NON-EXCLUSIVE DISTRIBUTION AGREEMENT

THIS AGREEMENT is effective as of dd/mm/yyy (the “Effective Date”) BY AND BETWEEN:

BIOCHEMICAL SYSTEMS INTERNATIONAL S.p.A., a company incorporated under the

laws of Italy, having its registered office in Milan, Galleria San Babila 4 B, Italy and head office
of production in Arezzo, Palazzo del Pero 23, Italy, VAT and registration number at the Register
of Enterprises 01736580513 (hereinafter referred to as “BSI”)
and
____________, a company incorporated under the laws of _________, having its registered office
in _____________________________, fiscal code [] and registration number at the Register of
Enterprises [] (hereinafter referred to as “Distributor”)

Hereinafter referred to individually as the “Party” and collectively as the “Parties”.

WHEREAS:

a. BSI sells systems for rapid and traditional diagnostics in the human healthcare sectors as
better defined in this Agreement;
b. it is the intention of the Parties that BSI shall grant Distributor the not exclusive right to
market and sell Products (as defined below) under BSI trade name in the Territory (as defined
below), in accordance with the terms and subject to the conditions herein contained.

NOW THEREFORE the Parties hereby agree as follows:

1.DEFINITIONS
1.1 Whenever used in this Agreement, the following terms shall have the following
meanings respectively, unless otherwise specified:
(a) “Affiliate” of a Party means any person which directly or indirectly controls, is
controlled by, or is under common control with, such Party; as used herein, the term "control" or
“controls” means possession of the power to direct, or cause the direction of the management
and policies of such person, whether through the ownership of voting securities, by contract,
law or otherwise.
(b) “Agreement” means this agreement, including recitals set forth in the preamble, all
annexes attached, as well as all amendments or additions made hereto and all other documents
incorporated herein by reference, all of which are hereby made an integral part of this
agreement;
(c) “Confidential Information” means any and all information, documentation or
knowledge in any form, relating to the business and assets of BSI, not generally known to the
public, disclosed to, or which may be obtained directly or indirectly by, the Distributor, or
which may be derived in any way by it as a consequence of the performance of its obligations
hereunder, including, without limitation, information relating to BSI’s present and
contemplated products and services; product designs; inventions, improvements; standards,
specifications, systems, methods and operating procedures; techniques and modes of
manufacturing, compounding or preparing products, formulations and recipes; merchandising,
marketing plans and strategies; tests and reports; profits, costs, pricing, product sourcing and
sales policies and strategies; buying habits and preferences of present customers of BSI as well
as prospective and potential customers, their names and addresses; trade secrets, know-how,
data, research and development; patent, trade-mark, copyright, industrial design and all other
intellectual property and proprietary rights and shall also include terms of this Agreement.
Confidential Information shall not include information that: (i) was in the Distributor’s
possession before receipt hereunder from the party requesting confidentiality without an
obligation to keep it confidential; (ii) is or becomes a matter of public knowledge other than as a
result of any action or inaction of Distributor; (iii) is rightfully received by Distributor from a
third party not under any duty of confidentiality with respect thereto; (iv) is independently
developed by or on behalf of the Distributor by individuals who have not received Confidential
Information hereunder; or (v) is required to be disclosed to any governmental agency or court
of competent jurisdiction by written order, subpoena or decree, provided however, that the
Distributor is given advance written notice thereof and has a reasonable opportunity to obtain
an appropriate protective order or otherwise challenge such disclosure. BSI shall cooperate with
the Distributor to the extent the latter may seek to limit such disclosure;
(d) “Effective Date” means dd/mm/yyy;
(e) “Minimum Annual Purchase Quantity” as specified in Annex 4 means those minimum
annual purchase quantity targets required to be satisfied by the Distributor as specified in
Section 4.1 below;
(f) “Products” means the finished products specified in Annex 1 supplied by BSI according
to this Agreement;
(g) “Term” means the term of this Agreement as set forth in Section 3 below, comprising the
Initial Term and any Renewal Term;
(h) “Territory” means the territory specified in Annex 2;
(i) “Trade-marks” means the trademarks specified in Annex 3 as well as all the
trade-marks and trade names, whether or not registered, which are owned and used by or
under license from BSI and/or which appear on Products.
1.2 The following terms, as used in this Agreement, have the respective meanings set forth
in the following Sections of this Agreement:
Term Section/Subsection
Initial Term 3.1
Renewal Term 3.2
Prices 5.1
EXW 5.2
IVD Directive 6.1
Notice of Claim 6.5
Investigation Period 6.5
Representatives 12.2
1.3 The following Annexes are incorporated into this Agreement by reference and form an
integral part hereof:
− Annex “1” Products List
− Annex “2” Territory
− Annex “3” Trademarks
− Annex “4” Minimum Annual Purchase Quantity (where applicable)
− Annex “5” Products Prices
− Annex “6” BSI Claim procedure
2.DISTRIBUTION GRANT
2.1 On the terms and subject to conditions set forth in this Agreement BSI hereby grants to
Distributor and Distributor hereby accepts from BSI the not exclusive right to distribute
Products, as set forth specifically in Annex 1.
For sake of clarity, the Parties covenant and agree that BSI has at any time the right to appoint
any other distributors, resellers and dealers operating in the Territory.
2.2 During the term of this Agreement BSI will have the right to amend or add Products
listed in Annex 1 by inserting any other product manufactured and/or sold by BSI or deleting
any Products already listed in Annex 1, by giving Distributor a 12 (twelve) months prior written
notice.
2.3 On the terms and subject to conditions set forth in this Agreement, BSI agrees to sell
Products to Distributor, it being specifically agreed that Distributor covenants and agrees to
purchase Products for its own account and exclusively from BSI and to market, distribute and
sell Products only in the Territory.
2.4 Distributor acknowledges and agrees that the rights granted pursuant to this Agreement
are limited to the Territory and confer no rights upon Distributor with respect to the
distribution of Products outside the Territory.
Without limiting the generality of the foregoing, Distributor shall not, directly or indirectly,
including through the Subsidiary or any Affiliate, reseller, dealer, agent, distribute or sell
Products outside the Territory and shall not solicit orders for Products, advertise Products or
keep any stock of Products outside the Territory. Distributor covenants and agrees that all
enquiries with respect to and any unsolicited orders for Products received, directly or indirectly,
by Distributor from outside the Territory shall be promptly referred in writing to BSI.
2.5 Distributor shall inform BSI in writing of, and BSI shall have the right to approve or
disapprove, any sub-distributor, reseller and dealer proposed to be appointed by Distributor in
respect to the sale and distribution of Products in the Territory, provided, however, that the
appointment of any such sub-distributor by Distributor, following approval by BSI, shall not
relieve Distributor of any of its obligations hereunder.
2.6 Distributor represents and warrants to BSI that any sub-distributor, reseller and dealer
appointed by Distributor in respect to the sale and distribution of Products in the Territory shall
comply with the terms and conditions of this Agreement.
 2.7 Distributor agrees to provide to BSI from time to time, and promptly upon request by
BSI, a list of the different distribution channels in which Products are being distributed or
intended to be distributed by Distributor within the Territory.
3.TERM
3.1 The initial term of this Agreement shall come into effect on the Effective Date and, unless
terminated earlier in accordance with the terms of this Agreement, shall continue in full force
and effect for a period of 1 (one) year (the “Initial Term”).
3.2 Provided Distributor shall have complied with all the terms and conditions hereof
(including, but not limited to, provision concerning the Minimum Annual Purchase Quantity)
and if notice of termination is not given 30 (ninety) days prior to the expiration of the Initial
Term (or of any Renewal Term as defined below, as the case may be), this Agreement shall be
automatically renewed for successive periods of 1 (one) year at the end of the Initial Term (or of
any subsequent Renewal Term, as the case may be) (“Renewal Term”).
3.3 After termination of the Agreement, Distributor may purchase – at a price that may be
updated – from BSI reagent strips included in Products, in order to provide customers that have
already bought Products, to keep it functioning for a period of 12 (twelve) months, unless an
agreement has been entered into with a new distributor.

4.PURCHASE ORDERS AND SUPPLY OF PRODUCTS

4.1 During the Term, Distributor covenants and agrees to yearly purchase from BSI, for
distribution within the Territory, not less than the minimum quantities of Products required in
order to meet the Minimum Annual Purchase Quantity as set forth in Annex 4. In the event that
Distributor shall purchase more than the prescribed Minimum Annual Purchase Quantity for a
particular year, the excess shall not be credited towards the Minimum Annual Purchase
Quantity in any subsequent year. In the event Distributor does not achieve the requisite
Minimum Annual Purchase Quantity for any year during the Term, then BSI may, at its sole
discretion: (a) terminate this Agreement at any time thereafter upon 90 (ninety) days written
notice to Distributor; or (b) revoke the exclusivity right granted to Distributor pursuant to
Section 2.1, upon simple written notice by BSI (for sake of clarity, in this event BSI shall directly
and/or indirectly sale and distribute Products within the Territory, appointing any other
distributors, resellers and dealers).
 4.2 Distributor shall place a firm written order with BSI for the quantity of Products to be
purchased. Such orders shall have to be sent to BSI by means of fax, certified e-mail or e-mail as
set forth in Section 16.1 below. Only such orders placed by Distributor and accepted in writing
by BSI through an order confirmation shall be binding on the Parties hereto. BSI’s order
confirmation shall set forth, amongst other, purchase order numbers, Prices (as defined below),
BSI’s bank account and expected delivery time. Where there is a conflict between the terms and
conditions stated in the purchase order and the provisions of this Agreement, the provisions of
this Agreement shall prevail.
4.3 During the Term Parties will yearly mutually agree to and set the Minimum Annual
Purchase Quantity to be met by the Distributor in each calendar year of the Term, whereupon
Annex 4 hereto shall be deemed amended accordingly to reflect such Minimum Annual
Purchase Quantity. The Parties shall convene the new Minimum Annual Purchase Quantity not
less than 90 (ninety) days prior to the expiry of any calendar year of the Term.
4.4 In the event Distributor and BSI are unable to mutually agree to and set the Minimum
Annual Purchase Quantity to be met by the Distributor in each calendar year of the Term within
the period set forth in Section 4.3 above, the Parties agree that the Minimum Annual Purchase
Quantity for the relevant calendar year will automatically be set as follows: an amount equal to
the greater of (a) 80% (eighty) of the Minimum Annual Purchase Quantity applicable to the
immediately preceding year; or (b) the actual gross sales realized by the Distributor in the
Territory during such immediately preceding year.

5.PRODUCT PRICING, PAYMENT AND DELIVERY

5.1 Subject to and in accordance with the terms and conditions hereof, BSI agrees to sell to
Distributor, and Distributor agrees to buy from BSI, the Products at the prices set forth in Annex
5 hereto (the “Prices”). Prices of Products are intended ex works in Euro, unless otherwise
agreed in writing by the Parties. Prices are subject to change at any time, subject to 120
(onehundredtwenty) days prior written notice.
5.2 Delivery of all Products according to this Agreement shall be ex works (“EXW”
INCOTERMS 2020 published by the International Chamber of Commerce) warehouse in
Palazzo del Pero, Arezzo, Italy.
5.3 Distributor will pay BSI the Prices of the total amount of Products through wire transfer
to BSI’s bank account as set forth in the order confirmation according to the following schedule:
100% in advance.
6.QUALITY AND CHANGES IN PRODUCTS
6.1 BSI, through its Affiliates and subcontractors, shall manufacture, assemble, test, package
and label the Products in accordance with the EC Directive 98/79/EC (“IVD Directive”), as well
as any other EU Regulation that might be applicable or enter into force during the effectiveness
of the Agreement.
6.2 BSI is certified according to the IVD Directive by a Notified Body and any Product is
provided with EC Certification. Furthermore, BSI keeps all technical documentation, which
allows the assessment of the conformity of the products, and copy of it will be provided to
Distributor upon request.
6.3 BSI will inform the Distributor about any changes to the status of the applicable
Products’ certificate and/or any change to its quality management system. BSI may make
modifications to the Products, to Products’ specification as well as to the related controls at any
time or discontinue the sale of, or limit its production of, any Product without thereby incurring
any liability whatsoever to Distributor with respect to any order placed by Distributor. BSI will
endeavour to give Distributor suitable prior notice in the event of any such discontinuance or
modifications.
6.4 BSI will provide exclusively to Distributor ordinary technical assistance in order to
pursue the scope of the Agreement.
6.5 Distributor shall, promptly following receipt of Products, examine such Products and
verify that it meets all requirements. To be valid, any claim in respect to short-shipment or for
defective Products must be made in writing by Distributor to BSI (the “Notice of Claim”)
within 15 (fifteen) days as of the date such Products arrived at Distributor’s warehouse or
within 15 (fifteen) days as of the discovery date of hidden defects (“Investigation Period”), and
such short-shipment or defect must not have been caused while the Products were in transport
from BSI’s warehouse to Distributor’s warehouse or while in storage by or on behalf of
Distributor. If Distributor has not notified BSI any Notice of Claim within the Investigation
Period, then it shall be deemed to have accepted the Products.
6.6 In case of Notice of Claim pursuant to Section 6.5, BSI has the right to verify within 15
(fifteen) days after receipt of the relevant Notice of Claim the compliance of Products to the
afore-mentioned specifications, requesting Distributor to provide samples of such defective
Products or evidence of short-shipment. The defective Products will be compared to samples
retained by BSI in its warehouse of each batch of production. If BSI agrees with Distributor that
 any rejected Product is defective, BSI will replace such defective Products with replacement
Products free of defect and BSI will reimburse only justified landed costs. The replacement
Products shall constitute the sole and exclusive liability of BSI in respect to defective Products
and short-shipment. BSI has the faculty to request to Distributor, in place of the return of such
defected Products, their destruction.

7.PACKAGING AND WAREHOUSING RESPONSIBILITIES

7.1 Distributor shall provide BSI with all potential necessary information pertaining to
packaging and packaging labelling with respect to specific local requirements in each
jurisdiction within the Territory.
7.2 Distributor will use its best efforts to ensure that warehousing and transportation to and
within the Territory are carried out in such a manner that they do not have a negative effect on
the quality of Products.
7.3 Without limiting the generality of the foregoing, Distributor undertakes to perform, at
its sole expense, the following services and activities in connection with and for the benefit of
maintaining Products:
(a) suitable warehousing with appropriate climate control as per BSI requirements as they
may be revised by BSI, in its sole discretion, from time to time; and
(b) loading Products in accordance with BSI’s prescribed standards as per BSI requirements.
7.4 Distributor shall assume full responsibility for and shall indemnify and save BSI
harmless from any damage, claim, liability, loss or expense (including any legal costs) which
BSI may suffer or incur by reason of Distributor’s packaging, stocking, warehousing, storage,
use, sale and/or distribution of the Products.

8.SALES AND MARKETING OF PRODUCTS

8.1 Distributor will resell any Products purchased hereunder in compliance with all
applicable laws in the Territory and only in the packaging supplied or approved by BSI.
Distributor is responsible for compliance with all applicable laws and regulations, including,
without limitation, laws and regulations regarding health and safety, in vitro devices and
medical products, marketing practices, etc. If Distributor considers or has reason to believe that
a Product is not in conformity with the applicable laws, shall immediately inform BSI and
co-operate with BSI to ensure that all necessary corrective action to conform, withdraw or recall
the relevant Product. Distributor represents and warrants that it has obtained all permits,
licences, registrations and other approvals required by every national, local or municipal
government or agency, in respect of the performance of Distributor’s obligations under this
Agreement.
8.2 Distributor is responsible for marketing and promotional activities in the Territory.
Consequently, Distributor shall use its best efforts, at its own expense, to market, promote and
sell the Products in the Territory and shall use the same channels and methods and exercise the
same diligence, including making regular and sufficient contact with present and prospective
customers of Products in the Territory, which Distributor uses in marketing its other
non-competing products. All advertising by Distributor in any medium shall be conducted in a
dignified manner that will reflect favourably upon the goodwill and reputation of BSI, and shall
conform to the highest standards and shall display the Trade-marks only in a manner approved
in writing by BSI. Distributor shall forward to BSI copies or samples of all advertisements and
promotions for its approval and Distributor agrees to withdraw any advertisements or
promotions which are considered unsuitable by BSI. Distributor further acknowledges that all
advertising and promotional materials relating to the Products or bearing the Trade-marks shall
remain the intellectual property of BSI who shall retain the sole and exclusive ownership of all
copyright therein.
8.3 Distributor shall report regularly to BSI in regard to any market trends or conditions or
regulations affecting or which may affect the sale of Products in the Territory that come to its
attention, or of any new products which might be competitive with the Products, providing
details thereof.
8.4 Distributor shall submit to BSI, in order to facilitate the production planning of the
following year, a yearly forecast at the latest 90 (ninety) days prior to the end of previous year.
8.5 In performing its duties hereunder, Distributor agrees not to make any representation or
give any warranty with respect to any Products other than those contained in any current
brochures, leaflets or other printed matter relating to such Products, which may be issued from
time to time by BSI. In the event that Distributor does make any representation or warranty in
violation of the foregoing, then Distributor undertakes to indemnify and save BSI harmless from
any claims, demands, suits, proceedings, damages, liabilities, costs or losses of any nature or
kind whatsoever (including any legal costs) suffered or incurred, or which may be suffered or
incurred, by BSI arising out of or in any way connected with any such representation or
warranty.
 8.6 The restrictive covenants imposed on the Distributor hereunder shall extend and apply
to its Subsidiary and to any Affiliates of the Distributor and their respective shareholders,
directors, officers, employees and representatives as if they were also parties to this Agreement
and Distributor shall cause such persons to comply with such restrictive covenants and will be
responsible for the actions of all such persons in contravention thereof.

9.ADDITIONAL OBLIGATIONS OF DISTRIBUTOR

9.1 During the Term, in addition to any other obligations set forth herein, Distributor shall:
(a) use its best efforts in the performance of its obligations under this Agreement, including
without limitation, in respect to the active solicitation of orders in the Territory for the purchase
of Products;
(b) commit and adhere to the highest standards of operation, including those standards that
may be prescribed by BSI from time to time;
(c) comply and cause its Subsidiary and any sub-distributor, reseller and dealer to comply
with the transport instructions of Products recommended on the external boxes of Products;
(d) provide to BSI ongoing market evaluations for Products and use its best efforts to
develop and enhance BSI name and brand image in order to increase market awareness and
sales of such Products within the Territory;
(e) grant records providing the traceability of Products up to the final users. Distributor
shall have to provide the records at any request of BSI. In case of Products’ recall from market, it
has to be possible to trace and recall any single Product;
(f) comply with and cause its Subsidiary as well as any permitted sub-distributor, reseller
and dealer to comply with all applicable laws, rules, regulations and/or guidelines in the
Territory relating to the use, storage, handling, transportation, marketing, advertisement,
distribution, sale, transfer and/or disposal of Products, as well as with the terms and conditions
of this Agreement;
(g) store Products at proper hygienic and technical conditions as well as comply and cause
its Subsidiary and any sub-distributor, reseller and dealer to comply with BSI instructions on
humidity and temperature requirements as well as all other storage conditions. Distributor will
be liable for any deterioration or bad functioning of Products caused by a not appropriate
storage system and not compliant with BSI’s instructions;
 (h) grant records of any technical assistance for troubleshooting occurred and provide BSI
every 90 (ninety) days with related periodical reports or statistics;
(i) shall promptly inform BSI about any claim related to Products or any problem
communicated by a local authority. Distributor shall have to comply with BSI’s claim procedure
enclosed hereto as Annex 6 with regard to the handling time and information about incidents
and product traceability to its sub-distributors, resellers and dealers. It is Distributor’s duty to
cause its sub-distributors, resellers and dealers to grant Products traceability up to final users;
(j) keep complete and accurate records with respect to any and all Products purchased
from BSI and sold by Distributor in the Territory.

10.REPRESENTATIONS AND WARRANTIES OF DISTRIBUTOR

10.1 Distributor represents and warrants to BSI, acknowledging that BSI is relying upon such
representations and warranties in connection with its entering into this Agreement, as follows:
(a) Distributor is a valid subsisting corporation incorporated pursuant to the laws of
_______;
(b) Distributor has all requisite, power and authority to execute and deliver this Agreement
and has all necessary power and authority to perform the obligations as set out herein;
(c) the entering into of this Agreement will not result in violation of any of the terms and
provisions of any agreement, written or oral, to which Distributor may be a Party;
(d) the execution and performance of this Agreement has been duly authorized by all
necessary action of Distributor and this Agreement, when duly executed and delivered by
Distributor, will constitute a legal and binding obligation enforceable in accordance with its
terms;
(e) the performance by Distributor of relevant obligations hereunder, including the sale of
Products, will be conducted in compliance with all applicable laws in the Territory; and
(f) Distributor possesses a readily available and extensive sales network in the Territory.

11.TRADE-MARKS
11.1 Products will be marketed and sold by Distributor solely under the Trade-marks.
Distributor will not alter, obscure, remove, cancel or otherwise interfere with any markings
(including without limitation any Trade-marks, logos, trade names or trading style of BSI) and
other indications of origin, which may be placed on Products.
11.2 Distributor acknowledges that BSI is the exclusive owner of the Trade-marks and
Distributor has no right, title or interest whatsoever in the Trade-marks and any goodwill
association therewith and that any goodwill associated with the Trade-marks is owned by and
shall stand exclusively to and for the benefit of BSI. Furthermore, Distributor agrees not to
represent in any manner that it has acquired any ownership rights in the Trade-marks.
Distributor shall, during the Term of this Agreement and subject to due compliance with the
provisions of this Section 11, have the right to use and display BSI’s Trade-Marks and
copyrighted material in the Territory solely in connection with the marketing, sale, distribution
and support of Products in such Territory in accordance with the terms of this Agreement and,
except as may be otherwise permitted in writing by BSI, for no other purpose whatsoever.
11.3 In connection with the foregoing, Distributor covenants and agrees as follows:
(a) to market, distribute and support the Products only under the Trade-marks, and not
under any other trade-mark or logo of the same Distributor or of any other person;
(b) to obtain from BSI written approval for all promotional material, alternative product
packaging including, without limitation, blister packaging and cartons, and to comply with all
instructions issued by BSI relating to the form and manner in which BSI’s Trade-marks shall be
used and to discontinue forthwith, upon notice from BSI, any practice relating to the use of BSI’s
Trade-marks which in BSI’s opinion would or might adversely affect the rights or interests of
BSI in such Trade-marks;
(c) to conduct business in a manner that reflects favourably at all times on the Products and
reputation of BSI in order to develop, promote and maintain same with customers and to
protect and preserve the goodwill and image of BSI and the Products;
(d) not to use or permit any of its Affiliate to use the Trade-marks or any other trade-marks
or trade names or trade dress of BSI or any trade-marks, trade dress, words, names, symbols, or
designs which could reasonably be expected to be considered confusingly similar thereto, as
part of its corporate or trading name or style, or on any of its products;
(e) not to infringe BSI’s rights in and to any of the Trade-marks and not to dispute, contest,
attack or impair the validity or ownership of the Trade-marks or do any act which tends to
impair the validity of the Trade-marks or the title of BSI to any Trade-marks, trade names,
copyrights and registrations used in connection with the Products, nor to carry out any
 application or registration thereof without the express written consent of BSI, and not to take
any action to the detriment of BSI’s interest therein or which would or could dilute the value of
the goodwill attaching to the Trade-marks;
(f) not to carry out or permit the removal, renewal or alteration of any Trade-marks, trade
names, notices, name plates, or serial numbers affixed to any Product or its packaging.
11.4 Distributor shall provide prompt written notice to BSI of any claims, allegations, actions
and demands that the marketing and/or distribution of the Products infringes or may infringe
the intellectual property rights of any other person and once such notice has been duly given,
BSI shall have full carriage of any resulting action and Distributor shall extend its full
co-operation to BSI in the defence by BSI of any such claim, action or demand.
11.5 Distributor shall immediately report to BSI any actual or potential infringements of the
Trade-marks or any matter which may give rise to any infringement of the Trade-marks, or any
imitation of Products of which Distributor is or may become aware, and Distributor shall
co-operate with BSI in protecting such Trade-marks and Products from any such infringement.
Distributor shall not initiate any protective action with respect to the Trade-marks or Products
without prior written authorization of BSI.
11.6 Distributor agrees that the provisions of this Section 11 are reasonable having regard to
the necessity of BSI to protect its ownership rights in the Trade-marks and that any breach of the
terms contained in this Section 11 shall be deemed a material breach of this Agreement.
12.CONFIDENTIAL INFORMATION AND NON-COMPETITION
12.1 When and if required, BSI will provide Distributor the necessary information in order to
fulfill Distributor’s obligations, if any, regarding Products’ registration within the Territory. This
information shall constitute part of the Confidential Information defined in the Agreement.
12.2 Distributor acknowledges that in its relationship with BSI and/or by virtue of the
performance of this Agreement, it and/or its employees, shareholders, officers, directors,
principals, agents and contractors (collectively, “Representatives”) will be and shall hereafter
continue to be entrusted with Confidential Information, the disclosure of any of which to
competitors of BSI or to the general public would be highly detrimental to the best interests of
BSI. Accordingly, Distributor covenants and agrees with BSI:
(a) that it shall not use or copy, or permit the use or copy of any of the Confidential
Information, directly or indirectly, for any purpose other than the performance of its duties and
obligations hereunder and only in the best interests of BSI;
(b) that it will maintain the absolute confidentiality of the Confidential Information and that
it will not (without the prior written consent of BSI) either individually, or in partnership or
jointly, or in conjunction with any other person, as principal, agent, shareholder, or in any
manner whatsoever, disclose, reveal, release, utilize, sell, assign, supply, or transfer to any
person at any time, any of the Confidential Information, except to the extent necessary to
discharge its duties and obligations relating to its appointment hereunder and only in the best
interests of BSI;
(c) that it will take all necessary action and will do all that is reasonably within its power to
prevent the disclosure, release or supply of any of the Confidential Information to any person,
including by any of its Representatives, except to the extent necessary to discharge its duties
and obligations hereunder and only in the best interests of BSI;
(d) further, Distributor will advise its Representatives, and any other persons who are given
access to the Confidential Information, of the confidential and proprietary nature of the
Confidential Information and of the restrictions imposed by this Agreement and, if appropriate,
shall require each of them to signify in writing their agreement to abide by the terms of this
Agreement and maintain the confidentiality of the Confidential Information. Notwithstanding
any such agreement, by any of such Representatives, Distributor acknowledges that it shall be
fully responsible and liable to BSI for any and all damages and costs (including legal fees)
suffered or incurred by it as a consequence of any breach by any of Representatives, and/or any
other persons given access to the Confidential Information, of the restrictive covenants
contained herein.
12.3 Distributor shall not, directly or indirectly, develop, manufacture, sale or distribute any
products similar to or competitive with the Products in the Territory or elsewhere. Distributor
hereby further covenants and agrees that during the Term of this Agreement, Distributor shall
not, for whatever reason, either individually or in partnership or jointly or in conjunction with
any person as principal, agent, employee, shareholder, owner, investor, partner or in any other
manner whatsoever, directly or indirectly, carry on or be engaged in or be interested in, or
advise, lend money to, guarantee the debts or obligations of or permit its name or any part
thereof to be used or employed by any person engaged in or concerned with or interested in, the
business of manufacturing, developing, producing, marketing, distributing, supplying or
selling, for wholesale or retail, nor shall it hold in stock or solicit or be directly engaged or
interested in soliciting orders for, any products similar to or competitive with the Products
within the Territory.
 12.4 Distributor acknowledges that the restrictions contained in Sections 12.2 and 12.3 are
reasonable, valid and necessary for the protection of the business and operations of BSI and that
any breach of the provisions will cause BSI substantial and irreparable harm which may not be
adequately compensated for by monetary award of damages to BSI. Therefore, Distributor
acknowledges that violation of restrictions contained in Sections 12.2 and 12.3 constitutes a
material breach for the purpose of Section 13.2. Accordingly, it is expressly agreed by
Distributor that in the event of any such breach, in addition to any other remedies which may be
available to it, BSI shall be entitled to and may seek an order for specific performance and other
injunctive and equitable relief as may be considered necessary or appropriate to restrain or
enjoin Distributor from any further breach of the terms hereof.

13.TERMINATION
13.1 Save as otherwise provided for in this Agreement, BSI may, without prejudice to any
other rights, immediately terminate this Agreement by written notice to Distributor if:
(a) any change occurs in control of Distributor;
(b) any change occurs in the constitution, management, financial or other circumstances of
Distributor which, in the sole opinion of BSI, is materially detrimental to the interests of BSI;
(c) if applicable, Distributor fails to duly register any Product for sale in the Territory within
the time period prescribed pursuant to the terms of this Agreement;
(d) Distributor assigns or attempts to assign this Agreement or any of the rights or
obligations hereunder without the prior written consent of BSI being given.
13.2 Furthermore, this Agreement may also be terminated by either Party at any time in the
event that the other Party commits a material breach of any provision of this Agreement and
such other Party fails to remedy such breach within 90 (ninety) days after receipt of written
notice specifying the breach from the non-defaulting Party.
13.3 Early termination pursuant the above paragraphs shall not relieve either Party of any
obligation arising hereunder prior to such termination including, without limitation,
Distributor’s obligation to (i) purchase Products covered by purchase orders confirmed BSI; and
(ii) pay BSI for the Products pursuant to purchase orders accepted by BSI prior to early
termination.
 13.4 Notwithstanding the termination or expiration of this Agreement all rights and
obligations of the Parties, which by their nature survive the termination or expiration of this
Agreement, shall survive.
13.5 Upon termination of this Agreement for any reason whatsoever:
(a) Distributor and its Subsidiary shall promptly return to BSI all advertising and
promotional material (including but not limited to price lists, catalogues, sales literature and
advertising literature), technical material and any other materials, documents given to
Distributor and relating to this Agreement or otherwise to the business of BSI;
(b) Distributor shall immediately return to BSI any Confidential Information and shall
refrain from using or disclosing any such Confidential Information to any person for any
purpose whatsoever;
(c) Distributor shall cease the use of BSI’s Trade-marks and shall thereafter refrain from
holding itself out as an authorized distributor of BSI, and Distributor will forthwith remove and
thereafter discontinue all advertisements, signs and notifications stating or implying that it is a
distributor of Products or in any way connected with BSI;
(d) BSI shall not be liable to Distributor by reason of the proper termination of this
Agreement for any damages, whether direct, consequential or incidental, on account of the loss
of prospective profits on anticipated sales or on account of expenditures, investments, leases or
commitments in connection with the business, arising from such termination of this Agreement.
13.6 If BSI continues to supply Products to Distributor after termination of this Agreement,
such supply will not be construed as a waiver of any such termination, or as a renewal of this
Agreement.

14.LIMITATION OF LIABILITY AND INDEMNITIES

14.1 Except as expressly provided in this Agreement, there are no representations or
warranties, expressed or implied, relating to Products, including, without limitation, any
implied warranty of merchantability or fitness for any particular purpose. Distributor assumes
all risk and liability for any loss, damage or injury resulting from the sale and use of Products,
either alone or in combination with other products.
14.2 Distributor hereby agrees to defend, indemnify and hold harmless BSI against any
liability, losses, damages or costs (including any legal costs) incurred or suffered by BSI as a
 result of any breach, negligent act or omission or wilful default of Distributor, its Subsidiary or
its Representatives arising either directly or indirectly from the performance (or
non-performance) by Distributor or any of its Representatives of any obligations under this
Agreement.
14.3 BSI shall not be liable to the Distributor for any special, indirect, consequential, punitive
or exemplary damages, including any damages on account of the loss of prospective profits on
anticipated sales or on account of expenditures, investments, leases or commitments in
connection with the business.
14.4 Notwithstanding anything to the contrary herein, if BSI notifies Distributor that any of
the Products needs to be recalled or otherwise withdrawn from the market, and Distributor
refuses or otherwise fails to do so in a timely manner, Distributor agrees to indemnify BSI, its
Affiliates, and their respective officers, directors, employees, agents and shareholders, from and
against any and all liability, losses, damages or costs, including legal costs, incurred or suffered
by BSI as a result of any such failure or refusal.

15.FORCE MAJEURE
15.1 No failure or omission by BSI or Distributor in the performance of any obligation under
this Agreement shall be deemed a breach of this Agreement or create any liability if it arises on
account of force majeure, which term shall include any event or cause beyond the control of BSI
or Distributor, as the case may be, including but not restricted to acts of God, acts or omissions
of any government, or agency thereof, rebellion, insurrection, riot, sabotage, invasion,
quarantine, restrictions, strike, lock out and transportation embargoes, provided that the Party
relying on this Section shall forthwith after any such event give written notice to the other Party
of its inability to perform such obligation and the reasons therefore. During the period of force
majeure BSI has the right to delay the delivery of Products and Distributor has the right to
postpone the purchasing orders. If force majeure continues for a period of more than 6 (six)
months, without the Parties hereto being able to develop an alternative satisfactory
arrangement, then either Party has the option to immediately terminate this Agreement.
15.2 The Parties agree that economic hardship, changes in market conditions, currency
fluctuations, or insufficiency of funds do not constitute a force majeure event under this
Agreement.
16.MISCELLANEOUS
16.1 Any notice, request, demand, consent or other communication required or permitted
under this Agreement shall be in writing and shall be given by personal delivery (including
courier), by registered letter or certified mail or by mail addressed to the Party for which it is
intended at the address below:
(a) if to BSI:
Address: Località Palazzo del Pero 23
52100 Arezzo (AR)
Certified Email bsisrl@arubapec.it
Email: info@biosys.it
Tel: +39 0575 984164
Attention: Export Department

(b) if to Distributor:
Address:
Certified Email []
Email: []
Tel:
Attention:

16.2 Either Party may change its address for notices and other communications upon notice
to the other Party in the manner aforesaid.
16.3 Except as otherwise provided herein, this Agreement may not be amended or otherwise
modified except in writing signed by both Parties.
16.4 This Agreement, including all annexes attached hereto, constitutes the entire agreement
and understanding between the Parties with respect to all matters herein and supersedes all
prior oral or written agreements and understandings between the Parties with respect to the
subject matter of this Agreement.
16.5 The words “hereof”, “herein”, “hereunder” and similar expressions used in any section
of this Agreement relate to the whole of this Agreement (including any annexes attached hereto)
and not to that section only, unless otherwise expressly provided for or the context clearly
indicates to the contrary. Words importing the singular number only will include the plural and
vice versa and words importing the masculine gender will include the feminine and neuter
genders and vice versa. The word “including” will mean “including without limitation”.
16.6 BSI may sell, transfer and assign any or all of its rights and obligations arising from this
Agreement to any of its Affiliates, upon written notice to Distributor. Distributor agrees as of
now in accordance to Article 1407 Italian Civil Code to such assignment. Upon such assignment
and assumption, BSI shall be under no further obligation hereunder with respect to any of the
rights and obligations so assigned. Further, BSI may, at its sole discretion, contract or agree with
third parties for the manufacture and supply of Products or its components; provided, however,
that it shall remain fully and unconditionally obligated and responsible for the full and
complete performance of all of its obligations under the terms and conditions of this
Agreement. Distributor shall not assign or transfer its rights or obligations under this
Agreement or any document relating to this Agreement to any person without the prior written
consent of BSI, which shall not be unreasonable withheld. This Agreement shall be binding
upon the Parties hereto and their respective successors and permitted assigns. Any attempted
assignment in violation of this Section 16.6 shall be void and of not effect.
16.7 The status of Distributor shall be that of an independent contractor. Nothing in this
Agreement shall constitute or be deemed to constitute a partnership or joint venture between
the Parties or constitute or be deemed to constitute Distributor as the agent of BSI for any
purpose whatsoever and Distributor shall have no authority or power to bind BSI in any
manner whatsoever or to assume or incur any obligation or responsibility, express or implied,
for or on behalf of, or in the name of BSI, except as specifically provided for herein. Distributor
shall not list, print or display BSI’s name in any manner so as to indicate or imply that there is a
principal-agent relationship between BSI and Distributor. All expenses related to Distributor’s
performance of this Agreement shall be borne by Distributor who shall be solely responsible for
the payment thereof.
16.8 The failure by either Party at any time to require performance by the other Party of any
provision of this Agreement shall in no way affect its right to require performance at any time
thereafter, and no term or provision of this Agreement is deemed waived and no breach
excused unless such waiver or consent is in writing and signed by the Party to have so waived
or consented. Any consent by any Party to, or waiver of, a breach by the other Party, whether
expressed or implied, does not constitute a consent to, waiver of, or excuse for, any other
different or subsequent breach by such other Party of the same or any other provision.
16.9 If any provision of this Agreement should, to any extent, be invalid or unenforceable, it
shall be deemed to be separate and severable from the remaining provisions of this Agreement,
 which shall remain in full force and effect and be binding as though the invalid or
unenforceable provision had not been included.
16.10 Each of the Parties hereto covenants and agrees to execute and deliver such further and
other agreements, assurances, undertakings or documents, cause such meetings to be held,
resolutions passed and by-laws enacted, exercise their votes and influence and do and perform
and cause to be done and performed any further and other acts and things as may be necessary
or desirable in order to give full effect to this Agreement.
16.11 Unless otherwise specifically provided for herein in writing, all monetary amounts
referred to herein shall be in Euro.
16.12 The language of all communications between the Parties pursuant to this Agreement,
including notices and reports, will be the English language.

17.GOVERNING LAW AND JURISDICTION

17.1 This Agreement shall be governed and construed in accordance with the laws of Italy
with the express exclusion of the United Nations Vienna Convention on Contracts for the
International Sales of Goods of April 11, 1980.
17.2 If any dispute arises concerning the validity, enforce ability, execution, performance or
termination of this Agreement, such dispute will be finally resolved by the Courts of Milan,
Italy.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the day
and year first written above.

___________________ ___________________
Biochemical Systems International S.p.A. _______________
Name: Emilio Dellepiane Name: __________________
Title: CEO Title: ____________________

Date: dd/mm/yyy Date: dd/mm/yyy

 ANNEX 1 - Products List
-

ANNEX 2 – Territory
-

ANNEX 3 – Trademarks
-

ANNEX 4 - Minimum annual purchase quantity

-

ANNEX 5 - Products Prices

 ANNEX 6 – BSI Claims Procedure
In order to hedge the problems related to the use of Product and the consequent technical
assistance, the Distributor should perform a deepen training at BSI laboratory. If this is not
possible, the training should be performed by a video conference.

Technical Assistance procedure:

I. In case of an error message, check the solution inside the manual and support the
customer. If the problem occurs again, ask the meter back.
II. In case of not correct results follow the diagram below:
If the problem is not solved, the Distributor should ask the meter back to the customer in order
to perform a “checking procedure” able to detect the problem occurred.

If the Distributor is not able to solve the problem, he will send back the “defective meter” to BSI
without the packaging material (external box, manual and rapid guide, hard case, lancing
device and lancets, vial of strips). When the Distributor returns the “defective meters” to BSI, he
should provide a list of serial numbers and related defect of the meter using the attached
complaint report. The Distributor should agree with BSI for return shipment documentation.

Within the warranty period, BSI will replace defective meters to Distributor if the damage is
caused by defective components. If defect is caused by improper use, these meters will be
repaired or replaced charging the Distributor of related costs. BSI will send back
repaired/replaced meters without packaging.

The Distributor should refer to MEDDEV 2.12 -1 REV 8 if an accident occurs and inform BSI
within the time line indicated in that document.

​CUSTOMER CLAIM FORM

OBJECT: CLAIM REPORT - PRODUCT QUALITY RE
SP.:
Distributor name: __________________________________________________ DIS
Address: __________________________________________________ TRI
BU
__________________________________________________
TO
Tel: ________________ Fax : _______________ R
e-mail______________
Product : ___________________________________________________________
Lot, S/N or other specifications __________________________________________
Problem:

__________

Date: __________________ Signature: _____________________

Comments and final decision: RE

SP.:
CO
M
OR
Product replacement: YES  NO  N.A. 
QC

Date: __________________ Signature: _____________________________

A. Corrective action YES  NO 

C.
If not, justify: _______________________________________
RE
SP.:
B. Date of replay to customer: __________________ RA
Q
by: tel.  fax  e-mail 

Signature RAQ: _____________________