Contrat de distribution

(Version Anglaise)
Document1/ END BALL Page - 0 - sur 14 Rev. 3

Rédaction Vérification Approbation

Nom, Date et signature Nom, Date et signature Nom, Date et signature

Resp. Commercial Responsable AQ/AR Directeur

SUIVI DES MODIFICATIONS

Resp. de la
Ind. Date Nature de la MAJ
MAJ

0.1 2009 J.M. VERD Création

1 15/10/2010 JM VERD Mise à jour suite audit GMED (NC 21)

1.1 15/11/2010 JM VERD Mise à jour suite Réponse Auditeur 26.10.2010

2 17/12/2010 JM VERD Mise à jour Réponse Auditeur 17/12/2010

Mise à jour suite réunion CEISO du 10/04/2012 & des normes et retirer
3 10/04/2012 JMVERD
l’annexe D
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EXCLUSIVE DISTRIBUTION CONTRACT

BETWEEN THE UNDERSIGNED:

- ENDALIS SARL, a société à responsabilité Limitée [≈ limited liability company] with capital of 601.588
Euros, whose registered office is at Parc de SACUNY, 313B Avenue Marcel MERIEUX, PARK
AVENIR II, 69530 BRIGNAIS/France, recorded in the trade register under the number 501 065 023
RCS LYON.

Represented by Mr. Pierre André DENIS, in his capacity of Chairman.

Hereinafter referred to as “the Manufacturer”.

On the one part,

AND

The Company IYADAH TRADERS whose registered office is at TARIQ COLONY SHAMSI ROAD
MARDAN, K.P.K., PAKISTAN., Zip Code: 23200, recorded in the trade register under the number 25410.

Represented by Mr. Muhammad Tariq Khan in his capacity as owner and managing partner.

His Co partner is his son namely Mr Umar Tariq Khan

Hereinafter referred to as “the Distributor”,

On the other part,

IT BEING RECALLED THAT:

The Manufacturer is renowned for the manufacture of medical implants for the non surgical treatment of
obesity.

The Distributor was interested in the distribution of the Manufacturer’s products.

THE FOLLOWING WAS AGREED:

ARTICLE 1: TERRITORY AND PRODUCTS

1.1 The Manufacturer grants the Distributor, who accepts, the exclusive right to market and sell the Products
indicated in Appendix A (hereinafter “the Products”) for the Territory indicated in Appendix B (hereinafter the
Territory).

1.2 If the Manufacturer decides to market other products in the Territory, it shall inform the Distributor so that
the possibility of including these products in those to which article 1.1 refers can be examined.

However, there is no obligation on the Manufacturer who shall be able to entrust this distribution to another
distributor without this constituting a failure in its contractual obligations.
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ARTICLE 2: DISTRIBUTOR’S OBLIGATIONS

2.1 The Distributor sells, in its own name and on its own behalf, in the given Territory, the Products that are
supplied to it by the Manufacturer.
The Distributor is not authorised to act in the name and on behalf of the Manufacturer, unless it has been
expressly authorised by the latter beforehand.

2.2 The Distributor shall deal with all marketing authorisations and, more generally, shall be responsible for
accomplishing all formalities necessary for obtaining approvals from the competent authorities in order to fulfil
the obligations prescribed by law and/or regulations for marketing the Products in the Territory, according to
the conditions explained in Appendix E.

ARTICLE 3: NON-COMPETITION OBLIGATION

3.1 The Distributor cannot represent, manufacture, promote or sell a rival product in the Territory during the
entire period of the contract.

3.2 The Distributor is authorised to represent, manufacture, promote or sell any other non-rival product on
condition that it informs the Manufacturer in advance.

The latter shall be able to refuse if the products of which it is question, although not rivalling products, are
manufactured by a rival of the manufacturer.

ARTICLE 4: CONDITIONS OF SUPPLY – PRICES

4.1 All the orders issued by the Distributor must be approved and accepted by the Manufacturer.

In principle, the Manufacturer must deliver all the Products that are ordered from it, subject to their availability,
on condition that there are sufficient guarantees for the payment of the said products.

4.2 The Price payable by the Distributor is that fixed in the price list, appended in Appendix C, applicable when
the order is received by the Manufacturer. These prices are subject to modification at any time with one month’s
prior notice.

For the products not expressly listed in Appendix A, the prices shall be fixed at the time of the request and shall
be valid for 30 days.

4.3 The Distributor undertakes to respect, as scrupulously as possible, the conditions of payment agreed
between the Parties, that is to say that the payments shall be made in Euros by bank transfers in favour of the
manufacturer or in favour of any authorised agent designated by it, to whom the claim has already been
transferred, in the following conditions:

Cash on order

4.4 It is agreed that the Products continue to be the property of the Manufacturer until their full payment has
been received by the latter.
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ARTICLE 5: SALES TARGETS

5.1 The Parties shall agree each year on sales targets for the next year. These targets are indicated in Appendix D.

5.2 For the achievement of these targets, the Distributor acknowledges to have a sufficiently competent and
experienced sales force, whose size is appropriate for the Territory.

5.3 The non-achievement of the targets shall be considered to be a non-performance of the contract and the
Manufacturer shall be able to terminate it for this reason alone.

ARTICLE 6: INFORMATION

 PROVIDED BY THE MANUFACTURER:

6.1 The Manufacturer freely makes available to the Distributor all documentation relating to the Products which
appears reasonably necessary for the Distributor to be able to fulfil its obligations, such as brochures, instruction
manuals and sundry advertising material.

This documentation shall be drafted in English and/or French, which the Distributor declares to accept.

6.2 The Manufacturer forwards to the Distributor all other information that the latter reasonably needs to fulfil
its obligations, this to include, without reservation, all information relating to a reduction in its delivery
capacities.

6.3 The Manufacturer shall keep the Distributor informed of any pertinent information that may come to its
knowledge concerning the Territory and/or the customers in the Territory.

6.4 At the end of the contract, the Distributor shall return to the Manufacturer all the documents that have been
made available to it and that are still in its possession.

 PROVIDED BY THE DISTRIBUTOR:

6.5 The Distributor must show due diligence in keeping the Manufacturer promptly informed of its activities,
the conditions of the market, the state of competition in the Territory and all information relating to the
Products. It must also reply to any reasonable request for information made by the Manufacturer.

6.6 The Distributor must inform the Manufacturer promptly of provisions of laws and regulations applicable in
the Territory and relating to the Products, along with any modification relating to these.

This is judged to be a fundamental provision by the Parties and its non-respect shall constitute a failure to fulfil
the obligations of the contract, which can lead to its termination.
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ARTICLE 7: RESALE PRICE

The Distributor is free to fix the Products’ resale price.

However, the Distributor shall rule out any price policy which could harm the image of the Products and the
Manufacturer.

ARTICLE 8: SALE OUTSIDE THE GIVEN TERRITORY

The Distributor undertakes not to advertise the Products and not to distribute the Products outside the
Territory

However, the Manufacturer accepts that the Distributor promotes the Products on its Website on condition that
it refrains from marketing outside the Territory.

ARTICLE 9: TRADEMARK AND DISTINCTIVE SIGNS

9.1 The Distributor is authorised to use the trademark, trade name or any other distinctive sign belonging to the
Manufacturer but solely for the purpose of identifying and promoting the Products in the framework of this
contract and in the sole interest of the Manufacturer.

9.2 Whether in the Territory or elsewhere, the Distributor is prohibited from filing trademarks or other
distinctive signs belonging to the Manufacturer or which could lead to confusion with those of the
Manufacturer.

9.3 The Distributor’s right to use the trademark, trade name or other distinctive signs of the Manufacturer shall
immediately cease when this contract comes to an end for any reason whatsoever.

9.4 The Distributor informs the Manufacturer of any infringement in respect to the distinctive signs of which it
is the holder in the Territory.

ARTICLE 10: STOCKS

10.1 The Distributor undertakes to maintain, bearing the costs, during the entire period of the contract, a stock
of Products that is sufficiently large to cover the Territory’s normal needs.

10.2 At the end of the contract, the Manufacturer shall be able to buy back from the Distributor, at the price at
which the latter purchased them, the Products that the Distributor still has in stock, on condition that they are
still offered for sale by the Manufacturer, that they are as new and in their original packaging and that the sell-by
date has not passed.

If the termination of this contract is due to the Distributor, the sundry costs borne by the Manufacturer as a
result of this repurchase, such as, for instance, re-storage costs, shall be deducted from the repurchase price.

If the Manufacturer does not repurchase the Products in stock, the Distributor shall have a post-contract period
of three months, the so-called sell-off period, for selling off its stock.

At the end of this period, any distribution shall be wrongful.

10.3 The Distributor is responsible for monitoring the sell-by date of the products that it has in stock.
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ARTICLE 11: EXCLUSIVITY OF THE DISTRIBUTION

Throughout the entire period of the contract, the Manufacturer is prohibited from granting any person the right
to represent or sell the Products in the Territory.

In addition, the Manufacturer is prohibited from selling to customers established in the Territory.

As a result of this exclusivity, the Distributor must inform the Manufacturer when any office or branch is
opened or closed in the Territory.

ARTICLE 12: CONFIDENTIALITY

The Distributor undertakes, throughout the entire period of this contract and without limit after its expiry, to
treat as strictly confidential the contractual products, the Manufacturer’s distribution network and all
information marked confidential that may be passed on to it or to which it may have access in the framework of
the performance of this contract, unless the said information has fallen into the public domain.

The Distributor also undertakes to have this confidentiality obligation respected by all concerned members of its
staff, whose compliance it guarantees in respect to the Manufacturer.

ARTICLE 13: CONTRACT TERMS

13.1 This contract shall come into force on the date when it is signed for a period of three years.

It shall then be tacitly renewed for successive periods of one year, unless it is terminated by one of the Parties
duly giving three months’ prior notice.

If the contract has lasted more than five years, the period of notice is six months.

13.2 Each Party can terminate the contract with immediate effect, by written notification made by a means of
communication which enables the date of receipt to be known with certainty, in the case of substantial violation
by the other Party of its obligations stemming from this contract.

13.3 For the application of the above paragraph, a substantial violation is considered to be, in addition to the
obligations indicated as such, any non-performance by one of the contracting parties of all or part of its
obligations, which causes harm to the other party in that the latter is substantially deprived of what it had the
right to expect from the contract.

The following cases shall, in particular, be considered to be substantial violations:

 The Distributor is bankrupt or insolvent;

 The Distributor runs down the Manufacturer’s name and reputation ;
 The Distributor does not achieve the contractual sales targets;
 The Distributor does not respect the due dates for the payments of the invoices after a first formal
notice to pay having no effect during a period of 30 days.
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ARTICLE 14: INDEMNITY IN THE CASE OF TERMINATION

The Distributor shall not have the right to any goodwill indemnity or similar indemnity when the contract
comes to an end.

ARTICLE 15: LIABILITY AND INSURANCE

15.1 To be in compliance with EC regulations and the regulatory requirements in the Territory, the Parties
jointly undertake to fulfil all traceability and coding obligations as explained in the aforesaid Appendix E.

15.2 The Manufacturer ensures the following and traceability of all delivered products by batch number and/or
serial number and sell-by date. These files are kept for life by the distributor who accepts to forward information
relating to the customers and patients upon request from the Manufacturer, even after the termination of the
contract.

15.3 The Manufacturer shall report to the Distributor on any incidents that it may encounter concerning the
Products.

15.4 To allow the Manufacturer to establish irreproachable traceability, the Distributor must immediately inform
it of any incident involving the Products. Copies of these reports shall be sent to the competent local authorities.

The Distributor must keep the Manufacturer informed of the result of investigations conducted in the Territory.

15.5 Any product recall shall be managed by the Manufacturer in collaboration with the Distributor.

The recall of products shall be by batch number and/ or serial number and shall be managed in the Territory via
the Distributor using its traceability files in order to contact the hospitals, private clinics or final recipients of the
Products.

15.6 The Manufacturer and the Distributor undertake to take out an insurance policy covering their professional
liability for all activities and obligations stemming from this contract.

They undertake to maintain this policy throughout the entire period of this contract and to each supply proof of
this, upon request by the other party, by providing it with a certificate from its insurers listing the covers taken
out, their amounts and periods of validity.
Any modification, suspension or termination of their insurance policy, for any reason whatsoever, must be
promptly notified.

15.7 In the case of damage caused to third parties, the Distributor shall have the duty to promptly inform the
Manufacturer of the damage, whatever its extent, so that the latter has full information on the incident and its
seriousness, and can make a declaration to its insurance company, if necessary.

Whatever the method of recourse chosen for finding a solution to the litigation, notably friendly negotiation or
legal proceedings, the Distributor is bound to assist the Manufacturer in any steps it must take in this respect
locally.
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ARTICLE 16: FORCE MAJEURE

16.1 None of the parties to this contract shall be held responsible for its lateness or failure to perform one of the
obligations incumbent on it pursuant to this contract if this lateness or failure is the direct or indirect effect of a
case of force majeure, that is to say the occurrence of an event that could not be foreseen by the party
undergoing it, which was outside its control and which it was incapable of overcoming despite its due care and
efforts to resist it.

16.2 If such an event occurs, the party that undergoes it shall, however, only be exempted from the affected
obligation during the period of the event in question, all other obligations incumbent on it continuing to apply,
and it shall be bound to notify the other party in writing of this event within one fortnight of its occurrence and
to fulfil the obligation that it was prevented from fulfilling as soon as the event in question has ceased.

16.3 If the party is prevented from fulfilling the aforesaid obligation for more than thirty consecutive days, the
parties must consult each other within one week of the end of this period in order to examine in good faith
whether this contract should continue or end.

ARTICLE 17: APPLICABLE LAW – ATTRIBUTION OF COMPETENCE

17.1 Any disagreement stemming from this contract shall be referred before the competent courts of the city of
LYON (France).

17.2 This contract is governed by French law. However, it respects the principles of law generally recognised by
international trade.

17.3 This contract is drafted in English In the event that it is translated into one or more languages, only the
English text shall be good evidence in the case of dispute.

Thus done in Lyon

On April

For the Manufacturer For the Distributor

M. Pierre André DENIS / Gérant Mr.Muhammad Tariq Khan/ Umar Tariq

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Appendix A: Distributed Products

INTRA GASTRIC BALLOON SYSTEM – SIZE : 110 – REF. ENDT110

INTRA GASTRIC BALLOON SYSTEM – SIZE : 90 – REF. ENDT90
INTRA GASTRIC BALLOON SYSTEM – SIZE : 70 – REF. ENDT70
For non surgical Obesity Treatment

Appendix B: Distribution Territory

Appendix C: Product Prices

All prices are EXWORK LYON

REF. Designation Unit Price in Euros

Intra Gastric Balloon System

ENDT110
Size : 110
Intra Gastric Balloon System
ENDT90
Size : 90
Intra Gastric Balloon System
ENDT70
Size : 70

Appendix D: Sales Targets

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Appendix E: Quality and vigilance system for medical implants

Directive 93/42/CEE
http://eur-lex.europa.eu/LexUriServ/LexUriserv.do?uri=CELEX:31993L0042:EN:HTML
CFR 21 Part 850.198
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

Medical Device Reporting for Manufacturers http://www.fda.gov/cdrh/manual/mdrman.pdf

Document Meddev 2.12.1 Rev.5 March 2012 “GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM”
http://ec.europa.eu/enterprise/medicaldevices/meddev/212-104-2007.pdf

For the continuous improvement of its products & services and to be able to fulfill, if needed, the
obligations linked to the medical device vigilance system,

It is agreed that the Distributor :

 Ensures interface with the regulatory bodies of its country and

o if needed and contractually agreed, makes all compulsory notifications before the
placing on the market (Distributor and /or Devices licenses / Homologations) and
o after the placing on the market (Incident notification & Field Safety Notice, see below)

 Ensures, if needed and contractually agreed, its national Regulatory & Standards evolutions
monitoring.

 At the end of the Distribution Agreement, Distributor & Manufacturer shall agree on the solutions
concerning the follow-up of the existing products in relation to :
o Traceability to the Final User
o Performing maintenance (Preventive & Corrective)
o Deployment of corrective actions defined above without any undue delay (Field Safety
Notice FSN) & (Field Safety Corrective Action : FSCA)
o Handling of Customer feedback, including complaints, Incident

 Assists, if needed, the manufacturer, to obtain national Homologation, and in particular for the
translation validation of markings and accompanying documents in the country language.

 Establishes and implements documented procedures to ensure that complaints linked to the
Medical devices will be transmitted to the Manufacturer, in order to :

o Take care of customer feedback and post-production data to allow a continuous

improvement of products and services.

o Allow the manufacturer to fulfill the requirements of the medical Device Vigilance System
(Goal is to notify to competent authorities INCIDENTS as soon as possible and as stated in
MEDDEV 1.12.1 Rev.5 (§ 5.17 TIMESCALE FOR THE INITIAL REPORTING OF AN INCIDENT).
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 Serious public health threat : IMMEDIATELY (without any delay that could not be
justified) but not later than 2 calendar days after awareness by the MANUFACTURER
of this threat.

 Death or UNANTICIPATED serious deterioration in state of health : IMMEDIATELY

(with any delay that could not be justified) after the MANUFACTURER established a
link between the device and the event but not later than 10 elapsed calendar days
following the date of awareness of the event.

 Others : IMMEDIATELY (without any delay that could not be justified) after the
MANUFACTURER established a link between the device and the event but not later
than 30 elapsed calendar days following the date of awareness of the event.

 Establishes and implements documented procedures to ensure traceability to the Final user
(including the patient) in order to facilitate, if needed, deployment of corrective actions after the
placing on the market (Field Safety Notice FSN) & (Field Safety Corrective Action : FSCA). The
traceability records shall be kept in conformance with the national rules. For information in Europe,
at least five years after the last device has been manufactured (therefore by us). This period is
extended at 15 years for an implantable device.
Traceability checking exercise could be carried out periodically based on identified S/N or Lot
number in order to demonstrate the effectiveness of your organization in terms of Traceability
records.

 Provides needed resources for the deployment of corrective actions defined above without any
undue delay (Field Safety Notice FSN) & (Field Safety Corrective Action : FSCA). According national
laws, generally a contact with competent authorities is needed before sending the Field Safety
Notice FSN & the deployment of Field Safety Corrective Action : FSCA

 At the end of the Distribution Agreement, Distributor & Manufacturer shall agree on the solutions
concerning the follow-up of the existing products in relation to :
o Traceability to the Final User
o Performing maintenance (Preventive & Corrective)
o Deployment of corrective actions defined above without any undue delay (Field Safety
Notice FSN) & (Field Safety Corrective Action : FSCA)
o Handling of Customer feedback, including complaints, Incident
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Definitions
Any malfunction or deterioration in the characteristics and/or performance
of a device, as well as any inadequacy in the labeling or the instruction for
INCIDENT use which, directly or indirectly, might lead to or might have led to the death
of a patient, or USER or of other persons or to a serious deterioration in their
state of health.
Any event type which results in imminent risk of death, serious deterioration
in state of health, or serious illness that requires prompts remedial action.

This would include :

SERIOUS PUBLIC HEALTH  Events that are of significant and unexpected nature such that they
THREAT become alarming as a potential public health hazard, e.g. human
immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD).
These concerns may be identified by either the National Competent
Authority or the MANUFACTURER.

 The possibility of multiple deaths occurring at short intervals.

Written, electronic or oral communication that alleges deficiencies related to
the identity, quality, durability, reliability, safety or performance of a medical
Customer Complaint device that has been placed on the market.

(ISO 13485)
Injury or illness that directly or indirectly :

a) Is life threatening,

b) Results in permanent impairment of a body function or permanent

SERIOUS INJURY damage to a body structure, or

(IEC 62304) c) Necessitates medical or surgical intervention to prevent permanent

impairment of a body function or permanent damage to a body
structure.

NOTE : Permanent impairment means an irreversible impairment or damage

to a body structure or function excluding trivial impairment of damage.
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Field Safety Corrective Action (FSCA) (MEDDEV 2.12.1 )

A FIELD SAFETY CORRECTIVE ACTION is an action taken by a MANUFACTURER to reduce a risk of death or
serious deterioration in the state of health associated with the use of a MEDICAL DEVICE that is already
placed on the market. Such actions should be notified via a FIELD SAFETY NOTICE.

Note 1 :
The FSCA may include

 The return of a MEDICAL DEVICE to the supplier

 Device modification

 Device exchange

 Device destruction

 Retrofit by purchaser of MANUFACTURER’s modification or design change

 Advice given by MANUFACTURER regarding the use of the device (e.g. where the device is no
longer on the market or has been withdrawn but could still possibly be in use e.g. implants or
change in analytical or specificity for diagnostic devices)

A device modification can include :

 Permanent or temporary changes to the labeling or instruction for use

 Software upgrades including those carried out by remote access

 Modification to the clinical management of patients to address a risk of death or serious

deterioration in state of health related specifically to the characteristics of the device. For example

- For implantable devices it is often clinically unjustifiable to explants the device. Corrective
action taking the form of special patient follow-up, irrespective of whether any affected un-
implanted devices remain available for return, constitutes FSCA.

- For any diagnostic device (e.g. IVD, imaging equipment or devices) the recall of patients for
retesting or the retest or review of previous results constitutes FSCA.

 Advice relating to a change in the way the device is used e.g. IVD MANUFACTURER advices revised
quality control procedure – use of third party controls or more frequent calibration or modification
of control values for IVDs.

Note 2 : This guideline uses the definition of FSCA as synonym for recall mentioned in article 10(1),
paragraph 1b of the MDD and article 11 IVD Directive since there is no harmonized definition of recall.

(Report Form Field Safety Corrective Action : See § 10.4 Annex 4 of Medical Vigilance System (MEDDEV
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2.12.1)).

Field Safety Notice (FSN) (MEDDEV 2.12.1)

A communication to customers and/or USERs sent out by a MANUFACTURER or its representative in

relation to a Field Safety Corrective Action.

(See § 10.5 Annex 5 of Medical Devices Vigilance System (MEDDEV 2.12.1 ))

Advisory notice (ISO 13485)

Notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary
information and/or to advise what action should be taken in

 The use of a medical device

 The modification of a medical device
 The return of the medical device to the organization that supplied it, or
 The destruction of a medical device

NOTE: issue of an advisory notice might be required to comply with national or regional regulations.