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DISTRIBUTION, SUPPLY

AND

CONFIDENTIALITY AGREEMENT DRAFT

This Distribution, Supply and Confidentiality Agreement is made and entered on 13th May,
2019 by and between:

NEISS LABS LIMITED,

A company incorporated in India, having its business address at A/111, Part - A, Kushal
Mangal Industrial Estate, Tungareshwar Phata, Survey No. 16, Sativali, Vasai (East),
District - Palghar - 401 208, (hereinafter referred to as “SUPPLIER”) which expression
shall include its successors, administrators and permitted assigns.

and

FELIRNI LABS S.A.S,

A company incorporated in Colombia, having its business address at Carrera #76-26 OFIC
505 (hereinafter referred to as “AGENT”), which expression shall include its affiliates,
successors, administrators and permitted assigns.

- Hereinafter referred to as Parties

Whereas, SUPPLIER has acquired certain rights, and developed certain


methods/methodologies relating to the manufacturing of a Product (as hereinafter
defined);

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Whereas, SUPPLIER wishes to supply AGENT on exclusivity with the Products in
Annex A for its sale and distribution in the Territory during the term of this
Agreement;

Whereas, AGENT wishes to sell, distribute and market the Product in the Territory
(as hereinafter defined) during the term of this Agreement;

NOW THEREFORE FOR VALUE CONSIDERATIONS AND COVENANTS


AGREED TO BY AND BETWEEN THE PARTIES THIS AGREEMENT
WITNESSETH AS UNDER:

Article 1 – Definitions/Interpretations

As used, In this Agreement –

 clause headings are for convenience and shall not be used in its interpretation;

 unless the context clearly indicates a contrary intention –

 an expression which denotes –

 any gender includes the other genders;

 a natural person includes an artificial person and vice versa;

 the singular includes the plural and vice versa;

the following expressions shall bear the meanings assigned to them below and cognate
expressions bear corresponding meanings –

The following terms, when used in capitalized form in this Agreement, shall have the
following meaning:

1.01 “AFFILIATE/S” means an entity, (whether or not incorporated and including


without any limitation, a company, corporation, close corporation, trust, partnership,
joint venture or other association of persons) which, presently or in the future –

a) Is owned or controlled by a Party hereto by way of ownership, directly or


indirectly, of 50% or more of such entity’s share capital or otherwise, and such an

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entity shall continue to be deemed an affiliate only as long as such ownership or
control continues; or

b) Owns or controls a Party hereto by way of ownership, directly or indirectly,


of 50% or more of such Party’s share capital or otherwise, and such an entity shall
continue to be an affiliate only for so long as such ownership or control continues;

1.02 “Territory” shall mean the country of Colombia, where AGENT will

legally sell the Product;

1.03 “Trademark” shall mean: any trademark filed or owned by AGENT for the
marketing of the Product in the Territory;

1.04 PARTIES mean the Parties to this Agreement and Party shall mean any one
of them;

1.05 “APPLICABLE LAWS” means all or any:

a. statutes, subordinate legislation and common law;

b. regulations;

c. ordinances and bylaws; and

d. directives, codes of practice, circulars, guidance notes, judgments and


decisions of any competent authority;

e. compliance with which is mandatory in relation to the subject matter of this


Agreement;

1.06 “DOSSIER” means a compilation of documents such as administrative data


of the product, summary of product characteristics (SMPC), product
composition (including qualitative and quantitative), Finished product
specification, manufacturing method, analytical method of finished product
and stability testing and data of the product. wherein the SUPPLIER shall at
all times be the owner of the manufacturing formula and the Dossier;

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1.07 “EFFECTIVE DATE” means the first Business Day after the fulfilment of
the condition;..when the agreement comes into force;

1.08 “MARKETING AUTHORISATIONS / PRODUCT REGISTRATION”


means any license or approval of any Agency necessary for the

1.09 MANUFACTURE, export and/or Commercialisation of the Product(s) in the


Territory;

1.10 PRODUCT(S) means manufactured or Finished product containing Active


pharmaceutical ingredient (API) as mentioned in Annex A in a form
suitable for commercialisation in the territory;

1.11 ACTIVE PHARMACEUTICAL INGREDIENT (API): Is the substance


which includes salts, chelates, solvates, complexes, hydrates, crystalline or
amorphous forms, prodrugs of the Prodcut(s) for therapeutic or prophylactic
use in humans;

1.12 SHELF LIFE” means the period, as approved for the Product(s) between the
date of Manufacture and the expiration date;

1.13 FREE ON BOARD (FOB) means a trade term that indicates whether the
seller or the buyer has the liability for goods that are damaged or destroyed
during shipment between the two parties;

1.14 INDEPENDENT LABORATORY means a laboratory for conducting the


analytical tests with respect to the products and such independent laboratory
as shall be mutually agreed by the Parties in writing;

1.15 cGMP means the current practices recognized internationally by the


pharmaceutical industry with respect to the manufacture of the Product(s)
including any applicable laws, promulgated by any governmental body

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having jurisdiction over the Manufacture of the Product(s) and any guidance
documents (including but not limited to advisory opinions, compliance
policy guides and guidelines) which guidance documents are being
implemented within the manufacturing industry for such Product(s);

1.16 PACKAGING MATERIALS means the boxes, labels, inserts, bottles,


blister packs, lids, tubes, vials and the like and any other materials necessary
to pack the Product(s);

Article 2 - Marketing of the Product

2.01 AGENT agrees to maintain an active sales organization with personnel capable
of competently dealing with the promotion of the Product throughout the
Territory. AGENT shall commit adequate funding and exercise reasonable
best efforts, comparable to those that it devotes to other products with
similar potential, to fund and support the product launch and ongoing
promotion, marketing and sale of the Product.

2.02 AGENT shall ensure that the packaging, package inserts, marketing, promotion
and sale of the Product complies with the conditions and requirements of the
Marketing Authorization and all other applicable legal and regulatory
requirements in the Territory.

2.03 AGENT at its own discretion may register and use any of the Product’s trade
names for the promotion, sale and distribution of the Product in the
Territory. AGENT shall bear all costs associated with the Tradename.

2.04 After registration of SUPPLIER in Colombia is complete, AGENT will inform

the SUPPLIER about the completion of registration, and share all certificates
and documents related to registration.

Article 3 - Terms of Supply

3.01 AGENT agrees to purchase from SUPPLIER, all its requirements for the sale and
distribution of the Products in the Territory, and SUPPLIER agrees to supply

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AGENT with the Products as per Annex A on exclusive basis as per given
forecast to be fulfilled in a year.

3.02 The supply price for the Product shall be on FOB basis in US-Dollar (USD) and
will be the one agreed between the Parties and stated in Annex A. All
payments shall be made by bank transfer to an account designated by
SUPPLIER. AGENT shall pay 70% in advance on receipt of purchase order
and remaining 30% before dispatch of goods.

3.03 USD 3000 per dossier will be charged from AGENT, which will be reimbursed
by SUPPLIER if the brand name will belong to SUPPLIER.

3.04 The Product will be supplied only by AGENT written order, which shall be sent
to SUPPLIER at least sixty (60) days prior to the requested delivery date.

3.05 If at any time the economic terms of this Agreement become unreasonably
onerous for any of the Parties hereto, the Parties shall discuss, in good faith,
how to overcome the situation and try to find an equitable solution.

3.06 SUPPLIER holds all rights of the brand, and AGENT can never approach any
manufacturer for the manufacturing of same brand name as belonging to the
SUPPLIER.

Article 4 - Product Quality

4.01 SUPPLIER represents and warrants to AGENT that the Product supplied to
AGENT

a) Has been manufactured in accordance with the current Good Manufacturing


Practices (cGMP) as intimated by AGENT to SUPPLIER and as per the samples
approved by AGENT.

b) Shall have on delivery to AGENT an appropriate shelf life under normal


storage conditions indicated on the certificate of analysis and/or packaging
materials.

4.02 a) If the testing made by SUPPLIER within the said period confirms that such
Products do not conform with agreed and warranted conditions and requirements,
then AGENT shall dispose off or deliver such Products, at the expense of
SUPPLIER. SUPPLIER shall direct this in writing, and shall, at the option of
AGENT, replace such quantity of Product with conforming Products free of
charge to AGENT.

b) If the Parties fail to agree as to whether the Products conform to the agreed requirements,
then the Parties shall have such Products in dispute, tested and further analyzed by a

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recognized independent testing laboratory selected by agreement of the Parties and acting
as experts and not as arbitrators.

c) Should said laboratory’s testing determine that the quantity involved was defective or
non-conforming to the agreed conditions and its specifications, then its decision shall be
deemed final as to any dispute relating thereto; Subsequently in such case SUPPLIER will
bear the costs of the testing and will send conforming Products free of charge to AGENT or
credit AGENT’s account in full for the quantity involved in the dispute. AGENT shall
deliver or dispose of such non-conforming quantity at SUPPLIER’s expense in the way
SUPPLIER shall direct in writing. If the Products in dispute are determined to have been
conforming, then AGENT shall bear all costs of the independent laboratory testing and
proceed with the corresponding payment of the Products to SUPPLIER as per the agreed
payment terms.

d) All rights as aforementioned under this paragraph are subject to product control by
AGENT from the receipt of the Products.

Article 5 - Obligations/Ownership/Defects

5.01 AGENT, Its Affiliate or any Client is asked to absolutely refrain from any kind
of attempt of or communication or contacts made directly with the manufacturer of
the Product(s), since the same being contained in the Registration dossier supplied to
AGENT.

5.02 AGENT should desist from any and all kind of negotiations with the
manufacturer directly with respect to the product(s) mentioned in the Annex A and
any such products that belong to the manufacturer which may not be contained in the
given Annex A.

5.03 Infringements or litigations arising out of Patent Infringements pertaining to

the product will be liability of AGENT and in case of any litigation AGENT will
indemnify SUPPLIER.

Article 6 - Orders And Deliveries

6.01 AGENT shall give the SUPPLIER the volume commitment as specified in “Annex –
B” which may be mutually agreed by both the Parties, from time to time, over the Tenure
of the Agreement.

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6.02 AGENT shall purchase a minimum of 85% of the volume commitment as specified in
“Annex – B” for every forecasted year failing which, AGENT shall be liable to either take
possession of the Product(s) or make payment of the balance PRODUCT(S) it has failed to
purchase in the given forecasted year.

6.03 The Parties hereby agree that AGENT shall raise purchase orders to SUPPLIER for
supply of the Product as per directions contained in the said purchase orders. Purchase
orders once issued can’t be amended unless agreed to by SUPPLIER. In the event of any
ambiguity, contradiction or discrepancy between the purchase orders or other documents of
the AGENT and this Agreement, this Agreement shall prevail and be binding on the
Parties.

6.04 SUPPLIER shall use its best efforts to endeavor to supply the Product as per the
Purchase Order only after receipt of payment as specified in this Agreement. However,
should SUPPLIER, for any reason, be unable to supply in terms of the Purchase Order,
SUPPLIER shall promptly inform AGENT of the delay and use its best efforts to supply
the shortfall within a reasonable time.

ARTICLE 7 - Forecasts And Orders

7.01 Unless otherwise agreed in writing by the PARTIES, AGENT shall on a


monthly/biannually /quarterly basis provide SUPPLIER with a rolling 12-month
forecast of supply requirement of the Product. All rolling forecasts and any
updates of the rolling forecast shall be updated on a monthly basis and provided
to SUPPLIER by the 15th of the given month.

7.02 The provisions of the rolling forecast and the orders by AGENT shall be affected by
way of facsimile or email for the attention of SUPPLIER’S ordering department.

7.03 The first six months of this rolling plan will be backed by a firm purchase order for the
Product(s), valued at the agreed Supply order.

Article 8 - Force Majeure

8.01 A Party will not be liable in the event of non-performance or breach of this
Agreement resulting from any cause beyond its control, including without
limitation, war or civil war, insurrection, riots, civil commotion, acts of terrorism,
strike, lock-out, acts of nature, blockade, embargo, shortage of supplies also in
case of force majeure affecting a sub-contractor or supplier, any act of
government, any laws and regulations, difficulties to obtain raw materials or

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power supplies or equipment required to manufacture the Product, it being
understood, however that

a) The affected Party shall immediately notify the other Party of the occurrence of such
event of force majeure; and

b) The affected Party shall use its best efforts to overcome or minimize the effects of
such causes beyond its control, and shall discuss in good faith with the other Party to arrive
at an amicable solution.

Article 9 – Terms and Termination

9.01 The agreement Term will begin on the date of signature of the last party to sign and
will continue for a period of Five (5) years from the Effective date as mentioned in
the beginning of the Agreement.

9.02 Unless notice is given by either Party by registered letter twelve (12) months prior to
expiration of such term or any successive term, indicating its interest not to continue the
Agreement, it will continue in full force and effect for successive 5-year-periods. The
Agreement will be renewed for such further Term as would be mutually decided between
the Parties.

9.03 This Agreement may be terminated at any time

a) by either Party, upon breach of any of its material obligations under this Agreement
by the other Party, by sending a sixty (60) days prior written notice to the breaching Party,
notice to become effective at the end of the sixty (60) days period unless the breach is
sooner cured by the breaching Party or the breaching Party has initiated all reasonable best
efforts to cure the breach;

b) forthwith by notice from either Party to the other, if the other Party becomes
insolvent, goes into receivership, files a petition of bankruptcy or is adjudicated bankrupt or
if such Party ceases its operations for any cause; should any provision in a definition be a
substantive provision conferring rights or imposing obligations on any Party, effect shall be
given to that provision as if it were a substantive provision in the body of this Agreement;

i. any reference to an enactment, regulation, rule or by-law is to that enactment,

ii. regulation, rule or by-law as at the Signature Date, and as amended from time to
time;

iii. when any number of days is prescribed, such number shall exclude the first and
include the last day, unless the last day falls on a day other than a Business Day, in
which case the last day shall be the next succeeding Business Day;

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iv. any schedule or Annex to this Agreement shall form part of, and be deemed to be
incorporated in, this Agreement;

v. where any term is defined within a particular clause, other than the interpretation
clause, that term shall bear the meaning assigned to it in that clause wherever it is used
in this Agreement;

vi. the expiration or termination of this Agreement shall not affect those provisions of
this Agreement which expressly provide that they will operate after any such expiration
or termination or which of necessity must continue to have effect after such expiration
or termination, notwithstanding the fact that the clauses themselves do not expressly
provide for this;

vii. any reference to days (other than a reference to Business days), months or years
shall be a reference to calendar days, months or years, as the case may be; and

viii. recordals shall be binding on the Parties and are not merely for information
purposes.

9.04 Continuing Rights: Termination of this Agreement for any reason shall be without
prejudice to:

a) SUPPLIER’s right to receive immediately all payments accrued and unpaid on the
date of such termination;

b) The rights and obligations provided in Article 9 - Confidentiality Obligations.

c) Any other remedies which either Party may then or thereafter have here under or
otherwise;

d) In case of termination of this Agreement subject to Article 9.03- Term, AGENT shall
have the right to distribute its stocks of the Product existing on the date of termination in
the ordinary course of business under the prevailing price level, subject to honouring its
obligations provided for in this Agreement.

Article 10 - No Objection Certificate

10.01 In case AGENT is not able to register the SUPPLIER in Colombia for a period of
twelve (12) months even after all required documents are submitted, a No Objection
Certificate as mentioned in Annex C will be revoked.

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10.02 After registration of SUPPLIER is complete in Colombia, if order from AGENT is
not received by SUPPLIER within six (6) months, No Objection Certificate as mentioned in
Annex C will be revoked.

10.03 In case AGENT does less than 70% of volume projection as mentioned in Annex B,
SUPPLIER will reserve the right to appoint a new AGENT in Colombia.

Article 11 - Indemnification

11.01 SUPPLIER agrees to defend AGENT and its affiliates at SUPPLIER’S cost and
expense, and will indemnify and hold AGENT and its affiliates and their respective
directors, officers, employees and agents harmless from and against any and all
liability, direct losses, costs, damages, fees or expenses (including, without
limitation, reasonable attorney’s fees and expenses) hereinafter collectively referred
to as “Losses” suffered, incurred and/or paid in connection with or arising out of any
claim relating to (a) any material breach by SUPPLIER and/or of any of its
representations, warranties or obligations pursuant to this Agreement; (b) any
manufacturing defect in the Product(s) supplied hereunder while in SUPPLIER’S
possession; or (c) any gross negligence or willful misconduct of SUPPLIER and/or
its directors, officers, employees and agents in the exercise of any rights or the
performance of any of its obligations under this Agreement; provided, however, that
the foregoing indemnification obligations shall not apply to the extent such Losses
are caused by the action or omission to act of AGENT for which AGENT is required
to indemnify SUPPLIER under 10.02.
11.02 AGENT agrees to defend SUPPLIER and its affiliates, at AGENT’S cost and expense,
and will indemnify and hold SUPPLIER and its affiliates, and their respective directors,
officers, employees and agents harmless from and against any and all LOSSES suffered,
incurred and/or paid in connection with or arising out of any claim relating to (a) any
material breach by AGENT and its affiliates of any of its representations, warranties or
obligations pursuant to this agreement, (b) any alteration including adulteration of
Product(s) whilst in AGENT or its agent’s possession, (c) any damage caused to Product(s)
during their transportation, handling and storage after delivery thereof to AGENT in
accordance with the provisions of this agreement, (d) any violation of Applicable Laws by
AGENT and its affiliates in performing its obligations under this agreement; (e) any gross
negligence or willful misconduct of AGENT and its Affiliates or its directors, officers,
employees and agents in the exercise of any rights or the performance of any of its/their
obligations under this Agreement; or (f) any patent related suits or action taken against
SUPPLIER in-respect of the Product in the territory provided, however, that the foregoing
indemnification obligations shall not apply to the extent such Losses are caused by the
action or omission to act of SUPPLIER for which SUPPLIER is required to indemnify
AGENT under 10.01.

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Article 12 - Non-Assignment

This Agreement and any of the rights and obligations of the Parties hereunder cannot be
assigned or transferred by either Party, except with the prior written consent of the other
Party.

Article 13 – Confidentiality

13.01 Disclosure

After execution of this Agreement, SUPPLIER may disclose to AGENT certain


information, data, Know-how, materials, formulations, future plans, or the like. Such
information may also include technical and marketing information in relation to any
SUPPLIER product and mode and procedures of manufacture and laboratory practices and
status of facilities. The purpose of such a disclosure is to enable AGENT to evaluate the
information in order to provide consultancy support.

13.02 Form of Disclosure

All materials and know-how, which are provided by SUPPLIER and disclosures of any
information which are made whether orally or in writing or acquired by observation during
visits to SUPPLIER premises and or such other premises and or sites and or locations as
may from time to time be used and or occupied by SUPPLIER and notwithstanding
whether or not the information is termed confidential, are herewith collectively referred to
as the “Information” and made subject to the provisions hereof.

13.03 Confidentiality

In consideration of SUPPLIER disclosing Information to AGENT, AGENT shall, during


the Term of this Agreement and for a period of five (5) years from the date of termination
thereof and in accordance with the terms hereof, maintain confidential and not use, except
as contemplated herein, any Information provided by SUPPLIER or its agents. In this
regard AGENT shall disclose the information only to its officers and employees who are
directly concerned with the evaluation and use of the information for the purpose noted in
letter 12.01 as aforementioned. AGENT shall advise persons of the confidential nature of
the Information and shall take the same precautions to prevent the unauthorized disclosure
of the Information as it takes regarding its own information of similar importance.

13.04 Exceptions to Restrictions

No restrictions regarding non-use or confidentiality shall exist as to Information which:

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A) Is or becomes public or available to the general public otherwise than through AGENT’s
act or default or the acts of AGENT’s officers and employees;

B) is obtained by AGENT from a third party with the legal right to use and disclose the
same to AGENT.

C) is already known to AGENT at the time of receipt (which said knowledge shall if
requested by SUPPLIER be demonstrated to its reasonable satisfaction by AGENT) or is
subsequently disclosed to AGENT by a third party lawfully entitled to disclosure of the
same.

13.05 Return of Materials

If the parties are unable to agree on terms for the commercial development of SUPPLIER’s
Information within one hundred and eighty (180) days of the date hereof, or if AGENT
advises SUPPLIER that is not interested in doing so or if SUPPLIER expressly requests the
return of the information, then, promptly thereafter and in no event later than fifteen (15)
days after any request from SUPPLIER, AGENT shall return such Information and shall
not retain any copies, summaries, or notes thereof.

13.06 No Grant of Rights

No right or License is hereby granted to AGENT to any patent, trade secret, or other
intellectual property of SUPPLIER. Disclosure of proprietary information and materials
hereunder shall not result in any obligation to grant to AGENT any rights in or to the
property of SUPPLIER.

Article 14 - Miscellaneous

The entire Agreement between the Parties hereto is contained herein and this Agreement
cancels and supersedes all prior agreements, oral or written between the Parties hereto with
respect to the subject matter hereof. The terms hereof may not be changed or amended
except in writing and the failure by either of the Parties hereto to enforce any or all of the
provision (s) of this Agreement shall not be deemed a waiver or an amendment of the same
and shall not prevent future enforcement thereof.

Article 15 - Registration of the Products

a) AGENT shall request and pursue the registration of the Products in the Territory and
working with the relevant Health Authorities in SUPPLIER’s name. AGENT will
undertake all registration costs with Ministry of Health, Colombia including translation.

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Subsequently, AGENT shall review the dossiers submitted by SUPPLIER in relation to
Products from the point of view of their registration with the Health Authorities, and shall
inform SUPPLIER the deficiency, if any, in such dossiers. Dossier fees will be fixed at
1500 USD per product that is payable by AGENT. The same shall be reimbursed
completely against the first commercial order. Dossiers and Samples will be provided by
SUPPLIER as per the Ministry of Health, Colombia guidelines.

b) SUPPLIER undertakes to provide to AGENT all necessary documents in English as


required by the regulatory authority to enable AGENT to import and distribute the Products
in the Territory.

c) AGENT shall ensure that when any of the Products are so registered, it shall obtain an
official certificate of registration and shall immediately upon its receipt, provide copies
thereof to SUPPLIER.

d) AGENT may disclose to the Registration Authority such information concerning


Products as may be necessary for the purpose of obtaining or maintaining such registration.

Article 16 – Severability

The invalidity of one or several provisions of this Agreement does not affect the validity of
this Agreement as a whole. Instead of the invalid or not performable provisions, or in order
to fill in the gap, the parties shall agree an appropriate valid provision which, as much as
legally possible, should come closest to what the Parties hereto wanted or would have
wanted with the essence and the purpose of the Agreement if they had thought about that
shortcoming at the time of the conclusion of the Agreement or at the time of the
amendment of this Agreement.

Article 17 - Governing law / Jurisdiction

17.01 Any dispute arising out of or in connection with this agreement, including any
question regarding its existence, validity or termination shall be referred to and
finally resolved by arbitration under the Arbitration and Conciliation Act 1996 and
its Rules, which rules are deemed to be incorporated, by reference, into this
Agreement. The language to be used in the arbitral proceedings shall be in English.

17.02 Unless otherwise set forth herein, if any dispute, controversy, claim, or significant
event which is out of the control of either party arises out of or in relation to this agreement,
the parties agree to meet and to attempt to amicably settle or resolve such issue within 30
(thirty) days of a party bringing it to the notice of the other party.

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17.03 Any demand for arbitration must be made in writing to the other party.

17.04 The seat of the arbitration shall be at Mumbai, India, or such other place as the
parties may agree, in writing.

Attesting to this, the parties present to this Agreement accept the contents of each of the
clauses of this document and having read everything written in the legal framework, its
validity and its effects, both parties ratify, accept and sign the same to be executed by their
authorized representatives:

Signed beneath and executed by: Signed beneath and executed by:

For NEISS LABS LIMITED For GLOBAL MEDICAL SUPPLY S.A.S

Signed By: Signed By:

Director Gerente General

Place: Mumbai, India Place: Colombia

Date: Date:

Company Stamp/Seal Company Stamp/seal

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