Exhibit 10.5
EXCLUSIVE LICENSE AGREEMENT
between
NOVO NORDISK A/S, Xxxx Xxxx, 0000 Xxxxxxxxx, Xxxxxxx - Danish company
identification number CVR 24 25 67 90 (hereinafter referred to as "NOVO
NORDISK")
and
AMICUS THERAPEUTICS, Inc., 000 X.X. Xxxxxxx Xxx, Xxxxx Xxxxxxxxx, XX 00000, XXX
(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.
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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.
1
"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
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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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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, 0X,
0X)-0,0-xxxxxxxxx-0-xxxxxxxxxxxxx)xxxxxxxxxxxx
(0X,0X)-0-xxxxxxx-0,0-xxxxxxxxx-xxxxxxxxxx.
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.
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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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2.1.13 "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.
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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]
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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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Table 1
LICENSED PRODUCT DESCRIPTION ANNUAL NET SALES ROYALTY
---------------------------- ------------------------------------------- -------
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 [***]%
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.
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(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: XXXXXX0X.
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.
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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, Xxxxxx Xxxxxx
(xxx@xxxxxxxxxxx.xxx).
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 material as NOVO
NORDISK may reasonably request. NOVO NORDISK shall maintain the
confidentiality of all such reports and shall not use the information
therein for any purpose other than determining compliance of AMICUS
THERAPEUTICS with the terms of this Agreement.
3.10 The AMICUS THERAPEUTICS contact person responsible for communicating with
the NOVO NORDISK under the reporting requirements of this Agreement shall
be the same as is given in Article 16 (NOTICES), unless AMICUS THERAPEUTICS
designates otherwise to NOVO NORDISK in writing.
3.11 All payments due under this Agreement shall be made without deduction other
than such amount as AMICUS THERAPEUTICS is required to deduct or withhold
by law. When making any payment due under this Agreement, AMICUS
THERAPEUTICS shall also pay any value added (or similar) tax which is
payable. The sums payable by AMICUS THERAPEUTICS are non-creditable and
non-refundable. The previous sentences of this Article notwithstanding,
each Party undertakes to cooperate with the other Party to achieve the tax
arrangements that are most favourable for both Parties.
3.12 In the event of any delay in effecting the payments due under this
Agreement by the due date, AMICUS THERAPEUTICS, its Affiliates and
sublicensees agree to pay
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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to NOVO NORDISK 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 equal to the discount rate ("diskontoen") of the Danish
National Bank plus 2% (two percent).
3.13 Under a purchase order separate from this Agreement, AMICUS THERAPEUTICS
shall purchase and NOVO NORDISK shall sell and deliver to AMICUS
THERAPEUTICS, [***] kg of the Compound, at a price of $[***] per gram. Such
delivery shall be shipped no later than fifteen (15) calendar days after
receipt of the purchase order. Payment terms and other terms for use of the
Compound shall be established in such purchase order. NOVO NORDISK may
require that a Materials Transfer Agreement is entered into in connection
with such purchase.
4. CONFIDENTIALITY
4.1 Neither Party shall publish, disclose or commit to any Third Party any
information in whatever form concerning this Agreement and the license
granted hereunder, nor shall it make any reference to this Agreement to any
Third Party for five (5) years from the date of termination or expiration
of this Agreement without the prior written consent of the other Party.
4.2 All information disclosed by one Party ("Disclosing Party") to the other
Party ("Recipient") in oral, visual, written, or electronic form hereunder,
including but not limited to, any technical or non-technical information
concerning technical processes, specifications, instrumentation, chemical
formulae, assays, techniques, sales and marketing information, material, or
data related to this Agreement, ("Information"), shall be kept strictly
confidential and shall not be disclosed by Recipient to any Third Party
without the prior written and express consent of the Disclosing Party.
Information disclosed in oral form shall be deemed Confidential Information
only to the extent that it has been confirmed in writing to Disclosing
Party and marked "confidential" within 30 (thirty) days after the date of
oral disclosure.
4.3 Recipient shall not use the Information for any other purpose than
performing its obligations under this Agreement; however AMICUS
THERAPEUTICS shall be entitled to use Information for any regulatory
purposes, including clinical trials.
4.4 The obligations of confidentiality described above in Articles 4.1 - 4.3
shall not apply to
a) Information, which at the time of disclosure is already in the public
domain;
b) Information, which, after disclosure, becomes part of the public
domain through no violation of this Agreement;
c) Information, which Disclosing Party is able to prove has been
disclosed to Recipient and which Recipient is able to prove has been
in its possession of prior to disclosure. In this case, Recipient
shall, in writing and within forty-five (45) days from the date of
disclosure, demonstrate to the satisfaction of the Disclosing Party
that it was in possession of such Information;
d) Information, which is hereafter lawfully disclosed by a Third Party to
the Recipient, which Information such Third Party did not acquire
under a still effective obligation of confidentiality to the
disclosing Party;
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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e) Information, which can be demonstrated as independently developed or
acquired by Recipient without reference to or reliance upon
confidential Information defined in this Agreement, and as evidenced
by Recipient's written records;
f) Information disclosed to the extent required by law or regulation
provided that Recipient shall give the Disclosing Party prompt written
notice and sufficient opportunity to object, time permitting, to such
disclosure.
4.5 Notwithstanding the foregoing, Recipient may disclose Information of the
Disclosing Party to reliable employees, consultants and agents if necessary
for exploiting the license granted under this Agreement or for a Party in
order to fulfil its obligations under this Agreement, provided that such
persons are bound by obligations of confidentiality and non-use to
Recipient which are equal to the terms of this Agreement. Recipient shall
ensure that such employees, consultants and agents be fully aware of the
obligations of this Agreement and shall be responsible for any breach of
these provisions by its employees, consultants and agents. Further, AMICUS
THERAPEUTICS may disclose information relating to, or embodied by, NOVO
NORDISK Intellectual Property Rights, as well as NOVO NORDISK Data to:
manufacturing, distribution, marketing, co-development or other strategic
or corporate partners or vendors, potential sublicensees, investors, board
members, investment bankers, provided that such persons or entities are
bound by obligations of confidentiality and non-use to AMICUS THERAPEUTICS
which are equal to the terms of this Agreement. AMICUS THERAPEUTICS shall
ensure that such persons or entities are fully aware of the obligations of
this Agreement and shall be responsible for any breach of these provisions
by such persons or entities.
5. PUBLIC ANNOUNCEMENTS AND PUBLICATIONS
5.1 The Parties agree not to make, issue or release any public announcement,
statement or acknowledgement of the existence of this Agreement without the
prior written approval of the other Party. Such approval shall not be
unreasonably withheld or delayed. NOVO NORDISK needs fourteen (14) calendar
days for such approval.
5.2 The Parties agree that NOVO NORDISK has the rights to publish the papers as
indicated in APPENDIX B.
6 PATENT FILING AND MAINTENANCE
6.1 NOVO NORDISK agrees to execute any and all papers necessary in connection
with the applications set forth in Appendix A and any continuing
divisional, reissue, reexamination or corresponding application thereof.
6.2 NNOVO NORDISK agrees to execute all papers necessary in connection with any
interference which may be declared concerning the application or any
continuing divisional, reissue, reexamination or corresponding application
thereof and to cooperate with AMICUS THERAPEUTICS, in every reasonable way
to obtain evidence and go forward with such interference.
6.3 AMICUS THERAPEUTICS shall be obliged at AMICUS THERAPEUTICS costs and
expense to maintain and prosecute NOVO NORDISK Intellectual Property Rights
until their expiry and AMICUS THERAPEUTICS shall have sole responsibility
for the preparation, filing, prosecution, and maintenance of the
Intellectual Property
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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.
10
Rights. AMICUS THERAPEUTICS shall in good faith consider input from NOVO
NORDISK with respect to prosecution and maintenance. For the avoidance of
doubt, AMICUS THERAPEUTICS will pay for the continued filing of
Intellectual Property Rights concerning Licensed Products.
7 ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS
7.1 Notification. Should NOVO NORDISK become aware that a Third Party has been
or is threatening to infringe any of the Intellectual Property Rights, or
that a Third Party is challenging the validity of any Intellectual Property
Rights, NOVO NORDISK shall give AMICUS THERAPEUTICS prompt written notice
detailing as many facts as possible concerning such infringement or
potential infringement or challenge to validity.
7.2 Enforcement. AMICUS THERAPEUTICS shall at its own cost and expense be
responsible for taking action as AMICUS THERAPEUTICS - in any event after
consulting with NOVO NORDISK - may deem necessary to prevent an
infringement of the Intellectual Property Rights; to enforce the
Intellectual Property Rights and to defend the NOVO NORDISK Intellecutal
Property Rights against any action challenging the validity of the NOVO
NORDISK Patent Rights. No settlement shall be made unless with the prior
written approval of NOVO NORDISK. Any sums recovered in a suit or
settlement shall belong to AMICUS THERAPEUTICS. However, AMICUS
THERAPEUTICES shall not name NOVO NORDISK as a coparty in the enforcement
and defense of the Intellectual Property Rights without the express written
consent of NOVO NORDISK and AMICUS THERAPEUTICS shall hold harmless NOVO
NORDISK from all reasonable costs and expenses of such litigation,
including reasonable attorney's fees. In the event NOVO NORDISK as the
owner of the Intellectual Property Rights has to be joined in a suit, NOVO
NORDISK shall have the right to be represented by a counsel of its own
choice.
7.3 Obligations. AMICUS THERAPEUTICS shall be obligated to enforce any of the
Intellectual Property Rights covered by this Agreement at its own expense.
AMICUS THERAPEUTICS can partially be released from such obligation
according to Article 12.2.
8 PATENT VALIDITY
8.1 If any claim challenging the validity or enforceability of any Intellectual
Property Rights shall be brought against NOVO NORDISK, NOVO NORDISK shall
promptly notify AMICUS THERAPEUTICS. Article 9.2 shall govern the
disposition of any such claim.
8.2 If any Third Party challenges the validity or enforceability of any of the
Intellectual Property Rights, AMICUS THERAPEUTICS agrees not to suspend any
payments due to NOVO NORDISK until such time as that patent in Intellectual
Property Rights is determined to be invalid or unenforceable by final
judgement of a governmental agency or a court of competent jurisdiction
from which no appeal can be or has been taken.
9 REPRESENTATIONS AND WARRANTIES
9.1 NOVO NORDISK represents and warrants that, to the best of its knowledge, it
has the right to grant the license in and to Intellectual Property Rights
set forth in this
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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.
11
Agreement, that the rights granted to AMICUS THERAPEUTICS, hereunder do not
conflict with rights previously granted to any Third Party or any agreement
to which NOVO NORDISK is bound, and that, to the best of its knowledge,
there is no litigation pending or threatened with respect to the
Intellectual Property Rights.
9.2 Nothing in this Agreement shall be construed as:
9.2.1 A representation or warranty by NOVO NORDISK as to the patentability,
validity, scope, or usefulness of Intellectual Property Rights; or
9.2.2 A representation or warranty by NOVO NORDISK that anything made,
used, sold, or otherwise disposed of under any license granted in this
Agreement is or will be free from infringement of patents or other
proprietary rights not included in Intellectual Property Rights.
9.3 EXCEPT AS EXPRESSLY SET FORTH ABOVE, NOVO NORDISK EXPRESSLY DISCLAIMS ANY
AND ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, PERTAINING TO THE
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE INTELLECTUAL
PROPERTY RIGHTS, LICENSED PRODUCTS, OR ANYTHING ELSE LICENSED, DISCLOSED,
OR OTHERWISE PROVIDED TO AMICUS THERAPEUTICS UNDER THIS AGREEMENT. NOVO
NORDISKS' TOTAL LIABILITY UNDER THIS AGREEMENT IS LIMITED TO THE COSTS AND
FEES PAID BY AMICUS THERAPEUTICS TO NOVO NORDISK UNDER THIS AGREEMENT.
9.4 NOVO NORDISK warrants that NOVO NORDISK Data is transferred as is, i.e.
AMICUS THERAPEUTICS will be responsible for finalising reports or document
studies for the regulatory authorities. NOVO NORDISK will assist in tracing
existing documents, data and or information available which are requested
by such authorities under the terms and conditions described in Article
3.8.
10 GOVERNING LAW AND DISPUTES
10.1 Both Parties will use their best efforts to settle all matters in dispute
amicably. All disputes and differences of any kind related to this
Agreement, which cannot be solved amicably by the Parties, shall be
referred to arbitration as described below.
10.2 All disputes arising out of or in connection with the present contract
shall be finally settled under the Rules of Arbitration of the
International Chamber of Commerce by one or more arbitrators appointed in
accordance with the said Rules.
10.3 The arbitration shall take place in London, England, and shall be conducted
in the English language. The award of the arbitrators shall be final and
binding on both Parties. The Parties bind themselves to carry out the
awards of the arbitrators.
10.4 This contract shall be construed and interpreted pursuant to the laws of
Denmark to the exclusion of any rule that would refer the subject matter to
another forum. The English wording in this Agreement shall prevail.
11 TERM AND TERMINATION
11.1 This Agreement shall be in full force and effect from the Effective Date
and shall remain in effect until expiry of the last to expire patent of
Intellectual Property Rights, unless otherwise terminated by operation of
law or pursuant to the terms and conditions 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.
12
11.2 Either Party may terminate this Agreement on thirty (30) days written
notice to the other Party ("the Notified Party") if any of the following
events occur:
(a) If the Notified Party is in breach of any of the material terms or
obligations of this Agreement and such breach remains uncured for
sixty (60) days following receipt by the Notified Party of written
notice of such breach (if such default is cured within the cure
period, such written notice shall be null and void), provided that, if
the Notified Party can establish to the reasonable satisfaction of the
other Party that it is diligently and actively pursuing a cure at the
expiration of the cure period, and that the default is reasonably
capable of being cured, then the cure period shall be extended for up
to ninety (90) days from the date of receipt of the written notice of
breach by the Notified Party. For the avoidance of doubt, in the event
of a dispute whether a Party is in breach of the material terms and
obligations of the Agreement and/or whether the cure period shall be
extended, the dispute shall be resolved under Article 10. The
Agreement shall not terminate until a final decision has been reached
either by the Parties or under Arbitration as set forth in Article 10.
(b) In the event the Notified Party shall have become bankrupt, or shall
have made an assignment for the benefit of its creditors or there
shall have been appointed a trustee or receiver of the Notified Party
or for all or a substantial part of its property or any case or
proceeding shall have been commenced or other action taken by or
against the Notified Party in bankruptcy or seeking reorganization,
liquidation, dissolution, winding-up, arrangement, composition or
readjustment of its debts or any other relief under any bankruptcy,
insolvency, reorganization, or other similar act or law of any
jurisdiction now or hereafter in effect and any such event shall have
continued for ninety (90) days undismissed, unbonded and/or
undischarged. All rights and license granted under this Agreement by
one Party to the other Party are, and shall otherwise be deemed to be,
for purposes of Section 365(n) of the Bankruptcy Code, license of
rights to "intellectual property" as defined under Section 101 (56) of
the Bankruptcy Code. The Parties agree that the licensor under this
Agreement shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code in the event of a bankruptcy by
the other Party. The Parties further agree that in the event of the
commencement of a bankruptcy proceeding by or against one Party under
the Bankruptcy Code of their respective countries, the other Party
shall be entitled to complete access to any such intellectual property
pertaining to the rights granted in the licenses hereunder of the
Party by or against whom a bankruptcy proceeding has been commenced
and all embodiments of such intellectual property. However, if NOVO
NORDISK is the bankrupt party, this above shall only apply to the
extent this is allowed under the Danish Bankruptcy Code
("Konkursloven").
11.3 Lack of payments due to NOVO NORDISK under this License Agreement or in
relation to maintenance, defending and enforcing the Intellectual Property
Rights shall always be considered material breach.
11.4 AMICUS THERAPEUTICS may terminate this License Agreement in its entirety at
any time upon one hundred and eighty (180) days written notice to NOVO
NORDISK.
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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
11.5 This Agreement, and the license granted to AMICUS THERAPEUTICS, may be
terminated with effect immediately by NOVO NORDISK in the event that AMICUS
THERAPEUTICS either directly or indirectly opposes, or assists any Third
Party to oppose, the grant of any of the Intellectual Property Rights or
disputes, or directly or indirectly assists any Third Party to dispute, the
validity of any of the NOVO NORDISK Intellectual Property Rights.
11.6 The provisions under which this Agreement may be terminated shall be in
addition to any and all other legal remedies which either Party may have
for the enforcement of any and all terms hereof, and do not in any way
limit any other legal remedy such Party may have.
11.7 Termination of this Agreement shall terminate all rights and licenses
granted to AMICUS THERAPEUTICS relating to the Intellectual Property
Rights.
12 TERMINATION OF CERTAIN INTELLECTUAL PROPERTY RIGHTS
12.1 AMICUS THERAPEUTICS shall be entitled to give NOVO NORDISK a written notice
of ninety (90) days that AMICUS THERAPEUTICS wishes to exclude certain NOVO
NORDISK Intellectual Property Rights from the license granted under this
Agreement. In this case those NOVO NORDISK Intellectual Property Rights
excluded from the license granted under this Agreement shall revert to NOVO
NORDISK. The Parties shall enter into an amendment to this Agreement
stating that Intellectual Property Rights continue to be included in the
Agreement. The license granted under this Agreement shall continue to be in
full force and effect with respect to this remaining part of the
Intellectual Property Rights.
13 RIGHTS AND DUTIES UPON EXPIRATION OR TERMINATION
13.1 Upon termination of this Agreement, NOVO NORDISK shall have the right to
retain any sums already paid by AMICUS THERAPEUTICS hereunder.
13.2 Expiration or termination of this Agreement shall terminate all outstanding
grants, obligations and liabilities between the Parties arising from this
Agreement, except those described in Articles 4, 5, 11.6, 11.7, 13, 14, 15
and 17 which shall survive expiration or any termination of the Agreement
13.3 The grant under Article 3 of this Agreement shall cease by termination of
this Agreement and AMICUS THERAPEUTICS shall return its rights to NOVO
NORDISK Intellectual Property Rights to NOVO NORDISK.
14 USE OF NAMES
14.1 Nothing contained in this Agreement shall be construed as conferring any
rights to use in advertising, publicity or other promotional activities any
name, trade name, trademark, or other designation of a party hereto,
including any contraction, abbreviation, or simulation of any of the
foregoing, unless the express written permission of the other party has
been obtained. Each party hereby agrees not to use the names of the other
party without prior written approval from such other party.
[***] 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.
14
15 INDEMNIFICATION
15.1 AMICUS THERAPEUTICS agrees to indemnify, hold harmless, and defend NOVO
NORDISK, its officers, employees and agents against any and all claims,
suits, losses, damages, costs, fees and expenses resulting from or arising
out of exercise of this Agreement, including, but not limited to, any
damages, losses, or liabilities whatsoever with respect to death or injury
to any person and damage to any property arising from the possession, use,
or operation of Intellectual Property Rights by AMICUS THERAPEUTICS,
including any infringement by AMICUS THERAPEUTICS of the intellectual
property of a Third Party through AMICUS THERAPEUTICS' use or operation of
Intellectual Property Rights. NOVO NORDISK shall indemnify AMICUS
THERAPEUTICS in like manner with respect to any breach of the
representations and warranties set forth in Article 9.
16 NOTICES
16.1 Any notice or other communication required or permitted to be given by
either Party hereto shall be deemed to have been properly given and be
effective upon the date of delivery if delivered in writing to the
respective addresses set forth below, or to such other address as either
party shall designate by written notice given to the other Party. If notice
or other communication is given by facsimile transmission, said notice
shall be confirmed by prompt delivery of the hard-copy original.
If to NOVO NORDISK: Attn: Xxxxxx Xxxxxx,
Vice President Scientific Licensing
NOVO NORDISK A/S
Xxxx Xxxx
XX-0000 Xxxxxxxxx
Xxxxxxx
Fax: x00 00 00 00 00
Phone: x00 00 00 00 00
with a copy to: NOVO NORDISK A/S
Corporate Legal
Attn.: General Counsel
NOVO NORDISK A/S
Novo Alle
XX-0000 Xxxxxxxxx
Xxxxxxx
Fax: x00 00 00 00 00
If to AMICUS THERAPEUTICS:
Attn.: Xxxx X. Xxxxxxx
Amicus Therapeutics, Inc.
President and CEO
000 X.X. Xxxxxxx Xxx
Xx. Xxxxxxxxx, Xxx Xxxxxx XXX 00000
with a copy to:
Att.: Xxxxxxx X. Xxxxxx
Biotech Law Associates, P.C.
000 Xxxxxxxx Xxxxxxx, Xxxxx 000
Xxxxxxxx Xxxx, Xxxxxxxx XXX 00000
[***] 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.
15
Or such other address as either Party may request in writing.
17 INSURANCE REQUIREMENTS
17.1 AMICUS THERAPEUTICS shall maintain general liability insurance including
product liability and contractual liability coverage within the limits tied
to the risks inherent in use of the Intellectual Property Rights. AMICUS
THERAPEUTICS must declare whether the insurance is provided on a claims
made form and must notify NOVO NORDISK if coverage is cancelled. If
coverage is maintained by AMICUS THERAPEUTICS on Licensed Product(s) after
termination or expiration of this Agreement, such coverage must continue to
name NOVO NORDISK.
17.2 AMICUS THERAPEUTICS shall list NOVO NORDISK as an additional insured under
each liability policy that AMICUS THERAPEUTICS shall have or obtain that
includes coverage of claims relating to products or processes used, made or
sold as a result of AMICUS THERAPEUTICS'exercise of the Intellectual
Property Rights. This insurance clause shall survive the termination of
this Agreement.
18 GENERAL
18.1 Assignment. The License Agreement may not be assigned by either party
without the other party's consent. In the event a party gives its consent
to an assignment of the License Agreement, the assignee shall not be
entitled to exercise any rights or receive any benefits under the License
Agreement until it has expressly assumed in writing to the other party the
performance and obligations of all the assigning party's duties and
obligations as set forth in the License Agreement. No such consent of the
other party will be required for assignment of the License Agreement (a) in
connection with the transfer or sale of all or substantially all of the
business of such party to which the agreement relates to a Third Party,
whether by merger, sale of stock, sale of assets or otherwise, or (b) to
any Affiliate. However, in the event of assignment to a successor by merger
or by sale of all or substantially all of a party's assets, such successor
shall not be entitled to exercise any rights or receive any benefits from
this License Agreement until it has expressly assumed in writing to the
other party the performance and obligations of all the assigning party's
duties and obligations as set forth in the License Agreement. Any
assignment of the License Agreement which is not in accordance with the
aforementioned shall be void.
18.2 AMICUS THERAPEUTICS shall have the rights to assign or transfer any or all
of its rights or obligations under this Agreement at any time after AMICUS
THERAPEUTICS has paid the consideration set forth in Article 3.3.a, so long
as the obligations in Article 18.1. are fulfilled.
18.3 Article headings in this Agreement are for convenience only and do not
affect its interpretation.
18.4 In the event that one or more provisions of this Agreement are invalid for
any reason, the validity of the remaining provisions of this Agreement
shall not be affected. The Parties agree to replace such invalid provisions
or any gaps in the Agreement that might become evident, by new, valid
provisions that correspond as closely as possible to the intended purpose
of this Agreement.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
16
18.5 The Confidentiality Agreement dated March 1st, 2005, the Stand Still
Agreement dated April 1st, 2005 and the Material Transfer Agreement dated
4th of April, 2005 shall continue to be in full force and effect until the
Effective Date of this Agreement on which date those agreements shall be
terminated. Provisions of such agreements which according to the wording of
the agreements survive termination shall continue to be in full force and
effect notwithstanding the aforementioned termination.
18.6 No Waiver. The failure of any Party to enforce at any time any provision of
this Agreement, or any right with respect thereto, or to exercise any
election herein provided, shall in no way be considered to be a waiver of
such provision, right or election, or in any way affect the validity of
this Agreement. The exercise by any Party of any right or election under
the terms or covenants herein shall not preclude or prejudice any party
from exercising the same or any other right it may have under this
Agreement, irrespective of any previous action or proceeding taken by the
Parties hereunder.
18.7 Severability. Should a court of competent jurisdiction later consider any
provision of this Agreement to be invalid, illegal, or unenforceable, it
shall be considered severed from this Agreement. All other provisions,
rights, and obligations shall continue without regard to the severed
revision, provided that the remaining provisions of this Agreement are in
accordance with the intention of the parties.
18.8 Amendment. This Agreement may only be amended in writing signed by duly
authorised representatives of AMICUS THERAPEUTICS and NOVO NORDISK.
18.9 Interpretation. In this Agreement the headings are used for convenience
only and shall not affect its interpretation. References to the singular
include the plural and vice versa.
18.10 Further Action. Each party agrees to execute, acknowledge and deliver such
further instruments, and do all further similar acts, as may be necessary
or appropriate to carry out the purposes and intent of this Agreement.
18.11 Entire Agreement. Subject to Article 18.5 this Agreement sets out the
entire agreement between the Parties relating to its subject matter and
supersedes all prior oral or written agreements, arrangements or
understandings between them relating to such subject matter. The
confidentiality agreement, this exclusive license agreement and any
amendments hereto are signed by AMICUS THERAPEUTICS on behalf of the
company itself and its US based Affiliates.
18.12 Costs. Each party shall pay their own costs in connection with entering
into this Agreement.
18.13 Counterparts. This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
17
IN WITNESS WHEREOF, the Parties hereto have caused this instrument to be
executed in duplicate by their duly authorized representatives as of the
date stated below.
Date: 5/26/05 Date: 6/8/2005
AMICUS THERAPEUTICS, INC. NOVO NORDISK A/S
/s/ Xxxx X. Xxxxxxx /s/ Xxxxx Xxxxxxxxx
------------------------------------- ----------------------------------------
By: Xxxx X. Xxxxxxx By: Xxxxx Xxxxxxxxx
Title: Chairman and Chief Executive Title: Senior Vice President and
Officer Head of Discovery
/s/ Xxxxxx Xxxxxx
----------------------------------------
By: Xxxxxx Xxxxxx
Title: Vice President, Scientific
Licensing
18
APPENDIX A
ACTIVE PATENT FAMILIES RELATING TO NN4201
CASE NO. PRIORITY DATE SCOPE ACTIVE MEMBERS
-------- ------------------ ------------------------------------------------- --------------------------
4172 Xxxxx 0, 0000 XXX: Compounds of the formula (CHEMICAL FORMULA) EP patent: CH, DE, FR, GB,
US: Pharmaceutical compositions comprising SE (EP 749423)
(CHEMICAL FORMULA) or (CHEMICAL FORMULA) US 5,863,903
Methods of treating diabetes or reducing liver JP application
glucose production using said compositions
4573 September 8, 1995 EPO: Use of a compound of the formula (CHEMICAL EP 858335 in force in CH,
FORMULA) in the manufacture of medicaments for DE, FR, GB, SE.
inhibiting liver glucose production or inhibiting
liver glycogen phosphorylase. 42-1001 US 5,854,272
specifically for manufacturing of medicaments for US 6,541,836
diabetes
JP 3043430
US 5,854,272: A method of treating diabetes or
inhibiting liver glucose production by
administration of a (CHEMICAL FORMULA) compound
of the formula
US 6,541,836: A method or inhibiting liver
glycogen phosphorylase by administration of a
compound of the formula
(CHEMICAL FORMULA)
5243 May 6, 1997 Compounds of the formula US 6,046,214
(CHEMICAL FORMULA)
5841 March 15, 1999 Tatrate salt of 42-1001 EP, JP applications
US 6,316,489
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
19
CASE NO. PRIORITY DATE SCOPE ACTIVE MEMBERS
-------- ------------------ ------------------------------------------------- --------------------------
5842 March 15,1999 Napsylate salt of 42-1001 EP, JP applications
US 6,239,163
5941 September 29, 1999 Compounds of the formula (CHEMICAL FORMULA) EP, JP and US applications
US 6,590,118
6261 November 8, 2000 Compositions comprising 41-1001 and other Only in Denmark
anti-diabetica
NB Utility model
6474 October 28, 2002 The use of compounds of formula Applications in US and PCT
(CHEMICAL FORMULA), (CHEMICAL FORMULA), or WO 04/037233
(CHEMICAL FORMULA) in the treatment of early
cardiac diseases
[***] 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.
00
XXXXXXXX X
XX0000 PUBLICATIONS Responsible Data on Compound Authors (Initials) in random order Journal
------------------- ------------- ------------------------- ---------------------------------- ----------------
Safety package Klaus Ryetved All safety data on XXXX, XXXX, NILD Arzneimittel /
Compound Drug research
In vitro Klaus Ryetved VF/ECG data on Pathology, KRYT, INSJ, NCBN, KF, (?) Br. J. Pharmacol
glycogen, and enzyme
In vivo/AMI Xxxxx X Xxxx Biotrial report BEKI, KF, KRYT, NCBN Circulation
Xxxxxx and study director from Biotrial
Comparison to other Xxxx Xxxxxxxx Comparison of data from KRYT, NCBN, KF, BFH+ ? Br. J. Pharmacol
compounds heart, including isolated
muscle data.
Authors (Initials) in
NN4201 ABSTRACTS Responsible Data on Compound random order Journal
---------------- ------------------- ---------------- --------------------- --------
In vitro Xxxx Xxxxxxxx In vitro KF, KRYT, NCBN? ADA
In vivo Xxxxx X Xxxx Xxxxxx In vivo KF, XXXX XXX
NCBN+?
[***] 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.
21
