<PAGE>
Exhibit 10.5
LICENSE AGREEMENT
This
License Agreement (the "Agreement") is entered into by and
between
UNIVERSITY OF MARYLAND, BALTIMORE COUNTY, having an address of 1000
Hilltop
Circle, Baltimore, Maryland 21250, a constituent institution of the
University
System of Maryland, which is an agency of the State of Maryland
(hereinafter
"UMBC"); and AMICUS THERAPEUTICS, INC., a Delaware corporation
having an address
of 675 US Route 1, North Brunswick, New Jersey 08902 (hereinafter
"AMICUS").
WITNESSETH:
WHEREAS, UMBC is interested in licensing PATENT RIGHTS
(hereinafter
defined) in a manner that will benefit the public by facilitating
the
distribution of useful products and the utilization of new methods,
and as a
center for research and education, UMBC is without capacity to
commercially
develop, manufacture, and distribute any such products or methods;
and
WHEREAS, a valuable invention entitled "Glycohydrolase Inhibitors,
Their
Preparation and Use Thereof" (UMBC REF. 2221 MS) was developed
during the course
of research conducted by Michael Sierks, Mikael Bols, and Troels
Skrydstrup
(hereinafter collectively, the "Inventor(s)"); and
WHEREAS, UMBC has acquired through assignment all rights, title
and
interest to said valuable invention from the Inventors, with the
exception of
certain rights retained by the United States Government; and
WHEREAS, AMICUS desires to commercially develop, manufacture, use
and
distribute products and processes derived from said invention
throughout the
United States, but is unable to do so without a license from
UMBC.
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
NOW
THEREFORE, in consideration of the foregoing premises and the
following
mutual covenants, and for other good and valuable consideration,
the receipt and
sufficiency of which is hereby acknowledged, the parties hereto
agree as
follows:
ARTICLE 1 - DEFINITIONS
All
references to particular Exhibits and Articles shall mean the
Exhibits
to, and Articles of, this Agreement, unless otherwise specified.
For the
purposes of this Agreement and the Exhibits hereto, the following
words and
phrases shall have the following meanings:
1.1
"PATENT RIGHTS" shall mean the U.S. Patent No. 5,844,102, issued
on
December 1,1998, and assigned to UMBC entitled "Glycohydrolase
Inhibitors, Their
Preparation And Use Thereof and the invention disclosed and claimed
therein, and
any, reissues, and extensions thereof.
1.2
"LICENSED PRODUCT" as used herein in either singular or plural
shall
mean any material, compositions, drug, or other product, the
manufacture, use or
sale of which would constitute, but for the license granted to
AMICUS pursuant
to this Agreement, an infringement of a VALID CLAIM of PATENT
RIGHTS
(infringement shall include, but is not limited to, direct,
contributory, or
inducement to infringe).
1.3
"DERIVED PRODUCT" as used herein in either singular or plural
shall
mean a LICENSED PRODUCT the sale of which would not, in and of
itself,
constitute an infringement of a VALID CLAIM of PATENT RIGHTS
(infringement shall
include, but is not limited to, direct, contributory, or inducement
to
infringe), but the use or manufacture of which would constitute,
but for the
license granted to AMICUS pursuant to this Agreement, an
infringement of a VALID
CLAIM of PATENT RIGHTS
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
2
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
(infringement shall include, but is not limited to, direct,
contributory, or
inducement to infringe).
1.4
"NET SALES" shall mean gross sales revenues and fees billed by
AMICUS,
AFFILIATED COMPANIES, and SUBLICENSEES from the sale of LICENSED
PRODUCTS less
trade discounts allowed, refunds, returns and recalls, and sales
taxes. In the
event that AMICUS, an AFFILIATED COMPANY, or a SUBLICENSEE sells a
LICENSED
PRODUCT in combination with other ingredients, components,
substances, or as
part of a kit or system, the NET SALES for purposes of royalty
payments shall be
based on the sales revenues and fees received from the entire
combination, kit,
or system.
1.5
"EXCLUSIVE LICENSE" shall mean a grant by UMBC to AMICUS and
its
AFFILIATED COMPANIES of its entire right and interest in the PATENT
RIGHTS
subject to the retained right of the University System of Maryland
to make, have
made, provide and use LICENSED PRODUCTS for its research and
educational
purposes.
1.6
"LICENSED FIELD" shall mean the [***].
1.7
"AFFILIATED COMPANY" as used herein in either singular or plural
shall
mean any corporation, company, partnership, joint venture or other
entity, which
controls, is controlled by, or is under common control with,
AMICUS. For
purposes of this Paragraph, 'control' shall mean the direct or
indirect
ownership of at least fifty-percent (50%).
1.8
"SUBLICENSEE" as used herein in either singular or plural shall
mean
any person or entity to which AMICUS or an AFFILIATED COMPANY has
granted a
sublicense under this Agreement.
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
3
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
1.9
"EFFECTIVE DATE" shall mean the date the last party hereto has
executed
this Agreement.
1.10
"VALID CLAIM" shall mean an issued claim in an in-force patent
that
has not been held unenforceable, unpatentable, or invalid by a
decision of a
government administrative agency or court of competent
jurisdiction, which
finding is unappealable or unappealed within the time allowed for
appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or
disclaimer.
ARTICLE II - LICENSE GRANT
2.1
GRANT. Subject to AMICUS' payment of the fees set forth in Article
III,
below, and AMICUS' and its AFFILIATED COMPANIES' compliance with
the other
terms and conditions of this Agreement, UMBC hereby grants to
AMICUS and its
AFFILIATED COMPANIES an EXCLUSIVE LICENSE to make, have made, use,
and sell
LICENSED PRODUCTS under PATENT RIGHTS in the LICENSED FIELD.
2.2
RIGHT TO SUBLICENSE. AMICUS and its AFFILIATED COMPANIES may
sublicense
others under this Agreement, subject to UMBC's approval, which
shall not be
unreasonably withheld, and shall provide a copy of each such
sublicense
agreement to UMBC promptly after it is executed. UMBC shall treat
all such
copies as confidential information of AMICUS. The applicable terms
of any such
sublicense shall be consistent with the terms of this
Agreement.
ARTICLE III - FEES, ROYALTIES, & PAYMENTS
3.1
LICENSE FEE. AMICUS shall pay to UMBC [***] as a license fee, which
is
nonrefundable and shall not be credited against future royalties or
other fees.
UMBC will not submit an invoice for the license fee. The license
fee shall be
payable as follows:
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
4
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
-
[***]
within thirty (30) days of the EFFECTIVE DATE;
-
[***] upon
a determination that UMBC is entitled to a patent claim to
IFG (claim 2 of the patent) or within twelve (12) months of the
EFFECTIVE DATE, whichever comes first.
3.2
ANNUAL FEES. AMICUS shall pay to UMBC annual fees in the amounts
set
forth below until the termination or expiration of this
Agreement:
<TABLE>
<CAPTION>
DUE DATE
ANNUAL FEE
------------------------------- ----------
<S>
<C>
Second Anniversary of the
Effective Date
[***]
Third Anniversary of the
Effective Date
[***]
Fourth Anniversary of the
Effective Date
[***]
Fifth Anniversary of the
Effective Date
[***]
Sixth and each subsequent
Anniversary of
the Effective
Date
[***]
</TABLE>
These annual fees shall be due within thirty (30) days of each
anniversary of
the EFFECTIVE DATE beginning with the second such anniversary. In
any year
following an anniversary of the EFFECTIVE DATE where: (i) sales of
LICENSED
PRODUCTS exist; (ii) milestone payments are made to UMBC pursuant
to paragraph
3.4 below; or (iii) sublicensing revenues are to be paid pursuant
to paragraph
3.5 below, the annual fee due on said anniversary shall be credited
against such
running royalties, milestone payments, and licensing revenues due
in the year
following said anniversary.
3.3
ROYALTIES. AMICUS shall pay to UMBC [***] of NET SALES as a
running
royalty for all LICENSED PRODUCTS sold by AMICUS, its AFFILIATED
COMPANIES, and
SUBLICENSEES during the term of this Agreement; provided
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
5
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
however, AMICUS, its AFFILIATED COMPANIES, and SUBLICENSEES shall
pay a [***] of
NET SALES during the term of this agreement when a LICENSED PRODUCT
is a DERIVED
PRODUCT. Should AMICUS be required to license patent rights from a
third party
other than those already licensed by AMICUS from New York
University's Mt. Sinai
School of Medicine (i.e. allowed U.S. patent applications
09/604,053 and
09/948,348, pending U.S. patent application 10/172,604, entitled "A
Method For
Enhancing Mutant Enzyme Activity In Gaucher Disease," and any
continuations,
divisionals, and reissues thereof) to sell a LICENSED PRODUCT,
AMICUS shall be
entitled to credit [***] of any royalties payable under said third
party license
against the royalties due to UMBC for such LICENSED PRODUCT,
provided however,
in any case, the royalty rate payable to UMBC shall not be reduced
below [***].
Royalty payments shall be made quarterly on either a calendar or
fiscal
quarterly schedule, at AMICUS' election, provided said quarterly
schedule is
reasonably consistent during the term of this Agreement. All non-US
taxes
related to the sales of LICENSED PRODUCTS shall be paid by AMICUS
and shall not
be deducted from any royalty or other payments due to UMBC.
In the event any LICENSED PRODUCT shall be sold by AMICUS or an
AFFILIATED
COMPANY to an AFFILIATED COMPANY, or any person, corporation, firm
or
association with which AMICUS or an AFFILIATED COMPANY has any
agreement,
understanding or arrangement with respect to consideration (such
as, among other
things, an option to purchase stock or actual stock ownership, or
an arrangement
involving division of profits or special rebates or allowances),
the royalties
to be paid hereunder for any such LICENSED PRODUCT shall be based
upon the
greater of: 1) the net selling price at which the purchaser of
LICENSED PRODUCTS
resells such products to the end user, 2) the fair market value of
the LICENSED
PRODUCT which shall be determined based on the sales price of
similar products
or services sold in the market, as applicable, or as may be
mutually agreed by
the parties, or 3) the net selling price of LICENSED PRODUCTS paid
to AMICUS or
an AFFILIATED COMPANY.
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
6
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
3.4
MILESTONE PAYMENTS. AMICUS shall pay:
1)
[***] upon the first demonstration of safety and efficacy over a
dosing
interval of greater than 28 days in a human phase II clinical trial
for a
LICENSED PRODUCT; and
2)
[***] upon receiving marketing approval for a first LICENSED
PRODUCT
from
the U.S. Food and Drug Administration.
The
milestone payments set forth in this Paragraph shall be
credited
against running royalties due to UMBC; provided however, the amount
credited in
any given year shall not exceed [***] of the running royalties that
would
otherwise be due to UMBC for that year.
3.5
SUBLICENSE CONSIDERATION. In addition to the running royalty due
to
UMBC as set forth in Paragraph 3.3, AMICUS shall pay the following
percentages
of any consideration, other than royalties, received by AMICUS or
an AFFILIATED
COMPANY for the grant of a sublicense under this Agreement:
1)
[***] until AMICUS has identified a lead compound covered by
PATENT
RIGHTS and demonstrated safety and efficacy of said compound in an
animal
model;
2)
[***] after AMICUS has identified a lead compound covered by
PATENT
RIGHTS and demonstrated safety and efficacy of said compound in an
animal
model, but before commencement of a clinical trial on a lead
compound
covered by PATENT RIGHTS; and
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
7
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
3)
[***] following commencement of a clinical trial on a lead
compound
covered by PATENT RIGHTS.
For
the purpose of clarification, such consideration shall include,
without
limitation, any licensing fees or other cash consideration, and any
premium paid
by the SUBLICENSEE over Fair Market Value for stock, or stock
options, of the
AMICUS or an AFFILIATED COMPANY. The term "Fair Market Value" shall
mean the
daily weighted average of the price at which said stock is publicly
trading
during the period twenty (20) business days prior to the effective
date of said
sublicense, or if the stock is not publicly traded, the value of
such stock as
determined by the most recent private financing through a Financial
Investor in
AMICUS or an AFFILIATED COMPANY that issued the shares. The term
"Financial
Investor" shall mean an entity whose sole interest in AMICUS or an
AFFILIATED
COMPANY is for the purpose of investment.
3.6
REIMBURSEMENT. In accordance with Paragraph 4.1 below, AMICUS
will
reimburse UMBC, within thirty (30) days of the receipt of an
invoice from UMBC,
for all patent office fees associated with the maintenance of
PATENT RIGHTS
incurred by UMBC subsequent to the EFFECTIVE DATE of this
Agreement.
3.7
FORM OF PAYMENT. All payments under this Agreement shall be paid
to
UMBC in United States Dollars by check(s) drawn on a United States
Bank. Checks
are to be made payable to "UMBC" and shall reference:
[***]
And shall be sent to:
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
8
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
OFFICE OF TECHNOLOGY DEVELOPMENT
UNIVERSITY OF MARYLAND, BALTIMORE COUNTY
ADMINISTRATION BUILDING
1000 HILLTOP CIRCLE
BALTIMORE, MD 21250
ATTN: DIRECTOR
3.8
FOREIGN CURRENCY. To the extent NET SALES of Licensed Products
manufactured in the United States are made by AMICUS or a
SUBLICENSEE in a
foreign country, any royalties due to UMBC based thereon shall be
first
determined in the currency of the country in which the royalties
were earned and
then converted to their equivalent in United States Dollars using
an average of
the currency exchange rates quoted in the Wall Street Journal for
the last
business day of each of the three (3) consecutive calendar months
constituting
the calendar quarter in which the royalties were earned. To the
extent that
statutes, laws, codes, or government regulations (including
currency exchange
regulations) shall prevent or limit royalty payments by AMICUS or
its
SUBLICENSEES in any country, all monies due to UMBC shall promptly
be deposited
by AMICUS or its SUBLICENSEE, as the case may be, in an account in
a local bank
in such country, said bank to be designated by UMBC in writing; or
paid to UMBC,
or deposited in its account, in any other country where such
payment or deposit
is lawful under the currency restrictions, as directed in writing
by UMBC.
3.9
LATE PAYMENTS. In the event that any payment due hereunder is not
made
when due, the payment shall accrue interest beginning on the tenth
day following
the due date thereof, calculated at the annual rate of the sum of
(a) two
percent (2%) plus (b) the prime interest rate quoted by The Wall
Street Journal
on the date said payment is due, the interest being compounded on
the last day
of each calendar quarter, provided however, that in no event shall
said annual
interest rate exceed the maximum legal interest rate for
corporations. Each such
payment when made shall be accompanied by all interest so accrued.
Said interest
and the payment and acceptance thereof shall not negate or waive
the right of
UMBC to seek any other remedy, legal or
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
9
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
equitable, to which it may be entitled because of the delinquency
of any payment
including, but not limited to termination of this Agreement as set
forth in
Paragraph 9.2.
ARTICLE IV - PATENT PROSECUTION, MAINTENANCE, &
INFRINGEMENT
4.1
PROSECUTION & MAINTENANCE. UMBC, at AMICUS' expense, shall
maintain all
patents specified under PATENT RIGHTS upon authorization of AMICUS
and AMICUS
shall be licensed thereunder. Title to all such patents and patent
applications
shall reside in UMBC. UMBC shall have full and complete control
over all patent
matters related to the PATENT RIGHTS, provided however, that UMBC
will consider
and incorporate reasonable comments received from AMICUS. AMICUS
will provide
payment authorization to UMBC at least one (1) month before an
action is due,
provided that AMICUS has received timely notice of such action from
UMBC and has
the opportunity to provide comments. Failure to provide
authorization can be
considered by UMBC as an AMICUS decision not to authorize an
action.
4.2
NOTIFICATION. Each party will notify the other promptly in writing
when
any infringement of the PATENT RIGHTS by another is uncovered or
suspected.
4.3
INFRINGEMENT. AMICUS shall have the first right to enforce any
patent
within PATENT RIGHTS in the FIELD against any infringement or
alleged
infringement thereof, and shall at all times keep UMBC informed as
to the status
thereof. AMICUS may, in its sole judgment and at its own expense,
institute suit
against any such infringer or alleged infringer and control,
settle, and defend
such suit in a manner consistent with the terms and provisions
hereof and
recover, for its account subject to Paragraph 4.4, any damages,
awards or
settlements resulting therefrom. This right to sue for infringement
shall not be
used in an arbitrary or capricious manner. UMBC shall reasonably
cooperate in
any such litigation, including being joined as a party plaintiff if
AMICUS'
attorneys, in their sole discretion, determine that UMBC is
necessary to any
[***] 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 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
10
<PAGE>
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
such litigation, at AMICUS' expense using AMICUS' counsel of
choice. UMBC shall
have the right to retain counsel of its own selection, at UMBC's
expense, in any
litigation instituted by AMICUS pursuant to this Paragraph 4.3,
provided that
AMICUS' counsel shall be lead counsel.
If
AMICUS elects not to enforce any patent within the PATENT RIGHTS,
then
it shall so notify UMBC in writing within ninety (90) days of
receiving notice
that an infringement exists, and UMBC may, in its sole judgment and
at its own
expense, take steps to enforce any patent and control, settle, and
defend such
suit in a manner consistent with the terms and provisions hereof,
and recover,
for its own account, any damages, awards or settlements resulting
therefrom.
UMBC shall reasonably consider any comments from AMICUS regarding
any settlement
that may impair AMICUS' rights under this Agreement in any way
prior to UMBC
entering into such settlement. AMICUS shall have the right to
participate in
such litigation and, if it elects to do so, will retain counsel of
its own
selection and at its expense, provided that UMBC's counsel shall be
lead
counsel.
4.4
RECOVERY. Any recovery by AMICUS under Paragraph 4.3 shall be
deemed to
reflect loss of commercial sales, and AMICUS shall pay to UMBC a
percent,
according to the rate determined for Sublicens
