Exhibit 10.3
[CONFIDENTIAL TREATMENT REQUESTED]
/*/ INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,
AS AMENDED.
PATENT SUBLICENSE
AGREEMENT,
This Agreement, by and between
IMPRA, Inc., an Arizona corporation (hereinafter called LICENSOR),
and Endomed, Inc., also an Arizona corporation (hereinafter called
LICENSEE), effective as of Match 7, 2003,
WITNESSETH THAT:
WHEREAS, LICENSOR holds certain
license rights under United States Patent No. 6,436,135,
including the right to grant sublicenses; and
WHEREAS, LICENSEE desires to acquire
a nonexclusive sublicense under said Patent;
NOW, THEREFORE, in consideration of
the premises and mutual covenants herein contained. LICENSOR and
LICENSEE agree as follows:
Section 1. Definitions
.
1.1. “Sublicensed
Patent” shall mean United States Patent No. 6,436,135
issued to David Goldfarb, MD. on August 20, 2002, and any
reissues and/or any reexaminations thereof.
1.2. “Licensed Products”
shall mean products (i) that LICENSEE makes, has made, uses,
imports, sells, leases, or offers for sale, (ii) that are
covered by a Valid Claim of the Sublicensed Patent, and
(iii) that are within the Field of Use.
1.3. “End User(s)” shall
mean the hospital or other entity or person that purchases a
Licensed Product for intended use in a human patient.
1.4. “Distributor(s)”
shall mean any entity or other person, other than an Affiliate of
Licensee, which purchases finished Licensed Products from LICENSEE
or an Affiliate of LICENSEE solely for the purpose of resale to an
End User without any addition, modification or alteration to the
Licensed Product or its packaging.
1.5. “OEM Customer(s)”
shall mean (i) any entity or other person which purchases or
otherwise obtains from LICENSEE or an Affiliate of LICENSEE a
product or product component for the purpose of adding to,
modifying, altering, or finishing such product or its packaging, or
combining it with other products, prior to sale thereof by said OEM
Customer, or (ii) any entity or other person which purchases
or otherwise obtains from LICENSEE or an Affiliate of LICENSEE a
product made to specifications that are particular to that entity
or person.
1.6. “Field of Use”
shall mean the field of endovascular products: i.e., medical
products that are placed within the arteries or veins of the human
body. The Field of Use expressly excludes any surgical prosthetic
device intended in whole or in part to replace any portion of any
artery, vein or other vessel or conduit within the human body,
including but not limited to bypass grafts, dialysis grafts, aortic
grafts or thoracic grafts.
1.7. “Net Annual Sales”
shall mean the total of Net Annual Domestic Sales and Net Annual
Foreign Sales as hereinafter defined.
1.7.1 Except as provided in section
1.7.3, “Net Annual Domestic Sales” shall mean the total
of:
(i) the total gross invoiced price
of all Licensed Products sold or otherwise transferred by LICENSEE
or any Affiliate of LICENSEE to an End User in the United States
during a specific calendar year, less (a) any discounts or
rebates actually allowed and taken, (b) any separately stated
taxes, freight, insurance, customs duties or other similar charges,
and (c) any credits actually issued for rejected or returned
products; and
(ii) in the case of all Licensed
Products that are sold to a Distributor located in the United
States or to any Distributor located outside the United States who
resells Licensed Products to any End Users in the United States,
the Distributor’s total gross invoiced price to its End User
customers for such Licensed Products, less (a) any discounts
or rebates actually allowed and taken, (b) any separately
stated taxes, freight, insurance, customs duties or other similar
charges, and (c) any credits actually issued for rejected or
returned products.
1.7.1.2 If any Licensed Products are
sold or otherwise transferred by LICENSEE, any Affiliate of
Licensee or a Distributor to End Users as part of a kit or other
assemblage of products, then in such cases “Net Annual
Domestic Sales” shall be calculated on the basis of the total
gross invoiced price to the End User for such kits or other product
assemblage.
1.7.1.3 In the event that Licensed
Products are transferred by LICENSEE, any Affiliate of LICENSEE, or
a Distributor to an End User other than by an outright sale
requiring full payment within thirty (30) days of shipment,
and under circumstances other than those listed in section 1.7.3,
said Licensed Products shall be deemed to have been
“sold” at the transferor’s then-current list
price for sale of such products to End Users.
1.7.1.4 “Net Annual Domestic
Sales” shall exclude (a) the gross invoiced price of
Licensed Products supplied by LICENSEE exclusively for use in
clinical trials being conducted in the United States pursuant to an
approved investigational device exemption (IDE) for the purpose of
obtaining U.S. Food & Drug Administration approval for the
sale of such Licensed Products for particular indications, and
(b) any Licensed Products supplied free of charge solely to
comply with LICENSEE’s warranty obligations.
1.7.1.5 In the event that any
Licensed Products (or kits or other product assemblages including
Licensed Products) (hereinafter “royalty-bearing
products”) are
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sold or otherwise transferred as
part of a group or “bundle” of products that includes
products which are not royalty-bearing products, or pursuant to a
discount arrangement or other price adjustment that includes
products which are not royalty-bearing products, the “Net
Annual Domestic Sales” of such royalty-bearing products shall
be computed as follows. (i) The actual average discount (in
percentage terms) for the royalty-bearing products sold or
otherwise transferred as part of such an arrangement during the
course of the royalty period at issue shall be determined.
(ii) The actual average discount (in percentage terms) for the
other, non-royalty-bearing sold or otherwise transferred as part of
such an arrangement during the course of the royalty period at
issue shall also be determined. (iii) If the average
percentage discount for such royalty-bearing products (D 1) is
greater than the average percentage discount for the
non-royalty-bearing products (D2), the actual Net Annual Domestic
Sales of the royalty-bearing products so sold or transferred shall
be adjusted by multiplying that figure by the following fraction:
[CONFIDENTIAL TREATMENT REQUESTED] /*/. The resulting figure shall
be included in the Net Annual Domestic Sales reported by LICENSEE
and shall form the royalty base for royalty payments due on such
sales or transfers.
1.7.2 “Net Annual Foreign
Sales”
1.7.2.1 Except as provided in
section 1.7.2.3, “Net Annual Foreign Sales” shall
mean
(i) the total gross invoiced price
of all Licensed Products sold or otherwise transferred by LICENSEE
or an Affiliate of LICENSEE to an End User located outside the
United States, less (a) any discounts or rebates actually
allowed and taken, (b) any separately stated taxes, freight,
insurance, customs duties or other similar charges, and
(c) any credits actually issued for rejected or returned
products; and
(ii) in the case of Licensed
Products sold or otherwise transferred by LICENSEE or an Affiliate
of LICENSEE to a Distributor located outside the United States for
resale to End Users located outside the United States,
LICENSEE’s or its Affiliate’s total gross invoiced
price to such Distributor, less (a) any discounts or rebates
actually allowed and taken, (b) any separately stated taxes,
freight, insurance, customs duties or other similar charges, and
(c) any credits actually issued for rejected or returned
products.
1.7.2.2 If any Licensed Products are
sold or otherwise transferred by LICENSEE, or any Affiliate of
Licensee to an End User or a Distributor located outside the United
States as part of a kit or other assemblage of products, then in
such cases “Net Annual Foreign Sales” shall be
calculated on the basis of the total gross invoiced price to the
End User for such lilts or other product assemblage.
1.7.2.3 In the event that Licensed
Products are transferred by LICENSEE or any Affiliate of LICENSEE
to an End User or a Distributor located outside the United States
other than by an outright sale requiring fill payment within thirty
(30) days of shipment, said Licensed Products shall be deemed
to have been “sold” at the transferor’s
then-current list price for sale of such products to End
Users.
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1.7.2.4 In the event that any
Licensed Products (or kits or other product assemblages including
Licensed Products) (hereinafter “royalty-bearing
products”) are sold or otherwise transferred to End Users or
Distributors outside the United States as part of a group or
“bundle” of products that includes products which are
not royalty-bearing products, or pursuant to a discount arrangement
or other price adjustment that includes products which are not
royalty bearing products, the “Net Annual Foreign
Sales” of such royalty-bearing products shall be computed as
follows. (i) The actual average discount (in percentage terns)
for the royalty-bearing products sold or otherwise transferred as
part of such an arrangement during the course of the royalty period
at issue shall be determined. (ii) The actual average discount
(in percentage terms) for the other, non-royalty-bearing sold or
otherwise transferred as part of such an arrangement during the
course of the royalty period at issue shall also be determined.
(iii) If the average percentage discount for such
royalty-bearing products (D1) is greater than the average
percentage discount for the non-royalty-bearing products (D2), the
actual Net Annual Foreign Sales of the royalty-bearing products so
sold or transferred shall be adjusted by multiplying that figure by
the following fraction: [CONFIDENTIAL TREATMENT REQUESTED] /*/. The
resulting figure shall be included in the Net Annual Foreign Sales
reported by LICENSEE and shall form the royalty base for royalty
payments due on such sales or transfers.
1.8. “Affiliate” shall
mean any person or entity that LICENSEE or any shareholder(s) of
LICENSEE directly or indirectly controls, through one or more
intermediaries or otherwise, or which is controlled by or is under
common control with LICENSEE. As used herein, “control”
means the possession, directly or indirectly, of the power to
director cause the direction of the management or policies of the
controlled entity, whether through ownership of capital stock, by
contract, or otherwise. “Affiliate” shall also include,
but not be limited to, the entities identified as
“Insiders” in that certain Stock Purchase Agreement of
even date herewith by and between Endomed, Inc. and C.R. Bard,
Inc.
1.9. “Valid Claim” shall
mean a claim of the Sublicensed Patent which, at the time a sale is
made has not been held unenforceable or invalid or otherwise
finally rejected by a decision of a court or other governmental
agency of competent jurisdiction, which decision is no longer
subject to a right of appeal or other judicial review, and which
has not been disclaimed or admitted to be invalid by
LICENSOR.
1.10. “United States”
shall mean all fifty states and all foreign possessions or
dependencies of the United States, including Puerto Rico, the U.S.
Virgin Islands and Guam.
Section 2. Scope of License
.
2.1. LICENSOR hereby grants to
LICENSEE a personal, nonexclusive sublicense under the Sublicensed
Patent to make, have made for its own account, use, and import
Licensed Products, and to sell, lease, offer for sale and otherwise
transfer Licensed Products as hereinafter provided. LICENSEE or an
Affiliate of Licensee may sell or transfer Licensed Products
directly to End Users. LICENSEE or, in the event that LICENSEE
first sells or transfers Licensed Products to any Affiliate of
LICENSEE, such Affiliate, may also sell or transfer Licensed
Products to Distributors for resale to End Users; provided,
however, that any such Distributor must resell the Licensed
Products to End Users in unchanged form, and
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provided further, that there shall
be [CONFIDENTIAL TREATMENT REQUESTED] /*/ distribution channel for
Licensed Products ([CONFIDENTIAL TREATMENT REQUESTED] /*/) in any
specific country in the world. This sublicense specifically
excludes any right of LICENSEE (or any Affiliate or Distributor of
LICENSEE) to sell or otherwise transfer Licensed Products to OEM
Customers.
2.1.1 This Agreement and all rights
granted hereunder are personal to LICENSEE except to the extent
specifically hereinafter provided. LICENSEE shall have no right to
further sublease its rights hereunder.
2.1.2 LICENSEE understands and
agrees that, notwithstanding the License Agreement between LICENSEE
and its Affiliate Transform Technologies, L.L.C.
(“Transform”), neither Transform nor any
successor-in-intent or assignee or transferee of Transform has or
will hereafter acquire any rights with respect to the Sublicensed
Patent or any rights or licenses under this Agreement.
2.2. This Agreement shall not be
construed to grant LICENSEE any license or other rights except as
specifically contained herein, and is strictly limited to the
defined Field of Use. No license or other right is granted herein
to either party, directly or by implication, estoppel or otherwise,
with respect to any trade secrets or know-how of the other, and no
such license or other right shall arise from the execution or
performance of this Agreement or from any acts, statements or
dealings loading to such execution or performance. Except as
specifically stated herein, neither party is required to furnish o
r disclose to the other any technical or other information. Neither
party shall use or refer to the name, logo or trademarks of the
other in any form of advertising or promotion, written or
oral.
Section 3. Royalty
Obligations .
3.1. Except as hereinafter provided,
LICENSEE shall pay to LICENSOR a royalty on the Net Annual Sales of
all Licensed Products during each calendar year in accordance with
the following royalty rate schedule:
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[*] $[*] /*/million of Net
Annual Sales
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[*]
/*/%
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[*] $[*] /*/million (to $[*]
million)
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[*]
/*/%
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[*] $[*] /*/million (to $[*]
million)
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[*]
/*/%
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[*] $[*] /*/million (to $[*]
million)
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[*]
/*/%
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[*] $[*] /*/million (to $[*]
million)
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[*]
/*/%
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[*] $[*] /*/million (to $[*]
million)
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[*]
/*/%
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[*] sales over
$[*] /*/million
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[*]
/*/%
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[*] [CONFIDENTIAL TREATMENT
REQUESTED]
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The above schedule shall start anew
on January 1 of each calendar year.
3.1.1 Minimum Royalties on Sales to
Distributors Located Outside the U.S. for Resale to End Users
outside the U.S. Notwithstanding the foregoing, if the per-unit
royalty calculated on any sale of Licensed Products by LICENSEE or
an Affiliate of LICENSEE to a Distributor pursuant to Sections
1.7.2.1(ii), 1.7.2.2 and/or 1.7.2.4 is less than the minimum
royalty applicable to such sale as set forth below, then LICENSEE
shall pay to LICENSOR such minimum royalty in lieu of the
calculated royalty:
Minimum Royalties on Foreign
Distributor Sales:
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[CONFIDENTIAL TREATMENT REQUESTED] /*/
Products
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$[CONFIDENTIAL TREATMENT REQUESTED] /*/ per
unit
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[CONFIDENTIAL TREATMENT REQUESTED] /*/
Products
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$[CONFIDENTIAL TREATMENT REQUESTED] /*/ per
unit
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[CONFIDENTIAL TREATMENT REQUESTED] /*/
Products
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$[CONFIDENTIAL TREATMENT REQUESTED] /*/ per
unit
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[CONFIDENTIAL TREATMENT REQUESTED] /*/ Products
(for [CONFIDENTIAL TREATMENT REQUESTED] /*/ uses)
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$[CONFIDENTIAL TREATMENT REQUESTED] /*/ per
unit
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[CONFIDENTIAL TREATMENT REQUESTED] /*/
Products
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$[CONFIDENTIAL TREATMENT REQUESTED] /*/ per
unit
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[CONFIDENTIAL TREATMENT REQUESTED] /*/
Products
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$[CONFIDENTIAL TREATMENT REQUESTED] /*/ per
tout
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If an adjustment is hereafter made
to the royalty schedule pursuant to Section 3.4 hereof, the
minimum royalties set forth in this Section 3.1.1 shall be
proportionately adjusted to the extent that the adjusted royalty
rate is less than [CONFIDENTIAL TREATMENT REQUESTED] /*/%. In the
event that LICENSEE sells or develops a Licensed Product that does
not fall within any of the above categories (a “Nora-Listed
Licensed Product”), LICENSOR and LICENSEE shall negotiate in
good faith an appropriate minimum royalty for sales of such
Non-Listed Licensed Product that are subject to
Section 1.7.2.1(ii), 1.7.2.2 and/or 1.7.2.4. Such minimum
royalty shall in no event be less than the greater of
(1) [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the Net Annual
Foreign Sales for such Non-Listed Licensed Product, or
(2) [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the applicable
Distributor’s average End User selling price for such
Non-Listed Licensed Product (subject to any adjustment made
pursuant to Section 3.4, if applicable).
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3.2. LICENSEE’s obligation to
pay royalties with respect to the products currently being sold by
LICENSEE shall be retroactive to the issuance of the Sublicensed
Patent, notwithstanding the later execution of this
Agreement.
3.3. Royalty payments shall be due
and payable no later than [CONFIDENTIAL TREATMENT REQUESTED] /*/
([CONFIDENTIAL TREATMENT REQUESTED] /*/) days following the end of
each calendar quarter with respect to sales made (or deemed to have
been made pursuant to Sections 1.7.2 or 4.1 hereof) during said
calendar quarter and any prior sales on which a royalty due
hereunder has not been paid. Except as provided in
Section 1.7.2, sales to an End User shall be deemed to have
been made on the date of shipment.
3.4. LICENSEE shall have, at its
option, the right to replace the royalty schedule set forth in
Section 3.1 hereof or the method of calculating the royalty
base (defined in this Agreement as “Net Annual Sales”)
with any more favorable sublicense royalty rate or royalty base
calculation method hereafter granted in the same Field of Use by
LICENSOR or any assignee or successor of LICENSOR for sales to End
Users, except that (i) such right shall not extend to any
royalty rate or royalty base calculation method contained in any
sublicense granted to any affiliate of LICENSOR or to [CONFIDENTIAL
TREATMENT REQUESTED] /*/ or in any sublicense granted as part of a
bona fide cross-licensing arrangement or in settlement of a claim,
and (ii) to the extent that LICENSOR or its assignee or
successor grants a more favorable sublicense royalty rate or
royalty base calculation method that is limited to some portion of
the Field of Use, LICENSEE shall be entitled to such more favorable
rate or method only with respect to products sold in said limited
portion of the Field o