Exhibit
10.1
CONFIDENTIAL TREATMENT REQUESTED. Confidential
portions of this document have been redacted and have been
separately filed with the Commission.
LICENSE
AGREEMENT
This Agreement
made and entered into as of the 29 th day of September 2006 (the
“Effective Date” ) by and between
Kyowa Hakko Kogyo Co., Ltd. , a Japanese
corporation having its principal office at 1-6-1 Ohtemachi,
Chiyoda-ku, Tokyo, 100-8185, Japan (hereinafter referred to as
“KYOWA” ) and KERYX
Biopharmaceuticals, Inc. , a Delaware corporation having
its principal office at 750 Lexington Avenue, 20
th Floor, New York, New York 10022, the United
States of America (hereinafter referred to as
“KERYX” ). KYOWA and KERYX may be
individually referred to as a “Party”
or collectively referred to as
“Parties” .
WITNESSETH
WHEREAS, KYOWA has developed the Compound, and acquired
certain intellectual property rights relating to such
Compound;
WHEREAS, KYOWA has entered into a clinical trials
agreement with the National Cancer Institute under which
development of the Compound has been conducted;
WHEREAS, KERYX wishes to obtain a right and license from
KYOWA to such intellectual property rights in the Field and the
KERYX Territory;
WHEREAS, KYOWA is willing to grant such right and license
to KERYX, and KERYX is willing to accept such right and
license;
NOW,
THEREFORE, the
Parties agree as follows:
In this
Agreement the following terms shall have the following
meanings:
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1.1.
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“Affiliates”
shall mean, with respect to either
Party, any business entity which controls, is controlled by, or is
under common control with such Party. A corporation or
non-corporate business entity shall be regarded as in control of
another corporation if it owns or directly or indirectly controls
more than fifty percent (50%) of the voting stock of the other
corporation.
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“Annual Payment”
shall have the meaning set forth in
Section 8.6.
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“Approval”
shall mean the technical, medical
and scientific license, registrations, authorizations and approvals
of any national, supra-national, regional, state or local
regulatory agency, necessary for the development, testing,
commercial manufacture, distribution, marketing, promotion, offer
for sale, use, import, export and sale of a Product.
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“Authority”
shall mean a governmental authority
having jurisdiction over import, export, development, manufacture,
marketing or sales of pharmaceutical products, not limited to the
FDA.
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“Business Day”
shall mean a day other than a
Saturday, Sunday, national or bank holiday in Japan or the United
States of America.
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“Combination
Product” shall
mean any pharmaceutical product in finished form which contains the
Compound and one or more active pharmaceutical ingredients other
than the Compound, which is used in the Field.
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“Combination
Therapy” shall
mean the use of Compound as an active pharmaceutical ingredient in
the Product, which is used with other pharmaceutical products in
the Field.
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“Compound”
shall mean KW-2401 (UCN-01), the
chemical structure of which is specified in Exhibit 1
hereof.
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“Control”,
or
“Controlled” means, with respect to a
particular information or intellectual property right, (i) that the
Party owns and has the ability to grant to the other Party the
licenses to such item provided for herein, without violating the
terms of any agreement or other arrangement with any Third Party,
and/or (ii) that the Party has a license to such item and has the
ability to grant to the other Party the licensees to such item
provided for herein, without violating the terms of any agreement
or other arrangement with any Third Party.
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“Data” shall mean and include all data relating to the
Compound and the Product, and all chemistry, manufacturing and
control data relating to the development and manufacture of the
Compound and the Product, results of pre-clinical and clinical
studies and all other documentation containing or embodying any
pre-clinical, clinical and chemistry and manufacturing and control
data relating to any application for any Approval for a
Product.
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“Development Plan”
shall mean a written plan to be
prepared by KERYX for all activities that are reasonably required
to obtain MAA and/or NDA for the Product in the KERYX Territory.
The Development Plan as of the Effective Date is attached hereto as
Exhibit 5.
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“EMEA” shall mean the European Agency for the
Evaluation of Medicinal Products in the European Union.
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“Expiration”
of a patent shall mean the
expiration, abandonment or cancellation of all of the claims of the
patent which are being practiced, or, the declaration of invalidity
or non-enforceability of all the claims of the patent being
practiced by a court or other governmental authority of competent
jurisdiction (including final rejection in re-examination or
re-issue proceedings) for which the period to file an appeal has
expired, and from which no further appeal has been taken during the
applicable appeal period or is not allowed to be taken against such
declaration.
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“FDA” shall mean the Food and Drug Administration of
the United States Department of Health and Human
Services.
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“Field” shall mean the treatment and prevention of any
diseases in human beings.
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“Gross Sales”
of the Product made by KERYX or the
Sublicensees shall mean the aggregate total amount of the invoice
prices charged for such Product in Product sales, computed in
respect of invoice applicable to the transfer between parties
constituting an arm’s-length sales transaction. Sales,
transfer or other disposition of the Product among KERYX, the
Sublicensees and their respective Affiliates shall not be
considered at-arm’s-length.
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“Improvement”
shall mean any invention and/or
Know-How made or developed after the Effective Date, whether
patentable or not, that improves any characteristics or use of the
Compound and/or the Product, including but not be limited to, the
use of the Compound in Combination Product or in Combination
Therapy, or any new Indications of the Product.
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“Indication”
shall mean a recognized disease or
condition, sign or symptom of a disease or condition, or symptom
associated with the disease and symptom for which use of a Product
is indicated. For purposes of this Agreement and the payment of
milestones, all cancer disease, conditions or symptoms shall
collectively qualify as one indication.
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“KERYX Data”
shall mean any Data Controlled by
KERYX, which has been developed or acquired by KERYX or the
Sublicensees during the Term. KERYX Data shall include, but not be
limited to, the Data regarding KERYX Improvements.
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“KERYX Improvements”
shall mean any Improvements
Controlled by KERYX, which have been developed by or otherwise
brought under the Control of KERYX or the Sublicensees during the
Term.
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“KERYX Territory”
shall mean any and all countries of
the world other than the KYOWA Territory.
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“Know-How”
shall mean any technical and other
information, whether patentable or not, including without
limitation technology, experience, formulae, concepts, discoveries,
trade secrets, inventions, modifications, improvements, data,
results, designs, formulae, ideas, analyses, methods, techniques,
assays, research plans, procedures, tests, processes (including
manufacturing processes, specifications and techniques), laboratory
records, chemical, pharmacological, toxicological, clinical,
analytical and quality control data, reports, summaries, and
information contained in submissions to, and information from,
regulatory authorities which are not generally known.
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“KYOWA Data”
shall mean any Data in the Field
which has been developed or acquired by KYOWA and under
KYOWA’s Control as of the Effective Date or which has been
developed by or brought under the Control of KYOWA during the Term.
KYOWA Data shall include, but not limited to, any documents filed
with regulatory agencies and the Data regarding KYOWA Improvements.
For clarity, KYOWA Data shall not include the NCI Data.
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“KYOWA Improvements”
shall mean any Improvements in the
Field Controlled by KYOWA, which have been developed by or
otherwise brought under the Control of KYOWA during the Term. For
clarity, KYOWA Improvements shall not include the NCI
Data.
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“KYOWA Know-How”
shall mean any Know-How relating to
the Compound in the Field Controlled by KYOWA and KYOWA Data which
has been developed or acquired by KYOWA as of the Effective
Date.
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“KYOWA Patent Rights
A” shall mean
the Patent Rights in the Field owned or Controlled by KYOWA as of
the Effective Date relating to the Compound as listed in Exhibit 2,
and any additional Patent Rights in the Field to which KYOWA
acquires rights during the Term , which pertain in any way to the
Compound or the Product. Exhibit 2 shall be updated from time to
time by KYOWA.
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“KYOWA Patent Rights
B” shall mean
the Patent Rights in the Field owned or Controlled by KYOWA as of
the Effective Date as listed in Exhibit 3, and any additional
Patent Rights in the Field to which KYOWA acquires rights during
the Term, which pertain in any way to the subject matter claimed or
disclosed in the Patent Rights listed in Exhibit 3. Exhibit 3 shall
be updated from time to time by KYOWA.
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“KYOWA Patent
Rights” shall
mean any Patent Rights of KYOWA Patent Rights A and KYOWA Patent
Rights B.
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“KYOWA Territory”
shall mean Japan.
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“Launch Date”
shall mean the date set forth in
Section 8.4.
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“Lonza” shall mean Lonza Ltd. headquartered at Basel,
Switzerland.
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“MAA” shall mean the Market Authorization Application
to be filed with the EMEA.
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“Major Countries”
shall mean the United Kingdom,
Germany, France, Italy, Spain and Switzerland.
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“NCI” shall mean National Cancer Institute.
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“NCI Agreement”
shall mean the Clinical Trials
Agreement executed between KYOWA and NCI on September 24, 1999
including its amendments thereafter.
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“NCI Data”
shall mean the Data which has been
developed or acquired by NCI under NCI Agreement.
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“NDA” shall mean the new drug application to be filed
with the FDA.
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“Net Sales”
shall mean the Gross Sales of the
Product made by KERYX or the Sublicensees, less the following
deductible items to the extent that they are documented on the
applicable invoice or other related document and have in fact been
paid or credited in relation to sales of such Product:
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the cost of
transportation and insurance;
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the cost of
rebates, and allowances
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the sum of
trade, quantity and cash discounts;
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the cost of
refunds as cash, credit or free goods supplied due to price
reduction, including retroactive price reduction, or billing
errors;
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the cost of
refunds as cash, credit or free goods supplied in compensation for
the Product damaged, rejected, returned or recalled;
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the sum of
taxes, tariffs, customs duties and other governmental charges
including mandated credits, refunds and rebates paid with respect
to such sales, however, excluding income or franchise taxes of any
kind; and
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all other
reasonable and customary allowances and adjustments actually
credited to customers.
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The Net Sales
shall be calculated according to the generally accepted accounting
principles consistently applied in the United States of America. In
the case the Product is a Combination Product, the Net Sales of the
Combination Product shall be the Gross Sales thereof (after the
above deductible items) multiplied by the fraction which the
Parties determine by mutual written agreement, estimating each
relative contribution in value that the Compound and other active
pharmaceutical ingredients contained in such Combination Product
would make to the total value of such Combination Product, as well
as, the cost of development, the cost of goods and other relevant
information with respect to such Combination Product, provided that
such fraction should not go below one half (0.5).
The sale of a
Product between KERYX and any of its Sublicensees solely for the
research and testing of such Product shall be excluded from the
computation of Net Sales.
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“Patent Rights”
shall mean all issued patents and
patent applications, certificates of invention, or applications for
certificates of invention, together with any extensions,
registrations, provisionals, divisionals, continuations,
continuations-in-part (to the extent the claims in such
continuation-in-part application are directed to subject matter
specifically described in such prior patent application), and
patents issuing therefrom, reissues, divisions, continuations, or
continuations-in-part, reexaminations, substitutions, renewals,
restorations, additions, registrations, as well as extensions and
supplementary protection certificates based thereon, and any
government Approvals or authorizations relating thereto.
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“Product”
shall mean any pharmaceutical
product in finished form which contains the Compound as an active
pharmaceutical ingredient. For avoidance of doubt, the Combination
Product is a Product.
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1.41.
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“Royalty”
or
“Royalties” shall mean the royalties
set forth in Sections 8.3, 8.4 and 8.5.
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1.42.
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“SPC” shall mean the supplementary protection
certificates in Europe and any similar rights elsewhere in the
world.
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1.43.
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“Strain”
shall mean the strain which produces
the starting material (staurosporine) for the Compound. The
identification of the strain and the quantity to be transferred is
set forth in Exhibit 4.
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1.44.
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“Sublicensee”
shall mean any Third Party to which
KERYX grants a sublicense under the KYOWA Patent Rights and the
KYOWA Know-How according to Section 4.
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1.45.
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“Term” shall mean the term set forth in Section
27.1.
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1.46.
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“Third Party”
shall mean any entity other than
KYOWA, KERYX and their respective Affiliates. .
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SECTION
2. INTERPRETATION
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2.1.
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Headings and
titles are inserted for convenience only and shall not affect the
interpretation hereof;
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2.2.
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Unless the
context requires otherwise, neither singular nor plural of a word
shall not affect the interpretation hereof;
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3.1.
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KYOWA hereby
grants to KERYX an exclusive right and license, with the right to
sublicense, under the KYOWA Patent Rights A and KYOWA Patent Rights
B (subject to Sections 8.6 and 27.3) and the KYOWA Know-How to
make, have made, use, have used, sell, offer for sale, have sold
and distribute the Product in the KERYX Territory within the
Field.
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3.2.
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KYOWA hereby
grants to KERYX an exclusive right and license, with the right to
sublicense, under the KYOWA Patent Rights A and KYOWA Patent Rights
B (subject to Sections 8.6 and 27.3) and the KYOWA Know-How to make
and have made, use and have used the Compound in the KERYX
Territory within the Field.
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3.3.
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KYOWA hereby
grants to KERYX an exclusive right and license, with the right to
sublicense, under the KYOWA Improvements to make, have made, use,
have used, sell, have sold, offer for sale and distribute the
Product in the KERYX Territory within the Field.
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3.4.
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KYOWA hereby
grants to KERYX an exclusive right and license, with the right to
sublicense, under the KYOWA Improvements to make and have made, use
and have used the Compound in the KERYX Territory within the
Field.
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3.5.
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KYOWA hereby
grants to KERYX a non-exclusive right and license, with the right
to sublicense in the KERYX Territory to use, have used the Strain
in order to make, or have made the Compound within the
Field.
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3.6.
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Notwithstanding
the above Sections 3.1 to 3.5, KYOWA reserves the right to make and
have made the Compound and/or the Product in the KERYX Territory
for the sole purpose of developing and marketing the Product in the
KYOWA Territory.
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3.7
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Except as
otherwise expressly provided in this Agreement, KYOWA hereby grants
to KERYX the right to file with the appropriate Authorities all
applications and other materials needed to obtain the Approvals
necessary to implement this Agreement and protect the respective
rights of the Parties, and KYOWA shall provide KERYX with
reasonable assistance in such filings.
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4.1
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KERYX shall
make and shall have Sublicensees make commercially reasonable
efforts to develop, to manufacture, to market, and to sell the
Product within the KERYX Territory. When KERYX makes any changes to
the Development Plan, KERYX shall notify KYOWA and update Exhibit 5
accordingly. By the end of the month immediately following the
month of the yearly anniversary of the Effective Date, KERYX shall
provide KYOWA with a written report outlining such efforts made by
KERYX and the Sublicensees during the previous one (1) year period
between anniversaries of the Effective Date.
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4.2
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KERYX shall
immediately notify KYOWA in writing upon commencement of each phase
in clinical studies conducted by KERYX or, if applicable, by
Sublicensees. KERYX shall provide any relevant documents, upon
request from KYOWA.
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4.3
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Within ten (10)
Business Days after KERYX or the Sublicensee is officially notified
by the Authority that the Approval for sales of the Product in the
KERYX Territory is granted by such Authority, KERYX shall notify or
have such Sublicensee notify KYOWA in writing, and shall send or
have such Sublicensee send to KYOWA a copy of (1) the certificates
for such grant and (2) any related documentation.
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KERYX shall
have the right to grant a sublicense under the license granted
hereunder, provided:
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5.1.
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that KERYX
shall obtain KYOWA’s prior written approval, which shall not
be unreasonably withheld;
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5.2.
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that, KERYX
shall notify KYOWA in writing of (a) the identity of such intended
Sublicensee and (b) the key terms and conditions of such intended
sublicense;
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5.3.
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that, KERYX
shall not substantially change the key terms and conditions of the
sublicense without prior written consent of KYOWA, which shall not
be unreasonably withheld;
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5.4.
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that, the
Sublicensee shall not grant a further sublicense hereunder without
KYOWA’s prior written consent, provided that KYOWA shall not
unreasonably withhold such consent.
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5.5.
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that KERYX
shall be responsible for the Sublicensee’s compliance with
all the obligations under this Agreement which apply to such
Sublicensee;
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5.6.
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that, KERYX
shall defend and indemnify KYOWA with respect to any claims arising
out of KERYX’s acts or failure to act relating to such
sublicense;
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5.7.
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that such
sublicense shall be subject to termination upon expiration or early
termination of this Agreement for any cause; and
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5.8.
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that the
Royalties shall be payable to KYOWA from KERYX with respect to the
Net Sales by any Sublicensee, regardless of whether or not the
Sublicensee has actually paid any royalties due to
KERYX.
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SECTION
6. DATA TRANSFER AND ASSISTANCE
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6.1.
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KYOWA shall
provide KERYX with KYOWA Data and KYOWA Know-How reasonably
required for production, development and regulatory approval of the
Product in the field of the treatment and prevention of cancer
(“Cancer-field”), at KYOWA’s reasonable judgment,
within one (1) month of the Effective Date. KYOWA shall continue
providing any KYOWA Data in the Cancer-field during the Term. KYOWA
shall also provide KERYX with KYOWA Data in the field other than
Cancer-field, if any, when KYOWA completes the preparation for
clinical studies, at the latest, Provided however, KYOWA has no
obligations to acquire any new KYOWA Data. KERYX agrees that any
KYOWA Data shall be held in confidence pursuant to Section 15
below.
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6.2.
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KYOWA Data
shall be transferred on “as is” basis. Notwithstanding
the foregoing, in the event that KERYX requests KYOWA to translate
KYOWA Data from Japanese to English, and KYOWA accepts such
request, such KYOWA Data may be transferred to KERYX from KYOWA in
English after a reasonable period for such translation. KERYX shall
bear the costs and expenses of such translation.
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6.3.
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The ownership
of KYOWA Data transferred to KERYX from KYOWA hereunder shall
remain with KYOWA. KERYX may utilize such KYOWA Data only for
exercise of the rights granted to KERYX by KYOWA hereunder and for
no other Purpose.
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6.4
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Within three
(3) months from the Effective Date, at a time mutually agreed by
the Parties, KYOWA will host a technical review meeting (up to two
days) in Tokyo to provide KERYX an opportunity to discuss and ask
questions about the KYOWA Data and KYOWA Know-How with
knowledgeable KYOWA staff to ensure no misunderstanding or
confusion exists. To facilitate the meeting KERYX will provide to
KYOWA, at least two (2) weeks in advance of the meeting, a written
summary of questions or areas to be discussed. Each Party shall
bear their own expenses for the meeting.
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6.5.
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During the
first two (2) years from the Effective Date, KYOWA will answer by
letter, facsimile or email to the questions which KERYX may have
regarding the KYOWA Data. KERYX shall notify KYOWA in writing as to
whom KERYX designates among its employees, officers and directors
as its contact person for such assistance.
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SECTION
7. STRAIN TRANSFER, TECHNICAL ASSISTANCE AND
MANUFACTURE
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7.1.
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KYOWA shall
provide KERYX with technical information concerning the cultivation
of the Strain and instruction for maintenance of Strain purity and
potency (“Strain Information”) within one (1) month of
the Effective Date.
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KYOWA shall
provide KERYX or a contract manufacturer designated by KERYX with
the Strain within thirty (30) days after specific site is
instructed to KYOWA by KERYX. Such thirty (30)-day period shall
exclude the period of time required to obtain permission from the
Authorities for the transfer of the Strain, if necessary. Upon
request of KERYX, KYOWA may arrange culture media for the Strain as
set forth in Exhibit 4 for KERYX at KERYX’s cost.
The Parties acknowledge that the Strain and the
Strain Information are a part of KYOWA Know-How.
KERYX shall be
responsible for maintaining the cell bank of the Strain. In the
case KERYX requests additional supply of the Strain, KYOWA may
charge reasonable costs for such supply.
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7.2.
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During the two
(2) year period immediately following the Effective Date, KYOWA
shall, at KERYX’s written request and KYOWA’s
reasonable consent as to timing, duration and the number of
employees, KYOWA shall send its employees to KERYX’s
designated premises during KERYX’s normal business hours, to
instruct KERYX’s employees, officers or directors for
cultivation of the Strain and manufacture of the Compound on
non-commercial scale.
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*****Confidential material redacted and filed
separately with the Commission.
The total
working man-hours shall not exceed two hundred (200) working
man-hours. At one premise, the working man-hours per day per person
shall be at least eight (8) hours.
The rate of
man-hour is ***** per working man-hour. No charge shall be payable
for ***** (other than out-of-pocket disbursements). Travel time
shall not be considered the time for such technical
assistance.
KERYX shall
bear KYOWA’s out-of-pocket costs and disbursements including
translation costs for relevant documents incurred in connection
with the technical assistance, including hotel accommodation and
business class air transportation.
KERYX shall
make payment for these items specified in this Section 7.2 in US
Dollars within two (2) months of KERYX’s receipt of
KYOWA’s invoice therefor.
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7.3.
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KYOWA shall
make reasonable efforts to provide the technical assistance to make
the information understood by KERYX, provided however, KYOWA shall
not guarantee the manufacture of the Compound by KERYX or its
designated contract manufacturer. KERYX shall be solely responsible
for manufacture of the Compound, and KYOWA will not supply any
Compound to KERYX for the purposes of conducting clinical trials.
KYOWA will supply to KERYX reasonable quantity of Compound for the
purposes of demonstration of regulatory equivalency or as
analytical standard. KYOWA will charge KERYX for such Compound at
*****.
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SECTION
8. CONSIDERATIONS
KERYX shall pay
to KYOWA a non-refundable, one-time payment of Six Hundred Thousand
US Dollars (US$600,000) within fifteen (15) days of the Effective
Date.
In
consideration for the rights and license granted to KERYX by KYOWA
with respect to KYOWA Patent Rights A and related KYOWA Know-How
pursuant to Section 3, KERYX shall pay to KYOWA the following
non-refundable, one-time milestone payments:
1. ***** within
twenty-four (24) months of the Effective Date;
2. For the
first Indication:
(i) *****
within ninety (90) days of KERYX’s or its Sublicensee’s
initiation of the Phase III clinical trial for the
Product;
(ii) *****
within ninety (90) days of the earlier to occur of the following:
(a) KERYX’s or its Sublicensee’s filing of NDA for the
Product in the USA, or (b)KERYX’s or its Sublicensee’s
filing of MAA for the Product in the EU.
(iii) *****
within ninety (90) days from the day KERYX or its Sublicensee
obtains the first marketing Approval from FDA for the
Product;
*****Confidential material redacted and filed
separately with the Commission.
(iv) ***** within ninety (90) days from the day
KERYX or its Sublicensee obtains the first marketing Approval for
the Product in a first country of the Major Countries.
3. For the
second Indication:
(i) *****
within ninety (90) days of KERYX’s or its Sublicensee’s
initiation of the Phase I clinical trial for the
Product;
(ii) *****
within ninety (90) days of KERYX’s or its Sublicensee’s
initiation of the Phase III clinical trial for the
Product;
(iii) *****
within ninety (90) days of the earlier to occur of the following:
(a) KERYX’s or its Sublicensee’s filing of NDA for the
Product in the USA, or (b)KERYX’s or its Sublicensee’s
filing of MAA for the Product in the EU.
(iv) *****
within ninety (90) days from the day KERYX or its Sublicensee
obtains the first marketing Approval from FDA for the
Product;
(v) *****
within ninety (90) days from the day KERYX or its Sublicensee
obtains the first marketing Approval for the Product in a first
country of the Major Countries.
In
consideration for the rights and license granted to KERYX by KYOWA
with respect to KYOWA Patent Rights A and related KYOWA Know-How
pursuant to Section 3, KERYX shall pay to KYOWA a royalty fee of
***** the annual Net Sales in each country.
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8.4
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The payment set
forth in 8.3 shall begin from the first commercial sales of the
Product in each country ( “Launch
Date” ) and continue with respect to each Product
until the later to occur of the following: *****.
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Upon occurrence
of (a) or (b) set forth in Section 8.4, and for additional *****
from such date, KERYX shall pay to KYOWA a royalty fee of ***** the
annual Net Sales of the Product in such country.
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KERYX shall pay
to KYOWA a non-refundable, annual payment of ***** each year in
consideration for the rights and license granted to KERYX by KYOWA
pursuant to Section 3 with respect to KYOWA Patent Rights B and
related KYOWA Know-How ( “Annual
Payment” ). The first payment shal
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