EXHIBIT 10.4
DISTRIBUTION AGREEMENT
This agreement ("Agreement") is made on 01. January 2002 between MESYS GMBH, a
company organized under the laws of Germany with offices at Xxxxxxxxxxxx 00,
X-00000 Xxxxxxxx ("MESYS") and OccuLogix Corporation, 000 Xxxxxxx Xxxxxx, Xxxx
Xxxxxx, Xxxxxxx 00000, XXX.
MESYS developed and produces on the order of DIAMED a blood- and plasma therapy
device. This device has been introduced into the market under the tradenames
Octo Nova and Octo Therm. These tradenames have been registered, among others,
by DIAMED in various countries. Furthermore, DIAMED holds all rights worldwide
on Octo Nova and Octo Therm. MESYS is the manufacturer of the plasma therapy
devices "Octo Nova/Octo Therm" and shall be authorized to enter into
distribution agreements with distributors outside Germany, provided that the
exclusive marketing agreement between DIAMED and OccuLogix Corp. has been
concluded (Exhibit D).
OccuLogix Corp. is the exclusive distributor for Octo Nova and Octo Therm in the
territory of United States, Canada and Mexico.
MESYS manufactures Octo Nova/Octo Therm including accessories and spare parts,
according to the terms of this Agreement, and for which MESYS has the necessary
facilities, equipment, qualified personnel and experience.
Accordingly, the parties agree as follows:
1. MANUFACTURE OF PRODUCT
1.1 MESYS shall manufacture and sell to OccuLogix Corp. the device(s),
accessories, spare parts, and other tools (hereinafter "Product(s)") as
described in Exhibit A, attached to this Agreement and in the quantity
agreed between the parties. MESYS shall also furnish the Product and spare
parts and meet other conditions as set forth in this Agreement, including
those provided in Exhibit A and in the following specifications,
descriptive literature, and other documents ("Specifications").
Exhibit A: List of Product(s) and Quantities
Exhibit B: Spare Parts
Exhibit C: Price List
Exhibit D: marketing agreement
MESYS reserves the right to change the Specifications at any time in
agreement and upon a written notice to OccuLogix Corp.
No change to the Products shall be made by OccuLogix Corp. without MESYS's
prior written consent. During the term of this agreement OccuLogix Corp.
shall submit to MESYS for their approval and acceptance in writing all
proposed enhancements to the Product during the term of this Agreement.
All cost related to such product
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enhancements will be paid by OccuLogix Corp. Procedures for handling of
property rights in case of product enhancements have been included in the
marketing agreement between DIAMED and OccuLogix Corp. (Exhibit D).
1.2 MESYS shall furnish OccuLogix Corp. the following services for the Product
purchased under this Agreement:
1.2.1 Adequate technical and maintenance training for personnel. OccuLogix
Corp. will bear the costs of those training. The first training is
free of charge at MESYS.
1.2.2 Meetings between OccuLogix Corp. and MESYS shall take place in so
far as reasonable at Hannover. Upon appropriate notification by
OccuLogix Corp. participation of MESYS personnel shall also be
possible at other places.
1.3 If requested by OccuLogix Corp. in writing, MESYS shall have sufficiently
spare parts available, during a period of five (5) years after expiration
of this Agreement and sell to OccuLogix Corp. within agreed delivery times
and at reasonable prices.
1.4 MESYS warrants that the Products delivered to OccuLogix Corp. are free
from defects in materials, workmanship and manufacturing and is
merchantable, fit for the purpose intended, and in compliance with the
requirements of this Agreement. MESYS shall replace or repair any Product,
Product component, work, or other item furnished by it under this
Agreement, that fails to conform to the requirements of this Agreement if
such non conformance appears within a period of twelve (12) months as of
delivery of the Product by MESYS to OccuLogix Corp.
2. ORDERS, PAYMENTS AND TERMS OF DELIVERY
2.1 Forecast and orders
2.1.1 Upon execution of this Agreement, and no later than thirty (30) days
after each succeeding anniversary date of this Agreement, OccuLogix
Corp. shall submit to MESYS an annual rolling forecast. OccuLogix
Corp. guarantees that for the term of this Agreement will purchase
25 units of the Product Octo Nova per year beginning after FDA
approval (12 month period).
2.1.2 OccuLogix Corp. shall submit to MESYS purchase orders indicating the
type and quantity of Product required. OccuLogix Corp. shall submit
such purchase orders regularly in the form of a rolling forecast
over a period of 12 months, whereby the running and the following 3
subsequent months shall be binding orders allowing lead time of
thirty (30) business days for MESYS to fill the orders. OccuLogix
Corp. purchase orders shall be deemed accepted by MESYS unless it
notifies OccuLogix Corp. to the contrary within ten (10) business
days of its receipt thereof.
2.1.3 All sales of the Products by MESYS to OccuLogix Corp. and orders
from OccuLogix Corp. to MESYS shall be subject to the provisions of
this Agreement,
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and shall not be subject to the terms and conditions contained in
any purchase order of MESYS or OccuLogix Corp.
2.2 Delivery
2.2.1 OccuLogix Corp. or its agent shall collect Products at MESYS
facility in Hannover. Till collection the Products remain under the
custody and the responsibility of MESYS. The following shall be
agreed as delivery term: "ex works MESYS".
2.2.2 After the Product has passed all required test, verification and
approvals and has been properly packed by MESYS, MESYS will inform
in writing OccuLogix Corp. of availability of the Product.
2.3 OccuLogix Corp. shall pay MESYS the prices for the Product as stipulated
in Exhibit C. These prices include not freight and packing costs. MESYS
shall be authorized to raise the prices as per 1st January of every year
according to the general price increase. Exceptional price increases shall
be proven separately and can be enforced if deemed essential.
2.4 OccuLogix Corp. shall pay accepted MESYS invoices within thirty (30) days
of the date of invoice or per letter of credit. Invoices are payable in
DEM or EURO.
2.5 In the event OccuLogix Corp. were not to purchase the full guaranteed 25
units per year of Product within the terms of this Agreement specified in
Section 7, the parties agree that OccuLogix Corp. would pay MESYS DEM
5,000 or EURO 2.560 for every not purchased unit up to the limit of 25
units per year.
3. QUALITY REQUIREMENTS
All Products shall be manufactured and packaged in accordance with EU/MDD
with FDA and UL standards.
4. REGISTRATION/REGULATORY MATTERS
The Octo Nova/Octo Term is labelled with CE xxxx and have the registration
for all EU States. OccuLogix Corp. is responsible for FDA approval.
5. EXCLUSIVITY
During the term of this Agreement, MESYS shall not enter into any
agreement with third parties for the sale of the Octo Nova in United
States, Canada and Mexico.
6. CONFIDENTIALITY
Any information conveyed to OccuLogix Corp. by MESYS in connection with
this Agreement, and specifically identified as confidential, shall be used
by OccuLogix Corp. only for the purposes of this Agreement and shall not
be disclosed to third parties during
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the term of this Agreement or for a period of five years thereafter,
provided, however, that such obligation of confidentiality shall not apply
to information that:
(a) was known prior to its disclosure by the transferring Party;
(b) is received at any time in good faith from a third party with the
legal right to disclose the same; or
(c) is in the public domain or subsequently enter the public domain
other than by reason of acts or omissions of the employees or
agents.
7. TERM, TERMINATION
7.1 This Agreement shall be in effect for the initial term beginning with the
execution date and for a duration of three (3) years after the date of FDA
approval. It will expire at that date without requiring termination. Any
prolongation must be agreed upon in advance and in writing.
7.2 Either party may immediately terminate this Agreement if any breach of its
terms is not cured within sixty (60) days following receipt of written
notice from the other Party.
7.3 Either party may terminate this Agreement, effective immediately upon the
giving of notice, if
(a) the other Party shall file a petition in bankruptcy, or shall be
adjudicated a bankrupt, or shall become insolvent, or shall make an
assignment for the benefit of creditors, or shall be voluntarily or
involuntarily dissolved, or shall have a receiver, trustee or other
court officer appointed for its property.
(b) the production contract between DIAMED and MESYS is terminated.
(c) the marketing contract between DIAMED and OccuLogix Corp. is
terminated.
7.4 Termination shall not relieve or release either party from performing all
obligations hereunder and making any and all payments which may be due and
owing under the terms of this Agreement.
8. INTELLECTUAL PROPERTY RIGHTS
8.1 This Agreement shall not affect the rights of the parties in their
respective trademarks or patents.
8.2 OccuLogix Corp. shall not retain any MESYS documents, files, records,
correspondence, notes, or other items, including copies, relating to the
business of MESYS, except as its association with MESYS shall require and
then only with permission of MESYS. In cases where MESYS permits OccuLogix
Corp. to retain such items, OccuLogix Corp. shall promptly return them to
MESYS upon request or upon completion or termination under this Agreement.
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8.3 All drawings, specifications, proposals, photographs, recordings, samples,
prototypes and products given to OccuLogix Corp. by MESYS or produced by
OccuLogix Corp. under this Agreement and which incorporates any of MESYS's
ideas or technology, shall not be shown or displayed by OccuLogix Corp. to
any third party.
8.4 OccuLogix Corp. shall not disclose to any third party in any manner the
fact or nature of its association with MESYS without first obtaining the
express written permission.
8.5 OccuLogix Corp. may disclose MESYS's information to subcontractors,
regulatory authorities, and others, as required to meet OccuLogix Corp.
obligations under this Agreement, provided:
(1) MESYS has approved such disclosure, and
(2) OccuLogix Corp. secures confidential/and proprietary treatment of
any information thus disclosed in a manner accepted by MESYS.
9. INDEMNITY
OccuLogix Corp. shall indemnify and hold MESYS harmless from all claims
resulting from any act or omission. OccuLogix Corp. agrees to maintain
product liability coverage in an amount sufficient to meet its obligations
under this Section 9. MESYS's liability shall be limited to liability in
compliance with German law. OccuLogix Corp. shall fulfil its obligations
as representative in accordance with FDA requirements.
10. RECALLS, INSPECTIONS AND PRODUCT COMPLAINTS
10.1 The parties shall notify and cooperate with each other as to any
complaints, inspections and recalls concerning the Product.
10.2 In the event of a recall of the Product, OccuLogix Corp. shall assume
complete responsibility for the conduct of the recall. MESYS shall provide
OccuLogix Corp. with any manufacturing information required by OccuLogix
Corp. in connection with the recall. The cost of any recall hereunder
shall be equitably allocated between the parties in accordance with their
responsibility for its underlying cause.
11. TECHNICAL SERVICE
OccuLogix Corp. is responsible for the technical service in United States,
Canada and Mexico. OccuLogix Corp. has the necessary equipment, stock of
spare parts and qualified personnel to realize the technical service in
accordance with MESYS requirements. OccuLogix Corp. should only use
original spare parts delivered from MESYS for repair. Maintenance and
safety checks for Octo Nova/Octo Therm has to be done in accordance with
MESYS requirements.
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12. CUSTOMER TRAINING
OccuLogix Corp. is responsible for customer training in United States,
Canada and Mexico. OccuLogix Corp. has the necessary equipment and
qualified personnel to realize the training in accordance with MESYS
requirements.
13. FORCE MAJEURE
Neither party shall be liable to the other party for failure to perform
any of its obligations hereunder because of any cause beyond the control
of or occurring without the fault of such party.
14. NOTICES
All notices or communications shall be effective when sent via registered
mail, with sufficient postage, prepaid, addressed to the recipient party
at the address of that party first above written, or to such other
address(es) as either party shall specify by notice to the other party.
15. MISCELLANEOUS
15.1 This Agreement shall be binding upon the parties, their successors and
assigns. Neither party shall assign this Agreement without the prior
consent in writing of the other party, except that either party may assign
this Agreement to an entity under common control.
15.2 This Agreement constitutes the entire agreement between the parties
relating to its subject matter and all prior proposals, discussions, and
writings by the parties and relating to the subject matter of this
Agreement are superseded. This Agreement may be amended only by written
agreement of the parties.
15.3 This Agreement is to be deemed to have been entered into in Hannover, and
its construction shall be in accordance with the laws of Germany, and all
disputes under it shall be adjudicated in the courts of Hannover.
Partner MESYS
By: /s/ Xxxxxxx Xxxxx By: /s/ X. Xxxxxxx
_________________________ _______________________
Title: Chairman, President & CEO Title: Managing Director
EXHIBIT A
List of Products
Octo Nova EU Version
Octo Therm Heater for Octo Nova
Quantities
Octo Nova 25 units per year (minimum)
Octo Therm 25 units per year (minimum)
EXHIBIT B
MESYS
Medizinische Systeme
MeSys GmbH
Beneckeallee 30
30419 Hannover
Fon: 0000 000000-0
Fax: 0000 000000-00
Email: xxxxx@xxx.xxx
SPARE PART LIST 2000
OCTO NOVA
05/2000
Valid from 01.05.2000
_______________
Price changes and errors excepted. All Prices without packaging and
transportation costs. For Shipments with a goods worth below DM 50.-a fee of DM
35.- will be charged.
DOOR INSIDE VIEW
PART NO. DESCRIPTION EURO DM
---------- ---------------------------------------------- ------ --------
KM E039-10 Chargeable Battery Pack Octo Nova LCR 24V/2, 2P 168,73 330,00
BG-F467-00 Power Supply Octo Nova complete 762,34 1491,00
AN-F028-00 Fan Octo Nova 39,88 78,00
SZ-E030-00 Fuse 5x20 T10A 0,92 1,80
BG-E313-04 Motherboard 220,88 432,00
BG-E300-04 PCB, CPU-517 315,47 617,00
BG-E325-00 PC/104 CPU complete 1692,37 3310,00
BG-E308-02 PCB, Scale 140,61 275,00
BG-E309-01 PCB, Bloodleak detector 87,43 171,00
BG-E310-00 PCB, Alarmtone 78,74 000,00
XX-X000-00 XXX, Xxxx Counter 108,39 212,00
SZ-E027-00 Fuse 5x20 T200mA 0,92 1,80
IT-E020-00 Toroidal Transformer 119,64 234,00
IE-E007-00 Line Filter 75,16 147,00
DOOR OUTSIDE VIEW
PART NO. DESCRIPTION EURO DM
---------- ---------------------------- ----- ------
SE-F022-00 Fuse Holder 6,44 12,60
SE-F020-00 Power Connector 37,32 73,00
SZ-E029-00 Fuse 5x20 2AmT 0,92 1,80
SI-F148-00 Label Technical Service 2,53 4,95
SI-F144-00 Label Fuses 0,82 1,60
SI-F147-00 Label Connector Octo Therm 2,30 4,50
SI-F016-00 Label Potential Equalization 0,61 1,20
KK-F037-00 Power Cord 8,08 15,80
KT-F326-00 T-Clip Cableguiding Cart 1,64 3,20
FRONT OUTSIDE VIEW
PART NO. DESCRIPTION EURO DM
---------- ------------------------------------ ------ --------
SE-F088-00 Keyboard with plate German 728,08 1424,00
KT-F286-00 Line holder, red 2,94 5,75
KT-F287-00 Line holder, blue 2,94 5,75
KT-F288-00 Line holder, yellow 2,94 5,75
KT-F324-00 Bubble catcher holder D=21 blue 3,89 7,60
BG-F473-00 Sensors, Air detector 319,56 625,00
BG-F493-00 Blood pump rotor 314,96 616,00
BG-F494-00 Balance pump rotor 293,99 575,00
BG-F484-00 Reedswitch for Pump housing 9,25 18,10
BG-F495-00 Citrate pump rotor 219,86 430,00
BG-F479-00 Door, Blood pupmpen 99,19 194,00
BG-F477-00 Door, Balance pump 1 113,37 166,00
BG-F478-00 Door, Balance pump 2 113,37 166,00
BG-F470-00 Door, Citrate pump 55,73 109,00
SE-F090-00 Keyboard, Level Lifter 44,99 88,00
BG-F481-00 Mirror, Bloodleak detector 11,40 22,30
BG-F482-00 Drip Counter 324,67 635,00
BG-F500-00 Scale 1014,91 1985,00
BG-F464-00 Detector, Substitution 371,71 727,00
KT-F276-00 Roller with Brake 60,33 118,00
KT-F277-00 Roller without Brake 49,08 96,00
KT-F129-00 Plexiglass Supporting Disk blue 5,47 10,70
KT-F130-00 Plexiglass Supporting Disk red 5,47 10,70
KT-F132-00 Plexiglass Supporting Disk yellow 5,47 10,70
KT-F200-00 Plexiglass Supporting Disk transparent 3,78 7,40
KT-F325-00 Plexiglass Supporting Disk orange 5,47 10,70
ACCESSORIES
PART NO. DESCRIPTION EURO DM
---------- -------------------- ----- -----
BG-F485-00 Filter holder blue 49,80 97,40
BG-F486-00 Filter holder yellow 49,80 97,40
MT-F050-10 Crank, Blood pump 25,31 49,50
MT-F362-00 Key for Case 2,20 4,30
EXHIBIT C
PRICE LIST
Octo Nova 15.000 Euro
Octo Therm 1.125 Euro
(in combination with Octo Nova)
EXHIBIT D: MARKETING AGREEMENT DIAMED / OCCULOGIX CORP.
Addendum to Distribution Agreement from 01. January 2002 between MESYS GMBH,
Hannover (Germany) and OccuLogix Corporation, Florida (USA)
MESYS and OccuLogix agrees to change section 9 - Indemnity as follows
9. INDEMNITY
OccuLogix shall indemnify and hold MESYS harmless from all claims resulting from
any act or omission of OccuLogix. MESYS shall indemnify and hold OccuLogix
harmless from all claims resulting from any act or omission of MESYS.
OccuLogix Corp. and MESYS agrees to maintain product liability coverage in an
amount sufficient to meet its obligations under this Section 9. MESYS's
liability shall be limited to liability in compliance with German law. OccuLogix
Corp. shall fulfill its obligations as representative in accordance with FDA
requirements.
The additional insurance cost for MESYS will be charged per each invoice to
OccuLogix with the amount of 4.90 Euro (at the moment) per 500, Euro turn over.
The insurance rate depends on the actual insurance rate and can be adapt in
future to the actual rates. OccuLogix agrees to bear this cost.
April 7th 2003
OCCULOGIX CORPORATION/VSC MESYS
By: /s/ Xxxx Xxxxxxx By: /s/ X. Xxxxxxx
------------------------ -------------------
Title: Chief Technology Officer Title: Managing Director
SECOND ADDENDUM TO DISTRIBUTION AGREEMENT
On January 1, 2002, an Agreement ("AGREEMENT") was executed between MESYS GMBH
("MESYS") and VASCULAR SCIENCES CORPORATION ("VSC"), formerly known as Occulogix
Corporation,
On April 7, 2003, the first addendum to the AGREEMENT was signed, thereby
changing the Indemnity provision in Section 9.
On September 22, 2003, MESYS and VSC hereby agree to a second addendum ("SECOND
ADDENDUM") as follows:
WHEREAS, VSC distributes the Octo Nova Blood Plasma Therapy Machine
(manufactured by MESYS) in North America. VSC hereby agrees to:
1. Providing technical training for the Octo Nova to the end-user. VSC's
technical representative will receive formal training, and be certified,
by MESYS, or an authorized MESYS representative.
2. VSC will maintain traceability of all Octo Nova units distributed, and
make this information available to MESYS upon the request.
3. Any complaints received by VSC regarding the Octo Nova will be forwarded
to MESYS for review. VSC shall forward MESYS' response and conclusion to
the complainant. VSC maintains complaint handling procedures in compliance
with FDA regulations as well as Canadian Medical Device Regulation (CMDR).
4. The contact person for VSC will be:
Xx. Xxxx Xxxxxxx
Director of Regulatory Affairs
Vascular Sciences Corporation
Xxxx Xxxxxx XX 00000
PH 000-000-0000
VASCULAR SCIENCES CORPORATION
By: /s/ Xxxx X. Xxxxxxx
------------------------------
Title: Director of Regulatory Affairs
MESYS GMBH
By: /s/ X. Xxxxxxx
------------------------------
Title: Managing Director
Addendum to Distribution Agreement from 01, January 2002 between MESYS GMBII,
Hannover (Germany) and OccuLogix Corporation, Florida (USA)
MESYS and OccuLogix agrees to change section 9 - Indemnity as follows
9. INDEMNITY
OccuLogix shall indemnity and hold MESYS harmless from all claims resulting from
any act or omission of OccuLogix. MESYS shall indemnify and hold OccuLogix
harmless from all claims resulting from any act or omission of MESYS.
OccuLogix Corp. and MESYS agrees to maintain product liability coverage in an
amount sufficient to meet its obligations under this Section 9. MESYS's
liability shall be limited to liability in compliance with German law. OccuLogix
Corp. shall fulfil its obligations as representative in accordance with FDA
requirements.
The additional insurance cost for MLSYS will be charged per each invoice to
OccuLogix with the amount of 4,90 Euro (at the moment) per 500,- Euro turn over.
The insurance rate depends on the actual insurance rate and can be adapt in
future to the actual rates. OccuLogix agrees to bear this costs.
April 7th 2003
OccuLogix Corporation VSC MESYS
By: /s/ Xxxx X. Xxxxxxx By: /s/ X. Xxxxxxx
---------------------------- -------------------------
Title: Chief Technology Officer Title: Managing Director
SECOND ADDENDUM TO DISTRIBUTION AGREEMENT
On January 1, 2002, an Agreement ("AGREEMENT") was executed between MESYS GMBH
("MESYS") and VASCULAR SCIENCES CORPORATION ("VSC"), formerly known as Occulogix
Corporation,
On April 7, 2003, the first addendum to the AGREEMENT was signed, thereby
changing, the Indemnity provision in Section 9
On September 22, 2003, MESYS and VSC hereby agree to a second addendum
("SECOND ADDENDUM") as follows:
WHEREAS, VSC distributes the Octo Nova Blood Plasma Therapy Machine
(manufacture by MESYS) in North America, VSC hereby agrees to;
1. Providing technical training for the Octo Nova to the end-user,
VSC's technical representative will receive formal training, and be
certified, by MESYS, or an authorized MESYS representative.
2. VSC will maintain traceability of all Octo Nova units distributed,
and make this information available to MESYS upon the request.
3. Any complaints received by VSC regarding the Octo Nova will be
forwarded to MESYS for review. VSC shall forward MESYS response and
conclusion to the complainant. VSC maintains complaint handling
procedures in compliance with FDA regulations as well as Canadian
Medical Device Regulation (CMDR).
4. The contact person for VSC will be:
Xx. Xxxx Xxxxxxx
Director of Regulatory Affairs
Vascular Sciences Corporation
Xxxx Xxxxxx XX 00000
PH. 000-000-0000
VASCULAR SCIENCES CORPORATION
BY: /s/ Xxxx X. Xxxxxxx
---------------------------------------
Xxxx X. Xxxxxxx, Director of Regulatory
Affairs
MESYS GMBH
BY: /s/ X. Xxxxxxx
---------------------------------------
Title: X. Xxxxxxx, Managing Director
