1
DISTRIBUTION AGREEMENT
BIOSTAR, INC./WYNTEK DIAGNOSTIC, INC.
THIS AGREEMENT ("Agreement"), made effective this 1st day of July, 1997, by and
between BioStar, Inc., a corporation organized and existing under the laws of
the state of Delaware and having its principal place of business at 0000
Xxxxxxx Xxxx, Xxxxxxx, Xxxxxxxx 00000 (hereinafter referred to as "BioStar")
and Wyntek Diagnostics, Inc., a corporation organized and existing under the
laws of the State of California and having its principal place of business at
0000 Xxxxx Xxxxx Xxxxx, Xxx Xxxxx, XX 00000 (hereinafter referred to as
"Wyntek").
WHEREAS, BioStar(R) is engaged in the business of developing and marketing
various in vitro diagnostic products which utilize Optical ImmunoAssay (OIA(R))
technology and products ancillary thereto, and is seeking additional products
to market through its sales organization, and
WHEREAS, Wyntek is also engaged in the business of developing and marketing
various in vitro diagnostic products and is seeking an improved method of
distribution of its products.
NOW, THEREFORE in consideration of the mutual covenants and obligations set
forth below, the parties hereby agree as follows:
ARTICLE I
DEFINITIONS
The following definitions, whether used in the singular or in the plural, shall
apply throughout this Agreement:
1.1 "CONTRACT YEAR" shall mean the period of twelve (12)
successive calendar months commencing on the 1st day of July, 1997, and each
successive twelve (12) month period thereafter.
1.2 "EFFECTIVE DATE" shall mean the date appearing at the
beginning of this Agreement.
1.3 "PRODUCT(S)" shall mean the rapid human in vitro diagnostic
products set forth in Appendix A attached hereto and made a part hereof, and
such other diagnostic products, if any, as may be added thereto from time to
time by the parties in accordance with Section 2.6 hereof.
1.4 "SPECIFICATIONS" shall mean the product and packaging
specifications for each Product referred to in the Quality Control Agreement,
Exhibit A, attached hereto and made a part hereof, each of which has been
mutually agreed upon and, in respect of new products added pursuant to Section
2.6, will be mutually agreed upon in good faith by the parties hereto and set
forth in such product and packaging specifications, giving due consideration to
applicable regulatory requirements.
1.5 "TERRITORY" shall have the meaning set forth in Section 2.2
below.
1.
* CERTAIN CONFIDENTIAL MATERIAL CONTAINED IN
THIS DOCUMENT HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406
OF THE SECURITIES ACT OF 1933, AS AMENDED
2
1.6 "TRADEMARKS" shall mean those trademarks and trade names,
whether or not registered in the United States, trade dress and packaging which
(a) are owned by BioStar, and (b) are applied to or used in connection with a
Product.
1.7 "TERM" shall have the meaning set forth in Section 6.1 below.
1.8 "PURCHASE PRICE" shall be the price BioStar pays Wyntek for
the Products in Appendix A under the column titled "Cost/Test."
ARTICLE II
DISTRIBUTORSHIP
2.1 LICENSE. Subject to the terms of this Agreement, Wyntek
hereby grants to BioStar and BioStar hereby accepts from Wyntek a non-exclusive
right and license for the Term, (i) to market, sell, demonstrate and distribute
for sale the Products in the Territory, and (ii) to label the Products as
BioStar products manufactured for BioStar. The foregoing license includes a
right to sublicense to distributors.
2.2 TERRITORY. The license granted to BioStar set forth in
Section 2. 1 above shall be for the right and license to distribute the
Products in the Territory. "Territory" shall mean the United States, including
without limitation managed care outpatient facilities, physician offices,
urgent care facilities, clinics, student health centers, public school
facilities, public health facilities, hospitals and reference laboratories
located in the United States. The rights to sell the Products in additional
areas or markets may be discussed and agreed to separate from this contract.
2.3 BIOSTAR'S OBLIGATIONS. BioStar agrees to use its best efforts
to promote and maximize the sale, marketing and distribution of the Products in
the Territory. BioStar may distribute the Products in the Territory under the
Trademarks. BioStar, at its own expense, may prepare advertising and
promotional materials. All of BioStar's advertising and promotional materials
shall designate the Products by the Trademarks and shall identify the Products
as being manufactured for BioStar.
(A) REPRESENTATIONS AND WARRANTIES. BioStar
represents and warrants that it has adequate financial resources, management,
sales force and facilities (including warehouse facilities, business offices and
clerical staff): (i) to acquire and maintain a reasonable inventory of Products;
(ii) to sell and promote the sale of the Products as herein provided; and (iii)
to otherwise perform all of its obligations under this Agreement.
(B) CUSTOMER LIST. For regulatory purposes,
BioStar shall establish and maintain a system of record keeping identifying each
end user by name, address, the date of sale and lot number for each of the
Products sold (the "Customer List"). If the customer does not use the Products
itself, but rather delivers the Products to other end users, then BioStar shall
require the customer to maintain a similar Customer List.
(C) TECHNICAL SUPPORT OBLIGATIONS. BioStar shall
provide technical assistance and support to its customers who purchase the
Products.
2.
3
2.4 WYNTEK'S OBLIGATIONS. Wyntek will make available to BioStar the
following support:
(A) REPRESENTATIONS AND WARRANTIES. Wyntek represents and
warrants that it has adequate financial resources, management and facilities
(including manufacturing and warehouse facilities, business offices and
clerical staff): (i) to produce and maintain an inventory of Products
sufficient to meet its supply obligations under this Agreement; and (ii) to
otherwise perform all of its obligations under this Agreement.
(B) Wyntek shall keep BioStar fully informed of all governmental,
commercial and industrial activities and plans of which it has knowledge which
Wyntek believes does or could affect the sale of the Products in the Territory.
(C) Wyntek will support BioStar's marketing efforts by conducting
meetings to train BioStar personnel for the sale, after-sale service and
support of the Product sold in the Territory pursuant to this Agreement. Such
support will include training of BioStar employees at BioStar's offices
specifically as it relates to new product introductions and QC/QA standards.
Wyntek will be responsible for the cost of transportation and living expenses
for its training staff.
(D) TECHNICAL ASSISTANCE. Any technical support BioStar may
reasonably require for the promotion, sale, after-sale service and support of
Product sold in the Territory pursuant to this Agreement.
(E) Copies of third party publications and scientific support
material for the Products.
(F) Support for BioStar's customer product evaluations as needed
and agreed to by both parties.
2.5 RESERVATION OF RIGHTS. Wyntek agrees not to develop private label
agreements with other companies for the United States domestic market for the
products listed in Appendix A and subsequent products that may be listed in
Appendix A that contain more favorable terms than the contract with BioStar.
2.6 NOTIFICATION OF INTENT TO MARKET. Wyntek agrees to notify BioStar of
plans to market new Products and, if it is appropriate, to discuss including
the distribution of the new Products in the agreement between BioStar and
Wyntek.
ARTICLE III
MANUFACTURE BY AND SUPPLY FROM WYNTEK
3.1 PURCHASE OF PRODUCTS. BioStar undertakes to purchase the
Products in its own name and for its own account. Purchase of Products shall
be made on a monthly basis and shall be made by delivery to Wyntek, sixty (60)
days in advance of the requested delivery date, of written purchase orders for
the Products (the "Purchase Orders"). The first thirty days represent
committed purchase volumes. BioStar may increase or decrease stated purchase
volumes for the second thirty (30) days by up to 20%, provided a written
purchase order is placed at Wyntek at
3.
4
least thirty (30) days prior to requested delivery. In the event of any
inconsistency between the terms and conditions of a Purchase Order and this
Agreement, this Agreement shall prevail.
3.2 PACKAGING TO OCCUR AS FOLLOWS.
(A) FOR THE STREP A PRODUCT. Initially, Wyntek shall
deliver the Products to BioStar in finished form (in packaging designed by
BioStar), ready for delivery to BioStar customers. BioStar is to develop
artwork for all packaging and deliver this artwork to Wyntek. Wyntek will
produce all packaging using the BioStar artwork. The packaging shall include
all Wyntek labeling, package inserts and cartons with artwork designed by
BioStar. As soon as possible, but, prior to December 31, 1997, Wyntek will
initiate shipments of strips in tube, reagents in bottles, test tubes and tray
to BioStar for BioStar to package. BioStar will be responsible for purchase of
swabs, package inserts and packaging required for the completion of the
assembly of the Product and the Product packaging. Cost of the Products is
listed in Appendix A.
(B) FOR THE HCG PRODUCT. Wyntek shall deliver the
Products to BioStar in finished form (in packaging designed by BioStar), ready
for delivery to BioStar's customers. BioStar is to develop artwork for all
packaging and deliver this artwork to Wyntek. Wyntek will produce all
packaging using the BioStar artwork. The packaging includes all Wyntek
labeling, package inserts and cartons using the BioStar artwork.
(C) Wyntek will purchase a set quantity of BioStar
packaging and labeling material. At the transition of final assembly for the
Strep A product from Wyntek to BioStar, BioStar will pay Wyntek for all of the
unused material at Wyntek's cost. BioStar will also pay for any set up fees
for the initiation or changes of BioStar packaging and labeling.
3.3 REGULATORY APPROVALS. Wyntek shall be fully responsible for
obtaining and maintaining United States Food and Drug Administration
(hereinafter referred to as "FDA") approval/clearance with respect to all
Products. Any provision of this Agreement to the contrary notwithstanding, the
obligations of Wyntek to supply and BioStar to purchase from Wyntek any Product
under this Agreement are expressly conditioned upon receipt of all required
regulatory approvals for any such Product, including but not limited to
approval/clearance by the FDA for any such Product, and unless such approvals
are granted, Wyntek shall be under no obligation to supply and BioStar shall be
under no obligation to purchase any such Product.
ARTICLE IV
PRICES AND PAYMENTS
4.1 PRICES; TAXES. The per test prices of the Products are set
forth in Appendix A. Prices listed on Appendix A do not include sales, use, or
excise or similar taxes. The amount of any present, retroactive or future
sales, use, excise or similar tax applicable to BioStar's purchase of Products
will be paid by BioStar.
4.2 PAYMENT. Payment shall be due to Wyntek not later than
forty-five (45) days following the date of the invoice. Payment shall be made
to Wyntek in United States Dollars by check. Wyntek shall not invoice BioStar
for any Product prior to the shipment of such Product.
4.
5
4.3 PRICE CHANCES. At least ninety (90) days prior to the end of
the Contract Year ending 6/30/98 and each Contract Year thereafter, Wyntek and
BioStar shall meet and negotiate in good faith the purchase price to govern the
purchase of each Product by BioStar from Wyntek for the succeeding Contract
Year. The purchase price of each Product will be reviewed annually taking into
account market conditions and any changes in the cost of manufacture of the
Product. In the event no agreement is reached on a price revision following
such review, Wyntek shall be entitled to adjust the purchase price fifty
percent (50%) of the US Consumer Price Index (All Items) over the preceding
contract period, provided Wyntek can document to BioStar's satisfaction that
Wyntek's costs have increased an equivalent amount. All orders received and
accepted by Wyntek prior to the effective date of the price increase will be
billed at the price in effect at the time of acceptance of the order. All
other orders will be billed at the increased price.
4.4 SPECIFIC BUSINESS OPPORTUNITIES. In certain situations,
BioStar and Wyntek may mutually agree to pursue specific business opportunities
at special prices. It is agreed that BioStar and Wyntek will establish a
pricing system appropriate for each situation.
4.5 CAMDON LABORATORY AND MEDICAL SUPPLY, PRICING. Camdon will be
contacted jointly by BioStar and Wyntek upon the signing of the agreement to
determine which source (BioStar or Wyntek) Camdon will use for product supply.
4.6 SAMPLES. BioStar will purchase from Wyntek [ * ] 10-test
BioStar-labeled kits. Wyntek agrees to sell these [ * ] 10-test kits to BioStar
for a total of [ * ]. These [ * ] kits are to be delivered to BioStar as
soon as possible, but no later than July 15, 1997. In addition, BioStar may
purchase additional 10-kits for [ * ] per kit. These kits are to be
purchased as agreed to in 3.1. Wyntek will supply BioStar one (1) up or two (2)
up sample kits of the hCG test in printed envelopes. Wyntek will supply the
sample tests at no charge and BioStar will pay for the printing and other
materials. Initially, [ * ] two (2) up kits are to be delivered to BioStar as
soon as possible, but no later than July 15, 1997. Additional tests will be
ordered as agreed to in 3.1.
ARTICLE V
DELIVERY AND ACCEPTANCE
5.1 DELIVERY. Wyntek shall use its best efforts to deliver
Products ordered by BioStar on or before the requested delivery date to the
extent that such date is at least thirty (30) days from the date Wyntek
receives the order. All shipments will be ground; any expediting of shipments
will be charged to BioStar. Deliveries shall be made FOB BioStar's facility
and shall be shipped to BioStar's address as set forth in this Agreement.
Delivery quantities shall be plus or minus 10% of the order quantity. Wyntek
shall bear the risk of loss until such time as a shipment has been accepted by
BioStar at the BioStar facility. Any claims for damage or loss in transit
shall be placed by Wyntek through the carrier. All shipments will be shipped
by Wyntek freight paid.
5.2 ACCEPTANCE. BioStar shall inspect all goods and shall
validate the quantity of goods promptly upon receipt thereof at the shipping
destination. BioStar will notify Wyntek if any order quantities are incorrect.
Product received at BioStar shall have a minimum of ten (10) months shelf life.
BioStar may reject any goods which fail to meet BioStar's acceptance
5.
6
specifications prevailing on the date of delivery. The acceptance
specifications will be mutually determined by BioStar and Wyntek and set forth
in Exhibit A. Goods not rejected by written notification to Wyntek within
twenty-one (21) days of receipt shall be deemed to have been accepted.
Rejected goods shall be returned freight collect to Wyntek within ten (10) days
of rejection. As promptly as possible but not later than thirty (30) days
after receipt by Wyntek of properly rejected goods, Wyntek shall, at its option
and expense, either repair or replace rejected goods. Wyntek shall bear the
entire risk of loss for goods during shipment. Any insurance proceeds payable
in respect of any loss incurred shall be received by Wyntek.
ARTICLE VI
TERM; TERMINATION
6.1 TERM. Except as otherwise expressly provided in this
Agreement:
(A) INITIAL TERM. The initial term of this Agreement
shall extend from the Effective Date for a period of three (3) years with
options to renew for one (1) year periods as set forth in subsection (b) below
(collectively, the "Term").
(B) RENEWAL OPTION. BioStar shall have the right and
option to renew the term of this Agreement for additional successive periods of
one (1) Contract Year by giving Wyntek written notice thereof at least ninety
(90) days prior to the end of the preceding Contract Year.
If no such written notice is given within such time period, the term of
the agreement will expire.
6.2 TERMINATION BY BIOSTAR. In addition and without prejudice to
any other rights or remedies, this Agreement may be terminated by BioStar as
follows:
(A) TERMINATION FOR BREACH BY WYNTEK. This Agreement may
be terminated by BioStar in the event of the breach or default by Wyntek of the
terms and conditions hereof; provided, however, that with respect to a breach
or default other than Wyntek's inability to supply the Products otherwise than
for a cause reasonably beyond its control, as provided in Section 11.1 hereof,
BioStar shall first give Wyntek written notice of the proposed termination or
cancellation of this Agreement, specifying the grounds therefore, and Wyntek
shall have sixty (60) days after such notice is given to cure such default. If
not so cured, this Agreement shall terminate or be deemed canceled at the
expiration of such sixty (60) days.
(B) EXCHANGE OF MANUFACTURING RIGHTS. BioStar and Wyntek
will discuss appropriate royalties for the perpetual right to manufacture the
Products for sale in the territory upon (i) (A) all or a substantial portion of
the assets of Wyntek are transferred to an assignee for the benefit of
creditors, to a receiver or to a trustee in bankruptcy, (B) a proceeding is
commenced by or against Wyntek for relief in bankruptcy or similar laws and
such proceeding is not dismissed within sixty (60) days, or (C) Wyntek is
adjudged bankrupt, or (ii) Wyntek announces that it is discontinuing or has
discontinued its business that is directed to the manufacture of the Products,
any of which shall be deemed to substantially impair the value of this
Agreement to BioStar. In any such event, Wyntek agrees to immediately deliver
to BioStar the manufacturing processes, materials supplier, any necessary
rights, licenses, and know-how,
6.
7
and any other information that would provide BioStar the ability to assume the
manufacturing of products listed in Appendix A.
6.3 TERMINATION BY WYNTEK. In addition and without prejudice to
any other rights or remedies, this Agreement may be terminated by Wyntek in the
event of the breach or default by BioStar of the terms and conditions hereof;
Wyntek shall first give BioStar written notice of the proposed termination or
cancellation of this Agreement, specifying the grounds therefor, and BioStar
shall have sixty (60) days after such notice is given to cure such default. If
not so cured, this Agreement shall terminate or be deemed canceled at the
expiration of such sixty (60) days.
6.4 TERMINATION BY EITHER PARTY. Notwithstanding anything in this
Agreement to the contrary, either party shall have the right, in addition and
without prejudice to any other rights or remedies, to terminate this Agreement
immediately upon written notice to the other party if:
(A) (i) all or a substantial portion of the assets of
the other xxxxx are transferred to an assignee for the benefit of creditors, to
a receiver or to a trustee in bankruptcy, (ii) a proceeding is commenced by or
against the other party for relief under bankruptcy or similar laws and such
proceeding is not dismissed within sixty (60) days, or (iii) the other party is
adjudged bankrupt;
(B) the other party shall cease to carry on business; or
(C) an event described in Section 11.1 continues for a
period of three (3) months, provided that the party seeking a termination gives
the other party thirty (30) days prior written notice.
6.5 EFFECT OF A TERMINATION ON AGREEMENT AND OUTSTANDING ORDERS.
Termination or cancellation of this Agreement is not a release and shall not
relieve either party from any obligation under this Agreement which may have
accrued prior thereto, including any confidentiality obligation of either party
under Article XIII of this Agreement. In the event that Wyntek terminates, all
orders or portions thereof remaining unshipped as of the effective date of
termination shall automatically be canceled. If BioStar terminates, BioStar
shall have the option to require that all orders be fulfilled.
6.6 GUARANTEE OF SUPPLY TO BIOSTAR CONTRACT ACCOUNTS. In the
event that this Agreement is terminated by Wyntek for any reason, Wyntek agrees
to continue to supply Products to contracted accounts which BioStar identifies
to Wyntek for the term of and according to the terms and conditions of
BioStar's agreement with such contracted accounts.
6.7 PRODUCT DEPLETION IN THE EVENT OF TERMINATION. In the event
of termination of the Agreement by BioStar or by mutual agreement of the
parties, BioStar has the right to sell its remaining inventory.
ARTICLE VII
WARRANTIES AND INSPECTIONS
7.1 WARRANTIES. Wyntek covenants and warrants as follows:
7.
8
(A) All Products supplied hereunder shall, at all times
(i) be approved/cleared by the FDA for marketing in the Territory, (ii) meet
the applicable Specifications and requirements set forth in Exhibit A hereto;
(iii) have a minimum shelf life equal to ten (10) months, and (iv) be free from
material faults and defects in workmanship. Notwithstanding the above, the
shelf life of Products added to this Agreement by the parties after the
Effective Date will be individually determined and mutually agreed to by the
parties.
(B) Wyntek guarantees that no Products supplied hereunder
will, at any time, (i) be adulterated, misbranded, banned or restricted within
the meaning of the Federal Food, Drug and Cosmetic Act, as amended, or (ii) be
a product which may not under the provisions of Section 404 or 505 of such Act
be introduced into interstate commerce. This guarantee shall be a continuing
guarantee and shall be binding upon merchandise shipped or delivered by Wyntek
to BioStar before the receipt by BioStar of written notice of revocation
thereof.
(C) All Products supplied hereunder will be manufactured
and packaged in accordance with, and will materially meet, all other applicable
federal, state and local laws, including but not limited to FDA regulations
covering good manufacturing practices.
(D) The required tests and quality control procedures
shall have been carried out by Wyntek on Product prior to delivery to BioStar
and the test results shall be available for inspection by BioStar.
(E) Human-based materials incorporated into any Product
shall have been tested and found free from HIV I+II and Hepatitis BsAg and HBC
viruses and other contaminants as agreed in the tests and quality control
procedures and any additional tests required for BioStar to sell the Products
in the Territory shall be completed.
(F) All animal derived materials incorporated into
Product shall have been obtained from sources acceptable to all relevant US
authorities for importation into and use in the US.
(G) Product shall be generally safe when used by trained
individuals in a clinical testing site in accordance with the procedures and
specifications included in its instructions.
(H) The Products shall not infringe any copyrights,
trademarks, trade secrets or patents of any third party.
7.2 LIMITATION OF LIABILITY. IN NO EVENT SHALL EITHER PARTY BE
LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES,
INCLUDING LOSS OF PROFITS, REVENUE, DATA, OR USE, INCURRED BY EITHER PARTY OR
ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR TORT OR BASED ON A
WARRANTY, EVEN IF THE OTHER PARTY OR ANY OTHER PERSON HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES. SOME STATES DO NOT ALLOW THE LIMITATION FOR
INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION MAY NOT APPLY.
8.
9
7.3 BIOSTAR RIGHT TO INSPECT.
(A) BioStar shall have the right during regular business
hours to inspect any facility on a biannual basis with appropriate advance
notice where Products are manufactured. Wyntek further agrees to cooperate
fully with, and to provide all data and records relating to the manufacture or
assembly of the Products, including but not limited to analytical methodologies
and quality assurance records reasonably requested by the authorized
representatives of BioStar, but not including any Wyntek proprietary
information.
(B) Notwithstanding anything herein to the contrary, any
failure on the part of BioStar to discover any non-conformance either during
the production process or upon inspection of shipments shall not relieve Wyntek
of its warranties hereunder.
ARTICLE VIII
WARRANTY CLAIMS
8.1 QUALITY ASSURANCE DOCUMENTATION. Each delivery of Products
shall be accompanied by documentation in a form agreed between the Managers of
Quality Assurance for both parties.
8.2 NOTICE OF PRODUCT FAILURE. Each party will immediately notify
the other, by rapid means of communication, and, in any event, within three (3)
business days, in the event of failure of the Products to meet the
Specifications or of any Product's failure to meet, or difficulties disclosed
by, the quality control tests carried out on the Product, or of any continued
stability testing, customer complaints or otherwise, the details of such
notification to be confirmed in writing.
8.3 REMEDY. Upon its verification of any claim or defect or
nonconformity of a unit of the Products, Wyntek will use its reasonable best
efforts to provide BioStar with a replacement unit or parts thereof to the
extent necessary to honor Wyntek's warranties contained in Section 7.1 within
ten (10) days of such determination. If Wyntek is unable to provide BioStar
with a replacement Product, BioStar will be entitled to a refund of the
purchase price paid for such Product. In the event that Wyntek decides to
recall, replace or take other action with respect to any Products, BioStar will
immediately cease sales of any units of Products in its possession or control
that are subject to the action until Wyntek determines the course of action to
be taken. BioStar will return to Wyntek, if so requested, by a reasonable
method, non-complying Product in accordance with the directions of and at the
cost of Wyntek. If the Product is found to be complying pursuant to Section
8.5, then all costs associated with having returned the Product to Wyntek shall
be borne by BioStar.
8.4 EFFECT OF ACCEPTANCE ON WARRANTY CLAIMS. BioStar's acceptance
of products pursuant to Section 5.2 above shall in no way prejudice BioStar's
right to a replacement in the event that Product does not conform to the
warranties given in Section 7.1.
8.5 RESOLUTION OF WARRANTY CLAIMS. In the event of any dispute
arising between the parties which they are unable to settle amicably as to the
quality and/or conformity of a Product to its Specifications when used in
accordance with the procedures included in the Product's instructions, taking
account of the terms of this Agreement and in particular the warranties of
9.
10
Wyntek under Section 7.1, the matter shall be referred to a suitable,
independent, mutually agreed upon laboratory of repute in the United States,
which shall be requested to make a determination with respect to the quality
and/or conformity of the Product. If quality and/or conformity of the disputed
Product is found to be in accordance with the terms of this Agreement, the
laboratory expense shall be borne by BioStar; otherwise the laboratory expense
shall be borne by Wyntek. The parties agree that any such determination shall
be final and binding on both parties and that the laboratory shall act as
expert, not arbitrator.
8.6 BATCH SAMPLE RETENTION. Wyntek shall retain samples from each
batch of a Product for at least three (3) months after the expiration date
sufficient for the purpose of verification in the case of complaints from
purchasers or other users of the Product.
8.7 QUALITY CONTROL/QUALITY ASSURANCE INVESTIGATION.
(A) If BioStar reasonably considers it necessary in the
light of customer complaints it receives in respect of a Product (or when an
appropriate regulatory authority requires it), Wyntek shall at BioStar's
request instigate a quality control/quality assurance investigation in respect
of a Product and report its findings to BioStar as soon as such findings are
available and in any event provide a preliminary report within two (2) weeks
after the receipt of BioStar's request.
(B) If Wyntek's findings are not in BioStar's reasonable
opinion considered adequate to explain and resolve the problem or complaint
giving rise to BioStar's request, Wyntek shall allow BioStar the right to raise
specific questions about the complaint and the findings and any other matter
pertinent thereto, to examine relevant documentation and to audit relevant
manufacturing procedures at Wyntek's manufacturing premises and Wyntek shall
ensure that its relevant personnel shall provide BioStar with such reasonable
information and assistance as BioStar may require in this regard.
ARTICLE IX
PRODUCT WITHDRAWALS
9.1 PRODUCT WITHDRAWALS. Wyntek shall promptly notify BioStar of
and shall provide BioStar with copies of any correspondence and other
documentation received or prepared by Wyntek in connection with any of the
following events:
(A) receipt of a regulatory letter from the FDA in
connection with Wyntek's manufacture, or a third party's manufacture, of any
Product;
(B) the recall of any Product;
(C) the withdrawal of any Product from the market;
(D) any regulatory comments or inquiry from a government
entity requiring a response or action by Wyntek or a third party manufacturer
with respect to any Product; or
(E) receipt of repetitive complaints about a Product
which relate to the clinical efficacy of such Product.
10.
11
9.2 PRODUCT CHANGES. Wyntek will notify BioStar thirty days in
advance of making any significant change in the composition of, the
manufacturing process for, or the labeling of any Product. Wyntek shall be
responsible for obtaining all relevant FDA or other US government approvals
prior to shipping such Product to BioStar for sale in the US. The following
constitutes significant change or modifications:
(A) A change or modification in the product that could
significantly affect the safety or effectiveness of the device, e.g., a
significant change or modification in design, material, chemical composition,
or manufacturing process.
(B) A major change or modification in the intended use of
the device.
9.3 COSTS OF PRODUCT WITHDRAWAL, NOTIFICATION OR LABELING CHANGE.
In the event of a recall, market withdrawal, notification, labeling change or
correction of a Product, Wyntek shall reimburse BioStar for all documented
costs and expenses associated with such action, including labeling and postage
cost. Such costs and expenses shall be substantiated in a reasonably
satisfactory manner.
ARTICLE X
INTELLECTUAL PROPERTY
10.1 OWNERSHIP OF WYNTEK INTELLECTUAL PROPERTY. Wyntek shall
retain all of its rights, title and interest in and to and ownership of all
copyrights, Wyntek trademarks, trade secrets, patents and all other industrial
and intellectual property embodied in the Products other than any BioStar
trademarks, packaging or marketing materials including any improvements or
enhancements to the Products developed by Wyntek (the "Wyntek Intellectual
Property"). Except as otherwise expressly provided in this Agreement, BioStar
has no right, title or interest in the Products or any Wyntek Intellectual
Property relating to the Products and shall not reproduce or otherwise use, in
whole or in part, the Products or the Wyntek Intellectual Property.
10.2 OWNERSHIP OF BIOSTAR INTELLECTUAL PROPERTY. BioStar shall
retain all of its rights, title and interest in and to and ownership of all
copyrights, trademarks, trade secrets, patents and all other industrial and
intellectual property embodied in the Products developed by BioStar including
any improvements or enhancements to the Products (the "BioStar Intellectual
Property"). Except as otherwise expressly provided in this Agreement, Wyntek
has no right, title or interest in the Products or any BioStar Intellectual
Property relating to the Products and shall not reproduce or otherwise use, in
whole or in part the BioStar Intellectual Property.
10.3 USE OF TRADEMARKS. In connection with the manufacturing of
the Products, Wyntek may use the Trademarks. The Trademarks shall bear the
designation (TM) or the designation specified by BioStar.
(A) Wyntek acknowledges the validity of the other party's
right, title and interest in the Trademarks and shall not have, assert or
acquire any right, title or interest in or to any of the Trademarks, except to
the extent expressly provided herein. If Wyntek acquires any goodwill or
reputation in any of the Trademarks, then at the expiration or termination of
this Agreement, all such goodwill or reputation automatically shall vest in
BioStar without any
11.
12
separate payment or other consideration of any kind to Wyntek and Wyntek agrees
to take all such actions necessary to effect such vesting.
(B) Wyntek shall use the Trademarks only in connection
with the production of the products that will be shipped to BioStar for sale to
BioStar customers.
(C) Wyntek shall, at the request and expense of BioStar,
do such acts or things as BioStar may reasonably require for the purpose of
obtaining, maintaining, enforcing and preserving any of the Trademarks, trade
names or other proprietary rights of BioStar in the Territory; provided,
however, that Wyntek agrees that only BioStar has the right to enjoin any
infringement or registration by a third party of such Trademarks, trade names
or similar rights. Wyntek shall give BioStar notice of any infringement or
threatened infringement of the Trademarks used in connection with the Products.
Such notice shall include the full facts of the infringement or threatened
infringement known to Wyntek, including the identity of the suspected
infringer, the place of the asserted infringement and evidence thereof. Wyntek
agrees to cooperate fully with BioStar at the expense of BioStar if BioStar
sues to enjoin such infringement.
(D) Each party shall not (nor shall it attempt to) adopt,
use, or register any acronym, trademark, trade name or other marketing name of
the other party or any confusingly similar work or symbol as part of such
party's own name or the name of its affiliates or the names of the products
which it markets.
ARTICLE XI
EXCUSES FOR NONPERFORMANCE
11.1 FORCE MAJEURE. No party shall be held liable or responsible
for failure or delay in fulfilling or performing any obligation of this
Agreement in case such failure or delay is due to Acts of God, strikes or other
labor disputes, governmental regulations or actions, inability to obtain or
provide material, labor, equipment or transportation, or any other condition
beyond the reasonable control of the affected party.
(A) Each party agrees to give the other party prompt
written notice of the occurrence of any such condition, the nature thereof, and
the extent to which the affected party will be unable to fully perform its
obligations hereunder. Each party further agrees to use all reasonable efforts
to correct the condition as quickly as possible, and to give the other party
prompt written notice when it is again fully able to perform such obligations.
(B) All quantities of Products not shipped by Wyntek
hereunder due to any such condition shall be confirmed, in writing, by the
parties immediately after such condition has been corrected.
11.2 PRODUCT ALLOCATION. If, as a result of conditions as set
forth in Section 11.1 above, Wyntek at any time is unable fully to supply the
orders of BioStar and Wyntek's other customers, Wyntek shall equitably allocate
(by percentage of total sales for the three months prior to the occurrence) its
available resources and production capacity among BioStar and Wyntek' s other
customers.
12.
13
ARTICLE XII
INSURANCE; INDEMNIFICATION
12.1 PRODUCT LIABILITY INSURANCE.
(A) Wyntek shall take out and maintain, at its own
expense, from the signing of this Agreement until November of 1997 product
liability insurance for one million dollars ($1,000,000) and after November of
1997 and for a minimum of two (2) years following the expiration, termination
or cancellation of this Agreement, at least two million dollars ($2,000,000) of
product liability coverage from an insurance company or companies reasonably
satisfactory to BioStar. The insurance policy relating to such coverage shall
name BioStar as an additional insured by endorsement. BioStar will notify
Wyntek prior to contacting Wyntek's insurance company for any reason.
(B) Promptly upon execution of this Agreement, Wyntek
shall cause to be delivered to BioStar an insurance certificate evidencing the
insurance coverage required by Section 12.1(A). Such insurance certificate
shall name BioStar as an additional insured and shall include a certification
that such insurance coverage includes contractual coverage for Wyntek's
liability under this Agreement. In the event of cancellation or modification
of Wyntek's policy thirty (30) days prior notification will be sent to BioStar.
12.2 INDEMNIFICATION BY WYNTEK. Wyntek shall indemnify, defend and
hold harmless BioStar and BioStar's directors, officers, employees and agents
from and against any and all losses, costs, liabilities or expenses (including
costs and reasonable fees of attorneys and other professionals) arising out of
or in connection with Wyntek's performance under or breach of this Agreement to
the extent caused by, in whole or in part, any negligent act or omission or
willful misconduct of Wyntek or Wyntek's employees or agents, including but not
limited to any act or omission that contributes to (i) any personal injury,
sickness, disease or death; (ii) any damage to or destruction of any property
of BioStar or BioStar's customers; or (iii) any violation of any statute,
ordinance or regulation. Wyntek shall indemnify, defend and hold harmless
BioStar and BioStar's directors, officers, employees and agents from and
against any and all losses, costs, liabilities or expenses (including costs and
reasonable fees of attorneys and other professionals) arising out of or in
connection with the infringement by the Products of copyrights, trade secrets
or patents of third parties.
12.3 INDEMNIFICATION BY BIOSTAR.
(A) BioStar shall indemnify, defend and hold harmless
Wyntek or Wyntek's directors, officers, employees and agents from and against
any and all losses, costs, liabilities or expenses (including costs and
reasonable fees of attorneys and other professionals) arising out of or in
connection with BioStar's performance under or breach of this Agreement to the
extent caused by, in whole or in part, any negligent act or omission or willful
misconduct of BioStar or BioStar's employees or agents, including but not
limited to any act or omission that contributes to (i) any personal injury,
sickness, disease or death; (ii) any damage to or destruction of any property
of Wyntek; or, (iii) any violation of any statute, ordinance or regulation.
13.
14
(B) BioStar, at its own expense, will defend and hold
Wyntek harmless against a claim that any copy, bar codes or artwork supplied to
Wyntek by BioStar infringes the trademarks and/or copyrights of the claimant.
BioStar will pay all costs, damages and attorney's fees that a court finally
awards as a result of such claim. To qualify for such defense and payment,
Wyntek must give BioStar prompt written notice of any such claim and allow
BioStar to completely control, and fully cooperate with BioStar, in the defense
thereof and all related settlement negotiations. Wyntek agrees that if the
ownership or use of any of the BioStar supplied copy, bar codes or artwork
becomes or is likely to become the subject of such a claim, Wyntek will permit
BioStar, at BioStar's option and expense, to either secure the right to
continue to fully utilize all such copy, bar codes or artwork or to modify such
BioStar supplied copy, bar codes or artwork so that it is no longer subject to
such claim.
(C) Wyntek may retain counsel of its own choice, at its
own expense and option, with respect to its involvement in the disposition of
any claim made under Section 12 (B), but BioStar's right to completely control
and settle any claim indemnifiable under Section 12 (B) shall not be diminished
or altered in any fashion thereby.
(D) Not withstanding the foregoing, BioStar shall have no
indemnity obligation to Wyntek where the claim of infringement would not have
been made or sustained except for the copy, bar codes or artwork submitted by
BioStar to Wyntek.
(E) Not withstanding the foregoing, BioStar shall have no
indemnity obligation to Wyntek where the claim of infringement is covered by
insurance carried by Wyntek to the extent that Wyntek seeks to collect
reimbursement or indemnification from its insurance carrier therefore.
ARTICLE XIII
CONFIDENTIALITY
During the term of this Agreement and for a period of two (2) years
thereafter, any Confidential Information which is disclosed by one party
(either BioStar or Wyntek) (the "disclosing party") to the other party (either
BioStar or Wyntek), (the "recipient") shall be maintained in confidence by the
recipient and shall be used by the recipient only in carrying out the purposes
of this Agreement. For the purposes of this Agreement, the term "Confidential
Information" shall mean and include any and all proprietary information
relating to the design, development, manufacture, operation and marketing of
the Products, as well as other information relating to know-how, technologies,
process, assets, business plans, and financial information relating to the
Products and to each of the parties and all information which a party should
reasonably expect to be considered Confidential Information. Confidential
Information may be communicated orally, in writing or in any other recorded or
tangible form. The foregoing obligations regarding confidentiality and use of
Confidential Information shall not apply to Confidential Information (i) which
at the time of disclosure is in the public domain; (ii) which after disclosure
is published or otherwise becomes part of the public domain through no fault of
the recipient, but only after it is published or comes into the public domain;
(iii) which the recipient can document by written records as having been its
possession at the time of disclosure hereunder; (iv) which the recipient can
document by written records as having been received by it after the time of
disclosure from a third party who did not acquire it directly or indirectly
under
14.
15
an obligation of confidence from the disclosing party; and (v) is required to
be disclosed in a judicial or administrative proceeding after all reasonable
legal remedies for maintaining such information in confidence have been
exhausted; or (vi) which the recipient can document by written records to have
been independently developed by the recipient. Each party acknowledges that
irreparable injury will result to the other in the event of a breach or
threatened breach of any of the provisions of this Article and agrees that in
the event of a breach or threatened breach, the complaining party shall be
entitled, in addition to any other available remedy, to seek injunctive and
other equitable relief from a court of competent jurisdiction. The obligations
contained in this Article shall survive the termination of this Agreement.
BioStar may disclose Confidential Information to third parties to the extent
necessary to perform its obligations under this Agreement.
ARTICLE XIV
MISCELLANEOUS PROVISIONS
14.1 RELATIONSHIP OF THE PARTIES. Nothing herein contained shall
be deemed to constitute the relationship of partners, joint venturers nor of
principal and agent between Wyntek and BioStar.
14.2 ASSIGNMENT. Neither Wyntek nor BioStar shall assign this
Agreement without the prior written consent of the other, provided, however,
that either party, without such consent, may assign or sell this Agreement in
connection with the transfer or sale of all or substantially all of the assets
of its diagnostics business or a change in control of BioStar. Any permitted
assignee shall assume all assigned obligations of its assignor under this
Agreement. No assignment shall relieve either Wyntek or BioStar of
responsibility for the performance of any accrued obligation which it then has
hereunder. If either party is acquired by a competitor than the acquired party
must agree to the terms of the contract for twelve (12) months from the date of
the acquisition. Any consent required hereunder shall not be unreasonably
withheld.
14.3 WAIVER. Either party's waiver of any breach or failure to
enforce any of the terms and conditions of this Agreement, at any time, shall
in no way affect, limit or waive such party's right thereafter to enforce and
compel strict compliance with every term and condition of this Agreement.
14.4 SEVERABILITY. If any provision of this Agreement shall be
held invalid or unenforceable, such invalidity or unenforceability shall apply
only to such provision and shall not in any manner affect or render invalid or
unenforceable any other severable provision of this Agreement, and this
Agreement shall be carried out as if any such invalid or unenforceable
provision were not contained herein.
14.5 CAPTION. The captions at the beginning of the several
Articles of this Agreement have been inserted for convenience only and shall
not be used in any way to construe or interpret this Agreement.
14.6 NOTICE. All notices required or permitted to be given under
this Agreement shall be in writing and shall be sent by registered or certified
mail (return receipt requested), postage prepaid, by commercial overnight
courier, or by telex or facsimile (confirmed), and shall be
15.
16
deemed to have been given upon mailing, deposit with the courier, or receipt of
facsimile confirmation, as the case may be. Any such notices shall be
addressed to the receiving party at such party's address set forth below or at
such other address as may from time to time be furnished by a similar notice by
either party.
If to Wyntek: If to BioStar:
Wyntek Diagnostics, Inc. BioStar, Inc.
0000 Xxxxx Xxxxx Xxxxx 0000 Xxxxxxx Xxxx
Xxx Xxxxx, XX 00000 Xxxxxxx, Xxxxxxxx 00000-0000
Fax: (000) 000-0000 Fax: (000) 000-0000
14.7 SALES REPRESENTATION. Wyntek agrees not to hire any BioStar
sales representatives that have left the company within a prior three month
period of the proposed hiring date.
14.8 GOVERNING LAW AND VENUE. This Agreement shall be governed by
and construed under the laws of the State of Colorado (excluding the conflicts
of law thereof). Any matter subject to judicial review or enforcement shall be
heard in the state or federal court in the city of San Diego, CA.
14.9 COUNTERPARTS. Two or more duplicate originals of this
Agreement may be signed by the parties, each of which shall be an original, but
all of which together shall constitute the same instrument.
14.10 ENTIRE AGREEMENT. This Agreement represents the entire
agreement between the parties with respect to the subject matter hereof and
supersedes any prior agreement or understanding among them with respect to the
subject matter hereof. No provision hereof may be amended, modified, terminated
or revoked except by a writing signed by each of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have each caused this Agreement
to be executed by their respective, duly authorized representatives as of this
day and year first above written.
Agreed to for and on behalf of: Agreed to for and on behalf of:
BIOSTAR, INC. WYNTEK DIAGNOSTICS, INC.
0000 Xxxxxxx Xx. 0000 Xxxxx Xxxxx Xxxxx
Xxxxxxx, XX 00000 Xxx Xxxxx, XX 00000
By: /s/ Xxxxxx X. Xxxxx By: /s/ Xxxxx Fan
--------------------------------- ---------------------------------
Xxxxxx X. Xxxxx Xxxxx Fan
President/Chief Executive Officer President/Chief Executive Officer
Date: 6-29-97 Date: 6/30/97
--------------------------------- ---------------------------------
16.
17
APPENDIX A
PRODUCTS, COST TO BIOSTAR
PRODUCTS COST/TEST
-------- ---------
Wyntek OSOM Brand Strep A test-50 tests per kit-completely [ * ] delivered to
packaged with BioStar labels BioStar
Wyntek OSOM Brand Strep A-50 test strips in a BioStar-labeled [ * ] delivered to
tube container, BioStar-labeled reagents (reagents to include; BioStar
Reagents 1 and 2, and Positive and Negative Control), test tubes
and holder
Wyntek Perfecta Brand Pregnancy Test-20 tests per kit-completely [ * ] delivered to
packaged with Biostar labels BioStar
17.
18
EXHIBIT A
CONTENTS
Acceava Strep A Purchase Specification and Inspection Report
Acceava hCG Purchase Specification and Inspection Report
19
PURCHASE SPECIFICATION AND INSPECTION REPORT
================================================================================
ACCEEVA HCG 20 TEST KIT DOC. NO. RMACCHCG
(PART # ACCHCG) REVISION NO. 00
SUPERSEDES NEW
PAGE 1 OF 3
================================================================================
Q.A. Approval
By:______________________ Date:_______________ Effective Date:______________
================================================================================
1. DESCRIPTION: Acceava hCG 20 test kit. BioStar labeling throughout.
Components as listed on Certificate of Analysis.
2. UNITS OF MEASURE: Each.
3. VENDOR LIST: Wyntek Diagnostics Cat. # ACCHCG
4. STORAGE CONDITIONS: Ambient
5. SHELF LIFE/EXPIRATION DATE: Based on Manufacturer's Dating and labeling;
Certificate of Analysis required.
6. SAMPLING: Mil Std 105E, 2.5% AQL, GEN, Level I1, Single/Normal sampling
for visual characteristics. One kit for performance, 2 kits
for retention.
7. TESTING METHOD:
METHOD EXPECTED RESULT
------ ---------------
7.1 Visual
Material check Conforms to Certificate of Analysis (COA) description.
Label text check Matches current approved text (See Master Label Log).
Kit check Kit is clean and free of debris, spilled reagents, etc.
Expiration date Conforms to Manufacturer's expiration date from (COA).
Lot Number Conforms to Manufacturer's Lot Number from (COA).
7.2 Performance Testing (vs. QC Reference Chart) (See page 2 for procedure)
Negate Control Negative is clean
500mlp/mL LH < +
- -
25mlp/mL hCG > - 1.5 +
-
500mlp/mL hCG > 2 +
-
Control line Clearly visible red line
Test and Control Lines a. Should be inside result window.
b. Lines should have no major
breaks in line form.
8. PURCHASE SPECIFICATION: N/A
20
ACCEAVA HCG 20 TEST KIT DOC. NO. RMACCHCG.00
(PART # ACCHCG) PAGE 2 OF 3
================================================================================
2. PERFORMANCE TESTING PROCEDURE (7.2)
TEST MATERIALS LOT #
Test Sticks
------------------------------
Negative Control
------------------------------
500mlp/mL LH
------------------------------
25mlp/mL hCG
------------------------------
500mlp/mL hCG
------------------------------
TEST PROCEDURE
Test 3 sticks for each of the control samples.
Remove sufficient solution into a tube to dip the entire tip of the entire
absorbent tip of the stick into the test solution for 3 seconds. Place the
stick on a clean, fiat, dry disposable surface.
Other Inspections:
Inspect Control Line intensity during QC testing. The Control Line
should be a visible red line.
Inspect Test and Control Line location during QC testing. The Test
and Control Lines should be inside the result window with no major
break in the line form.
Record the results on the QC Testing Data Sheet. The lot is deemed acceptable
when all test results recorded on the sheets are within the specifications
listed. If any non-conforming result occurred, the lot should be withheld for
further review and disposition.
21
ACCEAVA HCG 20 TEST KIT DOC. NO. RMACCHCG.00
(PART # ACCHCG) PAGE 3 OF 3
================================================================================
INSPECTION RECORD:
Manufacturer: ______________________ Date Received _____________________
Manufacturer Lot #: ________________ BioStar Lot #: ____________________
Manufacturer Exp. Date: ____________ BioStar Exp. Date: ________________
P.O. #: ____________________________ Quantity Received: ________________
================================================================================
TEST RESULTS:
1. VISUAL: YES NO
Conforms to Certificate of Analysis Description [ ] [ ]
Matches current approved test [ ] [ ]
Kit is clean and free of debris, spilled reagent, etc. [ ] [ ]
Lot and expiration conform to Certificate of Analysis [ ] [ ]
2. PERFORMANCE:
Negative clean [ ] [ ]
500mlp/mL LH < + [ ] [ ]
- -
25mlp/mL hCG > 1.5 + [ ] [ ]
-
500mlp/mL hCG > 2 + [ ] [ ]
-
Control line red and visible [ ] [ ]
Test and control lines in result window [ ] [ ]
Test and control lines have no major break in line form [ ] [ ]
================================================================================
MATERIAL DOES/DOES NOT MEET PURCHASE SPECIFICATION IDENTIFICATION REQUIREMENTS.
================================================================================
Comments: ______________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
[ ] ACCEPTED [ ] REJECT
Inspected By: _________________________ Reviewed By: ______________________
Date: _________________________________ Date: _____________________________
22
PURCHASE SPECIFICATION AND INSPECTION REPORT
================================================================================
DOC. NO. RMACCGAS
ACCEAVA STREP A 50 TEST KIT REVISION XX. 00
(XXXX # XXXXXX) SUPERSEDES NEW
PAGE 1 OF 3
================================================================================
Q.A. Approval
By:___________________________ Date ______________ Effective __________________
================================================================================
1. DESCRIPTION: Acceava Strep A 50 test kit. BioStar labeling throughout.
Components as listed on Certificate of Analysis.
2. UNIT OF MEASURE: Each.
3. VENDOR LIST: Wyntek Diagnostics Cat. # ACCGAS
4. STORAGE CONDITIONS: Ambient
5. SHELF LIFE/EXPIRATION DATE: Based on Manufacturer's Dating and labeling;
Certificate of Analysis required.
6. SAMPLING: Mil Std 105E, 2.5% AQL, GEN, Level II, Single/Normal sampling
for visual characteristics. One kit for performance, 2 kits for retention.
7. TESTING METHOD:
METHOD EXPECTED RESULT
------ ---------------
7.1 Visual
Material check Conforms to Certificate of Analysis (COA) description.
Label text check Matches current approved text (See Master Label Log).
Kit check Kit is clean and free of debris, spilled reagents, etc.
Expiration date Conforms to Manufacturer's expiration date from (COA).
Lot Number Conforms to Manufacturer's Lot Number from (COA).
7.2 Performance Testing (vs. QC Reference Chart) (See page 2 for procedure)
Negate Control Negative is clean
Positive Control ) 2.5 +
-
QC Control, Level II ) 2 +
-
QC Control, Level I ) +
- -
Control Line Clearly visible red line
Test and Control Lines a. Should be inside result window.
b. Lines should not touch either edge of
window.
c. There should be a minimum of 1mm spacing
between lines.
8. SPECIFICATIONS: N/A
23
ACCEAVA STREP A 50 TEST KIT DOC. NO. RMACCGAS.00
(PART # ACCGAS) PAGE 2 OF 3
================================================================================
2. PERFORMANCE TESTING PROCEDURE (7.2)
TEST MATERIALS LOT #
Test Sticks _____________________________
Reagent 1 _____________________________
Reagent 2 _____________________________
Negative Control _____________________________
Positive Control _____________________________
Quality Control, PN283, Level II _____________________________
Quality Control, Level I _____________________________
TEST PROCEDURE
Test 3 sticks for each of the control samples. Use the same lots of Reagent 1,
Reagent 2, Positive and Negative Controls found in the kit.
For testing Positive Control and Negative Control, place 3 drops each of
Reagent 1 and Reagent 2 into a tube followed by one drop of the Control. Mix
well with a clean swab and incubate for one minute. Remove the swab after
extraction and place a stick into the tube. Determine the results at 5
minutes.
For testing Strep A QC Control, Level II, place 20 mL of the control in a test
tube followed by 0.15 mL each of Reagent 1 and Reagent 2. Mix and incubate the
mixture for one minute. Place a stick into the mixture and leave in for 5
minutes. Determine the results at 5 minutes.
For testing Strap A QC Control, Level I, place 20 mL of the control in a test
tube followed by 0.60 mL each of Reagent 1 and Reagent 2. Mix and incubate the
mixture for one minute. Remove 0.3 mL to a clean tube. Place a stick into
sample and leave in for 5 minutes. Determine the results at 5 minutes.
Other Inspections
Inspect Control Line intensity during QC testing. The Control Line should
be a visible red line.
Inspect Test and Control Line location during QC testing. The Test and
Control Lines should be inside the result window and not touched to either
edge of the window. There should be a minimum of 1 mm space between the
Test Line and the Control Line.
Record the results on the QC Testing Data Sheet. The lot is deemed acceptable
when all test results recorded on the sheets are within the specifications
listed. If any non-conforming result occurred, the lot should be withheld for
further review and disposition.
24
ACCEAVA STREP A 50 TEST KIT DOC. NO. RMACCGAS.00
(PART # ACCGAS) PAGE 3 OF 3
================================================================================
INSPECTION RECORD:
Manufacturer: ______________________ Date Received _____________________
Manufacturer Lot #: ________________ BioStar Lot #: ____________________
Manufacturer Exp. Date: ____________ BioStar Exp. Date: ________________
P.O. #: ____________________________ Quantity Received: ________________
================================================================================
TEST RESULTS:
1. VISUAL: YES NO
Conforms to Certificate of Analysis Description [ ] [ ]
Matches current approved test [ ] [ ]
Kit is clean and free of debris, spilled reagent, etc. [ ] [ ]
Lot and expiration conform to Certificate of Analysis [ ] [ ]
2. PERFORMANCE:
Negative clean [ ] [ ]
Positive Control > = 2.5 + [ ] [ ]
QC Control, Level II > = 2 [ ] [ ]
QC Control, Level I > = + [ ] [ ]
Control line red and visible [ ] [ ]
Test and control lines in result window [ ] [ ]
Test and control lines do not touch edge of window [ ] [ ]
Test and control lines are minimum of 1mm apart [ ] [ ]
================================================================================
MATERIAL DOES/DOES NOT MEET PURCHASE SPECIFICATION IDENTIFICATION REQUIREMENTS.
================================================================================
Comments: ______________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
[ ] ACCEPTED [ ] REJECT
Inspected By: _________________________ Reviewed By: ______________________
Date: _________________________________ Date: ____________________________
25
[WYNTEK LETTERHEAD]
June 30, 1997
Xx. Xxxxxx Xxxxx
President And Chief Executive Officer
BioStar, Inc.
0000 Xxxxxxx Xxxx
Xxxxxxx, XX 00000
Xx Xxxxx:
This letter is intended to clarify several issues on the Distribution Agreement
between our two companies (as referenced in section 14.10).
1. 3.2.C: The repurchase of packaging material by BioStar will cover all
products stated in the Distribution Agreement and up to six months
inventory of BioStar labeled and labeling material.
2. 9.3: BioStar will bear all costs of any product recall, market
withdrawal, notification or correction product that is BioStar's fault.
3. 14.8: The entire Distribution agreement shall be governed by and
construed under the laws of the State of California.
Sincerely:
/s/ XXXXX X. XXXXXXX
Xxxxx X. Xxxxxxx
Vice President Sales and Marketing
Agreed to for and on the behalf of:
BioStar, Inc. Wyntek Diagnostics, Inc.
0000 Xxxxxxx Xxxx 0000 Xxxxx Xxxxx Xxxxx
Xxxxxxx, XX 00000 Xxx Xxxxx, XX 00000
By: /s/ Xxxxxx X. Xxxxx By: /s/ Xxxxx Fan
-------------------------------- -------------------------------
Xxxxxx X. Xxxxx Xxxxx Fan
President and Chief Executive Officer President and Chief
Executive Officer
26
FIRST AMENDMENT TO DISTRIBUTION AGREEMENT
The First Amendment to Distribution Agreement (the "Agreement") is
entered into this 17th day of November, 1997, by and between BioStar, Inc., a
Delaware corporation (the "COMPANY") and Wyntek Diagnostics, Inc., a California
corporation ("WYNTEK").
WHEREAS, the company and Wyntek entered into a Distribution Agreement
dated July 1, 1997 (the "DISTRIBUTION AGREEMENT") pursuant to which Wyntek
granted the Company a license to distribute certain Wyntek products to certain
customers in the United States (as further defined in the Distribution
Agreement, the "TERRITORY"); and
WHEREAS, the Company and Wyntek desire to amend the Distribution
Agreement to expand the definition of the Territory to include certain customers
worldwide.
NOW, THEREFORE, in consideration of the mutual promises and covenants
contained in this Agreement, the parties hereto agree as follows:
1. THE TERRITORY
Section 2.2 of the Distribution Agreement shall be amended to read in
full as follows:
"2.2 TERRITORY. The license granted to BioStar set forth in
Section 2.1 above shall be for the right and license to distribute the
Products in the Territory. "Territory" shall mean the world, including
without limitation managed care outpatient facilities, physician
offices, urgent care facilities, clinics, student health centers,
public school facilities, public health facilities, hospitals, and
reference laboratories located anywhere in the world. The rights to
sell the Products in additional markets may be discussed and agreed to
separate from this contract."
2. REGULATORY APPROVAL
BioStar shall be responsible for obtaining regulatory clearance to
sell all Products in the Territory outside of the United States in which they
intend to sell Product. Wyntek shall inform BioStar of any countries in the
Territory in which Wyntek or any of Wyntek's licensees, successors of assigns
has obtained regulatory approval. In addition, BioStar will inform Wyntek if
BioStar obtains any regulatory approvals.
3. OTHER TERMS
The Distribution Agreement shall remain in full force and effect
except as modified by this Amendment.
1.
27
In Witness Whereof, Wyntek and the Company, intending to be legally
bound by the terms of this Amendment, have caused this Amendment to be executed
by their duly authorized representatives.
WYNTEK DIAGNOSTICS, INC.
By: /s/ Xxxxx Fan
--------------------------------------
Name: Xxxxx Fan
Title: President
BIOSTAR, INC.
By: /s/ Xxxxxx X. Xxxxx
---------------------------------------
Name: Xxxxxx X. Xxxxx
Title: President/CEO
