PRODUCT MANUFACTURE AND SUPPLY AGREEMENT
THIS AGREEMENT, effective as of this 28th day of February, 1998 ("Effective
Date"), by and between BIOSERV CORPORATION, having a principal place of business
at 0000 Xxxxxxxx Xxxx, Xxx Xxxxx, XX 00000-0000 ("Supplier"), and BIEX, INC.,
having its principal place of business at 0000 Xxxxxx Xxxx, Xxxxx X, Xxxxxx, XX
00000 ("Biex").
WHEREAS, Biex has developed a proprietary test for screening for risk of
preterm labor and delivery;
WHEREAS, such test is performed with a kit consisting of plates with xxxxx
filled with certain reagents;
WHEREAS, Supplier has the capability of producing test kits which can be
used for Biex's proprietary test;
NOW, THEREFORE, the parties hereto agree as follows:
1. MANUFACTURE AND SUPPLY OBLIGATIONS.
(a) During the term of this Agreement, Supplier agrees to manufacture and
supply the estriol test 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. Supplier agrees to meet
Biex's requirements for the Product.
(b) Biex will supply to Supplier the components of the Product listed on
Appendix B ("Biex-Supplied Components"). Supplier will incorporate the
Biex-Supplied Components into the Product. Supplier will use the Biex-Supplied
Components solely for production of the Products under this Agreement.
(c) Supplier will manufacture, perform quality control and deliver the
Product in accordance with Biex's manufacturing processes and standard operating
procedures listed on Appendix C, and Supplier's standard operating procedures
that have been submitted to Biex prior to the Effective Date, as such processes
and procedures may be amended from time to time by mutual written agreement
(collectively "Production Procedures").
2. REQUISITIONS.
(a) Biex will order Product under this Agreement by submitting written
requisitions to Supplier any time from the Effective Date until thirty (30) days
before the termination date of the Agreement. All requisitions submitted by
Biex will state the delivery dates, which will be at least thirty (30) days
after submission of the requisition, and must be submitted within the term of
this Agreement. Supplier shall acknowledge promptly each requisition in writing
and confirm delivery dates.
(b) Commencing with the quarter preceding anticipated commercial launch of
Biex's SalEst-TM- product, Biex will supply Supplier with a rolling 12 month
forecast of Product
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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 Supply
[*************] [*************]
[*************] [*************]
[*************] [*************]
(c) The requisition shall contain the following information: reference to
the Product Specifications, quantity to be supplied, routing instructions,
delivery schedule, destination of shipment and confirmation of price. Each
requisition will make specific reference to this Agreement.
3. BIEX-SUPPLIED COMPONENTS.
(a) Supplier shall inform Biex at least once every month on the status of
its inventory of Biex-Supplied Components. Supplier shall order further
supplies of Biex-Supplied Components if the Biex-Supplied Components stored at
Supplier'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).
(b) Supplier shall store the Biex-Supplied Components at no cost to Biex.
If Biex doesn't order in any quarter, there will be a storage charge of
[************] per month in such quarter. The Biex-Supplied Components will
remain the property of Biex, will be set aside in a distinct and separate area
of the Supplier's storage facility, and will be marked with a sticker reading:
"Property of Biex, Inc." Supplier will execute the appropriate public filings
to reflect such ownership of Biex.
(c) Upon receipt of Biex-Supplied Components, Supplier 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 Biex-Supplied Components
with the Product Specifications. Biex-Supplied Components which do not meet
such specifications in the tests performed by Supplier will be replaced by Biex
at no cost to Supplier and open orders will be reviewed for revised delivery
dates.
(d) Supplier will protect and preserve the Biex-Supplied Components and
indemnify Biex against any loss of or damage to any Biex-Supplied Components
while in the possession of Supplier.
(e) If the manufacturing process results in waste of more than [*****] of
the amount of Biex-Supplied Components used for a particular lot, Supplier will
reimburse Biex for the costs of procuring Biex-Supplied Components so wasted.
For the purposes of this Agreement, "waste" means excess consumption of
Biex-Supplied Components.
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4. PACKING, SHIPPING AND TITLE.
(a) The method of packaging will be in accordance with Biex's
instructions. Product will be shipped in accordance with Supplier's standard
procedures. Biex will be responsible for all shipping expenses, insurance, and
similar charges which, if paid by Supplier, will appear as additional items on
Supplier's invoice to Biex. Delivery time is of the essence. Products are to
be delivered on the dates set forth in requisitions or within five days thereof.
(b) Biex is the owner of Product at all stages of the manufacturing
process. Supplier will store the Product prior to shipment in a distinct and
separate area of its storage facility and will xxxx the Product with a sticker
reading: "Property of Biex, Inc." Supplier will execute the appropriate public
filings to reflect such ownership of Biex.
5. ACCEPTANCE AND REJECTIONS.
(a) If Biex discovers a Product defect, Biex may reject the defective
Product, or lot that contains the defective Product, and will promptly notify
Supplier of the rejection and the reason therefor. With regard to latent defects
which are not reasonably detectable at the time of acceptance, Biex may reject a
Product, or lot containing the Product, with latent defects within 30 days from
discovery of such defect. Supplier shall replace the rejected Products at no
cost to Biex, or at Biex's option, provide Biex with a refund or credit of the
purchase price. The parties acknowledge that reasons for rejection include the
failure, error or negligence on the part of Supplier. Examples include, but are
not limited to incorrect chemical used, improper pH adjustment, incorrect
incubation, mixing or other timing step, failure to maintain environment,
failure to maintain cGMP resulting in FDA action, and mislabeling, especially
lot number and expiration date. Both parties recognize that some failures have
no definable causes; in the absence of a definable cause, the failure will be at
Biex's expense.
(b) Per Section 5a, only for Supplier responsible failures, will the cost
of Biex-Supplied Components for replacement deliveries be charged to Supplier,
including reasonable transport and insurance charges paid by Biex for the
delivery of Biex-Supplied Components to Supplier.
6. PRICES, DISCOUNTS AND TAXES.
(a) The 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 price includes packaging and packing and all taxes, duties and
services, except sales tax, which shall be the responsibility of Biex.
(c) If Supplier fails to timely deliver the Product, the price of the
delayed shipment will be discounted by [***********] of delay, excluding failure
of Biex-Supplied Components to meet specifications. Bioserv is entitled to a
5-day grace period under this clause.
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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. 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) Supplier 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 Biex Indemnitees as additional insureds. Such comprehensive
general liability insurance shall provide product liability coverage and broad
form contractual liability coverage for Supplier's indemnification obligation
under this Section. The amounts of insurance coverage required hereunder shall
not be construed to create a limit on Supplier's liability with respect to its
indemnification under this Section. Supplier agrees to provide written evidence
of such insurance upon request and shall provide Biex with written notice at
least fifteen (15) days prior to the cancellation, non-renewal or material
change in such insurance. Supplier's obligation to maintain such insurance
shall continue until 2 years after termination or expiration of this Agreement.
9. WARRANTIES.
The Supplier warrants that the Product will conform to Product
Specifications, will be manufactured using Good Manufacturing Practices current
at the time of manufacture (cGMP).
10. REGULATORY RESPONSIBILITIES.
(a) RESPONSIBILITIES OF BIEX.
(1) Biex will be responsible for all FDA regulatory submissions for
Product.
(2) Biex will maintain FDA listing for Product.
(3) Biex is responsible for maintaining complaint handling procedures
for Product.
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(4) Biex will notify Supplier of any planned inspections by either
FDA or other auditing agencies.
(5) Biex will maintain the Product Device Master Record.
(6) Biex will not label its Products with Supplier's name.
(7) Biex will be responsible for the following functions:
Raw Material Release
Final Product Release
Maintenance of Process Validation
Performance of Raw Material Vendor Audits
Performance of Stability Studies
Maintenance of Labeling Copy
Maintenance of Retains
Calibration traceability on Biex equipment
(b) RESPONSIBILITIES OF THE SUPPLIER.
(1) Supplier will notify Biex of any site inspections that involve
Product or other products manufactured by Supplier. Supplier will make
available inspection reports as requested by Biex.
(2) Supplier 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 Biex.
(3) Supplier agrees to cooperate with any FDA or other agency
inspections involving Product. An inspection that requires in excess of 20
hours will be invoiced to Buyer at [*******] per hour for each hour over 20
hours, except to the extent the time incurred is attributable to Seller
deficiencies.
(4) Supplier will maintain and document environmental controls as
required in Biex's and Supplier's documentation.
(5) Supplier 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.
(6) Supplier will be responsible for calibration traceability on
Supplier equipment.
11. REPRESENTATIONS AND WARRANTIES.
(a) SUPPLIER'S REPRESENTATIONS AND WARRANTIES. Supplier hereby represents
and warrants to Biex that:
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(1) Supplier is duly incorporated and in good standing under the laws
of California;
(2) Supplier is duly authorized to enter into this Agreement; and
(3) this Agreement is binding and enforceable against Supplier.
(b) BIEX'S REPRESENTATIONS AND WARRANTIES. Biex hereby represents and
warrants to Supplier that:
(1) Biex is duly incorporated and in good standing under the laws of
Delaware;
(2) Biex is duly authorized to enter into this Agreement; and
(3) this Agreement is binding and enforceable against Biex.
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, Supplier shall, upon Biex's
request and at Biex's expense, provide to Biex any documentation and know-how
that Biex may require to manufacture or otherwise obtain a continuing source of
Products. Upon Supplier's breach or termination of this Agreement, Biex 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.
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(b) Any such proprietary information shall be used solely for the purposes
of this Agreement, or by Biex 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, Supplier expressly agrees that any
know-how, designs, engineering details, Production Procedures of Biex,
formulations, information concerning conjugates or antiserum, and other data
pertaining to Biex's products and processes, shall, without further need for
designation, be deemed proprietary and confidential information of Biex under
this Section 8. Notwithstanding the foregoing, Biex shall not be considered to
have received any proprietary information of Supplier unless Biex 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.
(e) Any information of a confidential nature learned by Biex employees
while in the Bioserv facility regarding other Bioserv clients shall be held in
confidence.
14. INTELLECTUAL PROPERTY.
(a) Biex shall own all Intellectual Property invented, made or developed
by Supplier or any of its subcontractors during the performance of this
Agreement. Supplier shall promptly report to Biex 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
Supplier will, at Biex's expense, provide all reasonable assistance to Biex in
the prosecution of any patents covering any such inventions.
(b) With regard to any intellectual property of Supplier relating to the
Products, Supplier hereby grants to Biex 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, Biex shall have the right to indicate to
the public that its systems utilize Supplier's Product.
16. COMPLIANCE WITH LAW.
Supplier 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. Supplier agrees to execute on request by Biex 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.
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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 Supplier shall notify Biex promptly of anticipated delays and use best
efforts to fill any orders as soon as possible. Biex may, in any event, without
limiting any rights or remedies, cancel any requisition, 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 Biex requisitions. This Agreement shall not be subject to the
terms, conditions or provisions of any confirmation or business form of
Supplier.
(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 right
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.
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(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.
By signing below, Biex and Supplier each acknowledges 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. BIOSERV CORPORATION
By: /s/ H. Xxxx Xxxx By: /s/ Xxxxxx Xxxxxx
---------------------------- ----------------------------
Signature Signature
H. Xxxx Xxxx Xxxxxx Xxxxxx
Title: Executive Vice President, Title: President
Technology
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APPENDIX A
PRODUCT SPECIFICATIONS
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APPENDIX A -
LIST OF DESCRIPTIONS (MFP's) AND SPECIFICATIONS (QCS's) FOR FINISHED COMPONENTS
PRODUCED BY BIOSERV FOR BIEX KITS:
9001 SALEST 480 TEST KIT
9005 SALEST 96 TEST KIT
COMPONENT P/N MFP QCS
Anti-Estriol Microtiter Strips, labeled 8001 019 019
HRP-Estriol conjugate bulk, B&L 8010 028 028
HRP substrate bulk, B&L 8011 029 029
Stop solution. B&L. 55 ml 8012 030 030
Standard A Bulk, B&L 8013 031 031
Standard B Bulk. B&L 8014 032 032
Standard C Bulk. B&L 8015 033 033
Standard D Bulk, B&L 8016 034 034
Standard E Bulk, B&L 8017 041 041
Wash Buffer Conc. Bulk Pack. B&L 8018 039 039
Pretreatment Buffer, B&L 8019 043 043
Enzyme conjugate, B&L 8002 020 020
Enzyme substrate. B&L 8003 021 021
Stop solution. B&L 8004 022 022
Standard A, B&L, 1 ml Fill 8005 023 023
Standard B, B&L, 1 ml fill 8006 024 024
Standard C, B&L, 1 ml fill 8007 025 025
Standard D, B&L, 1 ml fill 8008 026 026
Standard E, B&L, 1 ml fill 8009 027 027
Wash Buffer Conc., B&L, 20 ml 8020 045 047
Pretreatment Buffer, B&L, 4 ml 8021 046 046
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APPENDIX B
BIEX-SUPPLIED COMPONENTS
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APPENDIX B -
LIST OF MATERIALS SUPPLIED TO BIOSERV FOR PRODUCTION OF BIEX KITS:
9001 SALEST 480 TEST KIT
9005 SALEST 96 TEST KIT
QCS (QUALITY CONTROL SPECIFICATIONS)
MATERIAL PIN QCS
Sodium Chloride 1001 500
Sodium Phosphate (dibasic) 1002 501
Sodium Phosphate (monobasic) 1003 502
Hydrochloric Acid 1006 505
Tween 20 1007 506
Thimerosal 1009 508
TMBlue 1010 509
Sucrose 1011 510
Polyethylene Glycol (PEG 8000) 1014 513
Hydrochloric Acid solution, 5N 1019 518
Sodium Hydroxide solution, 1N 1020 519
BIS-TRIS 1021 520
Sodium Carbonate (monohydrate) 1022 521
Sodium Bicarbonate 1023 522
Proclin 300 1024 523
Mannitol 1025 565
Water, High Purity 1026 571
Primary Estriol Reference Solution 7016 015
Rabbit Anti-Estriol (Purified) 2002 525
HRP-Estriol conjugate 2003 526
Albumin, Bovine 2004 527
Gelati, Bovine skin, 75 Bloom 2005 528
Conjugate Diluent 2006 566
Microwell Strips 3001 529
15ml HDPE bottles w/ cap (Natural) 4001 530
4ml HDPE bottles w/ cap (Natural) 4002 531
15ml bottle - white 4003 532
Zip-lock foil pouch 4006 535
8ml HDPE bottles w/ cap (Natural) 4012 541
60ml HDPE bottles w/cap (Natural) 4013 542
125ml HDPE bottles w/cap (Natural) 4014 543
60ml HDPE bottles w/ cap (Amber) 4015 544
1gm Desiccant 4016 545
30ml HDPE bottle w/cap30ml 4017 585
Label, Anti-Estriol 5001 546
Label, Conjugate, 50ml 5016 568
Label, Substrate, 50ml 5017 569
Label, Stop, 50ml 5018 570
Label, Wash Buffer concentrate, 100ml 5025 572
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APPENDIX B -
LIST OF MATERIALS SUPPLIED TO BIOSERV FOR PRODUCTION OF BIEX KITS:
9001 SALEST 480 TEST KIT
9005 SALEST 96 TEST KIT
QCS (QUALITY CONTROL SPECIFICATIONS)
MATERIAL P/N QCS
Label, SalEst-TM- 5 Kit Bulk Pack 5027 573
Label, Pretreatment Buffer, 14ml 5026 574
Label, Standard A, 4ml 5019 575
Label, Standard B, 4ml 5020 576
Label, Standard C. 4ml 5021 577
Label, Standard D, 4ml 5022 578
Label, Standard E, 4ml 5023 579
Label, Conjugate, 10ml 5002 547
Label, Substrate, 10ml 5003 548
Label, Stop, 10ml 5004 549
Label, Wash Buffer concentrate, 20ml 5029 583
Label, SalEst-TM- 1 Kit Pack 5011 556
Label, Pretreatment Buffer, 4ml 5030 582
Label, Standard A, 1ml 5005 550
Label, Standard B, 1ml 5006 551
Label, Standard C. 1ml 5007 552
Label, Standard D, 1ml 5008 553
Label, Standard E, 1ml 5009 554
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APPENDIX C
LIST OF MANUFACTURING PROCESSES
AND STANDARD OPERATING PROCEDURES
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APPENDIX C -
LIST OF PRODUCTION PROCEDURES REFERENCED IN PRODUCTION OF MATERIALS BY
BIOSERV FOR PRODUCTION OF BIEX KITS:
MFP (BATCH RECORDS) DOCUMENTS
DOC. # PN TITLE DATE
EFFECTIVE
002 7002 Phosphate Buffered Saline (PBS) 5-7-97
004 7004 Bulk HRP-Estriol Conjugate 4-16-97
005 7005 Bulk Stop Solution 10-9-97
007 7007 Bulk Plate Blocking Solution 8-12-97
009 7009 Bulk Calibrator Diluent 6-3-96
010 7011 Bulk Calibrator B 8-12-97
011 7012 Bulk Calibrator C 8-12-97
012 7013 Bulk Xxxxxxxxxx X 0-00-00
000 0000 Xxxx Xxxxxxxxxx E 8-12-97
015 7016 Estriol Primary Reference Solution 5-7-97
017 7018 2.5% Blue Dye 5-7-97
019 8001 Anti-Estriol Microtiter Strips 10-30-97
020 8002 Enzyme Conjugate (B&L) 10-9-97
021 8003 Enzyme Substrate (B&L) 10-9-97
022 8003 Stop Solution (B&L) 10-9-97
023 8005 Standard A (B&L) 10-9-97
024 8006 Standard B (B&L) 10-9-97
025 8007 Standard C (B&L) 10-9-97
026 8008 Standard D (B&L) 10-9-97
027 8009 Standard E (B&L) 10-9-97
028 8010 Enzyme Conjugate (B&L) 10-9-97
029 8011 Enzyme Substrate (B&L) 10-9-97
030 8012 Stop Solution ,(B&L) 10-9-97
031 8013 Standard A (B&L) 10-9-97
032 8014 Standard B (B&L) 10-9-97
033 8015 Standard C (B&L,), 10-9-97
034 8016 Standard D (B&L) 10-9-97
036 7020 Bulk Carbonate Antibody Coating- Solution 1-15-97
037 7021 Wash 10-9-97
038 7022 Bulk Stabilizing Solution 5-30-97
039 8018 Wash Buffer Conc. Bulk Pack (B&L) 10-9-97
041 8017 Standard E (B&L) 10-9-97
042 7023 Bulk Pretreatment Buffer 7-31-97
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APPENDIX C -
LIST OF PRODUCTION PROCEDURES REFERENCED IN PRODUCTION OF MATERIALS BY
BIOSERV FOR PRODUCTION OF BIEX KITS:
DOC. # PN TITLE DATE
EFFECTIVE
043 8019 Pretreatment Buffer (B&L) 10-9-97
044 7024 Bulk Carbonate Buffer 5-7-97
046 8021 Production Record, Pretreatment Buffer (B&L), 10-9-97
4ml
047 8020 Wash Buffer Concentrate (B&L), 20ml 10-9-97
MFG (MANUFACTURING SOP'S)
DOC. # TITLE DATE
EFFECTIVE
001 SMP-1000 Operation 2-28-97
004 Anthos XX XX Operation 1-8-97
005 Inventory Traceability 12-8-97
006 Label Production Using MS Word and Precut labels 2-10-97
007 Dri-rite Desiccant Regeneration 6-24-97
008 Use of Device History Records 10-3-97
010 Estriol Component Shipment 1-15-98
QAP (QUALITY ASSURANCE SOP'S)
DOC. # TITLE DATE
EFFECTIVE
001 Inspection, sampling, and testing of components, 11-20-97
containers, and closures
009 Quality Control Sample Retains 5-10-96
010 Approval B Issuance of Controlled Documents 1-8-97
011 Table of Contents 1-16-98
017 Equipment Cleaning, maintenance and calibration 6-6-97
019 Master Validation Plan 9-2-97
020 Process Validation of bulk stop solution mixing times 6-25-98
021 Performance Qualification of the Xxxx Creative 5-23-96
Systems plate filler Model SMP-1000
022 Validation Plan: Installation and Operation 5-21-96
Qualification of Xxxx Creative Systems Plate Filler,
Model SMP-100
023 Installation and operational qualification of the SLT 6-21-96
plate Reader, Model EAR 340 AT
024 Installation and operation qualification of Flexion 6-21-96
Filler, Model CCAD-80-1
025 Process Validation of Bottle Cap Torquing 6-25-96
026 Process Validation of Wash Buffer Concentrate Mixing 8-19-97
Time
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APPENDIX C -
LIST OF PRODUCTION PROCEDURES REFERENCED IN PRODUCTION OF MATERIALS BY
BIOSERV FOR PRODUCTION OF BIEX KITS:
DOC. # TITLE DATE
EFFECTIVE
027 Process Validation of Pouch Sealing Aluminum Foil. 6-28-96
029 Issuance of Batch Production Records 5-10-96
030 Validation Plan: Installation and Operation of Anthos 8-19-96
Plate Reader Model XX XX
031 Performance Qualification of SLT Plate Reader, Model 6-21-96
EAR 340 AT
032 Process Validation of the SalEst Salivary Estriol 6-18-96
Immunoassay Kit
033 Performance Qualification of Flexion Filler, Model 6-21-96
CCAD-80-1
034 Performance Qualification for Anthos Plate Reader. 7-26-96
Model XX XX
040 Validation Plan: Process Validation of SMP-1000 5-16-97
reagent purging procedure
052 Process Validation of Bottle Cap Torquing - 4 ml 1-19-98
bottle
QCS (QUALITY CONTROL SPECIFICATIONS)
DOC.# PN TITLE DATE
EFFECTIVE
002 7002 Phosphate Buffered Saline.(PBS) 7-31-97
004 7004 Bulk HRP-Estriol Conjugate 1-15-98
005 7005 Bulk Stop Solution 7-26-96
007 7007 Bulk Plate Blocking Solution 7-31-97
009 7009 Bulk Calibrator Diluent 7-31-97
010 7011 Bulk Calibrator B 7-26-96
011 7012 Bulk Calibrator C 7-26-96
012 7013 Bulk Xxxxxxxxxx X 0-00-00
000 0000 Xxxx Xxxxxxxxxx E 7-31-97
015 7016 Estriol Primary Reference Solution 7-26-96
017 7018 2.5% Blue Dye 8-28-97
018 7019 Sample Preservative Solution 8-28-97
019 8001 Anti-Estriol Microtiter Strips 10-30-97
020 8002 Enzyme Xxxxxxxxx (X&X} 0-00-00
000 0000 Xxxxxx Substrate (B&L) 3-14-97
022 8004 Stop Solution (B&L) 3-14-97
023 8005 Standard A (B&L) 3-14-97
024 8006 Standard B (B&L) 3-14-97
[****]Confidential Treatment Request.
APPENDIX C -
LIST OF PRODUCTION PROCEDURES REFERENCED IN PRODUCTION OF MATERIALS BY
BIOSERV FOR PRODUCTION OF BIEX KITS:
DOC.# PN TITLE DATE
EFFECTIVE
025 8007 Standard C (B&L) 3-14-97
026 8008 Standard D (B&L) 3-14-97
027 8009 Standard E (B&L) 3-14-97
028 8010 Enzyme Conjugate (B&L) 3-14-97
029 8011 Enzyme Substrate (B&L) 4-21-97
030 8012 Stop Solution (B&L) 2-12-97
031 8013 Standard A (B&L) 8-12-97
032 8014 Standard B(B&L) 8-12-97
033 8015 Standard C (B&L) 8-12-97
034 8016 Standard D (B&L) 8-12-97
035 9001 SalEst Test Kit. Bulk Pack 1-15-98
036 7020 Bulk Carbonate Antibody Coating solution 7-10-97
037 7021 Wash Buffer Concentrate 8-19-97
038 7022 Bulk Stabilizing Solution 7-31-97
039 8018 Wash Buffer Conc. Bulk Pack (B&L) 8-19-96
041 8017 Standard E (B&L) 8-12-97
042 7023 Bulk Pretreatment Buffer 8-19-96
043 80t9 Pretreatment Buffer 8-12-97
044 7024 Carbonate Buffer 4-4-97
046 8021 Pretreatment Buffer (B&L), 4 ml 6-13-97
047 8020 Wash Buffer Concentrate (B&L), 20 ml 6-13-97
[****]Confidential Treatment Request.
LIST OF BIOSERV SOPS USED FOR BIEX:
SOP/FORM NO. REVISION NUMBER TITLE
SOP0011 05 Line Clearance Procedure
SOP0054 02 Operation & Maintenance of Kenmore
Dehumidifier
SOP0049 03 Heat Sealer operation
SOP0045 02 Preparation of Bulk Reagents
SOP0020 03 Inventory Traceability Procedures
SOP0029 05 Fill Procedure Using the Flexicon Filler
SOP0022 03 Monitoring of Fill Volume
SOP0018 05 Receiving Procedures
SOP0019 03 Shipping Procedures
Form 003 05/6 QA Line Clearance
Form 042 03 Autoclaving of Hoses & Other Supplies
Form 024 05 Weight Check Form
Form 017 05 Fill Verification Worksheet
Form 112 00 Partial Product Release
Form 038 05 Label Request & Utilization Form
Form 005 04 Packing List
Form 015 04 Order Receipt
Form 0037 00 Work in Progress
Form 006 02 Variance Report
Form 099 00 Non-Conforming Materials
Form 032 00 Inventory Control Card
Form 048 01 Cleaning Verification
Form 033B 05 Conjugate Stabilizer Certificate of
Conformance
Form 079 01 Review Sheet for Release of Product
[****]Confidential Treatment Request.
1.
APPENDIX D
PRICES
[****]Confidential Treatment Request.
1.
[LETTERHEAD]
BIOSERV
June 13. 1996
Via Fax: (510} 000-0000
Xxxx Xxxx
Biex, Inc.
0000 Xxxxxx Xxxx, Xxx. X
Xxxxxx. XX 0000X
Dear Xxxx:
I've reviewed the new kit configuration and have determined the new prices per
reagent. This will allow us to have an agreement in place if only certain
components need to be made separately in the future.
Price when all Price when ordered
ACTIVITY QTY ordered together separately
& of one lot
Formulate, Fill Label [*******] [*******] [*******]
Fill, Label [*******] [*******] [*******]
Plates [*******] [*******] [*******]
Kit [*******] [*******] N/A
Obviously we want to encourage you to order its from us and when only components
are ordered, we must charge a minimum of [*****] per P.O. to cover our labor.
For all reagent orders greater than [****] each the price will be [****] for
formulation, fill and label and [****] for fill and label.
If you have any questions, please call me.
Sincerely,
Xxxxxx X. Xxxxxx
President
[****]Confidential Treatment Request.
2.
