FINAL SPG MEDISAFE Distributor Agreement
FINAL SPG MEDISAFE Distributor Agreement
FINAL SPG MEDISAFE Distributor Agreement
OR DISTRIBITOR AGREEMENT
THIS AGREEMENT is made and entered into on this day of , 2021 by and between
M/S SPG MEDISAFE PRIVATE LIMITED, a Limited Liability Non-Government Company incorporated
under the Companies Act, 2013, having its Registered Head Office at A – 239, Balaji Bhavan, Plot
No. 42A, CBD Belapur, Navi Mumbai – 400 614 and the Manufacturing unit situated at
Plati num Springs, Unit No. B-76, 77 & 78, Plot No. 6, MIDC, Taloja – 410 208
(hereinafter referred to as “THE COMPANY” (which expression shall, unless repugnant to the
context or meaning thereof, be deemed to include its successors and permitted assigns) of the
ONE PART
AND
THE COMPANY and DISTRIBUTOR are hereinafter collectively referred to as the “PARTIES” and
each individually as a “PARTY”).
RECITAL
WHEREAS:
B) M/s XYZ PRIVATE LIMITED is desirous being appointed as DISTRIBUTOR and as Official
Representative for the promotion and sale of the Products in the Territories on the
terms of this agreement. (hereinafter referred to as “THE DISTRIBUTOR”) of the
COMPANY. The Company hereby appoints the Distributor as an Official Representative
for the promotion and sale of the Products in the territories as defined in ANNEXURE –
2: Territories (the “Territories”); and
C) THE COMPANY after considering the aforesaid proposal and repeated request made
by M/s XYZ Private Limited has agreed to appoint them as DISTRIBUTOR, on the
following terms and conditions hereinafter appearing.
b. SOLE SUPPLIER: Distributor shall not obtain the Products for resale from any
person or entity other than from THE COMPANY. Notwithstanding the longer
duration of the Agreement, this exclusive purchase obligation applies for a
maximum period of five (5) years from the Effective Date and is contingent upon
the continued duration of the Agreement for such period of time. Distributor
may not sell the Products to customers in another territory where THE
COMPANY has exclusively reserved such territory for itself or another distributor,
Distributor shall be prevented from directly or indirectly (including through its
affiliates), actively searching and filling orders for any of the Products in other
territory.
c. COMPETITIVE PRODUCTS: During the Term THE DISTRIBUTOR shall not promote
or sell, directly or indirectly, any products manufactured or offered for sale by
another person or entity, which product competes with the Products (each, a
“Competing Product”). Distributor warrants that it does not promote or sell,
directly or indirectly, any Competing Products as of the Effective Date. During the
Term of this Agreement, THE DISTRIBUTOR shall disclose to THE COMPANY any
new products or treatments in the field of Medical Devices improvement that
Distributor intends to promote or sell, as well as the manufacturer of such
products, prior to promoting or selling such products and THE COMPANY shall
determine in its sole discretion whether such products are Competing Products.
ii. any law, regulation, policy, guideline, order, or similar authority issued by
a state or local government or any agency, board or commission thereof.
i. give either party the power to direct and control the day-to-day activities
of the other,
ii. constitute the parties as partners, joint ventures, co-owners or otherwise
as participants in a joint or common undertaking, or
f. SUB DISTRIBUTORS: Distributor shall not appoint or use any third parties to
market, sell or distribute the Products unless such sub distributors, and
Distributor’s written agreement authorizing such sub distributor to market, sell
or distribute Products, has been expressly approved by THE COMPANY in writing.
2 RESPONSIBILITIES OF DISTRIBUTOR: -
a. Marketing and Promotion: The Distributor shall use its best efforts to vigorously
promote and sell the Products in the Territory, and shall at its cost and expense:
b. Marketing Plan: The Distributor shall provide a twelve (12) month sales and
marketing plan (“Annual Marketing Plan”) for THE COMPANY’S review and
approval within sixty (60) days of the Effective Date of this Agreement, which
plan shall:
i. list sales goal for the following twelve (12) month period for each
Product,
iii. Distributor shall update the Annual Marketing Plan and provide such
updated plan to THE COMPANY at least sixty (60) days prior to each
anniversary of the date, the first Annual Marketing Plan was approved by
THE COMPANY. Upon THE COMPANY’S approval, Distributor shall
implement the Annual Marketing Plan.
iv. The Distributor must at all times seek prior approval from the Company
for all promotional and press release material prior to that material being
circulated in the public domain. Such approval shall not unreasonably be
withheld.
c. Quarterly System Quota: The Distributor agrees to purchase each year from the
Company a minimum quantity of Products in each Territory, which quantity shall
be as set forth in Annexure 3: Minimum Quantity by Period, by Territory. The
Distributor is obliged to provide a report to the Company every calendar Quarter
(3 months period) summarizing the quantity of Products sold within the
Territories and any other information relating to the performance of its
obligations under this Agreement the Company may reasonably require from
time to time. Should the Distributor fail, in any Territory, to purchase the
minimum quantity as agreed upon (Annexure 3: Minimum Quantity by Period, by
Territory) then the Company has the right (in its sole discretion), subject to one
(1) month notice in writing, to terminate this agreement for that territory.
iv. shall not promote the Products other than for use with their label
indications.
e. Legal Compliance. Distributor shall comply at its expense with all laws governing
the distribution, promotion, marketing, training and sale of the Products in the
Territory. Without limiting the foregoing, Distributor:
iii. shall comply promptly with any recalls of the Product issued by THE
COMPANY or by any applicable regulatory authorities;
iv. shall comply with the obligations specified in ANNEXURE – 2 and shall
otherwise accept notifications from Customers or any physician or user of
the Product in the Territory regarding complaints and adverse events
with respect to the Products, including: alleged or actual Product
malfunctions; alleged or actual injury to patients or operators (even if
caused by use error); alleged or actual counterfeiting; non-routine
servicing or installation, e.g., repairs of an unexpected nature,
replacement of parts earlier than their normal life expectancy, or
identical repairs or replacements of multiple units of a device are not
routine servicing (collectively, “Complaints”). Distributor shall notify THE
COMPANY of any Complaints within twenty four (24) hours of the
Distributor becoming aware of the complaint, meaning that an employee
or contractor of the Distributor has acquired information that suggests a
Complaint may have occurred;
vi. shall keep the required records and report complaints and investigations
for input to the Corrective & Preventive action system. The point of
contact to control the activities of Company regarding Corrective &
Preventive action shall be the Company’s Quality Manager. Documented
procedures for adverse events must meet the Medical Device
requirements for Problem Reporting.
vii. Distribution records shall be kept by the Distributor for the life-time of
the device. The Company shall have access to these records as required.
These distribution records must be adequate to permit a complete and
rapid withdrawal of devices from the market.
viii. shall provide the Company with all details like customer name, address
and contact details, including the batch or lot numbers, including
quantities sold to facilitate traceability to the end user.
ix. shall promptly advise THE COMPANY of any laws, rules or regulations in
the Territory that may require THE COMPANY to modify a Product
otherwise take any action in connection with the Products or this
Agreement;
xi. shall comply with the laws of the Territory and the standards of quality
and safety of medical devices are regulated in India by a law called The
Drugs and Cosmetics Act, 1940 (“DCA”) and ensure quality and safety of
notified medical devices at all levels of the supply chain, the Medical
Device Rules, 2017 and that rules came into force in January 2018
and devices are regulated by the Central Drugs Standard Control
Organization (CDSCO), an agency of the Ministry of Health and Family
Welfare. All medical devices in India to be regulated as “DRUGS” –
Medical Devices (Amendment) Rules, 2020.
g. Distributor shall maintain during the term insurance coverage consistent with
industry standards for businesses engaged in the distribution of medical devices,
including product liability and product recall insurance. Upon THE COMPANY
request Distributor shall provide certificate of insurance.
3 RESPONSIBILITIES OF THE COMPANY: -
a. THE COMPANY shall fulfill orders for Products and shall replace or repair
defective Products that are under warranty.
b. THE COMPANY shall provide Instructions for use, and product labelling in English
for each of the Products. The company shall pre-approve any promotional
material that is developed by the Distributor and contains references to the
Company before this material enters the local market/ territory
d. The Company shall have the right, upon reasonable notice to the Distributor and
during regular business hours, to inspect and audit the facilities being used by
the Distributor for distribution of the Products, to assure compliance by the
Distributor with applicable rules and regulations of the territories and with other
provisions of this Agreement.
a. During the term of this Agreement, the Company shall supply the Distributor
with Products as ordered by the Distributor pursuant to this Agreement for
distribution in the Territories. The Products shall conform to the specifications as
set forth in Annexure 1 The Product Range to this Agreement and as approved
by the regulatory authorities.
b. The Distributor shall provide an initial non-binding written twelve (12) month
forecast upon execution of this Agreement and every six (6) months thereafter of
the Distributor’s expected requirements for Products.
c. The Distributor shall place a binding order for Products, in the form agreed to by
the parties, on a quarterly basis by written or electronic purchase order (or by
any other means agreed to by the parties) to the Company, which shall be placed
at least sixty (60) days prior to the desired date or delivery. In no event shall the
Distributor be obligated to purchase Products except by means of the
aforementioned binding purchase order.
d. The Distributor agrees to purchase each year from the Company a minimum
quantity of Products in each Territory, which quantity shall be as set forth in
Annexure 3: Minimum Quantity by Period, by Territory. The Distributor is obliged
to provide a report to the Company every calendar Quarter (3 months period)
summarizing the quantity of Products sold within the Territories and any other
information relating to the performance of its obligations under this Agreement
the Company may reasonably require from time to time. Should the Distributor
fail, in any Territory, to purchase the minimum quantity as agreed upon
(Annexure 3: Minimum Quantity by Period, by Territory) then the Company has
the right (in its sole discretion), subject to one (1) month notice in writing, to
terminate this Agreement for that Territory.
e. The Company shall use all best efforts to deliver the Products ordered in
Distributor’s purchase orders within ten (10) working days after receipt of any
such order or such longer period as may be specified in such order. In case of
urgent delivery, the dispatch can be done through Air Cargo for which there will
be additional charges which will be borne by the Distributor. In case the parcel is
not accepted, collected and/or refused by the Distributor for any reason after
proper intimation being received by the Distributor, the Freight, demurrage, re-
booking and handling charges will be debited to the Distributor’s account.
f. Any damage/shortage of material should be intimated by the Distributor to the
Company within 72 hrs. of receipt in writing by post / courier/e-mail/fax. No
claim will be entertained by the Company beyond the specified time.
g. The Distributor should submit along with the Indent/order “C” Form, Road
Permit (In states where it is mandatory) or any other form as required at the
time of dispatch.
h. The Company shall have the right to reject any purchase order on the grounds
that the Distributor has changed to an unreasonable extent its previously
estimated requirements as to quality, quantity or payment of the Products.
i. The Products shall be delivered by the Company to the Distributor. For the
avoidance of doubt, the Distributor shall be responsible for obtaining any
necessary import or export licenses or permissions in relation to the Products
and any and all customs duties, clearance charges, taxes, brokers’ fees and other
amounts which may be payable in connection with the import, export, purchase
and delivery of the Products.
c. The Distributor shall provide payment to the Company for first 6 order/ invoices
of Products in full in advance of the agreed shipping date. Thereafter credit
period granted to the Distributor for payment of subsequent purchases shall be
30 days from the date of receipt of the shippment. In case of delay in payment
beyond the credit period of 30 days, interest @ 24 % p.a. shall be charged on the
amount of delayed payment at the discretion of the Company.
d. THE COMPANY shall have the right to modify the Purchase Price at its sole
discretion. The prices for Products shipped during the first year of the term of
this Agreement shall be as set forth in the Price List (ANNEXURE - 1). However,
The Company and the Distributor shall meet and revise the price as an when
required.
f. The Distributor shall furnish to the Company at the time of the execution of this
Agreement, at its own cost and expense, an unconditional and irrevocable
Corporate/Personal Guarantee for an amount of amount equivalent to average
purchase/average proposed purchase of 3 months from Company. The
Distributor/Distributor shall ensure that the corporate/personal guarantee shall
remain valid and enforceable up to a period of Thirty [30] days after the expiry or
early termination of this Agreement with a claim period of Thirty [30] days
beyond its validity.
g. In case of Distributor exceeding purchases than the credit limit he shall pay
advance against any such purchase. Similarly, any Distributor purchasing stock
exceeding Bank Guarantee shall pay advance, the payments to be made through
RTGS/NEFT/CHEQUE/CASH/DD. Mode of Payment shall be preferably RTGS, and
payment can also be made by cheque at sole discretion of Company.
h. The Purchase Prices do not include national, state or local excise, sales, use,
value added or other taxes (“Taxes”) now or hereafter levied by any
governmental authority on the sale, purchase, transport or delivery of the
Products. Distributor is responsible for all taxes associated with the order at the
(time of the sale or thereafter). Distributor shall be responsible for
reimbursement of any and all Taxes paid by THE COMPANY within thirty
(30) days of shipment.
8. Goods Return:
Except in case of quality issue or wrong supply, Manufacturer is not bound to accept return of
goods sold earlier. It will be at the sole detritions of Manufacturer whether to accept the
return goods or not.
In case if Manufacturer accept return goods except for the reason of quality issue (supported by
suitable evidence from a concerned Surgeon & from QC department of Manufacturer’s
company) or wrong supply, the return goods will be repurchased by Manufacturer at the
following rates:
a) Where the remaining life of products is 4 years or more then repurchase rate shall
be at 75 % of the value of the product.
b) Where remaining life of products is equal to or more than 3 but less than 4 years
then repurchase rate shall be at 65 % of the value of the product.
c) Where remaining life of products is equal to or more than 2 but less than 3 years
then repurchase rate shall be at 55 % of the value of the product.
d) Where remaining life of products is equal to or more than 1 but less than 2 years
then repurchase rate shall be at 40 % of the value of the product.
e) Where remaining life of products less than 1 years or NIL then repurchase rate
shall be at 25 % of the value of the product.
a. This Agreement shall come into effect on the date last signed and shall continue
in force for a period of one year unless otherwise terminated as provided herein.
b. Without prejudice to any remedy either Party may have against the other for
breach or non-performance of this Agreement, both Parties shall have the right
to terminate this Agreement with immediate effect by giving the other Party
written notice: (i) if the other Party commits any material breach of any of the
terms of this Agreement and (is such breach is remediable) fails to remedy that
breach within 30 days of that Party being notified of the; or (ii) an order is made
or a resolution is passed for the winding up of the other Party, or an order is
made for the appointment of an administrator to manage the affairs, business
and property of the other Party, or such an administrator is appointed, or
documents are filed with the Court for the appointment of an administrator, or
notice of intention to appoint an administrator is given, or a receiver is
appointed of any of the other Party's assets or undertaking, or circumstances
arise which entitle the Court or a creditor to appoint a receiver or manager or
which entitle the Court to make a winding-up order, or the other Party takes or
suffers any similar or analogous action in consequence of debt anywhere in the
world, or an arrangement or composition is made by the other Party with its
creditors or an application to a court for protection from its creditors is made by
the other Party.
c. If THE DISTRIBUTOR has not fulfilled any payment within 30 days (Thirty Days)
after having fallen due and if THE DISTRIBUTOR still has not made the payment
of such amount after [2 REMINDERS] from THE COMPANY within at least 10 days
between each reminder with reference to this Clause, THE COMPANY is entitled
to terminate this Agreement immediately on giving written notice.
e. The parties are entitled to terminate this Agreement under any of the following
change of control events (“Change of Control”) arising at either THE COMPANY
or THE DISTRIBUTOR:
iv. The sale of all or substantially all of the company’s assets or the
liquidation of the company.
a. Termination of this Agreement shall not release either Party from any obligation
or liability incurred prior to the effective date of such Termination.
b. THE DISTRIBUTOR shall, at his sole cost and expense, promptly return to THE
COMPANY all advertising materials, Confidential Information and all other
property or equipment of THE COMPANY in possession of THE DISTRIBUTOR.
d. The termination of this agreement (howsoever arising) shall not of itself give rise
to any liability on the part of THE COMPANY to pay any compensation to THE
DISTRIBUTOR, including but not limited to, for loss of profits or goodwill.
12 LIMITATION OF LIABILITY:
THE COMPANY and THE DISTRIBUTOR shall in no case have any liability to each other for
loss of use and other special, indirect or consequential losses or damages. However, THE
DISTRIBUTOR shall be liable to THE COMPANY for loss of profit.
a. Proprietary Rights: Distributor agrees that THE COMPANY owns all right, title,
and interest in the Products and in all of The Company’s patents, trademarks,
trade names, inventions, copyrights, know-how, trade secrets and other
intellectual property relating to the design, manufacture, operation or service of
the Products. THE COMPANY grants Distributor a license to sell the Products and
to use the Products solely as necessary to perform its obligations under this
Agreement. Except for the foregoing license, the sale of the Products hereunder
to Distributor does not and will not be deemed to confer upon Distributor any
right, interest or license in any patents or patent applications, or copyrights or
other proprietary rights that THE COMPANY or any third party may have in the
Products or otherwise and shall not confer on Distributor any right to
manufacture or have manufactured, duplicated or otherwise copied or
reproduced any of the Products or any part or component thereof. THE
COMPANY shall retain exclusive ownership of all proprietary rights in and to all
documentation and other data and materials pertaining to any Products. All
rights not expressly granted to Distributor in this Agreement are reserved by the
Company.
14 TRADEMARKS
a. THE COMPANY hereby grants to THE DISTRIBUTOR the non-exclusive right in the
Territories to use the trademarks [TRADEMARKS] in the promotion,
advertisement and sale of the Products in accordance with the terms of and for
the duration of this Agreement. The trademarks [TRADEMARKS] are registered
trademarks, owned and used by THE COMPANY. THE COMPANY makes no
representation or warranty as to the validity or enforceability of the trademark,
nor as to whether the same infringe on any intellectual property rights of third
parties in the Territories.
b. The Products shall be sold under THE COMPANY’S trademark and on all
Products, containers and advertisements for the Products as may be prescribed
by THE COMPANY. All representations of such trademark which THE
DISTRIBUTOR intends to use shall first be submitted to THE COMPANY for
approval.
d. THE DISTRIBUTOR may not put any trademark of his own on any Products or
Product’s documentation material (including without limitation any inserts),
without THE COMPANY’s permission in writing in advance. Such authorization
shall not be unreasonably withheld as long as regulatory requirements are met.
e. THE DISTRIBUTOR shall not, without the prior written consent of THE COMPANY,
alter or make any addition to the labeling or packaging of the Products displaying
the aforementioned Seller’s trademarks, and shall not alter, deface or remove in
any manner any reference to such trademarks, any reference to THE COMPANY
or any other name attached or affixed to the Products or their packaging or
labeling.
f. Both Seller and THE DISTRIBUTOR shall promptly inform each other of any
situation, where it has a reason to believe that trademark rights may be infringed
or challenged by third parties. THE DISTRIBUTOR shall not do or omit to do
anything in its use of THE COMPANY’s trademarks that may or would adversely
affect their validity.
g. THE COMPANY agrees to and at its own expense to take appropriate action (in its
sole discretion) to protect its trademark and other intellectual property rights.
THE DISTRIBUTOR agrees at the request and expense of THE COMPANY to
provide all reasonable assistance in connection with any action to be taken by
THE COMPANY.
15 SECRECY
a. Each Party agrees and undertakes that during the term of this Agreement and
thereafter it shall keep confidential and shall not use for its own purposes all
information of a confidential nature (including, without limitation, information
relating to a Party’s business, know-how, processes, product information and
trade secrets) which may become known to that Party from the other Party
(“Confidential Information”), unless the information is public knowledge or
already known to that Party at the time of disclosure or subsequently becomes
public knowledge other than by breach of this Agreement or subsequently
comes lawfully into the possession of that Party from a third party.
16 INFRINGEMENT
a. Both Distributor and Seller shall inform the other party of all acts of unfair
competition, breach of confidence and of all infringements of patent or similar
rights or other intellectual property rights of THE COMPANY or THE
DISTRIBUTOR, which come to their notice.
b. THE DISTRIBUTOR shall, at the request of THE COMPANY, assist THE COMPANY
to the best of its ability to protect THE COMPANY against such acts and
infringements. THE COMPANY shall compensate THE DISTRIBUTOR for
reasonable external expenses incurred in this regard, provided that, external
expenses over £500.00 must be pre-approved by THE COMPANY.
17 ASSIGNMENT
a. This Agreement may not be assigned by either Party without the prior written
consent of the other. Subject to the foregoing, this Agreement shall bind and
inure to the benefit of the parties hereto and their respective successors and
assigns
18 INDEMNIFICATION
i. the modification of the Products by any party other than the Company,
ii. the combination of the Products not supplied by the Company where the
Claim is directed at the combination.
iii. translations of the Company marketing, technical and other materials (to
the extent liability is caused by the translation and not the material in
their original form), or
iii. give the Indemnifying Party the right to control the defense and
settlement of any such claim. The Indemnified Party will have the right to
participate in the defense with counsel of its choice at its own expense,
provided that the Indemnifying Party will have the right to make final
decisions regarding the defense of a Claim as long as the Indemnifying
Party actively maintains the defense of such Claim.
19 GENERAL PROVISIONS: -
a. Governing Law and Jurisdiction: This Agreement will be governed in all respects
by the laws of India without regarding to conflicts of law principles that would
require the application of the laws. This Agreement shall be governed by, and
construed in accordance with Indian Law. Any dispute arising or touching the
construction, meaning or the effect of this Agreement or any Clause herein
contained or as to the rights / liabilities of the parties hereto shall be under
exclusive jurisdiction of the appropriate Courts in the City of Mumbai. In the
event of any dispute arising between the Company and the Distributor
necessitating legal redress, the Courts in Mumbai shall be competent Court to
decide the issue and shall have exclusive jurisdiction in that connection.
Email:
If to Distributor: Distributor's Address
Email id:
Any change in communication address, Tel No. E-Mail etc. and/or change of authorized
representative of the Distributor should be informed to the Manufacturer in Writing
immediately with a Confirmation from the Manufacturer. Any inconvenience or loss due
to delay in such communications will be on the part of Distributor only.
g. Assignment. Distributor may not assign, delegate or otherwise transfer any right
or obligation of Distributor under this Agreement whether by agreement,
operation of law, or otherwise, without the express prior written consent of the
Company. Any purported assignment, delegation, or transfer in violation of the
previous sentence will be null and void. Subject to the foregoing, this Agreement
in its entirety will bind each party and its permitted successors and assigns.
i. Entire Agreement. This Agreement and the exhibits hereto constitute the entire
agreement between the parties with respect to the subject matter hereof, and
supersedes all prior or contemporaneous representations, understandings,
agreements, or communications between the parties, whether written or oral,
relating to the subject matter hereof.
a) Distributor will maintain the record of distribution. - This is to ensure the Product distribution
and Batch traceability
b) Distributor will assist SPG MEDISAFE PVT. LTD. In case of any situation of hold or recall the
material
c) Distributor will store the material in good condition as per storage conditions mentioned on
packaging material of the product
d) Goods will be stored away from direct sunlight and always under shade.
f) Goods will be stacked in such a way that not more than 5 boxes or 40 Kgs outer cartons are one
above others, and
g) Goods will be stored in cool place
h) Neither of the Parties to this Agreement shall be responsible to the other for any delay in
performance or non-performance, due to any causes beyond their reasonable control, but the
affected Party shall promptly, upon the occurrence of any such cause inform the other Party in
writing, stating that such cause has delayed or prevented its performance hereunder and
thereafter each Party shall take all action within its power to comply with the terms of this
Agreement as fully and promptly as possible.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first set forth
above.
DISTRIBUTOR: MANUFACTURER:
_______________
Name: Name:
Title: Title:
Date: Date:
Product range
ANNEXURE 2 – Territories
Countries/States/District
ANNEXURE 3 – Minimum Quantity
Minimum Sales
Prices