CONFIDENTIAL TREATMENT REQUESTED
PRODUCT PURCHASE AGREEMENT
THIS AGREEMENT, effective as of this 17 day of November, 1997 ("Effective
Date"), by and between HORIZON MEDICAL, INC., having a principal place of
business at 0000 X. Xxxxx Xxx., Xxxxx Xxx XX 00000-0000 ("Seller") and BIEX,
INC., having its principal place of business at 0000 Xxxxxx Xxxx, Xxxxx X,
Xxxxxx, XX 00000 ("Buyer").
WHEREAS, Buyer has developed a proprietary test for screening for risk of
preterm labor and delivery;
WHEREAS, the sample for such test is performed with a saliva collection kit
consisting of a labeled tube, plunger with reagents, cap and other accessories;
WHEREAS, Seller has the capability of producing collection kits which can
be used for Buyer's proprietary test;
NOW, THEREFORE, the parties hereto agree as follows:
1. PURCHASE AND SUPPLY OBLIGATIONS.
(a) During the term of this Agreement, Seller agrees to sell and Buyer
agrees to buy the saliva collection kit (the "Product") which conforms to the
descriptions and specifications in Appendix A ("Product Specifications")
according to the terms and conditions set forth in this Agreement. Seller agrees
to meet Buyer's requirements for the Product.
(b) Buyer will supply to Seller the components of the Product listed on
Appendix B ("Buyer-Supplied Components"). Seller will incorporate the
Buyer-Supplied Components into the Product. Seller will use the Buyer-Supplied
Components solely for production of the Products under this Agreement.
(c) Seller will manufacture, perform quality control and deliver the
Product in accordance with Buyer's manufacturing processes and Seller's standard
operating procedures listed on Appendix C. Seller shall manufacture in
accordance with U.S. FDA Quality System regulations and EN46001. Seller shall
not modify applicable SOP's in a fashion which will affect Buyer's product.
(d) Seller understands that the current Product is an interim
configuration and that the final Product configuration will differ. When Buyer
provides specifications for the final Product configuration, the parties will
negotiate in good faith a new price list (Appendix D) for the final Product
configuration. Such new price list will provide approximately the same gross
margin to Seller as the prices set forth on Appendix B, except as the parties
may otherwise agree in writing.
2. PURCHASE ORDERS.
(a) Buyer will initiate purchases under this Agreement by submitting
written purchase orders to Seller any time from the Effective Date until thirty
(30) days before the termination date of the Agreement. All purchase orders
submitted by Buyer will state the
1.
delivery dates, which will be at least thirty (30) days after submission of the
order, and must be submitted within the term of this Agreement. Seller shall
acknowledge promptly each purchase order in writing and confirm delivery dates.
(b) Commencing with the quarter preceding anticipated commercial launch of
the Product, Buyer will supply Seller with a rolling 12 month forecast of
Product requirements on or about the first working day of each quarter. Forecast
for each period will be considered a firm commitment for the immediate quarter.
Changes from forecast for subsequent quarters may be made subject to certain
limitations as set forth in the following table:
QUARTER FORECAST STATUS
Immediate Firm Purchase
[**********] [**************]
[**********] [**************]
[**********] [**************]
(c) The purchase order shall contain the following information relative to
purchases under this Agreement: reference to the Product Specifications,
quantity purchased, routing instructions, delivery schedule, destination of
shipment, and confirmation of price. Each purchase order will make specific
reference to this Agreement.
3. BUYER-SUPPLIED COMPONENTS.
(a) Seller shall inform Buyer at least once every month on the status
of its inventory of Buyer-Supplied Components. Seller shall inform Buyer when
the Buyer-Supplied Components if the Buyer-Supplied Components stored at
Seller's facilities are insufficient to meet a [******] supply at the maximum
output requirement of Product as set forth in the rolling forecast (including
amounts for waste materials and rejects as reasonably assumed based on past
experience). Buyer shall then procure and supply materials in such a fashion
as to allow Seller to deliver product per Buyer purchase order. Seller shall
not be responsible for late delivery penalties as defined in Section 6
Paragraph c if Buyer does not delivery needed inventory within one week of
notification that Buyer-Supplied Components if the Buyer-Supplied Components
stored at Seller's facilities are insufficient as defined herein.
(b) Seller shall store the Buyer-Supplied Components at no cost to Buyer.
The Buyer-Supplied Components will remain the property of Buyer, will be set
aside in a distinct and separate area of the Seller's storage facility, and will
be marked in such a way as to easily allow traceability of ownership. Seller
will execute the appropriate public filings to reflect such ownership of Buyer.
(c) Upon receipt of Buyer-Supplied Components, Seller will perform such
tests as the parties mutually agree from time to time in the course of this
Agreement in order to confirm the consistency of the Buyer-Supplied Components
with the Product Specifications. Buyer-Supplied Components which do not meet
such specifications in the tests performed by Seller will be replaced by Buyer
at no cost to Seller.
[*] CONFIDENTIAL TREATMENT REQUESTED
2.
(d) Seller will protect and preserve the Buyer-Supplied Components and
indemnify Buyer against any loss of or damage to any Buyer-Supplied Components
while in the possession of Seller.
(e) If the manufacturing process results in waste of more than 10 % of the
amount of Buyer-Supplied Components used for a particular lot, Seller will
reimburse Buyer for the costs of procuring Buyer-Supplied Components so wasted.
4. PACKING, SHIPPING AND TITLE.
The method of packaging will be in accordance with Buyer's instructions.
Product will be shipped in accordance with Seller's standard procedures and will
be F.O.B. Seller's manufacturing plant. Buyer will be responsible for all
shipping expenses, insurance, and similar charges which, if paid by Seller, will
appear as additional items on Seller's invoice to Buyer. Title to the Product
and risk of loss will pass to Buyer upon Seller's delivery to the carrier.
Delivery time is of the essence. Products are to be delivered on the dates set
forth in purchase orders or within five days thereof.
5. ACCEPTANCE AND REJECTIONS.
(a) If Buyer discovers a Product defect, Buyer may reject the defective
Product, or lot that contains the defective Product, and will promptly notify
Seller of the rejection and the reason therefor. With regard to latent critical
defects which are not reasonably detectable at the time of acceptance, Buyer may
reject a Product, or lot containing the Product, with latent defects within 30
days from discovery of such defect. Seller shall replace the rejected Products
at no cost to Buyer, or at Buyer's or Seller's option, provide Buyer with a
refund or credit of the purchase price.
(b) The cost of Buyer-Supplied Components for replacement deliveries
will be charged to Seller, including reasonable transport and insurance
charges paid by Buyer for the delivery of Buyer-Supplied Components to Seller.
6. PRICES, DISCOUNTS AND TAXES.
(a) The purchase price for each item of Product will be as set forth in
Appendix D or as mutually agreed to by both parties in writing during the term
of this Agreement.
(b) Such purchase price includes packaging and packing and all taxes,
duties and services, except sales tax, which shall be the responsibility of
Buyer.
(c) If Seller fails to timely deliver the Product, the price of the
delayed shipment will be discounted by [**********] of delay.
[*] CONFIDENTIAL TREATMENT REQUESTED
3.
7. PAYMENT.
Payment for Products will be made within 30 days from receipt of Products
that conform to Product Specifications and a corresponding invoice. Past due
accounts will be charged a 1% per month late fee. All payments will be in U.S.
dollars.
8. INDEMNITY.
(a) Each party agrees to indemnify, defend and hold harmless the other
party and its officers, directors, employees and agents ("Indemnitees") from and
against all losses and liability (including reasonable attorney fees) on account
of third party claims for personal injury, death, or property damage resulting
from any negligent act, omission or willful misconduct by such party, including
that party's agents, employees or subcontractors, or defective Product supplied
by such party to the other party, in the course of performing its obligations
under this Agreement. Seller further agrees to indemnify, defend and hold
harmless Buyer from and against all losses and liability (including reasonable
attorneys fees) on account of third party claims that the tube portion of the
Product infringes on the patent or other proprietary rights of any third party.
An Indemnitee will notify the indemnifying party of any such claim. The
Indemnitee will have the right to participate at its own expense in defense of
such claim. No settlement of a claim against the Indemnitee may be made without
its consent, which will not be unreasonably withheld.
(b) Seller will obtain and maintain in force from and after the date of
the first shipment of Product comprehensive general liability insurance in
amounts not less than [*************] per incident and [***********] annual
aggregate and naming the Buyer Indemnitees as additional insureds. Such
comprehensive general liability insurance shall provide product liability
coverage and broad form contractual liability coverage for Seller's
indemnification obligation under this Section. The amounts of insurance
coverage required hereunder shall not be construed to create a limit on
Seller's liability with respect to its indemnification under this Section.
Seller agrees to provide written evidence of such insurance upon request and
shall provide Buyer with written notice at least fifteen (15) days prior to
the cancellation, non-renewal or material change in such insurance. Seller's
obligation to maintain such insurance shall continue until 2 years after
termination or expiration of this Agreement.
9. WARRANTIES.
The Seller warrants that the Product will conform to Product
Specifications, will be manufactured using Good Manufacturing Practices current
at the time of manufacture (cGMP) and will be free from defects in
Seller-supplied materials and workmanship for a period of one year from shipment
to Buyer.
10. REGULATORY RESPONSIBILITIES.
(a) RESPONSIBILITIES OF THE BUYER.
(1) Buyer will be responsible for all FDA regulatory submissions for
Product.
(2) Buyer will maintain FDA listing for Product.
[*] CONFIDENTIAL TREATMENT REQUESTED
4.
(3) Buyer is responsible for maintaining complaint handling
procedures for Product.
(4) Buyer will notify Seller of any planned inspections by either FDA
or other auditing agencies.
(5) Buyer will maintain the Product Device Master Record.
(b) RESPONSIBILITIES OF THE SELLER.
(1) Seller will notify Buyer of any site inspections that involve
Product or other products manufactured by Seller. Seller will
make available inspection reports as requested by Buyer.
(2) Seller will not rework any Product or change any raw materials or
method of producing, processing or testing any Product, or change
any subcontractor for, or site of manufacture of any Product, or
any component thereof without written authorization from Buyer.
(3) Seller agrees to cooperate with any FDA or other agency
inspections involving Product. Such cooperation should not
normally unduly disrupt Seller's operations.
(4) Seller will maintain and document environmental controls as
required in Buyer's and Seller's documentation.
(5) Seller will maintain records of cGMP and other quality assurance
records for at least three years, or such longer period as is
required by law, following termination of this Agreement.
11. REPRESENTATIONS AND WARRANTIES.
(a) Seller's Representations and Warranties. Seller hereby represents and
warrants to Buyer that:
(1) Seller is duly incorporated and in good standing under the laws
of the State of California;
(2) Seller is duly authorized to enter into this Agreement;
(3) this Agreement is binding and enforceable against Seller; and
(4) Seller is not infringing on any third party's intellectual
property rights with respect to Products.
(b) Buyer's Representations and Warranties. Buyer hereby represents and
warrants to Seller that:
5.
(1) Buyer is duly incorporated and in good standing under the laws of
Delaware;
(2) Buyer is duly authorized to enter into this Agreement; and
(3) this Agreement is binding and enforceable against Buyer.
12. TERM AND TERMINATION.
(a) This Agreement will be effective on the Effective Date and will
terminate three (3) years after the Effective Date.
(b) Either party may terminate this Agreement upon the insolvency,
bankruptcy or voluntary dissolution or assignment for the benefit of creditors
of or by the other party.
(c) A non-defaulting party may terminate this Agreement upon the failure
of a defaulting party to cure a material default in the performance of any
provision hereof within thirty (30) days after written notice thereof is given
by the non-defaulting party. Failure to make a payment shall not be considered a
default if such payment is being contested in good faith.
(d) The provisions of Sections 8, 9, 10, 13, 14, 16 and 17 hereof shall
survive the termination of this Agreement for any reason.
(e) Upon termination of this Agreement, Seller shall, upon Buyer's request
and at Buyer's expense, provide to Buyer any documentation and readily
transferable know-how that Buyer may require to manufacture or otherwise obtain
a continuing source of Products. Upon Seller's breach or termination of this
Agreement, Buyer shall have the right to purchase components, or machinery or
other capital investments purchased or developed specifically for the Products
or their manufacture, at a price to be agreed upon by the parties, but in no
event to exceed the reasonable value of the component, machinery or other
capital investment, prorated for any applicable depreciation.
13. CONFIDENTIAL INFORMATION.
(a) All proprietary information which is specifically designated as such,
which is disclosed by either party to the other, in any form in connection with
this Agreement, shall be kept confidential by the recipient.
(b) Any such proprietary information shall be used solely for the purposes
of this Agreement, or by Buyer solely in connection with regulatory approval and
sale of its products, and shall be protected by the recipient from disclosure to
others with at least the same degree of care as that which is accorded to its
own proprietary information, but in no event with less than reasonable care.
(c) Without limiting the foregoing, Seller expressly agrees that any
know-how, designs, engineering details, Production Procedures, formulations,
information concerning conjugates or antiserum, and other data pertaining to
Buyer's products and processes, shall, without further need for designation, be
deemed proprietary and confidential information of
6.
Buyer under this Section 8. Notwithstanding the foregoing, Buyer shall not be
considered to have received any proprietary information of Seller unless Buyer
expressly agrees in advance in writing to accept such specific information in
confidence.
(d) As used herein, "proprietary information" shall not include
information which is generally known and available in the public domain through
no fault of the recipient.
14. INTELLECTUAL PROPERTY.
(a) Buyer shall own all Intellectual Property (which specifically relates
to Buyer's Product) invented, made or developed by Seller or any of its
subcontractors during the performance of this Agreement. Seller shall promptly
report to Buyer any inventions that are potentially patentable, but will not be
responsible for carrying out any prosecution efforts with respect to such
inventions, PROVIDED, HOWEVER, that Seller will, at Buyer's expense, provide all
reasonable assistance to Buyer in the prosecution of any patents covering any
such inventions.
(b) With regard to any intellectual property of Seller relating to the
Products and developed during the term of this Agreement, Seller hereby grants
to Buyer a non-exclusive, royalty-free, irrevocable, worldwide right and
license, with the right to sublicense, to make, have made, use and sell Product.
15. TRADEMARKS AND TRADE NAMES.
During the term of this Agreement, Buyer shall have the right to indicate
to the public that its systems utilize Seller's Product. Buyer does not have the
right to label its Products with Seller's name.
16. COMPLIANCE WITH LAW.
Seller represents that it is and agrees that it will remain in compliance
with all applicable federal, state and local laws, regulations and orders and in
possession of all permits necessary for the conduct of its activities under this
Agreement. Seller agrees to execute on request by Buyer and to remain in
compliance with the terms of standard state and federal contractor certification
forms which certify compliance with certain laws, regulations and executive
orders.
17. MISCELLANEOUS PROVISIONS.
(a) This Agreement shall be governed by and interpreted under the laws of
the State of California without reference to conflict of laws principles, and
excluding the United Nations Convention on the International Sale of Goods.
(b) All disputes arising out of this Agreement shall be subject to the
exclusive jurisdiction of the federal and state courts within California and the
parties agree and submit to the personal and exclusive jurisdiction and venue of
those courts.
(c) Neither party shall be liable for any loss, damage or penalty
resulting from delays or failures in performance resulting from acts of God,
war, strike, or other causes beyond such party's reasonable control; PROVIDED
THAT Seller shall notify Buyer promptly of anticipated delays
7.
and use best efforts to fill any orders as soon as possible. Buyer may, in any
event, without limiting any rights or remedies, cancel any order, in whole or in
part, that is delayed more than thirty (30) days.
(d) Neither party shall assign this Agreement nor any right or license
hereunder without the prior written consent of the other party, except in
connection with a sale of substantially all of a party's business, or a merger
of acquisition of a party. Any assignment permitted hereunder shall be subject
to the written consent of the assignee to all the terms and provisions of this
Agreement.
(e) All sales of products shall be subject to this Agreement and, to the
extent they specify quantities, destinations and delivery dates or other
specifics, to Buyer purchase orders. This Agreement shall not be subject to the
terms, conditions or provisions of any confirmation or business form of Seller.
(f) Neither party shall make any public announcement of, or otherwise
disclose to a third party, the terms and conditions set forth in this Agreement,
except as necessary to provide such information to a potential corporate
partner, or as mutually agreed in writing, or as required by disclosure
obligations arising under law.
(g) No modification to this Agreement, nor any waiver of any rights, shall
be effective unless assented to in writing by the party to be charged. The
waiver of any breach or default shall not constitute a waiver of any other fight
hereunder or any subsequent breach or default.
(h) The prevailing party in any legal action hereunder shall be entitled
to reimbursement of its expenses including, without limitation, reasonable
attorney's fees.
(i) All notices and other communications hereunder will be made in writing
and shall be delivered by personal delivery or certified or registered mail,
return receipt requested, or by fax, and shall be deemed given upon personal
delivery, on the date of receipt of a document sent by mail, or upon actual
receipt of a fax. Addresses used shall be the ones set forth at the beginning of
this Agreement or any other address notified to the other party in writing.
Notices shall be addressed to the signatories of this Agreement. Notices shall
be effective upon receipt unless otherwise specified in the notice or in this
Agreement.
(j) This Agreement constitutes the entire and exclusive agreement between
the parties hereto with respect to the subject matter hereof, and supersedes any
and all prior negotiations, correspondence, understandings and agreements,
whether oral or written, between the parties with respect to the subject matter
thereof.
8.
By signing below, Buyer and Seller each acknowledge that it has read,
understands and agrees to be bound by the terms and conditions of this
Agreement, and that the person signing is duly authorized to do so.
BIEX, INC. HORIZON MEDICAL
By: /s/ H. Xxxx Xxxx By: /s/ Xxxxxx X. Xxxxxxx
--------------------------- --------------------------------
Signature Signature
Name: H. Xxxx Xxxx Name: Xxxxxx X. Xxxxxxx
------------------------------
Title: Executive Vice President, Title: VP/COO
Technology ---------------------------
9.
APPENDIX A
PRODUCT SPECIFICATIONS
1.
LIST OF DESCRIPTIONS (MFP's) AND SPECIFICATIONS (QCS's) FOR FINISHED COMPONENTS
PRODUCED BY MEDICAL PACKAGING FOR BIEX KITS:
COMPONENT P/N MFP QCS
2 pack sample collection kit 9003 045 045
4 Pack Collection Kit 9004 040 ' 040
Single Collection Kit 9006 050 050
Collection Unit 8022 049 049
2.
APPENDIX B
BUYER-SUPPLIED COMPONENTS
1.
LIST OF MATERIALS SUPPLIED TO MEDICAL PACKAGING FOR PRODUCTION OF BIEX KITS:
PN: 9003 2 PACK SAMPLE COLLECTION KIT
PN: 9004 4 PACK COLLECTION KIT
MATERIAL P/N QCS
Piston Filters 4009 538
Sample Preservative 7019 018
Label, Collection Tube 5012 557
Label, Single Collection Tube Box 5028 580
Label, Collection Kit NA NA
Collection tube and filter box (2 pack) NA NA
Collection Kit Box NA NA
Mailer Envelope NA NA
Remember .... Sticker NA NA
Directional Insert 5014 559
Plastic case 6013 586
Collection Unit Box 6012 587
Enrollment Card 5036 588
Single Pack Box 6011 589
Four Pack Box 6010 590
Assembled Envelope 8023 594
Calendar Reminder 5038 593
Funnel 6014 595
2.
APPENDIX C
LIST OF MANUFACTURING PROCESSES
AND STANDARD OPERATING PROCEDURES
1.
LIST OF PRODUCTION PROCEDURES REFERENCED IN PRODUCTION OF MATERIALS FOR
PRODUCTION OF BIEX KITS:
BIEX DOCUMENTS
ADP (ADMINISTRATIVE) Documents
Doc. # TITLE Date Effective
001 Approval and Issue of Controlled Documents 11-20-96
MFP (BATCH RECORDS) DOCUMENTS
DOC. # PN TITLE DATE EFFECTIVE
045 9003 2 pack sample collection kit 5-7-97
040 9004 4 pack collection kit 5-7-97
049 8022 Sample Collection Unit Draft
050 9006 Single Collection Kit Draft
018 7019 Sample Preservative Solution 5-7-97
MFG (MANUFACTURING SOP'S)
DOC. # TITLE DATE EFFECTIVE
005 Inventory Traceability 6-21-96
QAP (QUALITY ASSURANCE SOP'S)
DOC. # TITLE DATE EFFECTIVE
001 Inspection, sampling, and testing of components, 1-27-97
containers, and closures
002 Part Number Assignment 5-10-96
003 Lot Number Assignment 5-10-96
005 GMP Records Control 5-10-96
006 GMP Audits 5-10-96
007 Quality Assurance Document Audits 2-7-97
009 Quality Control Sample Retains 5-10-96
015 Testing and Release of GMP controlled material 2-12-97
016 Personnel Training 5-10-96
017 Equipment Cleaning, maintenance and calibration
018 Non-conforming materials and variance report 6-21-96
028 Label Copy Review and Approval 6-21-96
029 Issuance of Batch Production Records 5-10-96
035 Line-equipment sign-off and materials verification
036 Inspection, sampling, and testing of components,
containers, closures
I037 Line-equipment sign-off and materials verification 5-7-97
2.
039 Controlled documents filing system 12-6-96
BIEX DOCUMENTS
QCS (QUALITY CONTROL SPECIFICATIONS)
DOC. # PN TITLE DATE EFFECTIVE
508 1009 Thimerosal 7-26-96
506 1007 Tween 20 7-26-96
515 1016 Reagent Alcohol 3-12-97
538 4009 Porex Piston Filter 3-5-97
539 4010 Sample Collection Tubes 4-2-97
540 4011 Sample Collection Tube Cap 4-2-97
517 1018 FD&C Blue #1 8-19-96
557 5012 Label, Sample Collection Vial 5-30-97
558 5013 Label, Sample Collection Kit
559 5014 Package Insert, Sample Collection Kit 5-30-97
560 5015 Label, Sample Collection Kit, 4-Pack
563 6003 Box, Sample Collection Kit
564 6005 Bag, Sample Collection Kit, 4-Pack
571 1026 Water, hi purity 4-30-97
580 5028 Label, Sample Collection tube box (1 4-28-97
tube)
586 6013 Plastic Case Draft
587 6012 Collection Xxxx Xxx Xxxxx
000 0000 Enrollment Card Draft
589 6011 Single Pack Box Draft
590 6010 Four Pack Xxx Xxxxx
000 0000 Xxxxxxxx Xxxxxxxx Draft
592 5037 FedEx Shipment Label Draft
593 5038 Collection Reminders Draft
594 8023 Assembled Envelope Draft
595 6014 Funnel Draft
017 7018 2.5% Blue Dye 7-26-96
018 7019 Sample Preservative Solution 7-26-96
049 8022 Collection Unit Draft
040 9004 4-pack Sample Collection Kit 5-27-97
045 9003 Sample Collection Kit, 2 Pack Draft
050 9006 Single Sample Collection Kit Draft
3.
HORIZON DOCUMENTS
REGULATORY AND COMPLIANCE PROCEDURE NUMBER REV. NUMBER
Compliance Audits 100.001 C
FDA Investigator Audit 100.002 N/A
Regulatory Inspections 100.003 N/A
Device Master Record 100.004 D
Device History Record 100.006 C
Complaint Handling 100.008 N/A
Master Files 100.009 N/A
Product Recalls 100.010 N/A
Document Control System 100.012 E
Non-Conforming Material 100.013 C
Corrective Action 100.014 D
Customer Product Complaints 100.015 A
Management Responsibilities 100.016 B
Contract Review 100.017 C
FACILITIES AND MAINTENANCE PROCEDURE NUMBER REV. NUMBER
Facilities Maintenance 200.001 C
CEA Maintenance Procedure 200.002 C
HMI Controlled Environment 200.003 E
CEA PM Monitoring Procedure 200.004 B
Equipment Calibration & 200.005 C
Maintenance
Fire Safety 200.006 A
MATERIAL CONTROL PROCEDURE NUMBER REV. NUMBER
Supplier control 300.017 C
Receipt & Handling of Incoming 300.018 F
Materials
Finished Product Control 300.019 B
Product Returns 300.020 N/A
Label Control 300.021 C
Purchasing 300.022 B
4.
HORIZON DOCUMENTS
PRODUCTION AND Q.C. PROCEDURE NUMBER REV. NUMBER
Incoming Receiving Inspection 400.026 E
In-Process Control 400.027 G
Finished Device Rework 400.028 N/A
Production Retention 400.029 B
Horizon Processed Water (HPW) 400.032 F
Line Clearance Procedure 400.036 B
Validation/Design Verification 400.038 A
Program
Return to Stock, Finished 400.039 A
Goods
Design Control 400.040 A
GENERAL PROCEDURE NUMBER REV. NUMBER
Product Distribution 500.032 C
Xxxxx Label Making System 500.033 A
Capital Asset Control 500.034 A
TRAINING PROCEDURE NUMBER REV. NUMBER
New Employee General Training 800.001 C
Job Description 800.002 A
5.
APPENDIX D
PRICES
1.
[HORIZON MEDICAL, INC. LETTERHEAD]
15 August 1997
CONTRACT MANUFACTURING PROPOSAL:
SALEST SALIVA COLLECTION KIT, CLINICAL
VERSION
BIEX, INC.
0000 XXXXXX XXXX, XXXXX X
XXXXXX, XX 00000
ATTENTION: MR. H. XXXX XXXX, PH.D.,
V.P. RESEARCH & DEVELOPMENT
---------------------------------------
This proposal is intended to provide
the platform of information
necessary for Horizon Medical, Inc.
(Horizon) to provide the Clinical
SalEst Collection Kit to BIEX, INC.
(BIEX). It addresses the Scope of
Activities, Process Validation,
Process Lead Times, Raw Materials,
Documentation, Quality Assurance
Policy/Licensing and Pricing.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
SCOPE OF ACTIVITIES Horizon will perform the following:
1. Receive all raw materials from BIEX as Q.C. released (previously
inspected) materials.
2. Introduce job work order packet.
3. Cut piston filter tube to 3 1/4".
4. Label collection tube with label at approximately 5/8" from the
tube bottom.
5. Place cap on collection tube.
6. Impregnate filter with preservative and dry.
7. Erect chipboard box.
8. Place filter tube and collection tube in box.
9. Label and seal box.
10. Bulk pack completed product into stock Horizon shipping cases.
Apply Horizon's supplied label indicating contents, part number,
lot number and quantity.
11. Perform and document all Quality Control activities.
12. Prepare product and documentation including completion of Device
History Records, for shipment.
2.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
PROCESS VALIDATION Horizon will perform the following:
1. Process Validation for piston filter impregnation.
-----------------------------------------------------------------------------------------------------------------------
PROCESS LEAD TIMES Anticipated lead times are as follows:
-Production: Four (4) to six (6) weeks from approved
documentation and receipt of all material.
-Process Validation: Two (2) to three (3) weeks after document
approval and receipt of material. This assume a
colorimetric assay.
-----------------------------------------------------------------------------------------------------------------------
RAW MATERIALS Customer provided raw materials are required to be provided under the
following conditions to ensure quality and regulatory compliance.
1. Clean and ready for use.
2. Adequately labeled for identification, traceability and quantity.
3. Packaged in double poly bagged lined cases.
4. Free of direct contact with chipboard, corrugated cardboard and
similar particulate contaminates.
-----------------------------------------------------------------------------------------------------------------------
DOCUMENTATION Prior to any production activities, a complete Device Master Record (DMR)
will be created at Horizon. Contents included in the DMR:
-Manufacturing Procedures (MP).
-Parts List (PL), references appropriate drawings.
-Quality Control Instructions (QCI).
-Production Traveler (PT).
-Product Specifications (PS), where appropriate, including labeling and
applicable sterilization procedures.
A Device History Record (DHR) is a compilation of records containing the
complete production history of a finished product identified by a specific
traceable work order number. A DHR will be maintained by Horizon for each
lot of finished product to demonstrate that the product was manufactured
in accordance with it's DMR. include dates of manufacturing, quantity
produced, quantity released, lot numbers of components used, dates and
signatures of individuals performing tasks, inspection records and
sterilization process records.
-----------------------------------------------------------------------------------------------------------------------
3.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
Horizon strongly adheres to the position that it is the Customer's right
and responsibility to review and approve Horizon's documentation for the
Customer Devices.
-----------------------------------------------------------------------------------------------------------------------
QUALITY ASSURANCE Horizon Medical, Inc. is committed to providing our customers with
POLICY/LICENSING quality, cost-effectiveness products and services on a timely bases.
We will assure that the requirements of our customers are properly defined
so that we can consistently meet or exceed these requirements.
The management of Horizon Medical takes pride in the company's regulatory
compliance practices. Horizon Medical is committed to meeting or exceeding
customer's quality expectations the first time and every time. Horizon
Medical will consistently assure that the customer's product safety and
efficacy expectations are achieved.
In order to accomplish our goals, Horizon Medical will utilize sound
design, manufacturing controls, tests and inspections, record keeping,
audits, complaint responsiveness, corrective action and internal audits.
Horizon Medical will assure that all manufacturing and related practices
conform to F.D.A. requirements as established by law and by current
Quality System (GMP) Regulations.
Horizon Medical works with our customers, employees and suppliers and
solicits their cooperation in order to obtain these goals.
Horizon Medical is licensed and regulated by the U.S. Food and Drug
Administration and the California Department of Health Services as a
Medical Device and Pharmaceutical Manufacturer.
-----------------------------------------------------------------------------------------------------------------------
PRICING PRODUCTION
Minimum Order Quantity * Unit Price
------------------------- -----------
30,000 Individual Collection Units [*******]
100,000 Individual Collection Units [*******]
300,000 Individual Collection Units [*******]
*Defined as a single product/delivery quantity.
Terms: Net thirty (30) days.
-----------------------------------------------------------------------------------------------------------------------
[*] CONFIDENTIAL TREATMENT REQUESTED
4.
-----------------------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
F.O.B.: Santa Ana, CA.
-----------------------------------------------------------------------------------------------------------------------
SUMMARY Horizon looks forward to the challenge and opportunity to provide our
services to BIEX, INC. We maintain our quality and manufacturing systems
to exceed industry standards and we look forward to applying these skills
to your outsourcing needs.
-----------------------------------------------------------------------------------------------------------------------
Respectfully Submitted by:
/s/ Xxxxxxx X. Xxxxx
Xxxxxxx X. Xxxxx
National Sales Manager
Horizon Medical, Inc.
5.
[HORIZON MEDICAL, INC. LETTERHEAD]
15 August 1997
Contract Manufacturing Proposal:
SALEST SALIVA COLLECTION KIT,
NON-AUTOMATED ASSEMBLY
BIEX, INC.
0000 XXXXXX XXXX, XXXXX X
XXXXXX, XX 00000
ATTENTION: MR. H. XXXX XXXX, PH.D.,
V.P. RESEARCH & DEVELOPMENT
---------------------------------------
This proposal is intended to provide
the platform of information
necessary for Horizon Medical, Inc.
(Horizon) to provide the Clinical
SalEst Collection Kit to BIEX, Inc.
(BIEX). It addresses the Scope of
Activities, Process Validation,
Process Lead Times, Raw Materials,
Documentation, Quality Assurance
Policy/Licensing and Pricing.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
SCOPE OF ACTIVITIES Horizon will perform the following:
1. Receive all raw materials from BIEX as Q.C. released-(previously
inspected) materials.
2. Introduce job work order packet.
3. Cut piston filter tube to 3 1/4".
4. Label collection tube with label at approximately 5/8" from the
tube bottom.
5. Place cap on collection tube and tighten lightly.
6. Impregnate filter with preservative and dry.
7. Erect chipboard box.
8. Place one tube in collection unit with bar code facing opening.
9. Place funnel and piston filter in collection unit.
10. Fold mailer and place in collection unit.
11. Place DFU over inserted items and snap into collection unit.
12. Shrink wrap collection unit with seams away from opening to tube
bar code.
12. Scan bar code of four (4) shrink wrapped collection units and
place in kit case.
13. Scan bar code of one (1) pre-printed patient ID/Patient
Help/Doctor Reference Card.
14. Place in kit case.
15. Zip kit case closed.
-----------------------------------------------------------------------------------------------------------------------
6.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
16. Place kit case in outer sleeve and shrink wrap kit.
17. Place twelve (12) shrink wrapped kits in an outer corrugated
shipper.
18. Seal shipper and apply Horizon's supplied label indicating
contents, part number, lot number and quantity.
19. Perform and document all Quality Control activities.
20. Prepare product and documentation including completion of Device
History Records, for shipment.
21. Transfer bar code data base to Biex on a per lot basis.
Horizon will provide corrugated shipper case and shipper label.
Biex will supply custom database software for data storage and retrieval.
-----------------------------------------------------------------------------------------------------------------------
PROCESS VALIDATION Horizon will perform the following:
1. Process Validation for piston filter impregnation. Lead time is
two (2) to three (3) weeks.
2. Software Validation in conjunction with BIEX software vendor. Lead
time is approximately four (4) weeks
-----------------------------------------------------------------------------------------------------------------------
PROCESS LEAD TIMES Anticipated lead times are as follows:
-Production: Four (4) to six (6) weeks from approved
documentation and receipt of all material.
-Software Validation: Four to six weeks from approved documentation
and receipt of all material.
-----------------------------------------------------------------------------------------------------------------------
RAW MATERIALS Customer provided raw materials are required to be provided under the
following conditions to ensure quality and regulatory compliance.
1. Clean and ready for use.
2. Adequately labeled for identification, traceability and quantity.
3. Packaged in double poly bagged lined cases.
4. Free of direct contact with chipboard, corrugated cardboard and
similar particulate contaminates.
-----------------------------------------------------------------------------------------------------------------------
DOCUMENTATION Prior to any production activities, a complete Device Master Record
(DMR)will be created at Horizon. Contents included in the DMR:
-Manufacturing Procedures (MP).
-Parts List (PL), references appropriate drawings.
-Quality Control Instructions (QCI).
-Production Traveler (PT).
-----------------------------------------------------------------------------------------------------------------------
7.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
-Product Specifications (PS), where appropriate, including labeling and
applicable sterilization procedures.
-----------------------------------------------------------------------------------------------------------------------
DOCUMENTATION A Device History Record (DHR) is a compilation of records containing the
(continued) complete production history of a finished product identified by a specific
traceable work order number. A DHR will be maintained by Horizon for each
lot of finished product to demonstrate that the product was manufactured
in accordance with it's DMR, including dates of manufacturing, quantity
produced, quantity released, lot numbers of components used, dates and
signatures of individuals performing tasks, inspection records and
sterilization process records.
Horizon strongly adheres to the position that it is the Customer's right
and responsibility to review and approve Horizon's documentation for the
Customer Devices.
-----------------------------------------------------------------------------------------------------------------------
QUALITY ASSURANCE Horizon Medical, Inc. is committed to providing our customers with
POLICY/LICENSING quality, cost-effectiveness products and services on a timely bases.
We will assure that the requirements of our customers are properly defined
so that we can consistently meet or exceed these requirements.
The management of Horizon Medical takes pride in the company's regulatory
compliance practices. Horizon Medical is committed to meeting or exceeding
customer's quality expectations the first time and every time. Horizon
Medical will consistently assure that the customer's product safety and
efficacy expectations are achieved.
In order to accomplish our goals, Horizon Medical will utilize sound
design, manufacturing controls, tests and inspections, record keeping,
audits, complaint responsiveness, corrective action and internal audits.
Horizon Medical will assure that all manufacturing and related practices
conform to F.D.A. requirements as established by law and by current
Quality System (GMP) Regulations.
Horizon Medical works with our customers, employees and suppliers and
solicit their cooperation in order to obtain these goals.
Horizon Medical is licensed and regulated by the U.S. Food and Drug
Administration and the California Department of Health
-----------------------------------------------------------------------------------------------------------------------
8.
-----------------------------------------------------------------------------------------------------------------------
ITEM DETAIL OF PRODUCT AND SERVICES PROVIDED
-----------------------------------------------------------------------------------------------------------------------
Services as a Medical Device and Pharmaceutical Manufacturer.
-----------------------------------------------------------------------------------------------------------------------
PRICING PRODUCTION
Minimum Order Quantity * Unit Price
-------------------------- -----------
[*******] [*******]
[*******] [*******]
[*******] [*******]
*Pricing includes four (4) collection units per
kit
*Defined as a single product/delivery quantity.
Terms: Net thirty (30) days.
F.O.B.: Santa Ana, CA
-----------------------------------------------------------------------------------------------------------------------
SUMMARY Horizon looks forward to the challenge and opportunity to provide our
services to BIEX, INC. We maintain our quality and manufacturing systems
to exceed industry standards and we look forward to applying these skills
to your outsourcing needs.
-----------------------------------------------------------------------------------------------------------------------
Respectfully Submitted by:
/s/ Xxxxxxx X. Xxxxx
Xxxxxxx X. Xxxxx
National Sales Manager
HORIZON MEDICAL, INC.
[*] CONFIDENTIAL TREATMENT REQUESTED
9.
