third party whatsoever without the express, prior and written consent of both Parties. As an exception, the Distributor may freely be substituted by any company of its group ([[name distributor group]]) in the rights and obligations of this Agreement.
19.3 – Partial nullity and independence of clauses
19.3.1 The possible nullity of a clause of this Agreement shall not affect the validity of this Agreement, unless it upsets the economic balance of the Agreement.
19.3.2 In this case, the Parties undertake to replace the invalid clause with a clause whose effect will be as close as possible to that of the invalid clause and will preserve the economic balance of the Contract.
19.3.3 In the event of difficulty of interpretation between one of the titles and the content of one of the clauses, the clause shall prevail.
19.4 – Agreement of proof
The Parties declare that they may exchange the information necessary for the performance of the services that are the subject of the Contract by e-mail and fax, unless expressly stated otherwise. E-mails and faxes shall have the value of written proof between them and shall be deemed authentic until proven otherwise.
19.5 – Non-tolerance
The fact that one of the Parties does not avail itself of a breach by the other Party of any of the obligations of this Contract shall not be interpreted for the future as a waiver of the obligation in question.
The Manufacturer, with the exception of its subsidiaries, shall not assign, transfer or subcontract any of its rights and obligations under this Agreement without prior written notice to the Distributor. In the event that the Manufacturer subcontracts all or part of this Agreement, the Manufacturer shall remain solely liable to the Distributor.
19.7 Change of Control / Economic Dependence
If the Manufacturer’s share of the Distributor’s sales exceeds 25%, the Manufacturer shall immediately inform the Distributor in writing.
ARTICLE 20 – APPLICABLE LAW AND LANGUAGE
By express agreement between the Parties, this contract is governed by and subject to French law.
It is written in French. In the event that it is translated into one or more languages, only the French text shall be deemed authentic in the event of a dispute.
ARTICLE 21 – DISPUTES
The Parties shall make every effort to settle amicably any dispute that may arise from the Contract within a period of [[deadline for notification of request for mediation]] following notification of the dispute.
If this amicable procedure fails, the Parties agree to refer their dispute to the Paris Mediation and Arbitration Centre (CMAP, 39 avenue Franklin Roosevelt 75008 Paris) referred by the most diligent Party. The mediation rules and the mediator’s scale of costs and fees shall be those of the CMAP (www.cmap.fr).
21.2 Competent courts
In the event that mediation fails, all disputes to which this contract and the agreements arising from it may give rise, concerning both their validity, interpretation, performance, resolution, consequences and consequences, shall be submitted to the Commercial Court of [[ city competent court]].
Done in [[city of signature]], in two (2) original copies, on [[$date]]
For the Manufacturer
Mr. [[name of manufacturer]]
[[position of manufacturer]]
For the Distributor :
[[name of the resp distributor]]
[[position of the resp distributor]]
VERY IMPORTANT: EACH PAGE OF EACH ANNEX MUST BE INITIALLED