EXHIBIT 6.2
CONTRACT MANUFACTURING AGREEMENT
THIS CONTRACT MANUFACTURING AGREEMENT is entered into as of April 7, 2000,
by and between Retractable Technologies, Inc. ("RTI"), a corporation organized
under the laws of the state of Texas with its principal place of business at ▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇ and Nypro Precision Assemblies, Inc. ("NPA")
a corporation organized under the laws of the State of California, with its
principal place of business at Suite F, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
RECITALS:
A. RTI has designed and developed certain medical Products (as defined below).
B. NPA, in conjunction with its wholly owned Mexican subsidiary ENSAMBLES
NYPRO, S.A. de C.V. ("NPA - Mexico"), is in the business of toll
manufacturing medical products for third parties.
C. RTI wishes to contract with NPA to toll manufacture the Products at the
Tijuana Plant of NPA - Mexico located in Tijuana, Mexico.
D. In connection with the foregoing, RTI intends to purchase and consign to
NPA certain machinery and equipment to be used by NPA and NPA - Mexico in
the manufacture of the Products at the Tijuana Plant.
NOW THEREFORE, in consideration of the mutual covenants contained herein,
RTI and NPA agree to the following:
1. DEFINITIONS:
As used in this Agreement, the following terms shall have the following
meanings:
a. "Affiliates" shall mean (a) an entity controlled by a common parent
that owns more than fifty percent of the voting stock of both such
entity and one of the parties to this Agreement and (b) such parent
company.
b. "Approval Date" as to any particular Product, shall mean the date on
which such Product has been cleared for marketing pursuant to a 510(k)
submission to the FDA and all other necessary clearances, approvals or
registrations from the FDA or other appropriate regulatory authorities
have been obtained so as to enable the manufacture, distribution,
marketing and sale of such Product.
c. "Batch" with respect to any of the Products, refers to a separate and
distinct quantity of such Product processed under continuous and
identical conditions and designated by a batch or lot number and an
expiration date.
d. "Certificate of Compliance" shall mean a document certifying that a
Batch of a particular Product or Molded Component meets all
Specifications or other requirements therefor, as the case may be,
which Certificate is dated and signed by a duly authorized
representative of the Quality Control or Quality Assurance department
of the party rendering the same.
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e. "Chula Vista Facility" shall mean the facility of NPA located at Suite
F, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
f. "Contract Anniversary Date" shall mean the first day of May. By way of
illustration, the first contract Anniversary Date shall be May 1, 2001
and the Second Contract Anniversary Date shall be May 1, 2002.
g. "Contract Year" shall mean, with respect to each year, the period May
1 through the following April 30. By way of illustration, the Second
Contract Year shall commence on May 1, 2000 and shall run through
April 30, 2001.
h. "Cost of Assembly" shall mean the fully absorbed or total
manufacturing cost to NPA of assembling Products under the terms of
this Agreement, calculated in accordance with United States generally
accepted accounting principles consistently applied.
i. "Equipment" shall mean the machinery and equipment identified on
Schedule A hereto and any production, testing, manufacturing or other
machinery and equipment provided to NPA or its Affiliates on a
consignment basis by RTI for the purpose of assembling RTI Products.
j. "FDA" shall mean the United States Food and Drug Administration, or
any successor body.
k. "CGMP" shall mean current good manufacturing practice as required by
the regulations of the FDA.
l. "RTI" shall mean Retractable Technologies, Inc.
m. "Molded Components" shall mean any item listed on Schedule B hereto
(as such Schedule may be amended from time to time by mutual agreement
between the parties), which are produced and supplied by RTI to NPA
for incorporation into the Products.
n. "Initial Term" shall mean that period commencing on April 7, 2000 and
ending on April 6, 2001.
o. "Maximum Volume Commitment" shall mean the maximum amount of Product
which NPA shall be required to process for RTI in any given Contract
Year (unless otherwise mutually agreed to by the parties in writing),
pursuant to Section 7 hereof.
p. "Minimum Volume Commitment" shall mean the minimum amount of Product
which RTI shall order from NPA in any given Contract Year (unless
otherwise mutually agreed to by the parties in writing), pursuant to
Section 7 hereof.
q. "NPA" shall mean Nypro Precision Assemblies, Inc.
r. "NP" - Mexico" shall mean Ensambles Nypro, S.A. de C.V.
s. "Other Materials" shall mean all raw materials (other than RTI Molded
Components) utilized in the manufacture of the Products.
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t. "Products" or "Product" shall mean the Products set forth on Schedule
C hereto, as the same shall be amended in writing from time to time by
the mutual agreement of RTI and NPA.
u. "Purchase Orders" shall have the meaning set forth in Section 6 below.
v. "Shipment Instruction" shall mean the written shipment instructions
pursuant to which RTI shall direct NPA to ship Product; provided,
however, that in the event of any conflict between the terms of such
Shipment Instructions and the terms of this Agreement, the terms of
this Agreement shall be controlling.
w. "Specifications" of a particular Product shall mean the specifications
for such Product stated in the "RTI Assembly Product Specification" as
set forth in Schedule D, as the same may be amended from time to time
in writing by the mutual agreement of RTI and NPA.
x. "Technology" shall mean that technology (including technical,
scientific, industrial information or knowledge, confidential
information and expertise) in relation to the formulation and
composition of any of the Products and the processes, means and
procedures for the manufacture and production of Products utilizing
any of the Molded Components and/or any of the Other Materials.
y. "Tijuana Plant" shall mean the manufacturing plant owned and operated
by NPA - Mexico at 2 do Eje Oriente Poniente #20581 Cd. Industrial
Nueva Tijuana Otay Tijuana, B.C.C.P. 22500 Mexico.
z. "Trademarks" shall mean the trademarks set forth on Schedule E hereto.
aa. "Defects in Workmanship" shall mean making products which do not meet
specifications established by the RTI.
2. MANUFACTURING SERVICES
Subject to the terms and conditions of this Agreement, NPA shall, and shall
cause NPA - Mexico, to manufacture Product at the Tijuana Plant for RTI pursuant
to applicable Purchase Orders utilizing the Technology and in accordance with
the Specifications provided by RTI.
3. EQUIPMENT; INITIAL START-UP; ONGOING MAINTENANCE
a. RTI will provide the Equipment for assembly of the Products to NPA on
a consignment basis, for installation and use at the Tijuana Plant.
RTI will be responsible, at its cost, for arranging shipment of the
Equipment to the Tijuana Plant, and will coordinate and arrange for
the installation, debugging and validation of the Equipment, all with
assistance from NPA.
b. All validation documents related to the Equipment shall be the sole
property of RTI. To the extent that any of such documentation is
required to be maintained and updated at the Tijuana Plant, NPA shall
properly maintain and update the same in accordance with all
applicable FDA rules and regulations, and shall forward to RTI all
such copies of such documentation as RTI shall request. At the
termination of this Agreement all of such validation documentation
shall be promptly returned to RTI at RTI's cost. NPA may retain a copy
of all validation documentation for archival purposes.
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c. RTI will be responsible for providing the initial training of NPA's
staff in the operation and maintenance of the Equipment and in
connection therewith shall arrange for the provision to NPA of all
necessary training manuals and maintenance guides required for
operation of the Equipment and continual training by NPA of new
employees.
d. NPA agrees that all of such Equipment will be used exclusively for the
manufacture of the Products. Use of the Equipment for any other
purposes may occur only with the prior written consent of RTI.
e. NPA will be responsible for maintaining the Equipment in a reasonable
manner by adherence to equipment use and maintenance guidelines
provided by the manufacturer of the equipment. NPA agrees further to
use only those operators and mechanics who have been trained in the
proper and appropriate use and care of the Equipment pursuant to
Section 3(c) above.
f. RTI shall reimburse NPA for all reasonable maintenance costs of the
Equipment, including purchasing a reasonable spare parts inventory and
providing for any needed factory servicing, provided that NPA shall
provide to RTI appropriate invoices or other documentation detailing
such costs, in form reasonably satisfactory to RTI.
g. RTI will retain ownership of the Equipment at all times during and
after the term of this Agreement. Upon termination of this Agreement,
NPA will promptly return the Equipment to RTI at such location in the
United States of America as RTI shall designate. NPA shall ensure that
upon the termination of this Agreement, for whatever reason, the
Equipment is returned to RTI in good working order, subject to normal
wear and tear, and is shipped in an appropriate commercial manner, by
carrier reasonably acceptable to RTI. In the event that this Agreement
is terminated for any reasons the cost for the return of the Equipment
to RTI shall be borne by RTI, except in the event that NPA terminates
this Agreement for convenience.
h. NPA will use its best efforts and take all such actions as are
necessary or appropriate to identify the Equipment as the property of
RTI and to secure the ownership, right, title and interests of RTI in
and to the Equipment under the applicable state and federal laws of
the United States and Mexico.
4. MOLDED COMPONENTS AND OTHER MATERIALS
a. RTI shall provide to NPA all RTI Molded Components necessary to
produce the Products. In addition, RTI shall provide to NPA all Other
Materials required to produce the Products, except as otherwise
provided for in Section 4 (b) below.
b. Notwithstanding the provisions of Section 4(a) above, NPA and RTI may
agree from time to time that certain Other Materials will by purchased
by NPA on behalf of RTI. In no case shall such a purchase be made
except pursuant to prior written agreement. In the event of such a
purchase, NPA shall provide to RTI copies of invoices or other
statements detailing such purchases in a form reasonably complete and
satisfactory to RTI. Upon the receipt of such documentation, RTI shall
promptly reimburse NPA for all costs incurred by NPA in connection
with the purchase of such Other Materials for the account of RTI. In
such case, NPA shall be responsible for ensuring that all of such
Other Materials meet all Specifications and are otherwise in
compliance with all
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applicable FDA standards for use in the Products, all in a manner
consistent with the provisions of this Section 4.
c. All RTI Molded Components and all Other Materials provided or arranged
to be provided by RTI hereunder shall be delivered to NPA at the Chula
Vista Facility. All RTI Molded Components shall be packed in double
bagged clear poly bags with each bag labeled stating RTI part number,
lot number and quantity therein. RTI will assure suitable packing of
RTI Molded Components so as to withstand all reasonable handling.
d. RTI will ensure that all shipments of RTI Molded Components are
accompanied by shipping papers specifying the part numbers and lot
numbers and quantity of the shipment as well as a Certificate of
Compliance in respect thereof. It shall be the responsibility of the
party ordering any Other Materials (whether RTI or NPA) to ensure that
a Certificate of Compliance in respect of such Other Materials is sent
to the other party.
e. NPA will complete a receiving report upon receipt of each shipment
from RTI. If there is a discrepancy between the receiving report and
the shipping papers for any RTI Molded Components or any Other
Materials ordered or provided by RTI, then NPA shall notify RTI
immediately by fax. The notice shall detail the discrepancy and
provide all necessary information regarding the shipment. RTI shall be
responsible for resolving any such discrepancy and locating any lost
items. In the event of such a discrepancy, NPA shall not assemble any
portion of the shipment until directed in writing by RTI to do so.
f. NPA may refuse to accept or to process damaged or improperly packaged
RTI Molded Components or any Other Materials provided or ordered by
RTI within seven (7) days of receipt thereof. NPA shall notify RTI
immediately in writing of any refusal to accept shipment immediately
upon refusing shipment. The notice shall detail the reason for the
refusal and should be accompanied by the appropriate shipping papers
and Certificate of Compliance as well as any samples or pictures which
would demonstrate the reason given. RTI shall investigate the
complaint and respond to the NPA complaint. RTI shall provide NPA with
any written report resulting from such investigation. In the event the
complaint is deemed justified and the material is unusable, RTI shall
be responsible for procuring replacement material as quickly as
possible. In the event that the complaint is not deemed justified, the
parties shall meet to resolve the matter, negotiating in good faith.
g. RTI agrees to supply to the Chula Vista Facility all RTI Molded
Components and required Other Materials not less than one week prior
to the scheduled week for assembly thereof.
h. RTI will retain ownership of the Molded Components and Other Materials
at all times during and after the term of this Agreement. Upon
termination of the Agreement, NPA will promptly return all unused
Molded Components and Other Materials to RTI at such location in the
United States of America as RTI shall designate. NPA shall ensure that
upon the termination of this Agreement, the Molded Components and
Other Materials are returned to RTI in substantially the same
condition and packaged in the same manner as when received by NPA and
are shipped in an appropriate commercial manner, by carrier reasonably
acceptable to RTI. The party responsible for the cost of the return of
Equipment to RTI under Section 3(g) shall also be responsible for the
shipping cost for the return to RTI of the Molded Components and Other
Materials.
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i. NPA agrees that RTI shall be entitled to store at the NPA facility, at
no cost to RTI, quantities of RTI Molded Components and Other
Materials sufficient for fifteen (15) days of assembly of Products, as
detailed in the Forecasts described in Section 5 below. NPA shall use
appropriate care and diligence in storing such RTI Molded Components
and Other Materials, and shall keep the same in a segregated area in
the NPA facility. NPA will use its best efforts and take all such
actions as are necessary or appropriate to identify the RTI Molded
Components and Other Materials as the property of RTI and to secure
the ownership, right, title and interests of RTI in and to the RTI
Molded Components and Other Materials under the applicable state and
federal laws of the United States and Mexico. Notwithstanding the
foregoing, RTI shall bear the risk of loss or damage for the RTI
Molded Components and Other Materials stored at the NPA facility.
5. FORECASTS
a. RTI shall deliver to NPA, within thirty (30) days after the execution
of this Agreement, a non-binding, but best estimate, forecast of
orders for Products for the First Contract Year, broken out on a
calendar quarter basis. Thereafter, not later than sixty (60) days
prior to each Contract Anniversary Date, and subject to the applicable
Maximum Volume Commitments and Minimum Volume Commitments, RTI shall
deliver to NPA a non-binding, but best estimate, forecast of order for
Products for the subsequent Contract Year, broken out in the same
manner as for the First Contract Year.
b. RTI shall deliver to NPA, thirty (30) days prior to the commencement
of each month in a Contract Year, a binding Purchase Order of Product
to be assembled by NPA during said month and a best estimate forecast
of Product to be assembled by NPA during each of the two months
following said month. However, RTI shall deliver a binding Purchase
Order for assembly work to be performed during the first month of the
First Contract Year not less than 30 days in advance of such month.
6. PURCHASE ORDERS
Orders for NPA to assemble Product shall be placed by RTI by means of
written purchase orders ("Purchase Orders") in a form reasonably acceptable to
both RTI and NPA, accompanied by Shipment Instructions, which shall be delivered
by RTI to NPA at its designated address. All such Purchase Orders shall conform
with the requirements as to price and quantity that are set forth elsewhere in
this Agreement. In the event of any conflict between the terms of any such
Purchase Order or Shipment Instructions and the terms of this Agreement, the
provisions of this Agreement shall control unless the parties have specifically
agreed in writing otherwise. NPA shall confirm in writing to RTI each Purchase
Order within (5) days of its receipt of such order. For confirmed purchase
orders, RTI shall not issue any change orders pertaining to shipments within the
(15) days of the date of scheduled shipment.
7. MINIMUM AND MAXIMUM ORDERS
a. Set forth on Schedule H hereto is the Minimum Volume Commitment for
each Product for the Initial Contract Year, subject to the Approval
date for each particular Product.
b. Set forth on Schedule H hereto is the Maximum Volume Commitment for
each Product for the Initial Contract Year, subject to the Approval
Date for each particular Product.
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c. Not later than ninety (90) days prior to each Contract Anniversary
Date, the parties shall review and agree upon revised Minimum Volume
Commitments and Maximum Volume Commitments, on a product-by-product
basis, for the succeeding Contract Year. In the event that the parties
do not agree upon such revised commitments for a subsequent Contract
Year, then the existing Minimum Volume Commitments and Maximum Volume
Commitments shall remain in effect for such subsequent Contract Year.
8. PURCHASE PRICE FOR PRODUCT
a. The purchase price for each of the Products for the First Contract
Year shall be as set forth on Schedule G attached hereto. Not later
than ninety (90) days prior to each Contract Anniversary Date the
parties shall review the pricing for the subsequent Contract Year. In
the event that NPA's Cost of Assembly for assembling the Products
shall have increased or decreased during the prior twelve months, then
the parties shall adjust the purchase price for Products for the next
Contract Year, either upward or downward, to reflect such changes in
NPA's Cost of Assembly during the prior twelve months. Notwithstanding
the foregoing, in no event shall the price on any particular product
be increased or decreased in any Contract Year by more than five
percent (5%) from the preceding Contract Year.
b. In conducting the foregoing review of the purchase price, NPA shall
make available to RTI such books, records and evidence as NPA shall
provide to analyze the change in NPA's Cost of Assembly and justify a
change in pricing.
c. NPA will invoice after delivery of Products in accordance with RTI's
Shipping Instructions, and payment will be due within thirty (30)
calendar days after the date of invoice, without deduction or offset,
in United States dollars and delivered to NPA at the address stated on
the invoice.
9. SHIPMENT OF PRODUCT
a. Upon receipt and acceptance of a Purchase Order from RTI, NPA shall
use its best efforts to ship Products from the Chula Vista Facility to
RTI or other site designated by RTI in the Shipment Instructions
within seven (7) days of the shipment date specified in such Purchase
Order.
b. The shipment and delivery of the Products by NPA as provided in
Paragraph 9(a) above shall be by a freight company approved by RTI and
shall meet the FDA requirements for delivery of non-sterile medical
device Products. RTI shall pay for all freight, F.O.B. the Chula Vista
Facility, and for all insurance costs.
10. QUALITY CONTROL: ACCEPTANCE OF PRODUCTS AND PRODUCT COMPLAINTS
a. NPA shall perform the quality control tests on the Products as
prescribed by RTI for the assembled components and/or packaged
devices. NPA shall provide RTI with advance written notice of any
proposed changes to the method of manufacture, associated facilities
or other validated processes associated with any of the Products. All
changes to process shall require written prior authorization from RTI.
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b. NPA shall label the Products as outlined in quality control procedures
and instruction manuals provided by RTI. A copy of the Certificate of
Compliance to each Batch of Product shipped to RTI will be sent to RTI
upon shipment from NPA, pursuant to Section 9(a) above.
c. NPA will comply with all CGMP and other FDA and other regulatory
requirements applicable to the processing of Products at NPA and NPA-
Mexico facilities. RTI shall be entitled to conduct audits with or
without notice to NPA to assure compliance with said requirements.
During any such audit contemplated by this subsection RTI shall, in
order to ensure that NPA and NPA-Mexico comply with CGMP and other FDA
and other regulatory requirements applicable to the processing of the
Products, have the right: (i) to inspect manufacturing facilities of
NPA and NPA-Mexico; (ii) to inspect quality control procedures; and
(iii) to review any records maintained pursuant to this Agreement.
d. In the event that (i) any Products are returned to RTI by its
customers alleging that said Products are defective or (ii) RTI
receives any other Product complaints from its customers or (iii)
receives or is informed of any Product complaint from any consumer,
then RTI shall notify NPA in writing, specifying the manner in which
said Products are claimed to be defective or the nature of the
complaint. Upon receipt of such notification NPA shall, and shall
cause its Affiliates to, provide all reasonable assistance to RTI in
investigating and analyzing the Product complaints. NPA shall promptly
provide to RTI a written report within ten (10) days of its
determination and conclusion with respect to the Product complaint.
e. Except for returns of Product which fail to meet the Specifications or
other requirements set forth in this Agreement, the parties understand
and agree that the Products are made-to-order for RTI and that there
shall therefore be no returns whatsoever for credit of properly
manufactured Products which meet those Specifications and requirements
and are timely delivered in accordance with Purchase Orders.
11. PRODUCT WARRANTY AND RECALLS
a. PRODUCT WARRANTY
NPA warrants that the Products assembled for RTI under this Agreement
will be, at the time of delivery to RTI, free from any liens or other
defects in title, will conform to the applicable specifications set
forth by RTI, and will be free from material defects in workmanship
(and materials, if NPA is responsible for procuring materials from its
own sources) under normal use and service. NPA will not, however, be
responsible for, and this warranty will not apply to any defects in
the Products arising out of RTI's design or the use of materials or
components that RTI furnished to NPA or directed NPA to use. A claim
under this warranty must be made by RTI in writing within 2 months
from the date of delivery of the applicable units of Product. NPA's
obligations to RTI under this warranty are as follows:
i. RETURNS
A. NPA will, at its option, repair or replace without charge to
RTI any of Products found to be defective within the terms
of this warranty if RTI returns it, freight prepaid to NPA.
At NPA's option, however, NPA may also elect to accept
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return of the Product and refund to RTI the purchase price
RTI paid for such product. Repaired or replaced Product will
carry this same warranty for the balance of the warranty
period.
B. NPA will not be required to ship replacement Products until
NPA has confirmed through examination that the returned
units are defective within the terms of this warranty. NPA
will pay freight costs to shop any repaired or replacement
units to RTI. If NPA is unable to repair or replace the
returned units within a reasonable time, then RTI will be
entitled to the refund of its purchase price for the units.
C. This warranty does not apply to any defect attributed to
purchased components specified by RTI, or to any units of
Product which NPA determines have been subjected by a party
other than NPA to: operating or environmental conditions
beyond those normally expected for the Product based upon
the materials specified, improper application, improper
maintenance or repair, alteration, accident or any other
negligent omission in use or handling.
D. Products returned to NPA which NPA determines are not
defective within the terms of this warranty will be returned
to RTI, and RTI will reimburse NPA upon invoice for return
transportation charges and NPA's normal hourly charge
applicable to inspection of the Product.
E. Purchased components of the Products specified by RTI are
warranted only to the extent, and subject to the terms of
the original warranty given by the manufacturer to NPA.
NPA's sole obligation with respect to such components shall
be, at RTI's expense, to prosecute on behalf of RTI all
warranty claims against such component manufacturers upon
receipt of written authorization of RTI.
b. RECALLS
i. If RTI determines that a Product should be recalled for any
reason, including without limitation an FDA request for a recall
or a voluntary product withdrawal, RTI shall give written notice
to NPA specifying its reasons for the necessity of a recall (the
"Recall Notice").
ii. In the event that RTI believes that the reason for such Product
recall is a defect in the Product caused by the failure of the
Product to meet appropriate Specifications upon shipment by NPA,
then RTI shall so specify in the Recall Notice.
iii. If NPA agrees with RTI's determination of fault on the part of
NPA as stated in such a Recall Notice, then NPA shall, at the
option of RTI, either:
A. use all reasonable efforts to replace all Product so
recalled within sixty (60) days from the date of the Recall
Notice; or
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B. refund to RTI the purchase price RTI paid for the recalled
Products, or credit RTI the amount NPA invoiced RTI for the
recalled Products.
iv. In all other cases, if, within ten (10) days from the date that
NPA receives the Recall Notice, RTI and NPA have not reached an
agreement concerning RTI's determination as to the fault of NPA
in connection with such recall, then the parties shall submit the
recalled Product to a mutually acceptable independent laboratory
for a written report (the "Recall Report"), the cost of which
shall be paid by the party against whom the disagreement is
resolved. In the event that the Recall Report resolves the
disagreement against NPA, then RTI shall be entitled to the
remedies provided for in Section 11(b)(iii). In the event that
-
the Recall Report resolves the disagreement in favor of NPA, then
NPA shall have no obligation to RTI with respect to replacement
of the Product or reimbursement of expenses in connection
therewith. Notwithstanding the foregoing, nothing herein shall in
any way be deemed to limit or restrict the right of RTI to
implement a recall at its sole discretion for any reason, and
should it elect to do so, then NPA shall cooperate with RTI in
connection with such recall as elsewhere provided in this Section
11(b).
v. With respect to any recall, RTI shall contact the FDA and shall
be responsible for coordinating all of the necessary activities
in connection with such recall, Product withdrawal, or field
correction, and shall make all statements to the media, including
but not limited to, press releases and interviews for publication
or broadcast. NPA, as instructed by RTI, will use its best
efforts to cooperate in all investigations involving any recall,
Product withdrawal, or field correction of any Product.
vi. NPA shall immediately notify RTI of any inspections by the FDA
including, without limitation, inspections as a result of a
recall or any other regulatory issue relating to any of the
Products. NPA shall also have the duty to immediately notify RTI
if it becomes aware, or reasonably should have become aware, of
any concern that may affect the function or safety of any of the
Products.
c. NPA's liability to RTI for damages due to any return or recall of
Products shall not exceed the total price RTI paid NPA for the
Products at issued in RTI's claim. This limitation will apply
regardless of the form of the action (i.e. whether the lawsuit is in
contract or in tort, including negligence).
12. TRADEMARKS AND LABELING
a. The Trademarks shall remain the exclusive property of RTI. NPA and its
Affiliates shall use the Trademarks only in accordance with RTI
instructions and acceptable trademark practices. Nothing contained
herein shall impose any obligation upon RTI or any of its affiliates
to register or otherwise maintain in force any of the Trademarks.
b. NPA shall label each of the Products in accordance with the labeling
instructions provided by RTI and shall not affix or apply to any of
the Products any trademark or other name, logo or emblem without the
prior written permission of RTI.
c. Nothing contained herein shall be construed as conferring any license
in favor of NPA or its Affiliates to any other trademarks owned or
claimed to be owned by RTI or any of its Affiliates.
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d. NPA shall promptly bring to the attention of RTI any improper or
wrongful use of any of the Trademarks which may come to the attention
of NPA.
13. RELATIONSHIP OF RTI AND NPA
The relationship between RTI and NPA that is created by this Agreement
shall be that of vendor and purchaser, and not that of principal and agent. In
the performance of this Agreement, neither party shall have the authority to
assume or create any obligation or responsibility, either express or implied, on
behalf of or in the name of the other party, or to represent or bind the other
party in any manner whatsoever.
14. REPRESENTATIONS AND WARRANTIES OF RTI
RTI hereby represents and warrants to NPA as follows:
a. RTI has the corporate power and authority to execute, deliver and
perform this Agreement and the transactions contemplated hereby. The
execution and delivery of this Agreement have been duly authorized by
RTI. The execution, delivery and performance of this Agreement and the
consummation of the transactions contemplated hereby do not and will
not violate or conflict with any provision of RTI's Articles of
Incorporation or by-laws or, to the best of its knowledge, any
agreement, instrument, law or regulation to which RTI is bound. No
approvals of authorizations of this Agreement or of the acts or
transactions contemplated hereby is required by law or otherwise in
order to make this Agreement binding upon RTI. This Agreement, and all
other instruments required hereby to be executed and delivered to NPA
by RTI are now, or when delivered will be, the legal, valid and
binding instrument of RTI.
b. RTI has, or at the time of placing Purchase Orders for a particular
Product will have, all approvals required to fulfill, satisfy and
perform its obligations set forth in this Agreement.
c. RTI warrants that is has full power and authority to enter into this
Agreement, has title and interest in the Technology, the Product
design, the Specifications, and the manufacturing processes. RTI
further warrants that it has the power to authorize NPA to use the
same in connection with NPA's performance under this Contract.
d. OTHER THAN AS EXPRESSLY STATED ABOVE IN THIS SECTION 14, RTI MAKES NO
REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY.
15. REPRESENTATIONS AND WARRANTIES OF NPA
NPA hereby represents and warrants to RTI as follows:
a. NPA has the corporate power and authority to execute, deliver and
perform this Agreement and the transactions contemplated hereby. The
execution and delivery of this Agreement have been duly authorized by
NPA. The execution, delivery and performance of this Agreement and the
consummation of the transactions contemplated hereby do not and will
not violate or conflict with any provision of NPA's Articles of
Incorporation or by-laws or, to the best of its knowledge, any
agreement, instrument, law or regulation to which NPA is bound. No
approvals of authorizations
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 11 of 17 RTI T.S. NPA F.V.
--- ---
of this Agreement or of the acts or transactions contemplated hereby
is required by law or otherwise in order to make this Agreement
binding upon NPA. This Agreement, and all other instruments required
hereby to be executed and delivered to RTI by NPA are now, or when
delivered will be, the legal, valid and binding instrument of NPA.
b. NPA-Mexico has the corporate power and authority to perform all
obligations contemplated to be performed by it under this Agreement.
The performance by NPA-Mexico of its obligations contemplated under
this Agreement does not and will not violate or conflict with any
provisions of any organizational or corporate documents of NPA-Mexico,
or to the best knowledge of NPA or any of NPA's Affiliates, of any
agreement, instrument, law or regulation to which NPA-Mexico is bound.
No approvals or authorizations are required by law or otherwise in
order for NPA-Mexico to perform all obligations contemplated to be
performed by it under this Agreement. This Agreement shall not impede
on any rights to sell, ship, market, manufacture RTI products in
Mexico that RTI had prior to the signing of this Agreement.
c. NPA and its affiliates have all permits required to fulfill, satisfy
and perform its obligations and responsibilities set forth in this
Agreement.
d. All Products manufactured and shipped to RTI pursuant to this
Agreement will be manufactured, packaged, tested and stored in
accordance with the requirements of the then CGMP in an FDA approved
facility, and will at the time of shipment be free from defects in
workmanship.
e. OTHER THAN AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NPA EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES, GUARANTEES OR REMEDIES, WHETHER
EXPRESS, IMPLIED OR STATUTORY, INCLUDING ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
16. INDEMNIFICATION
a. NPA hereby agrees to indemnify, defend and hold harmless RTI and any
Affiliates of RTI from any and all loss (except direct reprocurement
costs and consequential loss, such as, for example, loss of business
or of profits), compensatory loss for personal injury, liability,
damage, claim, cost and expense (including, without limitation,
reasonable costs of defense and settlement) arising from or in
connection with:
i. the breach of any of NPA's representations and warranties made
under this Agreement;
ii. the breach by NPA or any of its Affiliates of any undertaking,
covenant or obligation hereunder of NPA or its Affiliates; and
iii. any claim asserted against RTI at law or equity by any person,
which arises at the Tijuana Plant or the Chula Vista Facility,
provided that such damage or injury does not arise from any
defects in Equipment or RTI Molded Components supplied by RTI
(unless caused by NPA's failure to maintain or handle properly
such Equipment or RTI Molded Components). Specifically excluded
from claims under this subsection (iii) shall be claims made by
any person who is an employee or agent of RTI who is on such
premises in a business capacity for RTI and who is otherwise
covered by ▇▇▇▇▇▇▇'▇ compensation or other similar insurance
provided by RTI.
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 12 of 17 RTI T.S. NPA F.V.
--- ---
b. RTI hereby agrees to indemnify, defend and hold harmless NPA and any
Affiliates of NPA from any and all loss (except for consequential
loss, such as, for example, loss of business or of profits),
liability, damage, claim, cost and expense (including without
limitation, reasonable costs of defense and settlement) arising from
or in connection with:
i. the breach of any of RTI's representations and warranties made
under this Agreement;
ii. the breach by RTI of any undertaking, covenant, or obligation
hereunder of RTI;
iii. any product liability or claim of failure of the Products made by
a third party, unless resulting solely and directly from a Defect
in Workmanship attributable to NPA; and
iv. any claim that (a) the design of any of the Products, (b) any
engineering or manufacturing process that RTI directs NPA to use,
or (c) any materials or components required by RTI to be used in
or with the Products, infringes any third party's patent,
copyright, trade secret or other intellectual property right.
c. Except as otherwise provided in Section 19 (d) herein, the parties
specifically agree that neither of them shall be liable to the other,
or the other's respective Affiliates, for lost revenues or profits, or
for any other similar consequential damages, whether indirect, special
or incidental, even if such damages were foreseeable or the party
seeking indemnification had informed the indemnifying party of their
potential.
d. Each party hereto shall give prompt written notice to the other of any
actual or threatened claim which might give rise to a claim for
indemnification hereunder. If the facts giving rise to any
indemnification hereunder shall involve any actual or threatened claim
or demand by any third party against either party hereto (the
"Indemnitee"), shall give notice of such fact to the other party
against whom such claim for indemnification is or will be made (the
"Indemnitor"). The Indemnitor shall then be entitled (without
prejudice to the right of the Indemnitee to participate at its own
expense through counsel of its own choosing) to defend such claim in
the name of the Indemnitee at the expense of the Indemnitor and
through any counsel of the Indemnitor's own choosing, reasonably
satisfactory to the Indemnitee, if the Indemnitor gives written notice
of its intention to do so to the Indemnitee within thirty (30) days
after receipt of the aforesaid notice from the Indemnitee. Whether or
not the Indemnitor chooses to defend any such claim, all parties
hereto shall cooperate in the defense thereof and shall furnish such
records, information and testimony, and attend such conferences,
discovery proceedings, hearings, trials, and appeals, as may be
reasonably required in connection therewith. No claim shall be settled
for which any Indemnitor shall be liable without the consent of the
Indemnitor, which consent shall not be unreasonably withheld.
17. CONFIDENTIALITY
a. Each party agrees that neither it nor any of its Affiliates will
disclose any confidential information of the other party that it may
acquire at any time during the term of this Agreement without the prior
written consent of such party. Each party agrees to use all reasonable
efforts to prevent unauthorized publication or disclosure by any person
of such confidential information, including
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 13 of 17 RTI T.S NPA F.V.
--- ----
requiring its or its Affiliates' employees, consultants or agents to
enter into similar confidentiality Agreements in relation to such
confidential information.
b. The obligations undertaken by each party under this section shall
continue in force for a period of five years following the termination
or expiration of this Agreement.
c. The obligations contained in this section do not apply to any
information:
i. which, at the time of receipt by a party, was already generally
known in the medical device industry through no breach of any duty
of confidentiality by such party to the other party;
ii. which a party can establish to have been known to it at the time
of receipt from the other party and not to have been acquired
directly or indirectly from the other party;
iii. acquired by a party from a third party through no breach of any
duty of confidentiality by such party to the other party;
iv. required by law to be provided to governmental agencies, but any
such disclosure shall be only for the purpose of providing such
information to such governmental agencies; and
v. disclosed to an affiliate of NPA for purposes consistent with this
Agreement.
18. INTELLECTUAL PROPERTY RIGHTS
NPA acknowledges and agrees that RTI owns, or has the right to use, the
Technology and all industrial and intellectual property rights of any kind in
relation to the Technology including patents, registered or other designs,
copyrights, the Trademarks and any trade names, manufacturing and assembly
methodologies and techniques, and any other confidential information related to
the assembly of the Products. Nothing contained in this Agreement shall be
effective to give NPA or any of its Affiliates any rights of ownership in or to
the Technology or any intellectual property relating to the Technology. The
Technology and related intellectual property and confidential information is
provided to NPA under this Agreement for the sole purpose of enabling NPA to
assemble the Products for RTI under this Agreement.
19. TERMS, RENEWAL, AND TERMINATION OF AGREEMENT
a. This Agreement shall run for the Initial Term and thereafter shall
automatically renew for additional successive terms of one year,
unless terminated pursuant to the provisions of this Agreement.
b. Either party may terminate this Agreement effective at the end of any
Contract Year by serving on the other party written notice of its
intent to terminate at least ninety (90) days prior to the next
Contract Anniversary Date.
c. This Agreement also may be terminated by notice in writing;
i. by either party if the other party shall default in the
performance of any obligation under this Agreement and such
default shall continue for a period of not less than thirty (30)
days after written notice specifying such default shall have been
given;
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 14 of 17 RTI T.S NPA F.V.
--- ----
ii. immediately by either party if the other party i) discontinues or
dissolves its business; ii) becomes insolvent; iii) makes an
assignment for the benefit of creditors or other arrangement
pursuant to any bankruptcy law; iv) institutes or permits to be
instituted against it legal proceedings seeking receivership,
trusteeship, bankruptcy, reorganization, readjustment of debt, or
any similar legal proceedings; or v) if a receiver is appointed
for the for the business and such receiver is not discharged
within thirty (30) days.
iii. immediately by either party if all or a major part of the assets
of the other party are disposed of or acquired by any other
person.
d. Immediately upon termination of this Agreement, RTI shall accept and
pay for:
i. any Other Materials ordered by NPA, pursuant to instructions
given under Section 4(b) hereof;
ii. all finished Products in transit and in NPA's inventory at the
close of business on the effective date of termination, provided
that the same have been assembled pursuant to valid Purchase
Orders;
iii. NPA's Cost of Assembly for all work-in-process on Products at the
close of business on the effective date of termination, such Cost
to be pro-rated to reflect the actual percentage of work
completed on such work-in-process, provided that such work-in-
process shall have been ordered pursuant to valid Purchase
Orders, and
iv. In the event RTI terminates this Agreement with 90 days notice,
RTI shall pay NPA direct labor costs NPA would have incurred in
its performance of the forecasted orders for the 90 day period
following the date of notification of termination. In the event
that RTI terminates this Agreement with less than ninety (90)
days notice, RTI shall pay the actual severance costs incurred by
NPA due to the unplanned termination.
e. Upon termination or expiration of this Agreement, the parties shall as
soon as possible reconcile all accounts and determine the disposition
of any Equipment and inventory of unfinished goods, Molded Components,
and other Materials, all of which are acknowledged to be owned by RTI
under this Agreement.
20. FORCE MAJEURE
The timely performance of obligations under this Agreement shall be excused
during each period of delay caused by an event or condition which is reasonably
beyond the control of the party obligated to perform such as an act of god,
unusually severe weather, flood, fire, unavailability or accident of transport,
shortage of power, equipment or qualified equipment or materials, strike, civil
commotion, riot, terrorism, sabotage, explosion, war, revolution, or act of
government ("Force Majeure Event"). In the event of a delay exceeding three days
caused by a Force Majeure Event, the party obligated to perform shall: i)
immediately give the other party written notice of the cause and expected
duration of the delay; and ii) take all reasonable steps to recommence
performance of its obligations under this Agreement as soon as possible. In the
event that performance is so delayed for more than thirty days, the other party
may give written notice immediately
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 15 of 17 RTI T.S NPA F.V.
--- ----
terminating this Agreement without liability, but subject to section 19(d). This
paragraph shall not excuse any obligation relating to payment or
indemnification.
21. NOTICES
Notices provided under this Agreement to be given or served by either party
on the other shall be given in writing and served personally or by prepaid
registered airmail post or by express mail or by means of facsimile to the
following respective addresses or to other addresses as the parties may
hereafter advise each other in writing. Any such notice given by registered mail
or express mail shall be deemed given and served on the day falling five days
after the date of postmark.
To: RTI
Retractable Technologies, Inc.
▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇.▇. ▇▇▇ ▇
▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇▇▇▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
To: NPA
Nypro Precision Assemblies
Suite F
▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: General Manager
____________________________________
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
22. EXECUTION OF ALL NECESSARY ADDITIONAL DOCUMENTS
Each party agrees that it will forthwith upon the request of the other
party execute and deliver all such instruments and Agreements and will take all
such other actions as the other party may reasonably request from time to time
in order to effectuate the intent and purposes of this Agreement.
23. WAIVER
The failure of either party to insist upon strict performance of any term
or provision herein shall not be deemed a waiver of any subsequent breach or
default of the same or any other term nor as an implied modification of this
Agreement.
24. ASSIGNMENT AND AMENDMENT
Other than an assignment by RTI to any of its affiliates, neither this
Agreement nor any rights arising hereunder may be assigned by either party
without the prior written consent of the other party, which consent shall not be
unreasonably withheld. No amendment hereof shall be binding unless made in
writing and signed by the parties hereto.
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 16 of 17 RTI T.S NPA F.V.
--- ----
25. ENTIRE AGREEMENT
This Agreement, together with the Schedule(s) hereto, constitutes the
entire Agreement between the parties. This Agreement supersedes, and the terms
of this Agreement govern, any prior, contemporaneous, or collateral Agreements
between the parties. The parties each acknowledge that they have not entered
into this Agreement in reliance upon any representation or warranty by any
person or entity other than those which are specifically set forth herein. This
Agreement may only be changed by mutual written Agreement of authorized
representatives of the parties.
26. GOVERNING LAW
The rights of the parties shall be governed by, and this Agreement
(including its form, execution, validity, construction and effect) shall be
interpreted in accordance with, the laws of the State of California and the
federal law applicable therein; without regard to its conflict of laws rules.
Any legal proceeding relating to this Agreement or the relationship of the
parties (including their affiliates) shall be settled in a court of general
jurisdiction in the State of California. Other than claims for indemnification,
no recovery in any legal proceeding relating to this Agreement may be based in
whole or in part upon conduct which occurred more than two years prior to the
filing of such legal proceeding, but a shorter time may be specified by
applicable law.
27. SEVERABILITY
If any provision of this Agreement is held by a court to be invalid, void
or unenforceable, then: i) the offending provision shall be deleted only to the
extent required by law; ii) the Parties shall cooperate in reforming this
Agreement to effectuate the intent of the offending provision to the fullest
extent allowed by law; and iii) any such reformations as well as the remaining
provisions of this Agreement shall survive and continue in full force and effect
without being impaired or invalidated in any way.
IN WITNESS WHEREOF, this Agreement has been executed by the parties on the
date first written above.
RETRACTABLE TECHNOLOGIES, INC. NYPRO PRECISION ASSEMBLIES INC.
By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇, By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
---------------------------------- -----------------------------
▇▇▇▇▇▇ ▇. ▇▇▇▇, President and CEO ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, President
ENSAMBLES NYPRO S.A. de C.V.
By: /s/ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
-----------------------------
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, Presidente
END
________________________________________________________________________________
April 7, 2000 RTI - NPA Agreement Confidential Page 17 of 17 RTI T.S NPA F.V.
--- ----
SCHEDULE A
EQUIPMENT LISTING BY I.D. NUMBER FOR MEXICO PROJECT
----------------------------------------------------------------------------------------------------------------------------
I.D. NUMBER DESCRIPTION QUANTITY DIMENSIONS
==========================================================================================================================
PRODUCT EQUIPMENT
--------------------------------------------------------------------------------------------------------------------------
RT001 Barrel Printer 1 64" x 36"
--------------------------------------------------------------------------------------------------------------------------
RT002 Barrel Lube Station 1 32" x 12" x 12"
--------------------------------------------------------------------------------------------------------------------------
RT003 Vacuum Pump 1 16" x 12"
--------------------------------------------------------------------------------------------------------------------------
RT004 Barrel Lube Reservoir 1 12" x 12" x 12"
--------------------------------------------------------------------------------------------------------------------------
RT005 Barrel Pushdown Station 1 25" x 16" x 36"
--------------------------------------------------------------------------------------------------------------------------
RT006 Lubrication Tumbler 1 36" x 36" x 60"
--------------------------------------------------------------------------------------------------------------------------
RT007 Plunger Plug Pushdown Station 1 28" x 16" x 30
--------------------------------------------------------------------------------------------------------------------------
RT008 Plunger Seal Loan Station 1 36" x 10" x 9"
--------------------------------------------------------------------------------------------------------------------------
RT009 Plunger Cap Push In Station 1 7" x 7" x 7"
--------------------------------------------------------------------------------------------------------------------------
RT010 Assembly Table 1 36" x 48"
--------------------------------------------------------------------------------------------------------------------------
RT011 Assembly Table 1 36" x 48"
--------------------------------------------------------------------------------------------------------------------------
RT012 Assembly Table 1 36" x 48"
--------------------------------------------------------------------------------------------------------------------------
RT013-015 Friction Ring/Needle Holder Assembly 3 6" x 6"
--------------------------------------------------------------------------------------------------------------------------
RT016-031 5cc Barrel Assembly Racks 15 15" x 1" x 6"
--------------------------------------------------------------------------------------------------------------------------
RT032-046 10cc Barrel Assembly Racks 15 15" x 1" x 6"
--------------------------------------------------------------------------------------------------------------------------
QUALITY INSPECTION TOOLS
==========================================================================================================================
RTQ001 20 Gauge Go-No-Go Pin 1
--------------------------------------------------------------------------------------------------------------------------
RTQ002 21 Gauge Go-No-Go Pin 1
--------------------------------------------------------------------------------------------------------------------------
RTQ003 22 Gauge Go-No-Go Pin 1
--------------------------------------------------------------------------------------------------------------------------
RTQ004 Zero Graduation Line Location Tool 1
--------------------------------------------------------------------------------------------------------------------------
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
---- ----
SCHEDULE B
COMPONENTS
MOLDED COMPONENTS
-------------------------------------------------------------------------------------
DESCRIPTION RTI PART # COUNTRY OF ORIGIN
------------------------------------------------------------------------------------
Unprinted Syringe Barrel SB050 USA
------------------------------------------------------------------------------------
Plunger Handle PH050 USA
------------------------------------------------------------------------------------
Plunger Seal PS050 USA
------------------------------------------------------------------------------------
Friction Ring FR030 USA
------------------------------------------------------------------------------------
Plunger Cap (Black) PC033 USA
------------------------------------------------------------------------------------
Plunger Plug PP030 USA
------------------------------------------------------------------------------------
Needle Holder (Black) ▇▇▇▇▇ ▇▇▇
------------------------------------------------------------------------------------
Plunger Cap (Deep Green) PC035 USA
------------------------------------------------------------------------------------
Needle Holder (Deep Green) NH035 USA
------------------------------------------------------------------------------------
Plunger Cap (Yellow) PC037 USA
------------------------------------------------------------------------------------
Plunger Holder (Yellow) ▇▇▇▇▇ ▇▇▇
------------------------------------------------------------------------------------
OTHER COMPONENTS
------------------------------------------------------------------------------------
DESCRIPTION RTI PART # COUNTRY OF ORIGIN
-----------------------------------------------------------------------------------
Retraction Springs PS030 USA
------------------------------------------------------------------------------------
UP 82 Ink Black #70 PI001 USA
------------------------------------------------------------------------------------
UP82H Hardener PI002 USA
------------------------------------------------------------------------------------
UP82T Thinner PI003 USA
------------------------------------------------------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇
------------------------------------------------------------------------------------
Medical Fluid 360 (12500cs) LU003 USA
------------------------------------------------------------------------------------
Medical Fluid 360 (1000cs) LU002 USA
------------------------------------------------------------------------------------
Silicone Fluid (350cs) LU004 USA
------------------------------------------------------------------------------------
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
----- -----
SCHEDULE C
PRODUCTS
------------------------------------------------------------------------------
RTI PART # ITEM DESCRIPTION
------------------------------------------------------------------------------
RT-522 5cc Sub-Assembly 22 Gauge Needle Holder / Black Plunger Cap
------------------------------------------------------------------------------
RT-521 5cc Sub-Assembly 21 Gauge Needle Holder / Green Plunger Cap
------------------------------------------------------------------------------
RT-520 5cc Sub-Assembly 20 Gauge Needle Holder / Yellow Plunger Cap
------------------------------------------------------------------------------
RT-1022 10cc Sub-Assembly 22 Gauge Needle Holder / Black Plunger Cap
------------------------------------------------------------------------------
RT-1021 10cc Sub-Assembly 21 Gauge Needle Holder / Green Plunger Cap
------------------------------------------------------------------------------
RT-1020 10cc Sub-Assembly 20 Gauge Needle Holder / Yellow Plunger Cap
------------------------------------------------------------------------------
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
----- -----
SCHEDULE D
RTI COMPONENT AND PURCHASING SPECIFICATIONS
(ATTACHED)
-----------------------------------------------------------------------------
ITEM
PART # DESCRIPTION
=============================================================================
RT-522 5cc Sub-Assembly 22 Gauge Needle Holder/Black Plunger Cap
-----------------------------------------------------------------------------
RT-521 5cc Sub-Assembly 21 Gauge Needle Holder/Green Plunger Cap
-----------------------------------------------------------------------------
RT-520 5cc Sub-Assembly 20 Gauge Needle Holder/Yellow Plunger Cap
-----------------------------------------------------------------------------
RT-1022 10cc Sub-Assembly 22 Gauge Needle Holder/Black Plunger Cap
-----------------------------------------------------------------------------
RT-1021 10cc Sub-Assembly 21 Gauge Needle Holder/Green Plunger Cap
-----------------------------------------------------------------------------
RT-1020 10cc Sub-Assembly 20 Gauge Needle Holder/Yellow Plunger Cap
-----------------------------------------------------------------------------
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
----- -----
Component Specification - RT-522
--------------------------------------------------------------------------------
Description : 5cc 22G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Ref. Drawing : RT-522
--------------------------------------------------------------------------------
1. Component Function
The 5cc VanishPoint syringe assembly once a needle is assembled, is
intended to draw and dispense fluid medication safely and accurately in
healthcare or other environments. After dispensing medication, the needle
retracts into the plunger handle and the syringe is rendered unusable.
2. Relevant Design Features
The relevant design features of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None Correct Plunger Cap Needle Holder Lubricant in Barrel None
[Black] (Interface Diameter [.0030g - .0065g]
.029" - .031")
----------------------------------------------------------------------------------------------------------
Correct Barrel Print Needle Holder
Alignment Pushout
[Minimum 2.0 lbs]
----------------------------------------------------------------------------------------------------------
Activation Force
[Maximum 12.5 lbs]
----------------------------------------------------------------------------------------------------------
3. Relevant Quality Defects
The relevant quality defects of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None None Missing Components None Smudged/Missing
Barrel Print which
does not inhibit
proper use
----------------------------------------------------------------------------------------------------------
Incorrectly Assembled Visible Contaminates
Components In Fluid Pathway
[Dark .04 - .05 mm/2/]
[Light .04 - .10 mm/2/]
----------------------------------------------------------------------------------------------------------
Visible Contaminates
In Fluid Pathway
[Dark (greater than) .06 mm/2/]
[Light (greater than) .015 mm/2/]
----------------------------------------------------------------------------------------------------------
Damage
----------------------------------------------------------------------------------------------------------
Illegible Barrel Print
which inhibits proper
use
----------------------------------------------------------------------------------------------------------
4. References
Procedure GQA011/QSP-66
Procedure IP028/QSP-32
Size Estimation Chart for use with TAPPI T 564 and ISO Standard 5350-3
==========================================================================================================
Quality Assurance Mgr/Date: Production Mgr./Date: Product Development Mgr./Date:
__________________________ _____________________ _______________________
▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇▇▇ 1009 ▇. ▇▇▇▇ 1026
==========================================================================================================
--------------------------------------------------------------------------------
Page 1 of 1
Purchasing Specification -- RT-522
--------------------------------------------------------------------------------
Description : ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇(▇) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Material :
--------------------------------------------------------------------------------
Component Specification : RT-522
--------------------------------------------------------------------------------
Vendor Code NY-1
Vendor Name NYPRO
Reorder Part RT-522
Vendor Code NA
Vendor Name NA
Number NA
--------------------------------------------------------------------------------
Supply Vendor With
Tool : Yes
Specification : Yes
Material : Yes
Vendor to Supply
Material Cert. : No
Compliance Cert. : Yes
Inspection Report : No
--------------------------------------------------------------------------------
Special Instructions
Double poly bags with gussets
================================================================================
Purchasing/Date: Quality Assurance Product Development
Manager/Date: Manager/Date:
____________________ ____________________ _______________________
▇. ▇▇▇▇▇▇▇ 1279 ▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇ 1026
================================================================================
--------------------------------------------------------------------------
Page 1 of 1
Component Specification - RT-521
--------------------------------------------------------------------------------
Description : 5cc 21G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Ref. Drawing : RT-521
--------------------------------------------------------------------------------
1. Component Function
The 5cc VanishPoint syringe assembly once a needle is assembled, is
intended to draw and dispense fluid medication safely and accurately in
healthcare or other environments. After dispensing medication, the needle
retracts into the plunger handle and the syringe is rendered unusable.
2. Relevant Design Features
The relevant design features of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None Correct Plunger Cap Needle Holder Lubricant in Barrel None
[Green] (Interface Diameter [.0030g - .0065g]
.033" - .035")
----------------------------------------------------------------------------------------------------------
Correct Barrel Print Needle Holder
Alignment Pushout
[Minimum 2.0 lbs]
----------------------------------------------------------------------------------------------------------
Activation Force
[Maximum 12.5 lbs]
----------------------------------------------------------------------------------------------------------
3. Relevant Quality Defects
The relevant quality defects of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None None Missing Components None Smudged/Missing
Barrel Print which
does not inhibit
proper use
----------------------------------------------------------------------------------------------------------
Incorrectly Assembled Visible Contaminates
Components In Fluid Pathway
[Dark .04 - .05 mm/2/]
[Light .04 - .10 mm/2/]
----------------------------------------------------------------------------------------------------------
Visible Contaminates
In Fluid Pathway
[Dark (greater than) .06 mm/2/]
[Light (greater than) .015 mm/2/]
----------------------------------------------------------------------------------------------------------
Damage
----------------------------------------------------------------------------------------------------------
Illegible Barrel Print
which inhibits proper
use
----------------------------------------------------------------------------------------------------------
4. References
Procedure GQA011/QSP-66
Procedure IP028/QSP-32
Size Estimation Chart for use with TAPPI T 564 and ISO Standard 5350-3
==========================================================================================================
Quality Assurance Mgr/Date: Production Mgr./Date: Product Development Mgr./Date:
__________________________ _____________________ _______________________
▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇▇▇ 1009 ▇. ▇▇▇▇ 1026
==========================================================================================================
--------------------------------------------------------------------------------
Page 1 of 1
Purchasing Specification -- RT-521
--------------------------------------------------------------------------------
Description : ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇(▇) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Material :
--------------------------------------------------------------------------------
Component Specification : RT-521
--------------------------------------------------------------------------------
Vendor Code NY-1
Vendor Name NYPRO
Reorder Part RT-521
Vendor Code NA
Vendor Name NA
Number NA
--------------------------------------------------------------------------------
Supply Vendor With
Tool : Yes
Specification : Yes
Material : Yes
Vendor to Supply
Material Cert. : No
Compliance Cert. : Yes
Inspection Report : No
--------------------------------------------------------------------------------
Special Instructions
Double poly bags with gussets
================================================================================
Purchasing/Date: Quality Assurance Product Development
Manager/Date: Manager/Date:
______________________ _______________________ ________________________
▇. ▇▇▇▇▇▇▇ 1279 ▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇ 1026
================================================================================
___________________________________________________________________________
Page 1 of 1
Component Specification - RT-520
--------------------------------------------------------------------------------
Description : 5cc 20G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Ref. Drawing : RT-520
--------------------------------------------------------------------------------
1. Component Function
The 5cc VanishPoint syringe assembly once a needle is assembled, is
intended to draw and dispense fluid medication safely and accurately in
healthcare or other environments. After dispensing medication, the needle
retracts into the plunger handle and the syringe is rendered unusable.
2. Relevant Design Features
The relevant design features of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None Correct Plunger Cap Needle Holder Lubricant in Barrel None
[Yellow] (Interface Diameter [.0030g - .0065g]
.036" - .038")
----------------------------------------------------------------------------------------------------------
Correct Barrel Print Needle Holder
Alignment Pushout
[Minimum 2.0 lbs]
----------------------------------------------------------------------------------------------------------
Activation Force
[Maximum 12.5 lbs]
----------------------------------------------------------------------------------------------------------
3. Relevant Quality Defects
The relevant quality defects of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None None Missing Components None Smudged/Missing
Barrel Print which
does not inhibit
proper use
----------------------------------------------------------------------------------------------------------
Incorrectly Assembled Visible Contaminates
Components In Fluid Pathway
[Dark .04 - .05 mm/2/]
[Light .04 - .10 mm/2/]
----------------------------------------------------------------------------------------------------------
Visible Contaminates
In Fluid Pathway
[Dark (greater than) .06 mm/2/]
[Light (greater than) .015 mm/2/]
----------------------------------------------------------------------------------------------------------
Damage
----------------------------------------------------------------------------------------------------------
Illegible Barrel Print
which inhibits proper
use
----------------------------------------------------------------------------------------------------------
4. References
Procedure GQA011/QSP-66
Procedure IP028/QSP-32
Size Estimation Chart for use with TAPPI T 564 and ISO Standard 5350-3
==========================================================================================================
Quality Assurance Mgr/Date: Production Mgr./Date: Product Development Mgr./Date:
__________________________ _____________________ _______________________
▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇▇▇ 1009 ▇. ▇▇▇▇ 1026
==========================================================================================================
--------------------------------------------------------------------------------
Page 1 of 1
Purchasing Specification - RT-520
--------------------------------------------------------------------------------
Description : ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇(▇) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Material :
--------------------------------------------------------------------------------
Component Specification : RT1-520
--------------------------------------------------------------------------------
Vendor Code NY-1
Vendor Name NYPRO
Recorder Part RT-520
Vendor Code NA
Vendor Name NA
Number NA
--------------------------------------------------------------------------------
Supply Vendor With
Tool : Yes
Specification : Yes
Material : Yes
Vendor to Supply
Material Cert. : No
Compliance Cert. : Yes
Inspection Report : No
--------------------------------------------------------------------------------
Special Instructions
Double poly bags with gussets
================================================================================
Purchasing/Date: Quality Assurance Product Development
Manager/Date Manager/Date:
__________________________ ____________________ _________________________
▇. ▇▇▇▇▇▇▇ 1279 ▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇ 1026
================================================================================
------------------------------------------------------------------------------
Page 1 of 1
n
Component Specification - RT-1022
--------------------------------------------------------------------------------
Description : 10cc 22G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Ref. Drawing : RT-1022
--------------------------------------------------------------------------------
1. Component Function
The 10cc VanishPoint syringe assembly once assembled with a needle, is
intended to draw and dispense fluid medication safely and accurately in
healthcare or other environments. After dispensing medication, the needle
retracts into the plunger handle and the syringe is rendered unusable.
2. Relevant Design Features
The relevant design features of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None Correct Plunger Cap Needle Holder Lubricant in Barrel None
[Black] (Interface Diameter [.0060g - .0100g]
.029" - .031")
----------------------------------------------------------------------------------------------------------
Correct Barrel Print Needle Holder
Alignment Pushout
[Minimum 2.0 lbs]
----------------------------------------------------------------------------------------------------------
Activation Force
[Maximum 12.0 lbs]
----------------------------------------------------------------------------------------------------------
3. Relevant Quality Defects
The relevant quality defects of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None None Missing Components None Smudged/Missing
Barrel Print which
does not inhibit
proper use
----------------------------------------------------------------------------------------------------------
Incorrectly Assembled Visible Contaminates
Components In Fluid Pathway
[Dark .04 - .05 mm/2/]
[Light .04 - .10 mm/2/]
----------------------------------------------------------------------------------------------------------
Visible Contaminates
In Fluid Pathway
[Dark greater than .06 mm/2/]
[Light greater than .015 mm/2/]
----------------------------------------------------------------------------------------------------------
Damage
----------------------------------------------------------------------------------------------------------
Illegible Barrel Print
which inhibits proper
use
----------------------------------------------------------------------------------------------------------
4. References
Procedure GQA011/QSP-66
Procedure IP028/QSP-32
Size Estimation Chart for use with TAPPI T 564 and ISO Standard 5350-3
==========================================================================================================
Quality Assurance Mgr/Date: Production Mgr./Date: Product Development Mgr./Date:
__________________________ _____________________ _______________________
▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇▇▇ 1009 ▇. ▇▇▇▇ 1026
==========================================================================================================
-------------------------------------------------------------------------------
Page 1 of 1
Purchasing Specification -- RT-1022
--------------------------------------------------------------------------------
Description : 10cc 22G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Material :
--------------------------------------------------------------------------------
Component Specification : RT-1022
--------------------------------------------------------------------------------
Vendor Code NY-1
Vendor Name NYPRO
Vendor Part Number RT-1022
Vendor Code NA
Vendor Name NA
Vendor Part Number NA
--------------------------------------------------------------------------------
Supply Vendor With
Tool : Yes
Specification : Yes
Material : Yes
Vendor to Supply
Material Cert. : No
Compliance Cert. : Yes
Inspection Report : No
--------------------------------------------------------------------------------
Special Instructions
Double poly bags with gussets
================================================================================
Purchasing/Date: Quality Assurance Product Development
Manager/Date: Manager/Date:
__________________________ ____________________ _________________________
▇. ▇▇▇▇▇▇▇ 1279 ▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇ 1026
================================================================================
--------------------------------------------------------------------------
Page 1 of 1
Component Specification - RT-1021
--------------------------------------------------------------------------------
Description : 10cc 21G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Ref. Drawing : RT-1021
--------------------------------------------------------------------------------
1. Component Function
The 10cc VanishPoint syringe assembly once assembled needle, is
intended to draw and dispense fluid medication safely and accurately in
healthcare or other environments. After dispensing medication, the needle
retracts into the plunger handle and the syringe is rendered unusable.
2. Relevant Design Features
The relevant design features of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None Correct Plunger Cap Needle Holder Lubricant in Barrel None
[Green] (Interface Diameter [.0060g - .0100g]
.036" - .038")
----------------------------------------------------------------------------------------------------------
Correct Barrel Print Needle Holder
Alignment Pushout
[Minimum 2.0 lbs]
----------------------------------------------------------------------------------------------------------
Activation Force
[Maximum 12.0 lbs]
----------------------------------------------------------------------------------------------------------
3. Relevant Quality Defects
The relevant quality defects of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None None Missing Components None Smudged/Missing
Barrel Print which
does not inhibit
proper use
----------------------------------------------------------------------------------------------------------
Incorrectly Assembled Visible Contaminates
Components In Fluid Pathway
[Dark .04 - .05 mm/2/]
[Light .04 - .10 mm/2/]
----------------------------------------------------------------------------------------------------------
Visible Contaminates
In Pathway
[Dark (greater than) .06 mm/2/]
[Light (greater than) .15 mm/2/]
----------------------------------------------------------------------------------------------------------
Damage
----------------------------------------------------------------------------------------------------------
Illegible Barrel Print
which inhibits proper
use
----------------------------------------------------------------------------------------------------------
4. References
Procedure GQA011/QSP-66
Procedure IP028/QSP-32
Size Estimation Chart for use with TAPPI T 564 and ISO Standard 5350-3
==========================================================================================================
Quality Assurance Mgr/Date: Production Mgr./Date Product Development Mgr./Date:
__________________________ _____________________ _______________________
▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇▇▇ 1009 ▇. ▇▇▇▇ 1026
==========================================================================================================
--------------------------------------------------------------------------------
Page 1 of 1
Purchasing Specification -- RT-1021
-------------------------------------------------------------------------------
Description : Syringe Barrels, 10cc 21G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Material :
-------------------------------------------------------------------------------
Component Specification :RT-1021
-------------------------------------------------------------------------------
Vendor Code NY-1
Vendor Name NYPRO
Reorder Part RT-1021
Vendor Code NA
Vendor Name NA
Number NA
-------------------------------------------------------------------------------
Supply Vendor With
Tool : Yes
Specification : Yes
Material : Yes
Vendor to Supply
Material Cert. : No
Compliance Cert. : Yes
Inspection Report : No
-------------------------------------------------------------------------------
Special Instructions
Double poly bags with gussets
================================================================================
Purchasing/Date: Quality Assurance Product Development
Manager/Date: Manager/Date:
_____________________ ____________________ ______________________
▇. ▇▇▇▇▇▇▇ 1279 ▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇ 1026
================================================================================
----------------------------------------------------------------------------
Page 1 of 1
Component Specification - RT-1020
--------------------------------------------------------------------------------
Description : 10cc 20G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Ref. Drawing : RT-1020
--------------------------------------------------------------------------------
1. Component Function
The 10cc VanishPoint syringe assembly once assembled needle, is intended to
draw and dispense fluid medication safely and accurately in healthcare or
other environments. After dispensing medication, the needle retracts into
the plunger handle and the syringe is rendered unusable.
2. Relevant Design Features
The relevant design features of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None Correct Plunger Cap Needle Holder Lubricant in Barrel None
[Yellow] (Interface Diameter [.0060g - .0100g]
.036" - .038")
----------------------------------------------------------------------------------------------------------
Correct Barrel Print Needle Holder
Alignment Pushout
[Minimum 2.0 lbs]
----------------------------------------------------------------------------------------------------------
Activation Force
[Maximum 12.0 lbs]
----------------------------------------------------------------------------------------------------------
3. Relevant Quality Defects
The relevant quality defects of the VanishPoint syringe that are inspected
are as follows:
----------------------------------------------------------------------------------------------------------
Class I Defects Class II Defects Class III Defects Class IV Defects Class V Defects
----------------------------------------------------------------------------------------------------------
None None Missing Components None Smudged/Missing
Barrel Print which
does not inhibit
proper use
----------------------------------------------------------------------------------------------------------
Incorrectly Assembled Visible Contaminates
Components In Pathway
[Dark .04 - .05 mm/2/]
[Light .04 - .10 mm/2/]
----------------------------------------------------------------------------------------------------------
Visible Contaminates
In Pathway
[Dark (greater than) .06 mm/2/]
[Light (greater than) .15 mm/2/]
----------------------------------------------------------------------------------------------------------
Damage
----------------------------------------------------------------------------------------------------------
Illegible Barrel Print
which inhibits proper
use
----------------------------------------------------------------------------------------------------------
4. References
Procedure GQA011/QSP-66
Procedure IP028/QSP-32
Size Estimation Chart for use with TAPPI T 564 and ISO Standard 5350-3
==========================================================================================================
Quality Assurance Mgr/Date: Production Mgr./Date: Product Development Mgr./Date:
__________________________ _____________________ _______________________
▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇▇▇ 1009 ▇. ▇▇▇▇ 1026
==========================================================================================================
--------------------------------------------------------------------------------
Page 1 of 1
Purchasing Specification -- RT-1020
--------------------------------------------------------------------------------
Description : Syringe Barrels, 10cc 20G VanishPoint(R) Syringe Subassembly
Revision : 0
CRO : 00-47
Date :
Material :
--------------------------------------------------------------------------------
Component Specification : RT-1020
--------------------------------------------------------------------------------
Vendor Code NY-1
Vendor Name NYPRO
Reorder Part RT-1020
Vendor Code NA
Vendor Name NA
Number NA
--------------------------------------------------------------------------------
Supply Vendor With
Tool : Yes
Specification : Yes
Material : Yes
Vendor to Supply
Material Cert. : No
Compliance Cert. : Yes
Inspection Report : No
--------------------------------------------------------------------------------
Special Instructions
Double poly bags with gussets
================================================================================
Purchasing/Date: Quality Assurance Product Development
Manager/Date: Manager/Date:
_______________________ _______________________ ________________________
▇. ▇▇▇▇▇▇▇ 1279 ▇. ▇▇▇▇▇ 1023 ▇. ▇▇▇▇ 1026
================================================================================
__________________________________________________________________________
Page 1 of 1
SCHEDULE E
TRADEMARKS
"Manufacturer's Proprietary Marks" include all trademarks, tradenames, logotypes
and trade dress employed by manufacturer and include, but not limited to :
a. the name "VanishPoint";
b. the letters "RT" surrounded by an oval;
c. the graphic depiction of a needle surrounded by a spring;
d. a colored spot on the exposed end of the syringe plunger;
e. the appearance and arrangement of information on the wrapper containing
each individual Product;
f. other marks which are sufficiently similar to the foregoing to cause
confusion regarding the source of goods;
g. additional marks identified by Manufacturer.
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
----- -----
SCHEDULE F
SET-UP CHARGES
------------------------------------------------------------------------------
DESCRIPTION NOT TO EXCEED
COST (USD)
------------------------------------------------------------------------------
Training at RTI: travel and per diem expenses $ 3,250.00
------------------------------------------------------------------------------
Wages for two engineers and two technicians $ 4,000.00
------------------------------------------------------------------------------
Equipment installation and layout $ 3,500.00
------------------------------------------------------------------------------
Set-up and validate assembly line $ 3,800.00
==========
------------------------------------------------------------------------------
Total set-up costs $14,550.00
------------------------------------------------------------------------------
April 7, 2000 RTI-NPA Agreement Confidential RTI T.S. NPA F.V.
----- -----
SCHEDULE G
F.O.B. NYPRO CHULA VISTA
--------------------------------------------------------------------------------------------------------------------------
PART # ITEM DESCRIPTION PRICE/U.S.D.
==========================================================================================================================
RT-522 5cc Sub-Assembly 22 Gauge Needle Holder/Black Plunger Cap 0.10
--------------------------------------------------------------------------------------------------------------------------
RT-521 5cc Sub-Assembly 21 Gauge Needle Holder/Green Plunger Cap 0.10
--------------------------------------------------------------------------------------------------------------------------
RT-520 5cc Sub-Assembly 20 Gauge Needle Holder/Yellow Plunger Cap 0.10
--------------------------------------------------------------------------------------------------------------------------
RT-1022 10cc Sub-Assembly 22 Gauge Needle Holder/Black Plunger Cap 0.10
--------------------------------------------------------------------------------------------------------------------------
RT-1021 10cc Sub-Assembly 21 Gauge Needle Holder/Green Plunger Cap 0.10
--------------------------------------------------------------------------------------------------------------------------
RT-1022 10cc Sub-Assembly 20 Gauge Needle Holder/Yellow Plunger Cap 0.10
--------------------------------------------------------------------------------------------------------------------------
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
----- -----
SCHEDULE H
VOLUME COMMITMENTS
---------------------------------------------------------------------------------------------------------------------------
ESTIMATED ESTIMATED
MINIMUM MAXIMUM
ITEM ANNUAL ANNUAL
PART # DESCRIPTION VOLUME VOLUME
---------------------------------------------------------------------------------------------------------------------------
RT-522 5cc Sub-Assembly 22 Gauge Needle Holder/ 150,000 1,500,000
Black Plunger Cap
---------------------------------------------------------------------------------------------------------------------------
RT-521 5cc Sub-Assembly 21 Gauge Needle Holder/ 100,000 1,500,000
Green Plunger Cap
---------------------------------------------------------------------------------------------------------------------------
RT-520 5cc Sub-Assembly 20 Gauge Needle Holder/ 300,000 3,000,000
Yellow Plunger Cap
---------------------------------------------------------------------------------------------------------------------------
RT-1022 10cc Sub-Assembly 22 Gauge Needle Holder/ 150,000 2,000,000
Black Plunger Cap
---------------------------------------------------------------------------------------------------------------------------
RT-1021 10cc Sub-Assembly 21 Gauge Needle Holder/ 150,000 2,000,000
Green Plunger Cap
---------------------------------------------------------------------------------------------------------------------------
RT-1020 10cc Sub-Assembly 20 Gauge Needle Holder/ 150,000 2,000,000
Yellow Plunger Cap
---------------------------------------------------------------------------------------------------------------------------
April 7, 2000 RTI - NPA Agreement Confidential RTI T.S. NPA F.V.
------ ------