LICENSE AGREEMENT
This License Agreement (hereinafter "Agreement"), effective as
of the date of the last signature below (the "Effective Date"), is by and
between Bio-Rad Laboratories, Inc., having an address at 0000 Xxxxxx Xxxxx
Xxxxx, Xxxxxxxx, Xxxxxxxxxx, 00000, Bio-Rad Pasteur, having an address at 0
Xxxxxxxxx Xxxxxxx Xxxxxxxx, 00000 Xxxxxx-xx-Xxxxxxxx Xxxxxx (collectively,
"Licensor") and Calypte Biomedical Corporation, having an address at 0000
Xxxxxxx Xxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxxxxx, 00000 ("Calypte") (each a
"Party" and collectively, the "Parties")
WHEREAS, Licensor has the right to grant a license under the
Licensed Patents, as defined below;
WHEREAS, Licensor is willing to grant to Calypte and Calypte
desires to obtain from Licensor a limited, non-exclusive license under the
Licensed Patents;
NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS.
For the purpose of this Agreement, the terms set forth
hereinafter shall be defined as follows:
1.1 Affiliate
"Affiliate" shall mean, with respect to an entity, any
corporation or other business entity controlled by, controlling or under common
control with such entity. For purposes of this Paragraph y1.1, "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 Licensed Patents
"Licensed Patents" shall mean those patents listed in Appendix
A and all divisions, continuations, continuations-in-part, and reissues of those
patents and all corresponding foreign counterparts to those patents.
1.3 Licensed Products
"Licensed Product(s)" shall mean Urine-based immunoassays and
serum, plasma, oral fluid or whole Blood-based Immunoassays (i) which have a
composition containing an HIV-2 antigen, (ii) which are manufactured, used or
sold by Calypte or its Affiliate and are capable of detecting HIV 1/2 antibodies
and/or antigen only on Calypte's Point of Care Rapid Test platform (as defined
in Paragraph 1.5) and (iii) which, in the absence of this Agreement, would
infringe one or more Valid Patent Claims.
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1.4 "Unit of Licensed Product(s)" shall mean that part of a
Licensed Product that is required to test a single sample.
1.5 Calypte's Point of Care Rapid Test Platform
Calypte's Point of Care Rapid Test Platform shall mean a
lateral flow immuno-assay developed, manufactured by or for Calypte or an
Affiliate of Calypte for the rapid, point-of-care detection of antibodies or
antigen to HIV-2 including any improvements or modifications that may be made
to such lateral flow, rapid test.
1.6 Point of Care
"Point of Care" shall mean both professional and
over-the-counter point of care.
1.7 Territory
"Territory" shall mean worldwide.
1.8 Third Party
"Third Party" shall mean any party other than Licensor and
Calypte or their respective Affiliates.
1.9 Net Sales
"Net Sales" shall mean the gross amount invoiced by Calypte or
its Affiliate from the sale of a Licensed Product to a Third Party in any
country within the Territory, less the following actually incurred by Calypte as
a result of such amounts invoiced: (1) shipping costs, insurance costs, custom
duties, sales tax, VAT and rebates and returns *. Samples of Licensed Product
provided to end users free of charge shall also be excluded in determining Net
Sales *.
If a Licensed Product is sold in the form of a combination
product containing one or more assays that are not Licensed Products under this
Agreement, Net Sales for such combination product shall be calculated by
multiplying actual Net Sales of such 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 assays in the combination if sold separately. If, on a
country-by-country basis, the Licensed Product and other assays 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 assays
in the combination product that are not Licensed Products. The total of A+B
shall not exceed two (2).
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* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
1.10 Valid Patent Claim
"Valid Patent Claim" shall mean a claim of an unexpired
Licensed Patent 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
Licensor grants to Calypte a royalty-bearing non-exclusive license
(without the right to grant sublicenses), under the Licensed Patents, to make,
have made by its Affiliates only, use, import, export, offer to sell, and sell
and have sold the Licensed Products in the Territory under Calypte's brand name.
*. Except as explicitly provided herein, Calypte does not have the right to have
the Licensed Products made by a Third Party, without the prior written consent
of Bio-Rad.
3. FEES AND ROYALTIES, RECORDS AND REPORTS
3.1 *
3.2 *
3.3
(a) Calypte shall pay to Licensor royalties on Net
Sales of Urine-based Licensed Products sold *.
(b) Calypte shall pay to Licensor royalties on Net
Sales of Urine-based Licensed Products sold *
3.4
(a) Calypte shall pay to Licensor royalties on Net
Sales of serum, plasma oral fluid or whole blood-based
Licensed Products sold *
(b) Calypte shall pay to Licensor royalties on Net
Sales of serum, plasma oral fluid or whole blood-based
Licensed Products sold *
3.5
Notwithstanding any contrary provision that may be contained
in the present License Agreement, Calypte agrees to pay the royalties set forth
in Paragraph 3.3 and 3.4 on all Net Sales of Licensed Products sold before and
after the Effective Date of this Agreement in every country within the
Territory, regardless of the country of manufacture of Licensed Products.
3.6 All Royalty payments under this Agreement shall be paid *.
The first royalty payment shall include payment of royalties due (if any) on Net
Sales of Licensed Products prior to the Effective Date. All payments shall be
made in U.S. dollars. If Net Sales are invoiced in a currency other than U.S.
dollars, then such Net Sales and Calypte's royalty obligations based on such Net
Sales shall be expressed in U.S. dollars converted on the basis of the average
daily New York foreign exchange rate for the thirty (30) day period ending on
the payment date, as quoted in The Wall Street Journal.
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* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
3.7 Calypte shall keep, and shall require its Affiliates * to
keep, full, true, and accurate books of account in accordance with
generally accepted accounting principles as applied in the United
States, containing all particulars necessary to show the amounts due
and payable to Licensor under this Agreement. Such books and the
supporting data shall be open during normal business hours upon
reasonable advance notice, at mutually agreed upon times, for three (3)
years following the end of the calendar year to which they pertain (and
access shall not be denied thereafter, if reasonably available), to the
inspection of an independent certified public accountant retained by
Licensor. If in dispute, such records shall be kept until the dispute
is settled. Inspection shall be at Licensor's expense, unless the
inspector concludes that the amount payable that is stated in a report
is understated by five percent (5%) or more, in which case Licensor'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 Paragraph 3.7 shall retain
as confidential all information, including information about Calypte's
finances and customers gained as a result of that inspection, with the
exception that the accountant shall be free to communicate information
to Licensor with respect to (i) whether or not Calypte is in compliance
with the terms of this Agreement, (ii) the results of the audit
including financial information but not customer information,
information relating to the accuracy of reports and payments made, and
(iii) if in the accountant's professional opinion Calypte is not
complying or has not complied with the terms of the Agreement, the
underlying facts and information relevant to said non-compliance. Such
accountant shall be required to execute an agreement with Calypte
agreeing to the confidentiality provisions set forth in this Paragraph
3.7. Information disclosed to Licensor as a result of an inspection
shall be subject to the confidentiality provisions set forth in
Paragraph 4.
3.8 Calypte shall within sixty (60) days after March 31st,
June 30th, September 30th and December 3lst of each year of this Agreement,
deliver to Licensor a true and accurate written accounting report for each
calendar quarter. Each report, which must be acceptable to Licensor, shall in
particular set forth, per Licensed Products and on a country-by-country basis,
(i) the Net Sales, (ii) all deductions from Net Sales made by Calypte pursuant
to Paragraph 1.9, (iii) the royalties payable by Calypte to Licensor pursuant to
Paragraph 3, (iv) the quantity of Licensed Products sold, (v) the name of
Licensed Products sold, (vi) the Licensed Products catalog codes, (vii) the
quantity of Units of Licensed Products corresponding to each Licensed Products
catalog code and, upon Licensor's written request (viii) the quantity of samples
of Licensed Products provided to end users by Calypte.
3.9 Simultaneously with the delivery of each royalty report,
Calypte shall pay to Licensor or to Licensor's designee, if designated in
writing, the monies then due under this Agreement for the period covered by the
report. Each report shall be made and sent by the due date to the following
addressees or any other address that Licensor may provide in writing:
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* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
Bio-Rad Laboratories, Inc.
0000 Xxxxxx Xxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
and
Bio-Rad Pasteur
0 Xxxxxxxxx Xxxxxxx Xxxxxxxx
00000 Xxxxxx-xx-Xxxxxxxx, Xxxxxx
Attention: Manager, Legal Affairs
Each payment shall be made and sent by the due date to the
following Bank Account (or to any other bank account, designee or address that
Licensor may advise in writing):
*
3.10 If Calypte shall fail to pay any amount owing under this
Agreement by the due date, the amount owed shall bear interest at *
3.11 Failure of Calypte to pay any amount specified under this
Agreement within thirty (30) days after the due date will give Licensor the
right to terminate this Agreement thirty (30) days after notice to Calypte of
the failure to pay which failure has not been cured within the latter thirty-day
period.
3.12 Calypte's obligation to pay royalties under this Section
3 shall exist until the expiration of the last to expire of the Licensed
Patents.
3.13 In the event that any taxes, withholding or otherwise,
are levied by any taxing authority in connection with accrual or payment of any
royalties payable to Licensor under this Agreement, Calypte shall have the right
to pay such taxes to the local tax authorities on behalf of Licensor and the
payment to Licensor 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
Licensor.
4. CONFIDENTIALITY
4.1 The Parties shall maintain the confidentiality of the
terms of this Agreement and shall not disclose the terms to any Third Party
without the prior written consent of the other Parties. In addition, Licensor
shall maintain the confidentiality of any information disclosed to Licensor as a
result of any inspection conducted under Paragraph 3.6 and shall use
5
* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
such information solely in connection with this Agreement. The confidentiality
obligations in this Paragraph 4 shall not apply where disclosure is required
under applicable law or regulation (including applicable securities laws or
regulations), in which case the affected Party shall notify the other Parties in
writing in advance of such disclosure and, upon request, shall cooperate in
seeking confidential treatment of the disclosed information. The Parties agree
that the obligation of confidentiality shall also not apply if:
(a) the information is at the material time in the public
domain through no fault of the receiving Party;
(b) the information is required by law to be communicated to a
person who is authorized by law to receive it;
(c) the information is required to be provided to a stock
exchange, regulatory body or government agency;
(d) disclosure of the information is necessarily made to a
court, or to an arbitrator or administrative tribunal or to legal counsel in the
course of proceedings provided that, in the case of any arbitration proceedings,
Licensor or Calypte, as the case may be, first obtains from each and every party
to those proceedings an undertaking, enforceable by Licensor or Calypte, as the
case may be, that each party will similarly not divulge or communicate, without
Licensor or Calypte, as the case may be, written consent, any information
referred to in this clause;
(e) the information is required to be disclosed to any
government agency whether in connection with the granting of any license or
otherwise, but such disclosure is to be made only with the consent of the Party
not disclosing the information; or
(f) the disclosure is made to effect registration of this
Agreement with a Patent Office or other Industrial Property Authority.
4.2 All press releases relating to this Agreement shall
require the prior approval of authorized representatives of Licensor and
Calypte, which approval shall not be unreasonably withheld or delayed. The
Parties acknowledge that it is their intention to agree upon an appropriate
press release regarding the signing of this Agreement.
5. COMPLIANCE AND QUALITY
5.1 In the exercise of any and all rights and in performance
hereunder, it shall be the duty of Calypte to comply fully with all applicable
laws, regulations and ordinances and to obtain and keep in effect any licenses,
permits and other governmental approvals (federal, state or local) necessary or
appropriate to carry on Calypte's activities hereunder.
5.2 Licensor does not approve or endorse Licensed Products
sold by Calypte in any way or for any purpose. Quality and quality control
according to standards and requirements that may exist in the marketplace from
time to time, are the sole responsibility of Calypte.
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* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
6. ASSIGNMENT
This Agreement may not be assigned by Calypte, by operation of
law, merger, change in ownership or control, including acquisition of the assets
or change in ownership or control of the stock of Calypte, without the prior
written consent of Licensor. The term "change in ownership or control" shall
have the meaning set forth in Section 8.6.
7. WARRANTY, NEGATION OF WARRANTIES AND INDEMNITY
7.1 Licensor warrants that it has the right to enter into this
Agreement and grant the license granted to Calypte herein.
7.2 Nothing in this Agreement shall be construed as: (a) a
warranty or representation by Licensor as to the validity or scope of any
Licensed Patent; (b) a warranty or representation that the practice under the
Licensed Patents is or will be free from infringement of patents of Third
Parties; (c) an authority or obligation to sublicense or to xxx Third Parties
for infringement; (d) except as expressly set forth herein, conferring the right
to use in advertising, publicity or otherwise, in any form, the name of, or any
trademark or trade name of Licensor; (e) conferring by implication, estoppel or
otherwise any license, immunity or right under any patent owned by or licensed
to Licensor other than the Licensed Patents, regardless of whether such patent
is dominant or subordinate to the Licensed Patents; (f) an obligation to furnish
any know-how; or (g) creating any agency, partnership, joint venture or similar
relationship between Licensor and Calypte.
7.3 Licensor makes no express or implied warranties of
merchantability or fitness for a particular purpose. Licensor shall not be
liable for any consequential damages or lost profits of Calypte.
7.4 Calypte shall assume full responsibility for its operation
under the Licensed Patents and shall defend, indemnify and hold Licensor
harmless from and against all liability, demands, damages, expenses (including
reasonable attorneys' fee) and losses for death, personal injury, illness,
property damage or any other injury or damage, including any damages or expenses
arising in connection with state or federal regulatory action, arising from the
manufacture, use or sale of Licensed Products.
7.5 BioRad shall indemnify and hold Calypte, its directors,
officers, agents or employees, or any of its Affiliates or their directors,
officers, agents or employees (each, a "CALYPTE PARTY") harmless from any and
all liability, damage, loss, cost or expense (including, without limitation,
reasonable attorneys' fees and expenses) resulting from any claims or suits
brought against a Calypte Party by a Third Party arising as a direct result of
(i) Bio-Rad's breach of any of the representations or warranties made by BioRad
in this Agreement, or (ii) any Third Party claim arising from Bio-Rad's breach
of any of such representations or warranties.
7.6 WITHOUT LIMITING THE INDEMNITY OBLIGATIONS OF EACH PARTY
ABOVE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL,
CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES OF ANY KIND OR NATURE.
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8. TERM AND TERMINATION
8.1 This Agreement, unless sooner terminated in accordance
with its terms, shall continue until the expiration of the last-to-expire of the
Licensed Patents.
8.2 This Agreement shall terminate upon a holding of
invalidity or unenforceability of all Licensed Patents by a final court decision
from which no appeal is or can be taken.
8.3 This Agreement may be terminated by Calypte *
8.4 The unappealable decision of a court or administrative
body finding Licensor liable or culpable due to Calypte's manufacture or sale of
Licensed Products covered by this Agreement shall give Licensor the right to
terminate this Agreement immediately upon notice, unless Calypte obtains a
complete release of Licensor and fully indemnifies Licensor for such liability.
8.5 This Agreement shall terminate upon (i) an adjudication of
either Party 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 either
Party 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 either Party 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 either Party. The Party causing such termination under this
Section 8.5 may apply for reinstatement of this Agreement if either of
conditions (iii) or (v) is removed within ninety (90) days.
8.6 Unless prior consent is given by Licensor, Licensor may
terminate this Agreement *
8.7 Upon any breach of or default of a material term under
this Agreement by Calypte (except for a payment default covered under Paragraph
3.11), Licensor may terminate this Agreement * Licensor will withdraw such
notice if, during the notice period, Calypte fully cures such breach or default.
8.8 Upon expiration or termination of this Agreement, all
rights granted to Calypte shall revert to or be retained by Licensor.
8.9 Notwithstanding the above, if Licensor terminates this
Agreement for any reason other than an uncured payment default by Calypte,
Calypte shall have the right to dispose of its existing inventory of Licensed
Products and to complete all outstanding orders for Licensed Products for a
period of up to six (6) months after the effective date of termination; provided
that Calypte fulfills its obligations to report and pay royalties on such
Licensed Products in accordance with this Agreement
* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
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8.10 Effect of Expiration or Termination
(a) Upon termination of this Agreement, Licensor shall
have the right to retain any sums already paid by Calypte hereunder, and Calypte
shall pay all sums accrued hereunder which are then due.
(b) Paragraphs 3.7, y3.8, y3.9, 3.10, y4, y7.2, y7.4,
7.5, 7.6, 8.8, 8.9, 10.1 and 10.2 shall survive any termination or expiration of
the Agreement.
9. COUNTERPARTS
This Agreement may be signed in any number of counterparts,
all of which taken together and when delivered shall constitute one and the same
instrument. Any one of the Parties may enter into this Agreement by signing any
such counterpart.
10. GENERAL
10.1 This Agreement constitutes the entire agreement between
the Parties as to the subject matter hereof, and supercedes all prior
negotiations, representations, agreements and understandings. This Agreement may
be modified or amended only by a writing executed by authorized representatives
of each of the Parties.
10.2 Any notice required or permitted to be given by this
Agreement shall be given by postpaid, first class, registered or certified mail,
or by courier, properly addressed to the other party at the respective address
set forth herein or another address that may be provided by written notice of
either Party to the other Party:
If to Licensor:
Bio-Rad Laboratories, Inc.
0000 Xxxxxx Xxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
and
Bio-Rad Pasteur
0 Xxxxxxxxx Xxxxxxx Xxxxxxxx
00000 Xxxxx-xx-Xxxxxxxx Xxxxxx
Attention: Manager, Legal Affairs
If to Licensee:
Calypte Biomedical Corporation
0000 Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxxxxxxx
Executive Vice President
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10.3 Force Majeure
If the performance of any part of this Agreement by any Party,
or of any obligation under this Agreement (with the exception of payment of
royalties), is prevented, by reason of acts of God, fire, earthquakes, acts of
war, civil unrest or other similar cause beyond the control of the Party liable
to perform, unless conclusive evidence to the contrary is provided, the Party so
affected shall, upon giving written notice to the other Party, be excused from
such performance provided that the affected Party shall use reasonable efforts
to avoid or remove such causes of non-performance and shall continue performance
with the utmost dispatch whenever such causes are removed. When such
circumstances arise, the Parties shall discuss what, if any, modification of the
terms of this Agreement may be required in order to arrive at an equitable
solution.
11. GOVERNING LAW AND VENUE.
11.1 This Agreement shall be construed and enforced in
accordance with the laws of the State of California, USA without giving effect
to its conflicts of law principles. The Parties agree that the exclusive
jurisdiction and venue for any dispute or controversy arising from this
Agreement shall be the courts in California, USA.
11.2 If any provision of this Agreement is held or discovered
to be illegal, invalid or unenforceable in any jurisdiction, all other
provisions of this Agreement shall be deemed valid and enforceable to the full
extent possible.
IN WITNESS WHEREOF, Licensor and Calypte have executed this
Agreement as of the date of the last signature below.
BlO-RAD PASTEUR CALYPTE BIOMEDICAL CORPORATION
By: /s/ Xxxxxxx Xxxxxx By: /s/ Xxxxxxx X. Xxxxxxxxxx
Name: Xxxxxxx Xxxxxx Name: Xxxxxxx X. Xxxxxxxxxx
Title: CEO Title: Executive Vice President and
Chief Financial Officer
Date: September 7, 2004 Date: August 23,2004
For Consent Only:
BlO-RAD LABORATORIES, INC. INSTITUT PASTEUR
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ X. Xxxxxxxx
Name: Xxxxxxx X. Xxxxxx Name: X. Xxxxxxxx
Title: Vice President and General Counsel Title: E.V.P. Business Development
Date: 09/28/04 Date: Feb. 17, 2004
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LICENSE AGREEMENT
APPENDIX A
LICENSED PATENTS
HIV-2 (Foundational)
*
Appendix A-1
* Certain information on this page has been omitted and filed
separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
LICENSE AGREEMENT
APPENDIX B
*
Appendix B-1
* Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.
