[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
THIS AGREEMENT
(“ Agreement ”), made this 9
th day of December, 2005 (“ Effective
Date ”), is entered into by and between Cook
Incorporated, an Indiana corporation having a place of business at
750 Daniels Way, Bloomington, Indiana 47404, USA, and its
Affiliates (“ Cook ”), and Cardica, Inc.,
a Delaware corporation having a place of business at 900 Saginaw
Drive, Redwood City, CA 94063, and its Affiliates (“
Cardica ”).
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A.
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Cardica is developing a medical
device known as the X-Port for use in femoral access closure
procedures, among other applications.
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B.
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Cook in engaged in the business of
developing, manufacturing and selling medical devices.
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C.
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Cook is amenable to funding certain
development work to be performed by Cardica in exchange for
receiving a license under the terms and conditions set forth herein
to continue to develop and to commercialize the X-Port device
worldwide for femoral access closure procedures, as further
described in this Agreement.
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The parties
agree as follows:
In addition to
the terms defined elsewhere in this Agreement, the following terms
have the meanings set forth below:
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1.1
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“ Affiliates
” with
respect to a party means any entity, existing now or in the future,
domestic or foreign, that directly or indirectly controls, is
controlled by or is under common control with such party; provided
that such entity will be considered an Affiliate only for the time
during which such control exists.
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1.2
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“ Approval
” means
receipt from the applicable regulatory authority in a given country
or countries to market a Product in such country or
countries.
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1.3
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“ Cardica Know-How
” means
Information that (a) is necessary or useful for the research,
development or commercialization of Products, and (b) is
Controlled by Cardica. Cardica Know-How shall exclude Cardica
Patents.
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1.4
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“ Cardica Patents
” means
a Patent that (a) claims the Product or any component thereof,
or any other method, apparatus, material or article of manufacture
useful in the development, manufacture, use or sale of Product, and
(b) is Controlled by Cardica.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
1.
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1.5
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“ Clinical Feasibility
Trial ” means the initial human clinical
trial conducted in Europe on Products that is expected to include
between 100 and 200 subjects.
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1.6
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“ Control
” means, with respect to any
Information or intellectual property right, the right and power of
the relevant party to grant the right to make, use, sell, offer to
sell, and import, or to grant a license or a sublicense to, such
Information or intellectual property right as provided for herein
and without violating the terms of any agreement or other
arrangement with any Third Party.
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1.7
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“ Cook Know-How
” means
Information that (a) is necessary or useful for the research,
development or commercialization of Products, and (b) is
Controlled by Cook. Cook Know-How shall exclude Cook
Patents.
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1.8
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“ Cook Patents
” means
a Patent that (a) covers the Product or any component thereof,
or any other method, apparatus, material or article of manufacture
useful in the development, manufacture, use or sale of Product,
(b) claiming an invention conceived by employees or agents or
independent contractors of Cook that have access to the
Confidential Information of Cardica related to the Product, and
(c) is Controlled by Cook.
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1.9
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“ Field
” means
use of the Product in any suitable medical procedure anywhere in
the body.
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1.10
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“ Invention
” means
any article, material, process or technology, whether or not
patentable, made or conceived in the course of developing and
commercializing Products pursuant to this Agreement, in whole or in
part by a party, its employees, agents, or independent contractors,
that have access to the Confidential Information of the other party
.
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1.11
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“ Information
” means
(a) techniques and data relating to the development,
manufacture, use or sale of Products, including, but not limited
to, inventions, practices, methods, knowledge, know-how, skill,
experience, test data including pre-clinical and clinical test
data, analytical and quality control data, regulatory submissions,
correspondence and communications, marketing, pricing,
distribution, cost, sales, manufacturing, patent and legal data or
descriptions, and (b) compositions of matter, devices,
prototypes, articles of manufacture, assays and biological,
chemical or physical materials relating to development,
manufacture, use or sale of Products.
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1.12
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“ Net Sales
” means
the gross revenue actually received by Cook, its Affiliates or
sublicensees from the commercial sale of the Products during a
given period of time, minus, to the extent billed to the purchaser,
the costs of (i) sales, value added and/or use taxes,
(ii) duties and similar governmental assessments paid,
(iii) transportation, packing, shipping, and insurances,
(iv) discounts allowed and taken (not to exceed two percent
(2%) of the gross revenue actually received), and (v) amounts
allowed or credited due to rejections and/or returns. If the
Products are sold as part of a kit, then royalties due with respect
to Net Sales of Products will be determined using the formula set
forth in Sections 5.4(C) and (D). Net Sales shall be
determined in accordance with generally accepted accounting
principles, consistently applied.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
2.
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1.13
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“Other Cardica
IP” shall mean any intellectual property
rights that are necessary or useful for the research, development
or commercialization of Products, and Controlled by Cardica, other
than the Cardica Patents and Cardica Know-How.
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1.14
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“Other Cook
IP” shall mean shall mean any
intellectual property rights that are necessary or useful for the
research, development or commercialization of Products, and
developed by Cook employees having access to the Confidential
Information of Cardica related to the Product and Controlled by
Cook, other than the Cook Patents and Cook Know-How.
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1.15
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“ Patent ”
means (a) unexpired United States and foreign patents,
including without limitation any substitution, extension,
registration, confirmation, reissue, re-examination, renewal of
such patents and (b) pending applications for such patents,
including without limitation any continuation, divisional or
continuation-in-part thereof and any provisional
applications.
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1.16
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“ Product
” means
the product designated by Cardica as of the Effective Date of this
Agreement as the X-Port device, size [*] as illustrated in
Exhibit C of this Agreement, and any improvements thereto
relating to vascular access closure developed under this Agreement,
including without limitation X-Port devices in formats other than
size [*], expressly excluding any devices not relating to vascular
access closure, such as any device used in the closure of holes
made in the performance of an anastomosis.
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1.17
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“ Sunk Costs
” means
pro-rated amounts for any work actually performed by Cardica under
the Development Plan up to the effective date of termination and
supported by documentation provided by Cardica to Cook, including
[*] overhead for such work and all expenditures for such work and
non-cancelable commitments that are consistent with the original
budget and milestones set forth in the Development Plan and
incurred by Cardica in performing the Development Plan prior to
Cardica’s receipt or refusal of Cook’s notice of
termination.
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1.18
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“ Territory
” means
worldwide.
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1.19
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“ Third Party
” means
any person or entity other than Cardica or Cook, or their
respective Affiliates.
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1.20
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“ Unexpectedly Low
Sales ” means sales in three consecutive quarters of
a number of Products less than [*] of the number forecast under
Section 2.4.
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1.21
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“ Valid Claim
” means an unexpired claim of an issued Patent which has not
been found to be unpatentable, invalid or unenforceable by an
unreversed and unappealable decision of a court or other authority
in the subject country and that has not been disclaimed or admitted
to be invalid or unenforceable through reissue, disclaimer or
otherwise.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
3.
DEVELOPMENT AND
COMMERCIALIZATION
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2.1
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Development Committee
. Each party will
appoint two (2) representatives to form a development
committee that will be responsible for making day to day decisions
regarding the strategy for the development of prototypes of
Products in accordance with this Agreement (“
Development Committee ”). Such decisions will
be made by unanimous consent of the Development Committee. In the
event unanimous consent regarding a development issue can not be
reached by the Development Committee during any meeting of the
Development Committee, then a cooling off period of at least two
(2) but no more than seven (7) calendar days will follow
such meeting after which period all of the members of the
Development Committee will meet again. In the event that the
Development Committee is unable to achieve unanimous consent after
the cooling off period, a senior executive from each party will
meet to resolve the issue.
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2.2
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Prototype Product
Development .
The respective obligations of the parties for developing prototypes
of the Product are set forth in Attachment A to this Agreement
(“ Development Plan ”), which may be
modified from time to time to time in accordance with
Section 11.9 (Integration) of this Agreement, and which is
hereby incorporated by reference. Each party will use commercially
reasonable efforts to perform its obligations under the Development
Plan. In the event a conflict arises between this Agreement and the
Development Plan, the terms of this Agreement will
control.
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2.3
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Production Product
Development .
After the development of a prototype of a Product that the
Development Committee considers suitable and feasible for
successful commercialization (“ Feasible
Prototype ”), Cook will use commercially reasonable
efforts to develop a production version of the Product for sale in
the Field and in the Territory, at its expense, within a specified
time period to be agreed upon by the parties. Without limiting the
foregoing, Cook will use commercially reasonable efforts to apply
for a CE Mark and FDA Approval within a reasonable period of time
after the development of a Feasible Prototype. It is understood
that commercially reasonable efforts to develop a production
version of the Product may be unsuccessful, and that neither party
guarantees or can guarantee that commercially reasonable efforts to
implement the Development Plan will result in a production version
of the Product or in a saleable Product.
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2.4
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Commercialization
. Cook will use
commercially reasonable efforts to commercialize Products for use
in the Field in each country in the Territory in which it obtains
regulatory approval, at its expense. Without limiting the
foregoing, Cook will be responsible, at its cost, for promoting,
detailing and distributing Products for use in the Field in each
country in the Territory in which it obtains regulatory approval,
and will book all resulting Product sales. Following the Approval
of Product, Cook will provide to Cardica on a semi-annual basis its
good faith non-binding quarterly forecast of Product sales in the
Field and in the Territory for the following eighteen
(18) month period.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
4.
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2.5
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Development Costs
. Except as otherwise
expressly provided in this Agreement, each party will make its
resources available that it reasonably deems necessary to fulfill
its obligations under this Agreement and shall bear its own costs
incurred with respect thereto.
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2.6
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Specifications.
The Development
Committee will approve Product specifications for each type of
Product being developed, which specifications may be updated from
time to time.
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OWNERSHIP OF INTELLECTUAL
PROPERTY
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3.1
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Ownership of Inventions
. Ownership by the
parties of Inventions will be determined in accordance with the
rules of inventorship and ownership under US law.
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3.2
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Joint Inventions.
With respect to
Inventions jointly owned by the parties, each party will enjoy all
of the rights of an owner thereof with no duty to account to the
other party regarding any economic benefit realized and no need to
seek approval from the other party for its disclosure or use of
such Invention, except with respect to exclusivity provisions
expressly stated in this Agreement. Each party’s interest in
such jointly owned Inventions and intellectual property rights
therein will be included in such party’s intellectual
property rights that are either licensed to the other party or the
subject of covenants made to the other party pursuant to this
Agreement.
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3.3
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Prosecution . The parties will cooperate in good
faith to decide whether to seek patent protection for any
Inventions that are owned jointly by the parties. The party solely
owning an Invention will be responsible, but not obligated, for
filing and prosecuting patent applications on such Inventions, and
maintaining patents issued thereon, at such party’s sole
expense. If a party responsible for filing patent applications on
Inventions solely owned by such party decides not to proceed with
the filing, prosecution or maintenance of patent applications and
patents on such Invention (without first filing a continuation or
continuation in part of any such application), such party shall
notify the other party in writing in advance of relevant deadlines,
and the other party shall have the right, but not the obligation,
to assume responsibility for such activities, on behalf of the sole
owner but at the assuming party’s sole expense. The parties
will meet to discuss whether or not to pursue patent protection for
Inventions jointly owned by the parties. If the parties agree to
pursue such protection for such Inventions, they shall designate
one party to be responsible for filing and prosecuting patent
applications on such Inventions, and for maintaining patents
issuing thereon. Unless otherwise agreed by the parties, the
parties will share equally all expenses of pursuing and maintaining
patent protection on jointly owned Inventions that they agree to
pursue under this Section 3.3. Each party will have the right
to review and comment on the other party’s correspondence
with any patent office with regard to patent applications and
patents on Inventions that are necessary or useful for the
development and commercialization of Products in the
Field.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
5.
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A.
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Cook has the first right to enforce
patents licensed to it by Cardica against Third Parties that make,
use, offer for sale, sell, or import products that are covered by
such patents and that are competitive with Products in the Field.
If Cook elects not to undertake such enforcement, then Cardica may
request and Cook may, in its sole discretion, permit Cardica to
enforce such patents against such Third Parties, such permission
not to be unreasonably withheld.
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B.
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Each party will cooperate with the
other party when asserting patents against Third Parties in
accordance with this Section 3.4. A party enforcing a patent
against a Third Party will give the other party notice prior to
bringing any enforcement action (including, but not limited to,
injunctions or restraining orders). The other party will have the
right to participate or not participate in such enforcement, at its
sole discretion. If the other party chooses to participate, it will
bear its own expenses and/or share expenses, as the parties jointly
determine to be appropriate. If the other party chooses not to
participate in an enforcement action brought in accordance with
this Section 3.4, it nonetheless agrees to be named in the
enforcement action, and upon request and at the cost of the
enforcing party, will make available all relevant information in
its possession or under its control.
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C.
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Any
money damages obtained as a result of any enforcement action under
this Section 3.4 shall first be allocated to reimburse the
parties’ respective expenses of such enforcement, and the
remainder of such proceeds, if any, shall be allocated [*] percent
([*]) to the party controlling such suit, and [*] percent ([*]) to
the other party.
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D.
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If
the sales volume of the Product in a calendar year is less than
$[*], Cook may offset against any payment due under
Sections 5.4 or 5.5 of this Agreement up to [*] percent ([*])
of any monies expended by Cook in defending Products against
assertions of intellectual property rights by third parties. If the
sales volume of the Product in a calendar year is at least $[*],
then Cook may offset against any payment due under
Sections 5.4 or 5.5 of this Agreement an amount that is the
lesser of (i) [*] percent ([*]) of any monies expended by Cook in
defending Products against assertions of intellectual property
rights by third parties or (ii) [*] percent ([*]) of the total
payment due to Cardica under Sections 5.4 and 5.5.
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3.5
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Cardica Patent
Prosecution .
Cardica will use reasonable efforts to obtain patents included in
the Cardica Patents in [*]. Cardica will notify Cook of
Cardica’s foreign filing decisions with respect to each of
the Cardica Patents in writing in advance of relevant deadlines,
and Cook will have the right, but not the obligation, to assume
responsibility at Cook’s sole expense for pursuing and/or
maintaining foreign patent protection for any of the Cardica
Patents in any country that Cardica decides not to pursue or to
abandon.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
6.
LICENSE AND
COMMERCIALIZATION
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4.1
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By Cardica. Subject to the terms and conditions
of this Agreement, Cardica hereby grants to Cook and its Affiliates
an exclusive license in the Territory, bearing royalties as set
forth in this Agreement, with the right to grant sublicenses, under
the Cardica Patents, Cardica Know-How and Other Cardica IP, to
make, have made, use, sell, offer for sale and import Products for
use solely in the Field and in the Territory. For clarity, Cardica
grants the foregoing exclusive license to the fullest extent
possible under the Cardica Patents, Cardica Know-How and Other
Cardica IP in the Field and in the Territory with respect to
Products, retaining only rights to the extent necessary or useful
for Cardica to perform its responsibilities under the Development
Plan with respect to Product in the Field and in the
Territory.
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4.2
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Cardica Representations.
Cardica represents and
warrants that as of the Effective Date: (a) Cardica has the right
and power to enter into this Agreement and to grant the rights it
grants to Cook under this Agreement; (b) it has not assigned,
granted a license under or otherwise transferred or encumbered any
intellectual property licensed to Cook under this Agreement in a
manner inconsistent with this Agreement, other than grants of
security interests disclosed pursuant to a letter agreement of even
date herewith; (c) to its knowledge, Cook’s practice of
the license granted to Cook pursuant to this Agreement under the
Cardica Know-How, Cardica Patents and Other Cardica IP will not
infringe any Patents owned or controlled by a Third Party;
(d) its performance under this Agreement is not inconsistent
with any obligation owed to a third party; and (e) its
employees and/or agents assigned to perform work under a
Development Plan have executed agreements that enable Cardica to
grant the rights it grants to Cook under this Agreement.
Additionally, Cardica represents, warrants and covenants that it
has not employed, contracted with or retained, and shall not
employ, contract with or retain, any person or entity in connection
with the development or manufacture of Products in the Field
pursuant to this Agreement who has been or is debarred by the FDA
under 21 U.S.C. § 335(a) or disqualified as described in 21
C.F.R. §812.119.
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4.3
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By Cook. Cook agrees not to sue Cardica under
any Cook Patents, Cook Know-How, or Other Cook IP solely to the
extent necessary or useful for Cardica to perform its
responsibilities under the Development Plan with respect to Product
in the Field and in the Territory. Subject to the terms and
conditions of this Agreement, and upon request by Cardica, the
parties shall negotiate in good faith the terms of a non-exclusive,
royalty-bearing license for use by Cardica in developing and
commercializing products other than the Products under all Cook
Patents, Cook Know-How and Other Cook IP covering Inventions as
defined in Section 1.10, which license Cook in its sole
discretion may elect, but is not obligated, to execute with
Cardica.
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4.4
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Cook Representations.
Cook represents and
warrants that as of the Effective Date: (a) Cook has the right
and power to enter into this Agreement; (b) its performance
under this Agreement is not inconsistent with any obligation owed
to a third party; (c) to its
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
7.
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knowledge, Cardica’s practice
of the covenant not to sue granted to Cardica pursuant to
Section 4.3 of this Agreement under the Cook Know-How, Cook
Patents and Other Cook IP will not infringe any Patents owned or
controlled by a Third Party; and (d) its employees and/or
agents assigned to perform work under a Development Plan have
executed agreements that enable Cook to grant the rights it grants
to Cardica under this Agreement. Additionally, Cook covenants that
it shall not employ, contract with or retain any person or entity
in connection with the development, manufacture and
commercialization of Products in the Field pursuant to this
Agreement who has been or is debarred by the FDA under 21 U.S.C.
§ 335(a) or disqualified as described in 21 C.F.R.
§812.119.
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4.5
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No Implied Licenses.
Neither party grants to
the other party any licenses or covenants not to sue under such
party’s intellectual property rights except as expressly
provided in this Agreement.
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5.1
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Signing Fee . Cook will pay Cardica a one-time
payment of Five Hundred Thousand Dollars ($500,000) due after
execution of this Agreement by both parties and payable within ten
(10) days after Cardica’s completion, to Cook’s
satisfaction, of the tasks identified in the paragraph entitled
“Animal Testing” of the section identified as
“Phase 1” of the Development Plan attached to this
Agreement as Exhibit A.
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5.2
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Milestone Payments
. Cook will pay Cardica
a one-time payment of One Million Five Hundred Thousand Dollars
($1.5 million) for the design and development of the first
Feasible Prototype of a Product in [*] format (as provided in the
Development Plan) (“[*] Format”) in [*], each due
within thirty (30) days following the achievement of the
relevant milestone as set forth below:
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A.
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[*]
upon the date the Development Committee determines that the results
of the acute animal testing of Products in [*] Format in the Field
as provided in the Development Plan support the commencement of
pre-production tooling efforts by Cardica.
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B.
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[*]
upon completion of verification and validation testing as set forth
in the Development Plan and confirmed by the Development Committee
of Products in [*] Format produced by Cardica using the
pre-production tooling described in Section 5.2(A) (“
Pilot Product ”) to support commencement by
Cook of a Clinical Feasibility Trial of such Product in the
Field.
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C.
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[*]
upon the delivery of [*] ([*]) Pilot Products in [*] Format to Cook
for use in the first Clinical Feasibility Trial of such Products in
the Field, as provided in the Development Plan.
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[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
8.
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5.3
|
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Reimbursement for Products in Other
Formats .
Cook will reimburse Cardica for additional reasonable research,
development and tooling costs actually incurred by Cardica for the
development of Feasible Prototypes and the production of Pilot
Product in formats other than [*] as requested by Cook and
completed by Cardica in accordance with a research plan and budget
approved in advance and in writing by each member of the
Development Committee. Such reimbursements will be calculated using
full time equivalent rates for engineering services and labor and
will include Cardica’s reasonable and actual out of pocket
expenses for fabrication of the pre-production tooling, fixtures
and prototypes. Cardica shall add an overhead charge of [*] percent
([*]) of the amounts to be so reimbursed, and Cook shall pay such
additional amounts, to compensate Cardica for overhead expenses.
The agreed upon research plan and budget will establish the
milestones and timing to be met by Cardica in order for such
reimbursement payments to be made by Cook to Cardica.
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A.
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i)
Cook will pay to Cardica (on a quarterly basis) during the Term of
this Agreement a royalty based on Net Sales by Cook, its Affiliates
or sublicensees (“ Earned Royalty ”) of
Product units in the calendar year in which such quarter occurs, as
follows:
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Portion of
Aggregate Number of
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Royalty Due (%
of Net
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Product Units
Sold in Calendar
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Sales of Product
Units)
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Year
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[*]
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[*]
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[*]
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ii) In the
event that Cook sells more than [*] units of Product per calendar
year for [*] consecutive calendar years at any time during the Term
of this Agreement, then instead of the Earned Royalty set forth in
subsection 5.4(A)(i) above, the Earned Royalty shall be as follows
for the remainder of the Term of this Agreement:
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Portion of
Aggregate Number of
|
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Royalty Due (%
of Net
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Product Units
Sold in Calendar
|
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Sales of Product
Units)
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Year
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[*]
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[*]
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[*]
|
iii) In the
event that within [*] years from the Effective Date of this
Agreement no Cardica Patent issues in the United States, or in any
European Community country in
[*] = CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
9.
which Product
is manufactured, used, or sold, that has a Valid Claim that covers
Product, then instead of the Earned Royalty set forth in either
subsection 5.4(A)(i) or 5.4(A)(ii) above, Cook will pay to Cardica
Earned Royalty, as follows, until such time as a Cardica patent
issues in the United States, or in any European Community country
in which Product is manufactured, used, or sold, that has a Valid
Claim that covers Product, at which time Cook will pay to Cardica
Earned Royalty under section 5.4(A)(i) or 5.4(A)(ii), as
applicable:
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