LICENSE AGREEMENT
EXHIBIT
10.21
CONFIDENTIAL
TREATMENT REQUESTED. Confidential portions of this document have been redacted
and have been separately filed with the Commission.
THIS
LICENSE AGREEMENT
(the “Agreement”), effective as of this 7th
day of November 2005 (the “Effective Date”), by and between Panion & BF
Biotech, Inc., with offices at 16F Xx. 0, Xxxxxx Xxxxxx, Xxxxxxx Xxxxxxxx,
Xxxxxx, Xxxxxx, ROC (hereinafter "Licensor"), and Keryx Biopharmaceuticals,
Inc,
with offices at 000 Xxxxxxxxx, 00xx
Xxxxx, Xxx Xxxx, XX 00000 (hereinafter "Licensee").
WHEREAS,
Xx. Xxxx Xxxxx Xxx (the "Inventor"), an employee of the University of Michigan
(the "Institution"), is the named inventor on U.S. Patent No. 5,753,706, issued
May 19, 1998 and entitled "Methods for Treating Renal Failure" (the "Licensed
Patent Property"),
WHEREAS,
the Institution has transferred to the Inventor all of the Institution's right,
title, and interest in and to the Licensed Patent Property (subject to certain
non-commercial applications, specified below), by an Agreement for the
Reassignment of Intellectual Property, with a last-signed date of August 16,
2000,
WHEREAS,
the Inventor has granted the Licensor the exclusive license, throughout the
world (except the People's Republic of China) to make, use, and sell products
embodying the inventions described in the Licensed Patent Properties, as well
as
rights to the Patent Rights (as hereinafter defined) (as specified below) (the
"Exclusive License"),
WHEREAS,
Licensor has developed certain Licensor Know-How (as hereinafter
defined),
WHEREAS,
by operation of this exclusive license, Licensor is the sole and exclusive
licensee of the entire right, title and interest in and to the Patent Rights
(with the exception of the People's Republic of China) and Licensor
Know-How,
WHEREAS,
Licensee desires to obtain an exclusive license under such Patent Rights and
Licensor Know-How to develop, have developed, make, have made, use, have used,
offer to sell, sell, have sold, import and export the Compound and Product
in
the Territory (as hereinafter defined), and
WHEREAS,
Licensor has the authority and is willing to grant such license to Licensee,
and
Licensee is willing to accept such license from Licensor, under the terms and
conditions set forth in this Agreement.
NOW
THEREFORE,
in consideration of the mutual promises and covenants set forth herein and
other
good and valuable consideration, the receipt of which is hereby acknowledged,
the parties hereto agree as follows:
ARTICLE
1. DEFINITIONS
As
used in this Agreement, the following terms, whether used in the singular or
the
plural, shall have the following meanings:
1.1
"Affiliate"
means any corporation or non-corporate business entity, which controls, is
controlled by, or is under common control with a party to this Agreement. A
corporation or non-corporate business entity shall be regarded as in control
of
another corporation if it owns or directly or indirectly controls at least
fifty-one percent (51%) of the voting stock of the other corporation, or (i)
in
the absence of the ownership of at least fifty-one percent (51%) of the voting
stock of a corporation, or (ii) in the case of a non-corporate business entity,
if it possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or non-corporate
business entity, as applicable.
1.2
“Combination
Product”
means a Product containing one or more therapeutically active ingredients in
addition to the Compound.
1.3 "Compound"
means ferric citrate (PBF1681).
1.4
"FDA"
means the United States Food and Drug Administration.
1.5 “Field”
means the field of nephrology.
1.6 “First
Commercial Sale”
means with respect to a Product, the first sale for end use or consumption
of
such Product in a country after all Registrations in such country have been
obtained.
1.7
"IND"
means an Investigational New Drug Application in the United States.
1.8
"Indication"
means any therapeutic application for a Product (i) for the treatment of
hyperphosphatemia in end-stage renal disease, and (ii) for all other indications
covered by the Patent Rights.
1.9 “Improvements”
means any and all improvements, materials, technical data and information
whether patented or unpatented, including but not limited to any changes to
the
Compound, to the Product or in the Licensor Know-How or Licensee Know-How
including, but not limited to any analogues, or derivatives of the Compound,
and
changes in the manufacturing process for the Compound or the Product which
are
conceived or reduced to practice during the term of this Agreement.
1.10
“Licensee
Development Data”
means and includes all data relating to the Compound or the Product and all
chemistry, manufacturing and control data relating to the development and
manufacture of the Compound or the Product, results of pre-clinical and clinical
studies and all other documentation containing or embodying any pre-clinical,
clinical, chemistry, manufacturing and control data relating to any application
for Registrations for a Product, which is generated by Licensee, its agents,
or
any Sublicensees during the term of this Agreement.
1.11 “Licensee
Know-How”
means all information and materials, including but not limited to, discoveries,
processes, instructions, formulas, data, inventions, know-how and trade secrets,
patentable or otherwise, which arise out of the development, manufacture and
commercialization by Licensee of the Compound or the Product, including, without
limitation, all biological, chemical, pharmacological, toxicological,
pharmaceutical, physical, analytical, clinical, safety, manufacturing and
quality control data and information related thereto, and all applications,
registrations, licenses authorizations, documents, approvals and correspondence
relating to the Compound or the Product, including without limitation,
correspondence submitted to Regulatory Authorities, and all information and
data
contained in Registrations. Licensee Know-How shall also include Licensee’s
interest in Improvements.
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1.12
“Licensor
Development Data”
means and includes all data to which Licensor has rights relating to the
Compound or the Product and all chemistry, manufacturing and control data
relating to the development and manufacture of the Compound or the Product,
results of pre-clinical and clinical studies and all other documentation
containing or embodying any pre-clinical, clinical, chemistry, manufacturing
and
control data relating to any application for Registrations for the Product,
whether such Licensor Development Data is in existence as of the Effective
Date
or generated by Licensor during the term of this Agreement.
1.13
"Licensor
Know-How” means all information and materials to which Licensor has rights,
including but not limited to, discoveries, processes, formulas, instructions,
data, inventions, know-how and trade secrets, patentable or otherwise, in each
case, which as of the Effective Date and during the term of this Agreement
are
necessary or useful to Licensee in connection with the development,
registration, manufacture, marketing, use or sale of a Product. Licensor
Know-How shall also include without limitation, all biological, chemical,
pharmacological, toxicological, pharmaceutical, physical, analytical, clinical,
safety, manufacturing and quality control data and information related thereto,
and all applications, registrations, licenses, authorizations, documents,
approvals and correspondence relating to a Licensed Compound or a
Product. Licensor
Know-How shall also include Licensor’s interest in Improvements.
1.
14 "NDA"
means a New Drug Application in the United States.
1.15 "Net
Sales"
with respect to any Product other than a Combination Product means the gross
sales (i.e. gross invoice prices) of such Product billed by Licensee and its
Sublicenses to Third Party customers on all sales of a Product, and exclusive
of
inter-company transfer or sales, less the reasonable and customary deductions
from such gross sales, including:
(i)
actual credited allowances to such Third Party customers for spoiled, damaged,
outdated and returned Product and for retroactive price reductions,
(ii)
the amounts of trade, cash discounts and rebates, to the extent such discounts
and rebates were not deducted by Licensee or its Sublicensees at the time of
invoice in order to arrive at the gross invoice prices,
(iii)
all transportation, handling charges and freight insurance, sales taxes, excise
taxes, use taxes or import/export duties paid, and
(iv)
all other reasonable and customary allowances and adjustments actually credited
to customers whether during the specific royalty period or not.
3
The
sale of a Product between Licensee and any of its Sublicensees solely for the
research or clinical testing of such Product shall be excluded from the
computation of Net Sales of such Product, provided that Licensee's sale of
the
Product was at cost, and such Product was used for research or clinical testing.
1.16
"Net
Sales"
with respect to any Combination Product means the gross sales of such Product
billed by Licensee and its Sublicensees to Third Party customers, on all sales
of a Combination Product, and exclusive of inter-company transfer or sales,
less
all the allowances, adjustment, reductions, discounts, taxes, duties and other
charges referred to in Section 1.15,
multiplied by a fraction
to be determined
by Licensor and Licensee at such time when the Combination Product becomes
available.
The
sale of a Combination Product between Licensee and any of its Sublicensees
solely for the research or clinical testing of such Product shall be excluded
from the computation of Net Sales for such Combination Product, provided that
Licensee's sale of the Combination Product was at cost, and such Combination
Product was used for research or clinical testing.
1.17
"Patent
Rights"
means the Licensed Patent Property,
and the patents and patent applications set forth in Exhibit
1
(which shall be updated from time to time by Licensor), patents and patent
applications in which Licensor holds rights and which are directed to Licensor’s
interest in Improvements, and any and all patents in which Licensor holds rights
and that may issue from all such patent applications, including any and all
divisions, continuations, continuations-in-part, extensions, substitutions,
renewals, registrations, supplementary protection certificates, revalidations,
reissues or additions of or to any of the aforesaid patents and patent
applications, and any additional patents or patent applications to which
Licensor acquires rights during the term of this Agreement which pertain in
any
way to the use or manufacture of the Compound or the Product.
1.18 “Payment
Default”
means Licensee’s failure to pay Licensor the license fee and milestone payments
under Article 4, and the royalties under Article 5 for more than 90 days past
the date on which these amounts are due.
1.19 "Product"
means the Compound or any pharmaceutical product containing the Compound as
an
active ingredient, either alone or in combination with other active
ingredients.
1.20 “Proprietary
Information”
means all information, including without limitation all Licensee Know-How,
Licensor Know-How, and all other scientific, clinical, regulatory, marketing,
financial and commercial information or data, whether communicated in writing,
orally or electronically which is provided by one party to the other party
in
connection with this Agreement.
1.21
"Registration"
in relation to any Product means such approvals by a Regulatory Authority in
a
country or community or association of countries as may be legally required
before such Product may be commercialized in such country or community or
association of countries.
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1.22
“Regulatory
Authority”
means the applicable government regulatory authority in each country in the
Territory involved in granting regulatory approval for the Product. Such term
includes, without limitation, the FDA and any successor agency thereto and
Committee on Proprietary Medicinal Products of the European Community and any
successor agency thereto
1.23
“Sublicensee”
means a Third Party to which Licensee has granted sublicense rights under the
license granted Licensee hereunder, which rights include at least the right
to
sell the Product. Third Parties that are permitted to manufacture the Compound
or the Product for supply only to Licensee or only to Sublicensees are not
“Sublicensees” and such transaction shall be deemed a transfer and not a sale of
the Product.
1.24 "Territory"
means the entire world, provided that (a) excluded from the Territory
are
China, Korea, and all other countries in the Asian Pacific Region, except that
(b) included within the Territory is
Japan.
1.25
"Third
Party"
means any party other than Licensor or Licensee or their respective Affiliates,
or Sublicensees of Licensee or its Sublicensees.
1.26
"Valid
Claim"
means a claim of an issued and unexpired patent included within the Patent
Rights which has not been held unenforceable or invalid in the applicable
jurisdiction by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal,
and
which has not been admitted to be invalid or unenforceable through dedication,
disclaimer or otherwise.
ARTICLE
2. REPRESENTATIONS AND WARRANTIES
2.1 Each
party represents and warrants to the other party that it has the full right
and
authority to enter into this Agreement, and that, to the best of its knowledge,
there are no prior agreements, commitments or other obstacles which could
prevent it from carrying out all of its obligations hereunder.
2.2 Licensor
represents to Licensee that:
(a) it
is the exclusive licensee of the entire right, title and interest in and to
the
Patent Rights, and to the best of its knowledge, there
are no charges, encumbrances, licenses, options,
restrictions, liens, rights of others, disputes, proceedings or claims relating
to, affecting, or limiting its rights or the rights of
Licensee under this Agreement, with the exception of non-commercial uses of
the
Licensed Patent Properties reserved to the Institution;
(b) there
is no claim, pending
or threatened, of infringement, interference or invalidity regarding
any
part or all of the Patent Rights and their use as contemplated in this
Agreement, and it has no present knowledge from which it can be inferred that
the Patent Rights are invalid or that their exercise would infringe the patent
rights of any Third Party;
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(c) it
has the right to enter into this Agreement and to grant the licenses granted
herein,
and
there is nothing in any Third Party agreement Licensor has entered into as
of
the Effective Date, which in any way, will limit the ability of Licensor to
perform any and all of
the obligations undertaken by Licensor hereunder,
(d) it
will not enter into any agreement after the Effective Date which will limit
its
ability to perform any and all of the obligations undertaken by Licensor
hereunder
(e) it
has delivered to Licensee all Licensor Development Data and Licensor Know-how;
and
(f) to
the best of its knowledge,
neither this Agreement, nor any document or piece of Licensor Development Data,
Licensor Know-How or Patent Rights contains any untrue statement of a material
fact or omits to state a material fact necessary in order to make the statements
contained herein or therein misleading.
2.3 Licensee
represents to Licensor that:
(a) it
has the right to enter into this Agreement and to the best of its knowledge,
there
is nothing in any Third Party agreement Licensee
has
entered into as of the Effective Date, which in any way, will limit the ability
of Licensee
to perform any and all of the obligations undertaken by Licensee hereunder,
and
(b) it
will not enter into any agreement after the Effective Date which will limit
its
ability to perform any and all of the obligations undertaken by Licensee
hereunder.
ARTICLE
3. LICENSE GRANT
3.1 Grant.
Subject to the terms and conditions of this Agreement, Licensor hereby grants
to
Licensee an exclusive license, in the Territory, with the right to sublicense,
to develop, have developed, make, have made, use, have used, offer to sell,
sell, have sold, and import and export the Product in the Territory under the
Licensor Know-How, and the Patent Rights for all Indications in the Field.
3.2 Sublicensing. Sublicensees
of Licensee shall be entitled to sublicense to third parties the right to
manufacture the Product, provided such third party manufacturers are permitted
to sell only to Licensee or its immediate Sublicensees. Sublicensees of Licensee
may not grant sublicenses under this Agreement without the written consent
of
Licensor, which consent shall
not be unreasonably withheld or delayed. Should Licensee or any Sublicensee
of
Licensee
grant any sublicenses, the terms and conditions of such sublicenses and the
identity of sublicensees shall be at the sole discretion of Licensee and no
consent shall be required from Licensor in connection with the terms and
conditions of such sublicenses or the identity of sublicensees, provided
however, that such sublicenses shall be co-terminated with this
Agreement.
3.3 Consent
of Inventor.
The Inventor has provided his written consent to the terms and conditions of
the
License Grant and the terms and conditions of this Agreement. The Written
Consent of the Inventor is set forth in Exhibit
2
hereto.
6
*****Confidential
material redacted and filed
separately with the Commission.
ARTICLE
4. LICENSE FEE; MILESTONE PAYMENTS
4.1
License
Fee.
Licensee will pay to Licensor a non-refundable, non-creditable license fee
of
***** in cash on or about the Effective Date.
4.2
Milestone
Payments.
Licensee will pay to Licensor the milestone payments as follows:
(a)
Within one hundred twenty (120) days following completion of Phase II clinical
trial: *****;
(b)
Within one hundred twenty (120) days following submission to the FDA of the
first New Drug Application for a Product: *****;
(c)
Within one hundred and twenty (120) days following a first FDA marketing
approval for a Product: *****;
(d)
Within one hundred and twenty (120) days following a first marketing approval
for a Product in any country in Europe: *****; and
(e)
Within one hundred and twenty (120) days following a first marketing approval
for a Product in Japan: *****.
4.3 Limitations.
It is understood and agreed that Licensee shall pay the milestone payments
set
forth in Section 4.2 only with respect to
the first Indication for
which a Product achieves a particular milestone event, and regardless of the
number of Products which achieve a particular milestone event.
4.4
Payment
in Equity.
At Licensee’s option, up to ***** or such greater amount as may be mutually
agreed by Licensor and Licensee of any milestone payment due pursuant to
Sections 4.2(b) and (c) can be made in shares of unrestricted, unlegended and
freely tradable common stock of Licensee, based on a per share price equal
to
the average closing price as listed in the Wall Street Journal over the last
thirty (30) business days immediately preceding the date of a particular
milestone payment is due; provided that (i) the Licensee’s common stock is
traded on the NASDAQ National Market or other national stock exchange in the
U.S. at the time the payment is made; (ii) the average trading price of such
shares of common stock on the NASDAQ National Market or
other national stock exchange in the U.S. in the three (3) months period
immediately preceding the last day of
a particular milestone payment pursuant to Sections 4.2(b) or (c) is due exceeds
***** and (iii) the ***** immediately
preceding the payment due date exceeds *****. It
is understood and agreed that the Licensee has the right to refuse any or all
payment in the form of stock by the Licensor pursuant to this Section 4.4 if
the
Licensor has reasons to believe that the stock delivered is not unrestricted,
unlegended or freely tradable.
7
*****Confidential
material redacted and filed
separately with the Commission.
ARTICLE
5. ROYALTIES
5.1
Royalties.
In consideration of the license rights granted to Licensee hereunder, Licensee
shall pay or cause any
Sublicensee
to pay to
Licensor a royalty on their
respective Net
Sales,
as follows:
for
each Product where the manufacture, use or sale of such Product would but for
the license granted hereunder, infringe a Valid Claim a royalty of *****
on
Net Sales.
5.2 Limitation.
If the laws of any country where royalties are payable under Section 5.1 limit
the amount of royalty or the duration of such royalty payments to less than
the
amount specified herein, then the royalty payment to Licensor shall be limited
to that permitted by law.
5.3
Accrual
of Royalties.
No royalty shall be payable on a Product made, sold, or used for testing or
development purposes or distributed as samples, provided such samples are sold
by Licensee (or its Sublicensee) at cost. No royalties shall be payable on
sale
among Licensee and its Sublicensees, but royalties shall be payable on
subsequent sales by Licensee or its Sublicensees to a Third Party. No multiple
royalty shall be payable because the manufacture, use, or sale of a Product
is
covered by more than one Valid Claim.
5.4
Royalty
Withheld
due to Invalid Claims.
In the event that all applicable claims of a patent included within the Patent
Rights under which Licensee is paying a royalty according to Section 5.1 shall
be held invalid or unenforceable by a court of competent jurisdiction in a
given
country of the Territory, Licensee may withhold payments of royalties which
would otherwise have been due on Net Sales in that country by reason of Section
5.1 until such judgment shall be finally reviewed by an unappealed or
unappealable decree of a higher court of competent jurisdiction in such country.
The Licensee shall promptly repay Licensor any withheld royalty payments
upon
a final adjudication that the applicable claims of a patent included within
the
Patent Rights under which Licensee is paying a royalty under Section 5.1 are
valid and enforceable.
5.5 Compulsory
Licenses.
If Licensee is caused to grant a compulsory license to any Third Party with
respect to a Product in any country in the Territory, then the royalty rate
to
be paid by Licensee on Net Sales due on such Product in that country under
Section 5.1 shall be reduced to the rate paid by such Third Party compulsory
licensee on such Product.
ARTICLE
6. ROYALTY REPORTS AND ACCOUNTING
6.1
Royalty
Reports and Records.
Beginning with the First Commercial Sale by Licensee or any Sublicensee as
the
case may be of a Product in any country of the Territory, and continuing
thereafter during the term of this Agreement, Licensee shall furnish,
and shall cause any Sublicensee to furnish,
to Licensor a written report covering each calendar quarter (the "Reporting
Period") showing (a) the Net Sales of each Product in each country of the
Territory where royalties are payable under Section 5.1 during the Reporting
Period; (b) the royalties, payable in United States Dollars, which shall have
accrued hereunder in respect of such sales with a summary computation of such
royalties; (c) withholding taxes, if any required by law to be deducted in
respect of such sales; and (d) the exchange rates used in determining the amount
of United States Dollars payable in respect of sales outside the United States.
With respect to sales of a Product invoiced in a currency other than United
States Dollars, the Net Sales and royalty payable shall be expressed in the
domestic currency of the party making the sale together with the United States
Dollars equivalent of the royalty payable, calculated using the simple average
of the exchange rate published in the Wall Street Journal on the last day of
each month of the Reporting Period. If any Sublicensee makes any sale invoiced
in a currency other than its domestic currency, the Net Sales shall be converted
to its domestic currency in accordance with its normal accounting principles.
Licensee's Sublicensees shall have the option of making any royalty payment
directly to Licensor. However, notwithstanding anything to the contrary, the
Licensee shall continue to be liable for all royalties due under Section 5.1
until they are paid. Licensee or its Sublicensee shall furnish to Licensor
appropriate evidence of payment of, and itemize any tax, credits or specific
amount deducted from any royalty payment.
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6.2
Royalty
Reports and Payments.
Royalty reports and payments shall be due sixty (60) days after the close of
each Reporting Period. Payment of royalties in whole or in part may be made
in
advance of such due date. In case no royalty is due for any given Reporting
Period, Licensee shall so report to Licensor. Licensee and its Sublicensees
shall keep accurate records in sufficient detail to enable the royalty payable
hereunder to be determined and confirmed. Licensee shall be responsible for
all
royalties, late payments, and interest that are due but have not been paid
by
Licensee's Sublicensees.
6.3
Right
to Audit.
Upon written request of Licensor, but not more than once in each calendar year
nor more than once in respect to any given calendar year, Licensee shall permit
an independent public accountant, selected by Licensor and acceptable to
Licensee, which acceptance shall not be unreasonable withheld, to have access
during normal business hours to those records of Licensee as may be reasonably
necessary to verify the accuracy of the royalty reports hereunder in respect
of
any calendar year ending not more than thirty-six (36) months prior to the
date
of such request. Licensee shall include in each Sublicense granted by it
pursuant to this Agreement a provision requiring the Sublicensee to keep and
maintain records of sales made pursuant to such sublicense and to grant the
same
right of access to such records to Licensor's independent accountant. Upon
the
expiration of thirty-six (36) months following the end of any calendar year,
the
calculation of royalties payable with respect to such calendar year shall be
binding and conclusive upon the parties, and Licensee and its Sublicensees
shall
be released from any liability or accountability with respect to
royalties
(and Licensor for an overpayment of royalties)
for such calendar year, unless (a) an audit requested by Licensor prior to
expiration of such thirty-six (36) months period has not yet been completed,
or
(b) Licensor has notified Licensee prior to the expiration of such thirty-six
(36) months period that such audit has revealed a discrepancy regarding such
calculation. The report prepared by such independent public accountant, a copy
of which promptly shall be provided to Licensee, shall disclose only the amount
of any underpayment or overpayment of royalties, if any, without disclosure
of
or reference to supporting documentation. If such independent accountant's
report shows any underpayment of royalties, Licensee shall remit or shall cause
its Sublicensees to remit to Licensor the amount of such underpayment within
thirty (30) days after Licensee's receipt of such report, and if such
underpayment exceeds five percent (5%) of the royalty due, Licensee shall
reimburse Licensor for its reasonable out-of-pocket expenses for the audit,
upon
submission of supporting documentation. Any
overpayment of royalties shall be creditable against future royalties payable
in
subsequent royalty periods, allocated evenly over the next-following two (2)
royalty periods. In
the event this Agreement is terminated or expires before such overpayment is
fully credited, Licensor shall pay Licensee the portion of such overpayment
not
credited within one hundred twenty (120) days after
the date of such termination or expiration.
9
*****Confidential
material redacted and filed
separately with the Commission.
6.4
Confidentiality
of Records.
Licensor agrees that all information subject to review under Section 6.3 or
under any sublicense agreement shall be deemed the Proprietary Information
of
Licensee.
6.5
Late
Payment Interest.
Royalties and other payments required to be paid by Licensee pursuant to this
Agreement shall, if overdue, bear interest at the rate equal to two percent
(2%)
over the prime rate as quoted by Citibank NA and not to exceed ten percent
(10%)
per annum.
until paid. The payment of such interest shall not preclude Licensor from
exercising any other rights it may have because any payment is
overdue.
ARTICLE
7. DEVELOPMENT AND MARKETING PROGRAM
7.1
Clinical
Development Program.
Licensee shall pay,
within thirty (30) days from the receipt of valid invoices from
Licensor,
***** of all costs for Licensor's current Phase II clinical trial up to a
maximum of *****, and shall at its expense, use commercially reasonable best
efforts (a) to conduct a clinical development program directed to obtaining
FDA
approval of at least one Product for at least one Indication to be selected
by
Licensee (the "Development Program"), and (b) if, in the opinion of Licensee,
the results of the Development Program so justify, to diligently seek FDA
approval for such Product for such Indication. For purposes of this Section,
"commercially reasonable best efforts" shall mean efforts consistent with those
used by Licensee in its own priority development projects with its own products
deemed to have high commercial potential.
7.2
Fulfillment.
Licensee's reasonable efforts set forth in Section 7.1
with respect to the US shall
be deemed to have been fulfilled if Licensee
(a)
*****
(b)
*****
For
purposes of this Section 7.2, *****. All clinical studies are to be conducted
under an IND in the United States, or if conducted by Licensee outside the
United States, are to be acceptable to the FDA for Registration of a Product
in
the United States.
While fulfilling or in Licensee’s discretion, upon fulfillment of the above
obligations, Licensee shall use commercially reasonable best efforts to
commercialize the Product outside the US, within the Territory.
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7.3
Suspension
of Development Program.
Licensee’s obligation to conduct the Development Program is expressly
conditioned on the continuing absence of any event or condition (such as, but
not limited to, a regulatory action affecting the Product or the existence
of an
issue relating to the safety or efficacy of the Product, the introduction of
a
therapy which has superior safety and/or efficacy, or the existence of any
circumstances, economic or otherwise, which make the development or marketing
of
the Product, in Licensee’s judgment, commercially unrewarding) that would
suggest to Licensee, in exercising prudent and justifiable business judgment,
that development or marketing of the Product should be suspended or stopped
altogether, and Licensee’s obligation to develop or market the Product may be
suspended for up to six (6) months, after which time the Development Program
shall be resumed or this Agreement may be terminated by Licensor, at the sole
discretion of Licensor.
7.4 Assistance
by Licensor.
Licensor shall assist Licensee as follows:
(a) As
soon as practical after the Effective Date, Licensor will make available to
Licensee all Licensor Development Data in the possession of Licensor, and will
cooperate with and provide reasonable assistance to Licensee in its evaluation
of such Licensor Development Data. On a continuing basis during the term of
this
Agreement, Licensor shall make available to Licensee all additional Licensor
Development Data generated by Licensor or any Third Party on behalf of Licensor.
Licensor shall provide Licensee with a right of reference to all such Licensor
Development data and Licensee shall have the right to include such Licensor
Development Data in any of its applications for Registrations. All such Licensor
Development Data shall be deemed the Proprietary Information of Licensor, and
all right, title and interest in and to such Licensor Development Data shall
remain vested in Licensor.
(b) In
the event that Licensor receives any inquiries from any Regulatory Authority
which may affect the development and marketing of a Product, Licensor shall
immediately notify Licensee. Licensor agrees to assist Licensee in formulating
a
response to such inquiries, including being available to meet with the
Regulatory Authority at a time and place acceptable to Licensor. Licensee shall
reimburse Licensor for its reasonable expenses incurred in rendering such
assistance, upon presentation by Licensor of an invoice documenting such
expenses.
7.5 Registrations.
Subject to the terms and conditions of this Agreement, each application for
Registration shall be filed in the name of Licensee or a designated Affiliate.
Licensee shall own all right, title and interest in and to all applications
for
Registrations and granted Registrations. Licensee shall be responsible for
all
disclosures and correspondence to and with the Regulatory Authorities, and
all
disclosures and correspondence with any Regulatory Authority involving Licensor
shall be made through Licensee. Licensee shall keep Licensor advised of the
status of all Registrations and any applications for Registration.
11
*****Confidential
material redacted and filed
separately with the Commission.
7.6
Licensee
Development Data.
All Licensee Development Data shall be deemed the Proprietary Information of
Licensee, and all right, title and interest in and to such Licensee Development
Data shall vest in Licensee, subject to Section 12.4.2.
7.7 Production
of Clinical Supplies of the Compound.
(a)
Both
parties agree to work in good faith to fully collaborate to review and
administer the manufacturing program for the Compound and to resolve any
technical issues both immediately after the Effective Date and at least annually
thereafter during *****.
(b)
For
the period commencing on the Effective Date and continuing for
***** following Registration in the United States *****
Licensee (and its Sublicensees) *****. In
consideration for such supply, Licensee shall provide compensation to Licensor
at ***** over Licensor's manufacturing
and procurement
cost. Notwithstanding the preceding two sentences, decisions and actions related
to pharmaceutical development and manufacturing of the Clinical Supplies are
subject to joint review and approval. *****.
(c)
As
requested by Licensee, *****, Licensor shall make its best
efforts to assist Licensee *****. Licensor shall provide
assistance to Licensee to transfer any know-how and technology from
***** of Licensor to ***** by Licensee
*****.
(d)
In
the event that either party elects to procure Clinical Supplies from the
other
*****,
in consideration for such clinical supplies, the supplies shall be transferred
at ***** over
manufacturing and
procurement cost.
7.8
Indications
Outside the Field.
7.8.1 For
any indications or line extensions developed by Licensor utilizing the
Compound
outside the Field, Licensee shall have a Right of First Negotiation
and
Right of First Refusal (as such terms are defined below) as follows:
(a)
Right
of First Negotiation.
If Licensor conceives of an indication or line extension utilizing the Compound
outside the Field (a “New Development”), Licensor shall provide Licensee a right
of first negotiation (the “Right of First Negotiation”)
as follows Licensor shall describe the New Development in writing in reasonable
detail, and such description shall be protected as Proprietary Information
under
this Agreement (a "Confidential Disclosure”). If Licensor conceives of an
indication or line extension utilizing the Compound outside the Field (a "New
Development"), Licensor shall provide Licensee a right of first negotiation
(the
"Right of First Negotiation") as follows: (i) Licensor shall describe the New
Development in writing in reasonable detail, and such description shall be
protected as Proprietary Information under this Agreement (a "Confidential
Disclosure"); (ii) Licensor shall provide the Confidential Disclosure to
Licensee; and (iii) during the period commencing upon Licensee's receipt of
the
Confidential Disclosure and expiring ninety (90) days thereafter (the
"Discussion Period"), the parties shall discuss in good faith a license and
commercialization agreement with respect to the New Development. If
the parties do not reach agreement during the Discussion Period, then the Right
of First Negotiation shall expire, and Licensor shall be free to exploit the
New
Development on its own, or to market the New Development to others.
12
(b)
Right
of First Refusal
In the event Licensor receives an offer from any third party to license or
commercialize a New Development (an "Outside Offer"), Licensee shall enjoy
a
right of first refusal (the "Right of First Refusal") as follows: Licensor
shall
not accept any Outside Offer unless (i) Licensor has first provided the Outside
Offer in writing to Licensee; and (ii) Licensee is provided a period of thirty
(30) days from its receipt of the Outside Offer to evaluate the Outside Offer
(the "Evaluation Period"). If Licensor receives from Licensee before expiration
of the Evaluation Period a written offer that meets each of the terms of the
Outside Offer or is more advantageous to Licensor than the Outside Offer (a
"Qualifying Licensee Offer"), then Licensor shall either (a) reject the Outside
Offer, or (b) accept the Qualifying Licensee Offer. Licensor shall not be
obligated to accept the Qualifying Licensee Offer (in which event, the Licensor
shall not accept the Outside Offer). If a Qualifying Licensee Offer is not
received within the Evaluation Period, then the Right of First Refusal shall
expire, and Licensor shall be free to accept the Outside Offer.
7.8.2 For
any indications or line extensions developed by Licensee utilizing the Compound
outside the Field, Licensor shall have Right of First negotiation and Right
of
First Refusal similar to those available under Section 7.8.1 herein to obtain
a
license as follows:
(a)
Right
of First Negotiation.
If Licensee conceives of an indication or line extension utilizing the Compound
outside the Field, Licensee shall provide Licensor a Right of First Negotiation
as follows: (i) Licensee shall describe the New Development in writing in
reasonable detail, and such description shall be protected as Confidential
Disclosure under this Agreement; (ii) Licensee shall provide the Confidential
Disclosure to Licensor; and (iii) during the period commencing upon Licensor's
receipt of the Confidential Disclosure and expiring ninety (90) days thereafter,
the parties shall discuss in good faith a license and commercialization
agreement with respect to the New Development. If the parties do not reach
agreement during the Discussion Period, then the Right of First Negotiation
shall expire, and Licensee shall be free to exploit the New Development on
its
own, or to market the New Development to others.
13
(b)
Right
of First Refusal.
In the event Licensee receives an Outside Offer to license or commercialize
a
New Development, Licensor shall enjoy a Right of First Refusal as follows:
Licensee shall not accept any Outside Offer unless (i) Licensee has first
provided the Outside Offer in writing to Licensor; and (ii) Licensor is provided
a period of thirty (30) days from its receipt of the Outside Offer to evaluate
the Outside Offer. If Licensee receives from Licensor before expiration of
the
Evaluation Period a written offer that meets each of the terms of the Outside
Offer or is more advantageous to Licensee than the Outside Offer (the
"Qualifying Licensor Offer"), then Licensee shall either (a) reject the Outside
Offer, or (b) accept the Qualifying Licensor Offer. Licensee shall not be
obligated to accept the Qualifying Licensor Offer (in which event, the Licensee
shall not accept the Outside Offer). If a Qualifying Licensor Offer is not
received within the Evaluation Period, then the Right of First Refusal shall
expire, and Licensee shall be free to accept the Outside Offer.
7.9
Progress
Reports.
On a quarterly basis, and within thirty (30) days of the close of each quarter,
Licensee shall provide to Licensor a written report of Licensee's progress
and
activities in meeting Licensee's obligations under Sections 7.1 and 7.2 (each
a
"Progress Report"). Progress Reports shall be in writing, and shall set forth,
in reasonable detail, relevant information including (i) the status of clinical
development programs for any Product; (ii) the status of regulatory approvals
in
the US and in other jurisdictions within the Territory concerning Products;
and
(iii) the status of other development activities regarding Products. Licensee
shall promptly supplement or clarify such Progress Reports, upon Licensor's
reasonable request.
ARTICLE
8. PATENT PROSECUTION
8.1
Patent
Prosecution and Maintenance.
8.1.1 Patent
Rights.
Licensor shall use reasonable efforts to prosecute the patent applications
included in the Patent Rights, (subject to the provisions of Section 8.1.2(d)
to
obtain patents thereon, to conduct any interference, re-examination, reissue
and
opposition proceedings, and to maintain patents included in the Patent Rights
in
effect during the term of this Agreement using outside patent counsel acceptable
to Licensor. Licensor shall be solely responsible for all costs and expense
relating to such patent applications and patents. Licensor shall regularly
consult with Licensee and shall keep Licensee advised of the status of all
patent applications and patents relating to the Patent Rights by providing
Licensee with copies of such patent applications and patents and copies of
all
patent office correspondence relating thereto including any office actions
received by Licensor and responses or other papers filed by Licensor. Licensor
specifically agrees to provide Licensee with copies of patent office
correspondence in sufficient time for Licensee to review and comment on such
correspondence and submit to Licensor any proposed response thereto. Licensor
further agrees to provide Licensee with sufficient time and opportunity, but
in
no event less than ten (10) days, to review, comment and consult on all proposed
responses to patent office correspondence relating to such patent applications
and patents. Licensee agrees that all final decisions regarding the preparation
and prosecution of such patent applications and patents, reissues,
reexaminations, interferences and oppositions relating thereto shall be made
by
Licensor after consultation with Licensee. Notwithstanding the foregoing,
Licensor shall have the right in its sole discretion after consultation with
Licensee, to discontinue the prosecution of any such patent applications or
the
maintenance of any such patents, and Licensee shall have the right to assume
responsibility for the prosecution of such patent applications or the
maintenance of such patents at its own expense. No royalties shall be payable
by
Licensee to Licensor under Section 5.1 hereof in respect of any such patent
applications or patents being prosecuted or maintained by Licensee until
Licensee has been reimbursed for its out-of-pocket costs of prosecuting and
maintaining such patent applications or patents. If Licensor elects
not to prosecute,
and Licensee elects not to assume,
any such patent applications or not to maintain any such patents
in any country within the Territory,
Licensee’s license rights and its obligations under this Agreement, with respect
to such patent applications and patents in
such country shall
terminate,
without affecting its license rights
and other obligations to pay
with respect to any other patent applications or patents included in the Patent
Rights.
14
8.1.2 Improvements.
(a) Each
party shall notify the other party promptly of any sole or joint inventions
directed to Improvements under such party's control. Licensee shall own all
right, title and interest in and to Licensee solely invented Improvements and
Licensor shall own all right, title and interest in and to Licensor solely
invented Improvements. Patent applications and patents directed to jointly
invented Improvements shall be jointly assigned to and owned by Licensee and
Licensor, and the rights of the parties with respect thereto shall be determined
according to the laws of the countries in which such patent applications and
patents are held.
(b) During
the term of this Agreement, for patent applications and patents relating to
Improvements invented solely by Licensor, the provisions of Section 8.1.1 shall
apply.
(c) Following
expiration or termination of this Agreement, Licensor shall be solely
responsible, at its sole discretion and expense, for preparing, filing,
prosecuting and maintaining in such countries where it deems appropriate, patent
applications and patents relating to Improvements invented solely by Licensor
and for conducting interference, re-examination, reissue and opposition
proceedings relating to such patent applications and patents.
(d) During
the term of this Agreement, Licensee shall be responsible, in its sole
discretion and expense, for preparing, filing, prosecuting and maintaining
in
such countries where it deems appropriate, patent applications and patents
relating to Improvements invented solely by Licensee or jointly by Licensee
and
Licensor. Notwithstanding the foregoing, if Licensee elects (after consultation
with Licensor) not to prosecute, or to discontinue the prosecution of any patent
applications concerning joint inventions, or to discontinue the maintenance
of
any patents concerning joint inventions, then (i) Licensor shall have the right
to assume the full responsibility for the prosecution of such patent
applications or the maintenance of such patents at its own costs expense, (ii)
Licensee shall assign such patents and patent applications to Licensor, and
(iii) such patents and patent applications shall no longer be subject to this
Agreement.
15
(e) Following
expiration or termination of this Agreement, Licensee shall be solely
responsible, in its sole discretion and expense, for preparing, filing,
prosecuting and maintaining in such countries where it deems appropriate, patent
applications and patents relating to Improvements invented solely by Licensee
and for conducting interference, re-examination, reissue and opposition
proceedings relating to such patent applications and patents.
(f) Following
expiration or termination of this Agreement, the parties shall be jointly
responsible for preparing, filing, prosecuting and maintaining in such countries
where the parties jointly agree, patent applications and patents relating to
improvements jointly invented by the parties and for conducting interference,
re-examination, reissue and opposition proceedings relating to such patent
applications and patents. The parties shall jointly bear all costs relating
thereto. If one party elects to discontinue the prosecution of any patent
applications and patents filed pursuant to this Section 8.1.2(f), or not to
conduct any further activities with respect to such patent applications or
patents, the party electing to discontinue any such activities shall assign
to
the other party all right, title and interest in and to such patents or patent
applications. The party electing to continue such activities shall be solely
responsible for all costs relating to such activities.
ARTICLE
9. INFRINGEMENT
9.1 Infringement
by a Third Party.
In the event that either party becomes aware that a Compound or a Product being
made, used or sold by a Third Party infringes the Patent Rights licensed
hereunder, such party shall promptly advise the other party of all known facts
and circumstances relating thereto.
Licensor shall have the first right to enforce at Licensor’s sole expense the
Patent Rights licensed under this Agreement against infringement by third
parties. Licensee shall reasonably cooperate in any such enforcement and, if
necessary, join as a party therein, at the expense of Licensor. Licensor shall
have the right to retain 100% of the proceeds of any such enforcement action.
In
the event that Licensor does not file suit against or commence settlement
negotiations with a substantial infringer of the Patent Rights within six (6)
months after receipt of and a written demand from Licensee that Licensor bring
suit, then Licensee shall have the right to enforce at its own expense any
patent licensed hereunder on behalf of itself and Licensor, Licensor shall
reasonably cooperate with Licensee, at the expense of Licensee. In this case,
Licensee shall have the right to retain 100% of the proceeds of any such
enforcement action.
9.2
Infringement
by Licensee.
In the event that it is determined by any court of competent jurisdiction that
the manufacture, use or sale of any Product by Licensee or its Sublicensees
in
accordance with the terms and conditions of this Agreement infringes, or
Licensee and Licensor reasonably determine and agree that the manufacture,
use
or sale of such Product is likely to infringe, an additional Third Party patent
or related intellectual property right in any country in the Territory, Licensee
shall in consultation with Licensor use its reasonable best efforts to: (i)
procure at Licensee’s expense a license from such Third Party authorizing
Licensee to continue to manufacture, use or sell such Product; or (ii) modify
such Product or its manufacture so as to render it non-infringing. In the event
that neither of the foregoing alternatives is reasonably available or
commercially feasible, Licensee may at its option (i) either cease the
manufacture, use and sale of such Product for so long as and to the extent
that
such activities are infringing the relevant Third Party patents, in which case
the obligation of Licensee hereunder to pay royalties shall also cease, or
(ii)
terminate the rights and licenses granted solely with respect to a country
or
countries within the Territory in which the infringement of Third Party patents
has occurred or is likely to occur, in which case the obligation of Licensee
hereunder to pay royalties shall also terminate with respect to that country
or
countries within the Territory.
16
ARTICLE
10. INDEMNIFICATION
10.1
Indemnification
by Licensee.
Licensee agrees to indemnify and hold Licensor, its directors, officers,
employees and agents harmless from and against any liabilities or damages or
expenses in connection therewith (including reasonable attorneys' fees and
costs
and other expenses of litigation) resulting from (i)
any willful misrepresentation of a material fact or breach of warranty under
this Agreement, (ii) claims by Third Parties arising out of Licensee's or its
Sublicensees' manufacture, use, sale or testing of Product; and (iii) the
enforcement by Licensor of its indemnification rights against Licensee under
clause (ii) of this Section 10.1.
10.2 Indemnification
by Licensor.
Licensor hereby agrees to indemnify and hold Licensee and its officers,
directors, employees and agents harmless from and against any liabilities or
damages or expenses in connection therewith (including reasonable attorneys'
fees and costs and other expenses of litigation) resulting from any willful
misrepresentation of a material fact or breach of warranty under this Agreement
and the enforcement by Licensee of its indemnification rights under this Section
10.2.
10.3
Indemnification
Procedures.
Each indemnified party shall promptly notify the indemnifying party in writing
of any action, claim or liability in respect of which the indemnified party
intends to claim indemnification from the indemnifying party. The indemnified
party shall permit the indemnifying party, at its discretion, to settle any
such
action, claim or liability, and agrees to the complete control of such defense
or settlement by the indemnifying party, provided however, that such settlement
does not adversely affect the rights of the indemnified party hereunder or
impose any obligations on the indemnified party in addition to those set forth
herein in order for it to exercise such rights. No such action, claim or
liability shall be settled by the indemnified party without the prior written
consent of the indemnifying party, which consent shall not be unreasonably
withheld or delayed, and the indemnifying party shall not be responsible for
any
legal fees or other costs incurred by the indemnified party other than as
provided herein. The indemnified party and its directors, officers, employees
and agents shall cooperate fully with the indemnifying party and its legal
representatives in the investigation and defense of any action, claim or
liability covered by this indemnification, and shall have the right, but not
the
obligation, to be represented by counsel of their own selection and at their
own
expense.
17
10.4 Limitation
of Liability.
Notwithstanding anything to the contrary herein, neither party shall be liable
to the other party for any indirect, incidental or consequential damages arising
out of any terms or conditions in this Agreement or with respect to the
performance hereof.
10.5
Survival
of Representations and Warranties. The representations and warranties contained
in this Agreement shall survive the expiration or termination of this Agreement
and shall remain in full force and effect.
ARTICLE
11. CONFIDENTIALITY
11.1
Treatment
of Proprietary Information.
Except as otherwise provided in this Article 11, during the term of this
Agreement and for a period of five (5) years following expiration or termination
thereof, a party (the "Receiving Party") will retain in confidence and use
only
for purposes of this Agreement Proprietary Information supplied by or on behalf
of the other party (the "Disclosing Party"). For purposes of this Article 11,
all such Proprietary Information which a Receiving Party is obligated to retain
in confidence shall be disclosed in written form and marked "Confidential"
or
with similar designation, or if originally disclosed visually or orally, reduced
to such written form within thirty (30) days of such original
disclosure.
11.2
Right
to Disclose.
To the extent it is reasonably necessary or appropriate to fulfill its
obligations or exercise its rights under this Agreement or any rights which
survive termination or expiration hereof, a Receiving Party may disclose
Proprietary Information to its Affiliates, Sublicensees, consultants, agents,
outside contractors and clinical investigators (collectively the
“Representatives”) on condition that such Representatives agree (i) to keep the
Proprietary Information confidential for a least the same time periods and
to
the same extent as such party is required to keep the Proprietary Information
confidential and (ii) to use the Proprietary Information only for such purposes
as the Receiving Party is entitled to use the Proprietary Information. Each
party warrants that each of its Representatives to whom any Proprietary
Information is disclosed shall previously have been informed of the confidential
nature of the Proprietary Information and shall have agreed to be bound by
the
terms and conditions of confidentiality as set forth in this Agreement. The
Receiving Party shall ensure that the Proprietary Information provided by the
Disclosing Party shall not be used or disclosed by such Representatives except
as permitted by this Agreement. The Receiving Party shall stand responsible
for
any breach by its Representatives of the confidentiality provisions set forth
in
this Agreement.
18
11.3 Release
From Restrictions.
The obligation not to disclose Proprietary Information shall not apply to any
part of such Proprietary Information which:
(i)
is or becomes patented, published or otherwise part of the public domain other
than by the unauthorized acts of the Receiving Party or its Affiliates or
Sublicensees in contravention of this Agreement; or
(ii)
is disclosed to the Receiving Party by a Third Party which did not obtain such
Proprietary Information directly or indirectly from the Disclosing Party; or
(iii)
prior to disclosure under this Agreement, was already in the possession of
the
Receiving Party as evidenced by its written records, provided such Proprietary
Information was not obtained, directly or indirectly, from the Disclosing Party;
or
(iv)
is developed by the Receiving Party independent of Proprietary Information
received from the Disclosing Party as evidenced by its written
records.
11.4.
Public
Domain.
For the purpose of this Agreement, specific information disclosed as part of
the
Proprietary Information shall not be deemed to be in the public domain or in
the
prior possession of the Receiving Party merely because it is embraced by more
general information in the public domain or by more general information in
the
prior possession of the Receiving Party.
11.5
Ownership
of Proprietary Information.
Except as otherwise agreed to hereunder, all Proprietary Information disclosed
by the Disclosing Party shall remain the property of the Disclosing Party.
Upon
the written request of the Disclosing Party (i) all tangible Proprietary
Information provided by the Disclosing Party (including, but not limited to
all
copies thereof and all unused samples of materials provided by the Disclosing
Party) except for Proprietary Information consisting of analyses, studies and
other documents prepared by or for the benefit of the Receiving Party shall
be
promptly returned to the Disclosing Party, and (ii) all portions of such
analyses, studies and other documents not prepared by or for the benefit of
the
Receiving Party (including all copies thereof) which are within the definition
of Proprietary Information shall be destroyed, and the Receiving Party shall
certify such destruction in writing to the Disclosing Party. Notwithstanding
the
foregoing, the Receiving Party may retain one copy of the Proprietary
Information of the Disclosing Party in its legal department for the sole purpose
of determining its obligations hereunder.
11.6
Legal
Disclosure.
The Receiving Party may disclose the Proprietary Information of the Disclosing
Party to the extent reasonably necessary in prosecuting or defending litigation,
complying with applicable laws, governmental regulations or court order, or
otherwise submitting required information to tax or other governmental
authorities. If the Receiving Party intends to so disclose any such Proprietary
Information, the Receiving Party shall provide the Disclosing Party prompt
prior
notice of such fact so that the Disclosing Party may seek to obtain a protective
order or other appropriate remedy concerning any disclosure of such Proprietary
Information. The Receiving Party will reasonably cooperate with the Disclosing
Party in connection with the Disclosing Party’s efforts to obtain any such order
or other remedy. If any such order or other remedy does not fully preclude
the
disclosure of such Proprietary Information, the Receiving Party will make such
disclosure only to the extent that such disclosure is legally required and
will
use its reasonable efforts to have confidential treatment accorded to the
disclosed Proprietary Information.
19
11.7
No
Title.
Except as otherwise expressly set forth in this Agreement, nothing herein shall
be construed as giving the Receiving Party any right, title and interest in
and
to the Proprietary Information of the Disclosing Party.
11.8
Permitted
Disclosures.
11.8.1 Disclosure
by Licensee.
Notwithstanding the foregoing, subject to review and comment by Licensor,
Licensee may disclose Licensor Proprietary Information to the extent such
disclosure is reasonably necessary for (a) the development of the Compound
or
the Product, (b) the filing of applications for Registration, (c) the
commercialization of the Compound or the Product, or (d) the filing or
prosecution of a patent applications and patents relating to Improvements
invented solely by Licensee or jointly by Licensee and Licensor.
11.8.2 Disclosure
by Licensor.
Notwithstanding the foregoing, subject to review and comment by Licensee,
Licensor may disclose Licensee Proprietary Information to the extent such
disclosure is reasonably necessary for the filing or prosecution of patent
applications and patents relating to Improvements invented solely by Licensor.
11.9
Publications.
Neither Party shall submit or present any written or oral publication, any
manuscript, abstract or the like which includes data or other information
related to the Compound or the Products or the Proprietary Information of the
other Party without first obtaining the prior written consent of the other
Party.
ARTICLE
12. TERM AND TERMINATION
12.1
Term.
Unless terminated sooner as provided herein, this Agreement shall continue
in
full force and effect from the Effective Date until the expiration of Licensee's
obligation to pay royalties hereunder. Upon expiration or termination of this
Agreement with respect to one or more countries of the Territory, the rights
and
obligation of the parties with respect to each such country or countries shall
cease, except as follows:
(i)
upon expiration or termination by either party for any reason, the rights and
obligations under Articles 2, 6, 10, 11, 12 and 22 and the applicable provisions
of Section 8.1.2;
(ii)
expiration or termination of this Agreement shall not relieve either party
of
any obligations which accrued to that party prior to such expiration or
termination for any reason; and
(iii)
any cause of action or remedy for breach shall survive the expiration or
termination of this Agreement.
20
*****Confidential
material redacted and filed
separately with the Commission.
12.2
Termination
by Licensee.
12.2.1 Licensee
may terminate this Agreement (i) in its entirety or (ii) with respect to one
or
more countries of the Territory without affecting the Agreement or the licenses
granted hereunder in any other country of the Territory, without cause at any
time upon at least ninety (90) days prior written notice to
Licensor.
12.2.2 Licensee
may terminate this Agreement upon or after the breach of any material provision
of this Agreement by Licensor if such breach is not cured within ninety (90)
days after Licensee gives Licensor written notice thereof.
12.2.3
Licensee may terminate this Agreement in its entirety for cause upon at least
ninety (90) days prior written notice to Licensor
upon
or after the bankruptcy, insolvency, dissolution or winding up of Licensor
other
than for the purpose of reconstruction or amalgamation.
12.3
Termination
by Licensor.
12.3.1 Licensor
may terminate this Agreement in its entirety for cause at any time upon at
least
ninety (90) days prior written notice to Licensee upon the occurrence of any
of
the following:
(a)
upon or after the breach of any material provision of this Agreement by Licensee
if such breach is not cured within ninety (90) days after Licensor gives
Licensee written notice thereof;
(b)
upon a Payment Default; or.
(c)
upon or after the bankruptcy, insolvency, dissolution or winding up of Licensee
other than for the purpose of reconstruction or amalgamation; or
12.4
Development
Data
and Know-How.
12.4.1
In the event of termination of this Agreement with respect to all countries
in
the Territory, Licensee will, promptly transfer and hand over to Licensor all
Licensor Development Data and
Licensor Know-How provided
to Licensee hereunder. Each party will return to the other party
all copies of the Proprietary Information supplied by one party to the other
party hereunder, except that one copy of such Proprietary Information may be
retained by each party for archival purposes only.
12.4.2 Upon
termination of this Agreement or the license rights granted hereunder by either
party for any reason with respect to one or all countries
of the Territory (other than a termination by Licensee for an uncured breach
or
default by Licensor), Licensee will grant Licensor access to (and allow Licensor
to obtain copies of) all Licensee Development Data
and Licensee Know-How.
Licensor shall have the right to disclose to a Third Party all such Licensee
Development Data
and Licensee Know-How
in connection with Licensor’s effort to license to such Third Party the right to
manufacture and sell a Product in those countries where termination of
Licensee’s rights has occurred. Such use or disclosure shall be subject to the
Licensee’s rights in countries where termination has not occurred and to the
right, title and interest in such Licensee Development Data and Licensee
Know-How which shall remain vested in Licensee. The Third Party shall not be
entitled to sublicense, assign or transfer any of the rights granted to it
by
Licensor except to an Affiliate of such Third Party. Licensee
agrees to cooperate with and provide reasonable assistance to Licensor in its
effort to license to a Third Party the use of such Licensee Development
Data.
and Licensee Know-How. In
consideration thereof, Licensor shall
pay to Licensee a royalty of ***** on Net Sales of Product sold by Licensor
or
such Third Party
for a period of ***** from
the commencement of
the sale of the
Product.
Any
license granted by Licensor to such Third Party that bears a Licensee Royalty
(a
"Covered License") shall be consistent with the terms and conditions of this
Agreement and shall include without limitation, provisions necessary to ensure
that Licensor or such Third Party comply with royalty reporting and audit
requirements, and confidentiality. Any act or omission by such Third Party
under
a Covered License which would have constituted a breach of this Agreement had
it
been the act or omission of Licensor, shall be deemed to constitute a breach
of
this Agreement by Licensor. Licensor shall advise Licensee without delay of
any
breach by such Third Party and Licensor shall exercise without delay its rights
with respect to such breach against such Third Party.
21
12.5
Disposition
of Product.
Upon termination of this Agreement with respect to any country, Licensee shall
provide Licensor a written inventory of all Product (in the form of raw
material, work-in-progress and finished goods) in its and its Sublicensees'
possession in such country, and shall have the right to dispose of such Product
within six (6) months thereafter, subject to fulfillment of the royalty
obligations relating thereto.
ARTICLE
13. ASSIGNMENT
This
Agreement may not be assigned or otherwise transferred by either party without
the written consent of the other party except that either party without such
consent may assign or sell the license (i) in connection with the transfer
or
sale of all or substantially all of its business assets to a Third Party, or
(ii) in the event of its merger or consolidation with another company, or (iii)
to an Affiliate. Any purported assignment in violation of this clause shall
be
void. Any permitted assignee shall assume all the obligations of its assignor
under this Agreement. No assignment shall relieve either party of its
responsibility for the performance of any obligation that such party has accrued
hereunder as of the date of assignment.
ARTICLE
14 PATENT MARKINGS
Licensee
agrees to xxxx all Products made, used or sold under the terms of this
Agreement, or their containers, in accordance with applicable patent marking
laws.
ARTICLE
15. REGISTRATION OF LICENSES
Licensee
agrees to register or give required notice concerning this Agreement, through
itself or through a Sublicensee, in each country where there exists an
obligation under law to so register or give notice, to pay all costs and legal
fees connected therewith, and to otherwise comply with all national laws
applicable to this Agreement. Upon request by Licensee, Licensor agrees to
promptly execute any "short form" licenses in a form submitted to it by Licensee
in order to effectuate the foregoing registration in each such
country.
22
ARTICLE
16. PATENT TERM EXTENSION
Licensee
agrees, as exclusive Licensee, to apply for and to exercise due diligence in
obtaining an extension of the term of any patent included within the Patent
Rights under the applicable laws of any country where such extensions are
available, including, but not limited to, the Drug Price Competition and Patent
Term Restoration Act of 1984 in the United States. Licensor agrees to execute
such documents and take such additional actions as Licensee may reasonably
request in connection therewith. Each party shall bear its own expenses in
connection with the application for patent term extensions.
ARTICLE
17. FORCE MAJEURE
Neither
party shall be held liable or responsible to the other party nor be deemed
to
have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement, other than an obligation
to
make a payment, when such failure or delay is caused by or results from fires,
floods, embargoes, government regulations, prohibitions or interventions, wars,
acts of war, terrorism, insurrections, riots, civil disobedience, strikes,
lockouts, acts of God, or any other cause beyond the reasonable control of
the
affected party.
ARTICLE
18. NEGATION OF AGENCY.
Nothing
herein contained shall be deemed to create an agency, joint venture,
amalgamation, partnership, or similar relationship between Licensee and
Licensor. The relationship between the parties established by this Agreement
is
that of independent contractors. Neither party shall have the power to bind,
obligate, incur any debts or make any commitments for the other party except
to
the extent, if at all, specifically provided herein.
ARTICLE
19. PUBLICITY
Each
party shall give notice to the other party prior to issuing any press release
relating to this Agreement within due time to allow for reasonable
consideration. The party issuing the press release shall give due consideration
and weight to any comments or concerns raised by the other party.
Notwithstanding the foregoing, neither party shall issue a press release
announcing the execution of this Agreement outside of a joint press release
which will be prepared jointly by the parties.
23
ARTICLE
20. FILING OF THE AGREEMENT
To
the extent, if any, that a party concludes in good faith that it is required
to
file this Agreement or a notification thereof with any governmental authority,
including without limitation the U.S. Securities and Exchange Commission in
accordance with applicable laws and regulations, such party may do so, subject
to the confidentiality obligations set forth herein, and the other party shall
cooperate in such filing or notification and shall execute all documents
reasonably required in connection therewith at the, expense of the requesting
party. The parties shall promptly inform each other as to the activities or
inquiries of any such governmental authority relating to this Agreement, and
shall cooperate, in responding to any request for further information therefrom
at the expense of the requesting party.
ARTICLE
21. SEVERABILITY
Each
party hereby expressly agrees and contracts that it is not the intention of
either party to violate any public policy, statutory or common laws, rules,
regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries. If any word,
sentence, paragraph, clause or combination thereof in this Agreement is found
by
a court or executive body with judicial powers having jurisdiction over this
Agreement or any of the parties hereto in a final unappealable order to be
in
violation of any such provisions in any country or community or association
of
countries, such word, sentence, paragraph, clause or combination thereof shall
be inoperative in such country or community or association of countries, and
the
parties will seek in good faith to amend this Agreement in order to cure such
violation; the remainder of this Agreement shall in any event remain binding
upon the parties hereto.
ARTICLE
22. NOTICES
Any
notices required or permitted to be given hereunder shall be in writing and
shall be deemed to have been properly given if delivered in person, or if mailed
by registered or certified mail (return receipt requested), postage prepaid,
or
by telex or facsimile or e-mail promptly confirmed by first class mail, to
the
addresses given below or such other addresses as may be designated in writing
by
the parties from time to time during the term of this Agreement. Any notice
sent
or by telex or facsimile or e-mail shall be effective when sent, and any notice
sent by registered or certified mail shall be effective when
mailed.
In
the case of Licensee:
Keryx
Biopharmaceuticals, Inc
000
Xxxxxxxxx Xxx, 00xx
Xxxxx
Xxx
Xxxx, XX 00000
Attn:
Xxxxxxx X. Xxxxx
Chairman
& CEO
Email:
xxx@xxxxx.xxx
24
In
the case of Licensor:
Panion
& BF Biotech, Inc.
16F
Xx. 0, Xxxxxx Xxxxxx,
Xxxxxxx
Xxxxxxxx,
Xxxxxx,
Xxxxxx, ROC
Attn:
Xxxxxxx Xxxxxx
c/o:
Holland
& Knight LLP
0000
Xxxxxxxxxxxx Xxxxxx
Xxxxxxxxxx,
X.X. 00000
(000)
000-0000
Attn:
Xxxx X. X. Xxx, Esq.
ARTICLE
23. GOVERNING LAW
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of New York, exclusive of choice-of-law rules.
ARTICLE
24. AFFILIATES
Each
party may perform its obligations hereunder personally or through one or more
Affiliate and shall be responsible for the performance of such obligations,
and
any liabilities resulting from such performance. Neither party shall permit
any
of its Affiliates to commit any act (including any act of omission) which such
party is prohibited hereunder from committing directly.
ARTICLE
25. ENTIRE AGREEMENT
This
Agreement and the Exhibits hereto which are a part hereof, contain the entire
understanding of the parties with respect to the subject matter hereof. All
express or implied agreements and understanding, either oral or written,
heretofore made are expressly merged in and made a part of this Agreement.
The
parties hereto may alter any of the provisions of this Agreement, but only
by a
written instrument duly executed by both parties hereto.
25
ARTICLE
26. WAIVER
The
failure of a party to enforce at any time for any period any of the provisions
hereof shall not be construed as a waiver of such provisions or of the right
of
such party thereafter to enforce each such provision.
ARTICLE
27. CAPTIONS
The
captions to the several Articles and Sections hereof are not a part of this
Agreement, but are merely guides or labels to assist in location and reading
the
several Articles and Sections hereof.
IN
WITNESS HEREOF,
the parties have executed this Agreement as of the Effective Date.
| KERYX BIOPHARMACEUTICALS, INC. | PANION & BF BIOTECH INC. | |||
| By: | /s/ Xxxxxxx X. Xxxxx | By: | /s/ Xxxxxxx Xxxxxx | |
| Chairman & CEO | ||||
26
