Exhibit 10.151
LICENSE AGREEMENT AND TECHNOLOGY TRANSFER AGREEMENT
THIS AGREEMENT is made as of the 30th day of September, 2004 (the
"Effective Date"), by and between CALYPTE BIOMEDICAL CORPORATION ("Calypte"), a
corporation organized under the laws of the State of Delaware, U.S.A. and ANI
BIOTECH OY ("Ani"), a corporation organized under the laws of the country of
Finland.
RECITALS
WHEREAS, Calypte develops, manufactures, markets and sells human in vitro
clinical diagnostic tests for the detection of human infectious agents in the
worldwide professional clinical diagnostic markets.
WHEREAS, Ani develops, manufactures, markets and sells various human in
vitro clinical diagnostic rapid tests under their own brand name or the brand
name of other parties for the worldwide professional and over-the-counter (OTC)
clinical diagnostic markets, and has applied for patents describing certain
lateral-flow rapid test devices and sample applicators.
WHEREAS, Ani desires to license and transfer to Calypte certain
technology owned by Ani that is related to the development, manufacture and sale
of certain human in vitro clinical diagnostic rapid tests.
WHEREAS, Calypte desires to develop, manufacture and sell on a worldwide
basis in the professional and OTC clinical diagnostic markets certain human in
vitro clinical diagnostic rapid tests based on technology owned by Ani.
NOW THEREFORE, the parties hereto agree as follows:
1. Definitions.
1.1. "Affiliate" shall mean any corporation or other business
enterprise controlled by, controlling or under common control by Entity. For
purposes of this paragraph, "control" shall mean, with respect to an entity,
direct or indirect beneficial ownership of more than fifty percent (50%) of the
voting stock or equity.
1.2. "Analytes" shall mean HIV, HPV, Hepatitis B, Hepatitis C,
Syphilis, Gonorrhea, and Chlamydia.
1.3. "Best Price" shall mean the actual number of shares of Calypte
common stock transferred to Ani at any given time which shall be determined by
using the 5-day average closing stock price for Calypte common stock as listed
on the American Stock Exchange (AMEX) immediately before the date of said
transfer, provided however, the price at the time of transfer is equal to or
greater than the Threshold Price.
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1.4 "Confidential Information" of a party shall include any and all
material and information of such party whether identified as confidential
information or not, including, without limitation, ideas, inventions (whether
patentable or not), designs, product concepts, improvements, manufacturing
processes, quality standards, trade secrets, technical information relating to
ongoing research and development, business strategies, marketing plans, customer
lists, and financial data.
1.5. "Currency Exchange Rate" shall mean the conversion from US Dollars
to Euros at the exchange rates posted by the Federal Reserve Bank of New York,
representing the 12 Noon Eastern Time buying rates on the day of said
conversion.
1.6. "Entity" shall mean any corporation, partnership, joint venture,
or other such business organization.
1.7. "Field of Use" shall mean human in vitro clinical diagnostic and
non-therapy screening rapid tests.
1.8. "Improvement" shall mean all improvements and modifications made
to Licensed Technology or to Manufacturing Equipment by Ani during the term of
this Agreement.
1.9. "License Fee" shall mean the license fee set forth in Section 3
hereof payable by Calypte to Ani for the licenses granted hereunder.
1.10. "Licensed Products" shall mean human in vitro clinical diagnostic
and non-therapy screening tests incorporating Licensed Technology which are
designed by Calypte to detect Analytes in human blood, serum, plasma, urine,
oral fluids, or urogenital swabs.
1.11. "Licensed Technology" shall mean human in vitro clinical
diagnostic and non-therapy screening rapid test and sample applicator device
technology described in: (i) European Patent Application 04003603.0 filed on
February 18, 2004, and all issues, reissues, amendments, divisions,
continuations, continuations-in-part, and corresponding foreign counterparts
thereof; (ii) Finnish Patent Application FI200040825 filed on June 15, 2004, and
all issues, reissues, amendments divisions, continuations,
continuations-in-part, and corresponding foreign counterparts thereof; and,
(iii) all confidential know-how proprietary to Ani needed to assist Calypte in
developing and manufacturing Licensed Products.
1.12. "Manufacturing Equipment" shall mean all equipment set forth in
Section 5.1 and listed in Exhibit A.
1.13. "Net Sales" shall mean the gross amount invoiced by Calypte or
its Affiliate from the sale of a Licensed Products to a Third Party within the
Territory and Field of Use, less the following actually incurred by Calypte as a
result of such amounts invoiced: shipping costs, insurance costs, custom duties,
sales tax, VAT, promotional discounts, rebates and returns. If Licensed Products
are sold in the form of a combination product containing one or more diagnostic
tests that are not Licensed Products under this Agreement, Net Sales for such
combination product shall be calculated by multiplying actual Net Sales of such
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combination product by the fraction A/(A+B), where A is the list price in the
relevant country of the Licensed Product if sold separately and B is the total
list price in the relevant country of any other diagnostic tests in the
combination if sold separately. If, on a country-by-country basis, the Licensed
Products and other diagnostic tests contained in a combination product are not
sold separately in such country, the Net Sales of such combination product shall
be determined by multiplying the Net Sales of such combination product by the
fraction A/(A+B), where A is the number of Licensed Products in the combination
product and B is the number of other diagnostic tests in the combination product
that are not Licensed Products. The total of A+B shall not exceed two (2).
1.14. "Territory" shall mean the worldwide professional and OTC human
in vitro clinical diagnostic markets.
1.15. "Third Party" shall mean any party other than Calypte or Ani or
an Affiliate of either Calypte or Ani.
1.16. "Threshold Price" shall mean a per share price for Calypte common
stock equal to or greater than $0.40.
1.17. "Valid Patent Claims" shall mean any claim of any unexpired
patent covering Licensed Technology that has not been revoked, or held to be
unenforceable or invalid by a decision of a court or other government agency,
unappealable or unappealed within the time allowed for appeal.
2. Grants and Licenses.
2.1. Subject to payment of the License Fee set forth in Section 3 and
royalties on net sales set forth in Section 4 as well as compliance with other
terms of this Agreement, Ani grants Calypte the following royalty-bearing
licenses to Licensed Technology and any Improvement within the Field of Use in
the Territory:
2.1.1. Ani grants Calypte an exclusive license to make, use,
develop, have developed, manufacture, have manufactured, offer to sell, sell and
have sold Licensed Products utilizing urine or oral fluid as the sample material
under the Calypte brand name or the brand name of a Third Party; and,
2.1.2. Ani grants Calypte a non-exclusive license to make,
use, develop, have developed, manufacture, have manufactured, offer to sell,
sell and have sold Licensed Products utilizing blood, serum, plasma, or
urogenital swab as the sample material under the Calypte brand name or the brand
name of a Third Party.
2.2. Calypte shall have the right to sublicense to Affiliates of
Calypte the licenses granted in this Section 2. Calypte shall secure and be
fully liable that all sublicensees comply with all the terms of this Agreement,
as applicable.
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2.3. Calypte shall be liable for all claims of product liability
resulting from the manufacturing, marketing, sale and distribution of the
Licensed Products by Calypte, its Affiliates and its distributors. Calypte shall
indemnify and hold harmless Ani, its directors, employees and stockholders
against any and all third party product liability claims resulting from the
manufacturing, marketing, sale and distribution of the Licensed Products.
3. License Fee.
3.1. In consideration of the grant of the licenses set forth in Section
2, Calypte shall pay Ani a non-refundable License Fee as follows:
3.1.1. Three Hundred Thousand Euros (300,000 euro) payable in
cash or in shares of Calypte common stock, pursuant to Section 7.1.2 and Section
7.1.2.1, upon the Effective Date, or within five (5) business days after the
effectiveness of the Registration Statement set forth in Section 7.1.1; and,
3.1.2. Seven Hundred Thousand Euros (700,000 euro) payable in
shares of registered Calypte common stock, or cash, or a combination thereof, at
Calypte's sole discretion in seven (7) equal monthly installments of One Hundred
Thousand Euros (100,000 euro) each; the first installment payable five (5)
business days after the effectiveness of the Registration Statement set forth in
Section 7.1.1, and each subsequent installment payable on a monthly basis
thereafter.
3.2. The License Fee paid by Calypte in Section 3.1 shall give Calypte
the right to incorporate any Improvement made by Ani into Licensed Products at
no additional cost to Calypte.
4. Royalties.
4.1. Calypte shall pay Ani royalties on Net Sales of Licensed Products
according to the royalty rate schedule set forth in Exhibit B attached hereto.
4.1.1. In the event Licensed Products contain more than one
Analyte per rapid test device, the royalty rate for such Licensed Products shall
be equal to the numerical average of the individual royalty rates set forth in
Exhibit B attached hereto for the individual Analytes contained in such Licensed
Products.
4.2. Calypte's obligation to pay royalties hereunder shall exist until
the expiration of the last of any Valid Patent Claims. In the event no patents
covering Licensed Technology issue in the United States of America and it is
evident that such patent will not be issued, Calypte's royalty obligation shall
terminate in the United States of America on the tenth (10th) anniversary of the
Effective Date.
4.3. All royalty payments payable under this Agreement shall be paid on
a quarterly basis, within forty-five (45) days after March 31st, June 30th,
September 30th and December 31st of each year.
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4.4. All royalty payments paid by Calypte under this Agreement shall be
paid in the lawful currency of the European Union (euros).
4.5. Calypte shall keep, and shall require its Affiliates to keep,
true, complete and accurate books of accounts and records together with
supporting documentation for Licensed Products made, used or sold under this
Agreement in accordance with generally accepted accounting principles as applied
in the United States appropriate to determine the amount of royalties due
hereunder and their proper payment. Such records and supporting documentation
shall be open during normal business hours upon reasonable advance notice, at
mutually agreed upon times, for the longer of three (3) years or the time during
which such material should be held in accordance with applicable accounting
regulations following the end of the calendar year to which they pertain, to the
inspection of an independent certified public accountant retained by Ani for the
sole purpose of verifying the accuracy of the royalty payments made to Ani
hereunder. Such certified public accountant shall be entitled to obtain copies
of any of Calypte's or its Affiliates' documents reasonably necessary for the
verification of the amount of royalties and their proper payment. If in dispute,
such records shall be kept until the dispute is settled. Inspection shall be at
Ani's expense, unless the inspector concludes that the amount payable that is
stated in a report is understated by two percent (2%) or more or royalties were
not paid when due, in which case Calypte shall in addition to any other remedy
that may be available to Ani at law or in equity, pay Ani's reasonable expenses
incurred in connection with the inspection shall be paid by Calypte. The Parties
agree that any certified public accountant inspecting Calypte's books pursuant
to this Section 4.3 shall not disclose to Ani any information other than
information relating to the accuracy of reports and payments made hereunder.
Such accountant shall be required to execute an agreement with Calypte agreeing
to the confidentiality provisions set forth in this Section 4.3. Information
disclosed to Ani as a result of an inspection shall be subject to the
confidentiality provisions set forth in Section 8.
4.6. In the event Calypte fails to pay the royalties described in this
Section 4 and Exhibit B on or before the last day of the time period set forth
in Section 4.2, such royalties shall bear interest from and after such date
until paid at a per annum rate equal to the US prime lending rate (Prime Rate)
plus three (3) percent as quoted in The Wall Street Journal for the thirty (30)
day period ending on the payment due date. Each such royalty payment when made
shall be accompanied by all accrued and unpaid interest. Ani shall also be
entitled to compensation for its reasonable collection costs.
4.7. Calypte shall, within forty-five (45) days after March 31st, June
30th, September 30th and December 3lst of each year of this Agreement, deliver
to Ani a true and accurate written accounting royalty report for each calendar
quarter. Each such report shall set forth per Licensed Products per Analyte per
each country in which the Licensed Products have been sold: (i) the Net Sales;
(ii) all deductions from Net Sales made by Calypte pursuant to Section 1.10;
(iii) the royalties payable by Calypte to Ani pursuant to Section 4.1 and
Exhibit B; and, (iv) the product description/name per catalog code. Calypte
shall cooperate fully with any request by an authority or court to deliver
information about the buyers of Licensed Products distributed by Calypte or its
Affiliates.
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4.8. Each royalty report shall be made and sent by the due date to the
following addressees or any other address that Ani may provide in writing:
Ani Biotech Oy
Xxxxxxxxx 00 X
00000 Xxxxxxxx Xxxxxxx
Attn: Xx. Xxxx Xxxxxxxx, CEO
Telephone: x000-00-0000000
Facsimile: x000-00-0000000
Email: xxxx.xxxxxxxx@xxxxxxxxxx.xx
5. Purchase of Manufacturing Equipment.
5.1. Calypte shall purchase Manufacturing Equipment according to the
following price schedule:
Quantity Purchase Price
LP-03A Line Printing Machine
1 54,800 euro
AM-03A Assembling Machine - Short
Slides 1 76,600 euro
CA-03A Conjugate Application Machine 1 24,320 euro
ABM-03A Automatic Bottling Machine 1 51,120 euro
Sample Applicator Device Assembly
Machine 1 26,000 euro
-----------
Total Purchase Price: 232,840 euro
5.2. The purchase price for Manufacturing Equipment set forth in
Section 5.1 shall include: (i) installation at a Calypte designated facility;
(ii) a one (1) year factory warranty for parts and labor; (iii) reasonable
training of Calypte personnel in the use and maintenance of the said equipment
at the facilities of Ani in Finland on a time as mutually agreed between the
parties; and, (iv) a reasonable supply of spare parts as mutually agreed between
the parties.
5.3. Calypte shall make payment for the purchase of Manufacturing
Equipment set forth in Section 5.1 according to the following schedule:
5.3.1. Seventy-seven thousand six hundred thirteen Euros
(77,613 euro) payable in cash or in shares of Calypte common stock, pursuant to
Section 7.1.2 and Section 7.1.2.1, upon the Effective Date, or within five (5)
business days after the effectiveness of the Registration Statement set forth in
Section 7.1.1;
5.3.2. Seventy-seven thousand six hundred thirteen Euros
(77,613 euro) due upon inspection and acceptance of Manufacturing Equipment at
Ani's facility prior to shipment to Calypte, and payable in shares of registered
Calypte common stock, or cash, or a combination thereof, at Calypte's sole
discretion; and,
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5.3.3. Seventy-seven thousand six hundred fourteen Euros
(77,614 euro) due upon inspection, acceptance and installation of Manufacturing
Equipment at Calypte's designated facility, and payable in shares of registered
Calypte common stock, or cash, or a combination thereof, at Calypte's sole
discretion.
5.4. In the event Ani shall make improvements to Manufacturing
Equipment, Ani shall make available to Calypte all such improvements at mutually
agreed terms.
5.5. Ani shall provide Calypte at no additional cost all existing and
any updated engineering drawings, diagrams, schematics and blueprints for all
molds used to manufacture all plastic sample applicator device parts and rapid
test device parts assembled by Manufacturing Equipment to be used solely within
the limits of the license granted in Section 2. Ani shall remain the owner of,
and shall retain all rights in and to, all such technical documentation.
5.6. Calypte shall have the option to purchase all plastic sample
applicator component device parts and rapid test device component parts
assembled by Manufacturing Equipment directly from Ani at a price to be mutually
agreed between the parties. In no case shall the price paid by Calypte exceed
one hundred twenty percent (120%) of the price Ani pays for said component
parts. In the event, Ani's purchase price for said component parts decreases due
to the increased unit volume resulting from Calypte's purchase of said component
parts, Calypte shall be granted the same discount from the supplier as Ani for
the purchase of said component.
5.7. Ani shall provide Calypte with a fully annotated detailed
Xxxx-of-Materials (BOM) for all parts assembled by Manufacturing Equipment to be
used solely for the purpose of repair of and acquiring of spare parts for the
Manufacturing Equipment. Such BOM shall include the units required per
sub-assembly, a listing of all vendors for component parts, sub-assemblies and
final assemblies, and any other information necessary to identify the requisite
parts needed for each sub-assembly and final assembly.
5.8. Both parties shall conduct quality control and assurance testing
on Manufacturing Equipment prior to shipment to Calypte in order to confirm that
Manufacturing Equipment functions in accordance with the technical
specifications set forth in Exhibit A or documentation delivered together with
Manufacturing Equipment.
5.9. Ani shall package and ship Manufacturing Equipment to Calypte's
designated facility. Manufacturing Equipment shall be properly packaged and
labeled in accordance with industry standards and customs at Ani's expense. All
such shipments shall be FOB Helsinki, Finland.
5.10. Manufacturing Equipment received by Calypte at Calypte's
designated facility shall be subject to quality control testing by Calypte; such
quality control procedures used by Calypte to test Manufacturing Equipment shall
be the same quality control testing procedures used by Ani, and agreed to by
Calypte, to test Manufacturing Equipment prior to shipment from Finland.
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5.11. In the event there is a defect or non-conformity in Manufacturing
Equipment upon receipt by Calypte at Calypte's designated facility, Ani shall
promptly correct or repair such defect or non-conformity at Calypte's designated
facility, or in the event Ani is unable to promptly effect said repair, Calypte
shall have the right to return any such defective Manufacturing Equipment to Ani
for replacement. The shipping cost for returning any defective equipment shall
be at Ani's sole expense.
5.12. Any remarks or reclamations regarding Manufacturing Equipment
shall be made within two (2) weeks from the date of completion of installation
by Ani at Calypte's designated facility. Should Ani not receive any such notices
or remarks from Calypte stating non-compliance of such equipment by the end of
the two (2) week period following completion of its installation, Calypte shall
be deemed to have approved and accepted the delivery and installation of such
equipment.
6. Technology Transfer.
6.1. Ani and Calypte shall work together to reformat Calypte's current
HIV dipstick rapid test device and assay to perform as Licensed Products
(hereinafter known as the "Project"). Prior to commencing work on the Project,
Ani and Calypte shall prepare a mutually agreed upon research plan (hereinafter
known as the "Scope of Work") to define specifications, milestones and goals.
The results of the Project shall be the sole and exclusive property of Calypte.
6.2. Ani and Calypte shall each be responsible for their own costs
during the Project and the transfer of Licensed Technology from Ani to Calypte.
Calypte may, under mutually agreed terms, hire Ani to consult on the further
development of Licensed Products in preparation for the commencement of human
clinical trials.
6.3. Each party shall designate a Project Director to represent their
interests and serve as a central point of contact during the Project and the
transfer of Licensed Technology from Ani to Calypte.
6.4. As part of the Project, Ani shall permit a reasonable number of
technical personnel designated by Calypte to study the design and manufacture of
products resulting from the Project at Ani's place of business. Calypte shall
advise Ani, in advance, the names, qualifications and probable lengths of stay
of Calypte's designated personnel desiring to visit Ani. Ani shall make
available qualified personnel for consultation with, and training of such
Calypte's personnel. The cost for transportation, meals, lodging and other
expenses of Calypte's personnel dispatched for training shall be borne by
Calypte. Such Calypte's personnel shall fully comply with Ani's security
regulations and personnel rules.
6.5. As part of the Project, Ani shall transfer to Calypte all know-how
necessary to allow Calypte to develop and manufacture Licensed Products
including but not limited to all specifications for reagents and materials,
formula, manufacturing, analytical and testing procedures, release, packaging,
and other processes contained in any document related to Licensed Technology,
Licensed Products and the Project including all master formulas and process flow
diagrams.
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6.6. The transfer of Licensed Technology from Ani to Calypte shall be
accomplished in three (3) phases, and Licensed Technology shall be deemed
transferred upon the successful completion of Phase 3 as set forth below:
6.6.1. Phase 1: Ani and Calypte shall demonstrate a
laboratory-scale prototype of an HIV-1/2 rapid test based on Licensed Technology
meeting the specifications set forth in the Scope of Work.
6.6.2. Phase 2: Ani and Calypte shall demonstrate, at Ani's
facility, the successful pilot-scale manufacturing of the HIV-1/2 rapid test
developed in Section 6.6.1 using the Manufacturing Equipment purchased by
Calypte.
6.6.3. Phase 3: Ani and Calypte shall demonstrate, at
Calypte's facility, the successful pilot-scale manufacturing of the HIV-1/2
rapid test developed in Section 6.6.2 using the Manufacturing Equipment
purchased by Calypte.
7. Payments.
7.1. Common Stock Payments.
7.1.1. Within thirty (30) days from the Effective Date,
Calypte shall file a Registration Statement with the United States Securities
and Exchange Commission (SEC) in accordance with the provisions contained in the
Securities Act of 1933, as amended, for all shares of Calypte common stock
payable to Ani hereunder.
7.1.2. The pricing of the shares of Calypte common stock used
for payment of the 300,000 euro License Fee set forth in Section 3.1.1 and the
77,613 euro payment for Manufacturing Equipment set forth in Section 5.3.1
(hereinafter the "Pricing") shall be at Ani's option, either: (i) on the
Effective Date, or (ii) on the date of the filing of the Registration Statement
set forth in Section 7.1.1, provided however, the Pricing is equal to or greater
than the Threshold Price.
7.1.2.1. In the event the Pricing is less than the Threshold
Price, Calypte shall (i) make payment in cash for the 300,000 euro License Fee
set forth in Section 3.1.1 and the 77,613 euro payment for Manufacturing
Equipment set forth in Section 5.3.1, or (ii) Ani may elect to accept an
equivalent number of shares of Calypte common stock priced at $0.40 per share as
payment for the 300,000 euro License Fee set forth in Section 3.1.1 and the
77,613 euro payment for Manufacturing Equipment set forth in Section 5.3.1.
7.1.3. All Calypte common stock transferred to Ani as payment
for any portion of the 700,000 euro License Fee set forth in Section 3.1.2, and
as payment for any portion of the 155,227 euro Manufacturing Equipment set forth
in Sections 5.3.2 and 5.3.3, shall be registered with the SEC at the time of
said transfer.
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7.1.4. Calypte shall comply with Best Price and Currency
Exchange Rate provisions as defined elsewhere in this Agreement when making all
payments for License Fee, Royalty, and Manufacturing Equipment.
7.1.5. All payments made by Calypte in the form of shares of
Calypte common stock shall be deposited in Ani's brokerage account at:
Xxxxxx Xxxxxxx & Company, Inc.
00 Xxxxxx Xxxx
Xxx Xxxx, XX 00000
Account Number: 0X0000000
Attn: Xx. Xxxxx Xxxxxxxxxx, Director of Operations
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Email: xxxxxxxxxxx@xxxxxxxxxxxxx.xxx
7.1.6. In the event Calypte fails to make the payments in the
form of shares of Calypte common stock or cash pursuant to Section 3 and Section
5, such delayed payments shall bear interest from and after the due date of the
payment as set forth in the abovementioned Sections 3 and 5 until paid at a per
annum rate equal to the US prime lending rate (Prime Rate) plus three (3)
percent as quoted in The Wall Street Journal for the thirty (30) day period
ending on the payment due date. Each such delayed payment when made shall be
accompanied by all accrued and unpaid interest deposited via bank wire transfer
in Ani's bank account as described in Section 7.2.1. Ani shall also be entitled
to compensation for its collection costs.
7.2. Cash Payments.
7.2.1. All payments made by Calypte in the form of cash shall
be made in Euros and be electronically deposited via bank wire transfer in Ani's
bank account at:
Nordea Bank Oy
Helsingin Yrityspankki
Xxxxxxxxxxxxxxxx 00, 00000 XXXXXX
XXXXXXX
Account Number: 20011-800382023
Swift: XXXXXXXX
IBAN: XX0000000000000000
Telephone: x000-0-00000000
7.3. In the event that any taxes, withholding or otherwise, are levied
by any government taxing authority in connection with accrual or payment of any
royalties payable to Ani under this Agreement, Calypte shall have the right to
pay such taxes to the local tax authorities on behalf of Ani and the payment to
Ani of the net amount due, after reduction by the amount of such taxes, shall
fully satisfy Calypte's royalty obligations under this Agreement, provided that
appropriate documentation of such tax payment, including evidence of payment and
receipt or any other appropriate documentation, is provided to Ani.
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8. Confidentiality.
8.1. Each party shall protect all Confidential Information of the other
party with the same degree of care as it uses to avoid unauthorized use,
disclosure, publication or dissemination of its own confidential information of
a similar nature, but in no event less than a reasonable degree of care.
8.2. Except as provided in this Agreement, neither party shall use for
its own benefit or the benefit of any Third Party, or disclose, publish,
release, transfer or otherwise make available to any Third Party, any
Confidential Information of the other party without the other party's prior
written consent. Each of Calypte and Ani, however, shall be permitted to
disclose Confidential Information of the other to contractors and Third Parties,
and its employees, Affiliates, accountants, attorneys and other agents to the
extent such disclosure is reasonably necessary for the performance of its duties
and obligations hereunder or, with respect to Calypte, its use and enjoyment of
the Licensed Technology and Improvements. Each of Calypte and Ani shall be
responsible for any violation of the confidentiality obligations set forth
herein by any of the foregoing.
8.3. The obligations in this Section 8 shall not restrict any
disclosure of Confidential Information received by one party (the "Receiving
Party") from the other party (the "Disclosing Party") where the Receiving Party
can demonstrate that: (a) such Confidential Information was independently
developed by the Receiving Party prior to its receipt thereof without violating
its obligations hereunder or any of the Disclosing Party's proprietary rights;
(b) such Confidential Information is or becomes publicly known (other than
through the unauthorized disclosure by the Receiving Party); (c) such
Confidential Information was already known to the Receiving Party prior to its
receipt thereof without any obligation of confidentiality; (d) such Confidential
Information is received by the Receiving Party from a Third Party without any
obligation of confidentiality; or (e) the Receiving Party is required to do so
pursuant to any applicable law (provide that the Receiving Party shall provide
reasonable prior written notice to the Disclosing Party of such disclosure).
8.4. In addition to the foregoing, nothing contained in this Agreement
shall supercede the confidentiality requirements set forth in the
Confidentiality Agreement signed by the parties dated February 2, 2004, and its
Amendment signed by the parties on February 29, 2004 shall remain in full force
and effect.
9. Joint Investigation and Freedom to Operate Opinion.
9.1. The parties deemed that, prior entering into this Agreement, it
was in their mutual best interests to ensure that Calypte's sale of Licensed
Products did not infringe intellectual property rights of Third Parties.
9.2. Prior to entering into this Agreement, the parties obtained a
Freedom to Operate Opinion from competent patent counsel concerning Licensed
Technology. The parties have agreed to share equally the cost of obtaining said
Freedom to Operate Opinion.
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10. Term and Termination.
10.1. This Agreement, unless earlier terminated in accordance with the
terms set forth herein, shall continue until the expiration of all Valid Patent
Claims. In the event no patents covering Licensed Technology issue in the United
States of America within ten (10) years of the Effective Date, this Agreement
shall terminate with respect to the United States of America but shall remain in
force and effect outside of the United States of America until expiration of all
Valid Patent Claims.
10.2. This Agreement may be terminated by Calypte at any time by giving
written notice to Ani. The termination shall be effective six (6) months after
the date of notice. If the Agreement is terminated by Calypte, Calypte shall
cease manufacturing and selling Licensed Products within six (6) months after
the date of said notice.
10.3. This Agreement may be terminated by Ani if Calypte materially
breaches this Agreement and Calypte has not cured such material breach within
ninety (90) days after receipt of written notice to Calypte by Ani specifying
the nature of such alleged material breach. Failure of Calypte to pay any amount
specified under this Agreement within thirty (30) days after the due date shall
be deemed a material breach, which shall entitle Ani to terminate the Agreement
with immediate effect with a written notice to Calypte.
10.4. This Agreement shall terminate upon (i) an adjudication of
Calypte as bankrupt or insolvent, or admission in writing of its inability to
pay its obligations as they mature; (ii) an assignment of this Agreement by
either Party for the benefit of creditors; (iii) the appointment of, or Calypte
applying for or consenting to the appointment of, a receiver, trustee or similar
officer for a substantial part of its property; (iv) the institution of or any
act of Calypte instituting any bankruptcy, insolvency arrangement, or similar
proceeding; or (v) the issuance or levy of any judgment, writ, warrant of
attachment or execution or similar process against a substantial part of the
property of Calypte. Calypte may apply for reinstatement of this Agreement if
either of conditions (iii) or (v) is removed within ninety (90) days.
10.5. Section 8 (Confidentiality), Section 10 (Term and Termination),
Section 11 (Dispute Resolution), Section 12 (Representations, Warranties and
Limitation of Liability), and Section 13 (General Provisions) shall survive
termination of this Agreement.
11. Dispute Resolution.
11.1. Any dispute, controversy or claim arising from or relating to
this Agreement, or the breach, termination or invalidity thereof, will be
settled by arbitration in Hamburg, Germany, in accordance with the Rules of
Arbitration of the International Chamber of Commerce (the "Rules") by one or
more arbitrators appointed in accordance with the Rules. The award of the
arbitration will be final and binding upon the parties without appeal or review
except as permitted by German law.
12
12. Representations, Warranties and Limitation on Liability.
12.1. Calypte represents and warrants: (a) It is a corporation validly
existing and in good standing under the laws of the State of Delaware; (b) The
execution, delivery and authority to execute and deliver this Agreement have
been duly authorized by all necessary corporate action on the part of Calypte;
(c) It has the corporate power and authority to execute and deliver this
Agreement and to perform its obligations under this Agreement; and, (d) All
shares of Calypte common stock have been duly authorized and upon issuance,
pursuant to the terms hereof and for the consideration herein set forth, will be
validly issued, fully paid and nonassessable.
12.2. Ani represents and warrants: (a) It is a corporation validly
existing and in good standing under the laws of the country of Finland; (b) The
execution, delivery and authority to execute and deliver this Agreement have
been duly authorized by all necessary corporate action on the part of Ani; (c)
It has the corporate power and authority to execute and deliver this Agreement
and to perform its obligations under this Agreement; (d) Other than the grant
set forth herein, Ani has not encumbered, restricted, transferred or otherwise
burdened the Licensed Technology or Manufacturing Equipment; (e) It is not aware
of any claim of infringement by any other party in and to the Licensed
Technology; (f) Manufacturing Equipment shall be merchantable and fit for the
particular purpose it is being sold for hereunder; and, (g) Except as expressly
set forth herein, Ani hereby disclaims and negates any and all warranties,
whether express or implied, with respect to the Licensed Technology and
Improvement, or any rights hereunder transferred, including but not limited to,
any IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR ANY
PARTICULAR PURPOSE. Without limiting the generality of the foregoing, Ani makes
no representations or warranties as to the patentability, noninfringement, use
or other application of the Licensed Technology or any Improvement, or as to the
likelihood of the success of any research, development, testing, marketing or
other utilization of the Licensed Technology or any Improvement.
12.3. Under no circumstances shall either party be liable to the other
party for any consequential, incidental, special, indirect or exemplary damages
arising out of or related to this Agreement, whether in contract, tort, strict
liability or any other legal theory, including without limitation, damages for
loss of profits, business interruption, or for any claim or demand against one
party by any other party, or other pecuniary loss.
13. General Provisions.
13.1. Neither this Agreement nor any rights or obligations of a Party
under this Agreement may be assigned in whole or in part by such Party without
the prior written consent of the other Party, except that each Party may assign
this Agreement to an Affiliate or in connection with any merger, reorganization,
or consolidation with or into another Entity, or any sale or transfer of any of
its assets or business to a Third Party, provided however, the Third Party
agrees in writing to assume the assigning Party's obligations under this
Agreement. Any attempted assignment in violation hereof will be void.
13
13.2. This Agreement will bind and inure to the benefit of the
respective successors and permitted assigns of the parties.
13.3. This Agreement shall be construed and enforced in accordance with
the laws of the country of Germany without giving effect to its conflicts of law
principles.
13.4. If any provision of this Agreement is unenforceable or invalid
under any applicable law or is so held by applicable court decision, such
unenforceability or invalidity will not render this Agreement unenforceable or
invalid as a whole and such provisions will be changed and interpreted so as to
best accomplish the objectives of such unenforceable or invalid provision within
the limits of applicable law or applicable court decisions.
13.5. The failure of either party to require performance by the other
party of any provision of this Agreement will not affect the full right to
require such performance at any time thereafter; not will the waiver by either
party of a breach of any provision of this Agreement be taken or held to be a
waiver of the provision itself.
13.6. Ani and Calypte shall consult with each other and shall conduct
themselves in a manner consistent with all current regulatory guidelines
governing the manufacture and sale of human in vitro clinical diagnostic
products. The parties shall use commercially reasonable efforts to provide
requisite facilities, staff and supplies necessary to fulfill their respective
obligations as set forth in this Agreement. Each party agrees to execute and
deliver any and all documents, and to perform such other acts as may be
reasonably necessary or expedient to carry out and make effective the purposes
and transactions contemplated by this Agreement.
13.7. Information developed and produced during the course of the
parties fulfilling their obligations as set forth in the Agreement may be
translated into regulatory agency filings and manufacturing, packaging and
quality control procedures by the parties which will be reviewed and approved by
both parties. All such information, documentation and regulatory agency filings
shall be the sole property of Calypte. Calypte shall be solely responsible for
complying with requirements for testing, filings, marketing, advertising and
other compliance with applicable laws for Licensed Products sold by Calypte
within the Territory.
13.8. Neither party shall be responsible for any defaults or delays
that are due to causes beyond the party's control, including, but without
limitation, acts of God or public enemy, acts of a government or terrorist
group, or total or partial product recall (actual or threatened), fire, flood or
other natural disasters, embargoes, accidents, explosions, strike or other labor
disturbances (regardless of the reasonableness of the demands of labor),
shortages of fuel, power or raw materials, inability to obtain or delays of
transportation facilities, incidents of war, or other events causing the
inability of the party, acting in good faith with due diligence, to perform its
obligations or otherwise refrain from committing a breach.
14
13.9. Neither party shall issue or cause to be issued any press
release, public announcement or disclosure of any kind or nature whatsoever or
otherwise disclose the existence of an agreement between the parties or the
transactions contemplated hereby except as is required by law, or SEC public
disclosure reporting requirements, or to the extent that both parties jointly
agree to such press release, public announcement or disclosure in advance and in
writing.
13.10. Nothing in this Agreement will be construed as creating any
agency, partnership, or other form of joint enterprise between the parties.
Neither party will have the authority to act or create any binding obligation on
behalf of the other party and neither party will represent to any third party
that it has the authority to act or create any binding obligation on behalf of
the other party.
13.11. This Agreement may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
13.12. This Agreement, together with the Exhibits hereto, constitutes
the entire agreement between the Parties as to the subject matter hereof, and
supercedes all prior negotiations, representations, agreements and
understandings whether oral or written regarding such subject matter. This
Agreement may be modified or amended only by a writing executed by authorized
representatives of both of the parties.
13.13. All notices, consents, waivers and other communications intended
to have legal effect under this Agreement must be in writing, must be delivered
to the other party at the address set forth below by personal delivery,
certified mail, postage pre-paid, or an internationally recognized overnight
courier, and will be effective upon receipt (or when delivery is refused). Each
party may change its address for receipt of notices by giving notice of the new
address to the other party pursuant to this Section:
If to Ani:
Ani Biotech OY
Xxxxxxxxx 00 X
00000 Xxxxxxxx Xxxxxxx
Attn: Xx. Xxxx Xxxxxxxx, CEO
Telephone: x000-00-0000000
Facsimile: x000-00-0000000
Email: xxxx.xxxxxxxx@xxxxxxxxxx.xx
If to Calypte:
Calypte Biomedical Corporation
0000 Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000 XXX
Attn: Xx. Xxxxxxx Xxxxxxxxxx, EVP & CFO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Email: xxxxxxxxxxx@xxxxxxx.xxx
15
SIGNATURE PAGE
IN WITNESS WHEREOF, Ani and Calypte have executed this Agreement as of
the date first shown above.
FOR ANI BIOTECH OY: FOR CALYPTE BIOMEDICAL:
/s/ Xxxx Xxxxxxxx /s/ J. Xxxxxxx Xxxxxx
----------------------------- -------------------------------
XX. XXXX XXXXXXXX XX. XXXXXXX XXXXXX
President & CEO President & CEO
----------------------------- -------------------------------
TITLE TITLE
16
EXHIBIT A
MANUFACTURING EQUIPMENT
17
AUTOMATIC BOTTLING MACHINE [LOGO]
2004-08-11 ANIBiotech
Page 1 of 2
--------------------------------------------------------------------------------
AUTOMATIC BOTTLING MACHINE
ABM-03A
Introduction:
o Automatic feeding System for small vials and caps (Vial, Sarstedt 72.694,
2ml)
o Automatic feeding for liquid (Dispensette, Bottle-Top Dispenser)
o Adjustable speed of machine (100 - 1600 bottles / hour)
[PHOTO OMITTED]
================================================================================
TECHNICAL INFORMATION
================================================================================
================================================================================
AUTOMATIC BOTTLING MACHINE ABM-03A
================================================================================
Power 000 - 000 X,00 Xx
--------------------------------------------------------------------------------
Body Aluminium/steel
--------------------------------------------------------------------------------
Compressed Air Equipment Need for air about 60 l/min
--------------------------------------------------------------------------------
Vibration Vat for Vial 0 550 mm, 519 W
--------------------------------------------------------------------------------
Vibration Vat for Cap 0 250 mm, 240 W
--------------------------------------------------------------------------------
Speed Control 100-1600 bottles/h (adjustable)
--------------------------------------------------------------------------------
Emergency Stop Safety Switch
--------------------------------------------------------------------------------
Bottle-Top Dispenser Dispensette
--------------------------------------------------------------------------------
Vials and caps Sarstedt no 72.694, 2 ml
--------------------------------------------------------------------------------
Length 1000 mm
--------------------------------------------------------------------------------
Width 900 mm
--------------------------------------------------------------------------------
Height 1250 mm
--------------------------------------------------------------------------------
Weight 120 kg
--------------------------------------------------------------------------------
18
ASSEMBLING MACHINE [LOGO]
2004-08-11 ANIBiotech
Page 1 of 2
--------------------------------------------------------------------------------
ASSEMBLING MACHINE - SHORT SLIDES
AM-03A
Introduction:
o One cassette type per machine
o Small need for space
o Single operator
o Automatic cutting and feeding system of laminated strip
o Assembles the cutted strip, pill and cover
o Pick and push mechanism
o Manual feeding of bottom and cover cassettes into feeding belts
o Adjustable speed up to 1800 cassettes/hour
[PHOTO OMITTED]
================================================================================
TECHNICAL INFORMATION
================================================================================
--------------------------------------------------------------------------------
Body Industrial table, 1500 x 750 mm,
plastic/steel
--------------------------------------------------------------------------------
Power 230 V, 50 Hz
--------------------------------------------------------------------------------
Compressed Air Remove Button Safety Switch
--------------------------------------------------------------------------------
Cutting Width Depends of cassette type (X)
(5mm)
--------------------------------------------------------------------------------
Backing Plastic Depends of cassette type (X)
(71mm)
--------------------------------------------------------------------------------
Speed Control 1800 pc/h (adjustable)
--------------------------------------------------------------------------------
Emergency Stop Safety Switch
--------------------------------------------------------------------------------
Feeding System for Cassettes 2x18 W
--------------------------------------------------------------------------------
Cutting Blade Thickness 0.25mm
--------------------------------------------------------------------------------
Compressed Air Equipment Need for air about 120 l/min
--------------------------------------------------------------------------------
Length 1500 mm
--------------------------------------------------------------------------------
Width 1100 mm
--------------------------------------------------------------------------------
Height 1120 mm
--------------------------------------------------------------------------------
Weight 149 kg
--------------------------------------------------------------------------------
Vibration Vat for Pills (Drying Pill) Option
--------------------------------------------------------------------------------
Drying Pill Option
--------------------------------------------------------------------------------
(X) The cassette type must be agreed with Ani Biotech before the manufacturing
of the assembling machine can be started
19
CONJUGATE APPLICATION [LOGO]
2004-08-11 ANIBiotech
Page 1 of 2
--------------------------------------------------------------------------------
CONJUGATE APPLICATION
CA-03A
Conjugate Application for cold and latex conjugation
Introduction:
o New model - improved version
o Reel-To-Reel system
o Dispensing the reagents with peristaltic pump (Xxxxxx Xxxxxx 323 S)
o Holder of feeding nozzle
o Drying oven with heater
o Collection reel in the end of the process
o Digital Speed control (3-5) meters / minute)
o Machine will be assembled on a table - need for space is small
[PHOTO OMITTED]
================================================================================
TECHNICAL INFORMATION
================================================================================
--------------------------------------------------------------------------------
CONJUGATE APPLICATION CA-03A
--------------------------------------------------------------------------------
Power 230 V, 50 Hz
--------------------------------------------------------------------------------
Body Aluminium
--------------------------------------------------------------------------------
Input and collection reel 0 360/240/60 mm
--------------------------------------------------------------------------------
Supporting Input and Collect Reel Aluminium/Steel
--------------------------------------------------------------------------------
Speed Control 3-5 meter/min
--------------------------------------------------------------------------------
Protective Plates Plastic/aluminium
--------------------------------------------------------------------------------
Dry Air Fans 2 x 1400 W
--------------------------------------------------------------------------------
Blocking Peristaltic Pump, Xxxxxx Xxxxxx
323 S
--------------------------------------------------------------------------------
Length 3400 mm
--------------------------------------------------------------------------------
Width 800 mm
--------------------------------------------------------------------------------
Height 780 mm (+ table height 700-900 mm)
--------------------------------------------------------------------------------
Weight 100 kg
--------------------------------------------------------------------------------
Motor 250 W
--------------------------------------------------------------------------------
Tube for peristaltic pump Xxxxxx Xxxxxx - 0 0.79 mm
--------------------------------------------------------------------------------
20
LINE PRINTING MACHINE [LOGO]
2004-08-11 ANIBiotech
Page 1 of 3
--------------------------------------------------------------------------------
LINE PRINTING MACHINE FOR NITROCELLULOSE
LP-03A
Reel-To-Reel Line Printing System
Introduction:
o The system includes the place for dispensing the reagents with a
possibility to control the lines easily by visually
o Dispensing System (Offered separately)
o Lightning table for controlling the lines visually
o Drying Unit for drying the reagents lines
o Blocking Unit to block the nitrocellulose (Peristaltic Pump, Xxxxxx Xxxxxx
323)
o Drying Unit after blocking
o Collecting Reel System
[PHOTO OMITTED]
21
LINE PRINTING MACHINE [LOGO]
2004-08-11 ANIBiotech
Page 2 of 3
--------------------------------------------------------------------------------
================================================================================
TECHNICAL INFORMATION
================================================================================
--------------------------------------------------------------------------------
REAGENS XXXX
--------------------------------------------------------------------------------
Xxxxx 000 X, 00 Hz
--------------------------------------------------------------------------------
Body Indutrial table, 2250 x 750 mm
--------------------------------------------------------------------------------
Input Reel 0 500/400/60 mm
--------------------------------------------------------------------------------
Supporting of Reel Aluminium/Steel/Plastic
--------------------------------------------------------------------------------
Reagent printing table Plastic/Aluminium
--------------------------------------------------------------------------------
Lighting of the Table Fluorescence tube, 2 x 40W
--------------------------------------------------------------------------------
Reagent Dispensing Machine Xxxxxxx Technology / Bio Dot
(Offered separately)
--------------------------------------------------------------------------------
Speed Control 1-2 m/min (adjustable)
--------------------------------------------------------------------------------
Dry Air Fan 1400 W
--------------------------------------------------------------------------------
Blocking Unit Peristaltic Pump; Xxxxxx Xxxxxx
323 S
--------------------------------------------------------------------------------
Nozzles (Blocking) 0 0.7 mm
--------------------------------------------------------------------------------
Nozzle Tube Sarstedt / Xxxxxx Xxxxxx 0 0.79 mm
--------------------------------------------------------------------------------
Length 3000 mm
--------------------------------------------------------------------------------
Width 750 mm
--------------------------------------------------------------------------------
Height 1300 mm(table), 25000mm
(Drying Tower)
--------------------------------------------------------------------------------
Weight 150 kg
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
DRYING XXXX
--------------------------------------------------------------------------------
Xxxxx 000 X, 00 Hz
--------------------------------------------------------------------------------
Body Aluminium
--------------------------------------------------------------------------------
Motor 550 W
--------------------------------------------------------------------------------
Reels of Drying Unit Steel
--------------------------------------------------------------------------------
Bars of Body Aluminium
--------------------------------------------------------------------------------
Protective Plates Acryl (Perspex) / Aluminium
--------------------------------------------------------------------------------
Reel 0 500/400/60 mm
--------------------------------------------------------------------------------
Speed Control 1-2 m/min (adjustable)
--------------------------------------------------------------------------------
Dry Air Fans 2x1400 W
--------------------------------------------------------------------------------
Reflection Plates of Dry Air Aluminium
--------------------------------------------------------------------------------
Length 2800 mm
--------------------------------------------------------------------------------
Width 800 mm
--------------------------------------------------------------------------------
Height 1170 mm
--------------------------------------------------------------------------------
Weight 130 kg
--------------------------------------------------------------------------------
22
SAMPLING DEVICE ASSEMBLY MACHINE [LOGO]
2004-08-11 ANIBiotech
Page 1 of 2
--------------------------------------------------------------------------------
SAMPLING DEVICE ASSEMBLY MACHINE
SDA-03A (2.5/4.7mm)
Introduction:
o Single operator
o Manual speed control
o Automatic cutting of the laminated strip
o Automatic cutting of the sample end
o Makes two samples stick at once
o Machine will be assembled on a table
[PHOTO OMITTED]
This is a picture of an R&D machine, not a final version.
================================================================================
TECHNICAL INFORMATION
================================================================================
--------------------------------------------------------------------------------
Body Steel
--------------------------------------------------------------------------------
Power 230 V, 50 Hz
--------------------------------------------------------------------------------
Protective Plates Plastic
--------------------------------------------------------------------------------
Rolling surfaces Rubber
--------------------------------------------------------------------------------
Speed Control Up to 1000 pc/h
--------------------------------------------------------------------------------
Emergency Stop Safety Switch
--------------------------------------------------------------------------------
Sample stick 0 2.5 mm, length 270 mm
--------------------------------------------------------------------------------
Sample end (ready-made stick) 0 4.7 mm (length 135 mm)
--------------------------------------------------------------------------------
Lamination width 51 mm
--------------------------------------------------------------------------------
Cutting lenght 40 mm (Ready sample end length
20 mm)
--------------------------------------------------------------------------------
Cutting Blade Thickness 0.25mm
--------------------------------------------------------------------------------
Compressed Air Equipment Need for air about 6l/min
--------------------------------------------------------------------------------
Length 600 mm (feeding pipe)
--------------------------------------------------------------------------------
Width 900 mm
--------------------------------------------------------------------------------
Height 330 mm
--------------------------------------------------------------------------------
Weight 33 kg
--------------------------------------------------------------------------------
23
EXHIBIT B
ROYALTY RATES
24
ROYALTY RATES FOR URINE & ORAL FLUID
SYPHILIS, GONORRHEA,
HIV TEST HEPATITIS TEST HPV TEST CHLAMYDIA TEST
-------------------- ----------------------- ---------------------- ------------------------
----------------
EXCLUSIVE RIGHTS Professional OTC Professional OTC Professional OTC Professional OTC
---------------- ------------ --- ------------ --- ------------ --- ------------ ---
REGION I COUNTRIES 5.0% (Hep C)
(USA, Canada, EU, Japan) 5.0% 10.0% 3.0% (Hep B) 10.0% 7.0% 10.0% 4.0% 10.0%
REGION II COUNTRIES 2.0% (Hep C)
(Rest of World) 2.0% 3.0% 1.0% (Hep B) 5.0% 5.0% 8.0% 2.0% 8.0%
ROYALTY RATES FOR BLOOD & UROGENITAL SWAB
SYPHILIS, GONORRHEA,
HIV TEST HEPATITIS TEST HPV TEST CHLAMYDIA TEST
-------------------- ----------------------- ---------------------- ------------------------
--------------------
NON-EXCLUSIVE RIGHTS Professional OTC Professional OTC Professional OTC Professional OTC
-------------------- ------------ --- ------------ --- ------------ --- ------------ ---
REGION I COUNTRIES 3.0% (Hep C)
(USA, Canada, EU, Japan) 3.0% 10.0% 2.0% (Hep B) 10.0% 4.0% 10.0% 3.0% 10.0%
REGION II COUNTRIES
(Rest of World) 2.0% 3.0% 1.0% 3.0% 3.0% 8.0% 1.0% 8.0%
25
