1
Exhibit 10.50
Material omitted and filed
separately with the Securities
and Exchange Commission.
SUPPLY AGREEMENT
This agreement is made and entered into at the date of signature between
Selfcare Inc., 000 Xxxxxxxx Xxxxxx, Xxxxxxx, XX 00000, XXX and Selfcare
International GmbH, Xxxxxxxxxx 0, 00000 Xxxxxxxxxxx, Xxxxxxx (hereinafter
collectively called as the "COMPANY") and A. Menarini Industrie Farmaceutiche
Riunite S.r.L., xxx Xxxxx Xxxxx 0, 00000 Xxxxxxx, Xxxxx ("MENARINI").
WHEREAS
- The COMPANY is entitled to manufacture and sell the products described
in Appendix A (the "PRODUCTS");
- The COMPANY is willing to sell Menarini, on an exclusive basis, the
PRODUCTS described in Appendix A in accordance with the following terms
and conditions.
1. SUPPLY
The COMPANY hereby undertakes to sell exclusively to MENARINI all
quantities of the PRODUCTS which MENARINI shall require to market
and sell, under MENARINI's colours, labels and trademarks, directly
or through its distributors the PRODUCTS in the Territories described
in Appendix A (the "TERRITORY").
2. PRICES, EXCHANGE RATE VARIATION AND PAYMENT
2.1 The PRODUCTS shall be supplied to MENARINI at purchase prices
(in US $) described in Appendix B. They will be fixed for each calendar
year. Any eventual price modification will be discussed within September
1st of the preceding year. If the parties will not be able to reach an
agreement about the new prices the following official index will be used
as a reference: USA inflation rate.
2.2 In case of an exchange rate variation (between US $ and Italian
lira) bigger than +/-10% of the exchange rate at the date of the
signature of the agreement, the loss and gain will be shared in equal
part.
2.3 Payment for all PRODUCTS purchased by MENARINI shall be made in
US $.
2.4 Payment to the COMPANY shall be made sixty (60) days after the
shipment from the COMPANY. All prices are quoted FOB.
2.5 Without prejudice to its other rights in respect thereof, the
COMPANY shall be entitled to withhold supplies of PRODUCTS while payment
of any sums due from MENARINI remains outstanding.
2.6 The PRODUCTS will remain the property of the COMPANY as long as
MENARINI has not fully paid for such PRODUCTS. At the request of the
COMPANY, MENARINI shall return any and all unpaid PRODUCTS immediately
to the COMPANY to the COMPANY's address or to any other address
designated by the COMPANY. Notwithstanding the foregoing, MENARINI shall
be responsible for any loss or damage relating to any such PRODUCTS
while such PRODUCTS are in the possession of MENARINI, or while such
PRODUCTS are being returned to the COMPANY until they are accepted by
the COMPANY.
1
2
3. EXCLUSIVITY
The COMPANY shall not supply the PRODUCTS described in Appendix A to any
third party in the TERRITORY.
4. PRODUCT MODIFICATION
Any modification of the PRODUCTS that is affecting the performances or the
physical appearance will be agreed with MENARINI.
5. PRODUCT REGISTRATION
MENARINI will do its best efforts to obtain prompt registration for the
PRODUCTS with the appropriate governmental agencies in the TERRITORY, and to
obtain any other approvals required in connection with the marketing and
sale of the PRODUCTS hereunder.
6. MINIMUM QUANTITY
6.1. MENARINI shall purchase from the COMPANY for sale in the TERRITORY a
minimum quantity of the PRODUCTS as listed on Appendix C. The PRODUCTS will
be considered purchased when ordered by MENARINI. MENARINI will provide the
COMPANY with a twelve (12) months purchase forecast. This forecast will be
updated on a quarterly basis.
In case of failure to purchase the minimum commitments, the COMPANY will
notify MENARINI giving sixty (60) days to remedy. If MENARINI is failing to
remedy within sixty (60) days from such notification, the COMPANY may
terminate the agreement within seven (7) days from the aforesaid 60th day,
with a thirty (30) days written notice.
In case of significant changes in one or more of the PRODUCTS (quality or
price) the parties will adjust in good faith the minimum purchase
requirements for said Product(s).
6.2. Upon request of the COMPANY, MENARINI shall do its best efforts to
destroy, return to the COMPANY or make such other disposition as the COMPANY
shall direct of any portion of the PRODUCTS determined by the COMPANY to be
outdated or otherwise to require such disposition. In the event of such
return or destruction, the COMPANY shall either replace the PRODUCTS or
reimburse MENARINI in an amount equal to the price paid by MENARINI for the
PRODUCTS. The COMPANY shall have no liability for material that is outdated
as a result of MENARINI's inventory management practices.
7. DELIVERY TERMS AND SHELF LIFE
The PRODUCTS will be delivered to MENARINI within 60 days from the date of
the order. Each other will be confirmed within two working days. The
PRODUCTS will be delivered to MENARINI with at least 18 months shelf life.
2
3
8. INDUSTRIAL PROPERTY RIGHTS AND CONFIDENTIALITY
8.1 All technical and commercial information, data regarding
processes and know-how furnished by the COMPANY to MENARINI shall remain
the property of the COMPANY, and MENARINI shall not acquire any
proprietary rights or other interests, herein. For the avoidance of
doubt as to what may or may not be constitute information in respect of
which MENARINI is bound by the above obligations, the COMPANY will
notify MENARINI in writing, within no more than two weeks from the date
of disclosure MENARINI, any element of information to be regarded as
confidential.
8.2 The foregoing shall not apply to any information:
a) which is freely available to the public at the time it is
disclosed or made available by the COMPANY or which subsequently
becomes freely available to the public otherwise than by default
of MENARINI;
b) any information which MENARINI can show by dated written
records was known to MENARINI prior to it being disclosed or
made available by the COMPANY;
c) any information which MENARINI can show from its dated
written records was developed independently, without recourse or
reference to confidential information disclosed to MENARINI by
the COMPANY.
8.3 Upon termination of this Agreement (for whatever reason),
MENARINI shall without delay return to the COMPANY all documents and
other materials which include any of the Information (including all
copies thereof).
8.4 MENARINI shall ensure that all staff involved in the
distribution of the PRODUCTS (and the staff of any Distributors or
agents) are aware of and observe the obligation of confidence contained
in this Agreement.
8.5. The obligation of confidence in this Agreement shall survive the
termination of the Agreement for three (3) years from the date of
termination of Agreement.
9. WARRANTY
(a) The PRODUCTS shall be free from defects due to faulty materials or
workmanship and comply with the Technical Specifications attached in
Appendix E until the end of their shelf life.
(b) This warranty shall not apply, and the COMPANY shall be under no
obligation to repair or replace PRODUCTS or under any liability to
MENARINI of any nature, in relation to PRODUCTS which are not properly
used in accordance with their instruction or which have been altered or
modified by any person other than the COMPANY.
(c) Any PRODUCT, which MENARINI believes (having first examined and
tested it) not to comply with the Technical Specifications attached in
Appendix E during the relevant warranty period, shall be repaired by the
COMPANY free of charge to MENARINI but the COMPANY shall not pay any
labour or travel costs to MENARINI, and always provided
3
4
that MENARINI shall have notified the COMPANY in writing of the alleged
defect within thirty (30) days of it being brought to MENARINI's
attention.
If any PRODUCTS returned to the COMPANY pursuant to point 9 (c) is found
to perform in accordance with its specifications, it shall be returned
to MENARINI and the transport costs in relation thereto shall be borne
by MENARINI.
(d) Subject as aforesaid the COMPANY shall be under no liability of any
kind in respect of the PRODUCTS manufactured in conformity with
Technical Specification and applicable law.
10. COMPLIANCE WITH LAWS
(a) The COMPANY assumes the responsibility to assure that the PRODUCTS
are safe, effective, properly labelled and packaged, and that they
comply with all regulation applicable in the TERRITORY and with European
Regulations promulgated from time to time. MENARINI assumes the
responsibility to assure that the PRODUCTS, upon delivery, are received,
stored, handled, and shipped in compliance with the COMPANY's
directives.
(b) MENARINI shall inspect the PRODUCTS in the TERRITORY at MENARINI's
cost to determine whether the PRODUCTS meet the Technical Specifications
attached in Appendix E and the requirements of this Agreement.
MENARINI shall be deemed to have accepted any PRODUCTS not rejected by
notification to the COMPANY, setting forth in reasonable detail the
PRODUCTS rejected and the reasons therefor, and received by COMPANY
within thirty (30) days of MENARINI's receipt of such PRODUCTS, and
PRODUCTS which are not so rejected shall be deemed to comply with all
Technical Specifications required by this Agreement.
Up to the above mentioned dispute shall not be clarified, the payment of
the disputed PRODUCTS shall be suspended.
If any PRODUCTS returned to the COMPANY pursuant to point 10 (b) is
found to perform in accordance with its Technical Specifications, it
shall be returned to MENARINI and the transport costs in relation
thereto shall be borne by MENARINI.
(c) The COMPANY assumes the responsibility to perform appropriate tests
of stability for the PRODUCTS. If an expiration date or special handling
and storage conditions are required, The COMPANY will inform DISTRIBUTOR
of these requirements.
(d) The COMPANY assumes the responsibility to assure that its label and
labelling are in compliance with the regulation applicable in the
TERRITORY and with the European Regulations promulgated from time to
time.
(e) The COMPANY assumes the responsibility to conform to a Quality
System certified by a certification body and/or described in a Quality
Manual. The Quality Manual must be written in compliance with
International Quality Standards (e.g. ISO 9000).
The COMPANY is expected to have procedures and specifications which
adequately describe their Quality Program.
The COMPANY agrees to allow MENARINI periodic visits of the COMPANY's
facilities. Confidential disclosures of manufacturing operations can be
used to protect the proprietary nature of the manufacturer's operations.
(f) The COMPANY must ensure that PRODUCTS complies with all the
Technical Specifications mutually agreed with MENARINI and described in
Appendix E.
4
5
The COMPANY agrees to deliver the PRODUCT with related Quality Control
certificate and/or Declaration of Compliance.
(g) The COMPANY is required to notify MENARINI in writing and receive
approval to proceed prior to making any change that may affect
conformance to defined requirements. The notification must be provided
to MENARINI within reasonable time so MENARINI may evaluate the
proposed change for its approval.
(h) The COMPANY will maintain records of shipments. MENARINI will
maintain a traceability system for all transfusion related to PRODUCTS
from the COMPANY. This system ensures that PRODUCTS are traceable and
accountable after these PRODUCTS have left the premises of MENARINI.
Each batch of the PRODUCTS shall be traceable in terms of article code
and batch/lot number.
Serialised PRODUCTS shall be traceable by serial number.
(i) The COMPANY will provide MENARINI with the Material Safety Data
Sheet for any hazardous material used in manufactured the PRODUCTS,
within the meaning of the hazardous material of European Regulations.
(l) MENARINI will communicate to the COMPANY the PRODUCT complaints.
The COMPANY will cooperate in the resolution of PRODUCT complains and in
providing MENARINI with necessary information. Nothing in this paragraph
will relieve The COMPANY from its responsibilities, liabilities, and
warranties contained in this agreement, and in other possible agreements
between the COMPANY and MENARINI.
(m) If the COMPANY or MENARINI discovers any potential problem in one
or more of the PRODUCTS, it will be communicated to the other party. If
it is decided that such PRODUCT(s) should be recalled, withdrawn or
quarantined, and if the problem is caused by a manufacture error, then
the cost of PRODUCTS (plus freight), preparing customer lists, letters
and mailing shall be born by the COMPANY.
(n) The COMPANY will accept for full credit returned goods from MENARINI
when they are found not in conformance with Applicable Regulations.
11. LITIGATION
(a) If MENARINI becomes aware of or suspects that there is any
infringement of the COMPANY's patents or other industrial property
rights (including misuse of confidential information), MENARINI shall
promptly inform the COMPANY of the same.
(b) MENARINI shall not compromise or attempt, to take any proceedings
or other steps in respect of the matters referred to in paragraph (a)
above without the prior written consent of the COMPANY.
(c) If the COMPANY decides to take any proceedings in relation to the
matters referred to in paragraph (a) above, MENARINI shall assist the
COMPANY at its request to deal therewith, including without limitation
taking or joining with the COMPANY in the prosecution of any proceedings
that the COMPANY may deem necessary to protect its rights.
5
6
CONFIDENTIAL TREATMENT
All costs and expenses associated with the conduct of or participation
by MENARINI in such proceedings shall be changed to the COMPANY.
12. INSURANCE
The COMPANY and MENARINI warrant that they both carry product liability
insurance for the PRODUCTS being sold under the Agreement.
13. DURATION AND TERMINATION
This agreement shall become effective from the date of signature by both
parties and shall continue in force until 31 December 2001. The
automatic renewal terms will be of five years each. Two (2) years prior
to the end of each five (5) year period, the parties will meet to agree
in good faith reasonable minimum quantity of PRODUCTS to be purchased by
MENARINI for the following five (5) year period taking into
consideration the then current market conditions. Should the parties
fail to reach an agreement for the such new minimum quantity prior to
six (6) months before the expiration of the then current term, each
party reserves the right to terminate this Agreement within fifteen (15)
days starting from the beginning of such six (6) months, with a thirty
(30) days prior written notice.
13.2 Except for as otherwise agreed, this Agreement may be terminated
at any time by written notice from either party of the other.
(a) in the event of a breach by the other party of any of the
terms and conditions of the Agreement, which breach shall not be
remedied within sixty (60) days from receipt of a written notice
to that effect; or
(b) in the event that either party shall be unable to pay its
debts in the ordinary course of business or enter into
liquidation or have a receiver or administrator appointed
whether compulsory or voluntary, or otherwise becomes subject
to insolvency laws:
13.3 In case of expiration of termination for any reason of this
Agreement, MENARINI may continue at its own discretion to purchase -
and the COMPANY is obliged to sell-, on a non exclusive basis, the
PRODUCTS, provided that the ordered minimum quantities per shipment
will be bigger than [material omitted and filed separately with the
Securities and Exchange Commission] strips and that MENARINI does not
purchase the PRODUCTS also from a third supplier. The parties shall
sign a new supply agreement in conformity with what established in
this art. 13.3.
14. MINIMUM SHIPPING QUANTITIES
The minimum shipping quantity for each product is given in APPENDIX D.
15. NATURE OF RELATIONSHIP
MENARINI in an independent party and shall in no respect be or be
deemed to be an employee of the COMPANY or an agent of or subject to the
authority of the COMPANY. Except as specifically authorised in writing,
MENARINI shall not be in any way authorised or empowered to bind the
COMPANY.
6
7
16. APPLICABLE LAW
The Agreement shall in all respects be governed by and construed in
accordance with the laws of United Kingdom.
17. ADDRESSES
Unless otherwise specified in the Agreement, all notices required
hereunder shall be delivered by hand or sent by cable or by telefax or
by registered mail, postage paid. Unless otherwise specified by written
instructions, all notices shall be addressed as follows:
If to the COMPANY If to MENARINI
Selfcare International A. Menarini
Keltenring 8 Industrie Farmaceutiche Riunite SrL
82041 Oberhaching xxx Xxxxx Xxxxx, 0
Xxxxxxx 00000 Xxxxxxx
Xxxxx
18. ARBITRATION
Any dispute arising in connection with the Agreement shall be submitted
to arbitration in accordance with the rules of the International Chamber
of Commerce (the 'ICC'), in London, UK, and shall be determined by a
single arbitrator selected by agreement of the parties, or if the
parties fail to so agree, a single arbitrator selected by ICC in London,
UK. The arbitrator shall have had no dealings with either party or any
of its Affiliates for the five years prior to the arbitration. The
arbitration shall be held at the ICC in London, UK, and conducted in
English. The decision of the arbitrator shall be final and binding and
the arbitrator's award may be enforced in any court of competent
jurisdiction.
19. AMENDMENTS
This Agreement constitutes the entire Agreement between the parties and
may be modified only by written agreement specifically referring hereto
and signed by the parties.
20. VALIDITY
20.1. If any of the provision of this Agreement shall be void or
unenforceable by reason of any applicable law, it shall be deleted and
the remaining provisions hereof shall continue in full force and effect
and, if necessary, so amended as may be necessary to give effect to the
spirit of this Agreement so far as it is possible.
7
8
20.2 Parties entered in this Agreement provided that the provisions of
this Agreement do not contravene the articles 85 and 86 of the Treaty of
Rome. In the event that one or more provisions of this Agreement
conflict with the forementioned articles the parties agree that they
shall endeavour to find an alternative solution approaching as near as
possible to the contractual situation as agreed upon.
20.3. If due to a change in any applicable law or due to a decision or
other act by any competent authority one or more of the provisions of
this Agreement cannot any longer be enforced or an amendment of one or
more of the provisions of this Agreement is required, the parties agree
that they shall endeavour to find an alternative solution approaching as
near as possible to the contractual situation existing prior to such a
change, decision or act.
21. RIGHTS AND OBLIGATIONS
The termination of this Agreement for any reason shall be without
prejudice to the rights and obligations of the parties accrued up to and
including the date of termination.
22. PATENTS
The COMPANY holds harmless MENARINI in case of an infringement by the
COMPANY of a third party's patent(s).
IN WITNESS THEREOF, this Agreement has been executed, in duplicate, on the date
stated above and below.
Signed in threefold in Firenze On July 31st, 1996
------- ---------------
/s/ Xxx Xxxxxxxxx /s/ Xxxx Xxxx /s/ Enzo Xxxxx Xxxxx
-------------------- -------------------- --------------------
August 27th, 1996
Xxx Xxxxxxxxx Xxxx Xxxx Enzo Xxxxx Xxxxx
President Managing Director Europe President Diagnostic Business
Selfcare Inc. Selfcare International A. Menarini
000 Xxxxxxxx Xxxxxx Keltenring 0 Xxxxxxxxx Xxxxxxxxxxxxx
Xxxxxxx, XX 00000 82041 Oberaching Riuntite S.r.l.
USA Germany Xxx Xxxxx Xxxxx, 0
00000 Xxxxxxx, Xxxxx
8
9
CONFIDENTIAL TREATMENT
APPENDIX A
----------------------------
EXCLUSIVE PRODUCTS
----------------------------
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
Selfcare International Menarini Selfcare Inc.
/s/ Xxxx Xxxx /s/ Enzo Xxxxx Xxxxx /s/ Xxx Xxxxxxxxx
--------------------- -------------------- --------------------
Date: July 31st, 1996 8/27/96
--------------- -------------------- --------------------
* Material omitted and filed separately with the Securities and Exchange
Commission.
9
10
CONFIDENTIAL TREATMENT
APPENDIX B
*****
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
Selfcare International Menarini Selfcare Inc.
/s/ Xxxx Xxxx /s/ Enzo Xxxxx Xxxxx /s/ Xxx Xxxxxxxxx
---------------------- --------------------- -----------------
Date: July 31st, 1996 8/27/96
----------------- --------------------- -----------------
* Material omitted and filed separately with the Securities and Exchange
Commission.
10
11
CONFIDENTIAL TREATMENT
APPENDIX C
MINIMUM ORDER QUANTITIES
DISTRIBUTOR: Menarini
TERRITORY: see Appendix A
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
*******************************************************************************
Selfcare International Menarini Selfcare Inc.
/s/ Xxxx Xxxx /s/ Enzo Xxxxx Xxxxx /s/ Xxx Xxxxxxxxx
---------------------- -------------------- ------------------
Date: July 31st, 1996 8/27/96
---------------- -------------------- ------------------
* Material omitted and filed separately with the Securities and Exchange
Commission.
11
12
CONFIDENTIAL TREATMENT
APPENDIX D
MINIMUM SHIPPING QUANTITIES
DISTRIBUTOR: Menarini
TERRITORY: see Appendix A
******************************************************************************
******************************************************************************
******************************************************************************
Selfcare International Menarini Selfcare Inc.
/s/ Xxxx Xxxx /s/ Enzo Xxxxx Xxxxx /s/ Xxx Xxxxxxxxx
---------------------- -------------------- ----------------------
Date: July 31st, 1996 8/27/96
---------------- -------------------- -----------------------
* Material omitted and filed separately with the Securities and Exchange
Commission.
12
13
CONFIDENTIAL TREATMENT
APPENDIX E
TECHNICAL SPECIFICATIONS
DISTRIBUTOR: Menarini
TERRITORY: see Appendix A
************************************************************************
*************************************************
***************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
****************************************************************************
Appendix E: technical specifications pag. 1/3
* Material omitted and filed separately with the Securities and Exchange
Commission.
14
CONFIDENTIAL TREATMENT
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
*********************************************************************
Appendix E: technical specifications pag. 2/3
* Material omitted and filed separately with the Securities and Exchange
Commission.
15
CONFIDENTIAL TREATMENT
********************************************************************************
********************************************************************************
********************.
********************************************************************************
********************************************************************************
********************************************************************************
****************.
*****************************
********************************************************************************
**********************************.
*****************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
*********.
********************
********************************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
***********************************************.
***************************
********************************************************************************
************************************.
******************
***************************************.
*****************
********************************************************************************
********************************************************************************
***********************.
**********************************
Selfcare International Menarini Selfcare Inc.
/s/ Xxxx Xxxx /s/ Enzo Xxxxx Xxxxx /s/ Xxx Xxxxxxxxx
----------------------- -------------------- ------------------
Date: July 31st, 1996 8/27/96
----------------- -------------------- ------------------
Appendix E: technical specifications pag. 3/3
* Material omitted and filed separately with the Securities and Exchange
Commission.