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BY AND BETWEEN
AND
PT. Harsen as manufacturer, having its registered office at Jl. Raya Bogor KM 24,6,
Jakarta Timur – 13750, Indonesia represented by PT. Yafefa Primarta as distributor,
having its registered office at Perkantoran Taman Kebon Jeruk Blok A4 No.39,
Meruya Selatan, Jakarta Barat – 11650, Indonesia. The companies incorporated and
existing under the laws of Indonesia, hereinafter referred to as “Distributor” of the
Other Part.
Both JMB and the Distributor shall hereinafter be collectively referred to as “Parties”
and individually as a “Party”.
WHEREAS:
A. The JMB has access to market information and expert knowledge and
experience of business practices in relation to the registration, import,
distribution and marketing of pharmaceutical Products within the Territory.
1. GRANT OF LICENSE
2.2 Sub-licenses: The JMB shall not (and shall ensure that its Affiliates shall
not) grant sublicenses of the licenses granted under this Agreement, to any
agents, marketing partners and/or distribution partners or its Affiliates or any
other third party in the Territory, without the prior written consent of Distributor.
2.3 No Other Rights and Licenses: Except as explicitly set out in this
Agreement, PT. Harsen shall be and remain the sole owner of its Intellectual
Property Rights. No rights in and to any Intellectual Property Rights are granted
or assigned under this Agreement.
2. DOSSIER
3.1 Restrictions of Use: Except as set out otherwise in this Agreement, JMB shall
not (and shall ensure that its Affiliate shall not, if applicable), use the Dossier to
apply for more than one Marketing Authorization in the Territory or to apply for
any Marketing Authorizations for the Products outside the Territory.
3.2 Delivery, Format and Quality of the Dossier: Distributor shall provide to JMB
with a copy of the Dossier in English. The Dossier delivered to the JMB shall:
3. REGISTRATION PROCEDURE
4.1 Registration Procedure: JMB shall be solely responsible to file the Dossier in
the Territory and shall bear all costs, expenses, and obligations associated with
such filing and maintenance. Provided however, that any such costs (per
actuals) and expenses (which expenses shall be subject to a cap as
determined by Distributor in its sole reasonable discretion and communicated
to JMB from time to time) associated with such filing and maintenance shall be
reimbursed by Distributor on receipt by original invoices in respect of such
costs and expenses.
4.3 Shelf Life: A shelf life of five years (5 years) is expected to be approved in the
Registration Procedure.
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4.4 Stability Studies: Distributor shall conduct stability study for the Products and
shall keep the documentation as required by the Regulatory Authorities.
4.5 Regulatory Support: Distributor shall provide to the JMB all necessary support,
if applicable, for the filing of the Dossier and maintenance of the Marketing
Authorization in the Territory throughout the Term of this Agreement as long the
JMB sources the Products from Distributor. Distributor will provide JMB all
other information, documents, materials and assistance as reasonably required
by the Regulatory Authority for the purpose of maintaining the Marketing
Authorization in the Territory throughout the Term of this Agreement.
4.6 Registration Costs: Subject to Section 4.1 above, JMB shall bear all regulatory
fees charged by the Regulatory Authorities for the Registration Procedure and
associated maintenance fees of the Marketing Authorization in the Territory.
5.3 JMB shall obtain the Marketing Authorization for the Products within 3 (three)
months from the Effective Date.
5.4 JMB shall be solely responsible for the submission of the Dossier and follow-
up of the applications for Registration in the Territory. JMB shall be
responsible for payment of the Regulatory Expenses for obtaining and
maintaining the Registrations.
5.5 With respect to the rights granted in this Article, JMB agrees and undertakes
during the Term of this Agreement:
a. to abide by all the terms and conditions of the Registrations and all
other requirements of the Regulatory Authority for the purpose of
promoting, marketing, distributing and selling the Products in the
Territory;
b. not to allow any cross referral application of, or to transfer, sub-license
or assign the Registrations to any third party;
c. not to permit by any means any third party to have access to, or the
authority to use, the Registrations without Distributor’s prior written
approval;
d. not to transfer, license, sublicense, assign, sell or in any manner make
otherwise available the Registrations, Dossier or any other
Registration documentation nor any part of it, if in its possession, nor
disclose any Confidential Information or any right granted under this
Agreement to any third party without previous written consent from
Distributor; and
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e. to immediately inform Distributor in detail of all pending or threatened
litigation, governmental investigation, proceeding or action involving
Registrations.
5. TERM
6.1 This Agreement shall come into effect from the Effective Date and shall be
valid for a period of 5 (five) year from the Effective Date (“Term”) subject to
earlier termination in accordance with the terms of this Agreement. This
Agreement may be renewed under such terms and conditions as maybe
agreed upon by the Parties in writing.
7.2 Forecasting:
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shall be updated quarterly at least thirty (30) days prior to the
commencement of each calendar quarter.
b. JMB agrees to submit Purchase Orders to Distributor for the quantities
of the Products set out in the Binding Forecast.
7.3 Ordering:
8.2 Distributor shall deliver the Products to the Delivery Destination by sea on
FOB, Incoterm 2010 basis.
8.3 Responsibility for the Products, as well as risk of loss or damage to the
Products shall pass to JMB at the Delivery Destination. The JMB shall be
responsible for holding, insuring, transporting, and delivering the Products
from the Delivery Destination and shall keep the Products properly stored,
protected, and insured as per current good manufacturing practices (cGMP)
and the Applicable Law.
8.4 If Distributor is unable to deliver the Products within 180 (one hundred and
eighty) business days from the Delivery Date, Distributor shall notify JMB as
soon as possible its inability to deliver the Products. Further the Parties will
decide and fix up a new revised delivery schedule.
9.2 Any change that will affect the Dossier, including any intended change in
manufacturing site or change in process which may have an effect on the
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Specifications, quality or regulatory status of the Products shall be intimated
by Distributor to JMB.
10.1 Visual inspection claims: Immediately after delivery of any shipment of the
Products, JMB shall inspect the quality and quantity and conduct a visual
inspection of the Products. Complaints regarding the quality and quantity that
could be reasonably observed by visual inspection shall be reported to
Distributor in writing, immediately after their discovery but not later than 7
(seven) days from the arrival of the Products at Delivery Destination. If within
this period, the JMB has not informed Distributor of any complaints regarding
the quantity of the Products or quality that reasonably could be observed by
such visual inspection, the Products shall be deemed to be accepted by the
JMB. All claims shall be accompanied by proof of non-conformity to the
Specifications.
10.2 Quality related claims: If the Products do not conform to the Specifications,
JMB shall specify to Distributor in writing within 7 (seven) days from receipt of
the Products at the Delivery Destination, the reasons for which the Products
are found unacceptable. All claims shall be accompanied by proof of non-
conformity to the Specifications.
10.4 No such claim shall affect payments that are due in respect of other Products
under this Agreement.
10.5 If a claim made by JMB pertaining to the quality of the Products is not
accepted by Distributor, the Parties shall use Commercially Reasonable
Efforts to resolve such dispute and if the Parties fail to agree, within 90
(Ninety) days from the date of receipt of notice by Distributor, the dispute shall
be referred to an Independent Laboratory for evaluation, and the decision of
the Independent Laboratory (WHO Certified Lab) shall be final and binding on
the Parties. The Independent Laboratory shall act as an expert and not as an
arbitrator and its fees shall be borne by the Party against whom the decision
is given. If the analysis of the Independent Laboratory holds that the Products
have a proven manufacturing defect, Distributor shall at its own option either
(i) replace the defective quantity of the Products or (ii) credit the Distributor’s
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account for the defective quantity of the Products. If the analysis of the
Independent Laboratory finds no defect in Products from Distributor, then
expense shall be borne by JMB.
10.6 Both Parties acknowledge that in case where replacement delivery is provided
to the JMB, the Delivery Date of the future Confirmed Purchase Orders will be
rescheduled by Distributor.
10.7 The JMB shall take care to store the Products in storage facilities adapted to
pharmaceutical preparations, in compliance with local legal requirements and
in correspondence with the Specifications.
11.1 Anti-Diversion Program: JMB shall provide Distributor with a written notice
eight (8) months prior to its anticipated first sale of Products in the Territory.
Following Distributor’s receipt of such notice, the Parties shall discuss in good
faith programs that JMB may implement to minimize diversion of Products
outside the Territory, including by using commercially reasonable efforts in
ensuring Products are sold direct to patients within the Territory, as may be
determined by the Parties. If requested by Distributor at any time either prior
to Distributor’s sale of the Products in the Territory or at any time thereafter,
the Parties shall discuss and agree upon a written anti-diversion plan that
JMB shall implement to ensure that the Products are not diverted out of the
Territory (“Anti-Diversion Plan”). Distributor shall have the right to prohibit
Distributor’s sale of the Product, if it reasonably believes that material
quantities of the Products are being sold, transferred or otherwise diverted
from the Territory to another country or territory by providing written notice
thereof to JMB (“Diversion Notice”). Except as may be necessary for
patients within the Territory who have previously initiated their treatment with
the Products to complete such treatment, upon JMB’s receipt of a Diversion
Notice, the Distributor shall immediately cease all sales of Products in and
imports of Products to such other country or territory that is covered by such
Diversion Notice until such time that JMB and Distributor have developed an
Anti-Diversion Plan for such country or territory. JMB shall not enter into any
contractual arrangements or commitments that would prevent it from fulfilling
its obligations under this Clause.
11.2 The JMB will distribute the Products in the Territory and promote sales of the
Products throughout the Territory using Distributor’s Trademarks. The JMB
shall maintain an active sales organization with trained personnel capable of
competently dealing with the promotion of the Products in the Territory and
enabling the JMB to carry out its obligations under this Agreement.
11.3 The Parties will keep each other informed throughout the duration of the
Agreement of circumstances important for marketing the Products and will
exchange information on these matters throughout the Term.
11.4 The JMB shall be responsible for advertising and promoting the Products in
the Territory and shall ensure that any advertising materials and promotional
literature relating to the Products shall comply with all Applicable Law and
Registration.
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11.5 JMB shall not use JMB’s Trademarks, except for distribution, sale and
marketing purposes in relation to the Products and solely for the purposes of
performing its obligations under this Agreement. JMB shall:
11.6 The Trademarks in relation to the Products are the sole property of Distributor
and the JMB shall have no right to grant or transfer rights of any nature in the
Trademarks to any other party. JMB shall not purport to be the proprietor of
Distributor Trademarks. JMB’s rights to use Distributor’s Trademarks as
stated above shall expire with the expiry or earlier termination of this
Agreement.
11.7 JMB shall not repackage or tamper with the Products in any manner, without
obtaining prior written consent from Distributor and shall ensure that the
packaging, package inserts, marketing, promotion and sale of the Products
complies with the conditions and requirements of the Registration and the
relevant Regulatory Authority and all Applicable Law in the Territory.
11.8 JMB agrees that it shall take prior written consent from the Distributor before
participating and also before accepting any tenders offered by the Ministry of
Health in the Territory or any other tenders in respect of supply of the Products.
JMB shall provide Distributor with copies of the tender documents and all
other documents that Distributor may require regarding such tenders before
accepting any such tenders. JMB shall from time to time keep Distributor
informed about the anticipated demand of the Products in the Territory.
11.9 JMB shall immediately furnish copies of previous tender details to Distributor,
upon receipt of request from Distributor.
11.11 JMB shall take care to store the Products in storage facilities adapted to
pharmaceutical preparations, in compliance with local legal requirements and in
correspondence with the Specifications. JMB agrees that to avoid any potential
contamination of a Product from any other products or materials, it shall
properly handle and store the Products in compliance with cGMP requirements.
11.12 JMB shall render assistance including but not limited to regulatory assistance,
submission of the tender quotations on behalf of Distributor to the Regulatory
Authority and other tender bodies and further co-ordinate with such Regulatory
Authorities on behalf of Distributor as and when requested by Distributor.
11.13 JMB shall render assistance and provide access to Distributor to all the
documents including but not limited to the retention fees, Registration status,
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manufacturing site approvals and other information filed with the Regulatory
Authority.
12.2 Adverse drug reactions or adverse events associated with the use of any of
the Products, that come to the attention of JMB from any source including, but
not limited to, healthcare professionals and members of the public, must be
reported to Distributor immediately but no later than twenty four (24) hours of
JMB becoming aware of the adverse drug reaction or adverse event. To the
best of its ability, Distributor will provide assistance as and when required in
connection with these adverse drug reaction or adverse event.
12.3 Should JMB become aware of safety-related issue with the Products (such as
safety related product recall, any restriction on use of the Products in the
Territory where the Products are sold, obvious need to take risk minimizing
steps due to adverse reactions such as change of the label, Product
information, doctor letters, public warnings and similar), Distributor shall be
immediately alerted by the JMB.
12. RECALLS
13.1 If a Party wishes to initiate Voluntary Recall, such Party will provide the
other Party written notice of its intention to conduct or request a Voluntary
Recall of that quantity of the Products and specify its reasons.
13.2 If within thirty (30) days of the receipt of the notice, the Parties are unable
to agree upon the need to carry out the Voluntary Recall, the Parties agree to
submit a sample of the Products to an Independent Laboratory, which will
determine if there is any inherent proven manufacturing defect in the Products
and if so, the cause(s) of the defect. The cost of the report of the Independent
Laboratory will be paid by the Party against whom the decision of the
Independent Laboratory is given.
a. JMB will notify Distributor of the Mandatory Recall within two (2) days
of receiving notice from the relevant Regulatory Authority or any other
government agency; and
b. any Party may request the submission of a sample of the Products to
an Independent Laboratory, which will determine if there is any
inherent proven manufacturing defect in the Product or Products and if
so, the cause(s) of the defect. The cost of the report of the
Independent Laboratory as well as the Recall expenses will be paid by
the Party against whom the decision of the Independent Laboratory is
given. In case the defaulting Party is undetermined, the Parties shall
split such expenses equally.
13.4 In each case, the determination of the Independent Laboratory will be final
and binding on the Parties.
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13.5 Where the analysis of the Independent Laboratory confirms that the
cause or reason for any recall of the Products is due to a
manufacturing defect, Distributor shall be responsible for replacing the
recalled Products with new Products which meet the specification as
per term and agreement. The quality of the Product can be verified
through Independent Laboratory.
14.2 JMB agrees and confirms that it does not have and shall not have in the
future on expiry or termination of this Agreement any right, title, or interest in
any of the Intellectual Property Rights of Distributor in respect of the Products.
Both Parties agree that the Registration with respect to the Products
registered with the Regulatory Authority is the sole property of Distributor, and
JMB has no right to claim any rights to the same in respect of the said
Products or to transfer or license or sub-license any right to any third party,
person, firm, company or association.
14.3 JMB expressly acknowledges and agrees that subject to the rights granted
herein, all Intellectual Property Rights and the like, developed, conceived, or
reduced to practice pursuant to the terms of this Agreement and all
Intellectual Property Rights therein and thereto shall be owned exclusively by
Distributor. Notwithstanding the foregoing, all technology that is applicable in
the manufacture of the Products shall be owned exclusively by Distributor.
14.5 The Parties hereby agree that unless otherwise specifically provided herein or
unless permitted by either Party in writing, this Agreement does not constitute a
transfer of any Intellectual Property Rights belonging to either Party and does
not permit or allow the other Party to translate, disassemble, reverse engineer,
decompile, license, commercialize, or register or use in any other way any
Intellectual Property in respect of the Products including its documentation, nor
have such work carried out by third parties.
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14.6 If JMB becomes aware of a patent or other third party Intellectual Property
Rights in the Territory which may be potentially infringed by or infringing the
Products (including the packaging of the Products), its formulation, use or
process of manufacture, or receiving a notice alleging such infringement, then
JMB will forthwith notify Distributor.
14.7 JMB acknowledges that Distributor shall not be responsible for any third party
claims of Intellectual Property Rights including any patent infringement in the
Territory including in the transit route of the shipment. JMB acknowledges that
the decision to market the Products in the Territory is based on the JMB’s
study of Intellectual property Rights in the Territory and in the transit route of
the shipment.
15.1 The Price of the Products is based on the delivery of the Products at the
Delivery Destination. JMB shall make all the payments to Distributor in United
States Dollars (USD).
15.2 The Price of the Products shall be under FOB (Jakarta- Indonesia). JMB shall
be responsible for the remittance and payment of any or all taxes, charges,
levies, assessments and other fees of any kind imposed by government or
any other authority in the Territory in respect of the purchase, importation and
sale of the Products.
15.3 For the payment of goods below US$ 25,000 JMB shall make the payment for
the Products T/T full in advance, For the payment more than US$ 25,000, JMB
shall make the payment for the Products on irrevocable 30 days usance Letter
of Credit after Bill of Lading (B/L) date (“Payment Due Date”) opened by a first
class Indian Bank and acceptable in normal course by a bank in Indonesia. If
JMB fails to do so on or before the Payment Due Date, in addition to other rights
and remedies available to Distributor, JMB shall be liable to pay interest at a
rate of 18% per annum on a pro rata basis, till the actual receipt of payment by
Distributor.
15.4 The price and terms and conditions for the tenders in which JMB participates
shall be as established by Distributor from time to time. Upon receiving the
tender documents, Distributor shall quote the price of the Products in writing
and JMB shall apply for such tenders only in accordance with prices, terms
and conditions as directed by Distributor.
15.5 Within thirty (30) days after the end of each calendar quarter, JMB shall
provide Distributor with a detailed report (“Quarterly Report”) that includes
the following information:
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a. Quantifies of the Products supplied by Distributor to JMB;
b. Quantities of the Products sold by JMB to any third party;
c. Gross Sales (which will be calculated as price per unit multiplied by
the total units sold);
d. Net Sales (detailing any deductions, on a strength-by-strength basis);
and
e. Such other information concerning the Products as Distributor may
require from time-to-time.
15.6 Review of Price: If during the Term of this Agreement, there is any change in
the Applicable Law or demonstrable increase or decrease in manufacturing
costs of the Products (including but not limited to API, raw material, labour,
overheads, transportation, currency fluctuations in market prices), the Party
initiating the price revision shall provide a notice to the other Party and
thereafter the Parties shall renegotiate in good faith the prices of the affected
Products. The Parties shall agree in writing the revised Price within thirty (30)
days from the receipt of Price revision notice.
15.7 JMB shall not be entitled by reason of any set-off, counter-claim, abatement,
or other similar deduction to withhold payment of any amount due to
Distributor.
15.8 Title to the Product shall remain to Distributor and shall not pass to the JMB
until the JMB pays in full for such Products. Distributor reserves the right to
repossess Products for any reason where full payment for such Products
have not been received by Distributor.
15.9 JMB hereby undertakes to ensure at all times that it shall pay all sums owed
to Distributor under this Agreement.
15.10 If JMB fails to pay in the manner specified above for the Products ordered,
Distributor shall be entitled at its discretion (without prejudice to any other
right or remedy it may have) to:
15. CONFIDENTIALITY
16.1 Confidential Information: During the Term and continuing thereafter, all
Confidential Information received by JMB shall be kept confidential and shall
not be disclosed to third parties or used for any purpose, other than as
authorized by this Agreement. JMB shall disclose Confidential Information
only to those of its employees, directors and officers who may need to know
the Confidential Information for the purposes contemplated in this Agreement,
and who agree to keep such information confidential under the confidentiality
terms similar to those mentioned in this Agreement, and shall be treated by
JMB in such a way as to prevent unauthorized use or unauthorized
disclosure. The obligations of confidentiality and non-use specified herein
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shall remain in force during the Term of this Agreement and thereafter for as
long as the information is not part of the public domain by reasons other than
by unauthorized act or omission by the JMB or breach of this Agreement.
Information shall not be deemed to be in the public domain merely because it
may be derived from one or more items publicly known. The obligations of
JMB described in this Article shall not apply to information that:
16.2 Required Disclosure: If JMB is required under Applicable Law, by any court or
to any governmental authority to disclose Confidential Information, JMB shall
endeavor to give reasonable notice, prior to such disclosure, and notify
Distributor of such requirement and all particulars related to such
requirement. Distributor shall have the right, at its expense, to object to such
disclosure and to seek confidential treatment of any Confidential Information
to be so disclosed on such terms as it shall determine, and JMB shall fully
cooperate with Distributor in this regard.
16.3 Return of Confidential Information: This Agreement does not constitute the
conveyance of ownership with respect to any Confidential Information. Upon
the expiration or termination of this Agreement for any reason or upon request
of Distributor, JMB agrees to return to Distributor all documentation or other
tangible evidence or embodiment of Confidential Information belonging to
Distributor within fifteen (15) days from the date of such termination or
expiration or upon request by the Disclosing Party and not to use the same.
17.1 It is duly organized and validly existing and in good standing under the laws of
the Territory and its jurisdiction of incorporation. It has the requisite corporate
power to conduct its business as envisaged under this Agreement and is not
prohibited by Applicable Law from entering into this Agreement.
17.2 The execution, delivery, and performance of this Agreement do not and will
not violate (i) the incorporation document in JMB’s country of incorporation, or
(ii) any provision of any agreement or other instrument or document to which
JMB is a party or by which any of its assets or properties is bound or affected.
17.3 It has full authority to enter into this Agreement and that as of the date of this
Agreement, there are:
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a. no actions, suits or proceedings pending or threatened in writing
against JMB for the Product; or
b. no circumstances which might give rise to such actions, suits or
proceedings; or
c. no third party rights that would adversely affect performance by the
JMB of its obligations under this Agreement.
a. will not be committing breach of any agreement with any other party
and Distributor shall not be responsible to any third party or agencies
for the breaches or violations, if any are committed by JMB; and
b. it is under no obligation, contractual or otherwise, to any other person,
institution or other entity that would interfere with the performance of
the Agreement.
17.5 To the best of JMB’s knowledge, JMB has disclosed to Distributor all data and
other information that could reasonably be considered material to the safety
or efficacy of the Products or for Distributor to perform its obligations under
this Agreement.
17.7 It has and shall comply with all the Applicable Law and the fulfillment of the
terms and conditions of this Agreement.
TERMINATION
Each Party shall have the right to immediately terminate this Agreement in its
entirety upon giving written notification to the other Party if the other Party has
committed a material breach of this Agreement and the breaching Party does
not rectify such breach within the notice period of thirty (30) days from the
date of notice of such breach. Such termination shall be without prejudice to
any other remedy which the non-breaching Party may be entitled to. The
failure of either Party to terminate this Agreement for breach of any conditions
or covenant shall not affect its right to terminate it for subsequent breaches of
the same or other conditions or covenants.
Either Party may terminate this Agreement in its entirety with immediate effect
upon delivering a written notice to the other Party if other Party enters into
insolvency or is unable to pay its debts on the due dates, or a receiver (or
administrator or equivalent) is appointed for any of the other Party’s assets, or
if the other Party takes or suffers any similar or analogous action as a
consequence of debts, or if any Party files a petition against other party in
bankruptcy, or other party is adjudged a bankrupt, or a petition in bankruptcy
is filed against it and is not dismissed within thirty (30) days, or if the other
Party discontinues its business.
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Distributor may at its sole discretion terminate this Agreement in whole or in
part with respect to any Product, at any time upon prior written notice to the
JMB in one or more of the following events:
FORCE MAJEURE
The occurrence of a Force Majeure Event shall extend the period for the
performance of the obligations for the period equal to the period(s) of any
such delay; provided that such Party shall continue to perform to the extent
feasible in view of such Force Majeure Event; and provided further, that if
such Force Majeure Event shall continue for a period of three (3) months, the
Party that is not subject to the Force Majeure Event shall have the right to
terminate this Agreement immediately upon written notice of thirty (30) days
to the other Party.
Notwithstanding the above, the JMB shall in no event be excused from the
payment obligations, which have become due to Distributor.
MISCELLANEOUS
Assignment JMB shall not without the prior written consent of Distributor,
assign, transfer, charge any of its rights, powers, obligations or duties under
this Agreement or purport to do any of the same.
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Freedom to contract: The Parties declare that they have the right, power and
authority under law and have taken all actions necessary to execute, deliver
and to exercise their rights and perform their obligations under this
Agreement.
Waiver: The failure of a Party to exercise or enforce any right/s under this
Agreement shall not be deemed to be a waiver of that right (or rights) nor
operate to bar the exercise or enforcement of it at any time thereafter.
Notice:
All notices provided under this Agreement shall be in writing and signed by or
on behalf of the Party giving it and may be served by delivering it personally
or sending it by pre-paid recorded delivery or registered post to the address
and for the attention of the relevant Party. Any such notice shall be deemed to
have been received:
- in the case of personal delivery, at the time of delivery;
- in the case of registered airmail, pre-paid recorded
delivery or registered post, at the time of receipt;
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Annexure A
List of products
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Annexure B
Minimum Price
Brand Pack
S.No. Generic Name Batch (USD)
Name Size
Size
1.
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Annexure C
Congo
_________________________
Name: Benno John
Title: Director
Annexure E
Territory
1.
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