Exhibit 10.8
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LICENSE AGREEMENT
BETWEEN
UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION
AND
CONTROL DELIVERY SYSTEMS, INC.
September 9, 1997
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TABLE OF CONTENTS
ARTICLE 1 - DEFINITIONS.................................................... 1
ARTICLE 2 - GRANT.......................................................... 3
ARTICLE 3 - CONFIDENTIALITY................................................ 3
ARTICLE 4 - REPRESENTATIONS AND WARRANTIES................................. 6
ARTICLE 5 - ROYALTIES...................................................... 7
ARTICLE 6 - REPORTS AND RECORDS............................................ 9
ARTICLE 7 - PATENT PROSECUTION AND ENFORCEMENT.............................10
ARTICLE 8 - TERMINATION....................................................12
ARTICLE 9 - INDEMNIFICATION................................................13
ARTICLE 10 - ASSIGNMENT....................................................13
ARTICLE 11 - AGENCY........................................................14
ARTICLE 12 - PAYMENTS, NOTICES AND COMMUNICATIONS..........................14
ARTICLE 13 - MISCELLANEOUS PROVISIONS......................................14
LICENSE AGREEMENT
This AGREEMENT, effective as of this 9th day of September, 1997 ("EFFECTIVE
DATE"), by and between the UNIVERSITY OF KENTUCKY RESEARCH FOUNDATION, a
corporation duly organized and existing under the laws of the Commonwealth of
Kentucky and having a principal office at 00 Xxxxxxxxxxxxxx Xxxxxxxx, Xxxxxxxxx,
Xxxxxxxx (hereinafter referred to as "UKRF"), and CONTROL DELIVERY SYSTEMS,
INC., a Delaware corporation having its principal office at 00 Xxxxxxxx Xxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("LICENSEE").
WHEREAS, UKRF is the duly authorized agent of the University of Kentucky
for purposes of managing research support and intellectual property rights;
WHEREAS, LICENSEE has sponsored certain research (the "Research") at the
University of Kentucky which resulted in the patent application identified on
Exhibit A hereto (the "Patent Application");
WHEREAS, UKRF desires to have certain proprietary information conceived
and/or made in the course of performing the Research, including the Patent
Application, and any resulting patent rights, used in the public interest and is
willing to grant a license thereto on the terms set forth below; and
WHEREAS, LICENSEE desires to obtain a license for such proprietary
information and any resulting patent rights upon the terms and conditions
hereinafter set forth.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the parties agree as follows:
ARTICLE 1 - DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "AFFILIATE" shall mean a corporation or other business entity
controlled by, controlling or under common control with, a party hereto. For
this purpose, control of a corporation or other business entity shall mean
direct or indirect beneficial ownership of twenty-five percent (25%) or more of
the voting interest in, or a twenty-five percent (25%) or greater interest in
the equity of, such corporation or other business entity.
1.2 "FIRST COMMERCIAL SALE" shall mean the initial transfer by LICENSEE,
its AFFILIATE or sublicensee, to an unrelated third party of LICENSED PRODUCTS
subject to royalties hereunder for commercial use and not for research,
development or testing purposes.
1.3 "LICENSED PRODUCTS" shall mean any product the manufacture or sale of
which, in the absence of a license, will infringe a Valid Claim in a pending
application or an issued patent in PATENT RIGHTS; or any product which makes use
of all or a portion of the TECHNOLOGY.
1.4 "NET ROYALTIES" shall mean (a) the royalties based on NET SALES
collected by LICENSEE from its sublicensees for LICENSED PRODUCTS subject to
royalties hereunder, less the amount of any tax required to be withheld by a
government or governmental agency, and (b) any other fees received by LICENSEE
from its sublicensees in respect of the sale, or the right to sell LICENSED
PRODUCTS. NET ROYALTIES shall not include amounts paid by a sublicensee to
LICENSEE (i) as reimbursement of expenses, (ii) that are payable in respect of
research or development or (iii) to fund research and development, or (iv) in
respect of the sale of other transfer of LICENSEE'S entire business or of that
part of LICENSEE'S business to which the license granted hereby relates.
1.5 "NET SALES" shall mean the gross revenues collected from unrelated
third party customers by LICENSEE's sublicensees for LICENSED PRODUCTS subject
to royalties hereunder, less the amount actually allowed to such customers for
(a) any credits and allowances and adjustments granted to such customers on
account of the rejection or return of such LICENSED PRODUCTS previously sold,
(b) trade and cash discounts, rebates and distributor fees (but not sales
commissions) paid to unrelated third parties, (c) transportation, insurance and
handling charges, (d) sales, excise, turnover and similar taxes and any duties
and other governmental charges imposed upon the production, importation, use or
sale of such LICENSED PRODUCTS, (e) uncollectible debt and (f) royalties, fees
or cost of drug acquisition paid, directly or pursuant to a license, to holders
of patents for drugs used in connection with the LICENSED PRODUCTS, which shall
not exceed the average wholesale price for such drugs. LICENSED PRODUCTS shall
be considered "sold" when billed out or invoiced to a third party. In the event
that the LICENSED PRODUCT is sold in combination with one or more ingredients
which are not LICENSED PRODUCTS (e.g., a product combining more than one active
ingredient), Net Sales for computing royalties hereunder shall be determined by
multiplying Net Sales, as defined above, of such combination product (e.g., more
than one active ingredient) by a fraction, the numerator of which shall be
whichever is the higher of (1) the current standard list price for quantities
equal to the quantity listed or (2) the cost of manufacture, including direct
labor, materials consumed, and overhead plus one hundred percent (100%) thereof,
computed in accordance with generally accepted accounting practices
(consistently applied) of the LICENSED PRODUCT content thereof, and the
denominator shall be the total price or cost, calculated on the same basis as
the numerator, of all ingredients (including the LICENSED PRODUCT content as in
the numerator) contained in such combination product.
1.6 "PATENT RIGHTS" shall mean (a) the United States and foreign patents
or pending United States and foreign patent applications set forth in Exhibit A
hereto and any other United States or foreign applications subsequently filed by
UKRF which arise out of the
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inventions described in Exhibit A or which are based on the TECHNOLOGY; (b) any
additions, continuations, continuations-in-art, divisions, reissues or
extensions based thereon; (c) any United States or foreign patent obtained from
any of said United States or foreign patent applications; and (d) any other
proprietary rights embodied in any of said United States or foreign patents or
patent applications.
1.7 "TECHNOLOGY" shall mean all ideas, know-how, trade secrets, data,
inventions, developments, formulas, processes, techniques, discoveries and any
other proprietary rights in and to the technology described in Exhibit B
attached hereto.
1.8 "VALID CLAIM" shall mean a claim in a pending application for which
five years shall not have passed from the initial application date or a claim in
an issued patent that has not been declared invalid by an unappealed or an
unappealable decision of a court of competent jurisdiction.
ARTICLE 2 - GRANT
2.1 Grant. UKRF hereby grants to LICENSEE, subject to the terms herein
recited, an exclusive, nontransferable (except as provided in Article 10
herein), perpetual, royalty bearing, worldwide right and license, with the right
to grant sublicenses, to make, have made, use, sell and distribute (directly or
indirectly through third parties) LICENSED PRODUCTS and to use the TECHNOLOGY
and the PATENT RIGHTS.
2.2 Delivery. Promptly after the EFFECTIVE DATE and thereafter upon
reasonable notice, UKRF shall deliver to LICENSEE all data, documentation, and
other physical embodiments of the PATENT RIGHTS and TECHNOLOGY together with all
cooperation, assistance and access to data reasonably requested by LICENSEE to
effect transfer of the TECHNOLOGY.
2.3 Due Diligence. LICENSEE shall use all commercially reasonable efforts
to develop, commercialize and actively market LICENSED PRODUCTS based upon the
PATENT RIGHTS throughout the life of this agreement. LICENSEE shall strive to
file an INDA with the FDA within three years from the date of this agreement,
initiate a phase three clinical study within eight years from the date of this
agreement, and achieve a first commercial sale of LICENSED PRODUCT within eleven
years from the date of this agreement. If, as a result of events beyond the
reasonable control of the parties, achievement of the first or second milestones
is delayed, the parties shall negotiate mutually agreeable extensions of
subsequent milestones.
ARTICLE 3 - CONFIDENTIALITY
3.1 UKRF. Because LICENSEE has revealed, and may in the future reveal, to
UKRF, the University of Kentucky and certain employees, professors, technicians,
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consultants, visiting scientists, students, and post doctoral associates of the
University of Kentucky or UKRF (collectively the "Researchers") in the course of
this Agreement certain confidential knowledge, know-how, practices, processes,
or other information (hereinafter referred to as "CONFIDENTIAL INFORMATION"),
UKRF agrees to hold in confidence and shall require the University of Kentucky,
UKRF's other AFFILIATES, and the Researchers, their respective employees,
students and agents to hold in confidence, by using a reasonable degree of care,
any CONFIDENTIAL INFORMATION which is identified at the time of disclosure as
"CONFIDENTIAL" and, in the case of oral disclosures, is identified in writing
within 30 days as confidential, and UKRF agrees not to disclose and shall
require the University of Kentucky, UKRF's other AFFILIATES, their respective
employees, students and agents, and the Researchers not to disclose CONFIDENTIAL
INFORMATION to any third party without the express written consent of LICENSEE.
(UKRF agrees to cooperate with LICENSEE in obtaining suitable confidentiality
agreements from persons as may be deemed necessary by LICENSEE.) This
requirement shall remain in force for a period of five (5) years following
termination of this Agreement, or until the expiration of the last expiring
patent associated with the Confidential Information, whichever shall occur
later. Nothing in this paragraph shall in any way restrict the rights of UKRF,
the University of Kentucky, UKRF's other AFFILIATES, their respective employees,
students or agents, or the Researchers to use, disclose or otherwise deal with
any information which:
(a) Can be demonstrated to have been in the public domain as of the
effective date of this Agreement or comes into the public domain during the
term of this Agreement through no act of the recipient; or
(b) Can be demonstrated to have been independently known to the
recipient prior to the receipt thereof, or made available to the recipient
as a matter of lawful right by a third party; or
(c) Can be demonstrated to have been rightfully received by the
recipient after disclosure under this Agreement from a third party who did
not require the recipient to hold it in confidence or limit its use and who
did not acquire it, directly or indirectly, from LICENSEE under a
continuing obligation of confidentiality; or
(d) Shall be required for disclosure to any governmental regulatory
agencies pursuant to approval for use; or
(e) Is independently conceived, invented or acquired by researchers of
the recipient who have not been personally exposed to the information
provided to the recipient hereunder; or
(f) Is published by a governmental agency as part of the normal patent
filing and prosecution process.
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3.2 LICENSEE. Because UKRF or the Researchers have revealed, and may in
the future reveal, to LICENSEE in the course of this Agreement certain
CONFIDENTIAL INFORMATION, LICENSEE agrees to hold in confidence and shall
require LICENSEE's AFFILIATES, their respective employees and agents to hold in
confidence, by using a reasonable degree of care, any CONFIDENTIAL INFORMATION
which is identified at the time of disclosure as "CONFIDENTIAL" and, in the case
of oral disclosures, is identified in writing within 30 days as confidential,
and LICENSEE agrees not to disclose and shall require LICENSEE's AFFILIATES,
their employees and agents not to disclose CONFIDENTIAL INFORMATION to any third
party without the express written consent of UKRF. (LICENSEE agrees to cooperate
with UKRF in obtaining suitable confidentiality agreements from persons as may
be deemed necessary by UKRF.) This requirement shall remain in force for a
period of five (5) years following termination of this Agreement, or until the
expiration of the last expiring patent associated with the Confidential
Information, whichever shall occur later. Nothing in this paragraph shall in
any way restrict the rights of LICENSEE, the LICENSEE's AFFILIATES, their
respective employees or agents to use, disclose or otherwise deal with any
information which:
(a) Can be demonstrated to have been in the public domain as of the
effective date of this Agreement or comes into the public domain during the
term of this Agreement through no act of the recipient; or
(b) Can be demonstrated to have been independently known to the
recipient prior to the receipt thereof, or made available to the recipient
as a matter of lawful right by a third party; or
(c) Can be demonstrated to have been rightfully received by the
recipient after disclosure under this Agreement from a third party who did
not require the recipient to hold it in confidence or limit its use and who
did not acquire it, directly or indirectly, from UKRF or PRINCIPAL
INVESTIGATOR under a continuing obligation of confidentiality; or
(d) Shall be required for disclosure to any governmental regulatory
agencies pursuant to approval for use; or
(e) Is independently conceived, invented or acquired by researchers of
the recipient who have not been personally exposed to the information
provided to the recipient hereunder;
(f) Is published by a governmental agency as part of the normal patent
filing and prosecution process; or
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(g) May be disclosed to a third party pursuant to or in connection
with a license agreement between LICENSEE and such third party and such
disclosure is covered under a suitable confidentiality agreement.
ARTICLE 4 - REPRESENTATIONS AND WARRANTIES
4.1 Ownership. UKRF warrants that it is the owner of the PATENT RIGHTS
and TECHNOLOGY and that any resultant patents are free of any liens,
encumbrances, restrictions and other legal or equitable claims.
4.2 Authority. Each party represents and warrants that it has the right
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and authority to enter into this Agreement.
4.3 Conflicts.
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(A) UKRF represents and warrants that the making of this Agreement
does not violate any separate agreement it has with any other person or
entity. UKRF further represents and warrants that it has not granted any
rights or licenses to the TECHNOLOGY or PATENT RIGHTS, or any portion
thereof, to any party.
(B) LICENSEE represents and warrants that the making of this
Agreement does not violate any separate agreement it has with any other
person or entity.
4.4 Exceptions. Nothing in this Agreement shall be construed as:
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(A) conferring rights on UKRF to use in advertising, publicity or
otherwise the name of LICENSEE or of its employees, AFFILIATES or
sublicensees without the prior written approval of LICENSEE, which shall
not be unreasonably withheld; and
(B) conferring rights on LICENSEE to use in advertising or publicity
the names of "University of Kentucky" UKRF, their affiliates or their
employees without the prior written approval of UKRF.
4.5 Disclaimer. EXCEPT AS EXPRESSLY PROVIDED HEREIN, NEITHER PARTY MAKES
ANY REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
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[*]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETED ASTERISKS HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
ARTICLE 5 - ROYALTIES
5.1 Royalties. Beginning with the FIRST COMMERCIAL SALE and subject to
the terms hereof, LICENSEE agrees to pay to UKRF, as consideration for the
rights granted under this Agreement:
(A) An amount equal to [*] of NET ROYALTIES from LICENSED PRODUCTS
developed by LICENSEE's sublicensees and sold in the United States;
(B) An amount equal to [*] of NET ROYALTIES from LICENSED PRODUCTS
developed by LICENSEE's sublicensees and sold outside of the United States;
and
(C) An amount equal to [*] of the NET SALES of LICENSED PRODUCTS sold
For purposes of determining the royalty rate, all product dosage forms,
formulations, clinical indications and applications based on a particular
principal active ingredient or combinations thereof shall be considered a single
LICENSED PRODUCT for such purpose.
5.2 Royalty Period. The obligation to pay royalties under Section 5.1
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shall continue for the following periods:
(A) With respect to sales of LICENSED PRODUCTS subject to such
royalties, except as otherwise set forth in Section 5.7 hereof, for the
life of such patents until the last of said patent rights covering such
products, its use or its manufacturing expires, after which LICENSEE's
license under Article 2 above shall become fully paid-up and royalty-free.
(B) With respect to sales of LICENSED PRODUCTS subject to such
royalties which make use of all or a portion of the TECHNOLOGY which are
not covered by PATENT RIGHTS, for a period of five (5) years from the date
of first sale of such LICENSED PRODUCT, after which time LICENSEE's license
under Article 2 above shall become fully paid-up and royalty free.
Notwithstanding the foregoing, in the event that the TECHNOLOGY used in a
LICENSED PRODUCT comes into the public domain through no act of LICENSEE,
LICENSEE's license under Article 2 above shall become fully paid-up and
royalty free.
5.3 Payments. Royalties will be due and payable with each report
submitted in accordance with Section 6.2. Royalty payments shall be made in
United States dollars in Lexington, Kentucky or at such other place as UKRF may
reasonably designate; provided, however, that if the laws and regulations
controlling in any foreign country prevent a royalty
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[*]=CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETED ASTERISKS HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
payment to be made in Lexington, Kentucky, or at UKRF's designated place or
prevent a royalty payment in United States dollars, UKRF agrees to accept such
royalty in the form and place as permitted, including deposits by LICENSEE in
the applicable foreign currency in a local bank or banks designated by UKRF. If
any currency conversion is required in connection with the payment of royalties
hereunder, such conversion shall be made by using the exchange rate prevailing
at a first-class foreign exchange bank on the last business day of the calendar
biannual reporting period to which such royalty payments relate. If laws or
regulations require the withholding of income taxes owed by UKRF on account of
royalties accruing under this Agreement, such taxes shall be deducted on a
country-by-country basis by LICENSEE from such remittable royalty and will be
paid by it to the proper taxing authority. Proof of payment shall be secured and
sent to UKRF as evidence of such payment.
5.4 Multiple Royalties. No multiple royalties shall be payable because
LICENSED PRODUCTS, their manufacture, use or sale shall be covered by more than
one patent application or patent licensed under this Agreement. In the event
that a LICENSED PRODUCT'S manufacture, use or sale shall be covered by one or
more patent application or patent licensed under this Agreement and by one or
more patent application or patent license under any other agreement between
LICENSEE and UKRF or the University of Kentucky, (together with this Agreement,
the "Multiple License Agreements"), LICENSEE shall pay the highest of the agreed
upon royalty rate applicable for such LICENSED PRODUCT under any of the Multiple
License Agreements plus [*] of the second highest agreed upon royalty rate under
any of the other Multiple License Agreements.
In the event that a LICENSED PRODUCT's manufacture, use or sale shall be
covered by one or more patent application or patent licensed under this
Agreement and by one or more patent application or patent licensed under any
other agreement between LICENSEE and one or more third parties (not including
UKRF or University of Kentucky), then LICENSEE and UKRF shall negotiate in good
faith to determine the applicable royalty rate payable to UKRF for such LICENSED
PRODUCT hereunder.
5.5 Competing Products. If at any time during the term of this Agreement,
one or more competitors introduce in any country a product that competes with a
LICENSED PRODUCT, then the parties in good faith shall promptly review the facts
and circumstances, and if appropriate, negotiate an equitable adjustment to the
royalty rate on NET SALES of such LICENSED PRODUCT in that country.
5.6 Invalid Patent. In the event that no patent covering the LICENSED
PRODUCT shall have been issued in a given country within five (5) years from the
date of the initial patent application covering the LICENSED PRODUCT in such
country, no royalty shall be owed upon the sale of the LICENSED PRODUCT in such
country and sold for use in such country after said five (5) years. In the
event that the only patent or patents covering the LICENSED PRODUCT in a given
country are declared invalid by an unappealed or unappealable decision of a
court of competent jurisdiction, the royalty payments thereafter due
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under this Agreement by virtue of the sale of the LICENSED PRODUCT in said
country shall be at one-half the full rate which would otherwise be applicable
under this Agreement, and shall be due only until the period of royalty payments
in said country, prior to and after such adjustments, totals five (5) years. If
there are two or more conflicting judgments in courts of competent jurisdiction
of equal dignity with respect to the same patent, the decision more favorable to
the patent shall be followed until a less favorable decision has been followed
by the judgment of another court of competent jurisdiction and of higher
dignity.
ARTICLE 6 - REPORTS AND RECORDS
6.1 Records. LICENSEE and its sublicensees shall keep complete and
accurate books of account containing all particulars which may be reasonably
necessary for the purpose of showing the royalties payable to UKRF. Said books
of account shall be kept at LICENSEE's principal place of business or the
principal place of business of a division of LICENSEE which is marketing
LICENSED PRODUCTS. Said books and particulars shall be available during normal
business hours, upon reasonable notice, for two (2) years following the end of
the calendar year to which they pertain, to the inspection of an independent
certified public accountant retained by UKRF for the purpose of verifying
LICENSEE royalty statements. Inspection shall be limited solely to those
matters directly related to LICENSEE royalty obligations under this Agreement
and shall be allowed no more than once a year.
6.2 Delivery. Within thirty (30) days after June 30 and December 31 of
each year, LICENSEE shall deliver to UKRF true and accurate reports, giving such
particulars of the business conducted by LICENSEE during the preceding six (6)
month period under this Agreement as are pertinent to a royalty accounting under
this Agreement. These reports shall include at least the following:
(A) Total xxxxxxxx for LICENSED PRODUCTS sold;
(B) Deductions applicable;
(C) Total royalties due; and
(D) Name(s) and address(es) of all sublicensees.
6.3 Audit Costs. If an audit conducted on behalf of UKRF pursuant to
Section 7.1 reveals that LICENSEE has made an error of ten percent (10%) or more
in its favor in the aggregate payment due UKRF in any fiscal year of LICENSEE,
LICENSEE shall be obligated to pay the audit fee in connection with the audit.
6.4 Marking. LICENSEE and its sublicensees agree to xxxx all LICENSED
PRODUCTS sold in the United States with all applicable U.S. patent numbers. All
LICENSED PRODUCTS shipped to or sold in other countries shall be marked in such
a manner as to conform with the patent laws and practice of the country to which
such products are shipped or in which such products are sold.
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ARTICLE 7 - PATENT PROSECUTION AND ENFORCEMENT
7.1 U.S. Applications. LICENSEE hereby authorizes UKRF, in the name of
UKRF or its employees, at UKRF's expense, to apply for and seek prompt issuance
of, and upon issuance, maintain during the term of this Agreement U.S. patent
applications and patents as described in the PATENT RIGHTS or as may otherwise
apply to the TECHNOLOGY. UKRF shall apply all reasonable efforts to retain
broad patent claims as are reasonable and practical taking into consideration
the need and likelihood of patent issuance and enforceability. LICENSEE shall
take all actions necessary to cooperate with and assist UKRF in the filing and
prosecution of such patent applications including but not limited to appropriate
invention disclosures and execution of documents as requested by UKRF's patent
counsel. UKRF shall keep LICENSEE informed as to the status of such patent
applications including providing LICENSEE with copies of all written
communications with the patent offices, and consulting with LICENSEE on
responses to the patent offices in advance of submission. If UKRF fails to
diligently pursue any of such patent applications and, within sixty (60) days of
LICENSEE's written request, fails to take such actions set forth in such request
respecting the prosecution of any of such patent applications or if UKRF
abandons any such patent application, LICENSEE shall have the right, at its
expense, to take such actions as are necessary to pursue such patent
applications, and LICENSEE shall have the right to offset against payments due
to UKRF hereunder until the expenses incurred by LICENSEE to pursue such patent
application have been recouped.
7.2 Foreign Applications. UKRF hereby authorizes LICENSEE, in the name of
UKRF or its employees, at LICENSEE's expense, to apply for and seek prompt
issuance of, and upon issuance, maintain during the term of this Agreement
foreign patent applications and patents as described in the PATENT RIGHTS or as
may otherwise apply to the TECHNOLOGY. LICENSEE shall apply all reasonable
efforts to retain broad patent claims as are reasonable and practical taking
into consideration the need and likelihood of patent issuance and
enforceability. UKRF shall take all actions necessary to cooperate with and
assist LICENSEE in the filing and prosecution of such patent applications
including but not limited to appropriate invention disclosures and execution of
documents as requested by LICENSEE's patent counsel. LICENSEE shall keep UKRF
informed as to the status of such patent applications including providing UKRF
with copies of all written communications with the patent offices, and
consulting with UKRF on responses to the patent offices in advance of
submission. If LICENSEE fails to diligently pursue any of such patent
applications and, within sixty (60) days of UKRF's written request, which shall
include submission to LICENSEE of an invention disclosure suitable for
implementing the action specified in the request, fails to take such actions set
forth in such request respecting the prosecution of any of such patent
applications or if LICENSEE abandons any such patent application, UKRF shall
have the right, at its expense, to take such actions as are necessary to pursue
such patent applications. UKRF shall execute such documents as are reasonably
necessary to file with the Patent and Trademark Office notice of LICENSEE's
exclusive license under the PATENTS RIGHTS.
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7.3 Enforcement. UKRF and LICENSEE shall each give immediate notice to
the other of any infringement of PATENT RIGHTS by third parties which may come
to their attention. UKRF hereby grants to LICENSEE, at LICENSEE's expense, the
right to institute and conduct such legal action against third party infringers
of the PATENT RIGHTS and/or unauthorized users of the TECHNOLOGY, or enter into
such settlement agreements, as are deemed appropriate by LICENSEE. LICENSEE
shall control the conduct of such litigation, including the choice of its
counsel. LICENSEE shall receive the full benefits of any action it takes
pursuant to this Section 7.3. In any such action, UKRF shall be entitled to
join LICENSEE as a party plaintiff and UKRF will be obligated to reasonably
assist at LICENSEE's expense. In the event that such third party infringer or
such unauthorized user files a counterclaim or threatens to file a counterclaim
against LICENSEE, LICENSEE hereby agrees to indemnify UKRF against all losses,
liabilities, claims, costs, charges and expenses incurred or suffered by UKRF in
connection with such counterclaim or threat to the extent that any such losses,
liabilities, claims, costs, charges and expenses arise because of LICENSEE'S
gross negligence, bad faith or wilful misconduct; provided, however, that
LICENSEE shall not be obligated to indemnify UKRF to the extent that any such
losses, liabilities, claims, costs, charges and expenses arise because of the
alleged infringement of the rights of such third party by reason of practice by
LICENSEE, its AFFILIATES or sublicensees of the license granted herein (the
parties agree that such alleged infringement and any indemnification relating
thereto shall be covered by Section 7.4). Should LICENSEE fail to commence
actions or proceedings against infringers of the PATENTS or unauthorized users
of the TECHNOLOGY within ninety (90) days of receiving written notice thereof
from UKRF, UKRF, at UKRF's expense, shall have the right to initiate and pursue
such action and receive all resulting benefits.
7.4 Infringement. Subject to Section 5.6 hereof, in the event that a
claim or action for infringement of the rights of others is made or brought
against LICENSEE, its AFFILIATES or sublicensees during the term of this
Agreement, by reason of practice in such country by LICENSEE, its AFFILIATES or
sublicensees of the license granted herein, LICENSEE shall control the conduct
of such litigation, including the choice of its legal counsel, and shall pay all
costs and expenses, including attorneys fees, associated therewith. LICENSEE may
recover such costs and expenses and any judgment assessed against, or settlement
agreed upon by, LICENSEE by set-off against fifty percent (50%) of the amounts
payable to UKRF hereunder in any payment period. Any amount remaining to be
offset from any period shall be carried forward until offset against royalties
for future periods.
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ARTICLE 8 - TERMINATION
8.1 Bankruptcy. If LICENSEE undergoes a liquidation in bankruptcy, or
files a petition for liquidation in bankruptcy, or if the business of LICENSEE
shall be placed in the hands of a receiver, trustee or assignee for the benefit
of creditors, whether by the voluntary act of LICENSEE or otherwise, and if
LICENSEE fails to terminate any such proceeding within one hundred twenty (120)
days after its commencement, UKRF may at its election terminate this Agreement
upon thirty (30) days written notice to LICENSEE. LICENSEE agrees to provide
written notice to UKRF of LICENSEE or a third party's intention to file a
petition for liquidation of LICENSEE in bankruptcy prior to such filing, if
known.
8.2 Failure to Pay Royalties. Should LICENSEE fail in its payment to UKRF
of royalties due in accordance with the terms of this Agreement, UKRF shall have
the right to serve notice upon LICENSEE by certified mail at an address
designated in Article 12 hereof, of its intention to terminate this Agreement
within ninety (90) days after receipt of said notice of termination unless
LICENSEE shall pay UKRF within the ninety (90) day period. If such ninety (90)
day period expires and if the amount of royalties due is not paid by LICENSEE,
the rights, privileges and license granted hereunder shall terminate upon the
end of such ninety (90) day period.
8.3 Material Breach. Upon any other material breach or default by
LICENSEE, UKRF shall have the right to terminate this Agreement and the rights
and license granted hereunder by ninety (90) days' notice by certified mail to
LICENSEE. Such termination shall become effective at the end of such ninety
(90) day period unless LICENSEE has cured any such breach or default prior to
the expiration of the ninety (90) day period.
8.4 Termination by LICENSEE. LICENSEE may terminate this Agreement upon
one hundred twenty (120) days' notice by certified mail to UKRF.
8.5 Obligations on Termination: Upon termination of this Agreement for
any reason, nothing herein shall be construed to release either party of any
obligation which matured prior to the effective date of such termination, and
LICENSEE may, after the effective date of such termination, complete LICENSED
PRODUCTS in the process of or manufacture at the time of such termination and
sell the same together with LICENSED PRODUCTS in inventory for a period of one
year, provided that LICENSEE pays to UKRF royalties as required by Article 5 of
this Agreement and submits the reports as required by Article 6 on the sale of
LICENSED PRODUCTS.
8.6 Survival. Articles 3 and 4 and Sections 7.3, 7.4, 8.5, 9.1, 9.2, 9.3
and 13.1 shall survive termination of this Agreement as well as the right of
UKRF to collect any accrued royalties as recited in Article 5.
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8.7 Sublicenses. In the event the licenses granted to LICENSEE under
Section 2 above terminate for any reason, each of LICENSEE'S sublicenses in
effect at such time shall continue in accordance with the terms of such
sublicenses. UKRF agrees that each such sublicensee shall be entitled to
enforce such rights and license directly against UKRF. The foregoing shall be
subject to each such sublicensee agreeing in writing at any time prior to such
terms and conditions are to become effective that UKRF is entitled to enforce
the provisions in such sublicense directly against such sublicensee.
ARTICLE 9 - INDEMNIFICATION
9.1 Indemnification by Licensee. LICENSEE shall at all times during the
term of this Agreement and thereafter, indemnify, defend and hold UKRF, its
trustees, officers, employees and affiliates, harmless against all claims and
expenses, including legal expenses and reasonable attorneys' fees, arising out
of the death of or injury to any person or persons or out of any damage to
property and against any other claim, proceeding, demand, expense and liability
of any kind whatsoever resulting from the production, manufacture, sales, use,
consumption or advertisement of the LICENSED PRODUCTS or arising from any
obligation of LICENSEE hereunder.
9.2 Insurance. If LICENSEE produces, manufactures or sells any LICENSED
PRODUCTS, LICENSEE will maintain product liability insurance, with an
endorsement naming UKRF, the University of Kentucky, its Board of Trustees,
agents officers and employees as additional insureds covering liabilities for
the production, manufacture and/or sale of the LICENSED PRODUCT. The policy of
insurance shall contain a provision of non-cancellation except upon the
provision of thirty (30) days notice to the University. Policy limits shall be
not less than $1,000,000 per occurrence.
9.3 Sublicensees. If LICENSEE sublicenses any of the rights, privileges
and licenses granted hereunder, LICENSEE shall require the sublicense to provide
UKRF evidence of such product liability insurance.
ARTICLE 10 - ASSIGNMENT
Neither party will assign or transfer its rights and obligations under this
Agreement except with the consent of the other party which consent shall not be
unreasonably withheld or delayed, provided that any such assignee or transferee
must as a condition to such assignment agree in writing to be bound by the terms
and provisions of this Agreement. Upon such assignment or transfer and
agreement by such assignee or transferee, the term LICENSEE or UKRF, as the case
may be, as used herein shall mean such assignee or transferee.
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ARTICLE 11 - AGENCY
Neither party shall be deemed to be an agent of the other party as a result
of any transaction under or related to this Agreement, and shall not in any way
pledge the other party's assets or incur any obligation on behalf of the other
party.
ARTICLE 12 - PAYMENTS, NOTICES AND COMMUNICATIONS
Any payment, notice or other communication pursuant to this Agreement shall
be sufficiently made or given on the date of mailing if sent to such party by
certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other party:
In the case of UKRF: The University of Kentucky
Research Foundation
00 Xxxxxxxxxxxxxx Xxxxxxxx
Xxxxxxxxx, Xxxxxxxx 00000-0000
Attention: Xx. Xxxxxxxxxx Xxxxxxxx
In the case of LICENSEE: Control Delivery Systems, Inc.
00 Xxxxxxxx Xxxx
Xxxxxxxxx, XX 00000
Attention: President
ARTICLE 13 - MISCELLANEOUS PROVISIONS
13.1 Limitation of Liability. Neither party shall be liable to the other
for any special, consequential, incidental or indirect damages arising out of
this agreement, however caused, under any theory of liability.
13.2 Governing Law. This Agreement shall be construed, governed,
interpreted and applied in accordance with the laws of the Commonwealth of
Kentucky, except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent was
granted. The parties hereto further agree that any and all proceedings relating
to the subject matter hereof may be maintained in the State and Federal Courts
of the Commonwealth of Kentucky, which courts shall have non-exclusive
jurisdiction for such purpose.
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13.3 Confidentiality of Agreement. Each party agrees that the terms and
conditions of this Agreement shall be treated as confidential information except
as required by or for the University of Kentucky's standard funding disclosure
policies, applicable disclosure laws, financing sources, enforcement of the
Agreement, mergers and acquisitions, or as otherwise mutually agreed by the
parties.
13.4 Entire Agreement. The parties hereto acknowledge that this instrument
sets forth the entire agreement and understanding of the parties hereto as to
the subject matter hereof, and shall not be subject to any change or
modification except by the execution of a written instrument subscribed to by
the parties hereto.
13.5 Severability. The provisions of this Agreement are severable, and in
the event that any provisions of this Agreement are determined to be invalid or
unenforceable under any controlling body of law, such invalidity or
enforceability shall not in any way affect the validity or enforceability of the
remaining provisions hereof.
IN WITNESS WHEREOF, the parties hereto have hereunder set their hands and
seals and duly executed this Agreement as of the day and year first above
written.
UNIVERSITY OF KENTUCKY CONTROL DELIVERY SYSTEMS, INC.
RESEARCH FOUNDATION
By /s/ Xxxxxx X. Xxxx, III By /s/ Xxxx Xxxxxx
-------------------------------- -----------------------------------
Name Xxxxxx X. Xxxx, III Name Xxxx Xxxxxx
------------------------------ ---------------------------------
Title Associate Vice President for Title President
----------------------------- --------------------------------
Research and Graduate Studies
-----------------------------
00
Xxxxxxx X
XXXXXX XXXXXX
Xxxxxx Xxxxxx Patent Serial No. 08/534,854
Title: Implantable Controlled Release Device to Deliver Drugs to an Internal
---------------------------------------------------------------------
Portion of the Body;
-------------------
Author: Xxxx Xxxxxx, et al;
-- --
and all foreign counterparts
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Exhibit B
TECHNOLOGY
(i) All materials and methods used or useful in the development and
manufacture of all the compounds listed in the U.S. patent described in Exhibit
A hereto (the "Compounds"),
(ii) all published and unpublished materials, including but not limited
to, research data, human clinical data, other test results and know-how,
relating to the Compounds,
(iii) all reference spectra relating to the Compounds,
(iv) all production procedures of spectra relating to the Compounds,
(v) all molding device designs relating to the Compounds,
(vi) all manufacturing scale up know-how relating to the Compound, and
(vii) all samples of the Compounds.
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