[Ten Rupees Bill]
MEMORANDUM OF UNDERSTANDING
THIS AGREEMENT made at Pune this Tenth day of December 1997, between M/s
Bio-Ved Pharmaceuticals Pvt. Ltd., a company incorporated under the
provisions of the company act, 1956, and having its registered office at
6, Pradeep Chambers, Bhandarkar Institute Road, Pune 411005, Maharashtra,
hereinafter referred to as "the Company" (which expression shall unless
repugnant to or inconsistent to the context or meaning thereof the deemed,
mean and include its successors and assignees) of the ONE PART AND S.P.B.
(Inc.), a company incorporated under the provisions of the company act,
1956, and having its registered office at Maharashtra, hereinafter referred
to as "the Manufacturer" (which expression shall unless repugnant to or
inconsistent to the context or meaning thereof the deemed, mean and include
its successors and assignees) of the OTHER PART.
[Ten Rupees Bill]
WHEREAS:
A. The Company is carrying on business of manufacturing and sale of
pharmaceuticals and possesses expertise, technical know-how and
technology for the manufacture thereof;
B. The Manufacturer has represented to the Company that it has the
necessary manufacturing facilities, including that of filling,
packaging and supplying of pharmaceutical liquid with requisite
specifications of quality control as required by the Company; spare
capacity, adequate equipment and competent staff at its factory
situated at 179/2 Garmal, Vadgeon Dhayari, Sinhgad Road, Tal Haveli,
Dist. Pune 411041, has offered the same to the Company.
C. The Company is desirous of utilizing the manufacturing facilities and
the spare capacity of the manufacturer in respect of the products
listed in the "Schedule I" hereto annexed upon and subject to the
terms and conditions hereinafter appearing.
NOW IT IS HEREBY MUTUALLY AGREED TO BY AND BETWEEN the
parties hereto as follows:
I. MANUFACTURE (PRINCIPAL TO PRINCIPAL ARRANGEMENT):
i) The manufacturer will manufacture MULTICIDAL HICIDAL PERIBAN/
MICROCIDAL solely for the sale purpose to Company. The
Manufacturer shall not manufacture same product for sale to any
other buyer than the Company (Bio-Ved). The Company shall place
Purchase Orders to the Manufacturer for such products as
mentioned in 'Schedule I' hereto annexed. The manufacturer shall
manufacture such product/s as mentioned in the schedule I hereto
annexed as per
the standards and specifications specified in the 'Proposed
Manufacturing Guide' or 'Master Formula' (and currently in force)
given by the company to the Manufacturer. No deviation and/or
alterations in part or whole shall be carried out without prior
written permission of the Company.
ii) The Company shall provide the Manufacturer with Manufacturing
programme/schedule at least 6 weeks in advance and the
Manufacturer shall make available the required facilities to the
company as per the schedule previously agreed upon. The Company
agrees to purchase 30,000 units per month from the Manufacturer.
iii) The Manufacturer shall make arrangement of procuring raw and
packaging materials in advance in such a manner as to allow
sufficient time for its analysis and release for use in
manufacturing as per the schedule given by the Company. The
Manufacturer shall make arrangements to analyze all starting
materials so as to achieve production scheduled quantity on time.
iv) The Manufacturer shall make every effort to ensure delay
prevention by advance planning and shared projection. The
Manufacturer shall develop alternative sources to ensure adequate
supplies and build inventory for the purpose.
v) The manufacturer shall make adequate arrangement for storage of
raw materials, Packaging Materials, In-process goods, Finished
Product and Change-parts as per the guidelines given by the
Company.
vi) The Manufacturer shall follow and comply with all the
statutory/regulatory requirements mentioned in Drug Act 1940 and
Rules 1945 including Amendment to Drug Act 1988 - Good Mfg.
Practices (as per Schedule M and U).
vii) The Manufacturer shall document the batch details on the protocol
of Batch Manufacturing Record (B.M.R.) as provided by the Company
and arrange to send a photocopy of B.M.R. of each batch along
with the Certificate Of Analysis (COA) to the Company to obtain
their 'Release Note' before releasing a batch of finished product
for sale from the warehouse of the Manufacturer. Such a Release
note should be given within 10 days.
II. PERMISSIONS:
The Company and the Manufacturer shall obtain from the authorities
concerned and maintain from time to time and at all times during the
continuance of this Agreement all necessary permits, approvals and
licences, requisite, usual, expedient or proper in relation to or in
connection with the manufacture of the product under this Agreement.
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III. EQUIPMENT, MACHINERY AND OTHER FACILITIES:
The Manufacturer shall ensure and guarantee that adequate facilities
including power is available at all times for manufacture of the said
products as per the manufacturing schedule given by the Company. If
necessary the manufacturer shall install at its own cost generator set
for ensuring availability of power and make available all consumables
at all times.
IV. DISPATCHES:
The Manufacturer shall dispatch the finished products to locations and
parties/persons as may be intimated by the Company from time to time.
The Company shall arrange to make necessary documentations including
challans, debit notes, memos, etc. which shall accompany the goods to
various destinations. The Manufacturer thus co-operates and works
with the Company in getting necessary documentation and tapes in
place. Transportation costs including loading/unloading of goods
shall be borne by the Company. The Company agrees to lift the finished
goods within 10 days from the date of intimation by the manufacturer.
V. QUALITY ASSURANCE:
i) The Manufacturer shall analyze all the raw and packaging
materials as per the specifications provided by the Company
before using the same for manufacturing purpose. In case of any
problem of non-compliance with any of the control parameters of
specifications, the Manufacturer shall consult the Company
immediately and in such case, the Company's decision shall be
final and binding on the Manufacturer. The Manufacturer shall
keep detailed records of such analysis of RM, PM and finished
goods.
ii) The Company reserves the right to analyze independently any or
all batches of starting materials and finished product and reject
if found substandard. It also reserves the right to reject
partly or wholly the finished product based on its independent
analysis or suggest reprocessing method to be carried out by the
Manufacturer at the cost of the Manufacturer. The Manufacturer
shall ensure in such event that the agreed Production schedule is
not disturbed.
iii) The Company shall have an access to any and all documentation
pertaining to the manufacturing and testing documents of the
product including the inspection of storage conditions and Q.A.
systems. The Company may carry out an audit of the
Manufacturer's premises, systems and documents to ensure the
Quality, Purity and Integrity of the Company's products.
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iv) The Manufacturer shall arrange to hand over 'Control Samples' of
each batch of Company's products manufactured in its premises to
the Company as per the Sample quantity specified by the Company
in writing. This may include samples for stability studies. The
Manufacture shall maintain documentation records of all such
samples drawn by the Company on BMR.
v) The Manufacturer shall bear the loss of all market complaints and
credit it to the Company within 60 days from the date of
receiving complaint along with complaint sample. Alternately a
free replacement for the same quantity and pack size for market
complaints may be made by the Manufacturer.
vi) The Manufacturer shall observe the Company's authorized Standard
Operating Procedure for addition of Recovery and also for
Destruction of Non-Recoverable materials including finished
product.
VI. CHARGES:
i) Since the product is to be manufactured on P & P basis, the rates
will be mutually decided by the Company and the Manufacturer and
cost of the finished product will be reviewed and revised, if
required, after every six months starting by mutual discussion
and consent of both the parties.
ii) The Purchase Order shall accompany 50% Advance by cheque payable
at Pune. Balance against release of goods by our laboratory, by
30 days post dated cheque.
VII. DURATION:
This agreement shall commence on 10th day of December, 1997 and shall
be in force for a period of five years from that date subject to its
prior termination or determination as hereinafter provided.
VIII. RENEWAL:
This Agreement may be renewed by either party by giving to the other
three months' notice in that behalf on terms and conditions to be
mutually agreed upon.
IX. TERMINATION:
i) Either parties shall be entitled to terminate this agreement on
the happening of any of the following events -
a) If counter part commits a breach of any of the terms or
provisions of this Agreement and fails to rectify or remedy
the breach within seven days from
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the date of receipt of written notice calling upon it to do
so.
b) If the counter part goes into liquidation, voluntary or
otherwise.
c) If counter part makes any arrangement or compensation with
its creditors or if distress execution or other process of
the court is levied upon or if any encumbrancer takes
possession of or a receiver or other officer of the court is
appointed in respect of its assets or properties.
ii) Notwithstanding anything contained hereinabove and without
prejudice to the rights and remedies open, either party shall be
entitled to terminate this Agreement by giving three months'
notice to the other party. However, before the termination of
this Agreement, the parties shall discuss the cause of
termination. In such event none of the parties herein shall be
entitled to any compensation or compensation of any kind
whatsoever.
X. CONSEQUENCES OF TERMINATION:
Upon termination of this Agreement in any manner -
i) The manufacturer shall immediately discontinue the manufacture
packaging of the products.
ii) The Company shall pay and settle with the Manufacturer all the
due charges against production of bills, invoices, vouchers etc.
in respect thereof
iii) The Manufacturer shall not be entitled to any other compensation
or reimbursement of whatsoever nature.
iv) The Manufacturer shall not claim any right, title or interest in
respect of any of the trade marks of the Company whether
registered or not as well as any similar trade marks.
v) For a period of at least 10 years, the Manufacturer shall not
manufacture or produce directly or indirectly the same products
for itself or for any other person whatsoever.
XI. SECRECY CLAUSE AND UNDERTAKING:
i) The Manufacturer undertakes that it shall keep strictly secret
and confidential and shall not disclose, divulge or reveal during
the continuance of this Agreement or at any time thereafter the
know-how, formula, manufacturing process and its details or any
part disclosed or communicated by the Company to it under this
Agreement
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relating to the manufacturing or packaging of the products or
otherwise gained or acquired by virtue of or as a result of the
implementation of this Agreement to any person, firm, company,
body, corporate or authority and shall ensure that the same is
kept secret and confidential.
ii) The Manufacturer further undertakes not to manufacture/pack the
products mentioned in 'Schedule I' hereto annexed and, or
manufacture/pack or market similar products while this agreement
is in force and for at least 10 years from the termination of
this agreement for whatever reason.
iii) The Manufacturer further undertakes to take all reasonable measures
to ensure that its employees and/or personnel are responsible for
the satisfactory performance of conditions and obligations herein
including condition to preserve strict secrecy of the information
disclosed to them.
iv) The Manufacturer shall also take suitable undertakings to the
satisfaction of the Company from such employees or personnel not
to manufacture and/or market same products listed in the
'Schedule I' hereto annexed while this Agreement is in force.
XII. TRADEMARKS:
i) The Manufacturer hereby agrees forthwith upon the expiry or earlier
termination of this Agreement for any cause whatsoever or any or
all the rights or permission herein granted, to discontinue any and
every application and/or affixation whatsoever of the said trade
mark "MULTICIDAL/HICIDAL/PERIBAN/MICROCIDAL" and/or any other
trade mark of "MULTICIDAL/HICIDAL/PERIBAN/MICROCIDAL" in
connection with any goods, products, service or business or trade
as also of any other word, name, logo, device, alphabets, script or
language so closely similar in sound, appearance or meaning to the
trade mark "MULTICIDAL/HICIDAL/PERIBAN/MICROCIDAL" words, names,
logos or devices whether applied and/or affixed separately or in
conjunction or juxtaposition with or to the said trade mark or any
other trade mark as to be likely to cause confusion or deception or
to detract from or adversely affect the right, title or interest of
the Company in or to any other trade mark.
ii) The Manufacturer further agrees and undertakes that upon the
termination of this Agreement, it will not directly or indirectly
represent or describe or cause to be represented or described on
any labels, advertising materials, circulars or in any other
manner whatsoever that represents that Manufacturer was formerly
manufacturing the said goods under the said trade mark of the
Company and/or any other trade mark of the Company.
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iii) Upon the termination of this Agreement for any reason whatsoever
the Company shall purchase from the Manufacturer all the said
goods which are in the possession, custody or control of the
Manufacturer and which are in a good and saleable condition by
paying to Manufacturer the prices agreed under this Agreement.
XIII. INSURANCE
The Manufacturer shall insure all the raw materials and packaging
materials, finished products and stock in process to its own account.
The Company shall render the necessary documents in connection
therewith.
XIV. JURISDICTION
This Agreement shall be deemed to be an Agreement made in Pune and the
jurisdiction of Courts other than in Pune is hereby excluded by the
consent of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have these presents the day and year
first hereinabove written.
SIGNED AND DELIVERED BY SIGNED AND DELIVERED BY
within named "The Company" within named "The Manufacturer"
For Bio-Ved Pharmaceuticals Pvt. Ltd. For S.P.B. (Inc.)
S/ AJIT P. CHITRE S/ MANEESH SAPTE
Mr. Ajit P. Chitre Mr. Maneesh Sapte
Director (Operations) Partner
in the presence of in the presence of
Mr. R. Ramakrishnan Mr. Mahesh Belvalkar
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