[ * ] = Certain
confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange Act of 1934, as amended.
This LICENSE
AGREEMENT dated as of January 5, 2009 (the “
Effective Date ”), is entered into by and between
Inverness Medical Switzerland GmbH, a corporation organized and
existing under the laws of Switzerland, with its principal office
for the conduct of business located at Bahnhofstrasse 28, CH- 6300
Zug, Switzerland (“ Licensor ”) and Abaxis,
Inc,. a California corporation, having its principal office at 3240
Whipple Road, Union City, CA 94587 USA (“ Licensee
”).
WHEREAS, Licensor
owns or controls certain Patent Rights (as defined below)
pertaining to lateral flow immunoassay devices and methods;
and
WHEREAS, subject
to the terms and conditions of this License Agreement, Licensee
desires and is willing to secure from Licensor, and Licensor
desires and is willing to grant to Licensee an exclusive license in
the Field (as defined below) and in the Professional Channel (as
defined below) in and to the Patent Rights.
NOW, THEREFORE, in
consideration of these premises and the mutual covenants,
agreements, representations and warranties herein contained, the
Parties hereby agree as follows:
1.
Certain Defined Terms . The following terms shall have the meanings set
forth below:
1.1 “
Affiliates ” means any individual or entity that
directly, or indirectly through one or more intermediaries,
controls or is controlled by or is under common control with the
individual or entity specified. For purposes of this definition,
control of an individual or entity means the power, direct or
indirect, to direct or cause the direction of the management and
policies of such individual or entity whether by contract or
otherwise and, in any event and without limitation of the previous
sentence, any individual or entity owning fifty percent (50%) or
more of the Voting Stock of a second individual or entity shall be
deemed to control that second individual or entity. “
Voting Stock ” means, with respect to any entity,
securities ordinarily (and apart from rights arising under special
circumstances) having the right to vote in the election of
directors or persons performing similar functions with respect to
such entity.
1.2 “
Control ”, “ Controls ” or “
Controlled by ” means, with respect to any item of or
right under any Patent, the possession of (whether by ownership or
license), or the ability of Licensor and/or its respective
Affiliates to grant access to, or a license or sublicense of such
item or right as provided for herein without violating the terms of
any agreement or other arrangement with any Third Party existing at
the time Licensor would be required hereunder to grant such access,
right or (sub)license.
1.3 “
Effective Date ” shall have the meaning set forth in
the Introductory Paragraph.
1.4 “
Excluded Field ” means the detection of microbial food
pathogens to assess the safety of food for human
consumption.
1.5 “
Field ” means the detection of diseases, physiologic
conditions, and substances in non-human animals and products
obtained from non-human animals, excluding the Excluded
Field.
1.6 “
Improved Product ” shall have the meaning set forth in
Section 17.6.
1.7 “
Lateral Flow Patent Rights ” means Patents that
(i) exist as of the Effective Date, (ii) are Controlled
by Licensor as of the Effective Date, and (iii) claim or cover
a diagnostic test for at least one analyte and which test comprises
a detectable entity and when wetted provides for liquid flow under
capillary action.
1.8 “
Laws ” means all laws, statutes, rules, regulations,
ordinances and other pronouncements having the effect of law of any
federal, national, multinational, state, provincial, county, city
or other political subdivision, domestic or foreign.
1.9 “
License Agreement ” means this License Agreement,
including all exhibits and attachments hereto.
1.10 “
Licensed Company ” shall have the meaning set forth in
Section 3.2(b).
1.11 “
Licensed Product ” means any product, branded under
only one or more brands Controlled by Licensee or its Affiliates,
the making, having made (on Licensee’s behalf), using,
selling, offering for sale or importing of which by or on behalf of
Licensee would, but for the license granted to Licensee pursuant to
this License Agreement infringe a Valid Claim of a Patent included
in the Patent Rights in the country in which any such product is so
made, used, sold, offered for sale or imported by Licensee or on
Licensee’s behalf.
1.12 “
Licensee ” shall have the meaning set forth in the
Introductory Paragraph.
1.13 “
Licensor Competitor ” shall have the meaning set forth
in Section 17.6.
1.14 “
Licensor Indemnitees ” shall have the meaning set
forth in Section 14.1.
1.15 “
Licensor ” shall have the meaning set forth in the
Introductory Paragraph.
1.16 “
Minimum Annual Royalty ” shall have the meaning set
forth in Section 3.5(a).
1.17 “
Net Sales ” means the gross amounts invoiced or
billed, and all other amounts (including as a result of any
agreement or arrangement with any Third Party and whether in cash
or non-cash consideration) received by Licensee with respect to
sales by or on behalf of Licensee of Licensed Product to
unaffiliated Third Parties less the sum of actual amounts for the
following items: any outbound transportation, insurance and other
shipping and handling costs paid or allowed; trade, quantity and
discounts in amounts customary in the trade; allowances and credits
to purchasers for damaged and returned product, including
allowances and credits because of returns or rejections; excise,
duty, sales or similar taxes; allowances for promotional and
demonstration units permitted under Section 3.4; and [*].
“Net Sales” shall be measured on a country-by-country
basis, when a Licensed Product is first sold or otherwise
transferred for value by or on behalf of Licensee, or first used or
leased in such country.
1.18 “
Party ” means Licensee or Licensor, individually, and
“Parties” means Licensee and Licensor,
collectively.
1.19 “
Patent Challenge ” shall have the meaning set forth in
Section 2.7.
1.20 “
Patent Rights ” means the Patents listed on
Schedule A attached hereto.
1.21 “
Patents ” means (a) patents and patent
applications, (b) substitutions, divisionals, continuations,
continuations-in-part, reissues, provisional applications,
registrations, confirmations, reexaminations and renewals of any
such patents and patent applications, and (c)
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Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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any foreign
equivalents of the foregoing.
1.22 “
Pre-Existing Licenses ” shall have the meaning set
forth in Section 2.5.
1.23 “
Professional Channel ” means sales or distribution
channels where products or systems are designed or intended for, or
marketed to, (a) professional providers of non-human animal
health-care, including veterinary health-care, and professional
non-human animal health-care centers, (b) other Third Party
professionals trained to administer and/or analyze diagnostic tests
on non-human animals, and (c) diagnostic laboratories.
Notwithstanding anything to the contrary in this License Agreement,
“Professional Channel” does not include sales or
distribution channels where products or systems are primarily
intended for or marketed to an end-user consumer for private use,
including self-care, at-home care, and minute clinic
channels.
1.24 “
Representatives ” shall have the meaning set forth in
Section 12.1.
1.25 “
Royalties ” shall have the meaning set forth in
Section 3.2(a).
1.26 “
Third Party ” means any person or entity other than
Licensee, Licensor and their respective Affiliates.
1.27 “
Valid Claim ” means any unexpired issued claim or
pending claim prosecuted in good faith of any Patent Right which
has not lapsed, become abandoned or been held revoked, invalid, or
unenforceable by a decision of a court or administrative or
government authority or agency of competent jurisdiction from which
no appeal can be or has been taken within the time allowed for such
appeal, and which has not been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise.
2.1 Patent
Rights . Subject to the terms and conditions set forth in this
License Agreement, Licensor hereby grants to Licensee, and Licensee
hereby accepts, a worldwide, exclusive (subject to limitation in
Section 2.3), royalty-bearing, non-transferable (except as
expressly set forth in Section 17.6) and non-sublicenseable
right and license under Licensor’s rights in and to the
Patents included in the Patent Rights, in the Field only, to make,
have made for Licensee (including by contract manufacturers for
Licensee), use, sell, offer for sale and import Licensed Products
in the Professional Channel, and the right to practice the methods
claimed in such Patent Rights in connection with such Licensed
Products. Licensee may exercise its rights under this
Section 2.1 directly or through distribution channels on its
behalf.
2.2
Sublicensing; Additional Licenses .
(a) No
Sublicensing . Licensee shall not sublicense, directly or
indirectly, the rights granted to Licensee under Section 2.1.
The Parties agree that any potential sublicensee opportunity with
respect to rights under this License Agreement shall be addressed
pursuant to Section 2.2(b).
(b)
Additional License Opportunities . In the event that either
Party identifies a possible opportunity to grant licenses to Third
Parties under the Patent Rights in the Field and in the
Professional Channel, the other Party shall cooperate with such
Party in connection with such opportunity. [*]
2.3
Exclusivity . The license rights granted to Licensee under
Section 2.1 are exclusive in the Field and in the Professional
Channel as to (a) all persons and entities other
than
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Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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Licensor and
Third Parties to whom Licensor or any of its licensors or their
predecessors has granted licenses as of the October 10, 2008
under the Patent Rights that may be exploited in the Field,
including the Third Parties identified or contemplated under
Section 2.5 below; and (b) any subsequent licensee agreed
upon by the Parties pursuant to Section 2.2(b).
Notwithstanding anything to the contrary in this License Agreement,
the grant of rights by Licensor under this License Agreement shall
be subject and limited in all respects by the terms of the
applicable Third Party agreements and arrangements pursuant to
which Licensor acquired any Patent Rights, and all rights or
sublicenses granted under this License Agreement shall be limited
to the extent that Licensor may grant such rights and sublicenses
under the Patent Rights.
2.4 Licensor
Out-Licensing Restrictions . During the term of this License
Agreement Licensor shall not, except with the written consent of
Licensee, (i) enter into any new agreements with a Third Party
pursuant to which Licensor grants such Third Party new license
rights under any Lateral Flow Patent Rights in the Field and in the
Professional Channel except in accordance with Section 2.2(b),
or (ii) notwithstanding any rights to the contrary under any
Pre-Existing License, amend any Pre-Existing License in a manner
that extends or expands the license rights of such Third Party
under any Lateral Flow Patent Rights in the Field and in the
Professional Channel if such extension or expansion would
materially adversely affect Licensee’s rights under this
License Agreement.
2.5
Pre-Existing Licenses .
(a) The
grant of rights by Licensor under this License Agreement shall be
subject to and limited in all respects by the terms and conditions
of the applicable agreements existing as of the Effective Date
pursuant to which Licensor has control of any Patent Rights, and
all rights or sublicenses granted under this License Agreement
shall be limited to the extent that Licensor may grant such rights
and sublicenses under the terms and conditions of the applicable
agreements existing as of the Effective Date pursuant to which
Licensor has granted any right or license to a Third Party under
the Patent Rights (collectively, the “ Pre-Existing
Licenses ”).
2.6
Restrictions . Licensee shall not knowingly (i.e., knew or
should have known) sell, transfer or otherwise provide, directly or
indirectly, the Licensed Products for use or sale outside of the
Field and/or outside of the Professional Channel. In connection
with any Licensee transaction or agreement relating to any Licensed
Product with a Third Party, Licensee shall restrict (through
contracts and/or purchase orders, marketing literature, shipping
documents, or similar documents used when a supply, distribution or
similar agreement is not in place) such Third Party and require
similar restrictions throughout the supply chain, from shipping or
selling Licensed Products outside of the Field and/or outside of
the Professional Channel. Licensee shall use commercially
reasonable efforts to enforce such restrictions, including by
(i) promptly suspending shipments of the Licensed Products to
a Third Party if the Licensed Products are being sold or used by
such Third Party outside the Field and/or outside of the
Professional Channel, (ii) notifying such Third Party in writing of
such alleged violation, (iii) conducting an investigation of
such violation as reasonably appropriate under the circumstances,
(iv) following
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information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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completion of
such investigation, terminating any agreement with such Third Party
following the investigation of which revealed that such Third Party
failed to comply with such restrictions, and (v) pursuing a
damage claim (or authorizing Licensor to pursue such damage claim
on its behalf) against any such Third Party that failed to comply
with its restrictions in accordance with this Section 2.6. In
any written agreement of Licensee with a Third Party with respect
to a Licensed Product to which Licensor is not a party, Licensee
shall require that such Third Party agrees that Licensor shall be
treated as an intended third party beneficiary for purposes of
enforcing under such agreement the restrictions described in this
Section 2.6.
2.7 Licensee
No-Challenge Covenant . In the event that Licensee or any of
its Affiliates institutes or prosecutes itself or through a Third
Patty (other than to defend any Patent licensed to Licensee under
Section 2.1), or substantially supports a Third Party in
instituting or prosecuting, before any administrative or regulatory
body, including the U.S. Patent and Trademark Office or its foreign
counterparts, any claim, demand, action or cause of action for
declaratory relief, damages or any other remedy or for an
enjoinment, injunction or any other equitable remedy, including any
interference, re-examination, opposition or any similar proceeding,
alleging that any claim in a Patent included in the Lateral Flow
Patent Rights is invalid, unenforceable or otherwise not patentable
(a “ Patent Challenge ”), Licensor shall have
the right to terminate this License Agreement upon thirty
(30) day prior written notice, if not cured within such 30-day
period. For clarity, the term “substantially supports”
as used in this Section 2.7 shall not include cooperation required
to be provided pursuant to any order, subpoena or other response to
any action undertaken by an administrative or regulatory
body.
2.8 Reservation
of Rights . Licensor hereby reserves and retains all right,
title and interest in and to the Patent Rights and all other rights
not expressly granted hereunder and any and all remedies herein
expressly conferred upon a Party will be deemed cumulative with,
and not exclusive of, any other remedy conferred hereby, or by law
or equity upon such Party, and the exercise by a Party of any one
remedy will not preclude the exercise of any other remedy available
under this License Agreement or otherwise.
2.9 Covenant
not to Sue . Licensor hereby agrees that it will not (nor will
Licensor grant any rights to a Third Party to) threaten, make a
claim or undertake any action against Licensee, Licensee’s
distributors or customers with respect to Licensee’s making,
having made, using, selling, offering for sale or importing of
Licensed Products in the Field and in the Professional Channel in
accordance with this License Agreement during the term of this
License Agreement. The obligations of Licensor under this
Section 2.9 shall only apply with respect to any Valid Claims
of Patents Controlled by Licensor as of the Effective Date solely
to the extent that such Valid Claims claim or cover subject matter
or a method that is necessary for Licensee to make, have made, use,
sell, offer for sale or import Licensed Products in the Field and
in the Professional Channel in accordance with the terms and
conditions of this License Agreement. Notwithstanding anything to
the contrary in this License Agreement, the foregoing shall have no
force or effect with respect to any product manufactured, offered
for sale, sold, transferred, or otherwise used, directly or
indirectly, outside of the Field and/or outside of the Professional
Channel.
3.
License Fee and Royalties.
3.1 License
Fee . In partial consideration of the rights granted to
Licensee under this
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Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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5
Licensee
Agreement, Licensee shall pay to Licensor a license fee in the
amount of Five Million Dollars ($5,000,000). Such license fee
payment is due on the Effective Date and payable within two
business days following the Effective Date. In addition, such
license fee payment is nonrefundable and is not creditable against
any other payments due to Licensor under this License
Agreement.
(a) In
partial consideration of the rights granted to Licensee under this
License Agreement, Licensee shall pay to Licensor a royalty of [*]
of Net Sales of Licensed Products made by or on behalf of Licensee
(“ Royalties ”). Royalties shall be paid on a
Licensed Product by Licensed Product and country by country basis
from the first commercial sale of each Licensed Product in a
country until expiration of the last to expire of any issued Patent
within the Patent Rights covering such Licensed Product or its
manufacture or use in such country.
(b) In the
event that a Third Party that has a royalty-bearing license to or
under any of the Patent Rights (a “ Licensed Company
”) (i) is acquired by Licensee or (ii) sells
components to Licensee for integration by Licensee into a Licensed
Product, the royalty that would otherwise be payable to Licensor
with respect to Licensed Company’s or Licensee’s use of
the Patent Rights in connection with the Licensed Products shall be
included in (that is, not be in addition to) the [*] Royalties
payable to Licensor by Licensee in connection with Net Sales of
such Licensed Product.
3.3 Royalties
shall not be due on sales or transfers of any Licensed Product
manufactured by Licensor on behalf of Licensee as contemplated
under Section 5.
3.4 Licensee may
provide reasonable quantities of Licensed Products to Third Parties
solely for promotional or demonstration purposes without charge,
which Licensed Products shall not be deemed to be included in the
calculation of Net Sales.
(a) For each
completed calendar year during the term of this License Agreement,
Licensee shall pay Licensor the following minimum royalty payments
(“ Annual Minimum Royalty ”):
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Minimum Royalty
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0
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$
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500,000
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$
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750,000
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$
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1,000,000
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(b) If the
actual Royalties to Licensor in any calendar year are less than the
Annual Minimum Royalty payment required for the specified year,
Licensee may pay Licensor the difference between the actual
Royalties during the applicable calendar year and the Annual
Minimum Royalty payment in full satisfaction of its obligations
under this Section 3.5 within sixty (60) days after the
end of the applicable calendar year.
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Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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(c) If in any
calendar year Licensee fails to make the Annual Minimum Royalty
payment and does not cure such failure within fifteen days
(15) after written notice by Licensor, Licensor may, in its
sole discretion, immediately upon written notice to Licensee,
terminate this License Agreement or convert the exclusive license
into a non-exclusive license, at which point there shall be no
restrictions on Licensor’s ability to exploit or grant
licenses under the Patent Rights, including Licensor’s right
to grant additional licenses to Third Parties under the Patent
Rights in the Field and in the Professional Channel. Waiver of any
Annual Minimum Royalty payment by Licensor is not a waiver of any
subsequent Annual Minimum Royalty payment.
(d) Net Sales
attributable to Licensed Products manufactured by Licensor on
behalf of Licensee as contemplated under Section 5 shall be
credited against the applicable Annual Minimum Royalty (as if
earned Royalties had been paid on sales of such Licensed
Products).
3.6
Payments . Royalties shall be paid by Licensee within sixty
(60) days after the end of each calendar quarter in which the
applicable Net Sales are received by Licensee. Royalties payable to
Licensor by Licensee shall be computed and paid in U.S. dollars by
wire transfer. For purposes of determining the amount of Royalties
due, the amount of Net Sales in any foreign currency shall be
computed by converting such amount into U.S. dollars at a rate
equal to the prevailing commercial rate of exchange for purchasing
dollars with such foreign currency as published in the Wall Street
Journal for the close of the last business day of the calendar
quarter for which the relevant Royalty payment is to be made by
Licensee. Payments shall be without deduction of exchange,
collection, or other foreign currency translation charges. Any past
due amounts under this License Agreement will be subject to an
automatic late fee of 1 1 / 2
% per month or the highest rate
allowed by law, whichever is less.
3.7 Taxes .
If a law or regulation of any country requires withholding of taxes
of any type, levies or other similar charges with respect to any
amounts payable hereunder, Licensee shall promptly pay such tax,
levy or other charge to the appropriate government authority and
furnish Licensor with documentation of such payment. Licensee shall
be entitled to deduct such tax, levy or charge actually paid from
the payment due to Licensor. Licensee agrees to assist Licensor in
claiming exemption from such deduction or withholding.
3.8 Reports
. Licensee further shall deliver written reports to Licensor
relating to the Net Sales of each Licensed Product on a calendar
quarter basis, with each report setting forth (a) the quantity
and dollar value of Licensed Products sold during the immediately
prior calendar quarter by country in which such Licensed Product
was sold, (b) the Net Sales of each Licensed Product by
Licensee in each country and (c) a calculation of the amount
of Royalty due. Such reports shall be provided to Licensor no later
than sixty (60) days following the end of the corresponding
calendar quarter.
4.
Records and Audit . Licensee shall keep complete and accurate
records of sales by or on behalf of Licensee of each Licensed
Product in sufficient detail to allow the accruing Royalties to be
determined accurately for a period of not less than three
(3) years. Licensor shall have the right to appoint at its
expense an independent certified public accountant reasonably
acceptable to Licensee to inspect the relevant records of Licensee
to verify such report or statement, including historical payments
for a period of up to three (3) years from the date of notice
of inspection. Upon Licensee’s written request, Licensee
shall permit such independent certified public accountant who has
entered into a reasonably acceptable confidentiality agreement and,
if necessary, Licensor’s technical personnel, to examine
records, materials, and manufacturing
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information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of
1934, as amended.
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processes of
Licensee, during regular business hours and no more frequently than
one time per calendar year, at Licensee’s applicable
facility, to verify the accuracy of the reports and payments by
Licensee. Licensor agrees to hold in confidence and not use for any
purpose all information concerning Royalty payments and reports,
and all information learned in the course of any audit or
inspection, except to the extent necessary for Licensor to reveal
such information in order to enforce its rights under this License
Agreement or if disclosure is required by law.
5.
Manufacturing and Development .
6. Patent
Marking . Licensee
shall mark or cause to be marked all Lice
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