CONFIDENTIAL
EXHIBIT 10.4
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS *. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
LEVPHARMA - SANQUIN
EXCLUSIVE LICENSE AGREEMENT
This Agreement, effective this, January 27, 2004 between
Sanquin Blood Supply Foundation, hereinafter called SANQUIN and LEV
PHARMACUTICALS, INC., a corporation organized and existing under the laws of the
State of Delaware with a principal place of business in the State of New York,
hereinafter called LEVPHARMA.
WHEREAS, SANQUIN, under the direction of principal investigator Xxxx Hack,
M.D. has discovered and developed certain technology relating to C1 esterase
inhibitor and the diagnosis, prevention and treatment of inflammatory diseases
and in particular myocardial infarction, which technology includes the use of C1
esterase inhibitor for the treatment of Acute Myocardial Infarction (AMI); and
WHEREAS, SANQUIN represents that it has the right to grant licenses
granted in this agreement, and for the purpose of this agreement, any reference
to SANQUIN Patent Rights and SANQUIN Know-How shall mean the use of C1 Esterase
Inhibitor in AMI (the "Technology"); and
WHEREAS, LEVPHARMA wishes to obtain a license under the terms and
conditions hereinafter set forth, and to use its expertise and resources to
develop, manufacture and market the Technology;
NOW THEREFORE, in consideration of the premises and the faithful
performance of the covenants herein contained, IT IS AGREED:
ARTICLE I. Definitions
Section 1.01 SANQUIN Know-How. "SANQUIN Know-How" shall mean the ideas, methods,
inventions, trade secrets, improvements, characterization and techniques
developed by Dr. Hack relating to the use of C1 Esterase Inhibitor in AMI (the
"Technology') defined above, including, without limitation, all submitted and
granted world-wide patents described in "C1 Esterase Inhibitor in AMI" as
described in Exhibit A as well as any know-how, trade secrets, inventions and
improvements arising in whole or in part from the Sponsored Research of Section
5.01(a) herein.
Section 1.02 SANQUIN Patent Rights. "SANQUIN Patent Rights" shall mean the
patents and patent filings listed in Exhibit A hereto as well as any patents and
patent applications relating to any know-how, inventions and improvements
arising in whole or in part from the Sponsored Research of Section 5.01(a)
herein; including any provisionals, continuations, continuations-in part,
divisions, reissues, reexaminations or extensions thereof or any United States
or foreign patents issuing therefrom.
Section 1.03 Licensed Technology. "Licensed Technology" shall mean any use of
the Technology (use of C1 Inhibitor in the treatment of AMI) or processes
covered by or made, in whole or in part, by the use of SANQUIN Know-How or
covered by a Valid Claim of a patent included in SANQUIN Patent Rights.
Section 1.04 Licensed Product. "Licensed Product" shall mean any product made,
in whole or in part, by the use of SANQUIN Know-How or covered by a Valid Claim
of a patent included in SANQUIN Patent Rights or developed as a result of the
Sponsored Research.
Section 1.05 Field. The "Field" of this Agreement shall mean the research,
development, making, using, offering for sale, selling and/or importing of
products and methods for the diagnosis, prevention and treatment of myocardial
infarction, and related disorders in humans and animals, including, without
limitation, a Diagnostic Use and a Therapeutic Use of products and methods.
Section 1.06 Subsidiary. "Subsidiary" shall mean a legal entity at least 50% of
the voting stock of which is owned directly or indirectly by LEVPHARMA.
Section 1.07 Agreement. "Agreement" shall mean this License Agreement.
Section 1.08 Net Sales. "Net Sales" shall mean the gross sales price actually
charged by LEVPHARMA or an Affiliate, Subsidiary or Sublicensee in the
Commercial Sale of C1 Esterase Inhibitor for use in, less:
(a) trade, prompt payment, quantity or cash discounts, rebates, and
non-affiliated brokers' or agents' commissions, each as actually and
customarily allowed and taken;
(b) amounts actually repaid or credited to customers on account of
rejections or returns of specified products on which royalties have
been paid hereunder to SANQUIN or on account of retroactive price
reductions affecting such products;
(c) customary freight and other transportation costs, including
insurance charges, and duties, tariffs, sales, use and excise taxes and
other governmental charges based directly on sales, turnover or
delivery of the specified products and actually paid or allowed by
LEVPHARMA or an Affiliate, Subsidiary or sublicensee of LEVPHARMA.
(d) commercially reasonable allowances for bad debts not to exceed five
(5)% of gross sales, incurred with respect to the Licensed Products
during the first full year of Commercial Sales of any such Licensed
Product, provided that such bad debt reserve shall be deemed
extinguished within 180 days of the end of such first full year, and
any amount of such reserve not actually debited in accordance with
commercially reasonable practices during that period shall be deemed to
be receipts of Net Sales for all purposes of this Agreement.
Section 1.09 Effective Date. "Effective Date" shall mean the date first written
above and shall be the Effective Date of this Agreement.
Section 1.10 License Year. The "First License Year" shall mean the period
commencing on the Effective Date and ending December 31, 2003. The second and
all subsequent "License Years" shall commence on January 1 and end on December
31 of each year.
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Section 1.11 Calendar Quarter. "Calendar Quarter" shall mean the periods ending
on March 31, June 30, September 30 and December 31 of each year.
Section 1.12 Affiliate. "Affiliate" shall mean, as to any person or entity, any
other person or entity which directly or indirectly controls, is controlled by,
or is under common control with such other person or entity and it shall include
Subsidiaries as defined herein. For purposes of the preceding definition,
"control" means the right to control, or actual control of, the management of
such other entity, whether by ownership of voting securities, by agreement, or
otherwise.
Section 1.13 Commercial Sale. "Commercial Sale" shall mean any transfer to
another person or entity (including a distributor, wholesaler or sales agent),
for value, after which transfer the seller has no right, power or authority to
determine the transferee's resale price, if any. A transfer by LEVPHARMA to an
Affiliate or Subsidiary, sublicensee, or a transfer among or between Affiliates
and/or sublicensees, shall not constitute a Commercial Sale. "Commercial Sale"
does not include distribution of free promotional samples of any Licensed
Product or distribution or free promotional samples for use in the Licensed
Technology by LEVPHARMA or any of its Affiliates or sublicensees in amounts
determined to be commercially reasonable by LEVPHARMA in the exercise of its
reasonable discretion.
Section 1.14 Valid Claim. "Valid Claim" shall mean a claim of an issued,
unexpired patent that has not been held to be invalid or unenforceable by the
applicable administrative or judicial authority in a given territory.
Section 1.15 Diagnostic Use. "Diagnostic Use" shall mean the use of the Licensed
Technology or a Licensed Product in an assay or test.
Section 1.16 Therapeutic Use. "Therapeutic Use" shall mean the use of the
Licensed Technology or a Licensed Product in the treatment of a human or animal
and which is not a Diagnostic Use.
Section 1.17 Approval. "Approval" shall mean all approvals, licenses,
registrations and authorizations of all governmental agencies in a country
necessary for the manufacture, use, offer for sale, sale or import of the
Licensed Technology or a Licensed Product in the applicable country.
Section 1.18 First Commercial Sale. "First Commercial Sale" shall mean, with
respect to any Licensed Technology and/or Licensed Product, the first sale for
use or consumption by the general public of such Licensed Technology or Licensed
Product in each country following Approval, or otherwise permitted, by the
governing health authority of such country.
Section 1.19 Phase III Clinical Trial. "Phase III Clinical Trial" shall mean a
human clinical trial, the principal purpose of which is to establish safety and
efficacy in patients with the disease being studied as required in 21 C.F.R.
ss.312, or similar clinical study prescribed by the regulatory authorities in a
country other than the United States. A Phase III Clinical Trial shall also
include any other human clinical trial intended as a Pivotal Study. A Phase III
Clinical Trial shall be deemed to have commenced when the first patient has been
enrolled.
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Section 1.20 Development and Commercialization Plan. "Development and
Commercialization Plan" shall mean LEVPHARMA'S plan for the further development
and commercialization of the Licensed Technology and any potential Licensed
Products in the Field, see Exhibit B hereto.
Section 1.21 Research Plan. "Research Plan" shall mean the comprehensive plan
for the commercial exploitation of the Licensed Technology as more fully
described in Article V. The Research Plan shall also contain a Sponsored
Research Plan, which shall mean the plan described in Section 5.01(a). The
initial Sponsored Research Plan is included as Exhibit C hereto.
ARTICLE II. Grant
Section 2.01 License Grant. SANQUIN hereby grants to LEVPHARMA and its
Affiliates an exclusive, world-wide, royalty-bearing license under SANQUIN
Know-How and SANQUIN Patent Rights in the Field, including, without limitation,
the right to perform research for, develop, make, have made, use, offer for
sale, sell and/or import the Licensed Technology and Licensed Products in the
Field.
Section 2.02 Sublicenses. LEVPHARMA shall have the right to grant sublicenses to
third parties, under SANQUIN Know-How and SANQUIN Patent Rights to make, have
made, use, offer for sale, sell and/or import the Licensed Technology and
Licensed Products. LEVPHARMA covenants that any sublicensees shall act in
accordance with this Agreement as if they were a party thereto and, furthermore,
agrees to be responsible for the performance hereunder by its sublicensees.
LEVPHARMA shall promptly provide SANQUIN with copies of all sublicenseing
contracts under the SANQUIN Knowhow and/or SANQUIN Patent Rights.
Section 2.03 Patents. LEVPHARMA shall, within 60 days of execution of this
Agreement, reimburse SANQUIN for all expenses SANQUIN has incurred for the
mutually acceptable and agreed upon preparation, filing, prosecution and
maintenance of SANQUIN Patent Rights both prior to and as of the Effective Date.
The parties agree that this amount shall be $82,000. SANQUIN and LEVPHARMA shall
jointly control, including selection of outside counsel and consultants, all
future preparation, filing, prosecution and maintenance of SANQUIN Patent
Rights, for which LEVPHARMA shall reimburse SANQUIN for any and all future out
of pocket expenses (e.g., outside attorney fees, patent office registration and
renewal costs etc.) relating to such. If LEVPHARMA chooses to discontinue
prosecution or maintenance of any patent or patent application, which is a
subject of SANQUIN Patent Rights, it will so inform SANQUIN within a reasonable
time before implementation of such decision. SANQUIN then shall have the right
to prosecute or maintain such patent or patent application on its own and at its
own expense, in which case the license to LEVPHARMA under such patent or patent
application will terminate. LEVPHARMA shall notify SANQUIN by at least three (3)
months before the first anniversary of the application filing date whether it
will support the filing of patent applications, corresponding to the
aforementioned patent and patent application in foreign countries. If LEVPHARMA
decides not to support the filing or maintaining of foreign applications,
SANQUIN reserves the right to file or maintain such foreign applications, in
which case the license to LEVPHARMA in the particular territory in which such
foreign application is filed will terminate.
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Section 2.04. Transfer of Biological Materials. SANQUIN retains ownership of all
SANQUIN biological materials transferred to LEVPHARMA. Upon termination of this
Agreement, LEVPHARMA agrees to dispose of SANQUIN biological materials as
directed by SANQUIN. At SANQUIN's election, this shall mean either the return or
the transfer to a designated third party or the destruction of all or part of
the SANQUIN biological materials. All reasonable expenses incurred in the
return, transfer or disposal of the SANQUIN biological materials shall be borne
by LEVPHARMA.
If LEVPHARMA enters into an agreement with a third party to produce Licensed
Products for LEVPHARMA using the SANQUIN biological materials, LEVPHARMA shall
require that (i) such third party has the prior written consent of SANQUIN,
which shall not be unreasonably withheld and (ii) the third party agrees to
abide by the restrictions as to distribution of the SANQUIN biological materials
set forth in this section and to undertake the necessary precautions to
safeguard the Sanquin biological materials.
SANQUIN shall not provide SANQUIN's C1 esterase inhibitor to any third party for
use in acute myocardial infarction, without the express written consent of
LEVPHARMA. Such consent shall not be unreasonably withheld.
ARTICLE III. Disclosure of Invention, Confidentiality and Representations
Section 3.01 Disclosure of Know-How. SANQUIN agrees promptly after the Effective
Date of this Agreement to deliver and to disclose to duly authorized
representatives of LEVPHARMA, all proprietary technical data, methods,
processes, including the technology, and other information and specifications
relating to SANQUIN Know-How.
Section 3.02 Mutual Confidentiality. LEVPHARMA and SANQUIN realize that some
information received by one party from the other pursuant to this Agreement
shall be confidential. It is therefore agreed that any information received by
one party from the other, and clearly designated in writing as "CONFIDENTIAL" at
the time of transfer, shall not be disclosed by either party to any third party
and shall not be used by either party for purposes other than those contemplated
by this Agreement for a period of three (3) years from the termination of the
Agreement, unless or until --
(a) said information shall become known to third parties not under any
obligation of confidentiality to the disclosing party, or shall become
publicly known through no fault of the receiving party, or
(b) said information was already in the receiving party's possession
prior to the disclosure of said information to the receiving party,
except in cases when the information has been covered by a preexisting
Confidentiality Agreement, or
(c) said information shall be subsequently disclosed to the receiving
party by a third party not under any obligation of confidentiality to
the disclosing party, or
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(d) said information is approved for disclosure by prior written
consent of the disclosing party, or
(e) said information is required to be disclosed by court order or
governmental law or regulation, provided that the receiving party gives
the disclosing party prompt notice of any such requirement and
cooperates with the disclosing party in attempting to limit such
disclosure.
Section 3.03 Corporate Action. SANQUIN and LEVPHARMA each represent and warrant
to the other party that they have full power and authority to enter into this
Agreement and carry out the transactions contemplated hereby, and that all
necessary corporate action has been duly taken in this regard.
ARTICLE IV. Payments, Records and Reports
Section 4.01 Payments. For the rights and privileges granted under this license,
LEVPHARMA shall pay to SANQUIN:
(a) royalties as follows:
(1) for a royalty of *% of Net Sales by LEVPHARMA or each
sublicensee for any and all Licensed Technology or Licensed
Products sold for a Therapeutic Use.;
(2)a royalty of *% of Net Sales by LEVPHARMA or each
sublicensee for any and all Licensed Technology or Licensed
Products sold for a Diagnostic Use. .;
(b) A non-refundable, non-creditable, one-time license access fee of
$175,000 due within sixty (60) days of execution of this Agreement, in
addition to the patent costs reimbursement amount referred to in
Section 2.03 ;
(c) Minimum Annual Royalties: LEVPHARMA agrees to pay to SANQUIN
Minimum Annual Royalties (MAR) beginning in the License Year that
includes the First Commercial Sale of the Licensed Technology as
follows:
o Year of First Commercial Sale Pro Rata share of
$* based on actual
number of days from
First Commercial
Sale to the end of
the calendar year.
o years 1 - 4 after First Commercial Sale $ *
o years 5 - 9 after First Commercial Sale $ *
o years 10 - 14 after First Commercial Sale $ *
o years 15 - 19 after First Commercial Sale $ *
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(d) Non-royalty consideration as follows:
(1) for Licensed Technology or Licensed Products sold for a
Therapeutic Use: * percent (*%) of any consideration received
from a patent infringement settlement, less litigation
expenditures, as described in Section 7.01;
(2) for Licensed Technology or Licensed Products sold for a
Diagnostic Use: * percent (*%) of any consideration received
from a patent infringement settlement, less litigation
expenditures, as described in Section 7.01.
Section 4.02 Reports. LEVPHARMA shall render to SANQUIN:
(a) within thirty (30) days after the end of each Calendar Quarter a
written account of all quantities of Licensed Technology or Licensed
Products subject to royalty hereunder sold by LEVPHARMA, any
Subsidiary, Affiliate and any sublicensee during such Calendar Quarter,
the calculation of royalty thereon, and sufficient data for SANQUIN to
verify the calculation, including gross sales and allowable deductions
to derive Net Sales figures, and shall simultaneously pay in United
States dollars to SANQUIN the royalty due with respect to such sales.
Conversion of foreign currency to US dollars shall be made at the
conversion rate existing in the United States as printed in the Wall
Street Jounal on the date of the royalty payments by LEVPHARMA. Such
report shall be certified as correct by an officer of LEVPHARMA. If no
Licensed Technology or Licensed Products subject to royalty hereunder
have been sold by LEVPHARMA, its Subsidiaries, Affiliates and its
sublicensees during any such Calendar Quarter, LEVPHARMA shall so
report in writing to SANQUIN within thirty (30) days after the end of
said Calendar Quarter. If royalties for any license year do not equal
or exceed the Minimum Annual Royalties established in Section 4.01(c),
LEVPHARMA shall include the balance of the Minimum Annual Royalty still
owing with the payment for the Calendar Quarter ending December 31.
Late payments shall be subject to an interest charge of one and one
half percent (1.5%) per month.
(b) within sixty (60) days after the close of each License Year written
annual reports which shall include but not be limited to: reports of
progress on research and development, regulatory approvals,
manufacturing, sublicensing, marketing and sales during the preceding
twelve (12) months and plans for the coming year. LEVPHARMA shall also
provide any reasonable additional data SANQUIN requires to evaluate
LEVPHARMA's performance.
(c) within thirty (30) days of its occurrence a report of the date of
First Commercial Sale of Licensed Technology or Licensed Products in
each country.
Section 4.03 Books of Accounts. LEVPHARMA, its Subsidiaries, Affiliates and
sublicensees shall keep full, true and accurate books of accounts and other
records containing all particulars which may be necessary for the purpose of
ascertaining and verifying the royalties payable to SANQUIN by LEVPHARMA
hereunder. Upon SANQUIN's request, LEVPHARMA, its Subsidiaries, Affiliates and
sublicensees shall permit an independent Certified Accountant selected by
SANQUIN (except one to whom LEVPHARMA has some reasonable objection), to have
access once each year during ordinary business hours to such records of
LEVPHARMA, its Subsidiaries, Affiliates and sublicensees as may be necessary to
determine, for any quarter ending not more than two (2) years prior to the date
of such request, the correctness of any report and/or payment made under this
Agreement. In the event that any such inspection shows an underreporting and
underpayment in excess of four percent (4%) for any twelve (12) month period,
then LEVPHARMA shall pay the cost of such examination.
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ARTICLE V. Technical Assistance and Commercial Development
Section 5.01 Research Plan. LEVPHARMA shall create a Research Plan. LEVPHARMA
will provide a minimum of $125,000 per year for three years from the Effective
Date for the Research Plan as follows:
(a) Sponsored Research. LEVPHARMA shall provide $62,500 to SANQUIN for
each of the three years included above, which includes SANQUIN overhead
expenses, to support the Research Plan. Dr. Hack shall be the principal
investigator for this research, and will provide LEVPHARMA an annual
budget for each year and research plan at least three (3) months prior
to the beginning of the second year and each year thereafter. LEVPHARMA
and Dr. Hack will work to mutually agree on the budget and research
plan. LEVPHARMA shall pay the budgeted amounts to SANQUIN quarterly in
advance over the period of guaranteed support. All know-how, inventions
and improvements arising in whole or in part from the Sponsored
Research and developed or invented by SANQUIN personnel shall be
assignable to SANQUIN and become subject to this Agreement at no
additional cost to LevPharma as SANQUIN Know-How and/or SANQUIN Patent
Rights pursuant to Sections 1.01 and 1.02 herein. SANQUIN shall not
provide any Biological Materials derived from the Sponsored Research to
any other entity without the express written consent of LEVPHARMA.
In the event that Dr. Hack should be, unable, for whatever reason, to
continue with the Sponsored Research before its completion, SANQUIN
shall provide a replacement for Dr. Hack which shall be approved by
LEVPHARMA, such approval shall not be unreasonably withheld. In the
event that LEVPHARMA does not approve of the replacement, it shall have
the right to immediately terminate the Sponsored Research subject only
to the payment of any pro rated amount of the budget that may be due up
to the date of termination.
(b) SANQUIN shall provide LEVPHARMA with quarterly reports of the
progress of the Sponsored Research.
(c) Additional Research. LEVPHARMA shall provide an additional minimum
of $62,500 per year to be used to support the Research Plan.
Section 5.02 Technical Assistance. Throughout the term of the Agreement, SANQUIN
agrees to permit LEVPHARMA and its designees to consult with Sanquin and its
employees and agents regarding developments and enhancements made subsequent to
the Effective Date relating to the Licensed Technology and Licensed Products, at
such times and places as may be mutually agreed upon.
8
Section 5.03 Development and Commercialization Plan. During the term of this
Agreement, LEVPHARMA agrees to use commercially reasonable efforts to
manufacture and market Licensed Technology and Licensed Products. Such efforts
will include sublicensing, development of promotional literature, direct
marketing mailings, and journal advertisements. LEVPHARMA shall keep SANQUIN
informed of LEVPHARMA's annually updated Development and Commercialization Plan
for Licensed Technology and Licensed Products, including LEVPHARMA's planned
timing/timelines for launch dates. All dates and other information provided by
LEVPHARMA to SANQUIN shall be Confidential Information.
Section 5.04 Name. LEVPHARMA shall not use and shall not permit to be used by
any other person or entity the name SANQUIN nor any adaptation thereof, or the
name of any of SANQUIN's employees, in any advertising, promotional or sales
literature, or for any other purpose without prior written permission of
SANQUIN, except that LEVPHARMA may state that it is licensed from SANQUIN under
SANQUIN Know-How and Patent Rights and originated in the laboratory of Xxxx
Hack. SANQUIN shall not disclose the existence of this Agreement or originate
any publicity, news release or other public announcement, neither written nor
verbal, whether to the public, press or otherwise, relating to this Agreement,
without the prior express written consent of LEVPHARMA.
ARTICLE VI. Indemnity, Insurance, Disclaimers
Section 6.01 Indemnity. LEVPHARMA shall defend and indemnify and hold SANQUIN
and its trustees, officers, agents and employees (the "SANQUIN Indemnitees")
harmless from any judgments and other liabilities based upon claims or causes of
action against SANQUIN or its employees which arise out of (i) alleged
negligence in the development, manufacture or sale of Licensed Products by
LEVPHARMA, its Subsidiaries, Affiliates and Sublicensees, unless SANQUIN
manufacturers said Licensed Products and the claim or causes of action arise out
of any defects in the Licensed Products caused by acts or omissions of Sanquin,
or (ii) the use by the end users of Licensed Products, or (iii) any breaches by
LEVPHARMA, its Subsidiaries, Affiliates and Sublicensees of the terms of this
License Agreement, except to the extent that such judgments or liabilities arise
in whole or in part from the, gross negligence, fraud or willful misconduct of
SANQUIN or its employees, provided that SANQUIN promptly notifies LEVPHARMA of
any such claim coming to its attention and that it cooperates with LEVPHARMA in
the defense of such claim. If any such claims or causes of action are made,
SANQUIN shall be defended by counsel to LEVPHARMA, subject to SANQUIN's
approval, which shall not be unreasonably withheld. SANQUIN reserves the right
to be represented by its own counsel at its own expense.
SANQUIN shall defend and indemnify and hold LEVPHARMA and its trustees,
officers, agents and employees (the "LEVPHARMA Indemnitees") harmless from any
judgments and other liabilities based upon claims or causes of action against
LEVPHARMA or its employees which arise out of a breach by SANQUIN under its
representations and warranties referred to in Section 6.03, except to the extent
that such judgments or liabilities arise in whole or in part from the, gross
negligence, fraud or willful misconduct of LEVPHARMA or its employees, provided
that LEVPHARMA promptly notifies SANQUIN of any such claim coming to its
attention and that it cooperates with SANQUIN in the defense of such claim. If
any such claims or causes of action are made, LEVPHARMA shall be defended by
counsel to SANQUIN, subject to LEVPHARMA's approval, which shall not be
unreasonably withheld. LEVPHARMA reserves the right to be represented by its own
counsel at its own expense.
9
Section 6.02 Insurance. At such time as any product, process, service relating
to, or developed pursuant to, this Agreement is being commercially distributed
or sold (other than for the purpose of obtaining regulatory approvals) by
LEVPHARMA or by a sublicensee, Affiliate or agent of LEVPHARMA, LEVPHARMA shall
at its sole cost and expense, procure and maintain comprehensive general
liability insurance in amounts not less than $2,000,000 per incident and naming
Sanquin and the other SANQUIN Indemnitees (if such policy allows) and provided
that any additional premiums are paid for by Sanquin) as additional insureds.
Such comprehensive general liability insurance shall provide (i) product
liability coverage and (ii) broad form contractual liability coverage for
LEVPHARMA's indemnification under this Agreement. The minimum amounts of
insurance coverage required shall not be construed to create a limit of
LEVPHARMA's liability with respect to its indemnification under this Agreement.
LEVPHARMA shall maintain such comprehensive general liability insurance until i)
it has sufficient operating capital or reserves to meet the minimum insurance
requirements listed above, or ii) for 10 (ten) years after the last Commercial
Sale, whichever event occurs first.
Section 6.03 Representation and Warranties.
(a) Nothing contained in this Agreement shall be construed as:
(1) a warranty or representation by SANQUIN as to the validity
or scope of any SANQUIN Patent Rights;
(2) a warranty or representation that any Licensed Products
manufactured, used or sold will be free from infringement of
patents, copyrights, or third parties, except that SANQUIN
represents that it has no knowledge of any existing issued
patents or copyrights which might be infringed; and
(3) except as provided in Section 6.01, an agreement to defend
against actions or suits of any nature brought by any third
parties.
(b) SANQUIN represents that it has the right to grant licenses granted
in this Agreement.
(c) SANQUIN makes no warranties, express or implied, as to the
merchantability or fitness for a particular purpose of Licensed
Products.
(d) SANQUIN warrants that no governmental or third party non-government
commercial funding will be used for the development or research work
contemplated by this Agreement without the prior written agreement of
LEVPHARMA.
(e) SANQUIN warrants that this Agreement does not conflict with or
breach any other agreement or understanding to which SANQUIN is a
party.
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ARTICLE VII. Infringement Matters
Section 7.01 Infringement by Third Parties. LEVPHARMA shall give SANQUIN prompt
notice of any incident of infringement of SANQUIN Patent Rights coming to its
attention. The parties shall thereupon confer together as to what steps are to
be taken to stop or prevent such infringement. LevPharma shall have the right to
initiate actions against any such infringers. SANQUIN agrees to assist
LevPharma, including providing access to SANQUIN personnel, in LevPharma's
reasonable efforts to stop any such infringement. LEVPHARMA shall be responsible
for all expenses associated with such efforts to stop any such infringement,
except that LEVPHARMA shall not be required to reimburse SANQUIN for the time of
any SANQUIN employee. LEVPHARMA agrees to make the absolute minimum use of the
time of any SANQUIN employee required for this purpose. If LevPharma decides to
commence proceedings however, LevPharma shall be responsible for any legal costs
incurred and will be entitled to retain any damages recovered subject to any
payments required pursuant to Sections 4.01(a) and (c). Sanquin shall assist
LevPharma as reasonably requested by LevPharma in any such proceeding including
agreeing to be named as a party to the proceedings. Should LevPharma decide not
to commence proceedings or if LevPharma has not initiated such proceedings
within 60 days after becoming aware of the infringement, Sanquin shall be
entitled to do so in its own name against the infringer, in which event Sanquin
shall be responsible for all legal costs incurred and will be entitled to retain
any damages recovered , without recourse to LevPharma . In any action to enforce
SANQUIN Patent Rights, either party, at the request and expense of the other
party shall cooperate to the fullest extent reasonably possible.
ARTICLE VIII. Duration and Termination
Section 8.01 Term. This Agreement shall become effective upon the date first
written above, and unless sooner terminated in accordance with any of the
provisions herein, shall remain in full force until expiration, invalidation or
unenforceability of the last to expire patent under SANQUIN Patent Rights in the
last to expire territory . If mutually desired, the parties may negotiate for an
extension of this License. Upon the expiration or termination for a breach by
Sanquin (but not on premature termination in the case of breach by LevPharma, )
of the Agreement, LEVPHARMA shall have the right to sell the remainder of the
Licensed Product on hand, provided the sales will be subject to the royalty
payments of this Agreement; provided, however, that in the event of expiration
(but not in the event of premature termination) of the Agreement, LEVPHARMA
shall have a perpetual, royalty free, fully paid-up, non-exclusive license under
any SANQUIN Know-How to make, have made, use, sell, offer for sale and import
Licensed Technology and Licensed Products after such termination pursuant to
this provision.
Section 8.02 Termination - Breach. In the event that either party defaults or
breaches any of the provisions of this Agreement, the other party shall have the
right to terminate this Agreement by giving written notice to the defaulting
party, provided, however, that if the said defaulting party cures said default
within thirty (30) days after said notice shall have been given, this Agreement
shall continue in full force and effect. The failure on the part of either of
the parties hereto to exercise or enforce any right conferred upon it hereunder
shall not be deemed to be a waiver of any such right nor operate to bar the
exercise or enforcement thereof at any time or times thereafter.
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Section 8.03 Termination. LEVPHARMA shall have the right to terminate this
Agreement upon ninety (90) days written notice to SANQUIN, provided that
LEVPHARMA shall (1) pay all payments due under Section 4.01, as applicable, and
(2) finish paying for the Sponsored Research pursuant to Section 5.01(a) for the
term contained therein, unless LEVPHARMA should terminate this Agreement
pursuant to section 5.01(a), in which case LEVPHARMA shall only be required to
pay any pro rated amount of the Sponsored Research budget that may be due up to
the date of termination.
Section 8.04 Failure to Perform. If LEVPHARMA fails to use commercially
reasonable efforts to perform any material duty imposed upon LEVPHARMA under
this License Agreement and such failure to perform is not cured within sixty
(60) days of written notice thereof from SANQUIN, SANQUIN may elect, in its sole
discretions, to terminate this Agreement. LEVPHARMA shall be deemed to have
failed to use commercially reasonable efforts if (i) in any applicable year
LEVPHARMA has spent less than 50% of the amount budgeted for such year in the
then current Research Plan and/or if (ii) timelines set forth in the Development
and Commercialization Plan are delayed beyond 18 months; provided that the
failure to spend and/or delays are not caused by Xxxx Hack or Sanquin.
Section 8.05 Prior Obligations. Termination of this Agreement for any reason
shall not release either party from any obligation theretofore accrued.
ARTICLE IX. Miscellaneous
Section 9.01 Publications. SANQUIN retains the rights to report on the results
of research under this Agreement in professional journals, meetings, seminars,
and the like. Appropriate recognition of LEVPHARMA's support will be included in
all such reports. However, in recognition of LEVPHARMA's desire for patent
protection, SANQUIN shall provide LevPharma with the final draft of any
manuscript describing studies within the pertinent field and resulting from the
sponsored research at least ninety (90) days prior to publication, and LevPharma
shall have the right to a single 30 day delay in publication.
Section 9.02 Governing Law. This Agreement shall be construed, governed,
interpreted and enforced according to the laws of the state of Pennsylvania.
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Section 9.03 Notices. Any notice or communication required or permitted to be
given by either party hereunder, shall be deemed sufficiently given, if mailed
by certified mail, return receipt requested, and addressed to the party to whom
notice is given as follows:
If to LEVPHARMA, to:
LEVPHARMA
000 Xxx Xxxxxxxxx Xxxx
Xxxxxx Xxxxxxx, XX 00000,
If to SANQUIN, to: Stichting Sanquin Bloedvoorziening
T.a.v. Divisie Sanquin Research
Xxxxxxxxxxx 000
0000 XX Xxxxxxxxx
Xxx Xxxxxxxxxxx
Section 9.04. Assignment. This Agreement shall be binding upon and inure to the
benefit of the respective successors and assigns of the parties hereto. However,
LEVPHARMA may not assign this Agreement in whole or in part without the written
consent of SANQUIN, such consent not to be unreasonably withheld.
Section 9.05 Entire Agreement. This Agreement represents the entire Agreement
between the parties as of the effective date hereof, and may only be
subsequently altered or modified by an instrument in writing. This agreement
cancels and supersedes any and all prior oral or written agreements between the
parties which relate to the subject matter of this Agreement.
Section 9.06 Mediation and Arbitration. Both parties agree that they shall
attempt to resolve any dispute arising from this Agreement through mediation.
Both parties agree that at least one LEVPHARMA employee, capable of negotiating
an agreement on behalf of LEVPHARMA, shall, within three weeks of receipt of
written notification of a dispute, meet with at least one employee of SANQUIN
who is capable of negotiating an agreement on behalf of SANQUIN. If no agreement
can be reached, both parties agree to meet again within a four week period after
the initial meeting to negotiate in good faith to resolve the dispute. If no
agreement can be reached after this second meeting, both parties agree to submit
the dispute to binding arbitration under the Rules of the American Arbitration
Association before a single arbitrator.
Section 9.07 Waiver. A failure by one of the parties to this Agreement to assert
its rights for or upon any breach or default of this Agreement shall not be
deemed a waiver of such rights nor shall any such waiver be implied from
acceptance of any payment. No such failure or waiver in writing by any one of
the parties hereto with respect to any rights shall extend to or affect any
subsequent breach or impair any right consequent thereon.
Section 9.08 Severability. The parties agree that it is the intention of neither
party to violate any public policy, statutory or common laws, and governmental
or supranational regulations; that if any sentence, paragraph, clause or
combination of the same is in violation of any applicable law or regulation, or
is unenforceable or void for any reason whatsoever, such sentence, paragraph,
clause or combinations of the same shall be inoperative and the remainder of the
Agreement shall remain binding upon the parties.
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Section 9.09 Marking. LEVPHARMA agrees to xxxx the Licensed Products in the
United States with all applicable U.S. Patent numbers.
Section 9.10 Headings. The headings of the paragraphs of this Agreement are
inserted for convenience only and shall not constitute a part hereof.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement, in
duplicate originals, by their respective officers hereunto duly authorized, the
day and year herein written.
SANQUIN
By /s/ Xxxxx Xxxxxxx
Date 27/01/2004
Name: Xxxxx Xxxxxxx PhD
Title: Director SANQUIN Research
Division
By /s/ Th.X.X. Xxxxxx
Date 27/01/2004
Name: Th.X.X. Xxxxxx, PhD
Title: Chairman of the Sanquin
Executive Board
LEVPHARMA
By /s/ Xxxxxx Xxxxxxxxxx
Date 1/27/2004
Name: Xxxxxx Xxxxxxxxxx
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