Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act SUPPLY AGREEMENT
Exhibit
10.1
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
This
Supply Agreement (“Agreement”)
is
made and entered into as of the 14th day of September, 2007 (the “Effective
Date”), by and between Membrana
GmbH, a
company
organized under the laws of Germany (hereinafter called “Membrana”),
and
Xxxxxx
Systems, Inc.
a
corporation organized under the laws of Delaware (hereinafter called
“Xxxxxx”).
The
parties agree as follows:
1. Definitions. As
used
herein the following terms shall have the following meanings:
“Affiliate”
shall
mean any person or entity controlling, controlled by or under common control
with the party in question.
“Product”
or “Products”
shall
mean Membrana’s products listed on Exhibit
A.
“Specifications”
shall
mean the fiber and bundle specifications for the Products set forth on
Exhibit
B
as
amended from time to time by Xxxxxx with the reasonable consent of Membrana.
Each party shall bear its own costs with respect to any developmental activity
undertaken to arrive at modified Specifications. Xxxxxx acknowledges that
changes to the Specifications proposed by it may result in higher
prices.
2. Purchase
Commitments.
2.1 From
the
Sale Date (as defined below) until [***] as further provided herein (the
“Exclusive
Period”),
Xxxxxx agrees to purchase no less than [***] of its total commercial
requirements for membranes for use in products covered within a claim of an
issued U.S. patent that is owned by or licensed exclusively to Xxxxxx (as listed
on Exhibit
C)
for the
treatment of liver failure or sepsis anywhere in the world (the “Exclusive
Field”)
from
Membrana up to [***] kilometers per year (the “Requirements
Cap”).
Provided that Xxxxxx shall have ordered at least [***] km (cumulative) of
Product during the Exclusive Period and prior to [***] of the Sale Date, the
Exclusive Period shall be extended for [***] Provided that Xxxxxx shall have
ordered at least [***] km (incremental) of Product prior to [***] of the Sale
Date, the Exclusive Period shall be extended for [***]. Provided that Xxxxxx
shall have ordered at least [***] km (incremental) of Product prior to [***]
of
the Sale Date, the Exclusive Period shall be extended for [***]. Amounts in
excess of the Requirements Cap or for use outside of the Exclusive Field may
be
available upon Membrana’s written approval. If Membrana declines to supply
volumes in excess of the Requirements Cap, Xxxxxx may acquire such volumes
in
the Exclusive Field from third parties. Upon the expiration of the Exclusive
Period or upon conversion of this Agreement to a non-exclusive agreement as
expressly permitted by this Agreement, Xxxxxx may continue to purchase Products
from Membrana until end of the term described in Section 4.1 below, however,
Xxxxxx may also purchase membranes for use in the Exclusive Field from third
parties. If Xxxxxx does not place an order with Membrana for Products within
[***]months of the end of the Exclusive Period and does not order at least
[***]
km of Product within any [***]months period after the end of the Exclusive
Period, Membrana may elect to terminate this Agreement effective fifteen (15)
days following written notice to Xxxxxx of such desired termination, unless
Xxxxxx places an order for at least [***] km of Product within such notice
period for delivery within thirty (30) days of the order. Commencing in the
third year of the Exclusive Period, Membrana may review Xxxxxx’ purchases over
the first [***] months of each year and if it is reasonably certain that Xxxxxx
will not achieve the minimum for that year, Membrana may provide Xxxxxx with
written notice of its intent to terminate the Exclusive Period for failure
to
meet the minimum. If within thirty (30) days of such notice Xxxxxx has not
provided to Membrana reasonable assurances of its ability and intent to
place orders sufficient to maintain exclusivity, Membrana may on notice
to Xxxxxx terminate the Exclusive Period, however if Xxxxxx shall have
met the minimum by the end of that same year, the Exclusive Period may be
reinstated upon mutual agreement of the parties. Should Membrana terminate
the
Exclusive Period early under the immediately preceding provision, Xxxxxx may
at
any time within [***]months thereafter terminate this Agreement on one year's
notice to Membrana. Three (3) months before the end of each calendar year Xxxxxx
and Membrana will meet and discuss previous sales volumes, market trends and
share sales forecasts for the next calendar year and prospective sales
development in the next three (3) years.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
2.2 During
the Exclusive Period, Xxxxxx agrees to apportion its orders and requested
delivery dates as much as reasonably possible so that Xxxxxx purchases
approximately one-fourth of its annual requirements over each three month
period. The minimum order size shall be [***] km of Product.
3. Third
Party Sales.
During
the Exclusive Period, Membrana shall not knowingly commercialize or supply
the
Products specified by this Agreement or membranes with specifications that
are
substantially similar to the Specifications hereunder for use in the Exclusive
Field to any third party that will incorporate such membranes into a product
whose composition, method of manufacture or method of use falls within a claim
of an issued U.S. patent that is owned by or licensed exclusively to Xxxxxx
(as
listed on Exhibit
C)
anywhere in the world unless such product is licensed by Xxxxxx to the third
party for the relevant use in the relevant jurisdiction. The patents that are
owned by or licensed exclusively to Xxxxxx are listed on Exhibit
C
hereto.
During the term of this Agreement, Exhibit
C
may be
updated with newly issued or licensed patents in writing from time to time
by
Xxxxxx. In addition, Membrana shall be permitted to develop and test
independently of Xxxxxx, membranes for application in the Exclusive Field during
the Exclusive Period, provided that in no event and at no time shall any Xxxxxx
Confidential Information or intellectual property be used by Membrana other
than
for the purpose of manufacturing and supplying Products for Xxxxxx hereunder.
Each party shall notify the other party of any potentially infringing products
of which it becomes aware. For the avoidance of doubt, nothing in this Agreement
shall restrict either party’s activities outside the Exclusive
Field.
4. Term;
Termination.
4.1 The
term
of this Agreement shall commence upon the Effective Date and, unless otherwise
terminated as provided herein, shall continue until the sixth anniversary of
the
Sale Date, where the “Sale Date” shall be the date of first sale by Xxxxxx to a
third party of a device containing Product for use in the Exclusive Field or,
if
earlier, three months following the date of CE xxxx approval of such a device
for Europe (or any other similar registration in any other jurisdiction with
population of at least 250 million persons by a regulatory authority, whichever
is given earliest). Xxxxxx shall confirm the first such sale date or date on
which the first such registration is received to Membrana in writing with the
relevant documents attached. If the Sale Date does not occur by December 31,
2009, Membrana shall have the right to terminate this Agreement upon fifteen
(15) days written notice.
4.2 This
Agreement may be terminated by a party hereto on 90 days’ prior written notice
if the other party commits a material breach and does not cure such breach
within the 90-day notice period, or on 60 days’ prior written notice in the
event that the other party becomes or is adjudged insolvent, makes an assignment
for the benefit of its creditors, has a petition filed in bankruptcy for or
against it or goes into liquidation (except for the purposes of a bona fide
amalgamation or other reorganization) or a receiver is appointed over all or
a
major part of the property or assets of that other party and such condition
is
not removed during such 60-day notice period.
2
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
4.3 In
addition to any other remedies available under this Agreement, Xxxxxx shall
be
entitled in its sole discretion to either terminate this Agreement or to convert
this Agreement to a non-exclusive agreement upon sixty (60) days notice given
in
writing to Membrana if:
4.3.1 |
the
regulatory status of Membrana’s facility is such that manufacture in
accordance with the warranty set forth in Section 11.1.1 and/or in
accordance with agreed delivery times is not
possible;
|
4.3.2 |
more
than [***] ([***]) consecutive shipments of Product contain in excess
of
[***]% of Product that fails to meet the warranty specified in Section
11.1.1;
|
4.3.3 |
Subject
to Section 7 below, Membrana fails to ship at least [***] percent
([***]%)
of the quantity of Product to be delivered within any [***] ([***])
day
period as provided in acknowledged purchase orders any [***] ([***])
times
during the term of this Agreement;
|
4.3.4 |
Subject
to Section 7 below, Membrana is late on confirmed shipment dates
by [***]
days or more any [***] ([***]) times during the term of this Agreement
provided that Membrana receives a binding purchase order from Xxxxxx
at
least twelve (12) weeks before the requested shipment date and Xxxxxx
is
in compliance with Section 6.1; or
|
4.3.5 |
Membrana
seeks to excuse performance hereunder due to Force Majeure for a
period of
more than ninety (90) days.
|
4.4 In
addition to any other remedies available under this Agreement, Xxxxxx shall
be
entitled in its sole discretion to convert this Agreement to a non-exclusive
arrangement upon sixty (60) days notice given in writing to Membrana if, subject
to Section 7 below Membrana is late on confirmed shipment dates by [***] days
or
more [***] ([***]) consecutive times during the term of this Agreement provided
that Membrana receives a binding purchase order from Xxxxxx at least twelve
(12)
weeks before the requested shipment date and Xxxxxx is in compliance with
Section 6.1.
5. Prices;
Delivery Terms.
5.1 Initial
Product prices for single order volumes of up to [***] km of Product are set
forth on Exhibit
D
(the
“Base
Prices”).
Surcharges may apply for special delivery requests and changes in bundle
configuration or other Specifications. Prices for single order volumes of
greater than [***] km of Product shall be negotiated between the parties. If,
during the term of this Agreement, changes occur in one or more factors
impacting Membrana’s price calculation, such as costs of materials, freight,
exchange rates, energy and governmental actions, Membrana shall be entitled
to
increase the Base Prices accordingly as follows: (i) if the event giving rise
to
the price change occurs between July 1 and December 31, upon the later to occur
of sixty (60) days’ prior written notice to Xxxxxx and the next January 1; or
(ii) if the event giving rise to the price change occurs between January 1
and
June 30, upon the later to occur of sixty (60) days’ prior written notice to
Xxxxxx and such June 30, specifying in reasonable detail the reason for the
change in price; provided that such price increases may only occur [***] per
calendar year and in no event shall the resulting prices exceed the Base Prices
multiplied by [***] ([***]) plus the cumulative percentage change in the German
Consumer Price Index (GCPI) from the Effective Date to the date of the relevant
increase. Xxxxxx will be deemed to accept any such price increase unless it
informs Membrana in writing within 15 days after receipt of the notice that
it
will not pay the higher price, in which case Membrana may elect to continue
to
fill orders after the expiration of the required notice period at the old price
or terminate this Agreement as of the expiration of the required notice period.
Neither party shall be entitled to direct or indirect damages as a result of
any
such termination.
3
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
5.2 Prices
and terms of delivery are FCA Membrana’s manufacturing facility in Wuppertal,
Germany (Incoterms 2000). Title and risk of loss shall pass to Xxxxxx upon
shipment of the Products.
5.3 Xxxxxx
shall have sixty (60) days to inspect the Products after their receipt. Xxxxxx
shall notify Membrana in writing of any claims for non-conforming Products
within such inspection period. Xxxxxx shall provide Membrana with a sample
of
the claimed non-conforming Product to allow Membrana to test the Product and
determine whether it is non-conforming. If it is determined by agreement of
the
parties (or in the absence of agreement of the parties by a mutually acceptable
independent testing laboratory or consultant whose fees shall be paid by the
non-prevailing party) that the non-conformity is due to damage to the Product
(i) caused by Xxxxxx or its agents or (ii) which occurs subsequent to delivery
of such Product to the carrier at Membrana’s facility, Membrana shall have no
liability to Xxxxxx with respect thereto. If the non-conformity is caused by
a
breach by Membrana of the warranty set forth in Section 11.1.1 below, Membrana
shall at Membrana’s option, (i) pay Xxxxxx the amount of the price paid by
Arbios for such non-conforming Product, (ii) offset the amount paid by Xxxxxx
for such non-conforming Product against other amounts then due Membrana
hereunder or (iii) replace such non-conforming Product with conforming Product
at no additional cost to Arbios. Subject to Section 6.2, any claims with respect
to non-conforming Product not made within the 60 day inspection period shall
be
deemed waived. Except as set forth in Sections 6.2 and 11.1.3(b) below, the
foregoing shall be Xxxxxx’ sole remedy for breach of the warranty.
6. Payment
Terms.
6.1 [***]
percent ([***]%) of the total invoice price is due and payable within 30 days
of
receipt of an order confirmation.
Production
on confirmed orders shall commence upon receipt of this first payment. The
remaining [***]% of the invoice price is due and payable per shipment but based
on the effective price for the total purchase order within 30 days of receipt
of
the relevant shipment. For any amounts not paid when due, Membrana may apply
interest at a rate of 1% per month from the date due until the date paid.
Shipments that are shipped to Xxxxxx more than ten days after the shipment
date
acknowledged by Membrana upon confirmation of the relevant purchase order may
be
accepted by Arbios at its discretion, subject to a penalty of [***]% of the
relevant invoice price, which penalty shall only apply if Xxxxxx is current
on
its payments at the time the relevant shipment is accepted by Xxxxxx. Any such
late shipments, if accepted by Xxxxxx at the reduced price, shall not count
towards the early termination rights set forth in Section 4 above. Duty, sales,
use or excise taxes imposed by any governmental entity that apply to the
manufacture of Product hereunder will be borne by Arbios (other than taxes
based
upon the income of Membrana).
6.2 Xxxxxx
shall be entitled to receive a credit against amounts due hereunder for membrane
scrap rates which exceed an annual average of [***]% ([***]% if annual purchase
volumes exceed [***] km) of any shipment due solely to membranes that are
outside the Specifications as determined using mutually agreed fiber integrity
tests. Such scrap rates shall be reported to Membrana at least quarterly. By
January 30 of each year, the parties will review the quarterly scrap rates
of
the previous year in order to determine the annual average. Without limiting
the
terms of this Agreement, including without limitation Section 6.2 the parties
agree to share adverse product yield impacts as measured by Xxxxxx fiber leak
rate in Xxxxxx filter manufacturing plant, as follows: Membrana will credit
Xxxxxx 1.30 times the invoice price of Membrane bundles rejected over an annual
average of [***]% ([***]% if annual purchase volumes exceed [***] km) of
membrane bundles incorporated by Xxxxxx in devices in a calendar month if such
fiber leaks are proven to be present in the membranes as shipped by Membrana.
Xxxxxx will supply Membrana with regular leak rate updates and whenever a leak
rate of over an annual average of [***]% ([***]% if annual purchase volumes
exceed [***] km) is reached, Membrana may request samples of defective bundles
prior to payment of a leak rate claim to confirm the accuracy of the claim
and
to assist in investigations. Any payments to be made pursuant to the foregoing
paragraph shall be calculated and made quarterly at the end of each calendar
quarter. For the avoidance of doubt, this Section is not intended to cover
fiber
leaks incorporated in finished devices that are approved for commercial sale
by
Xxxxxx’ quality assurance department.
4
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
6.3 Membrana
may reasonably adjust the payment terms if the creditworthiness of Xxxxxx
changes in Membrana’s reasonable discretion.
7. Forecasts
and Orders.
Xxxxxx
shall submit to Membrana a non-binding good faith annual forecast by September
15th
of each
year of its membrane needs for the following calendar year. Xxxxxx shall also
submit to Membrana a non-binding rolling six-month forecast updated once per
quarter. Membrana shall promptly notify Xxxxxx in writing if at any time
Membrana has reason to believe that it will be unable to supply the amounts
forecasted by Xxxxxx within the timeframes specified in the relevant forecast.
Binding purchase orders must be placed no later than twelve weeks in advance
of
the first desired ship date recited in such purchase order. Membrana shall
confirm whether it will supply Products consistent with all purchase orders
placed in accordance with the terms of this Agreement within ten business days
of receipt. For all confirmed orders, Membrana will produce and ship Product
consistent with each amount and within fifteen days of the order ship date
stated in the order acknowledgement provided that any delay due to the late
receipt of the first half of the invoice price shall be excluded from the
foregoing provision. Pricing for each order shall be determined by corresponding
the total purchase order size to the volumes indicated in the pricing bracket
on
Exhibit
D.
8. Confidentiality . The
term
“Confidential
Information”
means
any and all confidential information, know-how, data, specifications, formulae,
techniques, prices, processes and business information concerning the Products
or either party’s business, including the existence of this Agreement and its
terms and conditions. Membrana and Xxxxxx agree not to use Confidential
Information of the other party for any purpose other than for the purpose of
this Agreement and will not disclose the other party’s Confidential Information
to third parties. This restriction will survive termination of this Agreement.
The
obligations with respect to Confidential Information as provided above shall
not
apply to any Confidential Information of the other party which:
(a) is
or
becomes known to the public through no fault of the receiving party
hereunder;
(b) is
known
to the receiving party prior to its receipt from the disclosing
party;
(c) becomes
known to the receiving party through disclosure by a third party who has a
lawful right to disclose such information on a non-confidential basis;
or
(d) is
independently developed by the receiving party without reference to or use
of
the disclosed information.
9. Cooperation.
9.1 Xxxxxx
will be responsible for obtaining, at its expense, all regulatory and
governmental approvals and permits necessary for Xxxxxx’ use of any Product
manufactured under this Agreement or sale of any resulting Xxxxxx product.
Membrana will reasonably cooperate with Xxxxxx, at Xxxxxx’ expense, in efforts
to obtain regulatory approvals and shall permit representatives of any
regulatory agency having jurisdiction over the manufacture or marketing of
Xxxxxx products made using Product to inspect its facilities as reasonably
required.
5
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
9.2 For
regulatory compliance purposes, Xxxxxx has been provided with a list of
substantial raw materials used in the manufacture of the Product as of the
Effective Date. Xxxxxx shall be promptly notified in writing of any material
change in any raw materials which occurs after the Effective Date. Membrana
agrees to provide directly to a governmental regulatory agency governing Xxxxxx’
products (a “Governmental
Authority”),
any
information requested by such agency.
9.3 If
a
change in Specifications is required by a Governmental Authority or in order
to
address other reasonable safety or marketability issues as are disclosed to
Membrana, the parties will work together in good faith to qualify membranes
with
alternate specifications that will meet the approval of the Governmental
Authority or such other requirements. In the event that, within ninety (90)
days
of any notice by Xxxxxx of such a required change and the reasons therefor,
the
parties, despite good faith negotiations, cannot agree on terms for the supply
of such alternate membranes on terms and conditions reasonably similar to those
specified herein it being understood that changes in Specifications may require
changes in price, Xxxxxx shall have the right to terminate this Agreement on
at
least sixty (60) days prior written notice to Membrana; provided that following
any such termination, Xxxxxx shall not be permitted to purchase membranes
meeting any previously agreed Specifications from any third party for use in
the
Exclusive Field.
9.4 Xxxxxx
shall co-brand any products it sells containing the Products with Membrana’s
name pursuant to this Section 9.4. Xxxxxx shall include language pre-approved
by
Membrana, such approval to not be unreasonably withheld or delayed, on product
labels, brochures, publications and other promotional materials indicating
that
Membrana’s membranes are incorporated in Xxxxxx’ products.
10. Notices.Notices,
demands and communications hereunder to Xxxxxx or to Membrana shall be deemed
to
have been duly given if in writing and delivered by overnight delivery service
or sent by registered or certified mail (postage prepaid) or by facsimile
(confirmed by delivery of the notice by mail or overnight delivery service)
as
follows:
If
to
Membrana: Membrana
GmbH
Öhder
Xxxxxx 00
X-00000
Xxxxxxxxx, Xxxxxxx
Attention:
Xx. Xxxxxx Xxxxxx-Xxxxx
Telephone:
x00 (0) 000 0000 000
Fax:
x00
(0) 000 0000 000
with
a
copy to: Polypore
International, Inc.
00000
Xxxxx Xxxxxxxxx Xxxxx Xxxx
Xxxxx
000
Xxxxxxxxx,
XX 00000
Attn:
General Counsel
If
to
Xxxxxx: Xxxxxx
Systems, Inc.
0000
Xxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx,
XX 00000
Attention:
Xxxxx Xxxx
Telephone:
0-000-000-0000
Facsimile:
0-000-000-0000
6
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
Any
party
may designate by notice in writing a new notice address.
11. General.
11.1 Warranties;
Claims; Limited Remedies.
11.1.1
|
Membrana
warrants that the Products shall meet the Specifications and shall
be
manufactured in accordance with applicable ISO standards and all
applicable laws and regulations. THE
FOREGOING IS THE SOLE WARRANTY APPLICABLE TO THE PRODUCTS. MEMBRANA
MAKES
NO WARRANTIES, WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OTHER THAN THE
WARRANTY SET FORTH IN THIS SECTION 11.1.
|
11.1.2
|
Except
as set forth in Section 11.1.3, neither party shall be liable for
indirect, special, punitive or consequential damages including business
interruption damages related to this Agreement regardless of the
nature of
the claim or theory of recovery.
|
11.1.3
|
(a)
Xxxxxx shall indemnify, defend and hold harmless Membrana, its Affiliates
and their respective officers, directors, employees and agents
(“Membrana
Indemnified Parties”)
against any losses, costs or other damages, including reasonable
attorneys’ fees, arising from third party claims to the extent related to
(i) a breach of this Agreement by Xxxxxx, (ii) the incorporation
of
Products into Xxxxxx’ products, other than as covered by Section
11.1.3(b)(ii) below , and/or (iii) claims that Xxxxxx’ products infringe
on the intellectual property of a third party, other than as covered
by
Section 11.1.3(b)(iii) below.
|
(b) Membrana shall indemnify, defend and hold harmless Xxxxxx, its Affiliates and their respective officers, directors, employees and agents (together with Membrana Indemnified Parties, the “Indemnified Parties”) against any losses, costs or other damages, including reasonable attorneys’ fees, arising from third party claims to the extent related to (i) a breach of this Agreement by Membrana, (ii) Products supplied to Xxxxxx that do not conform with the warranty set forth in Section 11.1.1 and/or (iii) claims that the Products as sold to Xxxxxx or the manufacture of such Products infringe on the intellectual property of a third party. |
(c) Neither party shall owe an indemnity to an Indemnified Party unless the party seeking indemnification (i) provides prompt notice of a claim for indemnification, (ii) allows the indemnifying party to control the defense including settling a claim in its sole discretion, provided that no settlement shall impose an obligation on the Indemnified Party without such party’s prior written consent, and (iii) provides reasonable cooperation in the claim. |
11.2 Neither
party shall be liable for non-performance or delays in performance when due
in
whole or in part to any actual or threatened act of God, war, the public enemy,
mobilization, riot, strike, lockout or labor difficulties, drought, fire, flood,
explosion, accident, shortage of cars, delays of carriers, embargoes, the acts
or orders of governments or political subdivisions thereof, inability to obtain
suitable and sufficient supplies of raw materials from its customary sources,
or
any other contingency or cause beyond the reasonable control of the affected
party which prevents the manufacture, shipment, transport or use of Products
sold hereunder.
7
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
11.3 This
Agreement and the Exhibits attached hereto set forth the entire agreement and
understanding of the parties with respect to the transactions contemplated
hereby and supersede all prior agreements or understandings between the parties
with respect thereto. This Agreement may be amended, modified, superseded or
canceled only by a written instrument which specifically references this
Agreement and which is executed by authorized representatives of both Xxxxxx
and
Membrana. Any terms or conditions in conflict with or in addition to those
set
forth in this Agreement which appear on any purchase order forms,
acknowledgement forms, shipping documents or other similar documents and printed
forms, shall not be valid or binding.
11.4 This
Agreement is not assignable or transferable by either party without the prior
written consent of the other party except to its successor or the transferee
of
all or substantially all of the assigning party’s business and assets to which
this Agreement relates, and shall be binding upon and inure to the benefit
of
the parties, their respective Affiliates and their successors and permitted
assigns. Each party will cause its Affiliates to abide by the terms and
conditions of this Agreement.
11.5 Governing
Law; Dispute Resolution.
11.5.1
|
This
Agreement shall be governed by North Carolina law. The United Nations
Convention on Contracts for the International Sale of Goods shall
not
apply to this Agreement or the transactions contemplated
hereunder.
|
11.5.2 |
The
parties recognize that a bona fide dispute as to certain matters
may from
time to time arise during the term of this Agreement which relates
to
either party’s rights and/or obligations hereunder. In the event of the
occurrence of such a dispute, either party may, by notice to the
other
party, have such dispute referred to their senior officers as may
be
designated by each party for attempted resolution by good faith
negotiations within thirty (30) days after such notice is received.
In the
event the designated officers are not able to resolve such dispute
within
such thirty (30) day period, or such other period of time as the
parties
may mutually agree in writing, each party shall have the right to
pursue
available remedies through the dispute procedure set forth in Section
11.5.3. Notwithstanding the foregoing, each party shall have the
right to
seek immediate injunctive relief to enforce its rights under Section
8.
|
11.5.3 |
Any
disputes relating to this Agreement of whatever nature that cannot
be
resolved by negotiation between the Parties shall be referred for
final
resolution to arbitration by an arbitration panel comprising one
arbitrator appointed by Membrana and one arbitrator appointed by
Xxxxxx,
and a Chairman of the Arbitration Panel who shall be appointed by
the
first two (2) arbitrators. Any such arbitration proceeding shall
be
conducted in accordance with the arbitration rules of the American
Arbitration Association, and the arbitration award shall be final
and
nonappealable and such award may be entered in any court having
jurisdiction.
|
11.5.4 |
Any
arbitration arising out of this Agreement shall be brought only in
Charlotte, North Carolina or Wuppertal Germany, at the option of
the party
requesting the arbitration.
|
11.6 Nothing
in this Agreement shall give either party any ownership or rights to acquire
or
use any of the intellectual property of the other party.
8
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
11.7 The
failure of either party to enforce at any time any of the provisions of this
Agreement or to require at any time performance by
the
other party of any of the provisions hereof shall in no way be construed to
be a
partial or future waiver of such provisions nor in any way to affect the
validity of this Agreement or any part hereof or the right of either party
thereafter to enforce each and any such provision.
11.8 This
Agreement may be executed in counterparts, each of which shall constitute an
original and all of which, taken together, shall be deemed to be one and the
same original instrument. Delivery of an executed signature page by facsimile
shall be effective as an original signature.
11.9 If
any
one or more of the provisions contained in this Agreement including any exhibit
hereto should be held invalid or unenforceable in any respect, the validity
and
enforceability of the remaining provisions shall not in any way be affected
or
impaired thereby. The parties shall endeavor in good faith to replace the
invalid or unenforceable provisions with valid provisions that preserve the
intent of the invalidated provision.
***
9
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
IN
WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
day
and date first above mentioned.
Membrana GmbH | ||||
By: | /s/ Xxx Xxxxxx | By: | /s/ Xxxxxx Xxxxxx-Lotus | |
Name: | Xx. Xxx Xxxxxx | Name: | Xx. Xxxxxx Xxxxxx-Lotus | |
Title: | VP Sales and Marketing - Medical Separations | Title: | Manager New Business Development |
Xxxxxx Systems, Inc. | ||||
By: | /s/ Xxxxxx Xxxxx | |||
Name: | Xxxxxx X. Xxxxx | |||
Title: | President and CEO |
10
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
Exhibit
A
Products
(Hollow Fiber Membrane)
1. SYNCLEAR
bundles 0.2
|
|
Capillaries/bundle: | 12,000 +/- 100 |
Length/bundle: | 272 +/- 2 mm |
Bundle diameter: | 39 +/- 2 mm |
Fiber to yarn ratio: | 10:2 |
2. SYNCLEAR bundles 0.35 | |
Capillaries/bundle: | 12,000 +/- 100 |
Length/bundle: | 272 +/- 2 mm |
Bundle diameter: | 39 +/- 2 mm |
Fiber to yarn ratio: | 10:2 |
3. SYNCLEAR bundles 0.5 | |
Capillaries/bundle: | 12,000 +/- 100 |
Length/bundle: | 272 +/- 2 mm |
Bundle diameter: | 39 +/- 2 mm |
Fiber to yarn ratio: | 10:2 |
11
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
Exhibit
B
Specifications
SYNCLEAR
Capillary Membranes 0.2, 0.35 and 0.5
· |
Water
used for the production of SYNCLEAR membrane lots must meet specifications
of Membrana’s Quality Testing Plan;
|
o |
[***]
|
o |
[***]
|
· |
Tensile
Strength: [***]
|
· |
Elongation
at Break : [***]
|
· |
Performance
Testing
|
Membrane
Type
|
BSA
Sieving Coefficient*
|
Ultrafiltrate
Rate**
|
SYNCLEAR
0.5
|
[***]
|
[***]
|
SYNCLEAR
0.35
|
[***]
|
[***]
|
SYNCLEAR
0.2
|
[***]
|
[***]
|
*
BSA
sieving coefficient data calculated using 3 σ analyses (using a 5% BSA solution)
**Measured
in water 200 mbar
· |
Additional
physical properties according to currently valid data sheets as attached
(polymer, wall thickness, inner diameter, Albumin sieving
coefficient).
|
· |
Data
will be collected and specifications may be changed during the term
of
this supply agreement. However, specification changes need to be
agreed
upon by both parties in writing.
|
12
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
Exhibit
C
Xxxxxx’
Patents
U.S.
Patent. No. and
Issue
Date
|
Title
|
Inventors
|
5,571,418
11/5/1996
|
Hemofiltration
of Toxic Mediator-Related Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxx,
Xxxxxx X.
|
6,287,516
9/11/2001
|
Hemofiltration
Systems, Methods, and Devices Used to Treat Inflammatory Mediator
Related
Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
6,730,266
5/4/2004
|
Hemofiltration
Systems, Methods, and Devices Used to Treat Inflammatory Mediator
Related
Diseases
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
6,736,972
5/18/2004
|
Method
and System for Providing Therapeutic Agents with Hemofiltration for
Reducing Inflammatory Mediator Related Diseases
|
Xxxxxx,
Xxxxx X.
|
6,787,040
9/7/2004
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
U.S.
Appln. No. and
File
Date*
|
Title
|
Inventors
|
20060129082
8/11/2003
|
Selective
Plasma Exchange Therapy
|
Xxxxx,
Xxxxx
|
10/796,882
3/8/2004
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
10/826,736
4/16/2004
|
Hemofiltration
Systems, Methods and Devices Used to Treat Inflammatory Mediator
Related
Disease
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
|
10/843,933
(now allowed)
5/12/2004
|
Hemofiltration
Systems, Methods, and Devices Used for Treatment of Chronic and Acute
Diseases
|
Xxxxxx,
Xxxxx X.
|
11/387,556
3/23/2006
|
Method
and System for Colloid Exchange Therapy
|
Xxx,
Xxxxxxx X.
Xxxxxx,
Xxxxx X.
Xxxxxxxx,
Xxxxx
|
*Applications
shall only be deemed a part of this Exhibit C once issued and written notice
of
such issuance is delivered to Membrana.
13
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant
to
the Company’s application requesting confidential treatment under Rule 406
of the Securities Act
Exhibit
D
Prices
Base
Prices for Products shall be determined based upon the order size according
to
the table below.
Individual
Purchase Order size,
Km
of Product
|
Allowable
Increment of shipment size
Km
of Product
|
Increment
of Invoice Amount, Euro
|
Net
Invoice Amount,
Euro
|
Effective
Price per km Product for Full Increment
Order
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Example
A: Cost/Price Calculation: Single order for [***]
14