Exhibit 10.3
EXECUTION COPY
AGREEMENT
BETWEEN
MOUNT SINAI SCHOOL OF MEDICINE OF
NEW YORK UNIVERSITY
AND
AMICUS THERAPEUTICS, INC.
LICENSE AGREEMENT
This License Agreement (the "Agreement") is made and effective as of April 15,
2002 (the "Effective Date"), by and between:
MOUNT SINAI SCHOOL OF MEDICINE OF NEW YORK UNIVERSITY, a corporation organized
and existing under the laws of the State of New York and having a place of
business at Xxx Xxxxxxx X. Xxxx Xxxxx, Xxx Xxxx, XX 00000 ("MSSM")
AND
Amicus Therapeutics, Inc., a corporation duly organized and existing under the
laws of Delaware, and having its principal office at 0000 Xxxxxxxxxx Xxxx.,
Xxxxxxxx, Xxxxxxxxxxx 00000, c/o CHL Medical Partners, L.P. ("AMICUS").
RECITALS
WHEREAS:
MSSM has an ownership interest in certain Patent Rights (as hereinafter
defined); and
AMICUS wishes to obtain a license to manufacture, use, sell and offer for sale
the products covered by the Patent Rights and MSSM desires to grant such
license, all on the terms and conditions set forth herein.
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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.
NOW, THEREFORE, IT IS HEREBY DECLARED AND AGREED BETWEEN THE PARTIES AS FOLLOWS:
1. Definitions.
Whenever used in this Agreement, the following terms shall have the following
meanings:
a. "Affiliate" shall mean any corporation, firm, limited liability
company, partnership or other entity that directly or indirectly
controls or is controlled by or is under common control with a party
to this Agreement. "Control" means ownership, directly or through one
or more Affiliates, of 50 percent or more of the shares of stock
entitled to vote for the election of directors, in the case of a
corporation, or 50 percent or more of the equity interests in the case
of any other type of legal entity, status as a general partner in any
partnership, or any other arrangement whereby a party controls or has
the right to control the board of directors or equivalent governing
body of a corporation or other entity.
b. "Calendar Year" shall mean any consecutive period of twelve months
commencing on the first day of January of any year.
c. "Chaperones" shall mean compounds that improve protein folding,
stability or sorting or decrease protein degradation.
d. "Conformational Diseases" shall mean any human disease in which at
least a sub-population of the affected individuals have a mutant
protein that results in impaired protein folding, stability,
degradation or sorting.
e. "Field" shall mean the discovery, validation, development,
application, production or sale of Licensed Products: (i) for the
prevention, diagnosis and treatment of Conformational Diseases (ii)
that are Chaperones to improve the production and/or manufacturing of
therapeutic proteins for the treatment of Conformational Diseases that
are manufactured and sold by third parties, (iii) that are Chaperones
discovered and developed by AMICUS to improve the production and/or
manufacturing of therapeutic proteins for the treatment of diseases
other than Conformational Diseases that are manufactured and sold by
third parties, or (iv) that are Chaperones discovered and developed by
Amicus for co-administration with therapeutic proteins for the
treatment of disease other than Conformational Diseases that are
manufactured and sold by third parties.
f. "License" shall mean the license under the Patent Rights to develop,
manufacture, have manufactured, use, offer for sale and sell the
Licensed Products as provided in Article 2, below.
g. "Licensed Product" shall mean any product or part thereof, the
manufacture, use, or sale of which is: (i) covered by one or more
Valid Claims of any Patent Rights, or (ii) which could not be
developed, manufactured, used, sold, comprised or delivered without
the Patent Rights.
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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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h. "Net Sales" shall mean the total amount invoiced by AMICUS or by any
AMICUS Affiliate or sub-licensee of AMICUS in connection with sales to
any purchaser of the Licensed Products that is not an Affiliate or a
sub-licensee of AMICUS or an AMICUS Affiliate, after deduction of all
the following to the extent applicable to such sales;
i) trade, cash and quantity credits, discounts, refunds or rebates;
ii) allowances or credits for returns;
iii) sales commissions;
iv) sales taxes (including value added tax), and
v) freight and insurance charges borne by the seller.
i. "Patent Rights" shall mean any issued patent or any patent to be
issued pursuant to any United States or foreign patent application
owned, by MSSM, listed in this subclause 1.i.(i)-(v) together with any
continuations in whole or in part, divisional or substitute patents,
any reissues or re-examinations of any such application or patents,
and any extension of the term of any such patent in the Field. The
issued patents and patent applications referred to in the preceding
sentence are:
i) U.S. Xxx. No. 6,274,597- "Method of Enhancing Lysosomal
AlphaGalA";
ii) U.S. Xxx. Applic. No. 09/604,053 (continuation in part) -
"Method of Enhancing Mutant enzyme activities in lysosomal
storage disease";
iii) U.S. Xxx. Applic. No. 09/926,285 (continuation of the '597
Patent; and
iv) U.S. Xxx. Applic. No. 09/948,348 (continuation of the '053
CIP Application.
v) U.S. Xxx. Applic. entitled "Screen for active site specific
chaperones for enhancing protein folding of mutant proteins"
filed on March 1, 2002.
j. "Valid Claim" shall mean a claim of (i) an issued patent included in
the Patent Rights which has not been declared invalid in a final,
unappealable decision of a court of appropriate jurisdiction, or (ii)
a pending patent application included in the Patent Rights which is
being diligently prosecuted by or on behalf of MSSM and has not been
formally terminated or abandoned without issuance of a patent.
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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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2. The License
a. Subject to the terms and conditions hereinafter set forth, MSSM hereby
grants to AMICUS and AMICUS hereby accepts from MSSM the world-wide
right under the Patent Rights to develop Licensed Products for use in
the Field and to manufacture, use, sell and offer for sale the
Licensed Products for use in the Field. Except as set forth in Section
2e and 8f the License shall be exclusive as to all rights of MSSM in
and to the Patent Rights. During the term of this Agreement, MSSM
shall make no further grant of rights in and to the Patent Rights
inconsistent with the rights of AMICUS herein.
b. AMICUS shall be entitled to grant sub-licenses under the License on
terms and conditions not inconsistent with this Agreement (except that
the rate of royalty may be at higher rates than those set forth in
this Agreement): (i) to an Affiliate, and (ii) to other third parties
for consideration and in arms-length transactions.
c. All sub-licenses shall only be granted by AMICUS pursuant to a written
agreement, a true and complete copy of which shall be submitted by
AMICUS to MSSM as soon as practicable after the signing thereof. Each
sub-license granted by AMICUS hereunder shall be subject and
subordinate to the terms and conditions of this License Agreement and
shall contain, inter alia, the following provisions:
i) the sub-license shall expire automatically on the termination of
the License;
ii) the sub-license shall not be assignable, in whole or in part;
iii) the sub-licensee shall not be entitled to grant further
sub-licenses; and
iv) both during the term of the sub-license and thereafter the
sub-licensee shall be bound by a secrecy obligation similar to
that imposed on AMICUS in Section 6 below, and that the
sub-licensee shall bind its employees and agents, both during the
terms of their employment and thereafter, with a similar
undertaking of secrecy.
d. The sub-license agreement shall also include the text of Sections 6, 9
and 10 of this Agreement and shall state that MSSM is an intended
third party beneficiary of such sub-license agreement for purposes of
enforcing such indemnification and insurance provisions.
e. The License shall be subject to (i) a non-exclusive license in favor
of the U.S. Government to the extent required by Title 35 U.S.C.A.
Section 200 et seq., or as otherwise required by virtue of use of
federal funding in support of inventions claimed within the Patent
Rights and (ii) a right and license retained by MSSM on behalf of
itself and its faculty, students and academic collaborators to
practice the Patent Rights for its own bona fide research, including
sponsored research and collaborations. The retained rights granted in
this Section 2e shall not give
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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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MSSM the right to offer or grant rights in the Field under the Patent
Rights to third parties.
f. Except for the License expressly provided in this Section 2, neither
party hereto will, as a result of this Agreement, obtain any ownership
interest in, or any other right or license to, any existing
technology, patents, or Confidential Information, as defined in
Section 6, below, of the other party.
3. Royalty
a. In consideration for the grant of the License hereunder, subject to
the provisions of Section 3.b, (i) AMICUS shall pay to MSSM [***] on
Net Sales; and (ii) in the event AMICUS grants sublicenses with
respect to any Licensed Product pursuant to which AMICUS receives
remuneration other than royalties, then AMICUS shall pay to MSSM [***]
of all payments that AMICUS receives from such sublicensee or other
parties, including, without limitation: (a) Contract Signature
Payments, (b) Third Party Milestone Payments, or (c) Maintenance Fees.
As used in this Section 3.a.(ii), the term "Contract Signature
Payment" means license initiation fees and all other up-front
payments made to AMICUS in connection with a sublicense or similar
agreement; "Third Party Milestone Payments" means payments made to
AMICUS upon fulfillment by AMICUS or the sub-licensee of designated
development objectives or regulatory requirements; and "Maintenance
Fees" means payments (such as annual minimum royalties) made by
sub-licensees to AMICUS to preserve, or to avoid a forfeiture of
rights under, the sublicense agreement;
With respect to any sublicensing or other transaction to which this
Section 3.a.(ii) applies but which relates to products and services in
addition to Licensed Products and for which an allocation would be
necessary, the parties shall meet and attempt to agree on which
portion of the total payments received by AMICUS pursuant to such
transaction would be subject to this Section 3.a.(ii). If the parties
cannot agree upon such allocation within a reasonable period of time,
AMICUS shall select a nationally recognized independent certified
public accountant, which meets MSSM's approval, to determine such
allocation. Such allocation shall be determined in accordance with
generally accepted accounting principles in the United States.
b. If AMICUS is required to acquire one or more licenses from third
parties to make, use or sell a Licensed Product such that aggregate
royalties payable by AMICUS on Net Sales (including the royalty amount
due to MSSM pursuant to Section 3.a) exceeds [***], then AMICUS shall
be entitled to a credit against the royalty payments due to MSSM
pursuant to Section 3.a equal to [***] of the amount of such excess;
provided, however, that in no event shall the amount otherwise payable
to MSSM be reduced to less than [***] of Net Sales.
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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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c. AMICUS shall notify MSSM of the date of the first commercial sale of a
Licensed Product as soon as practicable after the making of such
commercial sale.
d. Commencing on the date of first commercial sale of a License Product,
AMICUS shall, within 90 days from the last day of each June and
December in each Calendar Year during the term of the License, submit
to MSSM a full and detailed report of royalties or payments due MSSM
under the terms of this Agreement for the preceding half year (the
"Semi-Annual Report"), setting forth the Net Sales and lump sum
payments and all other payments or consideration from sublicensees
upon which such royalties are computed and including, on a Licensed
Product-by-Licensed Product basis at least:
i) the quantity of Licensed Products used, sold, transferred or
otherwise disposed of,
ii) the selling price of each Licensed Product,
iii) the deductions permitted to arrive at Net Sales,
iv) the royalty computations and deductions therefrom based on
royalty payments to third parties.
If no royalties are due, a statement shall be sent to MSSM stating
such fact. The full amount of any royalties or other payments due to
MSSM for the preceding half-year shall accompany each such report on
royalties and payments. AMICUS and all its sub-licensees shall keep
for a period of at least five years after the date of entry, full,
accurate and complete books and records consistent with sound business
and accounting practices and in such form and in such detail as to
enable the determination of the amounts due to MSSM from AMICUS
pursuant to terms of this Agreement.
e. At the request and expense of MSSM, AMICUS shall permit (and shall
require its sub-licensees to permit) an independent certified or
chartered public accountant appointed by MSSM, at reasonable times
during normal business hours and upon reasonable notice, but in any
event no more than once per calendar year, to examine the records of
AMICUS (and its sub-licensees) to the extent necessary to verify
royalty calculations made hereunder; provided, however, that such
examination shall be at the expense of AMICUS if it reveals a
discrepancy in the amount of royalties to be paid in MSSM's favor of
more than five percent. Results of such examination shall be made
available to both AMICUS and MSSM.
4. Method of Payment
a. Royalties and any other payments due to MSSM hereunder shall be paid
to MSSM in United States dollars.
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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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b. AMICUS shall be responsible for prompt payment to MSSM of all
royalties due on sale, transfer or disposition of Licensed Products by
the sub-licensees of AMICUS.
c. As to sales occurring in currencies other than U.S. Dollars, Net Sales
shall first be calculated in the currency in which sale occurred and
then converted to U.S. Dollars at the buying rate for such currency
calculated as the average of the closing buying rate for the first and
last business day of the six month period for which royalties are due,
as set forth in the Wall Street Journal for such dates.
5. Development and Commercialization
a. AMICUS shall use its commercially reasonable efforts to bring one or
more Licensed Products to market through a thorough, vigorous and
diligent program for exploitation of the Patent Rights in the Field.
AMICUS shall not, however, be required to pursue the development of
more than one Licensed Product at a time, nor shall AMICUS be required
to pursue every possible Licensed Product.
b. Attached as Appendix A to this Agreement is the current development
plan of AMICUS for the forthcoming period of twelve months (such plan,
as updated from time to time as described in clause (c) below, the
"Plan"). As and when appropriate, future Plans will incorporate
efficacy, pharmaceutical safety, toxicological and/ or clinical tests
or any other activities necessary in order to obtain the approval of
the FDA and counterpart foreign regulatory agencies for the
production, use and sale of Licensed Products, as well as marketing
plans to commercialize Licensed Products that have obtained such
approvals.
c. On the earlier of thirty (30) days prior to the first anniversary of
the Effective Date or the end of AMICUS's first fiscal year, and
thereafter on each successive anniversary of such date, AMICUS shall
deliver to MSSM a report setting forth in reasonable detail progress
and problems with the implementation of the Plan and, providing an
update on its efforts to commercialize Licensed Products, including a
forecast and schedule of major events required to market the Licensed
Products. Such report shall also include any amendments proposed by
AMICUS to the Plan based upon the progress made and then current
scientific, regulatory and commercial exigencies relating to Licensed
Products. Within forty-five (45) days following the delivery of such a
report (a "Diligence Report") representatives of MSSM may request a
meeting with AMICUS to review the Diligence Report, the status of the
efforts of AMICUS under the Plan and any proposed amendments to the
Plan. Any such proposed amendments to the Plan shall be subject to
approval by MSSM, which approval shall not be unreasonably withheld or
delayed. Upon approval of any such amendments, they shall be deemed
amendments to the Plan, added to Appendix A and deemed incorporated
into this Agreement.
d. AMICUS will use its commercially reasonable efforts to accomplish the
milestones described in the Plan.
e. Provided that applicable laws, rules and regulations so require, the
manufacture of Licensed Products shall be carried out by AMICUS or its
agents in accordance
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
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PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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with FDA Good Laboratory Practices and FDA Good Manufacturing Practice
("GMP") procedures in a facility which has been certified by the FDA
and the performance of the tests, trials, studies and other activities
specified in the Plan shall be so performed by AMICUS or its agents in
accordance with FDA clinical trial procedures. MSSM shall have no
responsibility for the actual production, distribution, sale or use of
any Licensed Product.
f. If at any time AMICUS abandons or suspends its efforts to
commercialize all Licensed Products for a period exceeding ninety (90)
days, AMICUS shall immediately notify MSSM giving reasons and a
statement of its intended actions. MSSM shall be entitled to terminate
this Agreement for "Cause" in accordance with Section 11 upon any such
abandonement.
g. MSSM shall also be entitled to terminate this Agreement for "Cause" in
accordance with Section 11 if AMICUS shall fail to deliver any
Diligence Report on a timely basis, or fail to use commercially
reasonable efforts to implement the Plan, and such failure is not
cured within the sixty (60) day period set by the notice provided
pursuant to Section 11, unless such failure is excused by:
i) causes beyond AMICUS's direct control; or
ii) MSSM's failure to meet its obligations hereunder; or
iii) inaction of any federal or state agency whose approval is
required for commercial sales of Licensed Products.
h. Provided that applicable laws, rules and regulations so require, the
performance of the tests, trials, studies and other activities
specified in subsection b, above, shall be carried out in accordance
with FDA Good Laboratory Practices and FDA Good Manufacturing Practice
("GMP") procedures in a facility which has been certified by the FDA
as complying with GMP. MSSM shall have no responsibility for the
actual production, distribution, sale or use of any Licensed Product.
6. Confidential Information.
a. In the course of research to be performed under this Agreement, it
will be necessary for each party to disclose "Confidential
Information" to the other. For purposes of this Agreement,
"Confidential Information" is defined as all information, data and
know-how disclosed by one party (the "Disclosing Party") to the other
(the "Receiving Party"), either embodied in tangible materials
(including writings, drawings, graphs, charts, photographs,
recordings, structures, technical and other information) marked
"Confidential" or, if initially disclosed orally, which is reduced to
writing marked "Confidential" within 21 days after initial oral
disclosure, other than that information which is:
i) known by the Receiving Party at the time of its receipt, and not
through a prior disclosure by the Disclosing Party, as documented
by the Receiving Party's business records; or
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PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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ii) at the time of disclosure, or thereafter becomes, published or
otherwise part of the public domain without breach of this
Agreement by the Receiving Party; or
iii) obtained from a third party who has the legal right to make such
disclosure and without any confidentiality obligation to the
Disclosing Party; or
iv) independently developed by the Receiving Party without the use of
Confidential Information received from the Disclosing Party and
such independent development can be documented by the Receiving
Party; or
v) disclosed to governmental or other regulatory agencies in order
to obtain patents, provided that such disclosure may be made only
to the extent reasonably necessary to obtain such patents or
authorizations, and further provided that any such patent
applications shall be filed in accordance with the terms of this
Agreement; or
vi) required by law, regulation, rule, act or order of any
governmental authority to be disclosed.
b. The Receiving Party agrees that at all times and notwithstanding any
termination, expiration, or cancellation hereunder, it will hold the
Confidential Information of the Disclosing Party in strict confidence,
will use all reasonable safeguards to prevent unauthorized disclosure
by its employees and agents. Notwithstanding the foregoing, the
parties recognize that industry standards with respect to the
treatment of Confidential Information may not be appropriate in an
academic setting. However, MSSM agrees to retain Confidential
Information of AMICUS in the same manner and with the same level of
confidentiality as MSSM retains its own Confidential Information.
c. The Receiving Party will maintain reasonable procedures to prevent
accidental or other loss, including unauthorized publication of any
Confidential Information of the Disclosing Party. The Receiving Party
will promptly notify the Disclosing Party in the event of any loss or
unauthorized disclosure of the Confidential Information.
d. Upon termination or expiration of this Agreement, and upon written
request, the Receiving Party will promptly return to the Disclosing
Party all documents or other tangible materials representing
Confidential Information and all copies thereof.
e. The Receiving Party will immediately notify the Disclosing Party in
writing, if it is requested by a court order, a governmental agency,
or any other entity to disclose Confidential Information in the
Receiving Party's possession. The Disclosing Party will have an
opportunity to intervene by seeking a protective order or other
similar order, in order to limit or prevent disclosure of the
Confidential Information. The Receiving Party will disclose only the
minimum
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
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PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Confidential Information required to be disclosed in order to comply,
whether or not a protective order or other similar order is obtained
by the Disclosing Party.
7. Patent Rights.
a. If either party to this Agreement acquires information that a third
party is infringing one or more of the Patent Rights, the party
acquiring such information shall promptly notify the other party to
Agreement in writing of such infringement.
b. In the event of infringement of the Patent Rights, AMICUS shall have
the right, but not the obligation, to bring suit against the
infringer. Should AMICUS elect to bring suit against an infringer,
AMICUS shall be entitled to retain counsel of its own choosing, and
shall have the right to join MSSM as party plaintiff in any such suit.
Except as otherwise provided herein, the expenses of such suit or
suits that AMICUS elects to bring, shall be paid for entirely by
AMICUS and AMICUS shall hold MSSM free, clear and harmless from and
against any and all costs of such litigation, including attorneys'
fees. AMICUS shall not compromise or settle such litigation without
the prior written consent of MSSM which shall not be unreasonably
withheld.
c. If AMICUS shall undertake the enforcement or defense of the Patent
Rights by litigation, AMICUS may withhold royalties otherwise
thereafter due MSSM hereunder and apply the same toward reimbursement
of up to half of AMICUS's expenses, including reasonable attorney's
fees, in connection therewith, provided however that the maximum
amount that can be withheld each year shall not exceed 50% of
royalties due to MSSM in that year.
d. If AMICUS exercises its right to xxx, it shall first reimburse itself
out of any sums recovered in such suit or in settlement thereof for
all costs and expenses of every kind and character, including
reasonable attorneys' fees, necessarily involved in the prosecution of
any such suit, and if after such reimbursement, any funds shall remain
from said recovery, the amount of said funds shall be added to the
amount of Net Sales for the calendar quarter in which such recovery
was made.
e. If AMICUS does not bring suit against said infringer pursuant to
subsection b, above, or has not commenced negotiations with said
infringer for discontinuance of said infringement, within 90 days
after receipt of such notice, MSSM shall have the right, but not the
obligation, to bring suit for such infringement and to join AMICUS as
a party plaintiff, in which event MSSM shall hold AMICUS free, clear
and harmless from and against any and all costs and expenses of such
litigation, including attorneys' fees. In the event MSSM brings suit
for infringement of the Patent Rights, MSSM shall have the right to
first reimburse itself out of any sums recovered in such suit or
settlement thereof for all costs and expenses of every kind and
character, including reasonable attorneys' fees necessarily involved
in the prosecution of such suit, and if after such reimbursement, any
funds shall remain from said recovery, MSSM shall promptly pay to
AMICUS an amount equal to 50 percent of such remainder and MSSM
shall be entitled to receive and retain the balance of the remainder
of such recovery.
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TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
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PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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f. Each party shall have the right to be represented by counsel of its
own selection, at its sole expense, in any suit for infringement of
the Patent Rights instituted by the other party to this Agreement
under the terms hereof.
g. AMICUS shall cooperate fully with MSSM at the request of MSSM,
including, by giving testimony and producing documents lawfully
requested in the course of a suit prosecuted by MSSM for infringement
of the Patent Rights; provided MSSM shall pay all reasonable expenses
(including attorneys' fees) incurred by AMICUS in connection with such
cooperation. MSSM shall cooperate with AMICUS in the prosecution of a
suit by AMICUS for infringement of the Patent Rights, provided that,
except as otherwise provided in Section 7.f., AMICUS shall pay all
reasonable expenses (including attorneys' fees) involved in such
cooperation.
h. AMICUS shall, upon receipt of reasonable documentation, promptly
reimburse MSSM for all of the reasonable and customary fees and
expenses incurred by MSSM as of the Effective Date, which the parties
expect to be approximately $100,000, in the prosecution and
maintenance of the Patent Rights. In addition, AMICUS will reimburse
MSSM, within 30 days of the execution of this agreement, for
$100,000 in total payments to Xxxx-Xxxxx Feh and Xxxxxxx Xxxxx
pursuant to the letter of agreement dated March 24, 2000 between MSSM
and Xxxx-Xxxxx Feh and Xxxxxxx Xxxxx.
8. Patent Prosecution
a. MSSM is the owner of the Patent Rights. MSSM has retained Xxxxx and
Xxxxx, PC to prepare, file, prosecute, and maintain the pending patent
applications and issued patents comprising the Patent Rights.
b. MSSM shall maintain an attorney-client relationship with Xxxxx and
Xxxxx (or other patent counsel mutually agreed to by both parties
("Law Firm")) with respect to the Patent Rights. Nothing in this
agreement shall prevent Amicus from establishing an attorney client
relationship with Law Firm, except that nothing herein shall authorize
or permit Law Firm to take any action for, or on behalf of Amicus that
would be adverse to MSSM and/or involve a conflict of interest or a
violation of the Code of Professional Responsibility.
c. From and after the Effective Date, Law Firm will interact directly
with Amicus on all patent prosecution and patent maintenance matters
related to the Patent Rights. Amicus shall request that the Law Firm
send to MSSM:
i) Copies of any document pertaining to the ongoing prosecution
of the Patent Rights received from the U.S. Patent and Trademark
Office, within ten (10) business days after such receipt; and
ii) Copies of any document to be submitted to the U.S. Patent and
Trademark Office (or any other patent granting authority) in any
such patents or applications, at least ten (10) business days
prior to the date
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on which such document is mailed to such patent office or
granting authority and at least twenty (20) days prior to such
mailing date for responses to Patent Office action for which the
Patent and Trademark Office accords a response period of more
than thirty (30) days. Amicus shall request that Law Firm, using
their professional judgment, accept reasonable changes that MSSM
communicates to such counsel if such request for changes are
received by Amicus more than five (5) business days prior to the
date on which such document is due at the patent granting
authority. The time limits contained in this Section 8.c.ii shall
not apply if the application of the time allowed herein would
create an imminent bar to patentability.
d. Prior to abandoning prosecution of any of the Patent Rights (or to
abandoning any patent) covered by this Agreement, Amicus will:
i) Notify MSSM of its intention to abandon such patent or
application(s) at least twenty (20) days prior to the last date
for taking action to preserve such patent or applications(s);
ii) Permit Law Firm to continue prosecution and/or maintenance of
such patent or application at MSSM's sole expense.
e. Except as otherwise expressly provided herein, Amicus shall bear all
costs and fees incurred during the term of this Agreement in
connection with the filing, maintenance, prosecution, protection and
the like of the Patent Rights. Law Firm shall invoice AMICUS directly
for all work relating to the filing, prosecution and maintenance of
the Patent Rights and shall provide copies of all invoices to MSSM.
AMICUS will pay invoices directly to Law Firm and copy MSSM on each
payment.
f. If at any time during the term of this Agreement AMICUS decides that
it is undesirable, as to one or more countries, to prosecute or
maintain any patents or patent applications within the Patent Rights,
it shall give prompt written notice thereof to MSSM, and upon receipt
of such notice AMICUS shall be released from its obligations to bear
all of the expenses to be incurred thereafter as to such countries in
conjunction with such patent(s) or patent application(s). MSSM shall
be free to grant rights in and to the released patent or patent
applications in such countries to third parties, without further
notice or obligation to AMICUS, and AMICUS shall have no rights
whatsoever to exploit the released patents or patent applications in
such countries.
g. Notwithstanding the foregoing, MSSM reserves the absolute right to
countermand any instruction given by Amicus to Law Firm with respect
to the Patent Rights.
h. Nothing herein contained shall be deemed to be a warranty by MSSM that
the manufacture, use, or sale of any element of the Patent Rights or
any Licensed Product will not infringe any patent(s) of a third party.
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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.
12
9. Liability and Indemnification.
a. AMICUS shall indemnify, defend and hold harmless MSSM and its
trustees, officers, directors, medical and professional staff,
employees, students and agents and their respective successors, heirs
and assigns (the "Indemnitees"), against any liability, damage, loss
or expense (including reasonable attorneys' fees and expenses of
litigation) incurred by or imposed upon the Indemnitees or any one of
them in connection with any claims, suits, actions, demands or
judgments: (i) arising out of the production, manufacture, sale, use
in commerce or in human clinical trials, lease, or promotion by AMICUS
or by a licensee, Affiliate or agent of AMICUS of any Licensed
Product, process or service relating to, or developed pursuant to,
this Agreement, or (ii) arising out of any other activities to be
carried out pursuant to this Agreement.
b. AMICUS's indemnification under subsection a(i), above, shall apply to
any liability, damage, loss or expense whether or not it is
attributable to the negligent activities of the Indemnitees. AMICUS's
indemnification under subsection a (ii), above, shall not apply to any
liability, damage, loss or expense to the extent that it is
attributable to the negligence, gross negligence or intentional
misconduct of the Indemnitees.
c. AMICUS shall, at its own expense, provide attorneys reasonably
acceptable to MSSM to defend against any actions brought or filed
against any party indemnified hereunder with respect to the subject of
indemnity contained herein, whether or not such actions are rightfully
brought.
d. EXCEPT AS PROVIDED IN THIS SECTION 9, NEITHER PARTY SHALL BE LIABLE TO
THE OTHER FOR INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR
PUNITIVE DAMAGES.
10. Security for Indemnification.
a. At such time as any Licensed Product is being commercially distributed
or sold (other than for the purpose of obtaining regulatory approvals)
by AMICUS or by a sub-licensee, Affiliate or agent of AMICUS and to
the extent that it is available on commercially reasonable terms,
AMICUS shall at its sole cost and expense, procure and maintain
policies of comprehensive general liability insurance in amounts not
less than [***] per incident and [***] annual aggregate and naming the
indemnitees as additional insureds. Such comprehensive general
liability insurance shall provide (i) product liability coverage and
(ii) broad form contractual liability coverage for AMICUS's
indemnification under Section 9 of this Agreement. The minimum amounts
of insurance coverage required under this Section 10 shall not be
construed as a limit of AMICUS's liability with respect to its
indemnification under Section 9 of 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.
13
b. AMICUS shall provide MSSM with written evidence of such insurance upon
request of MSSM. AMICUS shall provide MSSM with written notice at
least 60 days prior to the cancellation, non-renewal or material
change in such insurance; if AMICUS does not obtain replacement
insurance providing comparable coverage within such 60 day period
effective immediately upon notice to AMICUS, MSSM shall have the right
to terminate this Agreement effective at the end of such 60 day period
without notice or any additional waiting periods.
c. AMICUS shall maintain such comprehensive general liability insurance
beyond the expiration or termination of this Agreement during: (i) the
period that any product, process or service, relating to, or developed
pursuant to, this Agreement is being commercially distributed or sold
(other than for the purpose of obtaining regulatory approvals) by
AMICUS or by a licensee, Affiliate or agent of AMICUS and (ii) a
reasonable period after the period referred to in (c)(i) above which
in no event shall be less than seven years.
11. Term and Termination.
a. This Agreement shall come into force as of the Effective Date. Unless
sooner terminated as provided herein, this Agreement shall expire on
the expiration of the last to expire of the Patent Rights.
b. At any time prior to expiration of the term of this Agreement either
party may terminate this Agreement forthwith for cause upon notice to
the other party. "Cause" for termination of this Agreement shall be
deemed to exist if either MSSM or AMICUS materially breaches or
defaults in the performance or observance of any of the provisions of
this Agreement and such breach or default is not cured within 60 days
or, in the case of failure to pay any amounts due hereunder, 30 days
(unless otherwise specified herein) after the giving of notice by the
other party specifying such breach or default, or if either MSSM or
AMICUS discontinues its business or becomes insolvent or bankrupt.
c. Any amount payable hereunder by one of the parties to the other, which
has not been paid by its due date of payment shall bear interest from
its due date of payment until the date of actual payment, at the rate
of two percent per annum in excess of the Prime Rate prevailing at the
Citibank, Inc., New York, New York, during the period of arrears and
such amount and the interest thereon may be set off against any amount
due, whether in terms of this Agreement or otherwise, to the party in
default by any non-defaulting party.
d. Upon termination of this Agreement for any reason, all rights in and
to the Patent Rights shall revert to MSSM.
e. Termination of this Agreement shall not relieve the parties of any
obligation occurring prior to such termination.
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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.
14
f. Sections 2e., 3e., 6, 9, 10 and 14 hereof shall survive and remain in
full force and effect after any termination, cancellation or
expiration of this Agreement.
12. Representation and Covenants
a. MSSM hereby represents, warrants, and covenants to AMICUS that it is a
corporation duly organized and validly existing under the laws of the
state or other jurisdiction of its incorporation or formation;
a. AMICUS hereby represents, warrants and covenants to the other party
hereto that it is a corporation duly organized and validly existing
under the laws of the state or other jurisdiction of its incorporation
or formation;
b. Each of MSSM and AMICUS hereby represents, warrants and covenants to
the other party hereto as follows:
i) the execution, delivery and performance of this Agreement by such
party has been duly authorized by all requisite corporate action;
ii) it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;
iii) the execution, delivery and performance by such party of this
Agreement and its compliance with the terms and provisions hereof is
not prohibited and does not and will result in a breach of any of the
terms and provisions of, or constitute a default under, (i) a loan
agreement, guaranty, financing agreement, agreement affecting a
product, or other agreement or instrument binding or affecting it or
its property; (ii) the provisions of its charter documents or bylaws;
or (iii) any order, writ, injunction or decree of any court or
governmental authority entered against it or by which any of its
property is bound;
iv) the execution, delivery and performance of this Agreement by such
party does not require the consent, approval, or authorization of, or
notice, declaration, filing or registration with, any governmental or
regulatory authority, and the execution, delivery or performance of
this Agreement will not violate any law, rule or regulation applicable
to such party;
v) this Agreement has been duly authorized, executed and delivered and
constitutes such party's legal, valid and binding obligation
enforceable against it in accordance with its terms subject, as to
enforcement, to bankruptcy, insolvency, reorganization and other laws
of general applicability relating to or affecting creditors' rights
and to the availability of particular remedies under general equity
principles; and
vi) it shall comply with all applicable material laws and regulations
relating to its activities 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.
15
vii) Each party represents that performance of all the terms of this
Agreement will not breach any agreement to keep in confidence
proprietary information acquired by a party prior to the
execution of this Agreement.
c. Except as otherwise expressly provided herein, MSSM hereby represents,
warrants and covenants to AMICUS that:
i) MSSM has the full right, power and authority to grant all of the
right, title and interest in the License; and
ii) there are no judgments or settlements against or owed by MSSM, or
any pending or threatened claims or litigation relating to MSSM's
interest in the Patent Rights; and
iii) MSSM has not granted to any other party any rights that would
conflict with the rights granted in this Agreement.
13. Assignment.
Neither party shall have the right to assign, delegate or transfer at any
time to any party, in whole or in part, any or all of the rights, duties
and interest herein granted without first obtaining the written consent of
the other party to such assignment, such consent not to be unreasonably
withheld; provided, however, that AMICUS may, with thirty (30) days prior
written notice to MSSM, assign its rights and delegate its duties under the
Agreement to the purchaser of substantially all of the assets of AMICUS,
provided that the assignee agrees in writing to be bound by all the terms
and conditions of this Agreement.
14. Use of Name.
Neither party may use the name of the other or its Affiliates in any
publicity or advertising. A party may issue a press release or otherwise
publicize or disclose this Agreement or the confidential terms and
conditions hereof only with the prior written consent of the other party.
15. Miscellaneous.
a. In carrying out this Agreement the parties shall comply with all
local, state and federal laws and regulations including but not
limited to, the provisions of Title 35 U.S.C.A. Section 200 et seq.
and 15 CFR Section 368 et seq.
b. If any provision of this Agreement is determined to be invalid or
void, the remaining provisions shall remain in effect.
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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.
16
c. This Agreement shall be deemed to have been made in the State of New
York and shall be governed and interpreted in all respects under the
laws of the State of New York. Any and all disputes hereunder shall be
brought and resolved solely in the courts of the State of New York in
and for the Borough of Manhattan.
d. All payments or notices required or permitted to be given under this
agreement shall be given in writing and shall be effective when either
personally delivered or deposited, postage prepaid, in the United
States registered or certified mail, addressed as follows:
To MSSM: Mount Sinai School of Medicine of New York University
Attention: W. Xxxxxxx XxXxxxx, Ph.D.
Xxx Xxxxxxx X. Xxxx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
Copy to: General Counsel (at the same address)
To AMICUS: Amicus Therapeutics, Inc.
c/o Collinson Xxxx & Xxxxxx, LLC
0000 Xxxxxxxxxx Xxxx.
Xxxxxxxx, XX 00000
Attention: Xxxxxxx Xxxxxxxx, MD
or such other address or addresses as either party may hereafter
specify by written notice to the other. Such notices and
communications shall be deemed to have been received by the addresses
on the date of delivery if personally delivered or 14 days after
having been sent by registered mail.
e. This Agreement and the exhibits attached hereto constitute the entire
Agreement between the parties with respect to the subject matter
hereof and no variations, modification or waiver of any of the terms
or conditions hereof shall be deemed valid unless made in writing and
signed by both parties hereto. This Agreement supersedes any and all
prior agreements or understandings, whether oral or written, between
AMICUS and MSSM.
f. No waiver by either party of any non-performance or violation by the
other party of any of the covenants, obligations or agreements of such
other party hereunder shall be deemed to be a waiver of any subsequent
violation or non-performance of the same or any other covenant,
agreement or obligation, nor shall forbearance by any party be deemed
to be a waiver by such party of its rights or remedies with respect to
such violation or non-performance.
g. The descriptive headings contained in this Agreement are included for
convenience and reference only and shall not be held to expand, modify
or aid in the interpretation, construction or meaning of this
Agreement.
h. It is not the intent of the parties to create a partnership or joint
venture or to assume partnership responsibility or liability. The
obligations of the parties shall
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PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
17
be limited to those set out herein and such obligations shall be
several and not joint.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first above written.
MOUNT SINAI SCHOOL OF MEDICINE AMICUS THERAPEUTICS, INC.
OF NEW YORK UNIVERSITY
By: /s/ Xxxxxx Xxxx By: /s/ Xxxxxxx Xxxxxxxx
--------------------------------- ------------------------------------
Name: Xxxxxx Xxxx, M.D. Name: Xxxxxxx X. Xxxxxxxx
-------------------------------
Title: Interim Xxxx Title: Chief Executive Officer
------------------------------
Date: 4-15-02 Date: April 15, 2002
-------------------------------
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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
AMENDMENT TO LICENSE AGREEMENT
DATED APRIL 15, 0000
XXXXXXX
XXXXX XXXXX XXXXXX XX XXX XXXX UNIVERSITY
AND AMICUS THERAPEUTICS INC.
Whereas the Mount Sinai School of Medicine of New York University (MSSM) and
Amicus Therapeutics Inc. (AMICUS) desire to make amendments to the License
Agreement between the two parties dated April 15, 2002.
NOW THEREFORE, IT IS HEREBY DECLARED AND AGREED BETWEEN THE PARTIES THAT THE
FOLLOWING AMENDMENTS TO THE LICENSE AGREEMENT BE EFFECTIVE AS OF ______________:
1. Under Section 1 (Definitions) the definition of "Patent Rights" shall be
amended to the following:
i. "Patent Rights" shall mean any issued patent or any patent to be
issued pursuant to any United States or foreign patent application
owned, by MSSM, listed in this subclause 1.i.(i)-(v) together with any
continuations in whole or in part, divisional or substitute patents,
any reissues or re-examinations of any such application or patents,
and any extension of the term of any such patent in the Field. The
issued patents and patent applications referred to in the preceding
sentence are:
i) U.S. Xxx. No. 6,274,597-"Method of Enhancing Lysosomal
AlphaGalA";
ii) U.S. Xxx. Applic. No. 09/604,053 (continuation in part)-
"Method of Enhancing Mutant enzyme activities in lysosomal
storage disease";
iii) U.S. Xxx. Applic. No. 09/926,285 (continuation of the '597
Patent; and
iv) U.S. Xxx. Applic. No. 09/948,348 (continuation of the '053
CIP Application.
v) U.S. Xxx. Applic. entitled "Screen for active site specific
chaperones for enhancing protein folding of mutant proteins"
filed on February 28, 2003.
vi) US provisional patent application entitled "Combination
Therapy For Treating Protein Deficiencies( )" filed on January
31, 2003
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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.
vii) US provisional patent application entitled "Combination
Therapy For Treating Protein Deficiencies" filed on February 18,
2003
All other terms and conditions of the License Agreement remain unchanged and in
full force and effect.
MOUNT SINAI SCHOOL OF MEDICINE AMICUS THERAPEUTICS, INC.
OF NEW YORK UNIVERSITY
By: /s/ Xxxxxxx X. Xxxxx By: /s/ Xxxxxx Xxxxxxx
--------------------------------- ------------------------------------
Name: Xxxxxxx X. Xxxxx, M.D. Name: Xxxxxx Xxxxxxx, Ph.D.
Title: Xxxx Title: President and CEO
Date: 3-13-03 Date: 4.8.2003
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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.
Execution Copy
MOUNT SINAI SCHOOL OF MEDICINE
Xxx Xxxxxxx X. Xxxx Xxxxx, Xxx Xxxx, XX 00000
April 8, 2004
Amicus Therapeutics, Inc.
000 X.X. Xxxxxxx Xxx
Xxxxx Xxxxxxxxx, XX 00000
Re: Agreement between Mount Sinai School of Medicine of New York University
("MSSM") and Amicus Therapeutics, Inc. ("AMICUS") dated as of April 15,
2002 (the "License Agreement)
Gentlemen:
This will confirm the agreement and understanding between MSSM and AMICUS
regarding an amendment to the License Agreement as follows:
1. The definition of "Conformational Diseases" contained in Section 1.d. of
the License Agreement is hereby amended in its entirety to read as follows:
"Conformational Diseases" shall mean any inherited or acquired human
disease in which at least a sub-population of the affected individuals have one
or more mutant proteins that results in impaired protein folding, stability,
degradation or sorting. Examples of Conformational Diseases include lysosomal
story diseases (including Fabry and Gaucher), Cystic Fibrosis, Long QT Syndrome,
Diabetes Insipidus, and Hypogonadism.
2. The definition of "Field" contained in Section 1.e. of the License
Agreement is hereby amended in its entirety to read as follows:
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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.
April 8, 2004
Page 2
"Field" shall mean the discovery, validation, development, application,
production or sale of Licensed Products: (i) for the prevention, diagnosis
and treatment of Conformational Diseases (ii) that are Chaperones to
improve the production and/or manufacturing of therapeutic proteins for the
treatment of Conformational Diseases which are therapeutic proteins
manufactured and sold by third parties, (iii) that are Chaperones
discovered and developed by AMICUS to improve the production and/or
manufacturing of therapeutic proteins for the treatment of diseases other
than Conformational Diseases which are therapeutic proteins manufactured
and sold by third parties, or (iv) that are Chaperones discovered and
developed by Amicus for administration with therapeutic proteins or gene
therapy constructs for the treatment of diseases other than Conformational
Diseases which gene therapy constructs or therapeutic proteins are
manufactured and sold by third parties.
3. Section 2.c ii) of the License Agreement is hereby amended in its entirety
to read as follows:
2.c. ii) the sub-license shall not be assignable, in whole or in part;
provided, however, that the sublicensee may, written notice to
MSSM, assign the sub-license in connection with a merger or
acquisition of the sub-licensee or the sale by the sublicensee of
substantially all of its assets;
4. Section 13 of the License Agreement is hereby amended in its entirety to
read as follows:
Neither party shall have the right to assign, delegate or transfer at any
time to any party, in whole or in part, any or all of the rights, duties
and interest herein granted without first obtaining the written consent of
the other party to such assignment, such consent not to be unreasonably
withheld; provided, however, that AMICUS may, with written notice to MSSM,
assign its rights and delegate its duties under the Agreement to a
successor in interest of AMICUS by virtue of merger or acquisition or to
the purchaser of substantially all of the assets of AMICUS, provided that
the assignee agrees in writing to be bound by all the terms and conditions
of this Agreement.
5. MSSM hereby confirms that "Contract Signature Payments" and "Third Party
Milestone Payments" as such terms are used in the License Agreement
excludes (i) payment or reimbursement for patent expenses incurred by
AMICUS, (ii) payment or reimbursement for the costs of research or
development conducted by AMICUS that is sponsored by third parties or (iii)
purchases by third parties of AMICUS securities.
6. Except as expressly modified by this Amendment, all terms and conditions of
the License Agreement shall remain in full force and effect.
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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.
April 8, 2004
Page 3
Please indicate your acceptance of and agreement with the foregoing in the space
provided below.
Very truly yours,
Mount Sinai School of Medicine
of New York University
By: Xxxxxxx X. Xxxxx
------------------------
Name: Xxxxxxx X. Xxxxx, M.D.
Title: Xxxx
ACCEPTED AND AGREED
Amicus Therapeutics, Inc.
By: /s/ Xxxxxx Xxxxxxx
------------------------
Name: Xxxxxx Xxxxxxx
Title: CEO
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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
AMENDMENT #3 TO LICENSE AGREEMENT
DATED APRIL 15, 0000
XXXXXXX
XXXXX XXXXX XXXXXX XX XXXXXXXX XX XXX XXXX UNIVERSITY
AND
AMICUS THERAPEUTICS, INC.
Whereas, on April 15, 2002, the Mount Sinai School of Medicine of New York
University (MSSM) and Amicus Therapeutics, Inc. (AMICUS) entered into that
certain License Agreement attached hereto as Annex "A";
Whereas, on April 1, 2003, the parties entered into that certain Amendment
attached hereto as Annex "B"; and
Whereas, on April 8, 2004, the parties entered into that certain Amendment
attached hereto as Annex "C";
NOW THEREFORE, IT IS HEREBY DECLARED AND AGREED BETWEEN THE PARTIES THAT THE
FOLLOWING AMENDMENTS TO THE LICENSE AGREEMENT BE EFFECTIVE AS OF OCTOBER 25,
2006:
1. The definition of "Chaperone" in Section 1c is hereby deleted and
Section 1c shall be left blank intentionally.
2. The definition of "Conformational Diseases" in Section 1d shall be amended
and restated to read in its entirety as follows:
d. "Conformational Diseases" shall mean any inherited or acquired human
disease in which affected individuals have at least one mutant allele
that results in impaired protein folding, stability, degradation, or
sorting of the encoded mutant protein.
3. The definition of "Field" in section 1e shall be amended and restated to
read in its entirety as follows:
e. "Field" shall mean the discovery, validation, development,
application, production or sale of Licensed Products for the
prevention, diagnosis and treatment of all human indications,
diseases and conditions.
4. Under Section 1 (Definitions) the definition of "Patent Rights" shall be
amended and restated to read in its entirety as follows:
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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
i. "Patent Rights" shall mean any issued patent or any patent application
owned by MSSM, listed in this subclause 1(i)-(xiii), together with any
continuations in whole or in part, divisional, or substitute patents, any
reissues or re-examinations of any such application or patents, any foreign
counterparts of any such application or patents, and any extension of the
term of any such patent in the Field. The issued patents and patent
applications referred to in the preceding sentence are:
i) U.S. Xxx. No. 6,274,597-"Method of Enhancing Lysosomal
Alpha-Galactosidase A"
ii) U.S. Xxx. No. 6,583,158 (continuation-in-part)-"Method of Enhancing
Mutant Enzyme Activities in Lysosomal Storage Disorders"
iii) U.S. Xxx No. 6,744,135 (continuation of the '597 patent)-"Method of
Enhancing Lysosomal Alpha-Galactosidase A"
iv) U.S. Xxx. No. 6,599,919 (continuation of the '053 CIP application)-
"Method of Enhancing Mutant Enzyme Activities in Lysosomal Storage
Diseases"
v) U.S. Xxx. No. 6,589,964 (continuation of the '919 patent)-"Method of
Enhancing Mutant Enzyme Activities in Lysosomal Storage Diseases"
vi. U.S. Xxx. No. 6,916,829 (continuation of the '919 patent)-"Method of
Enhancing Mutant Enzyme Activity in Gaucher Disease"
vii) U.S. Xxx. Applic. No. 10/868,133 (continuation of '135 patent)-
"Method of Enhancing Lysosomal AlphaGalA"
viii) Allowed U.S. Xxx. Applic. No. 10/989,258 (continuation of the 829
patent)-"Method for Enhancing Mutant Enzyme Activities in Gaucher
Disease"
ix) U.S. Xxx. Applic. No. 11/264,672 (continuation of the '258
application)-"Method for Enhancing Mutant Protein Activity"
x) U.S. Xxx. Applic. No. 10/377,179-"Screen for Active Site-Specific
Chaperones for Enhancing Protein Folding of Mutant Proteins"
xi) U.S. Xxx. Applic. No. 10/781,356-"Combination Therapy for Treating
Protein Deficiencies"
xii) U.S. Xxx. Applic. No. 11/317,404-"Stable Formulations of Purified
Protein"
2
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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. Section 2c(iii) shall be amended and restated in its entirety as follows:
iii) the sub-licensee shall be entitled to grant further sub-licenses,
provided that the sub-licensee complies with the obligations of AMICUS
under this Section 2c, Section 2d and all other provisions of this
Agreement relating to sub-licenses by AMICUS;
6. Section 3.a. shall be amended and restated in its entirety as follows:
In consideration of the grant of the License hereunder, subject to the
provisions of Section 3b, AMICUS shall pay to MSSM a royalty of (a) [***]
percent [***] on Net Sales of Core Licensed Products and (b) [***] percent
[***] on Net Sales of Non-Core Licensed Products. If AMICUS grants
sublicenses with respect to any Licensed Product pursuant to which AMICUS
receives any Non-Royalty Remuneration, then AMICUS shall pay to MSSM:
(i) [***] of Non-Royalty Remuneration in connection with any Core Licensed
Product;
(ii) [***] of Non-Royalty Remuneration in connection with any Non-Core
Licensed Product which relates to any of the conditions, indications
or diseases listed on Schedule I to this Amendment No. 3;
(iii) [***] of Non-Royalty Remuneration in connection with any Non-Core
Licensed Product (other than (ii) above) where the pertinent
sublicense occurs after three (3) years from the date of this
Amendment No. 3; and
(iv) [***] of Non-Royalty Remuneration in connection with any Non-Core
Licensed Product (other than (ii) above) where the pertinent
sublicense occurs within three (3) years from the date of this
Amendment No. 3.
As used in this Section 3:
"Contract Signature Payment" means license initiation fees and other up-front
payments made to AMICUS in connection with a sublicense or other similar
arrangement;
"Core Licensed Product" shall mean any Licensed Product: (i) for the
treatment of Conformational Diseases, including, but not limited to, Licensed
Products used as monotherapy for Conformational Diseases and Licensed
Products used in combination therapy with exogenously administered
therapeutic proteins for Conformation Diseases; (ii) discovered and developed
by Amicus for use in combination therapy with exogenously administered
therapeutic proteins or gene constructs for the treatment of diseases other
than Conformational Diseases; (iii)
3
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
addressing the production, formulation, or storage of therapeutic proteins
manufactured by third parties for the treatment of Conformational Diseases
and (iv) discovered and developed by Amicus to address the production,
formulation, or storage of therapeutic proteins manufactured by third
parties for the treatment of diseases other than Conformational Diseases.
"Maintenance Fees" means payments (such as annual minimum royalties) made
by sublicensees to AMICUS to preserve, or to avoid a forfeiture of rights
under, the sublicense agreement;
"Non-Core Licensed Product" shall mean any Licensed Product other than a
Core Licensed Product. Non-Core Licensed Products include, but are not
limited to, Licensed Products which are not for the treatment of
Conformational Diseases, but are administered to increase the activity of
endogenous wide-type proteins;
"Non-Royalty Remuneration" means all remuneration, other than royalties,
received by AMICUS, including, but not limited to, Contract Signature
Payments, Third Party Milestone Payments and Maintenance Fees, but
excludes:
(i) payment or reimbursement for patent expenses incurred by
AMICUS;
(ii) payment or reimbursement for the costs of research or
development conducted by AMICUS that is sponsored by third
parties; or
(iii) purchases by third parties of AMICUS securities; and
"Third Party Milestone Payments" means payments made to AMICUS upon
fulfillment by AMICUS or the sublicense of designated development
objectives or regulatory requirements.
With respect to any sublicensing or other transaction to which this Section
3. applies but which relates to products and services in addition to
Licensed Products and for which an allocation would be necessary, the
parties shall meet and attempt to agree on which portion of the total
payments received by AMICUS pursuant to such transaction would be subject
to this Section 3.. If the parties cannot agree to such allocation within a
reasonable period of time, AMICUS shall select a nationally recognized
independent certified public accountant, which meets MSSM's approval, to
determine such allocation. Such allocation shall be governed by generally
accepted accounting principles in the United States.
7. Section 3.b. shall be amended and restated in its entirety as follows:
If AMICUS is required to acquire one or more licenses from third parties to
make, use or sell a Licensed Product such that aggregate royalties payable
by AMICUS
4
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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
on Net Sales (including the royalty due to MSSM pursuant to Section 3.a)
exceeds [***] percent [***], then AMICUS shall be entitled to a credit
against the royalty payments due to MSSM pursuant to Section 3.a equal to
[***] percent [***] of the amount of such excess; provided, however, that
in no event shall the amount otherwise payable to MSSM be reduced to less
than [***] percent [***] of Net Sales.
8. Except as expressly modified by this Amendment, all terms and conditions of
the License Agreement shall remain in full force and effect.
MOUNT SINAI SCHOOL OF MEDICINE AMICUS THERAPEUTICS, INC.
OF NEW YORK UNIVERSITY
By: /s/ Xxxxxxx X. Xxxxx By: /s/ Xxxxxx X. Xxxxxx
---------------------- --------------------
Name: Xxxxxxx X. Xxxxx, M.D. Name: Xxxxxx X. Xxxxxx
----------------------
Title: Xxxx Title: Interim President and CEO
----------------------
Date: Oct 25, 2006 Date: 10/24/06
----------------------- --------------------
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PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
SCHEDULE I
NON-CORE LICENSED PRODUCTS
i. NEUROLOGICAL DISORDERS:
- Neurological disorders and their corresponding wild-type protein targets:
- Xxxxxxxxx'x disease and glucocerebrosidase;
Xxxxxxxxx'x disease shall include (i) any pre-Xxxxxxxxx'x
condition in which there is, or is the potential for,
(alpha)-synuclein accumulation; (ii) diagnosed Xxxxxxxxx'x; and
(iii) any other condition associated with
(alpha)-synucleinopathies or abnormal presence or amount of
(alpha)-synuclein.
- Xxxxxxx-Pick Type C Disease and glucocerebrosidase;
- Alzheimer's disease and (alpha)-secretase; and
- Alzheimer's Disease and Pin1.
Alzheimer's Disease shall (i) any pre-Alzheimer's condition in
which there is, or is the potential for (Beta)-amyloid
accumulation; (ii) treatment of diagnosed Alzheimer's; and (iii)
any other condition associated (Beta)-amyloidoses or or abnormal
presence or amount of (Beta)-amyloid.
ii. CANCER:
- Cancer and Phosphotase and Tensin Homolog (PTEN).
Cancer shall include (i) any pre-cancerous condition in which
there is the potential for cancer to develop, including but not
limited to Xxxxxx disease and Xxxxxxxx-Xxxxxx Syndrome; (ii)
diagnosed cancer; and (iii) any other cancer that would benefit
from increased activity of PTEN.
iii. CARDIOVASCULAR DISEASE:
- Hyperlipidemia and lipoprotein lipase.
a. Hyperlipidemia includes (i) any pre-condition in which there
is the potential for hyperlipidemia to develop; (ii) any
condition in which hyperlipidemia is manifest.
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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
THE INDICATIONS COVERED BY THE NON-CORE LICENSED PRODUCTS INCLUDE NON-
CORE INDICATIONS FALLING INTO THE FOLLOWING CATEGORIES:
a. Individuals having no mutated proteins but in whom it would be beneficial
to increase the activity of specific wild-type proteins which are already
expressed.
i. e.g. glucocerebrosidase in Xxxxxxxxx'x patients who do not have any
mutant alleles
ii. glucocerebrosidase in Xxxxxxx-Pick Type C in patients who do not have
any mutant alleles
b. Individuals having heterozygous, non-conformational mutations (i.e., on one
allele), resulting in decreased levels of a protein, who would benefit by
increasing activity of the protein expressed from the wild-type allele.
i. e.g., Xxxxxxxxx'x in patients have a mutation in GCase on one allele,
but which mutation is not a "conformational mutation" and where the
patients do not have Gaucher disease
7
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FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
