Exhibit 10.6
AMENDED AND RESTATED PATENT AND
KNOW-HOW
EXCLUSIVE LICENSE
AGREEMENT
AS BETWEEN THE
UNDERSIGNED:
Mr. Jacques
SEGUIN
Mr. Jean-Claude
LABORDE
Hereinafter designated together as
the “GRANTORS”
AND:
DEVAX Inc.
, a Delaware corporation
Hereinafter designated as the
“LICENSEE”.
BACKGROUND:
Mr. Jacques
SEGUIN and Jean-Claude LABORDE are joint title owners of a patent
issued on November 20, 1998 by the National Institute of
Industrial Property of France, under the number 96 07245, entitled
“Device permitting the treatment of bodily conducts at the
level of a bifurcation” (“Underlying
Patent”) 1
It was published in
the Official Bulletin of Industrial Property of France N# 98/47,
November 20, 1998. 2
The Underlying Patent is for the
invention of a medical device called a “bifurcated
stent” specially conceived for treating cardiovascular
illnesses which require an intervention at the level of branching
blood vessels.
A patent application was filed with
the United States Patent and Trademarks Office on April 3,
1998 under application number 09/011,214 (“U.S. Patent
Application”).
A patent application
was filed under PCT/FR97/00999, under the following title:
“Endoprosthesis for vascular bifurcation” and a patent
application was filed having International Application No.
PCT/EP2002/012509, titled “Endoprosthesis for Vascular
Bifurcation” (collectively “the PCT Patent
Applications”). 3
Other patent applications related to
the Underlying Patent and PCT Patent Application were filed before
the European Union, Canada, Japan and the South African Union and
are presently pending (“Other Patent
Applications”).
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1
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Dispositif
permettant le treatment de conduits corporels au niveau d'une
bifurcation, Institut National de la Propriete Industrielle, brevet
n# 96 07245
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2
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Bulletin Officiel
de k Propriete Industrielle n3 98/47 du 20 novembre
1998.
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3
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“Endoprothese
pour bifurcation vasculaire”
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Licensee has been organized under
the laws of the State of Delaware (USA) for the purpose of, among
other things, research, development and marketing of medical
devices including those based on the Licensed Technology and the
Grantors desire to grant to Licensee the present exclusive license,
according to the terms set forth below.
A Patent and Know-How Exclusive
License Agreement was entered by and between the Grantors and the
Licensee on August 18, 1999 (the “Effective
Date”).
The parties now wish to amend and
restate the Patent and Know-How Exclusive License Agreement as of
April 30, 2007.
IT IS AGREED THAT:
DEFINITIONS
“ Licensed Patents
” means: (a) Underlying Patent; (b) the U.S. Patent
Application, the PCT Patent Application and the Other Patent
Applications; (c) any and all corresponding foreign patent
applications based on the Underlying Patent or PCT Patent
Application, the U.S. Patent Application or the Other Patent
Applications, whether now existing or hereafter filed; (d) any
divisionals, reissues, continuations, continuations-in-part, or
substitute applications and inventors’ certificates arising
from, or based upon, any of the foregoing patents and patent
applications and any other patent applications claiming priority to
any to the foregoing patents or patent applications or any other
patents or patent applications referenced in this definition;
(e) any patents issuing from any of the foregoing; and
(f) any reissues, re-examinations, renewals, extensions and
supplemental protection certificates of any of the
foregoing.
“ Grantors .”
“Grantors” are Mr. Jacques Seguin and
Mr. Jean-Claude Laborde, each referred to herein as a
“Grantor.”
“ Licensed Technology
.” “Licensed Technology” means the Licensed
Patents and the Know-How.
“ Know How .”
“Know-How” means (a) the Bifurcated Stent
Technology and (b) all information, and data which is not
generally known, including (without limitation) formulae, designs,
procedures, protocols, techniques and results of experimentation
and testing, which is necessary or useful to make, use, sell,
develop or seek regulatory approval in any country to market the
Licensed Products. For the avoidance of doubt,
“Know-How” does not include any technology or
intellectual property assigned by Mr. Seguin to Licensee
pursuant to the Technology Transfer Agreement dated
September 2, 1999.
“ Bifurcated Stent
Technology .” “Bifurcated Stent Technology”
means (a) all ideas, abstracts, diagrams, designs,
improvements, inventions, modification, know-how, trade secrets,
data, prototypes, techniques, and plans and any other proprietary
rights (the “Proprietary Rights”) as set forth or
described in the document titled “Description of the
Development of the Bifurcated Stent and any attachments thereto, a
copy of which is attached hereto as Exhibit A (the
“Bifurcated Stent Description”) and (b) all
Proprietary Rights arising out of any animal studies or other
experiments described in the Bifurcated Stent Description;
excluding, however, the Licensed Patents.
2
“ Licensed Product
.” “Licensed Product” means any product or device
based upon or comprising the Licensed Patents and developed by
Licensee, its affiliates or sublicensees that, when made, used or
sold would, but for the rights granted to Licensee hereunder
constitute an infringement of a Valid Claim in the country in which
such manufacture, use or sale occurs.
“ Valid Claim .”
“Valid Claim” means a claim of an issued patent within
the Licensed Patents which claim has not lapsed, been cancelled, or
become abandoned, has not been declared invalid by a final judgment
of a court of competent jurisdiction from which no appeal can be or
is taken, and has not been admitted to be invalid or unenforceable
through reissue or disclaimer.
“ Net Sales .”
‘Net Sales” means the gross revenue derived by
Licensee, its affiliates and sublicensee from sales of Licensed
Products to customers who are not affiliates, less:
(a) prompt payment or other trade or
quantity discounts as are customary in the trade;
(b) commissions paid or allowed to
distributors and agents who are independent third parties (and not
affiliates);
(c) amounts repaid or credited by
reason of rejections or returns of Licensed Products;
(d) taxes, customs duties and other
governmental charges actually paid or withheld;
(e) allowances actually granted,
including any allowances for bad debt, provided that upon the
extinguishment of any such allowance, the extinguishment will be
determined to be a receipt; and
(f) transportation and delivery
charges, including insurance premiums, actually
incurred.
In the event that a product sold by
Licensee, its affiliates or sublicensees is comprised in part of a
Licensed Product and in part done or more other products or
devices, Net Sales shall be determined by multiplying the amount
calculated pursuant to the immediately preceding paragraph for such
combination product by the Combination Allocated Portion (as
defined below). The “Combination Allocated Portion”
shall mean a fraction, the numerator of which is the average
selling price of the Licensed Product included in such combination
product and the denominator which is the sum of the average selling
price of such Licensed Product and the average selling price of the
other products or devices that are part of such combination
product. In the event that the average selling price for a product
is not available, then the fair market value for the product shall
be used instead.
TERMINATION OF PRIOR
AGREEMENTS
That certain license agreement dated
August 18, 1999, between the Grantors and DEVAX S.A. (a French
Company) (the “Prior Agreement”) shall be superseded
and replaced in its entirety by this Agreement and the Prior
Agreement shall be of no further force or effect.
ARTICLE 1.
NATURE AND EXTENT OF THE
LICENSE
The Grantors hereby grant to the
Licensee and its affiliates, and the Licensee and its affiliates
hereby accept, an exclusive worldwide license under the Licensed
Technology (the “License”) for any and all
purposes.
3
The License shall be exclusive even
as to the Grantors and the License rights shall include, without
limitation, the right to make, have made, use, import or sell and
offer for sale the Licensed Products or any other product based on
the Licensed Technology.
The Grantors relinquish the right to
directly exploit or grant to a third party any rights to the
Licensed Technology during the validity of the present
agreement.
ARTICLE 2.
SUB-LICENSES
The License shall include the right
to grant sublicenses and the Licensee shall be free to make, have
made, use, import, sell or offer for sale any products covered by
the Licensed Technology either directly or through its affiliates,
sublicenses, agents, distributor or any other means it deems
appropriate.
ARTICLE 3.
TECHNICAL
ASSISTANCE
The Grantors agree, at the request
of Licensee, to provide the Licensee without charge technical
assistance to commence the exploitation of the Licensed Technology
for a term of one (1) year starting from the Effective Date.
Reasonable travel, living, and accommodation expenses, incurred by
the Grantors engaged in this capacity will be borne by the
Licensee. Any work or other product Proprietary Rights resulting or
otherwise arising out of any technical assistance or work performed
for or on behalf of the Licensee by Grantor under this Agreement
shall be assigned to and owned by the Licensee for the purpose of
clarification, except as specifically set forth in Article 7
of this Agreement or any other contract or agreement that may be
entered between the Licensee and a Grantor, each Grantor shall own
all Proprietary Rights resulting or otherwise arising out of any
ideas, inventions or work that Grantor has developed or conceived
independent of the Company and outside the scope of this
Agreement.
Beyond this one (1) year
period, the Grantors will provide, upon the request of Licensee,
and in a manner consistent with their other professional
obligations, technical assistance, for which their compensation
shall be determined on a case by case basis, and reasonable food,
travel and lodging expenses incurred in this capacity shall be
borne by the Licensee.
ARTICLE 4.
CONFIDENTIALITY
4.1 Confidential Information
. Each party hereunder shall maintain the secret and confidential
nature of all technical documents, information and studies related
to the Licensed Technology and any other Proprietary Rights of the
other party for so long as (a) such information was not in the
public domain before its communication to the other party;
(b) such information subsequently entered into the public
domain after its communication to the receiving party (through no
fault of the receiving party); (c) such information was not
known lawfully by the receiving party prior to its communication;
(d) such information was not received by a third party in a
lawful manner without any restrictions on its disclosure; or
(e) the disclosure of such information was not authorized by
the other party.
4
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
4.2 Employee Agents . Each
party is responsible to ensure that its employees, agents,
affiliates and sublicensees observe and comply with the
confidentiality obligations of this Article 4.
4.3 Survival of Confidentiality
Obligations . The confidentiality obligations shall remain in
effect after the termination of this Agreement.
ARTICLE 5.
COMMERCIALIZATION
The Licensee shall take all
commercially reasonable steps to effectively exploit the Licensed
Technology and commercialize the Licensed Products. The Licensee
shall use commercially reasonable efforts to promptly avail itself
of funds necessary to develop the Licensed Products and gain
regulatory approval for marketing of the Licensed Products. For
avoidance of doubt, the parties agree that this Article 5 does not
require Licensee to exploit each and every Licensed Technology or
to commercialize each and every Licensed Product but only those
Licensee in good faith determines to commercialize.
ARTICLE 6.
FINANCIAL
CONDITIONS
The license is subject to the
following financial conditions:
6.1 Royalty Payments . The
Licensee will pay the Grantors royalty fees based as
follows:
(a) [ *** ] of the Net Sales
of all Licensed Products sold by Licensee, its affiliates and its
sublicensees in any country where the manufacture, use or sale of
such Licensed Product would absent the License grant set forth
herein, infringe on Valid Claims of Licensed Patent; the royalty
provision under this Section 6.1(a) shall be applicable until
the total royalty fees paid or payable to Grantors under this
Section 6.1(a) have reached [ *** ]; and
(b) Once the aggregate royalty fees
pursuant to Section 6.1(a) has reached [ *** ], the
total royalty rate [ *** ] of the Net Sales of all Licensed
Products sold by Licensee, its affiliates and it sublicensees in
any country where the manufacture, use or sale of such
Licens