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EXHIBIT 10.22
LICENSE AGREEMENT
This License Agreement (this "
Agreement ") is effective as of January 9, 2007 (the "
Effective Date ") by and between Vascular Solutions, Inc., a
Minnesota corporation (" VSI "), and King Pharmaceuticals,
Inc., a Tennessee corporation ("King Pharmaceuticals"), and King
Pharmaceuticals Research and Development, Inc., a Delaware
corporation and wholly owned subsidiary of King Pharmaceuticals
("King R&D", and together with King Pharmaceuticals, "
King ").
RECITALS :
WHEREAS , VSI owns and/or controls
certain technologies and intellectual property having application
in development and commercialization of Hemostatic Devices,
including certain Products that have been or will be developed by
VSI, (as such terms are defined below); and
WHEREAS , King desires to exclusively
license from VSI all such technologies and intellectual property
for worldwide use, and VSI desires to grant such license rights to
King, each under the terms and conditions set forth in this
Agreement.
NOW, THEREFORE , in consideration of the
foregoing premises and the mutual covenants herein contained, the
Parties hereby agree as follows:
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The terms used in this Agreement
have the following meaning:
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" Affiliates " means, in
relation to a party, any person, corporation, firm, partnership or
other entity, whether de jure or de facto , which
directly or indirectly through one or more intermediaries controls,
is controlled by or is under common control with such party. An
entity shall be deemed to control another entity if it: (i) owns,
directly or indirectly, at least fifty percent (50%) of the
outstanding voting securities or capital stock (or such lesser
percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) of such other entity, or
has other comparable ownership interest with respect to any entity
other than a corporation; or (ii) has the power, whether pursuant
to contract, ownership of securities or otherwise, to direct the
management and policies of the entity.
" Controlled " means, with respect to any
product, device, data, results, information, inventions, know-how,
formulas, trade secrets, techniques, methods, procedures,
development, material or compositions of matter of any type or
kind, whether or not patentable, or any intellectual property
right, possession of the ability, whether by ownership or license,
to assign, grant a license, sublicense, immunities or other rights
to such item or under such right without violating the terms of any
agreement or other arrangement with any Third Party.
" Device Supply Agreement " means that
Device Supply Agreement entered into by VSI and King
Pharmaceuticals as of even date with this Agreement.
" Exploit " means to make, have made,
import, use, sell, offer for sale or otherwise dispose of a product
or process, including the research, development, registration,
modification, enhancement, improvement, Manufacture, storage,
formulation, optimization, export, transport, distribution,
promotion or marketing of a product or process.
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" Field " means all
applications of Hemostatic Devices with or without active hemostats
in all areas outside catheterization laboratories (cardiac and
peripheral), electrophysiology laboratories, and holding and
recovery rooms for all such laboratories.
" Governmental Authority " means any
governmental agency, board or commission or other governmental
authority or other instrumentality of the United States, any state,
county, city or other political subdivision within the United
States or any other jurisdiction in the world (including the United
States Food and Drug Administration).
" Hemostatic Devices " means medical
devices, whether external, implanted, absorbable or otherwise,
intended to produce hemostasis by accelerating the clotting process
of blood.
" Know-How " means technical information,
know-how (including confidential data and Confidential
Information), formulae, processes, trade secrets, technologies,
improvements, enhancements, modifications, derivative works and
discoveries whether or not patentable, including without limitation
device, implant and instrument design, synthesis, preparation,
recovery and purification processes and techniques, materials,
testing and manufacturing processes, techniques, methods and data,
clinical data, medical uses, product forms and product drawings and
specifications, experimental protocols and procedures, biological,
chemical, pharmacological, toxicological, preclinical, clinical,
assay, control, manufacturing data and other information.
" Licensed Know-How " means all Know-How
owned and/or Controlled by VSI and/or its Affiliates as of the
Effective Date or at any time thereafter relating to Hemostatic
Devices in the Field and the Products in the Field.
" Licensed Patents " means all Patents
owned and/or Controlled by VSI and/or its Affiliates as of the
Effective Date or at any time thereafter relating to Hemostatic
Devices in the Field and the Products in the Field.
" Manufacture " and "
Manufacturing " means the manufacturing, processing,
formulating, packaging, labeling, holding and quality control
testing of Hemostatic Devices in the Field.
" Other Agreements " means the Device
Supply Agreement, the Device Quality Agreement, the
Thrombin-JMI® Supply Agreement, and the Thrombin-JMI®
Quality Agreement, each entered into between VSI and King
Pharmaceuticals as of even date with this Agreement.
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" Party " means King and
VSI, individually, and " Parties " means King and VSI,
collectively.
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" Patents " means all
patents and patent applications and utility models, including
without limitation, any and all continuations,
continuations-in-part, divisions, patents of addition,
confirmations, reissues, renewals, extensions, counterparts and
SPC’s thereof.
" Person " means any natural person,
corporation, firm, business trust, joint venture, association,
organization, company, partnership or other business entity, or any
government or any agency or political subdivision thereof.
" Products " means the Thrombix® 3x3,
ThrombiGel® 10, 40 and 100 and ThrombiGel Paste® medical
devices and all future medical devices developed, owned, or
Controlled by VSI having application in the Field, as amended from
time to time.
" Regulatory Approvals and Filings "
means any and all approvals (including pricing and reimbursement
approvals), licenses, registrations or authorizations of any
Governmental Authority (as well as any filings, data rights, rights
to cross-reference and correspondence relating thereto) necessary
or useful
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for the Exploitation of the
Hemostatic Devices in the Field anywhere in the world, including
any: (a) premarket approval or premarket notification of Hemostatic
Devices in the Field, including any supplements and amendments
thereto; (b) post-approval marketing authorizations (including any
prerequisite Manufacturing approval or authorization related
thereto); (c) labeling approval; and (d) technical, medical, and
scientific licenses; in each case owned and/or Controlled by VSI
and/or its Affiliates as of the Effective Date or at any time
thereafter.
" SPC " means a right based upon a Patent
to exclude others from making, using or selling any Product or any
Hemostatic Devices in the Field, such as a Supplementary Protection
Certificate.
" Third Party " means any party other
than VSI, King or their respective Affiliates. For purposes of Net
Sales, a Third Party shall not include any Sublicensees.
2.1
Grant to King . VSI hereby grants to King an exclusive (even
as to VSI), royalty-free, fully paid-up, perpetual, worldwide right
and license, with the right to grant sublicenses in multiple tiers,
under the Licensed Patents, Licensed Know-How and Regulatory
Approvals and Filings to develop, make, have made, use, sell, offer
for sale, import, and otherwise Exploit Hemostatic Devices in the
Field and the Products in the Field.
2.2
Grantback to VSI . During the term of the Device Supply
Agreement, King hereby grants to VSI the non-exclusive,
royalty-free, right and license under the Licensed Patents,
Licensed Know-How and Regulatory Approvals and Filings to develop
and make the Products in the Field. VSI shall have no right to
grant sublicenses under the foregoing license grant without
obtaining the prior written consent of King.
2.3
Transfer of Licensed Know-How . Upon request of King, VSI
shall use its commercially reasonable efforts to transfer, or cause
to be transferred to King, a copy of the materials and information
(whether in electronic or documented form) which are Controlled by
VSI and covered by the license granted to King in Section 2.1
above.
2.4
Reservation of Rights . No rights to any patents, know-how,
trade secrets, technical information, or other intellectual
property rights of either Party, other than as explicitly
identified herein, are granted or deemed granted by this Agreement
to the other Party. No right, expressed or implied, is granted by
this Agreement to a Party to use in any manner the name or any
other trade name or trademark of the other Party in connection with
the performance of this Agreement or otherwise.
3.1
Upfront Payment . In full consideration to VSI for the
licenses and other rights granted to King under this Agreement,
upon the Effective Date, King shall pay to VSI a one-time payment
of Six Million U.S. Dollars (US $6,000,000).
3.2
No Other Payments . For the avoidance of doubt, no other
payments or any milestone or royalty payments shall be due from
King to VSI in consideration for any licenses or other rights
granted to King under this Agreement.
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4.
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REPRESENTATIONS AND
WARRANTIES; NEGATIVE PLEDGE.
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4.1
Representations and Warranties of Both Parties . Each Party
represents and warrants to the other Party, as of the Effective
Date, that:
(a) Such
Party is duly organized and validly existing and in good standing
under the laws of the jurisdiction of its incorporation and has
full corporate power and authority to enter into this Agreement and
to carry out the provisions hereof;
(b) Such
Party has taken all corporate action necessary to authorize the
execution and delivery of this Agreement and the performance of its
obligations under this Agreement and has full power and authority
to enter into this Agreement and perform its obligations under this
Agreement;
(c) This
Agreement has been duly executed by such Party and assuming due
authorization, execution and delivery by the other Party,
constitutes a valid and legally binding obligation of such Party,
enforceable in accordance with its terms, subject to and limited
by: (i) applicable bankruptcy, insolvency, reorganization,
moratorium, and other laws generally applicable to creditors’
rights; and (ii) judicial discretion in the availability of
equitable relief;
(d) Such
Party is not required to obtain, the consent, approval, order, or
authorization of any Third Party, or is not required to complete
any registration, qualification, designation, declaration or filing
with, any regulatory authority, in connection with the execution
and delivery of this Agreement and the performance by such Party of
its obligations under this Agreement, including any grant of rights
to the other Parties pursuant to this Agreement; and
(e) The
execution and delivery of this Agreement, and the performance by
such Party of its obligations under this Agreement, including the
grant of rights to the other Party pursuant to this Agreement, does
not and will not: (i) conflict with, nor result in any violation of
or default under any such instrument, judgment, order, writ,
decree, contract or provision to which such Party is otherwise
bound; (ii) give rise to any lien, charge or encumbrance upon any
assets of such Party or the suspension, revocation, impairment,
forfeiture or non-renewal of any material permit, license,
authorization, or approval that applies to such Party, its business
or operations or any of its assets or properties, except any or all
of which could not reasonably be expected to have a material
adverse effect on its ability to perform its obligations under this
Agreement or on the rights of the other Party under this Agreement;
or (iii) conflict with any rights granted by such Party to any
Third Party or breach any obligation that such Party has to any
Third Party.
(f) No
representation or warranty made by a Party in this Agreement or the
Other Agreements, nor any statement or record contained in any
schedule or exhibit hereto or thereto furnished by a Party,
contains any untrue statement of a material fact or omits any
material fact necessary to make the statements contained herein or
therein not misleading.
4.2
Representations and Warranties of VSI . VSI represents and
warrants to King, as of the Effective Date, that:
(a) VSI
is the owner of, or has exclusive rights to, all of the Licensed
Patents and Licensed Know-How in existence on the Effective Date,
and has the exclusive right to grant the rights granted under this
Agreement therefor. All of the issued Licensed Patents in existence
on the Effective Date are valid, in full force and effect and have
been maintained to date, and are not the subject of any
interference or opposition proceedings;
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(b) VSI
has provided King, or given King access to, true, complete and
unredacted copies of all (i) files, filings, correspondence and all
other documentation relating to the prosecution, maintenance and/or
enforcement of the Licensed Patents in existence on the Effective
Date, (ii) regulatory documentation relating to the Products in
existence on the Effective Date, and (iii) material agreements
(including any letter agreements) between VSI and any licensee,
production or financing partner or other Third Party, including all
effective amendments to any such agreements or documents, which, in
any event (A) affects or may affect King’s rights under this
Agreement, or (B) relates to a Product or any Licensed Patents or
Licensed Know-How in existence on the Effective Date;
and
(c) There
is no pending or, to the knowledge of VSI, threatened claim,
interference, opposition or demand of any Third Party challenging
the inventorship, ownership, validity or scope of any Licensed
Patents in existence as of the Effective Date. The manufacture, use
or sale of the Products will not infringe or otherwise violate any
intellectual property right of any Third Party.
4.3
Disclaimer . EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION
4, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND EACH PARTY
EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND
OF FITNESS FOR A PARTICULAR PURPOSE OR USE.
4.4
Negative Pledge . VSI represents, warrants, and covenants
that there are no liens or claims currently existing on or to the
Licensed Patents or Licensed Know-How (including any liens or
claims on or to rights to sue for past, present and future
infringements thereof, any licenses, claims, damages, and proceeds
of suit arising
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