EXHIBIT 10.29
SUPPLY AND ASSEMBLY AGREEMENT
WITNESSETH, THIS SUPPLY AGREEMENT (the "Agreement") entered into and
effective as of the 31st day of January, 2000 ("Effective Date"), by and between
COMMAND MEDICAL PRODUCTS INC., a Florida corporation with an office and
principal place of business at 00 Xxxxxx Xxxxxx, Xxxxxx Xxxxx, XX 00000
("Command"); and HEMASURE INC., a Delaware corporation with an office and
principal place of business at 000 Xxxxx Xxxxx, Xxxxxxxxxxx, XX 00000
("HemaSure"). Command and HemaSure may be referred to hereinafter individually
as a "party" or collectively as the "parties."
WHEREAS, Command desires to manufacture and supply to HemaSure and
HemaSure desires to purchase from Command dry bag set Products, as defined
herein, on a non-exclusive basis pursuant to and in compliance with all of the
terms and conditions set forth herein; and
WHEREAS, Command desires to assemble HemaSure's r\LS System Filters, as
described herein, and HemaSure desires to retain Command for the assembly of
r\LS System Filters, on a non-exclusive basis pursuant to and in compliance with
all of the terms and conditions set forth herein.
NOW THEREFORE, in consideration of these premises, the promises and the
mutual agreements herein, and for other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the parties agree as
follows:
ARTICLE I
DEFINITIONS
In addition to words and expressions defined elsewhere in this
Agreement, for purposes of this Agreement, the following words and expressions
shall have the meanings hereby assigned to them. For the purpose of the
definitions contained in this Article and defined elsewhere in this Agreement,
the singular shall include the plural and vice-versa.
1. "Agreement Year" shall mean the period commencing on the Effective Date
and ending on December 31, 2000, and following such period, it shall
mean the applicable period of time during the term of this Agreement
and any extension or renewal thereof beginning on January 1 of that
respective Agreement Year and ending on December 31 of that respective
Agreement Year.
2. "Actual Annual Purchases" for any respective Agreement Year shall
mean, as applicable, the amount of each Product actually purchased by
HemaSure from Command as determined by release orders for the Products
issued by HemaSure and accepted by
908278.5
Command during that Agreement Year and/or the actual number of r/LS
System Filters assembled by Command and delivered to HemaSure during
that Agreement Year.
3. "American Red Cross" shall mean the American National Red Cross, a
not-for-profit corporation chartered by an act of Congress, and its
parents, subsidiaries, affiliates, permitted assignees, or successors
in interest.
4. "Assembly Pricing" shall mean the price per assembled r/LS System
Filter as set forth on Attachment A attached hereto and hereby
incorporated by reference, as amended in a writing signed by both
parties from time to time.
5. "COBE" shall mean Gambro, Inc. (formerly named COBE Laboratories,
Inc.), a corporation organized and existing under the laws of the state
of Colorado, and its parents, subsidiaries, affiliates, permitted
assignees, or successors in interest.
6. "Confidential Information" shall mean such confidential and
proprietary information each party hereto owns and uses in order to
conduct its business to which this Agreement pertains which includes,
without limitation, confidential and proprietary computer programs,
inventions, discoveries, tools, machines, articles of manufacture,
mechanisms, molds, fixtures, methods, processes, compositions,
mixtures, formulae, designs, techniques of production, manufacture or
assembly, know-how, show how, information which concerns the financial
affairs, development research, marketing practices, marketing plans and
strategies, internal policies and procedures, products, contracts,
suppliers, or customer lists, information with respect to any corporate
affairs, and other information which may or may not rise to the level
of a trade secret under applicable law, but which is not generally in
the public domain (and includes information transferred orally,
visually, electronically or by other means). Confidential Information"
shall include, without limitation, the Manufacturing Technology.
Confidential information shall not include: (i) information already
known or independently developed by the receiving party as evidenced by
competent proof; (ii) information in the public domain through no
wrongful act of the receiving party; or (iii) information received by
the receiving party from a third party having a lawful right to
disclose it.
7. "FDA" shall mean the Food and Drug Administration of the United
States of America.
8. "HemaSure Materials" shall mean the materials and parts supplied by
HemaSure to Command as set forth in Attachment B attached hereto and
hereby incorporated by reference, as may be amended in a writing signed
by both parties from time to time.
9. "Manufacturing Technology" shall mean those proprietary rights of the
respective parties in the molds, drawings, manufacturing processes,
know-how, show-how and technical data related to the manufacturing and
production of the Products and, in the case of HemaSure, the r/LS
System Filter.
908278.5
-2-
10. "Product Pricing" shall mean the price of each Product as set forth on
Attachment C attached hereto and hereby incorporated by reference, as
amended in a writing signed by both parties from time to time.
11. "Products" shall mean the dry bag sets listed and described on
Attachment D, attached hereto and hereby incorporated by reference, as
amended in a writing signed by both parties from time to time.
12. "Product and Assembly Specifications" shall mean the respective
Product and r/LS System Filter assembly specifications, in each case,
as set forth on Attachment E, attached hereto and hereby incorporated
by reference, as amended in a writing signed by both parties from time
to time, which in all cases, shall be deemed to meet requirements and
standards included in applicable federal, state and local laws
including, without limitation, the Food, Drug and Cosmetic Act, the
Medical Device Amendments of 1976, the Safe Medical Devices Act of
1990, and similar foreign laws, rules and regulations, including,
without limitation, the European Medical Device Directive.
13. "r\LS System Filter" shall mean HemaSure's filters used for pre-storage
reduction of the level of leukocytes in blood, and any revisions,
derivatives, or improvements thereto.
ARTICLE II
SUPPLY AND ASSEMBLY ARRANGEMENTS
1. Production of Products and Assembly of r/LS System Filters. Command
shall (i) manufacture and supply the Products and (ii) assemble r/LS System
Filters, in each case, solely in accordance with the Product and Assembly
Specifications supplied by HemaSure. Although the obligation to fabricate the
Products and assemble the r/LS System Filters conforming to Product and Assembly
Specifications belongs exclusively to Command, and the obligation to designate
and thereafter to approve the applicable specifications belongs exclusively to
HemaSure, and without intending to relieve either party of their respective
exclusive obligations, the parties hereto shall provide reasonable cooperation
and assistance to each other to facilitate the fabrication of the Products and
assembly of the r/LS System Filters. Command shall make no deviations or changes
from the Product and Assembly Specifications without HemaSure's prior approval.
2. Product and Assembly Pricing. Product & Assembly Pricing for each
purchase order issued by HemaSure shall be calculated per Attachment A
Attachment C. Hemasure shall issue quarterly purchase orders and annualize the
volumes to determine the corresponding price schedule. Product Assembly
Pricing shall be fixed for the term of the Agreement with the exception that
Command may increase or decrease the Product & Assembly Pricing on account of,
and solely to the extent of, (i) Command's raw material price increases or
decreases that are evidenced by Command's written records which shall be
provided to HemaSure and based on increases or decreases of Command's vendor
prices and (ii) after the first Agreement Year,
908278.5
-3-
Command's overhead cost increases or decreases that are evidenced by Command's
written records which shall be provided to HemaSure; and (iii) after one year,
Command's direct labor cost increases or decreases as evidenced by Command's
written records which shall be provided to HemaSure. Such Product & Assembly
Price increases may be affected only once per Agreement Year, and in any such
case, shall not be more than five percent (5%) of the then applicable Product &
Assembly Pricing. Notwithstanding the above, both parties acknowledge that this
five percent (5%) cap may need to be re-negotiated during the term of this
agreement based on any unforeseen circumstances beyond either parties control.
Overhead costs shall include costs associated with government mandated benefits,
payroll taxes, electricity and other utilities.
(a) In addition, at the end of every Agreement Year Command
shall compare the Actual Annual Purchases of Products by
HemaSure to the quantities that were used to establish the
mutually agreed upon invoiced Product Pricing as provided in
Attachment C or Assembly Pricing as provided in Attachment A
for that respective Agreement Year (and shall promptly provide
to HemaSure a detailed, written copy of such comparison). In
the event Actual Annual Purchases exceed said quantities for
that respective Agreement Year, then Command shall issue a
rebate or a credit to HemaSure in accordance with the quantity
pricing set forth on Attachment A and/or C, as the case may
be. In the event Actual Annual Purchases are less than said
quantities for that respective Agreement Year, then Command
shall issue a debit to HemaSure in accordance with the
quantity pricing set forth on Attachment A and/or C, as the
case may be. Command may, in its sole discretion, waive or
reduce any such debit for any respective Agreement Year. Any
such waiver or reduction of a debit for any respective
Agreement Year shall be on a non-precedential basis without
prejudice and Command shall not be obligated in any of the
following Agreement Years to waive or reduce any future debit.
(b) At least sixty (60) days prior to the commencement of any
Agreement Year, Command shall provide written notice (setting
forth reasonable details) to HemaSure of projected increases
or decreases to the Product Pricing for the upcoming
respective Agreement Year based on those Product Pricing
increase or decrease guidelines set forth above. The parties
hereby agree to negotiate in good faith and to agree upon
Product Pricing based on those Product Pricing increase or
decrease guidelines set forth above for each such respective
Agreement Year and to amend Attachment C each Agreement Year
accordingly. In the event no agreement on Product Pricing is
reached prior to the commencement of any respective Agreement
Year, such agreement shall be resolved pursuant to Section
12(b) 11(b) of Article III.
(c) The parties will use reasonable efforts to endeavor to develop
cost saving measures applicable to the Products and assembly
of the r/LS System Filter. After recoupment at a mutually
agreed upon rate of any capital investment made by a
908278.5
-4-
party in developing or implementing such cost saving measures,
such savings will be shared on a fifty/fifty (50/50) basis
between the parties in the form of reduced Product and/or
Assembly Pricing, as the case may be.
3. Delivery. HemaSure shall provide Command with specific order
delivery dates. Each order placed under this Agreement shall be considered
"on-time" if it is received by HemaSure during the period of 3 days prior to and
up until 3 days after the scheduled delivery date which is stated on the release
order issued by HemaSure and accepted by Command. If a delivery is not expected
to be made "on-time," as defined herein, Command shall notify HemaSure and shall
take all reasonable steps at its own cost to expedite delivery.
4. Supply Ability and Inventory. Command and HemaSure shall notify each
other of any events which may impact their respective abilities to supply and
purchase Products and assemble r/LS System Filters, including, without
limitation, FDA inspections, labor issues, facility issues and the like.
5. Tooling and Equipment of r\LS System Filters. HemaSure shall bear
the cost of tooling and equipment associated with the assembly of the r\LS
System Filters, and shall hold sole and exclusive title to such tooling and
equipment. The tooling and assembly equipment initially shall reside at
Command's facilities.
(a) In the event that Command fails to meet its delivery
requirements, HemaSure may request the transfer of its tooling
and assembly equipment to another facility designated by
HemaSure. In such Event, Command shall breakdown, package,
ship (FOB Ormond Beach, Florida), install and start-up the
applicable tooling and equipment. Command shall be paid for
the above services at a rate of $75 per hour, not to exceed
2,000 hours.
(b) Command shall be responsible for the maintenance of the
tooling and equipment and shall provide reasonable care in the
storage and handling of the tooling. HemaSure shall be
responsible for the repair of the tooling and equipment.
6. Forecasts to Command. HemaSure shall submit to Command, ninety (90)
days before each Agreement Year, in good faith, written forecasts setting forth
projected purchases on a quarterly basis of the Products and assembly
requirements for the upcoming twelve (12) month period. Forecasts prepared by
HemaSure pursuant to this Section shall be prepared by HemaSure in good faith
and shall represent HemaSure's reasonable expectation of its requirements for
the forecasted period. HemaSure shall commit to purchase eighty percent (80%) of
the Products and assembly requirements on account of such forecasts. The amount
of Products not purchased in any one Agreement Year shall rollover into the
following Agreement Year.
On a quarterly basis, HemaSure and Command shall review forecast and
capacity requirements for the following twelve (12) months and plan accordingly.
In the event that
908278.5
-5-
forecasts are updated or modified, HemaSure shall make a firm commitment to
purchase the Products and assembly requirements for the first two (2) months of
such updated forecast.
7. Ordering. HemaSure shall submit purchase orders on a monthly basis
setting forth its purchase requirements and delivery dates. The orders for
Products in the first two (2) months of an updated forecast as described in
Section 6 above shall become fixed orders.
(a) HemaSure shall submit a release order to Command on a monthly
basis at least six (6) weeks in advance of any required
shipment date in said release order in compliance with
HemaSure's most recent forecast. Command and HemaSure shall
keep each other apprised in good faith of their respective
requirements, projections, production capability limitations
and similar matters.
(b) Subject to the following sentence and Article III, Section
9(c), HemaSure agrees to purchase from Command from time to
time hereunder the minimum quantity purchases set forth on
Attachment F hereto. In the event HemaSure fails to purchase
the quantity of Products and assembly requirements as
designated in Attachment F in any respective Agreement Year,
then the remaining number of Products or assembly requirements
necessary to meet the quantity designated in Attachment F for
that respective Agreement Year shall be added to the purchase
quantities in for the subsequent Agreement Year. In the event
that HemaSure fails to purchase the quantity of Products or
assembly requirements designated in the purchase orders for
the third Agreement Year and any purchase requirements added
from previous Agreement Years as provided herein, then the
term of this Agreement shall be extended for one year during
which time HemaSure must purchase the remaining number of
Products and assembly requirements as are necessary to meet
the purchase requirements designated in Attachment F for the
third Agreement Year and any purchase requirements added from
previous Agreement Years as provided herein. Command's sole
recourse in the event of a breach by HemaSure of this Section
7(b) of this Agreement shall be as set forth in Article III,
Section 9(c). Notwithstanding the above paragraphs, HemaSure
must purchase at least 80% of the contract minimums per
Attachment F each Agreement Year.
8. HemaSure Supplied Materials. HemaSure shall provide Command with a
continuous supply of the HemaSure Materials at no cost to Command such that
Command can assemble the r\LS System Filters in quantities sufficient to meet
HemaSure's requirements of submitted and accepted purchase orders. If HemaSure
is unable to maintain a continuous supply of the HemaSure Materials and this
failure forces Command to shut down its production line, HemaSure agrees to pay
to Command, as its sole recourse, $1.71 per unit scheduled to be built during
the shutdown period at the then prevailing unit production run-rate. This will
cover all unrecoverable costs including labor and overhead. Command's failure to
supply HemaSure with assembly requirements or otherwise fail to perform its
obligations hereunder shall not be deemed a breach of this Agreement to the
extent such failure is caused by a lack of such a supply of the HemaSure
Materials from HemaSure. HemaSure intends to maintain a two (2) week inventory
908278.5
-6-
of the HemaSure Materials at Command's facility during the term of this
Agreement and any extension or renewal thereof as determined by reference to
purchase orders for assembly of r/LS System Filters issued by HemaSure and
accepted by Command.
9. Shipping. All Product shipments shall be EX WORKS Command's
manufacturing facility. Risk of loss shall pass to HemaSure at such time as the
Products are delivered to the carrier at Command's facilities. HemaSure shall
arrange for a carrier and mode of shipment. All freight, insurance and other
shipping expenses shall be borne by HemaSure and HemaSure shall be responsible
for filing any and all freight claims.
10. Acceptance.
(a) Acceptance by HemaSure or the receiving entities specified
by HemaSure of Products and assembled r/LS System Filters
delivered by Command hereunder shall be subject to reasonable
inspection and test by HemaSure or such receiving entities in
order to determine that the Products and assembled r/LS System
Filters comply with the Product and Assembly Specifications;
provided, however, HemaSure shall notify Command in writing of
any defects in any shipment of Products or assembled r/LS
System Filters within thirty (30) business days of the date of
delivery at HemaSure's designated manufacturing site. If
HemaSure does not notify Command of any such defects within
such time, the Products and assembled r/LS System Filters
shall be deemed accepted.
(b) The Products and assembled r/LS System Filters shall
consistently meet performance metrics mutually agreed upon by
HemaSure and Command. These metrics may change over the
performance of the Agreement to the satisfaction and
acceptance of both HemaSure and Command.
11. Quality Control. Command shall operate and maintain its
manufacturing and assembly operations in a sound state of control in compliance
with applicable XXX, XXX, XXX0000 and CEEN46002 regulations and/or HemaSure's
customer specifications as defined, including, but not limited to, the American
Red Cross and COBE. HemaSure and its customers shall have the right, but not the
obligation, to conduct periodic audits of all sites under Command's control
involved with manufacturing or assembling the Products and r/LS System Filters.
Command shall provide HemaSure and its customers with reasonable access to
Command's facilities, employees, specifications, production records, drawings,
or other records as necessary for HemaSure to secure regulatory approvals,
respond to regulatory inquires, investigate and address technical problems and
achieve technical improvements and address customer complaints. HemaSure and its
customers shall provide thirty (30) days written notice of any site audits. Each
party agrees to provide the other party with copies of any written notices
related to the manufacturing, sale, or use of the Products issued by any
governmental regulatory agency promptly after receipt from the governmental
regulatory agency or third party.
908278.5
-7-
12. Payment. Payment terms for all Products purchased pursuant to this
Agreement shall be in United States dollars and net thirty (30) days.
ARTICLE III
MISCELLANEOUS
1. Intellectual Property. Command expressly reserves its entire right,
title and interest in any and all intellectual property including, without
limitation, any inventions, patents, improvements, know-how, show-how, the
Manufacturing Technology, or other proprietary information of any kind related
to the production or manufacturing of the Products. All intellectual property of
HemaSure which shall include, without limitation, any inventions, patents,
improvements, trademarks, service marks, mask works, copyrights, trade secrets
or other proprietary information of any kind shall remain the sole and exclusive
property of HemaSure. HemaSure expressly reserves its entire right, title and
interest in any and all intellectual property including, without limitation, any
inventions, patents, improvements, know-how, show-how, or other proprietary
information of any kind related to the r/LS System Filter.
2. Indemnification. The provisions of this indemnification section
shall survive the termination, expiration, or non-renewal of this Agreement.
(a) HemaSure agrees to indemnify and hold harmless Command and
its directors, officers and employees from and against any and
all losses, costs, damages, fees and expenses arising out of
the assembly of the r/LS System Filter (excluding with respect
to the manufacture of the Products) but only to the extent
such losses, costs, damages, fees, and expenses were incurred
as a result of the negligence, gross negligence or willful
misconduct of HemaSure, provided that HemaSure shall have the
right to control the defense or settlement of any claim for
which Command is entitled to indemnification hereunder.
HemaSure shall not be liable for any litigation costs or
expenses incurred by Command (or its directors, officers or
employees) without HemaSure's prior written consent.
Notwithstanding the foregoing, HemaSure shall not be required
to indemnify Command for matters which HemaSure is indemnified
by Command hereunder.
(b) Command agrees to indemnify and hold harmless HemaSure and
its directors, officers and employees from and against any and
all losses, costs, damages, fees, and expense arising out of
the manufacture or sales of the Products and assembly of the
r/LS System Filter (excluding with respect to the HemaSure
Supplied Materials themselves), but only to the extent such
losses, costs, damages, fees, and expenses were incurred as a
result of the negligence, gross negligence or willful
misconduct of Command, provided that Command shall have the
right to control the defense or settlement of any claim for
which HemaSure is entitled to indemnification hereunder.
Command shall not be liable for any litigation costs or
expenses incurred by HemaSure (or its directors, officers or
employees)
908278.5
-8-
without Command's prior written consent. Notwithstanding the
foregoing, Command shall not be required to indemnify HemaSure
for matters which Command is indemnified by HemaSure
hereunder.
(c) A party seeking indemnification hereunder (the
"Indemnified Party") shall provide prompt written notice to
the party from whom indemnification is sought (the
"Indemnifying Party") of any written notice of a claim, action
or demand of any kind from a third party. The Indemnifying
Party shall undertake promptly the defense of such claim,
action or demand with defense counsel selected by the
Indemnifying Party, but reasonably satisfactory to Indemnified
Party. Notwithstanding any other provision of this Agreement,
the Indemnified Party may at any time elect to participate in
the defense of any claim, action or demand with counsel of its
own choice and at its sole expense without waiving the
Indemnifying Party's obligation to defend Indemnified Party.
The Indemnifying Party shall obtain the advance written
consent of the Indemnified Party (which consent shall not be
unreasonably withheld) prior to settling any claim, action or
demand.
3. Confidentiality. The parties may disclose certain Confidential
Information to each other. The party that discloses Confidential Information
pursuant to this Agreement is referred to herein as the "Disclosing Party" and
the party that receives such Confidential Information is referred to herein as
the "Receiving Party." The terms of this Agreement shall apply to any
Confidential Information that may be disclosed during the term of this Agreement
and any extension or renewal thereof and for a period of three (3) years after
the termination, expiration, or non-renewal of this Agreement for any reason,
with the exception that Confidential Information designated in writing by a
party to be a trade secret shall be protected by this Article for such time as
such Confidential Information remains a trade secret under applicable law. Such
Confidential Information shall be used solely for the purpose of each party
performing its obligations hereunder and not for any other purpose ("Purpose").
(a) Receiving Party acknowledges that the Confidential Information
is confidential and/or proprietary to Disclosing Party and is
claimed to be valuable, special and unique assets of
Disclosing Party. Accordingly, the parties agree that during
the term of this Agreement and for the respective
post-termination periods set forth herein, Receiving Party
shall:
(1) maintain the Confidential Information in confidence;
and
(2) not use any such Confidential Information received
from Disclosing Party except for the above-stated
Purpose; and
(3) disclose such Confidential Information received from
Disclosing Party only to its employees that have a
need to know such Confidential Information in order
to fulfill the Purpose; and
(4) not disclose any portion of the Confidential
Information received from Disclosing Party to any
third party without the prior written consent of
Disclosing Party, even if such third party is under
similar restriction on disclosure with Disclosing
Party.
908278.5
-9-
(b) Receiving Party agrees to use the same degree of care to
protect the confidentiality of all Confidential Information it
receives as it uses to protect its own Confidential
Information. However, Receiving Party in no event shall use
less than a reasonable degree of care to protect the
Confidential Information received from Disclosing Party.
(c) If Receiving Party is confronted with legal action to disclose
Confidential Information received under this Agreement,
Receiving Party shall promptly notify Disclosing Party, and
reasonably assist Disclosing Party in obtaining a protective
order requiring that any portion of the Confidential
Information required to be disclosed be used only for the
purpose for which a court issues an order, or for such other
purposes as required by law.
(d) All Confidential Information disclosed under this Agreement
shall remain the property of Disclosing Party. At Disclosing
Party's request, all Confidential Information received by
Receiving Party in tangible form shall be promptly returned or
destroyed.
(e) It is understood and agreed that damages may not be an
adequate remedy for Disclosing Party in the event of a breach
or threatened breach of this subsection (3) and, accordingly,
Receiving Party agrees that Disclosing Party will be entitled
to receive injunctive or other appropriate equitable relief
against Receiving Party and its representatives in the event
of such a breach or threatened breach.
4. Non-Solicitation. During the term of this Agreement and any
extensions or renewals thereof and for a period of one year thereafter, neither
party shall solicit for employment, employ, solicit for another business
relationship or otherwise retain any employee of the other party who is an
employee of the said other party at any time during the term of this Agreement
and any extensions or renewals thereof.
5. No Partnership or Agency. Nothing contained in this Agreement shall
be construed to create a partnership or joint venture among the parties or to
make a party an agent of the other party for any purpose.
6. Additional Representations and Warranties of the Parties.
(a) Each party represents and warrants that it shall obtain,
maintain and preserve any licenses, permits or other
authorizations necessary for the party to conduct its business
in accordance with this Agreement. Both parties shall comply
in all material respects with all of their respective
obligations under applicable federal, state and local laws
including, without limitation, the Food, Drug and Cosmetic
Act, the Medical Device Amendments of 1976, the Safe Medical
Devices Act of
908278.5
-10-
1990, and similar foreign laws, rules and regulations,
including, without limitation, the European Medical Device
Directive.
(b) In addition, each party represents and warrants to the
other party that, as of the date hereof, (i) it has the
authority to execute, deliver, and perform its obligations
under this Agreement, (ii) this Agreement has been duly
executed and delivered by such party and constitutes the
legal, valid, and binding obligation of such party enforceable
against such party in accordance with its terms (except as
enforceability may be limited by bankruptcy, insolvency, or
similar laws of general application from time to time
affecting the rights of creditors generally, or subject to
general principles of equity), (iii) neither the execution or
delivery of this Agreement nor the performance of its
obligations hereunder will conflict with or violate any
provision of, or result in the breach of, any material
agreement, note, mortgage, or indenture to which such party is
a party or by which its assets are bound, and (iv) there are
no actions, suits, proceedings, or investigations pending or
threatened in any court or before any governmental agency or
instrumentality against, by or affecting it or any of its
subsidiaries or their business, operations, or financial
condition or any of their properties or assets, or which would
prevent the carrying out of this Agreement or any of the
transactions contemplated hereby or declare the same unlawful
or cause the rescission thereof.
(c) Each party represents and warrants that it shall maintain the
following insurance coverages in full force and effect
throughout the term of this Agreement and any extension or
renewal thereof.
(i) Commercial General Liability Insurance in an
amount of at least $10,000,000 (Ten Million Dollars)
naming the other party as an additional insured
party, Workers' Compensation coverage covering the
party's own employees (but not employees of the other
party) with statutory limits for each jurisdiction
where required by the laws of that jurisdiction
(including monopolistic states if any work is to be
performed in one or more of them) and an employers'
liability policy with at least a limit of $250,000
per accident per employee.
(ii) Each party further agrees to maintain not less than
$10,000,000 (Ten Million Dollars) of products
liability coverage naming the other party as an
additional insured party. For Command such product
liability policy shall extend to Products
manufactured (and r/LS System Filters assembled) and
sold to HemaSure.
(iii) Command agrees to maintain full replacement
value "All Risk" property insurance on all property
and equipment of Command or HemaSure used by Command
at Command's facilities under this Agreement, and
further said property insurance shall insure at all
times all Products being
908278.5
-11-
manufactured or r/LS System Filters being assembled
and Command agrees to waive any right of subrogation
for loss or damage to any of Command's property at,
on, or in Command's facilities. Command agrees to
obtain, if required in such property insurance, a
waiver of subrogation in favor of HemaSure. Said
property insurance shall include Business
Interruption and Extra Expense coverage for such
losses arising from loss or damage to aforementioned
Command property without expectation of contribution
from any such insurance HemaSure may maintain.
(iv) Each party shall, at its sole expense, keep in
force policies of insurance in the amounts as
specified, and as required by statute, with carriers
reasonably satisfactory to the other party. Such
insurance shall be written as primary policy coverage
and not as contributing with, or in excess of, any
insurance which the other party shall carry.
Certificates of insurance evidencing all of the above
coverages and conditions (types and amounts) shall be
produced upon written request and remain in full
force and effect throughout the term of this
Agreement. Each party's certificate(s) of insurance
shall provide for not less than thirty (30) days
written notice of cancellation, non-renewal or
reduction to the other party.
7. Term. This Agreement shall commence on the Effective Date and shall
continue for an initial term of three (3) Agreement Years (i.e., the last
Agreement Year ending on December 31, 2002) unless extended for any additional
Agreement Years as provided herein or as may be mutually agreed upon by both
parties. Thereafter, this Agreement automatically shall renew for one (1) or
more additional successive year renewal terms until either party terminates this
Agreement upon one (1) year advance written notice to the other party.
8. Termination for Cause. This Agreement may be terminated at any time
immediately upon written notice upon the occurrence of any of the following
events:
(a) by either party in the event the other party materially
breaches any term or provision of this Agreement and such
breach is not cured within sixty (60) days of such party's
receipt of written notice of such breach;
(b) by either party in the event the other party makes an
assignment for the benefit of creditors, or is subject to any
voluntary or involuntary provincial or federal receivership,
insolvency or bankruptcy proceedings, or becomes unable, or
admits in writing its inability, to meet its obligations as
they mature;
(c) by either party in the event the other party is dissolved or
liquidated;
(d) by Command in the event HemaSure (i) fails to pay any order
invoices which are due and payable and which failure is not
remedied within sixty (60) days following written notice, (ii)
fails to purchase the minimum amount of Products or
908278.5
-12-
assembly requirements as specified in Article II, or (iii) is
permanently prevented from manufacturing the r/LS System
Filter due to material and adverse audit results of customers
or regulatory agencies;
(e) by HemaSure in the event Command (i) fails to meet its
delivery requirements and provide consistent product
acceptance metrics as mutually agreed upon by both parties, so
long as, in the case of the r\LS System Filters, HemaSure
supplies the HemaSure Materials as provided herein, (ii) fails
to meet, and agree to in writing, the cost targets set forth
in Attachments A and C hereto as and when specified therein,
or (iii) is prevented from manufacturing Product due to
material and adverse audit results of customers or regulatory
agencies; and/or
(f) as otherwise provided in this Agreement.
Without prejudice to any other remedy for breach of this Agreement,
upon termination for cause of this Agreement, neither party shall be released
from the payment of any sum owed to the other party, which sum shall become
immediately due and payable.
9. Rights and Obligations Upon Termination. Upon the termination,
non-renewal, or expiration of this Agreement, the following rights and
obligations shall apply:
(a) Notwithstanding the termination of this Agreement, each party
shall continue to hold the other party's Confidential
Information in confidence and prevent disclosure to third
parties as provided herein.
(b) In the event that Command fails to meet delivery, cost and
acceptance metrics, HemaSure shall not be obligated to
purchase the Product minimums.
(c) In the event that HemaSure fails to purchase the contract
minimums set forth in Attachment F and provided in Article II,
Section 7(b), HemaSure shall reimburse Command, as its sole
recourse, $0.75 per unit shortfall when and as provided in
such Section and Attachment. This shortfall will be used to
cover commitments made by Command to procure building and
other long term capital expenditures. This shortfall payment
obligation shall not be applicable if HemaSure terminates this
agreement due to any fault of Command.
(d) Immediately upon the termination, non-renewal, or expiration
of this Agreement, all sums owed by each party hereto to the
other shall become due and payable immediately upon such
termination, non-renewal, or expiration.
(e) The provisions of this Agreement which are expressed to
survive this Agreement or to apply notwithstanding termination
hereof shall be observed and respected by both parties.
908278.5
-13-
10. Force Majeure. Neither party shall be liable to the other party for
its failure to perform or for delay in the performance of its obligations under
this Agreement to the extent such failure or delay results from causes beyond
its reasonable control, including, without limitation, acts of God, fires,
hurricanes, explosions, wars or other hostilities, insurrections, revolutions,
strikes, labor unrest, earthquakes, floods, epidemics or quarantine
restrictions, lack of materials, unforeseeable governmental restrictions or
controls, or transportation embargoes or interruptions; provided, however, that
a party must provide written notice to the other party of such extraordinary
circumstances that may prevent or delay the party's performance hereunder. If a
party is prevented from performing its obligations under this Agreement because
of such extraordinary circumstances for a period of sixty (60) consecutive days,
then the other party may terminate this Agreement upon thirty (30) days' notice
to the other party with a further opportunity to perform until the date of such
termination.
11. Governing Law; Jurisdiction.
(a) This Agreement, all transactions executed hereunder, and the
legal relations between the parties shall be governed by and
construed solely in accordance with the laws of the State of
New York, without reference to the conflict of laws principles
thereof.
(b) In the event that any dispute or controversy arises
between the parties with respect to this Agreement or a breach
hereof, the parties shall submit such dispute or controversy
to binding arbitration before the American Arbitration
Association ("AAA") in New York, New York in accordance with
the Commercial Arbitration Rules of AAA. Each party hereby
irrevocably agrees that service of process, summons, notices
or other communications related to the arbitration procedure
shall be deemed served and accepted by the other party if
forwarded in accordance with the Notices section of this
Agreement. The arbitrator shall apportion all costs and
expenses of the arbitration including, without limitation, the
arbitrator's fees and expenses and the attorneys' fees and
expenses of both parties, between the prevailing and
non-prevailing party as the arbitrator deems fair and
reasonable. The award may be enforced in any court of
competent jurisdiction.
(c) Notwithstanding the foregoing or any other provision of this
Agreement, either party may seek and obtain provisional
equitable, injunctive or other judicial relief from a court of
competent jurisdiction in order to preserve the status quo
pending resolution of disputes or controversies pursuant to
this section. The provisions of this Article III, Section 11
shall survive the termination, expiration, or non-renewal of
this Agreement.
12. Binding Effect. This Agreement shall be binding upon and be for
the benefit of the parties and their respective successors and permitted
assigns.
908278.5
-14-
13. Supremacy. The terms and conditions of this Agreement take
precedence over all purchase orders and all sales confirmations between Command
and HemaSure. To the extent any term in any purchase order or any sales
confirmation conflicts in any manner with any term or condition of this
Agreement, this Agreement shall govern.
14. Severability. If any provision of this Agreement is held by a court
of competent jurisdiction to be invalid, illegal, or unenforceable, then the
remainder of this Agreement shall remain in full force and effect. In the event
any such provision previously held to be invalid, illegal, or unenforceable, is
thereafter held by a court of competent jurisdiction to be valid, legal, or
enforceable, then said provision shall automatically be revived and incorporated
into this Agreement.
15. Waiver. No waiver of any rights or breach of any provision of this
Agreement shall constitute a waiver of any other right or breach of any other
provisions, nor shall it be deemed to be a general waiver of such provision by
the waiving party or to sanction any subsequent breach by the other party.
16. Assignment. Neither party shall assign this Agreement, or any
right or obligation thereunder, to any third party without the prior written
consent of the other party. In the event either party consents to such an
assignment by the other party, then all provisions and obligations of this
Agreement shall apply equally to any assignee with the same force and effect as
they apply to the assignor.
17. Modification. This Agreement may not be altered or modified except
in writing, duly executed by an authorized representative of both parties.
18. Notices. All notices, requests or other communications to any party
shall be sufficient if contained in a written instrument delivered in person,
sent by fax with confirming copy sent by registered or certified mail or sent by
overnight courier, addressed to such party at the address set forth below or
such other address as may be designated in writing:
Command: HemaSure:
Command Medical Products, Inc. HemaSure Inc.
00 Xxxxxx Xxxxxx 000 Xxxxx Xxxxx
Xxxxxx Xxxxx, XX. 00000 Xxxxxxxxxxx, XX 00000
Fax No. 904/000-0000 Fax No. 508/485-604
Attn: Xxxxx X. Xxxxx, Xx. Attn: Xxxx X. XxXxxxx
Any notice sent in compliance with this section shall be effective upon the date
of delivery if delivered in person, upon the date of transmission if sent by
fax, or upon the date following the date the notice is sent by overnight
courier.
908278.5
-15-
19. Public Statements. No party hereto shall use or reference the name
of any other party hereto including, without limitation, issuing any press
releases or otherwise making any public statement with respect to this Agreement
(unless such press release or statement is required by applicable law,
regulation, or the requirements of any listing agreement with any applicable
stock exchange), without the prior written consent of the other party, which
consent shall not be unreasonably withheld.
20. Facsimile Signatures. Counterpart copies of this Agreement may be
signed by all parties hereto and signature pages exchanged by facsimile. The
parties intend that counterpart copies signed and exchanged as provided in the
preceding sentence shall be fully binding. Counterpart originals of this
Agreement shall be exchanged by United States mail or courier service at the
earliest reasonable date following the exchange of signature pages by facsimile.
21. Entire Agreement. This Agreement contains the entire agreement
between the parties with respect to the subject matter of this Agreement and
supersedes all prior arrangements, agreements or understandings with respect to
such matters. No course of performance or prior dealings nor any custom or usage
of trade shall be relevant to supplement or explain any terms used in this
Agreement.
908278.5
-16-
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed in duplicate originals by their duly authorized representatives as of
the day and year first above written.
COMMAND MEDICAL PRODUCTS HEMASURE INC.:
INC.:
/s/ Xxxxx X. Xxxxx, Xx. /s/ Xxxx X. XxXxxxx III
------------------------------ --------------------------------
Name: Xxxx X. XxXxxxx III
President President & CEO
908278.5
-17-
ATTACHMENT A
ASSEMBLY PRICING
Product Description Annual Quantity Price
R/LS DR0030 <2mm $3.60
R/LS DR0030 2mm and > $3.52
R/LS DR0030 3mm and > $3.18
R/LS DR0030 5mm and > *
R/LS DR0030 10mm and > **
o The packaging proposal and requirements incorporated into Assembly
Pricing shall meet conventional quality standards for shipment
integrity, maintenance of sterility and ease of use.
** No later than 45 days from the date of this Agreement, Command shall
agree in writing with HemaSure that the Assembly Pricing for the
specified annual quantity shall be less than $2.00 per unit, and in the
case of annual quantities at or in excess of 10 million units, the
price shall be reasonably less than the agreed upon pricing for
quantities at or in excess of 5 million.
908278.5
ATTACHMENT B
HEMASURE MATERIALS
1. Part Number BNSR01001, HemaSure r/LS(TM) Pre-Storage
Leukoreduction Filter-Bulk, Non-Sterile
908278.5
ATTACHMENT C
PRODUCT PRICING
Product Description Annual Quantity Price
R/LS Bulk Bag Assembly <2mm $2.25
H50050-001
R/LS Bulk Bag Assembly 2mm and > $1.85
H50050-001
R/LS Bulk Bag Assembly 3mm and> $1.70
H50050-001
R/LS Bulk Bag Assembly 5mm and > *
H50050-0
R/LS Bulk Bag Assembly 10mm and > *
H50050-0
* No later than 45 days from the date of this Agreement, Command shall
agree in writing with HemaSure that the Product Pricing for the
specified annual quantity shall be less than $1.00 per unit, and in the
case of annual quantities at or in excess of 10 million units, the
price shall be reasonably less than the agreed upon pricing for
quantities at or in excess of 5 million.
908278.5
ATTACHMENT D
PRODUCTS
1. Assembly, r\LS Xxxxx Xxx, 0 Xxxx, 000xx with Pillow Bag, Part
Number H50050
2. Assembly, r\LS, Part Number RLSDR0030, (Non-Sterile)
908278.5
ATTACHMENT E
PRODUCT AND ASSEMBLY SPECIFICATIONS
(Attached)
1. PS H00002, REV-, Assembly, r\LS, Dated 1/24/00
2. PS H00001, REV C, Assembly, r\LS Xxxxx Xxx, 0 Xxxx, 000xx, with Pillow Bag.
935008.1 3/28/2000 10:58p
Page 1 of 4
HemaSure PART DOC NO. REV
SPECIFICATION PS H00002
SUBJECT Assembly, r\LS DATE RCA
1/24/00
1.0 SCOPE
This document describes the conditions and specifications that must be met for
the part described herein regardless of the source of supply. This document is
to be used in conjunction with individual purchase specifications written for
each r\LS configuration and supplier.
2.0 CONDITIONS
2.1. For the purpose of this specification "visible" or "visual"
refers to features which are apparent to the unaided eye when
viewed at 18-20 inches maximum distance, for 5 seconds at
normal room lighting.
3.0 SPECIFICATIONS
3.1. General.
3.1.1. HemaSure is responsible for the design of the r\LS
assembly.
3.1.2. HemaSure will notify supplier in writing of any
changes to the materials, assembly, packaging, or
labeling that may be required.
3.1.3. Supplier is responsible for ensuring that the assembly
meets the requirements specified in this document and
the applicable assembly drawings.
3.1.4. Supplier may not make changes to the design,
materials, or processes, which could impact the
performance or appearance of the assembly without
notifying the HemaSure Purchasing Department and
securing written approval from HemaSure.
3.2. Quality Requirements.
3.2.1 The assembly must be manufactured, processed, and
tested in conformance with FDA's Medical Device
Quality System (21 CFR 820).
3.2.2 Supplier may not subcontract components,
sub-assemblies, or testing except for injection
molded parts. HemaSure reserves the right to perform
periodic audits of supplier.
3.2.3 The r\LS must be assembled in a class 100,000
cleanroom on operation per FED STD 209E.
AUTHOR DATE 1ST APPROVER DATE
MAB 1/24/00
2ND APPROVER DATE OTHER APPROVER DATE
935008.1 3/28/2000 10:58p
Page 2 of 4
HemaSure PART DOC NO. REV
SPECIFICATION PS H00002
SUBJECT Assembly, r\LS DATE RCA
1/24/00
3.2.4. Supplier is required to communicate any deviations to
the process that affect the ability of supplier to
release the assembly to HemaSure.
3.2.5. The assembly must be produced under controlled,
validated processes. A Quality Plan, Validation Master
Plan, and a Device Master Record are required for each
r\LS configuration and each manufacturing facility.
3.2.6. Supplier must ensure that Quality Control records are
to be kept for 7 years.
3.2.7. HemaSure reserves the right to audit the quality
system of its suppliers, to recommend corrective
actions, and to verify the implementation and
effectiveness of corrective actions.
3.2.8. A copy of the Quality Certification must be included
with each shipment of bags. The content of the Quality
Certification is specified in the individual Purchase
Specifications and is agreed to by HemaSure and the
supplier by the signing of the Purchase Specification
document.
3.2.9. A member of the supplier's QA department must sign the
Quality Certification.
3.3. Regulatory Requirements.
3.3.1. Supplier must maintain a device history record (DHR)
for the assembly which satisfies the requirements of
FDA's Medical Device Quality System Final Rule (21 CFR
820.184).
3.3.2. Supplier will perform environmental monitoring of all
cleanroom areas used in the manufacture of the r\LS
assembly. Monitoring will include particulate and
microbiological surveys at supplier defined frequency.
Results of the monitoring will be made available to
HemaSure for review.
3.4. Manufacturing/Materials of Construction Requirements.
3.4.1. Materials of construction per applicable HemaSure DMR
(refer to individual purchase specification).
3.4.2. No material substitutions can be made to the suppliers
DMR without written approval from HemaSure's Quality
Assurance.
3.4.3. Assembly and configuration.
935008.1 3/28/2000 10:58p
Page 3 of 4
HemaSure PART DOC NO. REV
SPECIFICATION PS H00002
SUBJECT Assembly, r\LS DATE RCA
1/24/00
3.4.3.1. per attached drawing.
3.4.4. Labeling
3.4.4.1. All devices are to be labeled with a lot number and
expiration date of 2 years from the date of
sterilization.
3.4.4.2. The lot number is to be located on the blood storage
bag, the tyvek lid and the outer box.
3.4.4.3. The expiration date is to be located on the tyvek
lid and the outer box.
3.4.5. Sampling
3.4.5.1. Samples of the production lot for testing and
retains are to be boxed in separate boxes and
identified as to prevent inadvertent mixup with the
rest of the normal production lot.
3.4.6. Sterilization
3.4.6.1. All devices are to be Gamma sterilized by a HemaSure
qualified sterilization facility. A sterilization
validation must be done for each facility that
manufactures the r\LS. (Per ANSI/AAMI/ISO 11137)
3.4.6.2. A dose setting validation must be done for each
manufacturing facility. (Per ANSI/AAMI/ISO 11137)
3.4.7. Device History Record (DHR)
3.4.7.1. A DHR must be maintained for each production
lot that is manufactured. The DHR must contain all
quality records listed in the Device Master Record
(DMR). Also, copy of all labeling that was used to
identify the product.
3.5. Physical and Functional Requirements
3.5.1. Tubing strength > 10 lb.
3.5.2. Tubing free of permanent kinks.
3.5.3. Port Bond strength: > 4.5 lb. force
3.5.4. The r\LS device and all connections to the device must
be integral and tested at 100%, with no exceptions.
The method of determining integrity shall be pressure
decay at 10.5 psi + .05psi. Leak limit rate shall be
.5in H2O.
3.5.5. Imbedded and/or loose particulate matter: No more than
6 particles exceeding .40 sq. mm. No more than 6
particles total; no more than 3 particles per sq. in.,
per TAPPI standards T213 & T437.
935008.1 3/28/2000 10:58p
Page 4 of 4
HemaSure PART DOC NO. REV
SPECIFICATION PS H00002
SUBJECT Assembly, r\LS DATE RCA
1/24/00
3.6. Packaging Requirements.
3.6.1. The supplier is responsible for insuring that devices
arrive at HemaSure (or designed storage location)
integral, damage free, and contamination free.
3.6.2. Package burst testing at the start and end of each
production shift required for each production lot.
Burst testing parameters:
Pressure 40.00 psig
Time 4.00 sec
Flow 8 porous
Burst test limit >.66
3.7. Testing Requirements.
3.7.1. The following tests are to be performed on the r\LS
after sterilization for final release testing:
3.7.2. 10 devices per lot for LAL pyrogen per USP XXIII
Pg. 1696
3.7.3. 1 device per quarter for Cytotoxicity (MEM Elution)
per USP XXIII
Pg. 1697
3.7.4. 10 device semi annually for Rabbit pyrogen per USP
XXIII Pg. 1718
3.7.5. 12 devices per lot for blood performance TP H00034.
3.7.6. 3 devices for bag bond strength TP H00030.
3.7. References.
ISO 10993 Biological Evaluation of Medical Devices.
USP XXIII
US Federal Standard 209E Airborn Particulate Cleanliness
Classes in Cleanrooms and Clean Zones.
Tappi-TC13, T437 methodology
21 CFR 820 FDA Medical Device Quality System Final Rule
ISO 3826 Plastic collapsible containers for human blood
and blood components
935008.1 3/28/2000 10:58p
Page 1 of 6
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
1.0 SCOPE
This document describes the conditions and specifications that must be met for
the part described herein regardless of the source of supply. This document is
to be used in conjunction with individual purchase specifications written for
each bag configuration and supplier.
2.0 CONDITIONS
Each shipment is to include a Quality Certification per section 3.8. Quality
Certifications may be formatted individually by each supplier as long as they
contain the information required by this specification.
3.0 SPECIFICATIONS
3.1. General.
3.1.1. HemaSure is responsible for the design of the Blood
Bag assembly.
3.1.2. HemaSure will notify supplier in writing of any
changes to the materials, assembly, packaging, or
labeling that may be required.
3.1.3. Supplier is responsible for ensuring that the assembly
meets the requirements specified in this document and
the applicable assembly drawings.
3.1.4. Supplier may not make changes to the design,
materials, or processes, which could impact the
performance or appearance of the assembly without
notifying the HemaSure Purchasing Department and
securing written approval from HemaSure.
3.1.5. Supplier will supply HemaSure with a cup of resin for
every lot of ES3000.
3.2. Manufacturing Requirements.
3.2.1. The assembly must be manufactured, processed, and
tested in conformance with FDA's Medical Device
Quality System (21 CFR 820).
3.2.2. Supplier may not subcontract components,
sub-assemblies, or testing except for injection molded
parts. HemaSure reserves the right to perform periodic
audits of supplier.
AUTHOR DATE 1ST APPROVER DATE
MAB, RBD 9/20/99
2ND APPROVER DATE OTHER APPROVER DATE
935008.1 3/28/2000 10:58p
Page 2 of 6
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
3.3. Quality Requirements.
3.3.1. Supplier is required to communicate any deviations to
the process that affect the ability of supplier to
release the assembly to HemaSure.
3.3.2. The assembly must be produced under controlled,
validated processes.
3.3.3. Supplier must ensure that the assemblies meet the
requirements of HemaSure's Test Specification TS
H00006. Quality Control records are to be kept for 7
years. Five (5) blood bag retains are to be kept by
HemaSure also for 7 years.
3.3.4. HemaSure reserves the right to audit the quality
system of its suppliers, to recommend corrective
actions, and to verify the implementation and
effectiveness of corrective actions.
3.4. Physical and Functional Requirements.
3.4.1. Pyrogenicity.
3.4.1.1. The assembly must pass the U.S.P. LAL
Pyrogen Test. Test method must comply
with USP XXIII.
3.4.1.2. A 10 unit composite (random samples) is
to be tested using the LAL methodology.
The maximum acceptable Pyrogen level is
< 5 EU/assembly.
3.4.1.3. Particles - no more than the following
effluent particulate
levels (USP XXIII):
50 particles per ml >10 u
5 particles per ml > 25 u
6.5 fibers
3.4.1.4. Once validated, the LAL and particulate
testing for each lot is not required. The
environmental monitoring will serve as an
indicator to the process.
3.4.2. Cleanliness
Surfaces of the assembly must be free of
non-embedded foreign matter. No embedded
particles larger than 0.4mm2, using Tappi
TC13 and T437 methodology, are
acceptable.
3.4.3. No visible film vestige on bag perimeter
seal edges.
3.4.4. The bag must be assembled in a class
10,000 cleanroom in operation per FED Std
209E.
935008.1 3/28/2000 10:58p
Page 3 of 6
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
3.4.5. Materials (refer to attached drawing for
configuration).
Description
600 ml storage bag: ES3000 clear virgin PVC
gamma stabilized compound containing plasticizer
di-2-ethylhexylphthalate (DEHP); taffeta finish
on inside, matte finish on other side. Thickness
.016" + 1"
Spike ports: TechnoFlex model TS450.50 (gamma
stable). Tube sleeves for 600 ml bag: ES3000
virgin PVC; 0.149" + .003 I.D., 0.209" + .003
O.D., 0.75" + .05 long; frosted finish. -
Spike Port Sleeve: 0.310" + .005 O.D., 0.250" +
.005 I.D., 1.0" + .05 long
50 ml pillow bag: ES3000 clear virgin PVC (same
as 600 ml storage bag).
Tube sleeve: virgin ES3000; 0.149" + .003 I.D.,
0.209" + .003 O.D., 0.54" - 0.80" long; frosted
finish.
Tubing: virgin ES3000; extruded;
frosted; 0.160" - .004 O.D., 0.118 - .004 I.D.
Two lengths of transfer tubing, both tubing
lengths imprinted with segmented identification
numbers. Outlet tubing: Minimum 13 usable
segments; tubing length 44" - 47" ref. only.
Pillow bag tubing: Minimum 4 usable segments;
tubing length 17" - 17.50" ref. only. Maximum
105o tubing end cut.
Tubing clamps: blue and Red polypropylene, gamma
stable; 1" long; Xxxxxx-Xxxxxxx #C340TCSPB
(blue), #C340TCSPR (Red) or equivalent.
3.4.6 Assembly and configuration.
3.4.6.1. The assembly is to be assembled per
attached drawing.
3.4.6.2. Coiling:
Refer to individual purchase
specifications for instructions.
3.4.6.3. The 600 ml bag must be free of scuff
marks, smudges, stray markings, or other
cosmetic defects.
3.4.6.4. Vinyl imperfections:
Material shall be free from wrinkles and grease
when viewed from a distance of 18 inches. Pin holes
are not allowed. Particulate - With a sample size
of 3 linear feet, particles embedded in the
material such as black, brown, yellow resin shall
be reported as follows:
935008.1 3/28/2000 10:58p
Page 4 of 6
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
Size Particle Count Score Point
---- --------------------------
> .031 Reject
.020 - .030 4
.010 - .019 10
.005 - .009 15
3.4.7. Labeling of the 600 ml blood storage bag (if
applicable - refer to individual Purchase
Specifications):
3.4.7.1. Label alignment - label should be no more
than .5" off centerline in any direction.
3.4.7.2. Printing must be clear and legible. No
smearing is allowed.
3.4.7.3. Misprinted letters are acceptable if no
more than 50% of a letter is misprinted
with a maximum of 1 misprinted letter per
word and 5 misprinted words per assembly.
3.4.8. Labeling of the tubing segments.
3.4.8.1. Outlet tubing: 13 segments per unit min.,
44" - 47" tubing length (ref. only).
Pillow bag tubing: 4 segments per unit
min., 17" - 17.5" tubing length (ref.
only). No missing letters or numbers.
3.4.9. Tubing strength: > 10 lb.
3.4.10. Tubing free of permanent kinks.
3.4.11. Open end of tubing must be cut evenly,
maximum 105o angle cut, no jagged cuts.
3.4.12. Port Bond strength: > 10 lb.
3.4.13. Final leak test: inline pressure decay
testing.
3.5. Packaging Requirements.
3.5.1. Assemblies are to be placed in a double poly lined
shipper in a manner that precludes damage during
shipping and handling. The inner poly liner must be
tied (or otherwise fastened) closed. The outer liner
must be closed to prevent contamination.
3.5.2. No more than 1 product lot is to be contained within
a shipper.
3.5.3. Refer to individual purchase specifications for
labeling of the shipment (shipper and packing slip)
and for the quantity of assemblies per container.
935008.1 3/28/2000 10:58p
Page 5 of 6
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
3.6. Regulatory Requirements.
3.6.1. Supplier must maintain a device history record (DHR)
for the assembly which satisfies the requirements of
FDA's Medical Device Quality System Final Rule (21
CFR 820.184).
3.6.2. The DHR must also indicate that each lot conforms
with the specified particulate levels and testing
protocol.
3.6.3. Supplier will perform environmental monitoring of
all cleanroom areas used in the manufacture of the
blood bag assembly. Monitoring will include
particulate and microbiological surveys at supplier
defined frequency. Results of the monitoring will be
made available to HemaSure for review.
3.7. References.
3.7.1. Refer to individual purchase specifications for any
unique labeling and packaging.
3.7.2. HemaSure Test Specification TS H00006, 600 ml Blood
Bag.
3.7.3. ISO 3826 Plastics collapsible containers for human
blood and blood components.
3.7.4. ISO 10993 Biological Evaluation of Medical Devices.
3.7.5. USP XXIII.
3.7.6. US Federal Standard 209E Airborne Particulate
Cleanliness Classes in Cleanrooms and Clean Zones.
3.7.7. Tappi - TC13, T437 methodology.
3.7.8. 21 CFR 820 FDA Medical Device Quality System Final
Rule.
3.7.9. Blood Bag Testing Protocol TP H00030.
3.7.10. Blood Bag Testing Form H148.
3.8. Quality Certification.
3.8.1. A copy of the Quality Certification must be included
with each shipment of bags. The content of the
Quality Certification is specified in the individual
Purchase Specifications and is agreed to by HemaSure
and the supplier by signing the Purchase Spec.
document.
3.8.2. A member of supplier's QA department must sign the
Quality Certification.
935008.1 3/28/2000 10:58p
Page 6 of 7
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
[DRAWING OMITTED]
935008.1 3/28/2000 10:58p
Page 7 of 7
HemaSure PART DOC NO. REV
SPECIFICATION PS H00001 C
SUBJECT Assembly, r\LS Blood Bag, 4 Port, DATE RCA
600 mL, with Pillow Bag 9/20/99 1523
REVISIONS
Rev RCA - Date Released Description
C 1523 / 9-21-99 Change length reference dimensions of tube sleeve,
outlet tubing, air bag tubing per GCM. Encompass
range suitable for both vendors. See Sections 3.4.5
chart, 3.4.8.1. drawing.
B 1477 / 5/26/99 See RCA 1477.
A 1473 / 5/26/99 See RCA 1473.
- 1461 / 4/14/99 Released - See RCA 1461.
935008.1 3/28/2000 10:58p
ATTACHMENT F
MINIMUM PURCHASE SCHEDULE*
Product/Agreement Year Ending 12/31/2000 12/31/2001 12/31/2002
1. Assembly, r\LS Xxxxx Xxx, 0 Xxxx, 0.0xx 3.0mm 3.0mm
600ml with Pillow bag.
2. Assembly, r\LS, Part Number: 1.00mm 2.0mm 2.00mm
RLSDR0030, (Non Sterile)
o SUBJECT TO ARTICLE II, SECTION 7(b).
935008.1 3/28/2000 10:58p
