<PAGE>
Exhibit 10.6
EXCLUSIVE LICENSE AGREEMENT
between
NOVO NORDISK A/S, Novo Alle, 2880 Bagsvaerd, Denmark - Danish
company
identification number CVR 24 25 67 90 (hereinafter referred to as
"NOVO
NORDISK")
and
AMICUS THERAPEUTICS, Inc., 675 U.S. Highway One, North Brunswick,
NJ 08902, USA
(hereinafter referred to as "AMICUS THERAPEUTICS").
Hereinafter individually referred to as "Party" and collectively as
"Parties";
WITNESSETH:
WHEREAS, AMICUS
THERAPEUTICS is involved in development of small molecule
enzyme chaperones for treatment of genetic and metabolic
diseases;
WHEREAS, NOVO
NORDISK is the owner of certain Intellectual Property Rights
relating to glycogen phosphorylase inhibitors, its use and in
particular patent rights relating to a specific glycogen
phosphorylase inhibitor NN4201;
WHEREAS, NOVO
NORDISK wishes to license to AMICUS THERAPEUTICS such
Intellectual Property Rights; and
WHEREAS, AMICUS
THERAPEUTICS wishes to acquire a license to such Intellectual
Property Rights from NOVO NORDISK;
NOW, THEREFORE, the Parties agree as follows:
1.
BACKGROUND
1.1 As of the
Effective Date and upon the terms and subject to the conditions
of
this Agreement, NOVO NORDISK agrees to grant to AMICUS
THERAPEUTICS, and
AMICUS THERAPEUTICS
agrees to acquire from NOVO NORDISK, a license to the
Intellectual Property Rights (as further defined in Article 2.1.9
below),
free
of any and all security interests, options or other third party
rights
(including but not limited to rights of pre-emption and royalties)
of any
nature what so ever.
2.
DEFINITIONS
2.1 For the purpose of
this Agreement, the following terms shall have the
following meanings in this Exclusive License Agreement and its
appendices:
2.1.1 "Affiliate" means any company, corporation, or other business
entity
which controls, is controlled by, or is under common control with,
a
Party hereto.
[***] 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.
1
<PAGE>
"Control," including the terms "controlled by" or "under common
control with," shall mean (a) in the case of corporate
entities,
direct or indirect ownership of stock or shares having the power
to
elect a majority of directors or similar body which governs the
affairs of such corporate entity; and b) in the case of
non-corporate
entities, direct or indirect ownership of equity interest with
the
power to direct the management and policies of such
non-corporate
entities.
2.1.2 "Agreement" shall mean this Exclusive License Agreement
including its
appendices.
2.1.3 "Analogue" shall mean any chemical structure that is a
structural
homolog
to, or derived from, the Compound and is covered by NOVO
NORDISK Intellectual Property Rights.
2.1.4 "Annual Net Sales" means the gross invoice price of the
Licensed
Product per year sold by AMICUS THERAPEUTICS, its Affiliates or
sublicensees to independent Third Party customers in bona fide
arms-length transactions, less the following deductions:
(a) trade, cash and/or
quantity discounts actually taken;
(b) sales taxes, use
taxes, tariffs, customs duties and value added
or other taxes;
(c) Outbound
transportation prepaid or allowed;
(d) refunds, rebates,
allowances, credits or returns, including
amounts repaid or credited by reason of rejections, return of
goods or retroactive price reductions.
For Annual Net Sales of a Licensed Product sold or supplied as
a
Combination, the Annual Net Sales of such a Combination in a
country
shall be determined as follows:
A) by multiplying the Annual Net Sales of the Combination by
the
fraction A/(A+B), where A is the invoice price of the Licensed
Product
in that country if sold separately and B is the total invoice price
of
any other active component or components in the Combination in
that
country if sold separately; or If the Licensed Product and the
other
active component or components in the Combination are not sold
separately, the Annual Net Sales, for purposes of determining
royalties on the Combination, will be calculated by multiplying
the
Annual Net Sales of the Combination by the fraction determined
by
mutual agreement of the Parties, that reflects the relative
contribution in value that the Licensed Product contained in
the
Combination makes to the total value of such Combination to the
end
user.; and
B) if the Licensed Product contained in the Combination is not sold
in
that country in a vial, the Parties shall negotiate in good faith
the
value of the cartridge or prefilled device and/or other
biologically
active pharmaceutical(s) to be deducted from the Annual Net Sales
of
the Combination.
2.1.5 "Combination" means A) where a Licensed Product is sold or
supplied
as a pharmaceutical product containing, in addition to the
Licensed
Product, one or more biologically active pharmaceuticals which are
not
a Licensed
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL
TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
2
<PAGE>
Product, and/or B) where the Licensed Product is sold or
supplied
incorporated in a cartridge or prefilled device.
2.1.6 "Compound" shall refer specifically to the compound
identified as NNC
42-1001 or NN4201 having the systematic name (2R, 3R,
4R)-2-hydroxymethyl-pyrrolidine-3,4-diol. The IUPAC name for
the
tartaric salt of this compound is (2R, 3R,
4R)-3,4-dihydroxy-2-hydroxymethyl)pyrrolidinum
(2S,3S)-3-carboxy-2,3-dihydroxy-propanoate.
2.1.7 "Effective Date" shall mean the date of the last signature to
this
Agreement.
2.1.8 "Field" shall mean any and all human therapeutic or
diagnostic
indications.
2.1.9 "Intellectual Property Rights" shall mean discoveries,
know-how, data
and technical information owned and controlled by NOVO NORDISK
related
to the NOVO NORDISK proprietary information, patents and patent
applications delineated in Appendix A (and in respect of Patent
Cooperation Treaty applications, European Patent Convention
applications or applications under similar administrative
international conventions, patent applications in the listed or
designated countries), as well as any and all patents derived
from
these patents and patent applications, including selection
patents,
continuations, continuations-in-part, continued prosecutions
applications, divisionals, reissues, re-examinations, renewals,
or
extensions, of the listed patent rights or any legal equivalent
thereof which have been or may be filed in any country for the
full
term or terms for which the same may be granted. Extensions
shall
include: (a) extensions under U.S. Patent Term Restoration Act;
(b)
extensions under Japanese Patent Law; (c) Supplementary
Protection
Certifications (SPCs) according to Council Regulation (EEC) No
1768/92
for members of the European Patent Convention and other countries
in
the European Economic Area, and (d) similar extensions under
applicable law anywhere in the world.
2.1.10 "Licensed Product(s)" shall mean any compound including but
not
limited to Compound, which is made, used, sold or offered for
sale
and/or imported in at least one country as a human therapeutic
and
that (a) is identified, discovered, made or developed, by
AMICUS
THERAPEUTICS for the benefit or on behalf of any Third Party, using
a
method covered by a Valid Claim of the Intellectual Property
Rights,
or (b) reasonably could not have been identified, discovered,
made,
used, developed, imported, offered for sale or been sold by
AMICUS
THERAPEUTICS but for the Intellectual Property Rights, or (c)
is
otherwise covered by a Valid Claim of the Intellectual Property
Rights
and would, in the absence of the License granted under this
Agreement,
infringe any Valid Claim. For the avoidance of doubt, Licensed
Product
includes compounds as described in the preceding sentence which
are
being made for and/or used in clinical trials in humans for the
purpose of obtaining regulatory approval for use as an human
therapeutic. Licensed Product also includes any Replacement
Product(s)
that may
be developed under the Agreement.
2.1.11 "NOVO NORDISK Data" as used herein, shall mean all NOVO
NORDISK
scientific and clinical/regulatory data relating to the use of
Compound in humans.
2.1.12 "Replacement Product" shall mean any Licensed Product which
is a
replacement for the Licensed Product or a potential Licensed
Product.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL
TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
3
<PAGE>
2.1.13 "Territory" shall mean all countries in the world.
2.1.14 "Third Party", as used herein, shall mean all individuals
or
entities other than NOVO NORDISK and AMICUS THERAPEUTICS and any
of
their respective Affiliates and/ or sublicensees.
2.1.15 "Valid Claim" shall mean a claim of any unexpired patent or
patent
application within Intellectual Property Rights so long as such
claim
shall not have been held invalid or unenforceable in a final
decision
rendered by tribunal of competent jurisdiction from which no
appeal
has been or can be taken.
3.
CONSIDERATIONS AND GRANT OF RIGHTS
3.1 NOVO NORDISK
hereby grants to AMICUS THERAPEUTICS and its Affiliates an
exclusive, worldwide, royalty-bearing license, with right to
sublicense
without restriction (provided that AMICUS THERAPEUTICS and its
Affiliates
remain responsible for the performance of their sublicensees),
under the
Intellectual Property Rights, to use, develop, promote,
manufacture, have
manufactured, market, register, package, distribute, sell, offer
for sale,
have
sold, import, export and otherwise commercialize Licensed Products
in
the
Field throughout the Territory (the "License"). NOVO NORDISK
hereby
also
grants to AMICUS THERAPEUTICS the exclusive right and license to
use
the
NOVO NORDISK Data in connection with regulatory filings with the
U.S.
Food
and Drug Administration and other comparable international
regulatory
bodies for approval of the Licensed Products.
3.2 If NOVO NORDISK
determines, after consultation with AMICUS THERAPEUTICS,
that
NOVO NORDISK controls or owns other Intellectual Property Rights as
of
the
Effective Date, that are necessary for the development, use or
manufacture of Licensed Products, then NOVO NORDISK shall to the
extent
legally possible include such other Intellectual Property Rights in
the
License granted under Article 3.1. If any such other Intellectual
Property
Rights are included in the License after the Effective Date, these
shall be
added to Appendix A together with the date for addition of
them.
3.3 In consideration
of the License granted hereunder to AMICUS THERAPEUTICS
and
its Affiliates, AMICUS THERAPEUTICS, its Affiliates or its
sublicenses
agree to pay to NOVO NORDISK the milestone payments and royalties
set forth
in
this Article 3.3 and Article 3.4.
a)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after the Effective Date into an account in the
bank
defined in Article 3.5.
b)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after the IND filing in the US for each
indication.
c)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after initiation of a Phase III clinical trial (the
date
of the Investigator's meeting) in the US for each indication.
d)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after filing of an NDA in the US for each
indication.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL
TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
4
<PAGE>
e)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after filing with EMEA for each indication.
f)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after filing for regulatory approval in Japan for
each
indication.
g)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after regulatory approval in the US for each
indication.
h)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after regulatory approval in EMEA for each
indication.
i)
A total of [***]
USD [***] to be paid in full no later than fifteen
business days after regulatory approval in Japan for each
indication.
The
above milestone payments shall be payable once for the first
Licensed
Product achieving these milestones for an indication. AMICUS
THERAPEUTICS
shall also make milestone payments to NOVO NORDISK for each
Replacement
Product developed by AMICUS THERAPEUTICS and/or a sublicensee
achieving
milestones (d) through (i) for an indication, provided that each
milestone
payment amount shall be reduced by [***]. For the purposes of
determining
the
satisfaction of these milestones, the category of diseases known
as
lysosomal storage diseases, and all classes of diseases within
such
category, shall be counted collectively as one indication
(provided,
however, that such disease is an orphan drug indication (US)), and
all
other human diseases shall each be counted individually as one
indication.
3.4 Royalties will be
payable by AMICUS THERAPEUTICS, its Affiliates or its
sublicensees to NOVO NORDISK on a product to-by product and country
by
country basis until the last to expire of the NOVO NORDISK
Intellectual
Property Rights claiming the making, using, selling, offering to
sell
and/or import of such Licensed Product in such country. The Royalty
rates
shall be according to the following:
[table begins on next page]
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL
TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
5
<PAGE>
Table 1
<TABLE>
<CAPTION>
LICENSED PRODUCT DESCRIPTION
ANNUAL NET SALES
ROYALTY
----------------------------
------------------------------------------- -------
<S>
<C>
<C>
Has Compound as an active component and the indication
$25 million or less
[***]%
is a lysosomal storage disease or other orphan drug (US)
> $25 million
but less than or equal to $50 [***]%
indication:
million
> $50 million but less than or equal to
[***]%
$100 million
> $100 million
[***]%
Has Compound as an active component and the indication
$25 million or less
[***]%
is other than a lysosomal storage disease or other
> $25 million but less than or equal to $50 [***]%
orphan drug (US) indication:
million
> $50 million but less than or equal to
[***]%
$100 million
> $100 million
[***]%
Has an Analogue of the Compound as an active component
$25 million or less
[***]%
and the indication is a lysosomal storage disease or >
$25 million but less than or equal to $50 [***]%
other orphan drug (US) indication:
million
> $50 million but less than or equal to
[***]%
$100 million
> $100 million
[***]%
Has an Analogue of the Compound as an active component
$25 million or less
[***]%
and the indication is other than a lysosomal storage >
$25 million but less than or equal to $50 [***]%
disease or other orphan drug (US) indication:
million
> $50 million but less than or equal to [***]%
$100 million
> $100 million
[***]%
Has neither the Compound nor an Analogue thereof as an
$100 million or less
[***]%
active component:
> $100 million
[***]%
</TABLE>
Notwithstanding the foregoing, if (a) AMICUS THERAPEUTICS and/or
its
Affiliates (and/or appertaining sublicensees, as the case may be)
is
required to obtain from any Third Party that is not an Affiliate or
a
sublicensee any licenses and/or sublicenses for patent rights in
order to
practice NOVO NORDISK Intellectual Property Rights in the Field or
in order
to
develop, make, have made, use, import, offer for sale, sell,
import,
export or provide Licensed Products (including, without limitation,
as a
result of any claim referred to in subsection (b)), or (b) any
claim is
made
against AMICUS THERAPEUTICS and/or its Affiliates (and/or
appertaining
sublicensees, as the case may be) alleging that the practice of the
NOVO
NORDISK Intellectual Property Rights in the Field infringes any
Third Party
patent rights, then AMICUS THERAPEUTICS and/or its Affiliates
(and/or
appertaining sublicensees, as the case may be) shall be entitled to
credit,
in
the case of subsection (a), any payment by AMICUS THERAPEUTICS
and/or
its
Affiliates (and/or appertaining sublicensees, as the case may be)
of
additional running royalties to such Third Party(ies), if any, on
Licensed
Products, and, in the case of subsection (b), [***] of any
reasonable costs and expenses
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL
TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
6
<PAGE>
(including, without limitation, attorneys' fees, but excluding
any
judgments or any settlements in connection with such claims)
incurred by
AMICUS THERAPEUTICS
and/or its Affiliates (and/or appertaining
sublicensees, as the case may be) in connection with any such
infringement
claim against the running royalty for the subject Licensed
Products, in the
appertaining country(ies) during the appertaining time period.
However, not
withstanding the above the minimum royalty payable by AMICUS
THERAPEUTICS
and
its Affiliates and sublicensees to NOVO NORDISK shall never be
reduced
below [***] of the royalties set forth in this Article 3.4, Table 1
and
which are payable for Licensed Product in the specific country or
countries
in
question.
3.5 All payments
required under this Agreement shall be made in US Dollars to
the
following bank account or to such account as NOVO NORDISK may,
from
time
to time, notify AMICUS THERAPEUTICS in writing:
Danske Bank,
Copenhagen
Account number: [***] send via the correspondent bank:
Bank
of America N.A.
New
York
SWIFT code: BOFAUS3N.
3.6 Royalty
Accounting. The tiered royalties under this Agreement shall be
paid
quarterly but calculated on an annual basis. Only a single royalty
rate
shall be applicable in any given year and that rate will be
determined by
the
total Annual Net Sales. An adjustment to prior quarters in any
given
year
shall be made in any subsequent quarter of the same year in which
a
threshold in a higher royalty bracket has exceeded. A yearend
adjustment
will
be made, if a royalty threshold is exceeded in the fourth
quarter.
3.7 Payments and
Reports. Royalties payable pursuant to this agreement shall be
due
quarterly within forty five (45) days following the end of each
calendar quarter for Annual Net Sales in such calendar quarter. All
sales
in
foreign currencies shall be converted into United States dollars
using
the
rate of exchange quoted by Bank of America and its successor(s) on
the
last
business day of the calendar quarter in which the sales were
made.
Each
such payment shall be accompanied by a statement of Annual Net
Sales
for
the quarter (including number of units), applicable exchange rates
and
the
calculation of royalty payable hereunder by Licensed Product
and
country. AMICUS THERAPEUTICS shall keep and shall cause its
Affiliates and
sublicensees to keep complete, true and accurate records for at
least five
(5)
years for the purpose of showing the derivation of all
milestone
payments and royalties payable under this Agreement.
3.7.1 NOVO NORDISK duly accredited representatives, which are
reasonably
acceptable to AMICUS THERAPEUTICS, shall have the rights to
inspect
and audit such records at any time with reasonable prior notice
to
AMICUS THERAPEUTICS or any of its Affiliates or sublicensees, but
such
right will not be exercised more often than once a year.
3.7.2 Any adjustment required as a result of an audit conducted
under this
Article shall be made within thirty (30) days after the date on
which
NOVO NORDISK completed the audit. In the event of an underpayment
by
AMICUS THERAPEUTICS, its Affiliates and/or sublicensees, AMICUS
THERAPEUTICS shall pay to NOVO NORDISK the amount underpaid
plus
interest (calculated on a daily basis) on the overdue payment from
the
date such payment was due to the date of actual payment an annual
rate
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL
TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
7
<PAGE>
equal to the discount rate ("diskontoen") of the Danish National
Bank
plus 2% (two percent). In case of overpayment by AMICUS
THERAPEUTICS,
ifs Affiliates and/or sublicensees, AMICUS THERAPEUTICS may, at
its
option, offset any future royalty payments payable to NOVO NORDISK
by
the amount of the overpayment. Each Party shall have five (5)
years
after receipt by NOVO NORDISK of any royalty paid by AMICUS
THERAPEUTICS, its Affiliates and/or sublicenses pursuant to
this
Agreement to dispute the amount of any such royalty payment.
3.8 Transfer of NOVO
NORDISK Data. NOVO NORDISK will transfer, and will
instruct its contractors about transfer, of NOVO NORDISK Data to
AMICUS
THERAPEUTICS after
AMICUS THERAPEUTICS has given NOVO NORDISK a written
notice that AMICUS wishes to receive such NOVO NORDISK Data. NOVO
NORDISK's
obligations on transfer of data will cease six (6) months after
the
Effective Date. After this date NOVO NORDISK will in good faith
consider
fulfilling requests from AMICUS THERAPEUTICS regarding
additional
information. NOVO NORDISK will charge AMICUS THERAPEUTICS the
costs
associated with such requests at a cost basis. The contact person
at NOVO
NORDISK will be head of Scientific Licensing, Pierre Honore
(pfh@novonordisk.com).
3.9 AMICUS
THERAPEUTICS shall deliver a written annual report on each
anniversary of the Effective Date covering the preceding year
regarding the
status of the NOVO NORDISK Intellectual Property Rights and the
Licensed
Products identified, discovered or developed fully or partly
through the
use
of Intellectual Property Rights by AMICUS THERAPEUTICS. Such
annual
report shall include, as a minimum; (a) identification by code
number of
Licensed Products identified, discovered or developed, using a
method
covered in whole or in part by the Intellectual Property Rights, or
which
reasonably could not have been identified, discovered or developed
but for
the
Intellectual Property Rights or which are otherwise covered by
the
Intellectual Property Rights, unless AMICUS THERAPEUTICS
provides
contemporaneous written evidence to NOVO NORDISK that such
identification,
discovery or development took place before the date of issue or
grant of
relevant Intellectual Property Rights; (b) the status of any
submissions to
a
regulatory agency in any country concerning Licensed Product;
the
identity of Third Parties that AMICUS THERAPEUTICS has granted
sublicensees
to
under this agreement to; and, (c) such additional
