Exhibit 10.4
LICENSE AGREEMENT
This License Agreement (the "Agreement") is entered into by and between
UNIVERSITY OF MARYLAND, BALTIMORE COUNTY, having an address of 0000 Xxxxxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000, 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 000 XX Xxxxx 0, Xxxxx Xxxxxxxxx, Xxx Xxxxxx 00000 (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 Xxxxxxx Xxxxxx, Xxxxxx Xxxx, 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.
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.
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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 treatment of Gaucher disease.
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.
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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.
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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:
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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.
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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:
DUE DATE ANNUAL FEE
------------------------------- ----------
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 [***]
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.
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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.
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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
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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.
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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:
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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.
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AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
OFFICE OF TECHNOLOGY DEVELOPMENT
UNIVERSITY OF MARYLAND, BALTIMORE COUNTY
ADMINISTRATION BUILDING
0000 XXXXXXX XXXXXX
XXXXXXXXX, XX 00000
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.
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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 xxx 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
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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.
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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 Sublicense Consideration as described in
Paragraph 3.5, of the recovery net of all reasonable costs and expenses
associated with each suit or settlement. If the cost and expenses exceed the
recovery, then one-half (1/2) of the excess shall be credited against royalties
payable by AMICUS to UMBC hereunder in connection with sales in the country of
such legal proceedings, provided, however, that any such credit under this
Paragraph shall not exceed fifty percent (50%) of the royalties otherwise
payable to UMBC with regard to sales in the country of such action in any one
calendar year, with any excess credit being carried forward to future calendar
years.
[***] 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.
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AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
ARTICLE V - OBLIGATIONS OF THE PARTIES
5.1 REPORTS. AMICUS shall provide to UMBC within thirty (30) days of the
end of each March, June, September and December after the EFFECTIVE DATE, a
written report to UMBC of the amount of LICENSED PRODUCTS sold, the total NET
SALES of such LICENSED PRODUCTS, and the running royalties due to UMBC as a
result of NET SALES AMICUS, AFFILIATED COMPANIES, and SUBLICENSEES. Payment of
any such royalties due shall accompany such report. The report of sales and
royalties due shall be substantially in the format of the sales and royalty
report form given in Exhibit A. Until AMICUS or a SUBLICENSEE has achieved a
first commercial sale of a LICENSED PRODUCT, a report shall be submitted at the
end of every June after the EFFECTIVE DATE and will include a full written
report describing AMICUS' or any SUBLICENSEE'S technical efforts towards meeting
its obligations under the terms of this Agreement as set forth in Paragraph 5.3.
UMBC shall treat all reports received pursuant to this Paragraph as confidential
information of AMICUS.
5.2 RECORDS. AMICUS and its AFFILIATED COMPANIES shall make and retain, for
a period of three (3) years following the period of each report required by
Paragraph 5.1, true and accurate records, files and books of account containing
all the data reasonably required for the full computation and verification of
sales and other information required in Paragraph 5.1. Such books and records
shall be in accordance with generally accepted accounting principles
consistently applied. AMICUS and its AFFILIATED COMPANIES shall permit the
inspection and copying of such records, files and books of account by UMBC or
its certified public accountants during regular business hours upon ten (10)
business days' written notice to AMICUS or an AFFILIATED COMPANY. Such
inspection shall not be made more than once each calendar year. All costs of
such inspection and copying shall be paid by UMBC, provided that if any such
inspection shall reveal that an error has been made in the amount equal to five
percent (5%) or more of such payment, such costs shall be borne by AMICUS.
AMICUS and its AFFILIATED COMPANIES shall include in any
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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.
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Exclusive License Agreement
agreement with its SUBLICENSEES, which permits such party to make, use or sell
LICENSED PRODUCTS, a provision requiring such party to retain records of sales
of LICENSED PRODUCTS and other information as required in Paragraph 5.1 and to
permit UMBC to inspect such records as required by this Paragraph. Any
information disclosed or provided to UMBC during any such inspection or
resulting from any such inspection shall be treated as confidential information
of the disclosing party.
5.3 COMMERCIALIZATION EFFORTS. AMICUS shall exercise commercially
reasonable efforts to develop and to introduce a LICENSED PRODUCT into the
commercial market as soon as practicable, consistent with sound and reasonable
business practice and judgment; thereafter, until the expiration of the
Agreement, AMICUS shall endeavor to keep LICENSED PRODUCTS reasonably available
to the public.
5.4 PATENT ACKNOWLEDGEMENT. AMICUS agrees that all packaging containing
individual LICENSED PRODUCTS sold by AMICUS and SUBLICENSEES will be marked with
the number of the applicable patent(s) licensed hereunder in accordance with
each country's patent laws.
ARTICLE VI - REPRESENTATIONS
6.1 REPRESENTATIONS BY UMBC. UMBC represents and warrants that it has, or
will obtain, all approvals from UMBC senior officials necessary for it to enter
into this Agreement. UMBC further warrants that it has good and marketable title
to its interest in the inventions claimed under PATENT RIGHTS with the exception
of certain retained rights of the United States government. EXCEPT AS EXPRESSLY
SET FORTH IN THIS PARAGRAPH 6.1, AMICUS AND ITS AFFILIATED COMPANIES AGREE THAT
THE PATENT RIGHTS ARE PROVIDED "AS IS", AND THAT UMBC MAKES NO REPRESENTATION OR
WARRANTY WITH RESPECT TO THE PERFORMANCE OF
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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.
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Exclusive License Agreement
LICENSED PRODUCTS INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL
VIABILITY. UMBC MAKES NO REPRESENTATION AS TO THE VALIDITY OF THE PATENT RIGHTS
OR THAT ANY PRACTICE UNDER THE PATENT RIGHTS SHALL BE FREE OF INFRINGEMENT OF
ANOTHER PATENT OR OTHER PROPRIETARY RIGHT NOT GRANTED TO AMICUS HEREUNDER. UMBC
DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCTS AND SERVICES LICENSED UNDER
THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESS OR
IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.
NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, UMBC ADDITIONALLY
DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF UMBC AND INVENTORS, FOR
DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND
CONSEQUENTIAL DAMAGES, ATTORNEYS' AND EXPERTS' FEES, AND COURT COSTS (EVEN IF
UMBC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS),
ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE
PRODUCT LICENSED UNDER THIS AGREEMENT. AMICUS AND ITS AFFILIATED COMPANIES
ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A LICENSED
PRODUCT MANUFACTURED, USED OR SOLD BY AMICUS, ITS SUBLICENSEES AND AFFILIATED
COMPANIES.
ARTICLE VII - INDEMNIFICATION
7.1 INDEMNIFICATION. UMBC and the Inventors of PATENT RIGHTS will not,
under the provisions of this Agreement or otherwise, have control over the
manner in which AMICUS or its AFFILIATED COMPANIES or its SUBLICENSEES or those
operating for its account or third parties who purchase LICENSED PRODUCTS from
any of the foregoing entities, practice the PATENT RIGHTS or LICENSED PRODUCTS.
AMICUS shall defend, indemnify, and hold UMBC, The University System of
Maryland, the State of Maryland, their present and former trustees, officers,
agents, faculty, employees, and
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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.
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AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
Inventors and students who were involved with the creation of the inventions
covered by the PATENT RIGHTS, as applicable, harmless as against any judgments,
fees, expenses, or other costs arising from or incidental to any product
liability or other lawsuit, claim, demand or other action brought as a
consequence of the practice of said inventions by any of the foregoing entities,
whether or not UMBC or said Inventors, either jointly or severally, is named as
a party defendant in any such lawsuit. Practice of the inventions covered by the
PATENT RIGHTS, by an AFFILIATED COMPANY or an agent or a SUBLICENSEE or a third
party on behalf of or for the account of AMICUS or by a third party who
purchases LICENSED PRODUCTS from AMICUS, an AFFILIATED COMPANY, or a
SUBLICENSEE, shall be considered AMICUS' practice of said inventions for
purposes of this Paragraph. The obligation of AMICUS to defend, indemnify, and
hold harmless, as set forth in this Paragraph, shall survive the termination of
this Agreement.
7.2 INDEMNIFICATION BY UMBC. UMBC will indemnify and hold AMICUS harmless
from any and all losses, claims, liabilities, damages, costs and expenses
(including reasonable attorney's fees) which arise out of the acts or omissions
of the University, its agents, employees or students in connection with this
Agreement or by any breach or default in the performance of the obligations of
the University hereunder. The obligations of UMBC pursuant to this Paragraph 7.2
are contingent upon the existence of an appropriation to UMBC by the State
Legislature for the purpose of satisfying this clause in particular or clauses
of this type, in general at the time that the acts or omissions giving rise to
the University's obligations occur. If UMBC has no such appropriation at the
time such acts or omissions occur, it will seek an appropriation to satisfy
claims pursuant to this subsection, but its obligations to pay AMICUS will be
subject to the receipt of such an appropriation.
[***] 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.
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AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
ARTICLE VIII - CONFIDENTIALITY
8.1 CONFIDENTIALITY. In performing under this Agreement, the parties may
exchange information that they consider to be confidential. The recipient of
such information agrees to accept the disclosure of said information which is
(a) marked as confidential at the time it is sent to the recipient, or (b)
orally, is stated by the disclosing party to be confidential, or (c) is of such
a nature that the receiving party in the exercise of reasonable business
judgment should know is confidential, and to employ all reasonable efforts to
maintain the information secret and confidential, such efforts to be no less
than the degree of care employed by the recipient to preserve and safeguard its
own confidential information. The information shall not be disclosed or revealed
to anyone except employees and consultants of the recipient who have a need to
know the information and who have entered into a secrecy agreement with the
recipient under which such employees and consultants are required to maintain
confidential the proprietary information of the recipient and such employees and
consultants shall be advised by the recipient of the confidential nature of the
information and that the information shall be treated accordingly; provided
however, a receiving party may disclose confidential information to its
accountants, banks, financing sources, financial officers, lawyers, and related
professionals or such other persons having a legitimate need to know such
information, or as otherwise permitted by the disclosing party, provided that
such individuals are under an obligation to keep such information confidential.
The obligations of this Paragraph shall also apply to the confidential
information of AFFILIATED COMPANIES and/or SUBLICENSEES provided by AMICUS to
UMBC. UMBC's, AMICUS', and its AFFILIATED COMPANIES' obligations under this
Paragraph shall extend until three (3) years after the termination of this
Agreement.
8.2 EXCEPTIONS. The recipient's obligations under Paragraph 8.1 shall not
extend to any part of the information:
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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.
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AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
A. that can be demonstrated to have been in the public domain or
publicly known and readily available to the trade or the public
prior to the date of the disclosure; or
B. that can be demonstrated from written records to have been in the
recipient's possession or readily available to the recipient from
another source not under obligation of secrecy to the disclosing
party prior to the disclosure; or
C. that becomes part of the public domain or publicly known by
publication or otherwise, not due to any unauthorized act by the
recipient; or
D. that is demonstrated from written records to have been developed
by or for the receiving party without reference to confidential
information disclosed by the disclosing party.
8.3 COMPLIANCE WITH LAW. The prohibitions on the disclosure of confidential
information of a disclosing party under this Agreement shall not preclude a
receiving party, on the advice of counsel, from complying with applicable law or
other demand under lawful process, including a discovery request in a civil
litigation, so long as the receiving party first gives the disclosing party
written notice of the required disclosure and reasonably cooperates with the
disclosing party, at the disclosing party's sole expense, in seeking reasonable
protective arrangements with respect to such confidential information. In no
event shall the receiving party's cooperation with the disclosing party require
the receiving party to take any action that, on the advice of their counsel,
could result in the imposition of any sanctions or other penalties against it.
8.4 RIGHT TO PUBLISH. Each party may publish manuscripts, abstracts or the
like describing the PATENT RIGHTS and inventions contained therein provided
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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.
17
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
confidential information of the other as defined in Paragraph 8.1, is not
included without first obtaining approval from the disclosing party to include
such confidential information. Otherwise, either party shall be free to publish
manuscripts and abstracts or the like related to the PATENT RIGHTS without the
other party's prior approval.
ARTICLE IX - TERM & TERMINATION
9.1 TERM. The term of this Agreement shall commence on the EFFECTIVE DATE
and shall continue until the date of expiration of the patent included within
PATENT RIGHTS.
9.2 TERMINATION BY EITHER PARTY. This Agreement may be terminated by either
party, in the event that the other party (a) becomes insolvent or seeks
protection under any bankruptcy, receivership, trust deed, creditors
arrangement, composition or comparable proceeding, or if any such proceeding is
instituted against a party and not dismissed within fourteen (14) days, or (b)
fails to perform or otherwise breaches any of its obligations hereunder, if,
following the giving of notice by the terminating party of its intent to
terminate and stating the grounds therefore, the party receiving such notice
shall not have cured the failure or breach within thirty (30) days. In no event,
however, shall such notice or intention to terminate be deemed to waive any
rights to damages or any other remedy that the party giving notice of breach may
have as a consequence of such failure or breach.
9.3 TERMINATION BY AMICUS. Notwithstanding termination pursuant to
Paragraph 9.2, above, AMICUS may terminate this Agreement and the license
granted herein, for any reason, upon giving UMBC sixty (60) days written notice.
9.4 OBLIGATIONS AND DUTIES UPON TERMINATION. If this Agreement is
terminated, both parties shall be released from all obligations and duties
imposed or assumed hereunder to the extent so terminated, except as expressly
provided to the
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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.
18
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
contrary in this Agreement. Upon termination, both parties shall cease any
further use of the confidential information disclosed to the receiving party by
the other party. This obligation extends as well to any other persons to whom a
party has disclosed confidential information of the other. Termination of this
Agreement, for whatever reason, shall not affect the obligation of either party
to make any payments for which it is liable prior to or upon such termination.
Termination shall not affect UMBC's right to recover unpaid royalties or fees or
reimbursement for patent expenses incurred pursuant to Paragraph 4.1 prior to
termination. At the end of the Sell-Off Period (defined below), AMICUS shall
submit a final royalty report to UMBC (which UMBC shall treat as confidential
information of AMICUS) and any royalty payments and unreimbursed patent expenses
due UMBC shall become immediately due and payable. Upon termination of this
Agreement, all rights in and to the PATENT RIGHTS shall revert immediately to
UMBC at no cost to UMBC; provided, however, that if this Agreement is terminated
pursuant to Paragraphs 9.2 or 9.3, AMICUS, its AFFILIATED COMPANIES and/or
SUBLICENSEES, shall have the right to continue to manufacture LICENSED PRODUCTS
to the extent AMICUS, its AFFILIATED COMPANIES and/or SUBLICENSEES, have parts,
components, or supplies on hand or on order, and to sell LICENSED PRODUCTS
already in inventory at the time of such termination ("Sell-Off Period"),
provided that the Sell-Off Period shall not exceed a period of one (1) year, and
subject to the royalty payment obligations of Paragraph 3.3, the reporting
provisions of Paragraph 5.1, and any other obligations that survive as set forth
in Paragraph 10.13. In the event of termination of this Agreement, AMICUS shall
provide all of its SUBLICENSEES with written notice of: (i) termination of this
Agreement; (ii) termination of all sublicenses under this Agreement; and (iii)
the right of any SUBLICENSEES to negotiate a license to PATENT RIGHTS directly
with UMBC. A copy of all such notices shall be provided to UMBC, and treated as
confidential information of AMICUS.
[***] 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.
19
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
ARTICLE X - MISCELLANEOUS
10.1 USE OF NAME. AMICUS shall not use the name of UMBC or The University
System of Maryland or any of its constituent parts, or any contraction thereof
or the name of the Inventors in any advertising, promotional, sales literature
or fundraising documents without prior written notice to UMBC. AMICUS shall
allow at least seven (7) business days notice of any proposed public disclosure
for UMBC's review and approval. If UMBC does not respond by the end of said
seven day period, any proposed use of the names contemplated herein shall be
deemed approved provided, however, that UMBC's name shall not be used in any
case as an endorsement of LICENSED PRODUCTS.
10.2 NO PARTNERSHIP. Nothing in this Agreement shall be construed to create
any agency, employment, partnership, joint venture or similar relationship
between the parties other than that of a licensor/licensee. Neither party shall
have any right or authority whatsoever to incur any liability or obligation
(express or implied) or otherwise act in any manner in the name or on the behalf
of the other, or to make any promise, warranty or representation binding on the
other.
10.3 NOTICE OF CLAIM. Each party shall give the other or its representative
immediate notice of any suit or action filed, or prompt notice of any claim
made, against them arising out of the performance of this Agreement.
10.4 PRODUCT LIABILITY. Prior to initial human testing or first commercial
sale of any LICENSED PRODUCT, as the case may be, in any particular country,
AMICUS shall establish and maintain, in each country in which AMICUS, an
AFFILIATED COMPANY or a SUBLICENSEE shall test or sell a LICENSED PRODUCT,
product liability or other appropriate insurance coverage appropriate to the
risks involved in marketing LICENSED PRODUCTS; provided however, such insurance
shall include coverage of at least one million dollars ($1,000,000) per
incident. Upon AMICUS'
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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.
20
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
request, UMBC agrees to reasonably consider agreeing to insurance coverage of
less than one million dollars ($1,000,000) subject to AMICUS ability to provide
evidence that a lesser amount of coverage is usual, customary, and sufficient to
cover product liability risk for LICENSED PRODUCTS or comparable products in the
industry. Upon UMBC's request, AMICUS will furnish UMBC with a Certificate of
Insurance for each product liability insurance policy obtained, which shall be
treated as confidential information of AMICUS. UMBC shall be listed as an
additional insured in AMICUS' said insurance policies. If such product liability
insurance is underwritten on a 'claims made' basis, AMICUS agrees that any
change in underwriters during the term of this Agreement will require the
purchase of 'prior acts' coverage to ensure that coverage will be continuous
throughout the term of this Agreement.
10.5 GOVERNING LAW. This Agreement shall be construed, and legal relations
between the parties hereto shall be determined, in accordance with the laws of
the State of Maryland applicable to contracts solely executed and wholly to be
performed within the State of Maryland without giving effect to the principles
of conflicts of laws. Any disputes between the parties to the Agreement shall be
brought in the state or federal courts of Maryland.
10.6 NOTICE. All notices or communication required or permitted to be given
by either party hereunder shall be deemed sufficiently given if mailed by
registered mail or certified mail or sent by overnight courier, such as Federal
Express, to the other party at its respective address set forth below or to such
other address as one party shall give notice of to the other from time to time
hereunder. Mailed notices shall be deemed received on the third business day
following the date of mailing. Notices sent by overnight courier shall be deemed
received the following business day. Notices may be sent by facsimile provided
that any notice sent by facsimile is confirmed by registered mail or certified
mail or sent by overnight courier. Notices received by facsimile shall be deemed
received on the day either party receives such a facsimile at the number listed
below.
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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.
21
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
If to AMICUS: Amicus Therapeutics, Inc.
000 XX Xxxxxxx Xxx
Xxxxx Xxxxxxxxx, XX 00000
Attn: Vice President of Research
Facsimile: 000-000-0000
If to UMBC: Office of Technology Development
University of Maryland, Xxxxxxxxx Xxxxxx
Xxxxxxxxxxxxxx Xxxxxxxx, 0xx Xxxxx
0000 Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: Director
Facsimile: 000-000-0000
10.7 COMPLIANCE WITH ALL LAWS. In all activities undertaken pursuant to
this Agreement, both UMBC and AMICUS covenant and agree that each will in all
material respects comply with applicable federal, state and local laws and
statutes, as may be in effect at the time of performance and all valid rules,
regulations and orders thereof regulating such activities.
10.8 SUCCESSORS AND ASSIGNS. Neither this Agreement nor any of the rights
or obligations created herein, except for the right to receive any remuneration
hereunder, may be assigned by either party, in whole or in part, without the
prior written consent of the other party, except that either party shall be free
to assign this Agreement in connection with any sale of all or substantially all
of its assets, stock or business to which this Agreement relates (whether by
sale, merger, acquisition, operation of law or otherwise) without the consent of
the other. AMICUS shall promptly notify UMBC of any such assignment by AMICUS.
This Agreement shall bind and inure to the benefit of the successors and
permitted assigns of the parties hereto. Any attempt to assign this Agreement
other than as expressly permitted by this Paragraph shall render the attempted
assignment null and void.
[***] 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.
22
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
10.9 NO WAIVERS; SEVERABILITY. No waiver of any breach of this Agreement
shall constitute a waiver of any other breach of the same or other provision of
this Agreement, and no waiver shall be effective unless made in writing. Any
provision hereof prohibited by or unenforceable under any applicable law of any
jurisdiction shall as to such jurisdiction be deemed ineffective and deleted
herefrom without affecting any other provision of this Agreement. It is the
desire of the parties hereto that this Agreement be enforced to the maximum
extent permitted by law, and should any provision contained herein be held by
any governmental agency or court of competent jurisdiction to be void, illegal
and unenforceable, the parties shall negotiate in good faith for a substitute
term or provision which carries out the original intent of the parties
10.10 ENTIRE AGREEMENT; AMENDMENT. AMICUS and UMBC acknowledge that they
have read this entire Agreement and that this Agreement, including the attached
Exhibits constitutes the entire understanding and contract between the parties
hereto and supersedes any and all prior or contemporaneous oral or written
communications with respect to the subject matter hereof, all of which
communications are merged herein. It is expressly understood and agreed that (i)
there being no expectations to the contrary between the parties hereto, no usage
of trade, verbal agreement or another regular practice or method dealing within
any industry or between the parties hereto shall be used to modify, interpret,
supplement or alter in any manner the express terms of this Agreement; and (ii)
this Agreement shall not be modified, amended or in any way altered except by an
instrument in writing signed by both of the parties hereto.
10.11 FORCE MAJEURE. If either party fails to fulfill its obligations
hereunder (other than an obligation for the payment of money), when such failure
is due to an act of God, or other circumstances beyond its reasonable control,
including but not limited to fire, flood, civil commotion, riot, war (declared
and undeclared), revolution, or embargoes, then said failure shall be excused
for the duration of such event and for such a time thereafter as is reasonable
to enable the parties to resume performance under this Agreement.
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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.
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AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
10.12 FURTHER ASSURANCES. Each party shall, at any time, and from to time,
prior to or after the EFFECTIVE DATE of this Agreement, at reasonable request of
the other party, execute and deliver to the other such instruments and documents
and shall take such actions as may be required to more effectively carry out the
terms of this Agreement.
10.13 SURVIVAL. All representations, warranties, covenants and agreements
made herein and which by their express terms or by implication are to be
performed after the execution and/or termination hereof, or are prospective in
nature, shall survive such execution and/or termination, as the case may be.
This shall include Articles VI, VII, VIII, IX, and X, including, but not limited
to, AMICUS' right to make, use, and sell LICENSED PRODUCTS during the Sell-Off
Period and its obligation to pay royalties as set forth in Paragraph 9.4.
10.14 NO THIRD PARTY BENEFICIARIES. Nothing in this Agreement shall be
construed as giving any person, firm, corporation or other entity, other than
the parties hereto and their successors and permitted assigns, any right, remedy
or claim under or in respect of this Agreement or any provision hereof.
10.15 HEADINGS. Article headings are for convenient reference and not a
part of this Agreement. All Exhibits are incorporated herein by this reference.
10.16 COUNTERPARTS. This Agreement may be executed in counterparts, each of
which shall be deemed an original and all of which when taken together shall be
deemed but one instrument.
[***] 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.
24
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the date the last party hereto
has executed this Agreement.
UNIVERSITY OF MARYLAND, BALTIMORE AMICUS THERAPEUTICS, INC.
COUNTY
By: /s/ Xxxxx X. Xxxx By: /s/ Xxxxxx Xxxxxxx
--------------------------------- ------------------------------------
Xxxxx X. Xxxx, Ph.D. Xxxxxx Xxxxxxx, Ph.D.
Vice Xxxxxxx for Research Chief Executive Officer
Date: 6/19/03 Date: 6.26.03
APPROVED
UMBC Legal Affairs
/s/ Illegible
-------------------------------------
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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.
25
AMICUS THERAPEUTICS, INC.
Exclusive License Agreement
EXHIBIT A
QUARTERLY SALES & ROYALTY REPORT
FOR LICENSE AGREEMENT BETWEEN AMICUS AND UMBC DATED _________
FOR PERIOD OF ______________ TO ____________
UMBC TOTAL NET
PRODUCT REFERENCE/ SALES/NET ROYALTY
NAME/ PATENT UNITS SERVICE ROYALTY AMOUNT
NUMBER NUMBER SOLD REVENUES RATE DUE
------- ---------- ----- --------- ------- -------
TOTAL ROYALTIES DUE FOR THIS PERIOD $______________________
This report format is to be used to report quarterly royalty statements to
UMBC. It should be placed on AMICUS letterhead and accompany any royalty
payments due for the reporting period. This report shall be submitted even if
no sales are reported.
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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.
26
FIRST AMENDMENT TO LICENSE AGREEMENT
This Amendment having an effective date as of March 31, 2007, is made
by and between AMICUS THERAPEUTICS, INC., a Delaware corporation having a
principal place of business at 0 Xxxxx Xxxxx Xxxxx, Xxxxxxxx, Xxx Xxxxxx 00000
(hereinafter "AMICUS") and UNIVERSITY OF MARYLAND, BALTIMORE COUNTY, having an
address of 0000 Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000, a constituent
institution of the University System of Maryland, which is an agency of the
State of Maryland (hereinafter "UMBC").
WHEREAS, UMBC and AMICUS entered into a license agreement dated
June 26, 2003 (hereinafter the "Agreement"); and
WHEREAS, UMBC and AMICUS find it in their mutual best interests to
amend said Agreement to broaden the "Licensed Field" to include all human
therapeutics; and
NOW THEREFORE; the parties hereto agree as follows:
1. PARAGRAPH 1.6 SHALL BE REVISED TO READ AS FOLLOWS:
"LICENSED FIELD" shall mean the prevention or treatment of any human
disease, indication or clinical condition.
2. PARAGRAPH 3.4, SUBPARAGRAPHS 1) AND 2) SHALL BE REPLACED WITH THE
FOLLOWING:
1) [***] the first demonstration of safety and efficacy of a LICENSED
PRODUCT over a dosing interval of greater than 28 days in a human
phase II clinical trial for each disease, indication or clinical
condition and
2) [***] upon receiving marketing approval from the U.S. Food and
Drug Administration for a LICENSED PRODUCT for each disease,
indication, or clinical condition.
The remaining paragraph of Paragraph 3.4 to the License Agreement shall
remain in effect.
3. ADD TO THE END OF PARAGRAPH 5.3 THE FOLLOWING:
AMICUS shall also exercise commercially reasonable efforts to develop
other LICENSED PRODUCTS suitable for different markets, so that the
PATENT RIGHTS can be commercialized as broadly and as speedily as good
scientific and business judgment would deem possible.
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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. ADD THE FOLLOWING AS PARAGRAPH 5.5:
OTHER PRODUCTS. In the event that evidence is provided, in writing by
UMBC or by another party, to AMICUS, demonstrating the practicality of
a particular market which is not being developed or commercialized by
AMICUS; AMICUS shall either provide UMBC with a reasonable development
plan and start development or attempt to reasonably sublicense the
particular technology to a third party. If within six (6) months of
such notification by UMBC, AMICUS has not initiated such development
efforts or sublicensed that particular market, UMBC may terminate this
license for such particular market. This Paragraph shall not be
applicable if AMICUS reasonably demonstrates to UMBC that
commercializing such additional LICENSED PRODUCTS or granting such a
sublicense in said particular market would have a potentially adverse
commercial effect upon marketing or sales of the LICENSED PRODUCTS
developed and being sold by AMICUS or its SUBLICENSEES.
5. In consideration for UMBC agreeing to amend the Agreement, AMICUS
agrees to pay UMBC [***] as a non-refundable licensing fee, which shall
not be creditable against future royalties or other fees due to UMBC
pursuant to the Agreement. Said licensing fee shall be due within
thirty (30) days of the effective date of this Amendment.
6. All other terms and conditions of the Agreement shall remain in full
force and effect.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed
the day and year first written above.
UNIVERSITY OF MARYLAND, AMICUS THERAPEUTICS, INC.
BALTIMORE COUNTY
By: /s/ Xxxxx X. Xxxx By: /s/ Xxxx Xxxxxxx
---------------------------- ----------------------------
Xxxxx X. Xxxx, Ph.D. Xxxx Xxxxxxx
Vice President for Research President & CEO
Date: 3/27/07 Date: 3/29/07
-------------------------- --------------------------
APPROVED
UMBC Legal Affairs
[ILLEGIBLE]
--------------------------------
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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.
