LICENSE AGREEMENT
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THIS LICENSE AGREEMENT is made and entered into this first day of
August, 1999, by and between Duke University, a North Carolina corporation
not-for-profit having its principal office at Durham, North Carolina
("DUKE"), and Cistron Biotechnology, a corporation having its principal
office at 00 Xxxxxxxxxx Xxxxxx, Xxxx Xxxxx, XX 00000 ("CISTRON").
WITNESSETH:
WHEREAS, Xxxxxx Xxxxxx, Ph.D., a resident of North Carolina and DUKE
employee ('XXXXXX") is an inventor of certain DUKE PATENTS as hereinafter
defined; and
WHEREAS, DUKE represents that it is the sole owner of the entire
right, title and interest in the DUKE PATENTS; and
WHEREAS, XXXXXX has assigned any and all of his right, title, and
interest in and to said DUKE PATENTS and said JOINT PATENTS to DUKE; and
WHEREAS, DUKE has the right to grant licenses under the DUKE PATENTS
and to the JOINT PATENTS and wishes to have the technology protected by
these patents utilized in the public interest; and
WHEREAS, as herein set forth and subject to the terms hereof, CISTRON
desires a license in and to DUKE's rights in the DUKE PATENTS and the
JOINT PATENTS;
NOW, THEREFORE, for good and valuable consideration, which DUKE
acknowledges having received from CISTRON, and in further consideration of
the mutual promises set forth herein, the parties agree as follows:
1. Definitions. As used herein the following defined terms shall
have the following respective meanings:
a. "AFFILIATED COMPANY" means any company (i) in which CISTRON
now or hereafter owns or controls, directly or indirectly, fifty percent
(50%) or more of the stock having the right to vote for directors thereof,
or (ii) which owns or controls, directly or indirectly, fifty percent
(50%) or more of CISTRON's stock having the right to vote for directors.
b. "AGREEMENT" means this License Agreement.
c. "BLA" shall mean Biologics License Application with the FDA
or its component PLA and ELA applications arising from the LICENSED
PATENTS, or any equivalent application filed with a similar foreign
regulatory or governmental agency with jurisdiction over new drug
approvals.
d. "DUKE PATENTS" means patent application serial number
09/168910 entitled "Substantially non-toxic biologically active mucosal
adjuvants in vertebrate subjects" filed October 8, 1998 in the United
States Patent and Trademark Office, including all amendments, continuation
applications, divisional applications, continuation-in-part applications,
and reissues based thereon, and foreign counter parts thereto.
e. "EFFECTIVE DATE" means the date of the last signature
inscribed on page 13 of this AGREEMENT.
f "FDA" means the United States Food and Drug Administration.
g. "FIELD" shall mean, and shall be strictly limited to, the
development, manufacture, importation, offer for sale, and sale of intra-
nasally administered vaccines or vaccine adjuvants formulated with IL-lb
for
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prophylaxis and/or therapy of all human diseases.
h. "FIRST COMMERCIAL SALE" means the initial transfer, following
Product Licensing Application or Biological Licensing Application approval
by the FDA, by CISTRON of LICENSED PRODUCTS in exchange for cash or some
equivalent to which value can be assigned for the purpose of determining
NET SALES.
i. "IL-1b" shall mean human Interleukin-1 beta protein,
fragments of human Interleukin 1-beta protein, and mutant forms of human
Interleukin 1-beta protein.
j. "JOINT PATENTS" shall mean any patent or patent application
that, first, has inventors from both CISTRON and DUKE, and, second,
relates to the FIELD, and, third, has claims protecting the use of a
mutant form of IL-1b as an intranasal vaccine adjuvant, and, fourth, is
based on an invention disclosed to DUKE in an Invention Disclosure Form
which was assigned File # 1689 and which is incorporated in its entirety
as Exhibit A of this AGREEMENT. The term "JOINT PATENTS" shall also
include all amendments, continuation applications, divisional
applications, continuation-in-part applications, reissues, and foreign
counter parts thereto.
k. "LICENSED PATENTS" shall mean, collectively, DUKE PATENTS and
DUKE's rights in JOINT PATENTS.
1. "LICENSED PRODUCT(S)" means any product which is produced or
sold by CISTRON, any AFFILIATED COMPANY or any sublicensee that infringes
one or more issued claims of the LICENSED PATENTS in the FIELD.
m. "NDA" means a New Drug Application with the FDA or its
component PLA and ELA applications arising from the development of a
LICENSED PRODUCT, or any equivalent application filed with a similar
foreign regulatory or governmental agency with jurisdiction over new drug
approvals.
n. "NET SALES" means the gross sales of the LICENSED PRODUCT by
CISTRON or any sublicensee of CISTRON to independent third parties, less
price adjustments, return goods, billing corrections, cash, trade and
contract discounts, taxes arising from the sale of the LICENSED PRODUCT,
freight, and other special charges. If a LICENSED PRODUCT is not sold
independently, but rather is sold in combination with other material which
is not a LICENSED PRODUCT, then (i) the NET SALES of said LICENSED PRODUCT
shall be deemed to be the current equivalent NET SALES for the same
quantity of said LICENSED PRODUCT which is sold independently; or (ii) if
there are not independent current sales of said LICENSED PRODUCT, the NET
SALES shall be deemed to be equal to one hundred fifty percent (150%) of
the direct cost of producing said LICENSED PRODUCT, determined in
accordance with generally accepted accounting principles consistently
applied, not to exceed the actual Net Sales price of such compound
product.
o. "PMC" shall mean the Pasteur-Merieux-Connaught division of
Aventis Pharmaceuticals.
2. License.
x. XXXX hereby grants to CISTRON and CISTRON hereby accepts from
DUKE, upon the terms and conditions herein specified, an exclusive license
to make, have made, use, import, offer for sale, and sell the LICENSED
PRODUCTS in the FIELD.
b. The territory of the license granted in this AGREEMENT shall
include the United States of America and all DESIGNATED COUNTRIES in which
CISTRON elects to support patent expenses under Sections 6 and 7 herein.
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CISTRON shall have the exclusive right to grant sublicenses
under this AGREEMENT without the payment of a further license fee. Any
such sublicenses shall be subject to the terms of this AGREEMENT but
may include such additional terms as CISTRON determines to be appropriate.
Royalties due on sublicenses shall be determined in the same manner as
royalties due from CISTRON, as set forth in Section 3 of this AGREEMENT,
and shall be based on the NET SALES of the sublicensee. Any income
received from such sublicensing is creditable against minimum royalty
requirements set forth in Section 3c of this AGREEMENT. CISTRON agrees to
be responsible for the performance hereunder by its sublicensees, if any.
If, for any reason, this AGREEMENT is terminated, CISTRON agrees to assign
all such sublicense directly to DUKE. In the event that, due to
termination of this AGREEMENT, a sublicense is assigned directly to DUKE
licensee shall have all the rights that CISTRON has under this AGREEMENT
including the termination on rights as set forth in Section 11 of this
AGREEMENT.
3. Royalties, Other Consideration, Records and Reports.
a. CISTRON shall pay to DUKE a license issue royalty of One
hundred Thousand Dollars ($100,000) upon the execution of this AGREEMENT
by all parties thereto. In addition, CISTRON shall pay to DUKE milestone
royalties upon the achievement by CISTRON, its sublicensees, or its
AFFILIATES of certain milestone-based royalties in the development of
LICENSED PRODUCTS as follows:
i. Fifty thousand dollars ($50,000) upon the issuance of
the first patent in the United States of America based on
DUKE PATENTS; and
ii. Twenty five thousand dollars ($25,000) upon the
issuance of the first patent in the United States of
America based on JOINT PATENTS; and
iii. Two Hundred Thousand Dollars ($200,000) upon approval
of the first NDA or BLA for a LICENSED PRODUCT.
iv. One hundred thousand dollars ($100,000) upon a
decision by PMC to exercise its option to participate with
CISTRON in the development of LICENSED PRODUCTS that are
therapeutic vaccines.
v. One hundred thousand dollars ($100,000) upon a
decision by PMC to exercise its option to participate with
CISTRON in the development of LICENSED PRODUCTS that are
prophylactic vaccines.
Such milestone-based royalties shall not be creditable to any
royalty or other fee or payment due to DUKE under this AGREEMENT. All such
milestone fees shall be due and payable thirty (30) days from the
attainment of the milestone by CISTRON.
b. Commencing with the FIRST COMMERCIAL SALE and at such times
and in such manner set forth hereinafter, CISTRON shall pay to DUKE a
royalty on NET SALES of LICENSED PRODUCTS. Such royalty shall be at the
rate of one-half of one percent (0.5%) of NET SALES.
c. If CISTRON, its AFFILIATES, or its sublicensees is required
to pay royalties based on net sales to any third party in order to make,
have made, use, or sell LICENSED PRODUCTS in a country, then the royalty
for such LICENSED PRODUCTS in such country payable to DUKE by CISTRON
shall be reduced by fifty-percent (50%) of the amount actually paid by
CISTRON to such third parties; provided, however, that in no event shall
the rate of the royalty paid by CISTRON to DUKE pursuant hereto be less
than one quarter of one percent (0.25%) of NET SALES of such LICENSED
PRODUCTS in such countries.
d. Beginning with the year that ensues on the second January 1
following the approval of the first LICENSED PRODUCT by the FDA or a
comparable regulatory authority in the European Union, CISTRON shall be
obligated to pay DUKE a minimum annual royalty of Twentyfive Thousand
Dollars ($25,000).
e. Commencing with the FIRST COMMERCIAL SALE and at such times
and in such manner set
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forth hereinafter, CISTRON shall render to DUKE prior to February 28th and
August 31st of each year a written account of the NET SALES of LICENSED
PRODUCTS subject to royalty hereunder made during the prior six (6) month
periods ending December 31st and June 30th, respectively, and shall
simultaneously pay to DUKE the royalties due on such NET SALES in United
States Dollars. Minimum annual royalties, if any, which are due DUKE for
any calendar year, shall be paid by CISTRON along with the written report
due on February 28th of each year. Reports of NET SALES shall reference
DUKE File numbers 1500 and 1689 and shall be made using a form
substantially similar to the model presented in EXHIBIT B of this
AGREEMENT.
f. CISTRON will make all payments due under this subsections a-d
of this Section 3 on or before the date required by the terms of this
AGREEMENT, or within thirty (30) days of any invoice date on invoices
received from DUKE pursuant to this AGREEMENT. If LICENSEE has not paid
any amount due to DUKE in accordance with this subsection d, DUKE may
increase the amount due (in U.S. Dollars) by an annual percentage rate
equal to one percent (1%) of the amount then due, compounded monthly until
such time as CISTRON has met the full financial obligation due at the time
of the next payment or invoice due date.
g. Excepting the existing business relationship between CISTRON
and PMC to develop IL1-based vaccine adjuvants, should CISTRON enter into
any strategic alliance, joint venture, partnership or other business
relationship with another commercial party or parties, other than an
AFFILIATED COMPANY, for the purpose of developing or commercializing the
LICENSED PRODUCTS, CISTRON shall pay to Duke the greater of Fifty Thousand
Dollars ($50,000) or ten percent (10%) of the aggregate of any
sublicensing fees or cash payments received by CISTRON pursuant to such
business relationship ("Rights Payments"); provided, however, such Rights
Payments shall specifically exclude amounts received by CISTRON in the
form of research and development funding, equity investments,
performance-based research, development, or commercialization milestone
payments, or sales bonuses. Should any Rights Payments be made in the form
of non-cash consideration, CISTRON and DUKE agree to negotiate in good
faith to determine a cash value for such consideration, and such
determined cash value shall be included in calculating the Rights
Payments, if any, due DUKE. All Rights Payments shall be due and payable
to DUKE by CISTRON thirty (30) days following the later of (i) the event
that obligates CISTRON for such Rights Payments or (ii) the agreement by
DUKE and CISTRON as to the cash value for any non-cash consideration
received by CISTRON which obligates CISTRON for such Rights Payments.
h. CISTRON shall keep full, true and accurate books of accounts
and other records containing all particulars which may be necessary to
properly ascertain and verify the royalties payable by them hereunder.
Upon DUKE's request, but no more than one time per calendar year, CISTRON
shall permit an independent Certified Public Accountant selected by DUKE
(except one to whom CISTRON has some reasonable objection) to have access
during ordinary business hours to such of CISTRON's records as may be
necessary to determine, in respect of 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.
i. During the term of this AGREEMENT, representatives of DUKE
will meet with representatives of CISTRON at times and places mutually
agreed upon to discuss the progress and results, as well as the ongoing
plans, with respect to the evaluation and development of the LICENSED
PATENTS; provided, however, that should DUKE's personnel be required by
CISTRON to consult with CISTRON outside of Durham, North Carolina, CISTRON
will reimburse reasonable travel and living expenses incident thereto.
4. Representations by DUKE.
x. XXXX represents that:
i. To the best of DUKE's knowledge, DUKE is the sole and
exclusive owner of the entire right, title and interest in
the DUKE PATENTS unencumbered by any outstanding contracts,
agreements or priority claims;
ii. DUKE has full right to enter into this AGREEMENT,
grant this license, and carry out the
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transactions contemplated hereby;
5. CISTRON's Due Diligence Requirements.
a. CISTRON shall use commercially reasonable efforts to bring
the LICENSED PRODUCTS to market through a thorough, vigorous and diligent
program for exploitation of the LICENSED PATENTS throughout the term of
this AGREEMENT.
b. In addition, CISTRON shall adhere to the following
commercialization milestones:
i. deliver to DUKE prior to November 1, 2001,
verification -of PMC's decision as to whether PMC will
participate with CISTRON in the development and marketing
of LICENSED PRODUCTS;
ii. present to DUKE on a yearly basis in the report
specified in Section 5.e. herein, evidence establishing
whether PMC and CISTRON are continuing to collaborate to
develop and market LICENSED PRODUCTS;
iii. initiate preparation of an Investigational New Drug
application with the FDA, or an equivalent application with
a comparable foreign regulatory agency, for a LICENSED
PRODUCT prior to November 1, 2006; and
iv. initiate clinical trials in humans prior to November
1, 2008.
c. CISTRON shall inform DUKE within fourteen [14] days of a
decision to terminate the existing business relationship between PMC and
CISTRON or of a decision by PMC not to collaborate with CISTRON to develop
and/or market LICENSED PRODUCTS.
d. In the event that PMC and CISTRON decide not to collaborate
to develop and/or market LICENSE PRODUCTS or terminate such a
collaboration, CISTRON shall, within six months following the date of such
a decision or termination, deliver to DUKE a plan reasonably acceptable to
DUKE describing how CISTRON will develop LICENSED PRODUCTS.
e. During the term of this AGREEMENT, CISTRON will submit
annual progress reports, including a financial report of moneys spent to
date, to DUKE by August 31 of each year which discuss the progress and
results, as well as ongoing plans, with respect to the LICENSED PATENTS.
DUKE shall have the right to request one meeting per year to discuss such
information.
x. XXXX may terminate this AGREEMENT or convert this AGREEMENT
to a non-exclusive agreement if CISTRON fails to meet any of the
commercialization milestones set forth in subsections b-d. of this Section
5. However, in the event that DUKE informs CISTRON that DUKE intends to
convert this AGREEMENT to a non-exclusive license because CISTRON has
failed to meet either of the milestones put forth in Section 5.b. iii. or
Section 5.b.iv, CISTRON may maintain an exclusive license by paying to
DUKE a non-refundable, noncreditable diligence royalty of twenty-five
thousand dollars ($25,000) per year in every year that the development of
LICENSED PRODUCTS is delayed relative to the specified milestone, such
diligence royalty to be paid within thirty (30) days of notification by
DUKE of an intent to convert the license to non-exclusive and on a yearly
basis in any subsequent years.
6. Matters relating to DUKE PATENTS.
a. Prosecution of DUKE PATENTS. Subsequent to the EFFECTIVE DATE
of this AGREEMENT, DUKE shall continue to have sole responsibility for the
filing, prosecuting and maintaining of appropriate worldwide patents for
the DUKE PATENTS. DUKE shall keep CISTRON advised as to the prosecution of
such
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applications by forwarding to CISTRON copies of all official
correspondence relating thereto. CISTRON agrees to cooperate with DUKE in
the prosecution of worldwide patent applications to insure that the
applications reflect, to the best of CISTRON's knowledge, all items of
commercial and technical interest and importance.
b. US. Patent Expense for DUKE PATENTS. DUKE shall pay for all
expenses prior to and during the term of this AGREEMENT associated with
prosecution and maintenance of patent applications and patents related to
the DUKE PATENTS in the United States of America, and CISTRON shall
reimburse DUKE for all such patent expenses within thirty [30] days of
being invoiced by DUKE.
c. Foreign Patent Expenses for DUKE PATENTS. DUKE shall request
from CISTRON a written list of foreign countries in which CISTRON wishes
DUKE to prosecute and maintain DUKE PATENTS ("DESIGNATED COUNTRIES"), and
DUKE shall proceed to prosecute and maintain DUKE PATENTS in the
DESIGNATED COUNTRIES. CISTRON shall reimburse DUKE for all expenses
associated with prosecution and maintenance of patent applications and
patents related to the DUKE PATENTS in the DESIGNATED COUNTRIES, such
reimbursement to be made within thirty [30] days of being invoiced. DUKE
shall be free, at its own option and expense, to file patents in foreign
countries that are not DESIGNATED COUNTRIES. CISTRON shall have no rights
under Section 2 of this AGREEMENT to practice patents in countries that
are not DESIGNATED COUNTRIES and no obligation to reimburse DUKE for
patent expenses incurred in pursuing patent protection in countries that
are not DESIGNATED COUNTRIES.
d. Discontinuance of Patent Support for DUKE PATENTS. CISTRON
may, at its sole option, elect to discontinue reimbursement of patent
expenses incurred during prosecution or maintenance of any individual
patent or patent application within DUKE PATENTS within the United States
or any DESIGNATED COUNTRY by providing DUKE with written notice that it no
longer wishes to reimburse DUKE for such expenses. However, any rights
granted to CISTRON in Section 2 of this AGREEMENT shall be revoked with
respect to any patent application or patent that CISTRON elects not to
support financially, such revocation of rights to become effective
immediately upon receipt by DUKE of written notice from CISTRON that it no
longer wishes to reimburse DUKE for patent expenses for a given patent or
patent application.
e. Sharing of Patent Expenses with Other Parties Licensing DUKE
PATENTS. DUKE agrees that any license agreement granting rights in DUKE
PATENTS outside the FIELD to third parties shall participate in
reimbursing DUKE for patent expenses related to prosecution and
maintenance of DUKE PATENTS, the share to be paid by each licensee to be
determined by DUKE. DUKE will consider total patent expenses incurred and
the scope of the field licensed by each licensee to determine an equitable
allocation of expenses. DUKE shall inform all licensees when any new
license agreement is executed and what the revised allocation of patent
expenses will be. To the extent a licensee has not paid its allocated
share of such patent expenses, said licensee will be invoiced for
reimbursement of its share of said expenses.
f. Divisional applications with no claims in the FIELD. In the
event that DUKE is required to respond to a restriction requirement issued
by the United States Patent and Trademark Office or a comparable foreign
agency during prosecution of the DUKE PATENTS and file divisional
applications which do not include claims in the licensed FIELD
[NON-LICENSED DIVISIONALS], CISTRON will have no rights in such
NONLICENSED DIVISIONALS, and no obligation to reimburse DUKE for expenses
incurred by DUKE in prosecuting or maintaining such NON-LICENSED
DIVISIONALS.
7. Matters relating to JOINT PATENTS.
a. Prosecution of JOINT PATENTS. CISTRON shall have sole
responsibility for the filing, prosecuting and maintaining of appropriate
worldwide patents and patent applications for the JOINT PATENTS using
counsel reasonably acceptable to DUKE, and CISTRON shall pay all expenses
incurred in such activities. CISTRON shall keep DUKE advised as to the
prosecution of such applications by forwarding to DUKE copies of all
official correspondence relating thereto. CISTRON and DUKE agree to
cooperate in the prosecution of worldwide JOINT PATENTS to insure that the
applications reflect, to the best of both parties' knowledge, all items of
commercial and technical interest and importance. CISTRON agrees to allow
DUKE sufficient time to
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make suggestions with regard to patent prosecution and to give such
suggestions reasonable consideration. CISTRON will not abandon, nor allow
to go abandoned, any patent application that is included in JOINT PATENTS
without first giving DUKE written notice that CISTRON intends to abandon
such an application, such notice to be given in sufficient time for DUKE
to assume responsibility for prosecution of such JOINT PATENTS. In the
event that DUKE assumes responsibility for prosecuting any JOINT PATENT
that CISTRON intends to abandon, CISTRON shall lose all rights in such
application, and DUKE shall assume full financial responsibility for the
prosecution and maintenance of such an application.
b. Foreign Patent Filings for JOINT PATENTS. CISTRON shall
supply to DUKE a written list of foreign countries in which CISTRON
intends to prosecute and maintain JOINT PATENTS ("DESIGNATED COUNTRIES"),
DUKE shall be free, at its own option and expense, to file, prosecute, and
maintain JOINT PATENTS in foreign countries that are not DESIGNATED
COUNTRIES. CISTRON shall have no rights under Section 2 of this AGREEMENT
to practice JOINT PATENTS in countries that are not DESIGNATED COUNTRIES.
8. Infringement of Third Party Patents. Each party to this
AGREEMENT (here, the "notifying party") shall give the other party to this
AGREEMENT prompt notice of each claim or allegation received by the
notifying party that the manufacture, use or sale of LICENSED PRODUCTS
constitutes an infringement of a third-party patent or patents. CISTRON
shall have the primary right and responsibility at its own expense to
defend and control the defense of any such claim against CISTRON, by
counsel of CISTRON's own choosing. The settlement of any such actions must
be approved by DUKE, which approval may not be unreasonably withheld or
delayed. DUKE agrees to cooperate with CISTRON in any reasonable manner
deemed by CISTRON to be necessary in defending or prosecuting such
actions. CISTRON shall reimburse DUKE for all expenses incurred in
providing such assistance. Notwithstanding the foregoing, DUKE, shall, in
its sole discretion and at its sole expense, be entitled to participate
through counsel of its own choosing in any such action.
9. Infringement by Third Parties. Upon learning of the infringement
of the LICENSED PATENTS by a third party, the party learning of such
infringement shall promptly inform the other party in writing of that fact
along with any evidence available pertaining to the infringement. CISTRON
may at its own expense take whatever steps are necessary to stop the
infringement and recover damages. In such case, CISTRON will keep DUKE
informed of the steps taken and the progress of any legal action taken.
DUKE shall receive twelve and one-half percent (12.5%) of any damages
received in excess of legal expenses incurred by CISTRON in enforcing
rights in the LICENSED PATENTS. If CISTRON does not undertake, within
sixty (60) days of notice, to enforce the rights in the LICENSED PATENTS
against the infringing party, the DUKE shall have the right, at its own
expense to take whatever steps are necessary to stop the infringement and
recover damages and shall be entitled to retain the damages so recovered.
10. Government Clearance, Publication, Other Use, Export.
a. CISTRON agrees that it and its sublicensees will use
reasonable efforts to have the LICENSED PRODUCTS cleared for marketing in
those counties in which CISTRON intends to sell the LICENSED PRODUCTS by
the responsible government agencies requiring such clearance. To
accomplish said clearances at the earliest possible date, CISTRON agrees
to file, according to the usual practice of CISTRON, any necessary data
with said government agencies. Should CISTRON cancel its development
efforts under this AGREEMENT, CISTRON agrees to assign its full interest
and title in such market clearance application, including all data
relating thereto, to DUKE..
x. XXXX shall be free to publish the results of its continued
research on the subject area of LICENSED PATENTS but agrees to submit to
CISTRON for its review and comment, a copy of any proposed publication
authored by XXXXXX and resulting from research involving IL1 beta in
vaccine adjuvants at least thirty (30) days prior to the date submitted
for publication, and if no response is received within thirty (30) days of
the date submitted to CISTRON, it will be conclusively presumed that the
publication may proceed without delay. DUKE shall in good faith consider
any comments provided by CISTRON and shall consider the sensitive nature
and
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timing of publication of unprotected intellectual property. If CISTRON
determines that the proposed publication contains proprietary subject
matters which require protection, CISTRON may request the delay of the
publication for sixty (60) days from the date first submitted to CISTRON
in order to perfect such protection. Nothing in this AGREEMENT shall be
construed as giving CISTRON editorial control over any publication.
Nothing in this AGREEMENT shall be construed as prohibiting DUKE or
CISTRON from reporting on the results of such research to a governmental
agency if so required by law. For purposes of this AGREEMENT, publication
shall mean the disclosure of information to any person or entity who is
not subject to the confidentiality provisions of Section 13 of this
AGREEMENT.
c. Except CISTRON's publication review rights set forth in
Section 10.b of this AGREEMENT, nothing in this Section 9 shall be
construed as to restrict DUKE's right to use the LICENSED PATENTS for its
own educational, teaching, and research purposes without restriction.
d. This AGREEMENT is subject to all United States laws, rules,
and regulations controlling the export of technical data, computer
software, laboratory prototypes and other commodities and technology.
11. Duration and Termination.
a. This AGREEMENT shall become effective upon the EFFECTIVE
DATE, and unless sooner terminated in accordance with any of the
provisions of this AGREEMENT, shall remain in full force and effect until
the last-to-expire of any LICENSED PATENTS, or any extension thereof under
the Xxxxxx-Xxxxx Act or any other relevant legislation extending patent
life or market exclusivity based on patent protection.
b. CISTRON may terminate this AGREEMENT by giving DUKE written
notice at least three (3) months prior to such termination, and thereupon
terminate the license granted under this AGREEMENT.
c. Either party may immediately terminate this AGREEMENT for
fraud, willful misconduct, or illegal conduct of the other party upon
written notice of same to such other party. If either party fails to
fulfill any of its obligations under this AGREEMENT, the non-breaching
party may terminate this AGREEMENT upon written notice to the breaching
party as provided in this subsection c. Such notice must contain a full
description of the event or occurrence constituting a breach of the
AGREEMENT. The party receiving notice of the breach will have the
opportunity to cure the breach within thirty (30) days of receipt of such
notice. If the breach is not cured within such thirty (30) day period, the
termination will be effective as of the thirtieth (30th) day after receipt
of notice.
d. Upon termination of this AGREEMENT, CISTRON may notify DUKE
of the amount of LICENSED PRODUCT CISTRON then has on hand, and CISTRON
shall then have a license to sell only that amount of the LICENSED
PRODUCT, provided CISTRON shall pay the royalty thereon at the rate and at
the time provided pursuant to this AGREEMENT.
e. If during the term of this AGREEMENT, CISTRON shall be
adjudicated bankrupt or insolvent or if the business of CISTRON shall be
placed in the hands of a receiver or trustee, whether by the voluntary act
of CISTRON or otherwise, or if CISTRON shall cease to exist as an active
business, this AGREEMENT shall immediately terminate, and DUKE shall have
all remedies and rights available to it for termination with cause.
12. Force Majeure.
a. Neither party shall be considered in breach of its
obligations under this AGREEMENT nor liable for any costs or damages due
to nonperformance under this AGREEMENT arising out of any cause or event
not within the reasonable control of such party and without such party's
fault or negligence, such causes or events being hereinafter referred to
as "Events of Force Majeure."
b. Each party shall give the other party prompt notice of the
occurrence of any Event of Force Majeure, including such information as is
reasonably necessary to establish the Event of Force Majeure; thereupon,
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the obligations of the party giving notice, so far as they are affected by
the Event of Force Majeure, shall be suspended during, but no longer than,
the continuance of the Event of Force Majeure.
c. Events of Force Majeure shall only excuse delays in
performance and only to the extent such delays are directly attributable
to the Event of Force Majeure. No Event of Force Majeure shall be an
excuse for permanent nonperformance.
d. Neither party shall be liable for any delay or failure in the
performance of its obligations under this AGREEMENT that directly results
from any failure of the other party to perform its obligations as set
forth in this AGREEMENT.
13. Confidentiality.
a. "Confidential Information" means all information, including,
but not limited to, the trade secrets and know-how of the respective
parties which is clearly identified as "Confidential" or "Proprietary" by
the disclosing party at the time of disclosure. If such transmittal occurs
orally, the disclosing party shall identify the oral disclosure as
confidential at the time of disclosure and shall confirm in writing the
confidential nature of such information within thirty (30) days of the
disclosure. Confidential information shall not mean any information that:
i. is known to the receiving party at the time of
disclosure by the disclosing party;
ii. is developed independently by the receiving party;
iii. is within, or later falls within, the public domain
without breach of this AGREEMENT by the receiving party;
iv. is publicly disclosed with written approval of the
disclosing party; or
v. becomes lawfully known or available to the receiving
party without restriction from a source having the lawful right to
disclose the information without breach of this AGREEMENT by the
receiving party.
Provided further, the receiving party shall have the burden of proof
as to prior knowledge and absence of breach.
b. Confidential Information disclosed on a restricted basis
pursuant to a judicial or other lawful government order shall remain
Confidential Information as between the parties and shall only be
disclosed under terms which provide for continued protection of the
information, and, where possible, the disclosing party shall be a party to
the negotiation of the terms for such protection. Notwithstanding any
provision herein to the contrary, this AGREEMENT shall not be construed to
limit the receiving party's obligation and ability to comply with any
judicial or other lawful government order to disclose Confidential
Information on a restricted basis.
c. Subject to the marking requirements of Section 13.a. of this
AGREEMENT, the obligation of confidentiality under this AGREEMENT shall
apply regardless of the form the Confidential Information takes..
d. Each party acknowledges that in the performance of this
AGREEMENT it shall receive Confidential Information from the other party
and that such Confidential Information is the exclusive property of the
disclosing party. The receiving party agrees to hold the Confidential
Information of the disclosing party in strict confidence in accordance
with the provisions of this AGREEMENT. A receiving party:
i. shall not permit or suffer its employees or agents to
remove any proprietary or other legends or restrictive
notices contained or included in any Confidential
information provided by the disclosing party;
ii. shall not permit or suffer its employees or agents to
copy any Confidential Information,
10
except as provided in this AGREEMENT or consented to in
writing by the disclosing party
iii. shall not, except as may be provided in Section 10 of
this AGREEMENT regarding publication, disclose any
Confidential Information to a third party without the prior
written consent of the disclosing party hereto;
iv. shall exercise care to keep secure and maintain the
Confidential Information of the disclosing party in a
manner no less protective than that used to maintain the
confidentiality of the receiving party's own Confidential
Information, but in any event not less than a reasonable
degree of care; and
v. agrees to use the Confidential Information only to
further the purposes set forth in this AGREEMENT.
e. A receiving party may disclose Confidential Information to
officers, employees or agents under the control and direction of the
receiving party only in the normal course of business and on a
need-to-know basis within the purpose of this AGREEMENT. Provided,
however, prior to any disclosure all such officers, employees or agents
shall have entered into written agreements with the receiving party, or
have in place binding policies covering the disclosure of such third-party
Confidential Information and have on file signed acknowledgments of such
binding policies from each officer, employee or agent to which
Confidential Information is disclosed, requiring such officers, employees
or agents to treat and use all such Confidential Information in a manner
consistent with the terms and conditions of this AGREEMENT.
f. A receiving party's obligation to comply with the
confidentiality provisions of this AGREEMENT with respect to Confidential
Information disclosed by the disclosing party shall extend for a period of
six (6) years from the date of disclosure of Confidential Information.
g. Upon thirty (30) days written notice from the disclosing
party, the receiving party shall: (i) surrender and deliver all
Confidential Information of the disclosing party, including all copies
thereof; or (ii) with the written consent of the disclosing party, destroy
the Confidential Information and all copies thereof and provide
satisfactory evidence of such destruction to the disclosing party within
one (1) month following said notice. Notwithstanding anything in this
AGREEMENT to the contrary, (i) a receiving party may retain one copy of
each item of Confidential Information disclosed by the disclosing party
solely as evidence of compliance with this AGREEMENT and for no other
purpose, and (ii) upon a request by CISTRON to surrender and deliver all
CISTRON's Confidential Information, DUKE shall be relieved of its
obligation to continue any research dependent upon CISTRON's Confidential
Information.
14. Notices. All notices or other communication shall be in writing
and shall be deemed duly given one (1) day after delivery by facsimile,
provided that an originator copy of the notice is deposited in the
international mail, postage pre-paid, and addressed as set forth below; or
five (5) days after deposit thereof in the registered international mail,
return receipt requested, postage pre-paid with copies to the other
parties addressed as follows:
If to DUKE:
Office of Science and Technology
Attn: License Administrator
Duke University
Xxxx 000, Xxxxx Xxxxxxxx
Xxx 00000
Xxxxxx, Xxxxx Xxxxxxxx 00000
Facsimile No.: (919) 681 - 7599
with a copy to:
Office of the University Counsel
00
Xxxx Xxxxxxxxxx Xxxxxxx Xxxxxx
XXXX Xxx 0000
0000 Xxxxx Xxxxxx, Xxxxx 0000
Xxxxxx, Xxxxx Xxxxxxxx 00000
Facsimile No.: (000) 000-0000
If to CISTRON:
CISTRON Biotechnology
00 Xxxxxxxxxx Xxxxxx
Xxxx Xxxxx, XX 00000
Facsimile no. 000-000-0000
Any party may change its address for notice by giving notice to the other
party of the change.
15. Assignment. Neither DUKE nor CISTRON may assign, delegate or
otherwise transfer any of its rights or obligations under this AGREEMENT
without the prior written consent of the other party; provided, however,
CISTRON may assign its rights and obligations under this AGREEMENT to any
AFFILIATED COMPANY of CISTRON or to any AFFILIATED COMPANY of such
AFFILIATED COMPANY of CISTRON or to any surviving entity with which
CISTRON merges or to which CISTRON sells substantially all of CISTRON's
assets, provided CISTRON shall give DUKE prior written notice of such
assignment.
16. Binding Effect. This AGREEMENT will be binding upon and will
inure to the benefit of the parties and their respective successors and
assigns.
17. Indemnity, Insurance, Representations, Status.
a. CISTRON agrees to indemnify, hold harmless and defend DUKE,
its officers, employees, and agents, against any and all claims, suits,
losses, damages, costs, fees and expenses asserted by third parties, both
government and non-government, resulting from or arising out of CISTRON's
omission, negligence or wrongful act in the development, production,
manufacturing, exploitation, or marketing of the LICENSED PATENTS. CISTRON
further agrees to indemnify and save DUKE harmless from and against any
loss, damage, or expense suffered by DUKE as a result of CISTRON's default
under or breach of this AGREEMENT. DUKE agrees to indemnify and save
CISTRON harmless against any loss, damages, or expense suffered by CISTRON
as a result of DUKE's negligence, wrongful acts or default under or breach
of this AGREEMENT.
b. CISTRON shall maintain in force at its sole cost and expense,
with reputable insurance companies, general liability insurance and
products liability insurance coverage in an amount reasonably sufficient
to protect against liability under subsection a of this Section 17. DUKE
shall have the right to ascertain from time to time that such coverage
exists, such right to be exercised in a reasonable manner.
c. NOTHING IN THIS AGREEMENT SHALL BE DEEMED TO BE A
REPRESENTATION OR WARRANTY BY DUKE OF THE VALIDITY OF ANY OF THE PATENTS
OR THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY PURPOSE, OF THE
LICENSED PATENTS. DUKE SHALL HAVE NO OBLIGATION, EXPRESS OR IMPLIED, TO
SUPERVISE, MONITOR, REVIEW OR OTHERWISE ASSUME RESPONSIBILITY FOR THE
PRODUCTION, MANUFACTURE, TESTING, MARKETING OR SALE OF ANY LICENSED
PRODUCT, AND, EXCEPT AS SET FORTH IN SECTION 17A ABOVE, DUKE SHALL HAVE NO
LIABILITY WHATSOEVER TO CISTRON OR ANY THIRD PARTIES FOR OR ON ACCOUNT OF
ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE, SUSTAINED BY, OR ANY
DAMAGE ASSESSED OR ASSERTED AGAINST, OR ANY OTHER LIABILITY INCURRED BY OR
IMPOSED UPON CISTRON OR ANY OTHER PERSON OR ENTITY, ARISING OUT OF OR IN
CONNECTION WITH OR RESULTING FROM:
12
i. the production, use, or sale of any LICENSED PRODUCT;
ii. the use of the PATENT RIGHTS; or
iii. any advertising or other promotional activities with
respect to any of the foregoing.
d. The parties to this AGREEMENT recognize and agree that each
is operating as an independent contractor and not as an agent of the
other. This AGREEMENT shall not constitute a partnership or joint venture,
and neither party may be bound by the other to any contract, arrangement
or understanding except as specifically stated herein.
18. Use of a Party's Name. Neither party will, without the prior
written consent of the other party:
a. use in advertising, publicity or otherwise, any trade-name,
personal name, trademark, trade device, service xxxx, symbol, or any
abbreviation, contraction or simulation thereof owned by the other party;
or
b. represent, either directly or indirectly, that any product or
service of the other party is a product or service of the representing
party or that it is made in accordance with or utilizes the information or
documents of the other party.
19. General.
x. Xxxxxxxxx. Each clause of this AGREEMENT is a distinct and
severable clause and if any clause is deemed illegal, void or
unenforceable, the validity, legality or enforceability of any other
clause or portion of this AGREEMENT will not be affected thereby so long
as the principal intent of this AGREEMENT is unaffected.
b. Waiver. The failure of a party in any instance to insist upon
the strict performance of the terms of this AGREEMENT will not be
construed to be a waiver or relinquishment of any of the terms of this
AGREEMENT, either at the time of the party's failure to insist upon strict
performance or at any time in the future, and such terms will continue in
full force and effect. No waiver of any obligation under this AGREEMENT
shall be effective unless in writing and signed by the authorized
representative of the party consenting to such waiver.
c. Modification. Any alteration, modification, or amendment of
this AGREEMENT must be in writing and signed by the authorized
representative of each party.
d. Governing Law. This AGREEMENT shall be construed and enforced
in accordance with and governed by the substantive law of the State of
North Carolina and the United States of America, including the patent and
copyright laws of the United States of America.
e. Construction. All titles and section headings contained in
this AGREEMENT are inserted only as a matter of convenience and reference.
Such titles and headings shall not define, limit, extend or describe the
scope of this AGREEMENT or any of its provisions.
f. Entire Understanding. This AGREEMENT represents the entire
understanding between the parties with respect to the subject matter
contained therein and supersedes all other agreements, express or implied,
between the parties with respect to the same.
g. Counterparts. This AGREEMENT may be executed in any number of
counterparts, each of which shall be deemed to be an original, but all of
which together will constitute one and the same document.
h. All references to payments of monies under this AGREEMENT
shall be deemed to be in U.S. dollars.
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IN WITNESS WHEREOF, the authorized representatives of the parties
have caused these presents to be executed under seal as of the date and
year first above written.
DUKE UNIVERSITY
By:/s/ XXXXXX X. XXXXX, Ph.D.
--------------------------
Name: Xxxxxx X. Xxxxx, Ph.D.
Title: Associate Vice Chancellor
CISTRON Biotechnology
By: /s/ XXXXXXXX X. XXXX
---------------------
Name: Xxxxxxxx X. Iris
Title: CEO
10/1/99
14
EXHIBIT A - DUKE UNIVERSITY INVENTION DISCLOSURE FOR OST FILE 1689
15
EXHIBIT B- FORM FOR REPORTING ROYALTIES BASED ON NET SALES
