Exhibit 10.10
AGREEMENT
THIS AGREEMENT made at Pune this l0th day of October 1997, between M/s
Bio-Ved Pharmaceuticals Pvt. Ltd., a company incorporated under the
provisions of the Company Act, l956, and having its registered office at
Office No. 6, Pradeep Chambers, Bhandarkar Institute Road, Pune 411 005,
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
Eisen Pharmaceutical Co. (Pvt.) Ltd., a company incorporated under the
provisions of the Company Act, 1956, and having its registered office at
34/7, Erandavana, Pune 411 004, Maharashtra, hereinafter referred to as "the
Manufacturer" on loan license basis (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.
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 capsulation and packaging as
per the requisite specifications of quality control as required by the
Company, spare capacity, adequate equipment and competent staff at its
factory situated at 34/7 Erandavana, Pune 411 004, has offered the same
to the Company.
C. The Company is desirous of utilizing the manufacturing facilities and the
spare capacity of the manufacturer to manufacture ARTREX 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 (LOAN LICENSE ARRANGEMENT):
i) The Manufacturer shall manufacture at its factory situated at
34/7,Erandavana, Pune 411 004, for and on behalf of the Company the
product ARTREX as per the orders placed by the Company in terms of
this agreement as per the standards and specifications and the
Quality Assurance requirement as specified in the "Proposed
Manufacturing Guide" or "Master Formula" given by the company (and
currently in force) to the Manufacturer. No deviation and/or
alterations in part or whole from standards shall be carried out
without prior written permission of the Company.
ii) The Company shall provide the Manufacturer with manufacturing
program/schedule at least Eight weeks in advance and the
Manufacturer shall make available the required facilities to the
company as per the schedule previously agreed upon.
iii) The manufacturer shall make adequate arrangement for storage of raw
materials, packaging materials, required for maximum one and half
month's production, requirement in-process goods, finished product
and change-parts as per the guidelines given by the Company.
iv) The Company shall make arrangement of procuring and supplying raw
and packaging materials to the Manufacturer 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.
v) 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 Manufacturing Practices
(as per Schedule M and U).
vi) The Manufacturer shall document the batch details on the protocol of
Batch Mfg 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.
vii) The Manufacturer shall furnish to the Company every month a
statement in the standard format given by the company showing
therein.
a) quantities of raw materials including the packaging materials
received from the Company and for the Company's suppliers
during the preceding English calendar month.
b) quantities of raw and packaging materials actually used and in
process by the Manufacturer during the preceding English
calendar month
c) quantities of raw and packaging materials and finished products
in stock at the beginning and end of each English calendar
month.
d) quantities of raw and packaging materials in process at the
beginning and end of each English calendar month.
e) quantities of finished products manufactured and supplied to
the Company.
viii)It shall be the duty of the manufacturer to keep the raw and
packaging materials and finished products under proper and adequate
storage conditions.
ix) The manufacturer shall take adequate steps to securely and safely
store the raw packaging, in-process and finished goods. However,
the manufacturer shall not deal with or dispose off the same or any
part thereof without prior written consent of the Company.
II. PERMISSIONS:
i) 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
licenses, requisite, usual, expedient or proper in relation to or in
connection with the manufacture of the product under this Agreement.
ii) The Company shall obtain the necessary licences under the Drugs and
Cosmetics Act, 1940 and the rules framed thereunder and wherever
Manufacturer is required to obtain any licences, approvals or
permissions viz. loan licences under the said Drugs and Cosmetics
Act and the rules or under any other law, Central or State, the
Company shall render to the manufacturer all possible assistance in
this regard and shall obtain wherever necessary in their name the
requisite permissions, approvals or licences.
III. EQUIPMENT, MACHINERY AND OTHER FACILITIES:
The Manufacturer shall ensure and guarantee that adequate facilities
are available at all times for manufacture of the said products as per
the manufacturing schedule given by the Company.
IV. RAW & PACKAGING MATERIALS & FINISHED PRODUCTS:
The Company shall supply to the Manufacturer the necessary raw
materials including packaging materials for the manufacture and
packing of the products under this Agreement as listed in "Schedule I"
hereto annexed which the Manufacturers shall manufacture as per the
specifications provided by the Company and supply the same to the
Company.
V. INDEMNITY & COMPENSATION FOR LOSSES ETC.:
i) In the event of all or any of the said raw and/or packaging
materials, semi-finished goods or finished goods,
stock-in-process are lost due to thefts the Manufacturer shall be
liable to reimburse to the Company such costs. However, the
company shall arrange for the insurance cover for all materials
supplied and kept in storage.
ii) If the Manufacturer contravenes any provisions of any Acts, Rules
or Regulations or the conditions of the loan licences or commits
breach of any other terms and/or conditions of this Agreement as
a result of which the Company incurs or suffers any loss, damage
or expense, the Manufacturer shall fully indemnify and keep
indemnified the Company of and from the same.
VI. RAW MATERIALS, FINISHED PRODUCTS AND CHANGE-PARTS TO BE HELD IN TRUST:
It is hereby agreed and declared that the raw materials to be supplied
by the Company to the Manufacturer are intended solely for the purpose
of being utilized in the manufacture or processing of ARTREX ordered
by the Company and for no other purpose and consequently the said raw
materials and/or the finished product resulting therefrom as well as
packing materials supplied to the Manufacturer and finished product
resulting therefrom shall be the property of the Company and be held
by the Manufacturer in trust for the Company and for the purpose of
being delivered to the Company.
VII. DISPATCHES:
The Company will lift the finished goods after paying the necessary
taxes/ duties etc. For this purpose the Manufacturer will make the
necessary documentations (including challans, debit notes, memos,
etc.) which shall accompany the goods to various destinations.
Transportation costs including loading/unloading of goods shall be
borne by the Company.
VIII. 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
conveyed to the Manufacturer in writing and will be final and
binding on the Manufacturer.
ii) The Company reserves the right to analyze independently any or
all batches of starting materials 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. In an event of reprocessing, the Company shall bear
the reprocessing charges.
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 product
/ s.
iv) The Manufacturer shall arrange to hand over "Control Samples" of
each batch of ARTREX 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 Manufacturer
shall maintain documentation records of all such samples drawn by
the Company on BMR.
v) The Company shall make payment for the analytical charges as per
the quotation given by the Manufacturer and given here in
SCHEDULE II within one week after the receipt of the invoice.
vi) The norms for material loss in handling and processing shall be
as under (based on an average of 6 months' production):-
Active raw materials : Not more than 2 %
Excipients : Not more than 0.5 %
Packaging materials : Not more than 3 %
vii) The yield of Finished Products of the first 10 production batches
ready for dispatch after setting aside analytical and retention
samples, will be validated mutually by Manufacturer and the
Company and revised if necessary based on the trend analyst.
viii) 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 time.
IX. CHARGES:
i) For carrying out the manufacturing of the products and other
obligations herein contained satisfactorily, the Company shall
pay to the Manufacturer, charges at the rates per product
mentioned in the "Schedule II" hereto annexed.
ii) The Manufacturer shall submit its debit notes immediately after
completion of the analysis of material/finished products. These
charges of the finished products, shall be payable, regardless of
whether they are lifted or not by the Company when the
Manufacturer had kept them ready for dispatch after compliance of
all the necessary procedures and formalities. The Manufacturer
shall not be entitled to any other payment except charges
referred to above and other duties payable in terms of Clause X
hereunder. The Manufacturer shall bear the necessary tax
deductions at source (T.D.S.) which are applicable and the
Company will issue a certificate in respect of the same.
EXCISE DUTIES & OTHER LEVIES:
i) The Company shall bear and pay excise duties, if any or any
other taxes, levies, etc., imposed in respect of the said
product. The Manufacturer shall maintain, keep and make available
to the Company all such records and documents that may be
required in connection therewith.
ii) The Manufacturer shall bear and pay all other taxes, duties,
assessments, etc. applicable under Loan-License arrangement to
them.
XI. DURATION:
This agreement shall commence on 10th day of October, 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.
XII. 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.
XIII. TERMINATION:
i) Either party 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 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 incumbrancer 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 herein above and without
prejudice to the rights and remedies upon, 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 payment of any kind whatsoever
except as provided in Clause XIV herein after.
XIV. 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 manufacturer shall immediately return to the Company all raw
and packaging materials and the finished goods and stock in
process along with the requisite statements after full settlement
of accounts.
iii) The Company shall pay and settle with the Manufacturer all the
due charges against production of bills, invoices, vouchers, etc.
in respect thereof.
iv) The Manufacturer shall not be entitled to any other compensation
or reimbursement of whatsoever nature.
v) The Manufacturer shall not claim any right, title or interest in
respect of the trade marks of ARTREX whether registered or not as
well as any similar trade marks of the product ARTREX.
vi) For a period of at least 10 years, the Manufacturer shall not
manufacture or produce directly or indirectly the same product
for itself or for any other person whatsoever.
XV. SECRECY CLAUSE AND UNDERTAKING:
The Manufacturer undertakes that it shall keep directly 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 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 strictly secret and
confidential.
i) The Manufacturer further undertakes not to manufacture/pack
ARTREX or the product with the same composition and formulation
of ARTREX while this agreement is in force and for at least 10
years from the termination of this agreement for whatever reason.
The Company is aware that Manufacturer has its own products
"Articulin and Articulin Forte" which are marketed by the
Manufacturer for more than last eight (8) years and both the
parties have no objection for the same. It is expressly agreed
and understood by and between the parties that the aforesaid
stipulations shall not apply to "Articulin" and "Articulin Forte"
which are already being manufactured by the manufacturer.
ii) 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.
XVI. TRADE MARKS:
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 "ARTREX" and/or any other trade
mark of "ARTREX" 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 "ARTREX" 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 in any
manner whatsoever.
However, the manufacturer shall be entitled to manufacture and
distribute its existing products "Articulin" and "Articulin
Forte" which are already registered trade marks of the
Manufacturer.
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.
Upon the termination of this Agreement for any reason whatsoever
the Manufacturer shall return all the said goods including the
raw materials which are in their possession, custody or control
and which are in a good and saleable condition to the Company.
XVII. INSURANCE:
The Company shall insure all the raw materials and packaging
materials, finished products and stock in process to its own account.
The Manufacturer shall render the necessary documents in connection
therewith.
XVIII. 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 present the day and year
first hereinabove written.
SIGNED AND DELIVERED BY SIGNED AND DELIVERED BY
withinnamed "The Company" withinnamed "The Manufacture"
For Bio-Ved Pharmaceuticals For Eisen Pharmaceuticals Co.
Pvt. Ltd. (Pvt.) Ltd.
Mr Ajit P. Chitre Mr Shrikant V Godbole
Director (Operations) Managing Director
in the presence of in the presence of
Dr. Bhushan Patwardhan Mr. Heramb B Joshi
Schedule I
[INSERT 2 PAGES HERE]
Schedule II
MANUFACTURING AND TESTING CHARGES
FOR ARTREX CAPSULES AT
EISEN PHARMACEUTICAL CO. ( PVT. ) LTD., PUNE
a) Manufacturing Charges : [*****]
b) Packing Charges : [*****]
c) Testing Charges
For every packing material : [*****]
For Finished Goods Physical Tests : [*****]
For Microbial Testing : [*****]
Every raw material : [*****]
* Confidential provisions omitted and filed separately with the Commission.
SPECIFICATIONS OF RAW MATERIALS
(Planned Extract Specifications to Be Reviewed after Receiving First 10 Batches
of Each Extract)
LOD (AT
90 DEG. C
UNDER 15
SR. MM. HG. FOR PH OF 5% AQ. TLC MICROBIAL
NO. DESCRIPTION 4 HRS.) SUSPENSION WT./ML(gm) PATTERN QUALITY STORAGE
- --------- -------------------- ------------ -------------- ------------- ---------------- ------------ ------------------
1 [******** [*****] [*****] [*****] [*****] [*****] [*****]
********
********]
2 [******** [*****] [*****] [*****] [*****] [*****] [*****]
********
********]
3 [******** [*****] [*****] [*****] [*****] [*****] [*****]
********
********]
4 [******** [*****] [*****] [*****] [*****] [*****] [*****]
********
********]
Excipients viz. Starch Maize, Collodal Slicone Dioxide, Methylparaben,
Citric Acid, BHT, Isopropyl Alcohol,
Purified Water and Hard Gelatin Capsule shells to be analysed as per latest
I.P. specifications and
Docusafe Sodium as per B.P. 1993 specifications.
* Confidential provisions ommitted and filed separately with the Commission.
ARTREX CAPSULES
PACKING MATERIAL SPECIFICATIONS
LOD (AT
90 DEG. C
UNDER 15
SR. MM. HG. FOR PH OF 5% AQ. TLC MICROBIAL
NO. DESCRIPTION 4 HRS.) SUSPENSION WT./ML (gm) PATTERN QUALITY STORAGE
- --------- -------------------- ------------ -------------- ------------- ---------------- ------------ ------------------
1 [********** 25 to 35% 4.5 to 6.5 1.25 to 1.40 Complies with E. coli and Store at a temp.
********** that of the Salmonella below 25 DEG. C.
********** working absent.
**********] standard.
2 [********** NLT 40% 4.5 to 6.5 0.95 to 1.10 Complies with E. coli and
********** that of the Salmonella
**********] working absent.
standard.
3 [********** NLT 15% N.A. N.A. Compiles with E. coli and Store at a temp.
********** that of the Salmonella below 25 DEG. C.
**********] working absent.
standard.
4 [********** NLT 15% N.A. N.A. Complies with E. coli and Store at a temp.
********** that of the Salmonella below 25 DEG. C.
**********] working absent.
standard.
[*****]
[*****]
[*****]
* Confidential provisions ommitted and filed separately with the Commission.
ARTREX CAPSULES
PACKING MATERIAL SPECIFICATIONS
SPECIFICATION ALUMINUM FOIL PVC/PVDC FOIL SALES CARTON P.S. CARTON CORRUGATED BOX
---------------- ---------------- ---------------- ---------------- ---------------- ----------------
1 Description Silver colored Clear, Box made of Box made of Brown colored,
foil plain on transparent PVC white back white back ply shipper
one side and foil with PVDC duplex duplex (with 2 gap
printed with coating chromoboard chromoboard plates and 1
text mate as per paper, printed paper, printed centre plate 5)
the approved as per the as per the printed on
approved artwork approved artwork both side
ARTREX Capsules of ARTREX sales of ARTREX sample (length wise)
foil on the carton. carton. as per the
other side. Foil approved
is free from artwork of
pinholes. ARTREX
corrugated
box.
2 Dimensions Width 87 + 1 mm Width 91 + mm 90 x 64 x 90 mm 90 x 10 x 65 mm 465 x 330 x 195 mm
3 Grammage About 70 gsm PVC. 345 gsm+ NLT 290 gsm NLT 290 gsm 1 x 150 A, 4 x
10%, PVDC about 100 A
40 gsm.
4 Thickness NLT 0.02 mm About 0.26 mm N.A N.A. N.A.
5 Printing Printing -with N.A. Printing - with Printing - with Printing -with
green and black green and black green and black green and black
colors, is clear colors; is clear colors; is clear colors; is clear
without smugging without smugging without smugging without smugging
or any othe or any other or any other or any other
defect. defect defect defect.