Exhibit 10.32
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT. THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
LICENSE AGREEMENT
This Agreement is entered into and effective as of October 17, 2003 by and
between
Bayer HealthCare AG
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ of Germany
- hereinafter referred to as "BAYER" -
and
deCode Genetics, Ehf.
▇▇▇▇▇▇▇▇▇▇ ▇
▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
- hereinafter referred to as "deCODE" -.
WHEREAS, BAYER has identified and pre-clinically and clinically developed to a
certain degree - including most of the requirements to fulfill the criteria of
Phase II - the pharmaceutically active compound having BAYER's code numbers BAY
X 1005, and pharmaceutical products containing such compound;
WHEREAS, BAYER is the exclusive owner of proprietary rights including
patents/patent applications and know how concerning BAY X 1005 and the
pharmaceutical products containing such compound;
WHEREAS, deCODE has received and evaluated confidential information upon BAYER's
compound under a Secrecy AGREEMENT dated October 29, 2002, concluded between
BAYER and deCODE and deCODE wishes to acquire from
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BAYER an exclusive worldwide license under BAYER's proprietary rights related to
BAY X 1005 for use in the defined field of application;
WHEREAS, BAYER is willing to grant to deCODE such licenses, subject to the terms
of and conditioned upon the provisions of this AGREEMENT;
NOW, THEREFORE, BAYER and deCODE agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 AFFILIATE shall mean any business entity which directly or indirectly
controls, is controlled by, or is under common control with a PARTY of
this AGREEMENT, for only so long as such control exists. A business
entity shall be deemed to "control" another business entity, if it (i)
owns directly or indirectly at least fifty percent of the outstanding
voting security, capital stock, or other comparable equity or ownership
interest of such business entity, or (ii) possess, directly or
indirectly, the power to direct the management or policies of an
entity, whether through the ownership of voting securities, by contract
or otherwise. If the laws of the jurisdiction in which such entity
operates prohibit ownership by a PARTY of more than 50% "control" shall
be deemed to exist at the maximum level of ownership allowed by such
jurisdiction.
1.2 AGREEMENT means this formal agreement, all written amendments and
supplements to this agreement and all schedules to this agreement,
including but not limited to the following:
Schedule A - BAYER PATENTS
Schedule B - Specifications of COMPOUND and Certificate of Analysis
Schedule C - deCODE's DEVELOPMENT PLAN for Asthma and new indications;
Schedule D - Study plan for evaluation of QTc interval prolongation in
dog
Schedule E - BAYER BAY X1005 Regulatory Filings
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1.3 BAYER IND shall mean the IND filed previously by BAYER with the FDA and
comparable regulatory filings in any other country of the TERRITORY, as
specified in Schedule E hereof.
1.4 BAYER KNOW HOW shall mean the scientific and technical information,
trade secrets, inventions (whether patentable or not), data (including
Confidential Information), improvements, discoveries, claims, formulae,
processes, , copyright and know how, including, without limitation, all
chemical, pharmacological, toxicological, preclinical, clinical data
studies, manufacture, formulation, handling and control information
relating to COMPOUND and PRODUCT that is required and/or useful within
the FIELD (i) for manufacture, formulation, and handling COMPOUND, and
(ii) developing, registering, marketing and selling PRODUCT in the
TERRITORY, which information is or will be in the possession of BAYER
and which BAYER is free to disclose during the term of this AGREEMENT.
1.5 BAYER PATENTS shall mean any and all patents and patent applications
owned or licensed by BAYER in the TERRITORY covering COMPOUND and
PRODUCT, and process for manufacturing COMPOUND and PRODUCT, and any
reissues or extension thereof, including respective supplementary
protection certificates; BAYER PATENTS existing at the EFFECTIVE DATE
being specified and included without limitation , in Schedule A to this
AGREEMENT.
1.6 CALENDAR QUARTER means any of the three-months periods beginning
January 1, April 1, July 1, and October 1 in any year;
1.7 COMPOUND shall mean
R-(-)-2-[4-quinolin-2-yl-methoxy)-phenyl]-2-cyclopentyl acetic acid]
having the molecular formula C23H23NO3 (BAY X 1005). The specification
of the COMPOUND (which may be modified after the date hereof) is
identified in Schedule B attached to this AGREEMENT.
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1.8 DEVELOPMENT PLAN means the identification of the development targets
and topics to be performed for the development of PRODUCTS including
the definition of milestones and timelines to be fulfilled, as outlined
in Schedule C, and potential adjustments thereof made from time to
time. In case of the development of additional indications in the
FIELD, the corresponding DEVELOPMENT PLANS will be added to this
AGREEMENT as Schedule C1, C2, etc.
1.9 EFFECTIVE DATE shall mean the date first written above.
1.10 FDA shall mean the United States Food and Drug Administration.
1.11 FIELD shall mean the use of PRODUCT for the inhibition of leukotrienes
in humans in connection with the prevention or treatment of any
condition or indication, e.g. for treatment of inflammatory diseases
such as Asthma, rheumatoid arthritis and inflammatory Bowel disease,
etc.
1.12 FIRST COMMERCIAL SALE shall mean the first sale of PRODUCT in
commercial quantities by deCODE and/or its SUBLICENSEEs to THIRD
PARTIES in the first country of the TERRITORY.
1.13 IND shall mean any filing made with an appropriate Regulatory Authority
in the respective jurisdiction within the TERRITORY for initiating
clinical trials in such jurisdiction with respect to a PRODUCT.
1.14 LICENSE has the meaning ascribed to it in Art. 2 of this AGREEMENT.
1.15 NET SALES shall mean the total gross sales (number of units shipped
times the invoiced price per unit) of PRODUCT sold by deCODE and/or its
SUBLICENSEEs (which term does not include distributors) to unaffiliated
THIRD PARTIES in bona fide arms-length commercial transactions less
certain deductions explained below, but only to the extent that such
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deductions are in the amount invoiced or received, borne by deCODE and
related to PRODUCT sold under the terms of this AGREEMENT:
(a) Allowances actually granted such as ordinary and customary
trade discounts, quantity and cash discounts, rebates
(including rebates to social and welfare systems and
administrative fees in lieu of rebates paid to managed care
and similar institutions, wholesaler charge-backs and
retroactive price adjustments). Allowances and discounts on
PRODUCT sold as part of a multi-product transaction or
agreement shall be proportionally allocated to the value of
all products included in such transaction or agreement.
(b) Government mandated rebates.
(c) Sales taxes, excise taxes, and consumption taxes, which are
imposed on PRODUCT and borne by the seller of the PRODUCT.
(d) Credits and/or allowances actually given for rejection, return
or recall of previously sold PRODUCT, but not in excess of the
original selling price of the PRODUCT rejected, returned or
recalled,
(e) Amounts equivalent to [**] of said gross sales as an allowance
for expenses such as transportation, insurance and the like.
(f) chargebacks and other amounts paid on sale or dispensing of
PRODUCT,
(g) retroactive price reductions that are actually allowed or
granted, and
(h) sales commissions paid to distributors and/or selling agents.
1.16 NDA shall mean a New Drug Application for PRODUCT as required under the
U.S. Food, Drug and Cosmetics Act and the regulations promulgated
thereunder, or a comparable filing for marketing approval for PRODUCT
in any other country, including pricing approvals where applicable.
1.17 PARTIES shall mean deCODE and BAYER, and PARTY means any one of them.
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1.18 PHASE II (IIa, IIb) means that part of the clinical development program
which provides for the first use of PRODUCT on sufficient numbers of
patients in pilot studies (IIa) and controlled studies (IIb) to
establish the dose range for single dose, repeated dose, and
administration intervals, tolerability, specific pharmaco-kinetic and
pharmaco-dynamic data of such product for the desired claims and
indications, as more closely defined by the rules and regulations of
the FDA and corresponding rules and regulations in other major
countries. It finally implies the decision whether to continue the
clinical investigation.
1.19 PHASE III means a wide-ranging clinical investigation of PRODUCT on
sufficient numbers of patients with the target indications under the
conditions of general practice in clinics and with general
practitioners in controlled and uncontrolled studies to establish the
dose-response relationship, indications and contraindications, the
type, duration and frequency of adverse drug events known, the safety
profile, the relationship (comparable or superior) of PRODUCT to
standard treatments, as more closely defined by the rules and
regulations of the FDA and corresponding rules and regulations in other
major countries. It finally implies the application for drug
approval/registration at the respective authority, e.g. FDA.
1.20 PRODUCT shall mean any pharmaceutical preparation for use in the FIELD,
containing COMPOUND as an active ingredient.
1.21 [CONFIDENTIAL TREATMENT REQUESTED].
1.22 SUBLICENSEE shall mean any THIRD PARTY acting pursuant to a sublicense
(including a distribution agreement) granted to it by deCODE under the
terms of this AGREEMENT.
1.23 TERRITORY shall mean all countries in the world.
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1.24 THIRD PARTY means any party other than PARTY and their AFFILIATES.
1.25 US $ shall mean United States dollars, the official currency of the
United States of America.
ARTICLE 2 - GRANT OF LICENSES, DELIVERY OF COMPOUND AND TRANSFER OF BAYER
KNOW-HOW.
2.1 BAYER hereby grants to deCODE the following LICENSES and rights
2.1.1 regarding BAYER PATENTS:
(i) an exclusive LICENSE for the TERRITORY to perform research, to
make, have made, develop, sell, have sold and use the COMPOUND
in the FIELD.
(ii) an exclusive LICENSE for the TERRITORY, to develop, to register,
to make, have made, use, import, sell and have sold PRODUCTS in
the FIELD.
2.1.2 regarding BAYER KNOW HOW:
an exclusive LICENSE for the TERRITORY to make, have made, develop,
sell, have sold and use the COMPOUND and PRODUCT in the FIELD .
2.1.3 regarding Sublicensing:
(i) the right to sublicense in the FIELD all or any portion of the
rights to the BAYER PATENTS, the BAYER KNOW-HOW, granted to it
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pursuant to this AGREEMENT to any or all of its AFFILIATES or
THIRD PARTIES. deCODE will identify its SUBLICENSEE to BAYER and
will inform BAYER on the principles of the collaboration, the
development strategy and the TERRITORY, in writing, within a
reasonable time.
(ii) Except as otherwise set forth herein, deCODE may grant
sublicenses, in its sole discretion, informing BAYER, to such
THIRD PARTIES on such terms and conditions as it deems
appropriate; provided, that deCODE for itself and its
SUBLICENSEEs shall at all times remain obligated to comply with
terms hereof.
2.2 Delivery of COMPOUND:
BAYER will deliver to deCODE existing batches of COMPOUND at no costs
to deCODE within a reasonable time following the EFFECTIVE DATE.
2.3 Transfer of Know-How:
Within 90 days of the Effective Date, BAYER shall transfer such items
of BAYER Know-How to deCODE as requested by deCODE and reasonably
practicable and available.
ARTICLE 3 - DEVELOPMENT AND COMMERCIALIZATION
3.1 Development and Commercialization Efforts
3.1.1 deCODE shall exercise diligent efforts at its own cost to have the QT
PROLONGATION EVALUATION completed as soon as possible after receipt of
COMPOUND and BAYER KNOW HOW according to the timeline and study plan
contained in Schedule D.
3.1.2 deCODE shall exercise reasonable development efforts ("reasonable
development efforts" shall mean the same degree of diligence that
deCODE, in its business judgment, would exercise in pursuing the
development and registration of comparable products for comparable
8
indications with comparable sales potential in comparable markets, it
being understood that reasonable development efforts will in no event
require deCODE to take any action that would be reasonably likely to
result in a breach of any other provision of this Agreement or any
other agreement to which deCODE is a party existing on the Effective
Date, or that deCODE in good faith believes may violate any applicable
law, regulation, rule, order, permit, direction or license of any court
or governmental authority having appropriate jurisdiction over deCODE)
to obtain necessary approvals to market PRODUCT (including, as the case
may be, pricing approval).
3.1.3 deCODE shall use reasonable efforts to comply with all applicable Good
Laboratory-, Good Clinical- and Good Manufacturing Practices in the
development of PRODUCT, and shall commit its AFFILIATES and
SUBLICENSEEs and subcontractors to do the same.
3.1.4 To support deCODE in achieving approvals and registrations for clinical
trials and PRODUCTS, BAYER will transfer ownership of the BAYER IND and
corresponding documents to deCODE effective as of the signature of the
Agreement.
3.2 Development and Approval Reports for PRODUCT(s)
3.2.1 During the term of this AGREEMENT, deCODE will regularly inform BAYER,
not less frequently than semi-annually, through written reports (in a
form to be agreed between the parties in good faith), of progress of
the PRODUCT development and provide a summary of results achieved
according to the Development Plan which is incorporated by reference
and made part of this AGREEMENT as Schedule C for [CONFIDENTIAL
TREATMENT REQUESTED] in additional Schedules C1, C2 , etc.
3.2.2 deCODE will promptly inform BAYER in writing, if and when its
development of a PRODUCT has met a milestone according to Article 4.1
and Schedule C hereinafter.
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3.2.3 Moreover, deCODE will inform BAYER within thirty (30) days of receipt
by deCODE of an approval for registration and/or marketing of PRODUCT
in any individual country.
3.3 Commercialization of PRODUCT
3.3.1 deCODE shall exercise reasonable commercial efforts ("reasonable
commercial efforts" shall mean the same degree of diligence that
deCODE, in its business judgment, would exercise in pursuing the
commercialization of comparable products with comparable sales
potential in comparable markets, it being understood that reasonable
commercial efforts will in no event require deCODE to take any action
that would be reasonably likely to result in a breach of any other
provision of this Agreement or any other agreement to which deCODE is a
party existing on the Effective Date, or that deCODE in good faith
believes may violate any applicable law, regulation, rule, order,
permit, direction or license of any court or governmental authority
having appropriate jurisdiction over deCODE ) to market PRODUCT in the
TERRITORY.
ARTICLE 4 - MILESTONES AND ROYALTIES
4.1 License Fee and Milestone Payments
4.1.1. In consideration of the rights and licenses granted hereunder to deCODE,
deCODE shall pay BAYER the following license fee:
[CONFIDENTIAL TREATMENT REQUESTED] will be due upon signature of this
AGREEMENT within 30 days, and the remaining balance [**] will be due
within 30 days at satisfaction or removal of the contingencies set
forth in Article 11.2.3;
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4.1.2 deCODE shall further make to BAYER the following milestone payments
within thirty (30) days after the first occurrence of each event set
forth below with respect to the first PRODUCT for [CONFIDENTIAL
TREATMENT REQUESTED] for which such event is achieved, irrespective of
whether such events are achieved by deCODE, or its SUBLICENSEEs in any
country of the TERRITORY:
(ii) [**] at initiation of clinical PHASE III trial;
(iii) [**] at NDA filing;
(iv) [**] at NDA approval;
4.1.3 The milestone payments set forth in Article 4.1.2 (ii) through (iv)
above shall be payable for each individual event with respect to the
first PRODUCT for each new indication within the FIELD for which such
event is achieved and shall be non-refundable and non-creditable
against royalties payable by deCODE to BAYER under the Article 4.2
hereinafter.
4.2 Running Royalty Payments
4.2.1 Subject to Article 4.2.2, from the FIRST COMMERCIAL SALE until the
expiration or termination of this AGREEMENT, deCODE shall pay to BAYER
the following royalties on the NET SALES obtained for each PRODUCT
during the term of this AGREEMENT, irrespective of whether such NET
SALES are achieved by deCODE or SUBLICENSEEs in any country of the
TERRITORY:
(i) [**] of NET SALES of marketed PRODUCTS in the indications
[CONFIDENTIAL TREATMENT REQUESTED].
(ii) [**] of NET SALES of marketed PRODUCTS in the indications
[CONFIDENTIAL TREATMENT REQUESTED].
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(iii) [**] of NET SALES of marketed PRODUCTS in all indications in
the FIELD other than those identified under Article 4.2.1 (i) and (ii) .
4.2.2 deCODE may deduct from the royalties it would otherwise owe pursuant to
Article 4.2.1 (i) through (iii), an amount equal to [CONFIDENTIAL
TREATMENT REQUESTED] paid by deCODE, its AFFILIATES and SUBLICENSEES to
THIRD PARTIES with respect to commercially reasonable licenses to
intellectual property rights pertaining to the development,
manufacture, sale or use of the COMPOUND or the PRODUCT (but excluding
licenses to trademarks and tradedresses pertaining thereto), but
excluding intellectual property rights specifically pertaining to the
condition or indication for which the COMPOUND or the PRODUCT receives
NDA approval. Notwithstanding the previous sentence, the minimum
royalty rate paid by deCODE pursuant to Article 4.2.1 (i) through (iii)
shall be [CONFIDENTIAL TREATMENT REQUESTED] of the applicable rate of
NET SALES.
4.2.3 If the sum of competing products containing the COMPOUND will gain a
market share of [**] or more in a specific country, the corresponding
royalty rate owed to BAYER will be reduced for the applicable time by
[**] for such country.
4.2.4 If the events envisioned under Article 4.2.3 have not materialized, and
if the sum of competing products representing the same mode of action
[CONFIDENTIAL TREATMENT REQUESTED] compounds) will gain a market share
of at least [**] in a specific country, there will be proportionate
reduction in the corresponding royalty rate owed to BAYER until a
maximum reduction of [**] is reached, e.g., if competing products gain
a market share of [**] there will be a [**] reduction in royalty, for
[**] market share a [**] reduction in royalty etc., up to a maximum of
[**] reduction in royalty for competing products that gain market share
of [**] or greater. However, the foregoing reduction described in this
Article 4.2.4 will only become effective in the country in question,
AFTER the expiry of the applicable BAYER PATENT covering COMPOUND in
such country. For the avoidance of doubt; the
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reduction may take place while the BAYER PATENT covering the process
for manufacturing COMPOUND is still in effect, as long as the BAYER
PATENT covering COMPOUND has expired.
ARTICLE 5 - ROYALTY REPORTS AND ACCOUNTING
5.1 Reports, Exchange Rates
5.1.1 Following the FIRST COMMERCIAL SALE and for the remaining term of this
AGREEMENT, deCODE shall furnish to BAYER, with respect to each Calendar
Quarter, a written report showing in reasonably specific detail, on a
country-by-country basis and based on local currency,
(a) the gross sales of each PRODUCT sold by deCODE and its
SUBLICENSEES in the TERRITORY during the corresponding
Calendar Quarter and the calculation of NET SALES from such
gross sales;
(b) the royalties payable in local currency, if any, which shall
have accrued hereunder based upon NET SALES of PRODUCT;
(c) the withholding taxes, if any, required by law;
(d) the date of the FIRST COMMERCIAL SALE of each PRODUCT in each
country in the TERRITORY during the applicable Calendar
Quarter,
The exchange rates to be used with respect to this Article 5.1.1 shall
be the official closing buying rates against US Dollars (US $) for such
currencies reported by the Wall Street Journal for the last business
day of the applicable calendar quarter.
Reports shall be due within forty five (45) days following the close of
each Calendar Quarter. deCODE shall keep complete and accurate records
in sufficient detail to properly reflect all gross sales and NET SALES
and to
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enable the royalties payable hereunder to be determined for a period of
five (5) years after the year in which the sales occurred.
5.1.2 In the event payment of all or part of the payments is not made by
deCODE within ten (10) days of the due date of the reports according to
Article 5.1.1, under this AGREEMENT, an interest rate per annum for
late payment at two (2) percent points above the interbank offering
rate of the US Federal Reserve Bank of the unpaid amount shall be
automatically due and become payable by deCODE without further notice.
The interbank offering rate of the US Federal Reserve Bank shall be
derived from the Wall Street Journal of the due date.
5.2 AUDITS
5.2.1 Upon the written request of BAYER, deCODE shall permit an independent
certified public accounting firm of internationally recognized
standing, selected by BAYER and reasonably acceptable to deCODE, and
subject to the confidentiality provisions of this AGREEMENT, to have
access during normal business hours and upon reasonable notice to such
of the records of deCODE as may be reasonably necessary to verify the
accuracy of the value and execution of NET SALES and royalty reports
hereunder for any year ending not more than five (5) years prior to the
date of such request. The accounting firm shall disclose to BAYER only
whether the records are correct or not and the specific details
concerning any discrepancies. No other information shall be shared.
5.2.2 If such accounting firm concludes that additional royalties were owed
during such period, deCODE shall pay the additional royalties within
thirty (30) days of the date BAYER delivers to deCODE such accounting
firm's written report so concluding. The fees charged by such
accounting firm shall be paid by BAYER; provided, however, that if the
audit discloses that the royalties payable by deCODE differ by more
than [**] of the royalties actually paid for such period, then deCODE
shall pay the reasonable
14
expenses as well as duties and fees charged by such accounting firm. In
the event that such audit discloses an overpayment of royalties by
deCODE, deCODE shall deduct the amount of such overpayment from
subsequent royalty payments.
5.2.3 deCODE shall include in each AGREEMENT with a SUBLICENSEE granted by it
pursuant to this AGREEMENT a provision requiring the SUBLICENSEE to
make reports to deCODE to keep and maintain records of sales made
pursuant to such AGREEMENT and to grant access to such records by
BAYER's independent accountant to the same extent required with respect
to deCODE's records and obligations under this Article 5 and under this
AGREEMENT.
5.2.4 Upon the expiration of three (3) calendar years following the end of
the most recent full calendar year, the calculation of royalties
payable with respect to such year shall be binding and conclusive upon
BAYER, and deCODE, the respective SUBLICENSEEs shall be released from
any liability or accountability with respect to royalties for such
year.
ARTICLE 6 - PAYMENTS
6.1 Payment Terms
Milestones will be paid in accordance with Article 4.1.2. Royalties
accrued in each CALENDAR QUARTER presented by the corresponding royalty
report according to Art. 5 of this AGREEMENT shall be due and effected
ten (10) days after the date such royalty report according to Article
5.1.1 is to be transmitted to BAYER. Payments of royalties in whole or
in part may be made in advance of such due date.
All payments to be made to the account:
[CONFIDENTIAL TREATMENT REQUESTED]
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6.2 Exchange Control
If at any time legal restrictions prevent the prompt remittance of part
or all royalties with respect to any country in the TERRITORY where
PRODUCT is sold, payment shall be made through such lawful means or
method as the PARTIES reasonably shall determine.
6.3 Withholding Taxes
deCODE shall have the right to withhold from the royalty payments the
tax which BAYER is liable to under the appropriate local tax laws and
for the payments of which deCODE is responsible. BAYER shall
immediately be sent tax receipts by deCODE certifying the payments of
the tax, so that BAYER may use it for claiming a credit on the tax
payable by BAYER in Germany on such payments. No deduction shall be
made or a reduced amount shall be deducted if BAYER furnishes a
document from the appropriate tax authorities to deCODE by the time of
the payments certifying that the payments are exempt from tax in the
country of the TERRITORY or subject to a reduced tax rate according to
the convention for the avoidance of double taxation between the Federal
Republic of Germany and the respective country. Except for such
withholding taxes, any taxes, assessments, fees and charges imposed
against payments due BAYER hereunder shall be borne by deCODE.
ARTICLE 7- RIGHTS OF AND OPTION TO BAYER
7.1 Rights of BAYER
7.1.1 BAYER receives the right to review of deCODE's results and know-how
achieved under the LICENSE AGREEMENT, these results to be kept
confidential by BAYER for use solely in connection with the
back-license referenced in Article 7.2 below, and, moreover, to use
COMPOUND for internal research purposes only excluding human clinical
trials.
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7.1.2 deCODE agrees to give BAYER the first right and opportunity to be
deCODE's primary supplier of COMPOUND and to negotiate the terms and
conditions of a supply and manufacturing agreement, which terms and
conditions shall be documented in separate SUPPLY & MANUFACTURING
AGREEMENT, subject to meeting deCODE's needs with regards to local
government reimbursement and regulatory issues, timeline, quantity and
quality assurance certification at a reasonable price structure. In the
event the PARTIES cannot reach an agreement with respect to supply and
manufacture of COMPOUND, deCODE may contract with a THIRD PARTY to be
the primary supplier of COMPOUND, provided that: (i) the terms and
conditions of any such supply and manufacturing agreement are equally
or more favorable to deCODE than those last offered in writing by BAYER
to deCODE, and (ii) if the terms and conditions of any such supply and
manufacturing agreement are equally or more favorable to deCODE
considered as a whole than those last offered in writing by BAYER,
BAYER shall have a right of first refusal, exercisable within thirty
(30) days after deCODE provides notice to BAYER of such equally or more
favorable terms and conditions, to supply and manufacture COMPOUND on
such terms and conditions. Nothing in this AGREEMENT shall prevent
deCODE from contracting with more than one supplier of COMPOUND.
7.2 Option and Right to BAYER
7.2.1 deCODE agrees to give BAYER the first right and opportunity to market
PRODUCTS and to negotiate the terms and conditions of a marketing
agreement, which terms and conditions shall be documented in separate
MARKETING AGREEMENT to be executed within six (6) months after BAYER's
receipt of a corresponding written notice, if deCODE elects to contract
with a THIRD PARTY that is not a SUBLICENSEE to co-market a PRODUCT or
PRODUCTS in certain countries of the TERRITORY.
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7.2.2 If deCODE elects not to market PRODUCT in certain countries of the
TERRITORY either directly, by AFFILIATE, or by establishment of a
competent SUBLICENSEE(s) to do so, deCODE shall notify BAYER to that
effect, and, BAYER will then have the right to market such PRODUCT in
such countries of the TERRITORY.
7.2.3 BAYER shall have the right to a grant-back of the LICENSE including the
right in using and exploiting the results, inventions and PRODUCTS
generated under this AGREEMENT including corresponding patent
applications and granted patents and formal approvals generated under
the LICENSE, if deCODE materially breaches a material term of the
AGREEMENT and does not cure or take steps to cure such breach within
ninety (90) days after BAYER's notice on such breach.
7.2.4 In the event BAYER elects to exercise its right to market any PRODUCT
in any country as permitted under Articles 7.2.2 or 7.2.3, it shall pay
to deCODE a running royalty on its NET SALES at a reasonable rate to be
negotiated based upon the relative efforts made by BAYER and deCODE in
the development and marketing of such PRODUCT, which rate shall be no
less than [**], on the same terms and conditions and for the same term
as otherwise contemplated by this AGREEMENT (if BAYER were the licensee
and deCODE were the licensor).
ARTICLE 8 - INFRINGEMENT ACTIONS OF THIRD-PARTIES
8.1 In the event that BAYER, deCODE, deCODE AFFILIATES or SUBLICENSEES,
practicing of BAYER PATENTS licensed hereunder in connection with the
development or the making, having made, importing, using, distributing,
marketing, promoting, offering for sale or selling PRODUCT will
infringe or is alleged to infringe a THIRD PARTY'S patent, the PARTY
becoming aware of same shall promptly notify the other PARTY.
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8.2 BAYER shall negotiate with said THIRD PARTY for a suitable license, if
the THIRD PARTY's claim is related to the manufacture of COMPOUND
and/or Compound's use for the manufacture of PRODUCT. In the event that
such negotiations result in a consummated agreement, then any lump sum
payment made thereunder shall be paid by BAYER. Should such agreement
require the payment of royalties, deCODE shall continue to pay
royalties due BAYER hereunder and BAYER shall pay any royalties due
said THIRD PARTY.
8.3 Except as set forth in Article 8.2, above, deCODE shall negotiate with
said THIRD PARTY for a suitable license, if the THIRD PARTY's claim is
related to making, having made, importing, using, distributing,
marketing, promoting, offering for sale or selling PRODUCT. In the
event that such negotiations result in a consummated agreement, then
any lump sum payment made thereunder shall be paid by deCODE. Should
such agreement require the payment of royalties, deCODE shall continue
to pay royalties due BAYER hereunder and deCODE shall pay any royalties
due said THIRD PARTY. Notwithstanding the foregoing, no license
agreement or other settlement shall be entered into by deCODE without
the prior consultation of BAYER.
8.4 If deCODE, BAYER, their respective AFFILIATES, or SUBLICENSEES, is
(are) sued by a THIRD PARTY for infringement of a THIRD PARTY's patent
because of the manufacture, use or sale of PRODUCT or manufacture or
use of COMPOUND, the PARTY which has been sued shall promptly notify
the other PARTY in writing of the institution of such suit. deCODE
shall have the first right, but not the duty, in its sole discretion,
to control the defense of such suit at its own expense, in which event
BAYER shall have the right to be represented by advisory counsel of its
own selection, at its own expense, and shall cooperate in the defense
of such
19
suit and furnish to deCODE reasonable evidence and assistance in its
control.
ARTICLE 9 - CONFIDENTIALITY
9.1 Non-disclosure Obligation and Use Restriction
Except as otherwise provided in this Article 9, during the term of this
AGREEMENT and for a period of ten (10) years thereafter, each PARTY
shall maintain in confidence, and use only for purposes as expressly
authorized and contemplated by this AGREEMENT, all information and data
supplied by the other PARTY under THE CONFIDENTIALITY AGREEMENT OF
OCTOBER 29, 2002 and under this AGREEMENT. The provisions of this
Article 9 supercede and replace, in their entirety, the provisions of
the said CONFIDENTIALITY AGREEMENT, between the PARTIES. For purposes
of this Article 9 the information and data exchanged under said
agreement and information regarding the terms and performance of this
AGREEMENT, shall be hereinafter included and referred to as
"CONFIDENTIAL INFORMATION".
9.2 Permitted Disclosures
9.2.1 To the extent it is reasonably necessary or appropriate to fulfill its
obligations or exercise its rights under this AGREEMENT, (a) a PARTY
may disclose CONFIDENTIAL INFORMATION it is otherwise obligated under
this Article 9 not to disclose, to its AFFILIATES, SUBLICENSEES,
consultants, outside contractors and clinical investigators
(hereinafter collectively referred to as PERSONS), on a need-to-know
basis, provided that such PERSONS agree to keep the CONFIDENTIAL
INFORMATION confidential and not use the CONFIDENTIAL INFORMATION to
the same extent as such PARTY is required pursuant to this AGREEMENT;
and (b) a PARTY may disclose such CONFIDENTIAL INFORMATION to
government
20
or other regulatory authorities to the extent that such disclosure is
required by applicable law, regulation of court order, or is reasonably
necessary to obtain patents copyrights or authorizations to conduct
clinical trials with, and the commercially market PRODUCT, provided
that the disclosing PARTY shall provide written notice to the other
PARTY and sufficient opportunity to object to such disclosure or to
request confidential treatment thereof.
9.2.2 Following the EFFECTIVE DATE, each of the PARTIES shall have the right
to issue press releases and similar public announcements about the
relationship of the PARTIES, with the prior consent of the other Party,
which shall not be unreasonably withheld. The PARTY making such
announcement shall exercise reasonable efforts not to divulge
CONFIDENTIAL INFORMATION, and provide the other PARTY with a copy of
the proposed text prior to such announcement, sufficiently in advance
of the scheduled release, to afford such other PARTY a reasonable
opportunity to review and comment upon the proposed text.
9.2.3 The obligation not to disclose or use CONFIDENTIAL INFORMATION shall
not apply to any part of such CONFIDENTIAL INFORMATION that
(i) is or becomes published or otherwise part of the public domain
or publicly available other than by acts of the PARTY
obligated not to disclose such CONFIDENTIAL INFORMATION, or of
its AFFILIATES or SUBLICENSEES in contravention of the
AGREEMENT;
(ii) is disclosed to the receiving PARTY or its AFFILIATES or
SUBLICENSEES by a THIRD PARTY, provided such CONFIDENTIAL
INFORMATION was not obtained by such THIRD PARTY directly or
indirectly from the other PARTY under this AGREEMENT on a
confidential basis;
(iii) prior to disclosure under the AGREEMENT, was already in the
possession of the receiving PARTY or its AFFILIATES or
SUBLICENSEES, provided such CONFIDENTIAL INFORMATION was
21
not obtained directly or indirectly from the other PARTY under
the AGREEMENT; or
(iv) both PARTIES have agreed in writing to publish certain
CONFIDENTIAL INFORMATION.
ARTICLE 10 - INVENTIONS AND PATENTS
10.1 Patent Prosecution, Maintenance, and Extension
10.1.1 BAYER shall be responsible for and shall control the preparation,
filing, prosecution, grant and maintenance of all BAYER PATENTS. BAYER
shall prepare, file, prosecute and maintain such BAYER PATENTS in good
faith consistent with its customary patent policy and its reasonable
business judgment, and shall consider in good faith the interests of
deCODE in so doing. BAYER shall not delegate such responsibility or
control to any party other than deCODE without deCODE's prior written
consent. BAYER shall inform deCODE of all actions taken or pending
under Article 10.1.1. and Article 10.1.2., furnishing deCODE with
copies of patent documents, e.g., draft applications and office actions
from patent authorities.
10.1.2 As soon as deCODE obtains NDA approval, deCODE shall so inform BAYER,
obligating BAYER to ensure the complete and timely filing and
prosecution of application for extension of BAYER PATENTS as specified
under the Drug Price Competition and Patent Term Restoration Act of
1984 (▇▇▇▇▇-▇▇▇▇▇▇ Act) in the United States, and in other
jurisdictions and countries in TERRITORY as permissible under such the
laws and regulation as may apply in such countries and jurisdictions,
e.g. European Supplementary Protection Certificates.
10.1.3 BAYER shall give deCODE notice of any decision by BAYER to cease
prosecution, maintenance, and or extension of BAYER PATENTS and in
22
such case permit deCODE, at its sole discretion, to continue
prosecution, maintenance and/or extension at its sole expense. Such
notice shall be sufficiently far in advance of the abandonment or lapse
of a BAYER PATENT to permit deCODE reasonable time to continue
prosecution, maintenance and/or extension. If deCODE elects to continue
prosecution, maintenance and/or extension, BAYER shall execute such
documents and perform such acts, at deCODE's expense, as may reasonably
be necessary to effect an assignment of such BAYER PATENTS to deCODE.
Any such assignment shall be completed in a timely manner to allow
deCODE to continue such prosecution, maintenance and/or extension. Any
patents or patent applications so assigned hereunder shall not be
considered BAYER PATENTS under this AGREEMENT.
10.2 Enforcement of BAYER PATENTS
10.2.1 deCODE shall have the first right, but not obligation, at its sole
expense, to determine the appropriate course of action to enforce the
BAYER PATENTS or otherwise ▇▇▇▇▇ the infringement by THIRD PARTIES
thereof, to take (or refrain from taking) appropriate action to enforce
the BAYER PATENTS, to control any litigation or other enforcement
action and to enter into, or permit, the settlement of any such
litigation or other enforcement action with respect to the BAYER
PATENTS, and in good faith shall consider the interests of BAYER in so
doing.
10.2.2 In the event that deCODE does not decide within ninety (90) days after
notice of any such infringement to take appropriate legal action to
protect BAYER PATENTS and deCODE license rights hereunder, or does not
diligently pursue such action after making a decision to take such
action, BAYER, at BAYER's cost, shall have the right, in its sole
discretion, and at its expense to take such action as BAYER deems
necessary to prevent any such infringement of BAYER PATENTS and recover
any damages realized by or threatened to BAYER as a result of such
infringement, and deCODE agrees to cooperate with and assist BAYER in
its so doing.
23
10.2.3 Notwithstanding the foregoing, deCODE and BAYER shall fully cooperate
with each other in any action to enforce the BAYER PATENTS. Any award
paid by THIRD PARTIES as a result of such an infringement action
(whether by way of settlement or otherwise) shall be applied first to
reimburse both PARTIES for [**] of all costs and expenses incurred by
the PARTIES with respect to such action on a pro rata basis and, if
after such reimbursement any funds shall remain from such award, deCODE
shall be entitled to retain same; provided, however, that such
remaining funds shall be deemed to constitute NET SALES for purposes of
this Agreement, and deCODE shall be obligated to pay the royalty due
and owing under this Agreement with respect thereto.
ARTICLE 11 - TERM AND TERMINATION
11.1 Term
This AGREEMENT shall come into effect and full force on the EFFECTIVE
DATE and, unless terminated earlier pursuant to the provisions of this
AGREEMENT, shall expire on the later of
(i) the date all BAYER PATENTS expire, or
(ii) ten (10) years after the FIRST COMMERCIAL SALE in the first
country.
11.2 Termination and Contingencies.
11.2.1 Either PARTY may terminate this AGREEMENT at any time by giving written
notice to the other PARTY in the event that:
(i) Any proceeding in bankruptcy or in reorganization (other than
internal reorganization) or for the appointment of a receiver
or trustee or any other proceedings under a law for the relief
of debtors shall be instituted by or against the other PARTY,
which proceedings are not dismissed within sixty (60) days and
prevent
24
the other PARTY from performing the material obligations
imposed on it by this AGREEMENT;
(ii) the other PARTY defaults in the performance of any material
obligations imposed on it by this AGREEMENT and such default
is not remedied in all material respects within ninety (90)
days of receipt of written demand from the notifying PARTY to
cure the default.
11.2.2 deCODE may terminate this AGREEMENT at any time before the FIRST
COMMERCIAL SALE upon ninety (90) days prior written notice to BAYER,
giving BAYER the relevant reasons for termination in writing. At the
effective date of the termination, all rights, KNOW HOW and the LICENSE
granted under the AGREEMENT to deCODE will expire.
11.2.3. Notwithstanding the foregoing, deCODE may terminate this Agreement by a
written notice no later than [**] after the Effective Date, if the
following contingencies still exist at such time:
i) In preclinical studies [CONFIDENTIAL TREATMENT REQUESTED];
ii) In clinical trials (Phase I or later) clinically relevant
[CONFIDENTIAL TREATMENT REQUESTED].
iii) deCODE's due diligence on BAYER KNOW-HOW has not been
completed in a satisfactory manner, e.g., unexpected
materially adverse circumstances pertaining to the BAYER
KNOW-HOW have been discovered.
Once the foregoing contingencies have been removed, deCODE's right to
terminate the AGREEMENT under this Article will expire. deCODE shall
exercise diligent efforts to have the contingencies removed as soon as
possible following the EFFECTIVE DATE, provided that the obligations
under Articles 2.2 and 2.3 hereof have been met.
25
No payment under the AGREEMENT executed to BAYER until the date of
termination will be refundable.
11.2.4 If this AGREEMENT is terminated, such expiration or termination shall
neither release the other PARTY from any obligation to make payments
accrued hereunder prior to the date of such expiration or termination
and shall not release the PARTIES from the secrecy obligations as
provided herein, or from the indemnity obligations.
If the AGREEMENT is terminated by BAYER according to Article 11.2.1, or
Article 14.2, or by deCODE according to Article 11.2.1 or Article
11.2.2, deCODE shall, upon request of BAYER, immediately reassign its
NDA approvals for PRODUCT in the TERRITORY to BAYER or to a party
designated by BAYER. deCODE shall also provide BAYER with all
information and results developed during the license term reasonably
necessary for maintaining regulatory approvals for sale of COMPOUND
which BAYER may use at its sole discretion. The royalty provision of
Article 7.2.4 shall apply.
11.2.5 If this AGREEMENT expires pursuant to Article 11.1 or is terminated by
either PARTY as provided in Article 11.2 or Article 14.2, all rights,
access to and use of KNOW HOW and the LICENSE granted under the
AGREEMENT to deCODE shall expire.
11.2.6 If this Agreement is terminated, and in the event that the ownership of
the BAYER IND has been transferred to deCODE under Article 3.1.4 hereof
at the time of such termination, deCODE will transfer ownership of the
BAYER IND back to BAYER.
11.2.7 The expiration or termination of this AGREEMENT shall not affect the
following Articles or Articles which shall remain in force unlimited or
as defined in such Articles or Articles: Article 1; Article 5.2;
Article 7.2.4, Article 7.8; Article 9; Articles 11.2.4-11.2.6; Article
12; Article 14.5 and 14.6
26
ARTICLE 12 - LIABILITY
12.1 deCODE shall bear full liability for PRODUCT developed, manufactured,
packaged, promoted, distributed and sold in the TERRITORY hereunder and
for its other activities related thereto.
12.2 BAYER shall not be responsible for any damages, claims or losses that
deCODE, its AFFILIATES, SUBLICENSEES or THIRD PARTIES may suffer by
reason of licensed exploitation of the BAYER PATENTS and of the BAYER
KNOW HOW or by manufacture, use and sale of PRODUCT or by reason of
acts of commission or omission on the part of deCODE or its employees
or agents with regard to the processing, use and sale of PRODUCT.
deCODE shall hold harmless and fully indemnify BAYER, its AFFILIATES,
and each of its and their respective employees, officers, directors and
agents (each a "BAYER Indemnified PARTY") from and against all damages,
claims or losses which may be made against BAYER by reason of deCODE's
manufacture, use and sale of PRODUCT or by reasons of acts of
commission or omission of deCODE's employees or agents with regard to
processing, use or sale of PRODUCT.
12.3 Notwithstanding the foregoing, BAYER shall be responsible for damages
incurred to THIRD PARTIES based on product liability if deCODE or the
THIRD PARTY can prove that the damage results from
- the restricted use of certain batches of COMPOUND - as to be
identified by BAYER in Schedule B - which will only be
released for use outside of any clinical trials or any human
application; or
- the non-conformity of COMPOUND delivered by BAYER released for
use in clinical trials - as to be identified by BAYER in
Schedule B - with specifications as set forth in Schedule B,
provided that such
27
non-conformity could not be detected by deCODE through quality
control tests agreed upon between the PARTIES; or
- intentional or gross negligence of BAYER during the
development or manufacture of the delivered COMPOUND.
12.4 deCODE shall have no obligation under this AGREEMENT to hold harmless
and fully indemnify any BAYER Indemnified PARTY from and against all
damages, claims or losses which result from willful misconduct or
negligent acts or omissions of BAYER, its AFFLILIATES, or any of its or
their respective employees, officers, directors or agents related to
the testing of COMPOUND.
ARTICLE 13 - REPRESENTATIONS AND WARRANTIES
13.1 deCODE represents and warrants that the execution and performance of
this AGREEMENT is within the corporate power of deCODE and has been
duly authorized by all necessary corporate action. BAYER represents and
warrants that the execution, delivery and performance of this AGREEMENT
is within the corporate power of BAYER and has been duly authorized by
all necessary corporate action. This AGREEMENT constitutes a valid and
binding AGREEMENT between BAYER and deCODE.
13.2 deCODE represents and warrants that there are no contractual
prohibitions or impediments including any claims, judgments,
settlements against or owed by deCODE preventing it from entering into
or performing its obligations under this AGREEMENT. BAYER represents
and warrants that there are no contractual prohibitions or impediments
including any claims, judgments, settlements against or owed by BAYER
preventing it from entering into or performing its obligations under
this AGREEMENT.
28
13.3 deCODE and BAYER each undertakes to the other to strictly adhere to all
applicable laws and regulations with respect to COMPOUND and PRODUCT.
13.4 BAYER does not represent or warrant that the BAYER PATENTS are or will
be valid or that they will not infringe the rights of THIRD PARTIES or
that the development, manufacture, use or sale of PRODUCT is not or
will not be an infringement of the rights of THIRD PARTIES. At the
EFFECTIVE DATE of this AGREEMENT, BAYER represents that to the best of
its knowledge, BAYER does not have any information that BAYER PATENTS
are not valid or that they will infringe the rights of THIRD PARTIES or
that the development, manufacture, use or sale of PRODUCT is or will be
an infringement of the rights of THIRD PARTIES. BAYER further
represents that it is not aware of any (i) BAYER PATENTS or BAYER KNOW
HOW that are required and/or useful within the FIELD (A) for
manufacture, formulation, and handling COMPOUND, or (B) developing,
registering, marketing and selling PRODUCT in the TERRITORY, which are
not being licensed or otherwise provided to deCODE hereunder, or (ii)
intellectual property rights of any THIRD PARTY that are required
and/or useful within the FIELD for, or would prevent or otherwise limit
or hinder deCODE's (A) manufacture, formulation, and handling COMPOUND,
or (B) developing, registering, marketing and selling PRODUCT in the
TERRITORY.
ARTICLE 14 - MISCELLANEOUS
14.1 Neither PARTY shall be responsible to the other for any failure or
delay in performing any of its obligations under this AGREEMENT or for
other non-performance hereof if such delay or non-performance is caused
by an event of Force Majeure such as strike, stoppage of labor, lockout
or other labor trouble, fire, flood, accident, act of God or of
government or of the public enemy of a PARTY, regulations, or laws of
any government; war, terrorist attack, civil commotion, epidemic,
failure of public utilities or
29
common carriers or by any cause unavoidable or beyond the reasonable
control of a PARTY ("FORCE MAJEURE").
14.2 However, the PARTY affected by such FORCE MAJEURE shall use its
reasonable efforts to avoid, remove or remedy such circumstances.
Either PARTY temporarily excused from performance hereunder by such
circumstances shall resume performance with utmost dispatch when such
circumstances are removed or remedied. Either PARTY claiming such
circumstances as an excuse for delay in performance shall give prompt
notice thereof and of the period for which such inability is expected
to continue. in writing to the other PARTY.
14.3 Neither PARTY shall be entitled to assign its rights and obligations
hereunder in whole or in part to a THIRD PARTY without the express
written consent of the other PARTY hereto which consent shall not
unreasonably be withheld, provided, however, that either party may,
without such consent, assign the AGREEMENT and its rights and
obligations but only IN TOTO, in connection with the transfer or sale
of all or substantially all of the assets of its business (or that
portion thereof to which this Agreement relates), or in the event of a
merger or consolidation or change of control or similar transaction.
This AGREEMENT shall be binding upon, and inure to the benefit of, each
PARTY, its AFFILIATES and permitted successors and assigns.
30
14.4 The invalidity or un-enforceability of an Article or any part of an
Article of the AGREEMENT in any jurisdiction shall not cause the
invalidity of the whole AGREEMENT as to such jurisdiction, and shall
not affect the validity or enforceability of such Article or such part
of an Article in any other jurisdiction. The PARTIES will replace any
Article or part of an Article found invalid or unenforceable with an
alternative which should as nearly as possible achieve the PARTIES
original intent.
14.5 No amendment of this AGREEMENT shall be valid or binding upon the
PARTIES hereto unless made in writing and duly executed on behalf of
each PARTY hereto.
14.6 The PARTIES hereto agree that the validity of this AGREEMENT and their
respective rights and obligations under it shall be governed by the
laws of the State of Delaware.
14.7 The PARTIES agree that if any dispute or disagreement arises between
them in respect to this AGREEMENT, they shall follow the following
procedure in an attempt to resolve the dispute or disagreement
amicably:
a. The PARTY claiming that such a dispute exists shall give notice in
writing to the other PARTY of the nature of the dispute.
b. Within fourteen (14) business days of receipt of such notice, a
nominee or nominees of deCODE and a nominee or nominees of BAYER
shall jointly decide the steps to be taken. If they do not agree
to a jointly accepted procedure, they shall meet at least once
within additional thirty (30) business days, in person, and
exchange written summaries reflecting, in reasonable detail, the
nature and extent of the dispute, and at this meeting they shall
use their reasonable endeavours to resolve the dispute.
c. If, within a further period of thirty (30) business days, the
dispute has not been resolved, or if for any reason, the required
meeting has not
31
been held, the PARTIES agree that any dispute may be referred to
arbitration according to Article 14.8.
14.8 All disputes between the PARTIES arising in connection with this
AGREEMENT shall, failing a settlement according to Section 14.7, be
referred to arbitration composed of a panel of three (3) persons, who
shall have knowledge of the pharmaceutical business. In such an event,
each PARTY shall appoint one (1) independent arbitrator, who together
shall jointly appoint a third arbitrator, who shall act as chairman. If
either PARTY fails to appoint an arbitrator within 30 days of request
by the other PARTY to so appoint, or if the arbitrators cannot agree on
a chairman, either PARTY or both PARTIES jointly, may submit a request
to the President of the Chamber of Commerce in Zurich, Switzerland, to
so appoint. The foregoing arbitration shall take place in Zurich. The
rules of procedure of the arbitration shall be governed by the Laws of
the Canton of Zurich, Switzerland. The language of the arbitration
shall be the English language. Judgment of the arbitration panel shall
be final and legally binding upon the PARTIES.
14.9 Any notice required to be given hereunder shall be considered properly
given if sent by registered letter or telex or telefax, prepaid, to the
applicable PARTY at the address set forth below:
Any notice to deCODE shall be addressed to:
deCODE Genetics, Ehf.
▇▇▇▇ ▇▇▇▇▇▇, PhD
Vice-President, Drug Discovery
Sturlugotu ▇
▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
main: ▇▇▇▇-▇▇▇-▇▇▇▇
32
GSM: [CONFIDENTIAL TREATMENT REQUESTED]
fax: ▇▇▇▇-▇▇▇-▇▇▇▇
with a copy to:
deCODE Genetics Ehf.
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ Esq.
Sturlugotu ▇
▇▇-▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
Phone: ▇▇▇▇-▇▇▇-▇▇▇▇
Any notice to BAYER shall be addressed to:
Bayer HealthCare AG
Division Pharma - BPA ICL
Gebaude Q 30
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Germany
Tel: ▇▇▇▇-▇▇▇-▇▇-▇▇▇▇▇
Fax: ▇▇▇▇-▇▇▇-▇▇-▇▇▇▇▇
with a copy to:
Bayer HealthCare ▇▇
▇▇▇ - L&P PL
Gebaude Q 18
▇-▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Germany
Tel: ▇▇▇▇-▇▇▇-▇▇-▇▇▇▇▇
Fax: ▇▇▇▇-▇▇▇-▇▇-▇▇▇▇▇
33
or to such other address for such PARTY as it shall have furnished
theretofore in writing to the other PARTY. If sent by mail, the date of
receipt shall be deemed to be one week from the date of mailing.
IN WITNESS WHEREOF the PARTIES have caused this AGREEMENT to be duly executed as
of the day and year first written above.
Leverkusen Reykjavik,
Date: Date:
Bayer HealthCare AG deCode genetics, Ehf.
/s/ ▇▇. ▇. ▇▇▇▇▇▇ /s/ Dr. W. van den Kerckhoff /s/ Dr. ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇. ▇. ▇▇▇▇▇▇ Dr. W. van den Kerckhoff Dr. ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
PH-Head of Int. Cooperation Patents and Licensing President & CEO
& Licensing Europe
34
SCHEDULE A: BAYER PATENTS
COMPOUND BAY X1005 (EP-B-344519 = LEA 26 119)
COUNTRY Filing Date PATENT-NO. EXPIRATION DATE
------------------------------------------------------------------------------------
DK 30.05.1989 169544 30.05.2009
NO 16.05.1989 174889 16.05.2009
FI 29.05.1989 91635 29.05.2009
HU 30.05.1989 207719 30.05.2009
HU 31.05.1995 211570 18.05.2009
PT 29.05.1989 90675 29.05.2009
IE 12.06.1989 61922 12.06.2009
ZA 30.05.1989 89-4093 30.05.2009
IL 29.05.1989 90435 29.05.2009
SG 30.03.1995 9590127 18.05.2009
PH 31.05.1989 38723* -
CN 15.05.1989 31912 15.05.2004
HK 16.03.1995 388-95 18.05.2009
KR 30.05.1989 131202 27.11.2012
TW 12.05.1989 44432 31.01.2006
JP 29.05.1989 2693576 29.05.2006
JP 23.05.1997 3076003 29.05.2006
US 19.05.1989 4970215 19.05.2009
CA 29.05.1989 1333802 03.01.2012
HN 22.02.1995 3477 22.02.2015
35
PA 10.08.1995 76772 18.05.2009
36
COUNTRY FILING DATE PATENT-NO. EXPIRATION DATE
------------------------------------------------------------------------------------
DO 03.03.1995 5182 16.11.2010
AR 15.03.1995 331346* Cancelled
AU 29.05.1989 616269 29.05.2009
NZ 26.05.1989 229310 26.05.2009
DE 18.05.1989 EDE 58904042.1 18.05.2009
SE 18.05.1989 ESE 89108895.7 18.05.2009
AT 18.05.1989 EAT 0344519 18.05.2009
GR 18.05.1989 EGR 0344519 18.05.2009
CH 18.05.1989 ECH 0344519 18.05.2009
IT 18.05.1989 EIT 0344519 18.05.2009
ES 18.05.1989 EES 0344519 18.05.2009
FR 18.05.1989 EFR 0344519 18.05.2009
BE 18.05.1989 EBE 0344519 18.05.2009
NL 18.05.1989 ENL 0344519 31.05.2009
GB 18.05.1989 EGB 0344519 18.05.2009
37
MANUFACTURING PROCESS (EP-B-509359 = LEA 28 305)
COUNTRY APPLICATION APPLICATION NUMBER OF DATE OF
NO. CODE NUMBER DATE ISSUE ISSUE TERM
----------------------------------------------------------------------------------------------------------
▇▇▇ ▇▇▇▇▇ ▇▇ 118492-92 1992-04-13 3224271 2001-08-24 2012-04-13
LEA ▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇ 1992-04-10 5306820 1994-04-26 2012-04-26
LEA 28305 US 01 164674 1993-12-08 5473076 1995-12-05 2012-12-05
LEA 28305 E AT 92105894.7 1992-04-06 EAT 0509359 2012-04-06
LEA 28305 E BE 92105894.7 1992-04-06 EBE 0509359 2012-04-06
LEA 28305 E CH 92105894.7 1992-04-06 ECH 0509359 2012-04-06
LEA ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 59205422.5 2012-04-06
LEA 28305 E DK 92105894.7 1992-04-06 EDK 0509359 2012-04-06
LEA 28305 E EP 92105894.7 1992-04-06 92105894.7 1996-02-28 ▇▇▇▇-▇▇-▇▇
▇▇▇ ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 EES 0509359 2012-04-06
LEA ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 EFR 0509359 ▇▇▇▇-▇▇-▇▇
▇▇▇ ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 EGB 0509359 2012-04-06
LEA ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 EGR 0509359 2012-04-06
LEA 28305 E IT 92105894.7 1992-04-06 EIT 0509359 2012-04-06
LEA 28305 E LU 92105894.7 1992-04-06 ELU 0509359 2012-04-06
LEA ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 ENL 0509359 2012-04-30
LEA ▇▇▇▇▇ ▇ ▇▇ 92105894.7 1992-04-06 92105894.7 2012-04-06
38
SCHEDULE B:
SPECIFICATION OF COMPOUND AND CERTIFICATE OF ANALYSIS
[CONFIDENTIAL TREATMENT REQUESTED]
39
SCHEDULE C:
DEVELOPMENT PLAN
[CONFIDENTIAL TREATMENT REQUESTED]
40
SCHEDULE D:
STUDY PLANS FOR EVALUATION OF [CONFIDENTIAL TREATMENT REQUESTED]
41
SCHEDULE E:
BAYER BAY X1005 REGULATORY FILINGS
- IND Reference No: # 37 130
- CTX Reference No: # 0010/0197/A
- German Clinical Trial Application No: # 6373 40