EXHIBIT 10.12
AGREEMENT
Between:
AMERICARE BIOLOGICALS, INC.,
a company duly registered in the United States of America
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(hereinafter referred to as "Americare")
and
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ (62 ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇, Rep. of South Africa)
A company therefore will be formed in the Federal Republic of South Africa
(hereinafter referred to as "Distributor")
1. PREAMBLE
WHEREAS, AMERICARE, a company duly registered in the United States of
America and doing business at ▇▇ ▇.▇. ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇, owns and/or has proprietary interests in certain non
invasive diagnostic testing technology as defined in Addendum "B",
which has been incorporated into its ▇▇▇-▇▇▇(R) Tests ("product").
AND
WHEREAS the Distributor has desire to market and sell the products in
the territory as defined herein.
BOTH PARTIES HEREBY AGREE AS FOLLOWS:
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2. INTERPRETATION
In this agreement unless the context clearly indicates a contrary
intention:
a. The head-notes are for reference purposes only and shall not
affect the interpretation of any part hereof.
b. The singular includes the plural and vice versa.
c. A reference to one gender includes the other genders
d. A reference to a firm or body corporate includes a natural person
and vice versa.
e. The schedules and addenda shall be initialled by the parties for
the purposes of identification and form part of this agreement as
if specifically included herein.
f. Words and expressions defined in the Companies Act ▇▇. ▇▇ ▇▇ ▇▇▇▇
▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ shall be given those defined
meanings when used in this agreement; the following words bear
the meaning set out opposite them below and cognate expressions
bear a like meaning:
1. effective date the date of last signature of this
agreement,
2. Commencement date the date where this agreement
commences, being 1. August 1999
3. Initial License Period The initial period of exclusivity granted by
AMERICARE to the Distributor while the
product goes through the certification stage
and while the Distributor introduces the
product in the territory; for a period of 2
(two) years, documentation of the progress
will be submitted by distributor monthly.
4. Territory The geographical area covered by all
countries of the continent Africa, except
"Nigeria".
5. The product non invasive diagnostic testing technology,
including but not limited to the testing of
HIV, using Americare's patent pending saliva
collection device, which has been
incorporated into its ▇▇▇-▇▇▇(R) HIV Test
6. The Mandate written approval by the South African
Health or Drug Administration that the
product is an accepted procedure and/or test
and complies with the country's appropriate
laws governing such testing device and/or
pharmacology
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7. Minimum quantity the minimum number of units to be purchased
by the distributor from AMERICARE over a
given period to maintain exclusivity for the
territory.
3. LICENSE
3.1. In order for the Distributor to acquire the necessary licenses,
certificates and mandates in the territory necessary to legally
market the Product and to introduce the product in the territory
AMERICARE grants the Distributor an initial exclusive right to
license, market and sell the product in the territory.
3.2. The distributor will:
- submit the product to the respective certification
authorities in the territory for approval and/or
certification in order to obtain a written Mandate from the
South African Government to market and sell the product in
the territory;
- not sell or market the product in the territory prior to the
issuance of the Mandate;
- bear all administrative and incidental costs in the
Territory necessary for the acquisition of the mandate and
registration in the territory;
3.3. AMERICARE will:
- Provide the Distributor with all product samples at the
Distributors price, that may be required by the authorities
to conduct the necessary tests in order to issue the written
mandate.
- Provide the distributor with all product documentation
necessary or required by the authorities in order to issue
the written mandate.
3.4. Any and all licenses, registrations, and/or Mandates obtained for
the product in the territory by the distributor shall be the
property of AMERICARE. If at any time Distributor is not in
compliance with any of the terms of this Agreement, Distributor
shall deliver to AMERICARE any and all licenses, registrations,
and/or Mandates with all duties paid. The Distributor warrants
further that it shall execute any documentation necessary to
facilitate the delivery of same.
3.5. In the event Distributor fails to receive the Mandate from the
authorities in the territory within one year from the effective
date of this Agreement, this Agreement shall terminate without
the parties having any further recourse against each other.
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3.6 In the event of the Distributor not ordering the minimum quantity
from AMERICARE during the licensing period as set out in Addendum
"A", the exclusivity for the Territory shall be terminated under
this agreement.
3.7. Any or authority imparted by the Supplier to the Distributor to
produce any and all licenses, registrations and/or mandates
pursuant to this Agreement shall not be considered in any way to
be a granting of any intellectual property and/or Proprietary
rights to the Distributor.
4. RESPONSIBILITIES
4.1. After the product being licensed for distribution in the
territory, Distributor will market and sell the HIV medical test
kits under the ▇▇▇-▇▇▇(R) label. Each unit of the Product sold by
Distributor must also list Distributor as the authorised
Distributor in the territory on the Product's label
4.2. AMERICARE will grant to the Distributor an exclusive license to
market and sell the Product in the Territory after Distributor
purchases the minimum units of the Product as set forth in
Addendum A. during the initial licensing period. Such exclusive
rights shall remain in force as long as Distributor maintains the
minimum annual purchase requirements set forth in Addendum A and
as long as Distributor maintains the Mandates.
4.3. Any authority granted by AMERICARE to Distributor to produce any
and all licenses, registrations, and/or Mandates pursuant to this
Agreement, shall not be considered in any way to be a granting of
any intellectual property and/or other proprietary rights to
Distributor.
4.4. Distributor will provide any and all documents that may be
necessary to assist AMERICARE in securing the necessary export
licenses from the United States to the territory.
5. PURCHASE ORDERS
5.1. Distributor will from time to time place purchase orders with
AMERICARE for the Product. AMERICARE will, upon receipt of any
and all purchase orders, fill such orders within a six weeks
period after receipt of an order, and letter of credit for full
amount of order.
5.2. AMERICARE will confirm each order in writing and confirm the
expected shipment date. If AMERICARE is unable to fill any order
within that period AMERICARE will contact Distributor and advise
it of the delay and inform Distributor when it can reasonably
expect shipment.
5.3. each order placed by the distributor shall contain a minimum
quantity of 5,000 units each.
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6. SHIPMENT
6.1. All shipments must be maintained in an air-controlled temperature
environment between forty five (45) and eighty five (85) degrees
Fahrenheit,
6.2. All orders will be shipped on the basis FCA Miami airport,
according to INCOTERM 1990.
6.3. It is the responsibility of the Distributor to secure all
necessary documents such as import licenses, insurance etc. for
the shipment.
7. PAYMENT
7.1. If not otherwise agreed in writing, payment to AMERICARE must be
in the form of an irrevocable, transferable, assignable, and
divisible and Letter of Credit from a FDIC approved bank. The
Letter of Credit has to comply with the ICC (International
Chamber of Commerce) Uniform Customs and Practice for Documentary
Credits (UCP 500).
8. MARKETING AND PRODUCT LITERATURE
8.1. Distributor must submit all Product marketing and sales
brochures, pamphlets, product inserts and other printed Product
materials to AMERICARE for final approval. Said approval shall be
within AMERICARE's sole discretion and shall not be unreasonably
withheld.
8.2. AMERICARE shall provide instructions for the use of the Product,
technical data, descriptions and explanations of the Product's
technology in English only. Distributor must perform all
translations. Distributor shall indemnify AMERICARE from any and
all liability which may arise as a result of any translated
document. Copies of all translated documents must be provided to
AMERICARE.
9. TECHNICAL SUPPORT AND TRAINING
9.1. AMERICARE is not obliged to provide any technical support,
research materials, lectures or training to Distributor free of
charge. From time to time AMERICARE may provide data,
descriptions and explanations of the Product. The provision of
any services or materials from time to time by AMERICARE will not
create any obligations under this Agreement.
9.2. Any support, lectures or training provided to Distributor at the
offices of AMERICARE will be provided free of charge.
9.3. AMERICARE will not charge Distributor any professional fees for
the use of any AMERICARE scientists, also in the whole period
during certification of the product.
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10. RELATIONSHIP OF PARTIES, DISCLAIMER OF RESPONSIBILITY
10.1. The relationship between AMERICARE and Distributor is that of
independent contractor. Distributor is not and shall not be deemed
to be the representative or agent of AMERICARE for any purpose
whatsoever and AMERICARE shall not be liable for any acts or
omissions of Distributor all of which shall be done or be deemed
to be done by Distributor in its own name as principal.
10.2. As an independent contractor, the mode, manner, method, and means
used by Distributor in the performance of services shall be of
Distributor's selection and under the sole control and direction
of Distributor. Distributor shall be responsible for all risks
incurred in the operation of Distributor's business and shall
enjoy all the benefits thereof. Any persons employed by or
subcontracting with Distributor to perform any part of
Distributor's obligations hereunder shall be under the sole
control and direction of Distributor. Distributor shall have
solely responsible for all liabilities and expenses thereof.
AMERICARE shall have no right or authority with respect to the
selection, control, direction, or compensation of such persons.
10.3 Other than any loss suffered as a result of inefficiency of the
product, AMERICARE makes no express warranty or representation and
none shall be implied and AMERICARE does not assume any
responsibility nor obligation to Distributor in regard to,
- the adequacy or usefulness of any rights granted hereunder;
- any and all liabilities, demands, expenses or damages,
including special or consequential damages, incurred by
Distributor;
- any claim of recourse arising out of or as a result of this
agreement and Distributor agrees to hold harmless and
indemnify AMERICARE against any and all liabilities,
demands, expenses or damages, arising out of or resulting
from any claim brought by anyone arising out of or related
in any way to the performance of Distributor under this
agreement. As used herein "damages" include loss, injury,
damage or loss of use or revenue, losses by reason of plant
shutdown or slow-down, cost of capital, claims of
customers, or other similar claims.
11. CONFIDENTIALITY AND PUBLICITY
11.1. Neither party will publish or otherwise disclose the terms,
conditions prices contained in this Agreement, except as required
by law. Should any AMERICARE's employee, in the performance of
this Agreement, disclose to Distributor information that is
confidential or proprietary and marked as such Distributor will
not disclose or distribute any such information, in whole or in
part, to any person other than the Distributor's employees and
agents, and solely to the extent necessary for the performance of
Distributor's employees and agents, and solely to
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the extent necessary for the performance of Distributors duties
hereunder. Distributor will notify AMERICARE immediately, but
within not more than three (3) business days, if this Agreement or
any other document pertaining to the business dealings between
the parties is subpoenaed by court, governmental agency or other
authority.
11.2 In the conduct of AMERICARE's business, AMERICARE has developed or
obtained certain Confidential Business information and Trade
Secrets that are specific to AMERICARE's business, and the
unauthorised use or disclosure of said Confidential Business
information and Trade Secrets would be injurious to AMERICARE. For
purposes of this Agreement
11.3. the term "Confidential Business information" means ideas,
information, methods and documentation concerning AMERICARE or the
business of AMERICARE (including but not limited to sensitive
customer data, AMERICARE data, information regarding corporate
organisation, pricing and other information) that is of value to
AMERICARE and is not known to competitors or the public.
11.4 The term "Trade Secrets" means scientific or technical
information, design, processes, techniques or other information
used or possessed by AMERICARE that derives economic and/or
goodwill value from not being generally known, including but not
limited to, information and documentation pertaining to the
design, elements, techniques and procedures of AMERICARE's present
and future products. The terms "Confidential Business information"
and "Trade Secrets" shall not include specific information that
Distributor had in its possession prior to disclosure by
AMERICARE, or information that is, or becomes generally known or
available to the public through no fault, act or omission of
Distributor.
11.5 Distributor shall never, directly or indirectly, use, disclose or
disseminate to any other person, firm, organisation or employee,
or otherwise employ any Trade Secrets.
11.6. Upon termination of Distributor's relationship with AMERICARE for
any reason, or at any time upon request of AMERICARE, Distributor
deliver to AMERICARE all material in Distributor's possession or
control which are or contain Confidential Business Information
and/or Trade Secrets or which are otherwise the property of
AMERICARE.
11.7. Distributor will not make reference to AMERICARE or any
AMERICARE's business units, subsidiaries, parent company,
officers, employees, representatives, agents and/or business
dealings, in any advertising, press releases, product labels or
publicity matter without the express written consent of AMERICARE,
which shall not unreasonably be withheld.
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11.8. The obligations contained in this paragraph shall survive the
termination of this contract and Distributor shall at no time
thereafter disclose any such information until, and the onus shall
be on Distributor to demonstrate this, that information has become
public knowledge as a result of deliberate disclosure by the
Company.
12. TESTING AND EVALUATIONS
12.1. Any samples of the Product for the purpose of evaluation must be
used under AMERICARE's protocol and a copy of any test results or
evaluation reports must be submitted to AMERICARE in the
appropriate format as supplied by the authorities in the
territory.
13. DEFINITION OF AMERICARE
13.1. For purposes of this Agreement, AMERICARE comprises its parent
company, affiliates, subsidiaries, divisions and related entities
or any corporation or other business directly or indirectly
controlling, controlled by or under common control by AMERICARE,
whether before or after execution of this Agreement.
14. COMPLIANCE WITH LAWS
14.1. Distributor represents that it has, as of the execution of this
Agreement all licenses and permits necessary under the law of the
territory to enable Distributor to fully perform this Agreement.
Further, Distributor will maintain such licenses and permits
current during the term of this Agreement.
14.2. Distributor agrees that it will not market, distribute and/or
otherwise use the Product in any manner which violates the laws of
any country he is acting in.
15. INDEMNITY
15.1. Distributor agrees to indemnify and hold harmless AMERICARE, its
officers, agents and employees from and against all liabilities,
damages, losses, judgements, claims and suits, including costs and
expenses incidental thereto, which may be suffered by, accrued
against, be charged to or recoverable from AMERICARE, its
officers, agents and employees by reason of loss or damage to
property or by reason of injury or death of any person resulting
from or in any way connected with the performance of services by
employees, representatives or agents of Distributor for or on
behalf of AMERICARE. This indemnity shall not be acceptable should
any loss or damage occur as a result of the product.
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16. NON-ASSIGNMENT OF AGREEMENT AND SUB-CONTRACTING
16.1 No part of this agreement may be ceded, assigned, transferred or
made over by either party except with the written consent of the
other, which consent shall not be unreasonably withheld. Any such
assignment or transfer shall provide that the transferee,
cessionary or assignee shall assume, from the date of assignment,
cession or transfer all obligations undertaken by the first
mentioned party pursuant to this agreement. AMERICARE is aware of
the fact, that distributor is planning to subcontract to a local
South-African company, which will perform the mandate after
checking that the company AMERICARE will agree with that.
17. DURATION
17.1. The beginning date of this Agreement will be 1 AUGUST 1999 and the
expiration date will be the 1st day of AUGUST, 2001 unless
otherwise terminated as set forth herein. The term of this
Agreement is two years. The agreement will be extended
automatically for another year for each year the Distributor has
met the minimum sales requirements under this agreement as
specified in Addendum "A".
17.2 This contract will be continued and binding in case of change of
ownership of the contracting parties for the legal successor.
18. TERMINATION
18.1. Should either party fail to comply partially or completely with
its obligation hereunder, the other party shall be entitled to
give notice of such failure and to require that such failure be
remedied within the period specified in that notice, which period
shall be not less than fourteen days from the registered date of
notice. Should such failure not be remedied within the period
specified, then the party who gave notice of such failure shall be
entitled to terminate this agreement provided always that the
foregoing shall not apply in any circumstances where specific
right of termination is available or will be available upon the
expiry of a specific period of time. Should termination occur in
accordance with the foregoing, the default party shall pay to the
non-defaulting party, as liquidated damages, an amount determined
by mutual agreement or by arbitration.
18.2. In the event the Product fails to meet its specifications, as set
forth in Addendum "B", this Agreement shall be terminated upon
sixty (60) days written notice AMERICARE shall have thirty (30)
days to cure any alleged defect on written notice of the default.
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19. DOMICILIUM
19.1. The parties hereto choose domicilii citandi et executandi for all
purposes of and in connection with this agreement as follows:
AMERICARE ▇▇ ▇.▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Distributor: ____________________________________
19.2. Any party hereto shall be entitled to change his domicilium from
time to time, provided that any new domicilium selected by the
distributor shall be situated in the Federal Republic of Austria,
shall be an address other than a box number, and any such change
shall only be effective upon receipt of notice in writing by the
other party of such change. All notices, demands, communications
or payments intended for any party shall be made or given at such
party's domicilium for the time being, and, if forwarded by
prepaid registered post, shall be deemed to have been made or
given 7 days after the date of posting.
19.3. Notwithstanding anything to the contrary herein contained a
written notice of communication actually received by a party shall
be an adequate written notice or communication to it
notwithstanding that it was not sent to or delivered at its chosen
domicilium citandi et executandi.
20. GOVERNING LAWS
20.1. This agreement shall be construed in accordance with and its
performance shall be governed by the Laws of the State of Florida.
Venue for any judicial proceeding shall be in Miami-Dade County,
Florida, USA.
21. FORCE MAJEURE
21.1. Neither party shall be liable to the other for failure or delay in
performance of its obligations under this agreement due to
embargoes, strikes, other labour difficulties, wars, civil unrest,
revolution, fires, floods, explosions, earthquakes, Government
regulations or any other cause beyond its control.
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22. SEVERABILITY
22.1. Each provision in this agreement is entirely separate, and
separately enforceable, from each other provision hereof.
22.2. If any term or provision of this agreement shall be found to
be void, illegal or unenforceable then, notwithstanding, the
remaining terms and provisions hereof shall be and remain
binding on the parties hereto.
22.3. Each of the parties undertakes to perform its obligations
hereunder in accordance with all applicable rules, laws and
regulations now or hereafter in effect.
23. VARIATIONS
23.1. No variation, modification or waiver of any provision of this
agreement (including, without limiting the generality of the
aforegoing this paragraph 0 or consent to any departure
therefrom) shall in any way be of any force or effect unless
confirmed in writing and signed by the parties and then such
variation, modification, waiver or consent shall be effective
only in the specific instance and for the purpose and to the
extent for which made or given.
24. SOLE AGREEMENT
24.1. This agreement constitutes the sole agreement between the
parties in relation to its subject matter and supersedes all
prior agreements and no documentation, representation,
warranty or agreement not contained herein shall be of any
force between the parties.
25. WAIVER
25.1. The waiver (whether expressed or implied) by either party of
any breach of the terms or conditions of this agreement by the
other party shall not prejudice any remedy of the waiving
party in respect of any continuing or other breach of the
terms and conditions hereof.
25.2. No favor, delay, relaxation or indulgence on the part of
either party in exercising any power or right conferred on
such party in terms of this agreement shall operate as a
waiver of such power or right nor shall any single or partial
exercise of any such power or right preclude any other or
further exercises thereof or the exercise of any other power
or right under this agreement.
25.3. The expiry or termination of this agreement shall not
prejudice the rights of either party in respect of any
antecedent breach or non-performance by the other party of
any of the terms or conditions hereof.
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26. ARBITRATION
26.1. Any dispute arising at any time, whether on the construction
hereof, the interpretation or termination hereof, or any
breach hereof by either party shall be submitted to and
finally determined by arbitration. Arbitration shall be
finally settled under the Rules of Conciliation and
Arbitration of the International Chamber of Commerce by one or
more arbitrators appointed in accordance with the said rules.
The decision resulting from such proceedings including as to
costs thereof shall be binding on the parties; shall be
carried into effect, and may at the instance of any party
thereto be made an order of court of competent jurisdiction.
27. BREACH
27.1. If Distributor breaches any provision hereof or does or
permits anything to be done which might prejudice the rights
or interests of AMERICARE, then AMERICARE shall be entitled,
without prejudice to any rights as to damages or otherwise
which it may have in law or under this agreement, to terminate
this agreement forthwith and claim immediate payment of all
amounts due in terms of this agreement.
28. I. DURATION OF CONTRACT
28.1. This agreement will be valid for a period of one years from
the implementation date. The validity of the agreement shall
be automatically extended by a period of another year if
Distributor fulfills the minimum requirements under this
contract.
29. NON PURSUANCE
29.1. Distributor agrees not to introduce a similar product or
products, neither on its own nor through a third party, for a
period of two years after termination of this agreement.
30. SUPPORT
30.1. The parties undertake at all times to do all such things, to
perform all such acts and to take all such steps and to
procure the doing of all such things, the performance of all
such actions and the taking of all such steps as may be open
to them and necessary for or incidental to the putting into
effect or maintenance of the terms, conditions and import of
this agreement.
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31. TRADEMARKS
31.1. During the terms of this agreement Distributor may advertise
the product under the trademark "▇▇▇-▇▇▇(R) HIV Test" and such
trademarks AMERICARE may adopt from time to time and
authorizes Distributor to use, but only in conjunction with
the managed promotion and only upon written agreement from
AMERICARE in respect of each product. Permission to display
the trademarks, property words and symbols which AMERICARE may
adopt from time to time is limited to such use, and nothing
contained herein will grant Distributor any rights title or
interest in the trademark.
THUS DONE and SIGNED at Vienna on this the 13th day of May 1999 in the
presence of the undersigned witnesses.
FOR DISTRIBUTOR:
/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
---------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
AS WITNESS:
/s/
-----------------------------
THUS DONE and SIGNED at Vienna on this the 13th day of May 1989 in the
presence of the undersigned witnesses.
FOR SUPPLIER: /s/ ▇▇. ▇▇▇▇▇▇ ▇. ▇'▇▇▇▇▇▇
-----------------------------
▇▇. ▇▇▇▇▇▇ ▇. ▇'▇▇▇▇▇▇
AS WITNESS:
/s/
------------------------------
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ADDENDUM A.
1. THE PRICE OF THE PRODUCT PER SINGLE' UNIT IS $9.23, (U.S.D.) THE PRICE
FOR MULTIPLE PACKAGE UNITS IS PER UNIT $8.23 (U.S.D.)
2. MINIMUM PURCHASE REQUIREMENTS: Each Order shall contain a minimum
quantity of 5000 units each. Total annual purchase amount must be
150,000 units per year.
SAMPLES MUST BE PURCHASED AT THE FULL PRICE.
3. The price per unit will remain stable for the first year. From the 2nd
year the price may be raised by a maximum of 3% per year, if there are
reasonable arguments.
AMERICARE BIOLOGICAL, INC.: SUPPLIER:
/s/ ▇▇. ▇▇▇▇▇▇ ▇. ▇'▇▇▇▇▇▇
----------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇:
/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ DISTRIBUTOR:
-----------------------------
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ADDENDUM "B"
A. PRODUCT
"Product" as used in this Agreement shall mean the ▇▇▇ ▇▇▇(R) Saliva
HIV 1,2& Subtype "0" test.
The ▇▇▇ ▇▇▇(R) Saliva HIV 1,2& Subtype "0" test is a rapid enzyme
immunoassay for the detection procedure for the detection of
antibiotics to those viruses. The test is designed as an initial
screening procedure for the detection of antibiotics which develop as
result of an HIV infection. The test is primarily designed to be used
with "freshly" collected saliva specimen using the patent pending ▇▇▇
▇▇▇(R) Saliva Collector.
The principle of the ▇▇▇ ▇▇▇(R) Saliva HIV 1,2& Subtype "0" utilises a
combination of a specific antibody binding protein, which is conjugated
on dye particles, and viral antigens which are bound to the membrane
solid phase.
B. TESTING MATERIALS
Saliva Collector
HIV Testing Device
Disposable Pipette ( to transfer saliva specimen from collector to
testing device )
Solution "A" Reagent dropper bottle containing diluent.
Instruction Pamphlet
C. PRECAUTIONS
▇.▇ ▇▇▇ ▇▇▇ ▇▇▇(▇) ▇▇▇▇▇▇ ▇▇▇ ▇,▇& Subtype "0" test is designated
for "in vitro" use only
C.2. Any test involving body fluids such as blood, urine, saliva,
etc. should be treated as potentially infectious. Therefore
use protective clothing (lab coats, gloves, safety glasses)
when handling the test kit or samples and performing this
assay.
C.3. Do not pipette any material by mouth. Do not drink, eat or
smoke when conducting this assay.
C.4. Never use test kit beyond expiration date.
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