Exhibit 10.8
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LICENSE AGREEMENT
AGREEMENT made this 20th day of January, 1996 by and between YALE
UNIVERSITY, a corporation organized and existing under and by virtue of a
charter granted by the general assembly of the Colony and State of Connecticut
and located in New Haven, Connecticut ("YALE"), and OncorPharm, Inc., a
corporation organized and existing under the laws of the State of Delaware, and
with principal offices located in Gaithersburg, Maryland ("ONCORPHARM" or
"LICENSEE").
W I T N E S S E T H:
WHEREAS, in the course of research conducted under YALE auspices, Xxxxx
Xxxxxx and Xxxxxx Havre, in the Department of Therapeutic Radiology of YALE (the
"INVENTORS"), have produced an INVENTION described and defined below;
WHEREAS, pursuant to an assignment by the INVENTORS to YALE of all their
right, title and interest in and to the INVENTION (as defined below) and any
patents resulting therefrom, YALE is the owner of the INVENTION, subject to
rights reserved by the U.S. Government; and
WHEREAS, LICENSEE wishes to obtain a license to the INVENTION and any
patents resulting therefrom, and YALE is willing to grant such a license to
LICENSEE subject to the terms and conditions hereof;
NOW, THEREFORE, in consideration of the mutual covenants herein
contained the parties agree as follows:
ARTICLE I - DEFINITIONS
As used in this Agreement, the following terms shall be defined as set
forth below:
1.01 "AFFILIATE" shall mean any corporation, company, partnership, joint
venture or other entity which controls, is controlled by or is under common
control with LICENSEE, including without limitation:
a) an organization of which 50% or more of the voting power is
controlled or owned directly or indirectly by ONCORPHARM;
b) an organization which directly or indirectly owns or controls
50% or more of the voting power of ONCORPHARM; and
c) an organization, the majority ownership of which is directly
or indirectly common to the majority ownership of ONCORPHARM.
For purposes of this Section 1.01, control shall mean the direct or indirect
ownership of at least fifty percent (50%), or the maximum percentage as allowed
by applicable law, of the voting power in respect to the entity. AFFILIATE shall
include Oncor, Inc, and OncorMed, Inc. Once an entity becomes an AFFILIATE, it
will remain so for purposes of this Agreement even if subsequently ONCORPHARM's
relationship drops below the required test of an AFFILIATE. ONCORPHARM may, by
separate agreement with its AFFILIATES, provide for a more limited scope of
license of the LICENSED TECHNOLOGY; provided, however, that no such agreement
shall limit or adversely affect the royalties or other amounts payable to YALE
pursuant to this Agreement.
1.02 "EARNED ROYALTIES" shall mean royalties paid or payable by LICENSEE
to YALE determined with respect to NET SALES.
1.03 "FIELD OF USE" shall mean all applications other than the SEPARATE
FIELD OF USE, including without limitation, all research, diagnostic and
therapeutic uses in or for humans.
1.04 The "INVENTION" shall mean the invention entitled *
1.05 "KNOW-HOW" shall mean any and all technical information, know-how,
processes, procedures, compositions, devices, methods, formulas, protocols,
techniques, software, designs, drawings or data, relating to either or both the
INVENTION and the LICENSED PRODUCTS, that is held by YALE, including but not
limited to INVENTIONS and/or know-how which are not disclosed in a patent
application or patent, but which are necessary or useful for practicing the
rights granted under this Agreement.
1.06 "LICENSED PATENTS" shall mean any United States or foreign patent
application(s) and patents(s) owned, in whole or in part, by YALE during the
term of this Agreement and which have claims covering the INVENTION, together
with any continuations, continuations-in-part, divisional or substitute patents,
any reissues or re- examinations of any such applications or patents, and any
extension of any such patent.
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* CONFIDENTIAL TREATMENT REQUESTED
1.07 "LICENSED PRODUCTS" shall mean the INVENTION and any products,
processes, devices, procedures, methods or treatments, the manufacture,
production, use or sale of which, but for a license granted by YALE to LICENSEE,
would infringe one or more claims of the LICENSED PATENTS, in the country where
the manufacture, production, use or sale takes place.
1.08 "LICENSED TECHNOLOGY" shall mean the INVENTION and the
KNOW-HOW.
1.09 "LICENSEE" shall include OncorPharm, Inc. and its AFFILIATES.
1.10 "NET SALES" shall mean gross revenues from sales of the LICENSED
PRODUCTS invoiced by LICENSEE in accordance with generally accepted accounting
principles, less credits, bad debts or allowances on account of rejections of
products previously invoiced, less discounts allowed and taken, in amounts
customary in the trade (such as the difference between the dollar amount charged
by LICENSEE for a LICENSED PRODUCT and the discounted amount paid by commercial
clients after applying their discounts or special prices extended), sales and/or
use taxes and/or duties if any. LICENSED PRODUCTS shall be deemed to have been
used and sold when invoiced or when shipped or mailed or otherwise delivered, or
when paid for, whichever is earliest. In the event that ONCORPHARM shall
transfer LICENSED PRODUCTS to an AFFILIATE and the AFFILIATE retransfers the
LICENSED PRODUCTS to third party customers within one year of its receipt, then
the gross revenues for such sales shall be the price charged by the AFFILIATE to
third party customers, less deductions. If such AFFILIATE does not retransfer
the LICENSED PRODUCTS within one year, then the gross revenues for the transfer
to the AFFILIATE shall be the higher of
a) the price charged by ONCORPHARM to the AFFILIATE, or
b) the average price charged by ONCORPHARM to third party
customers during such year or, in the absence of sales to third party customers,
the fair market price for the LICENSED PRODUCTS. In the event that the LICENSED
PRODUCTS are sold incorporated in other services or products, the gross sales
amount invoiced on the sale of LICENSED PRODUCTS shall be calculated by
multiplying the gross sales revenues received from such package by the fraction
A/(A+B), where A is the published list price of the LICENSED PRODUCT sold
separately during the QUARTER YEAR in question and B is the sum of published
list prices of the other active services or products sold separately during the
QUARTER YEAR in question. In the event that the LICENSED PRODUCT and the other
service or products are not sold separately, gross sales on the LICENSED PRODUCT
shall be calculated by multiplying the gross sales as defined above but applied
to the combination service or product, by the fraction A/(A+C), where A is
defined above and C is the reasonably estimated list price (using accepted
medical device industry standards) of
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the other service or products. NET SALES shall then be calculated by making
appropriate deductions from such gross sales in accordance with this article
1.07.
1.11 "QUARTER YEAR" shall mean the three-month periods ending March 31,
June 30, September 30 and December 31 of each Royalty Year.
1.12 "ROYALTY YEAR" shall mean each twelve month period commencing
January 1 and ending December 31 during the first seventeen years of this
Agreement. For the first year of this Agreement, the ROYALTY YEAR shall be the
period of time between the signing of the Agreement and December 31.
1.13 "SEPARATE FIELD OF USE" shall mean all applications for use solely
in or for insects, plants or animals other than humans.
1.14 "SUBLICENSE INCOME" shall mean the gross amount received by
LICENSEE, directly or indirectly, for or on account of sublicenses of any of the
rights granted hereunder, without deduction of any kind. If LICENSEE makes an
arrangement with another party that involves granting a sublicense of any of
such rights and also involves any of the following:
a) Payments received by LICENSEE for performance of research and
development, including but not limited to milestone payments for achievement of
objectives in research and development;
b) Investments made by a sublicensee in the LICENSEE, including
but not limited to, any payments or other consideration in return for shares in
the LICENSEE; and
c) Payments made to LICENSEE for conducting clinical testing and
other activities in connection with obtaining regulatory approval for a LICENSED
PRODUCT;
then the portion of the total amount received by LICENSEE under such arrangement
that represents the fair market value of the sublicense shall be included in
SUBLICENSE INCOME and the fair market value of such other payments or
investments, if any, shall be excluded from SUBLICENSE INCOME.
ARTICLE II GRANT OF LICENSE
2.01 Yale hereby grants to LICENSEE, subject to all the terms and
conditions of this Agreement, a non-transferable (except as set forth in Section
15.05), worldwide, exclusive license for the term defined by ARTICLE III, in
both the FIELD OF USE and the SEPARATE FIELD OF USE, to make, have made, use,
sell and practice the LICENSED TECHNOLOGY (including the INVENTION covered by
the LICENSED PATENTS) and to
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make, have made, use and sell the LICENSED PRODUCTS, subject to rights required
to be granted to the U.S. Government. YALE retains the right to use the KNOW-HOW
for educational and research purposes only and not for any commercial purpose
and to provide or transfer such KNOW-HOW to universities and other non-profit
research entities for educational and research purposes only and not for any
commercial purpose.
2.02 LICENSEE shall have the right to sublicense the rights granted
hereunder to third parties. All sublicenses hereunder granted by LICENSEE may,
at YALE's option, be coterminable with this Agreement to the extent Yale's
rights in the LICENSED PATENTS are involved.
2.03 YALE shall only retain the right to make, use and practice the
INVENTION for its own internal non-commercial purposes, without any right to
transfer or sublicense.
2.04 Upon execution of this Agreement YALE shall disclose to LICENSEE
all the LICENSED TECHNOLOGY as of the date of this Agreement, to the extent that
it has not already conveyed the same to LICENSEE. Thereafter YALE shall disclose
to LICENSEE any additional LICENSED TECHNOLOGY as and when the same shall arise.
Any such disclosure shall be made in tangible forms which are mutually
acceptable to both parties.
ARTICLE III TERM OF LICENSE
The term of the LICENSE granted hereunder shall commence upon the
signing hereof and shall continue for the life of the applicable LICENSED
PATENTS, and any license granted hereunder shall expire on a country by country
basis when the last to expire LICENSED PATENTS in such country expires or
lapses. Expiration of this Agreement under this provision shall not preclude
LICENSEE or its permitted sublicensees from continuing to make, have made, use
and sell and practice the LICENSED TECHNOLOGY and LICENSED PRODUCTS without
further royalty payments or other compensation to YALE.
ARTICLE IV ROYALTIES
As consideration for the rights granted hereunder, LICENSEE shall make
the following royalty payments to YALE:
4.01 LICENSEE shall pay to YALE a one-time license fee of *
within 30 days of the execution of this Agreement. Such payment shall be
separate from and not credited against any EARNED ROYALTIES.
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* CONFIDENTIAL TREATMENT REQUESTED
4.02 LICENSEE shall pay to YALE EARNED ROYALTIES of * of
NET SALES in respect of any LICENSED PRODUCTS sold for use as a human
therapeutic.
4.03 LICENSEE shall pay to YALE EARNED ROYALTIES of * of NET SALES in
respect of any LICENSED PRODUCTS sold for any use other than use as a human
therapeutic.
4.04 In the event that LICENSEE sublicenses the LICENSED TECHNOLOGY to a
third party without having first conducted any research and development work
itself in relation to the LICENSED TECHNOLOGY, then LICENSEE shall pay to YALE
* of all SUBLICENSE INCOME from that third party (the "PURE SUBLICENSE
PAYMENTS").
4.05 In the event that LICENSEE first conducts research and development
work in relation to the LICENSED TECHNOLOGY, and the LICENSED TECHNOLOGY
together with the additional research and development work and information is
sublicensed to a third party, then the LICENSEE shall pay YALE the following:
a) *
b) *
4.06 LICENSEE shall make milestone payments to YALE according to the
following schedule, but such milestone payments shall be paid only once,
irrespective of the number of LICENSED PRODUCTS that are covered by this
Agreement. If at the time any of these milestone payments become due under this
Section 4.06(a)-(j), no LICENSED PATENT has been granted by the United States
Patent and Trademark Office ("PTO"), then LICENSEE may withhold and place in
escrow * of each such milestone payment (the "Escrow Amount"). LICENSEE shall
pay to YALE the whole Escrow Amount within 30 days after issuance of a LICENSED
PATENT by the PTO. In the event that a) all patents and patent applications
relative to the INVENTION are either denied, withdrawn, abandoned, unenforceable
or not actively pursued at any time during the term of this Agreement, or b) a
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LICENSED PATENT has not issued prior to the expiration or termination of this
Agreement, then LICENSEE shall be entitled to retain and keep the Escrow Amount.
Schedule of Payments
Payment Due Date
* *
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* CONFIDENTIAL TREATMENT REQUESTED
4.07 EARNED ROYALTIES, PURE SUBLICENSE PAYMENTS and VALUE ADDED
SUBLICENSE PAYMENTS shall be payable by LICENSEE during the period that any
LICENSED PATENT remains pending or effective in any applicable country. In the
event that a LICENSED PATENT lapses or if all of its claims are finally declared
invalid by a non-appealable decision of a court of competent jurisdiction
through no fault or cause of LICENSEE, the obligation to pay royalties for that
patent on sales made subsequent to the lapse or declaration of invalidity shall
terminate but this Agreement shall remain in effect as to the remaining LICENSED
PATENTS or claims thereunder. If all LICENSED PATENTS lapse or all of their
claims are so finally declared invalid, either in a particular jurisdiction or
worldwide, the obligation of LICENSEE to pay royalties or other compensation to
YALE shall terminate but LICENSEE and its permitted sublicenses may continue to
make, have made, use, all and practice the LICENSED TECHNOLOGY and LICENSED
PRODUCTS in such jurisdictions or worldwide, as the case may be.
4.08 If LICENSEE believes that it must obtain or utilize a license under
any other patent(s) from any third party in order to make, have made, use or
sell LICENSED PRODUCTS in any particular country, LICENSEE shall advise YALE. If
YALE disagrees, the parties shall negotiate in good faith to resolve the
disagreement or make alternative arrangements. If the parties are unable to
agree, LICENSEE, in its sole discretion, shall make the final decision as to
whether such a license is required unless YALE provides to
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LICENSEE a written clean opinion ("Patent Opinion") of well respected patent
counsel that the making or sale of LICENSED PRODUCTS will not infringe such
third party patents or other intellectual property rights. If a Patent
Opinion is issued and not withdrawn, and LICENSEE still obtains the relevant
third party license, then LICENSEE shall not be entitled to a credit for such
third party license payments under this Section 4.08. If LICENSEE makes such
payments to any third party (other than one which was the subject of a Patent
Opinion) in order to manufacture, use or sell a LICENSED PRODUCT for which an
EARNED ROYALTY would be payable to YALE under this Article IV, LICENSEE may
credit * of the actual amount of any such payments to said third parties for
a given calendar quarter against the EARNED ROYALTY payable to YALE hereunder
with respect to such LICENSED PRODUCT for such quarter on a
country-by-country basis; provided, however, that in no event will the EARNED
ROYALTY payable to YALE with respect to such LICENSED PRODUCT be reduced to
an amount less than * of NET SALES of the LICENSED PRODUCT for human
therapeutic products nor less than one and * for use other than as a human
therapeutic.
ARTICLE V PAYMENTS AND REPORT
5.01 Within 30 days after the end of each QUARTER YEAR, LICENSEE shall
furnish to YALE a written report setting forth the NET SALES and the EARNED
ROYALTIES, PURE SUBLICENSE PAYMENTS and VALUE ADDED SUBLICENSE PAYMENTS (the
"AGGREGATE ROYALTIES") payable thereon, accompanied by full payment of such
ROYALTIES and PAYMENTS.
5.02 In the event that the AGGREGATE ROYALTIES paid to YALE for any
ROYALTY YEAR exceed the minimum royalty payments due for such year, the amount
by which such AGGREGATE ROYALTIES exceeds the minimum royalty payment shall be
credited against LICENSEE's future obligations to pay minimum royalties for the
next succeeding ROYALTY YEAR that actually arise pursuant to this Section 5.02,
but in no case shall reduce payment of AGGREGATE ROYALTIES. In the event that
the AGGREGATE ROYALTIES for any ROYALTY YEAR are less than the minimum royalty
payments due for such year, then LICENSEE shall include with the last report
furnished under Section 5.01 for such ROYALTY YEAR payment of the difference
(the "RESIDUAL ROYALTY PAYMENT") between the AGGREGATE ROYALTIES for such
ROYALTY YEAR and the applicable minimum royalty payment. LICENSEE may credit any
RESIDUAL ROYALTY PAYMENT made to YALE hereunder against future obligations for
the next succeeding ROYALTY YEAR to pay AGGREGATE ROYALTIES to YALE, until
exhausted in full; provided, however, for the avoidance of doubt, such RESIDUAL
ROYALTY PAYMENT may not be used to reduce the total of AGGREGATE ROYALTIES and
MINIMUM ROYALTY PAYMENT in any such succeeding ROYALTY YEAR below the * figure
specified in Section 4.06(j).
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* CONFIDENTIAL TREATMENT REQUESTED
5.03 The reports required by this Article V shall be certified by an
officer of LICENSEE to be correct to the best of LICENSEE's knowledge and
information. Each report shall be accompanied by LICENSEE's payment of the full
amount due, less any taxes required by a governmental agency to be withheld
therefrom; provided, however, that YALE shall have the right to contest any such
taxes and LICENSEE shall provide reasonable assistance with respect thereto. All
royalties shall be paid to YALE in U.S. dollars, and in full. In the event that
conversion from foreign currency is required in calculating a royalty payment
hereunder, the exchange rate used shall be the rate in effect at the end of the
last business day of the month just prior to the date payment is required to be
made hereunder as published in the Wall Street Journal.
5.04 If this Agreement should be terminated at any time other than at
the end of a QUARTER YEAR or ROYALTY YEAR, the last report and payment shall be
made within 60 days after the effective date of such termination, and shall
include any EARNED ROYALTIES, PURE SUBLICENSE PAYMENTS and VALUE ADDED
SUBLICENSE PAYMENTS prorated to the date of termination. If the amount of
LICENSEE's existing inventory of LICENSED PRODUCTS which had been manufactured
but not sold up to the date of termination exceeds a 30 day supply, LICENSEE
shall provide YALE with a report setting forth the amount of such inventory at
the date of termination, and may elect to continue to render QUARTER YEAR
reports on the sales of such existing inventory and to make payments as though
the Agreement were still in effect; provided, however, that in any event,
LICENSEE shall complete payment of AGGREGATE ROYALTIES thereon within one year
from the effective date of termination.
ARTICLE VI BOOKS AND RECORDS
LICENSEE and its sublicensees shall keep and maintain complete and
accurate records and books of account in sufficient detail and form so as to
enable verification of EARNED ROYALTIES, PURE SUBLICENSE PAYMENTS and VALUE
ADDED SUBLICENSE PAYMENTS payable by LICENSEE hereunder. Such records and books
of account shall be maintained for a period of no less 3 years following the
HALF YEAR to which they pertain. LICENSEE shall permit such records and books of
account to be examined at reasonable times by YALE or YALE's duly appointed
agent, to the extent necessary for Yale to verify the amount of royalties
payable. Upon receiving notification that YALE intends to verify LICENSEE's
accounts, should LICENSEE object in writing to the particular auditor that YALE
has chosen, YALE will reasonably take into account such objection and consider
appointing another auditor to examine LICENSEE's accounts, at the sole
discretion of YALE. Such examination shall be at YALE's expense, during normal
business hours, and upon 10 days' prior written notice to LICENSEE. The results
of such examination shall be kept confidential and be used only for the purpose
of this Article VI.
ARTICLE VII PATENT PROTECTION
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7.01 * covering the INVENTION has been prepared and *. It is understood
that as of the date hereof no patent protection exists in the U.S. or any
foreign country but only the potential to realize the same.
7.02 LICENSEE shall bear all reasonable patent prosecution and
maintenance expenses associated with the LICENSED PATENTS beginning with
invoices dated as of the date of execution of this Agreement.
7.03 YALE at LICENSEE's expense, shall prepare and file foreign patent
applications covering the INVENTION in such foreign countries as are determined
by YALE and agreed to by LICENSEE. Determination of which foreign countries in
which patent application shall be filed shall be made no later than 90 days
following the date hereof. YALE shall provide to LICENSEE for its review and
comment prior to filing copies of all patent applications and substantive patent
prosecution documents. LICENSEE shall provide its comments within 30 days of
receipt thereof and such comments shall be advisory in nature and not binding on
YALE or its patent counsel. Any and all such applications or patents shall
remain the property of YALE. Any taxes, annuities, working fees, maintenance
fees, renewal and extension charges with respect to each such foreign patent
application and patents shall be punctually paid by YALE on behalf of both
parties. LICENSEE shall reimburse YALE within 30 days of receiving a copy of the
invoice for all such taxes, annuities, fees and charges. If LICENSEE does not
agree to bear the expenses of filing patent applications in any foreign
countries in which YALE wishes to obtain patent protection, then YALE may file
and prosecute such application at its own expense. If YALE does file and
prosecute such application then LICENSEE'S rights terminate in that country.
7.04 If YALE should license the INVENTION to a third party other than
the U.S. government to the extent, if any, permitted by this Agreement, then
upon the execution of each and every future license by YALE with any third party
with respect to the INVENTION, the total patent costs incurred to the effective
date of such license shall be reapportioned and credit issued or refund made, as
appropriate, to LICENSEE and future costs similarly apportioned. YALE represents
that no such licenses exist as of the signing hereof.
7.05 LICENSEE shall apply, and shall require sublicensees to apply, the
patent marking notices required by the law of any country where LICENSED
PRODUCTS are made, sold or used, to the extent feasible and practical, and in
accordance with the applicable patent laws of that country.
ARTICLE VIII DUE DILIGENCE IN COMMERCIALIZATION
8.01 LICENSEE shall plan and implement appropriate research and
development, testing and production efforts directed toward commercialization of
the LICENSED
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PRODUCTS in the FIELD OF USE at a commercially practicable date and shall
provide to YALE a copy of such plan.
8.02 LICENSEE shall implement in reasonable commercial fashion following
the date of this agreement the plan for developing and commercializing the
LICENSED PRODUCTS in the FIELD OF USE. YALE shall be entitled to terminate this
Agreement in accordance with Article XI in the event that either:
a) YALE gives written notice to LICENSEE that it intends to elect to
terminate the license because of LICENSEE'S failure to implement the
plan in any material respect and LICENSEE, after such written notice
from YALE as provided in Section 11.01, fails to provide written
evidence to YALE of present, attempted or anticipated commercialization
in a manner and on a schedule reasonably commensurate with the scope of
the country or countries in question and LICENSEE's resources. YALE
agrees that: evidence provided by LICENSEE that it has an ongoing and
active or anticipated research, development, manufacturing, marketing or
licensing program as appropriate, directed toward production and sale of
a LICENSED PRODUCT shall be deemed satisfactory evidence; in the
discretion of LICENSEE commercialization efforts may be directed first
to industrialized nations of the world commencing with the United States
of America, and only subsequently to other regions as reasonably and
commercially practicable for LICENSEE given its strategies and
resources; certain countries may, in the discretion of LICENSEE, best be
commercialized by sublicense; and that LICENSEE may in the exercise of
prudent business judgment elect to defer commercialization efforts in
particular fields until the LICENSED PRODUCT has undergone substantial
and appropriate further development; or
b) LICENSEE shall fail to make the first commercial sale within two
years from the receipt of approval from the United States Food and Drug
Administration ("FDA") for a LICENSED PRODUCT, if such approval is
required for the LICENSED PRODUCT, or within one year from the
completion of the LICENSED PRODUCT if FDA approval is not required for
the LICENSED PRODUCT, and such failure is not excused by (i) causes
beyond LICENSEE's direct control; (ii) YALE's failure to meet its
obligations hereunder; (iii) infringement of third party patents; or
(iv) actions or inaction of any federal or state agency whose approval
is required for commercial sales.
8.03 LICENSEE shall provide periodic status reports to YALE, at least
annually, indicating progress and problems to date in commercialization in the
FIELD OF USE, and a forecast and schedule of major events required to market the
LICENSED PRODUCTS in the FIELD OF USE.
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8.04 If at any time LICENSEE abandons or suspends its marketing or its
intent to market the LICENSED PRODUCTS in the FIELD OF USE for a period
exceeding 90 days, LICENSEE shall immediately notify YALE giving reasons and a
statement of its intended actions.
8.05 In the case of research and development, testing and production
efforts directed toward commercialization of the LICENSED PRODUCTS in the
SEPARATE FIELD OF USE, the parties hereby acknowledge and agree that the
LICENSEE shall have up to one calendar year from the date hereof in which to
provide to YALE a proposed plan for developing and commercializing the LICENSED
PRODUCTS in the SEPARATE FIELD OF USE. If LICENSEE provides YALE with such a
business plan within one year, LICENSEE shall then implement in a reasonable
commercial fashion the plan for such development and commercialization of the
LICENSED PRODUCTS in the SEPARATE FIELD OF USE and Sections 8.01 to 8.04
inclusive, shall also apply to LICENSEE's commercialization of the LICENSED
TECHNOLOGY in the SEPARATE FIELD OF USE. However, in the event that LICENSEE
does not provide YALE with such a business plan within one year, then YALE may
give notice to LICENSEE according to Article XI of its intent to terminate its
grant of license in the SEPARATE FIELD OF USE. The license granted to LICENSEE
hereunder in respect of the LICENSED TECHNOLOGY in relation to the FIELD OF USE,
shall not be affected by the foregoing provisions of this Section 8.05.
ARTICLE IX INFRINGEMENT AND LITIGATION
9.01 LICENSEE shall have the sole obligation to defend the LICENSED
PATENTS against infringement or interference in the FIELD OF USE by other
parties in any country in which a LICENSED PATENT is in effect hereunder,
including by bringing any legal action for infringement or defending any
counterclaim of invalidity or action of a third party for declaratory judgment
of non-infringement or interference. LICENSEE may control and settle any such
actions solely at its own expense and through counsel of its selection;
provided, however, that YALE shall be entitled in each instance to participate
through counsel of its selection and at its own expense. YALE shall have no
obligation or responsibility with respect to any such actions unless legally
required to participate, except to provide reasonable assistance to LICENSEE as
requested, and LICENSEE shall reimburse YALE for YALE's out-of-pocket expenses
in connection with any such requested assistance. LICENSEE shall bear the
expenses of such actions and shall obtain all benefits in the recoveries, if
any, whether by judgement, award, decree or settlement, the excess of such
recoveries over such expenses shall be included in LICENSEE's NET SALES. In the
event LICENSEE fails to initiate and pursue or participate in such legal action,
YALE shall have the right to initiate legal action to uphold the LICENSED
PATENTS against third parties in any country in which a LICENSED PATENT is in
effect. LICENSEE shall have no legal or contractual obligation to YALE for its
failure to initiate or participate in any such legal action, except that YALE
may terminate the license granted to LICENSEE hereunder in respect of such a
country.
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9.02 Each party shall promptly notify the other in writing in the event
that a third party shall bring a claim of infringement against YALE or LICENSEE,
either in the United States or in any foreign country in which there is a
LICENSED PATENT. If the alleged infringement is so substantial as to threaten
the competitive position of LICENSEE and/or LICENSEE is temporarily enjoined
from exercise of its license hereunder, and if YALE elects not to defend against
such claim and not to obtain a license to permit LICENSEE to exercise its
license free of such claim, then LICENSEE may in its own name and at its sole
expense defend such claim and may compromise, settle or otherwise pursue such
defense in such a manner and on such terms as LICENSEE shall see fit. YALE, at
its own expense and through counsel of its selection may become a party to such
defense and/or settlement and compromise. In any event, YALE shall have the
right to defend, at its own expense, any such third party claim or action and to
settle or compromise the same in such manner as its shall see fit. LICENSEE may
participate in such litigation or claim on its behalf at its own expense.
9.03 In the event LICENSEE is permanently enjoined from exercising its
license rights granted hereunder pursuant to an infringement action brought by a
third party, or if both LICENSEE and YALE elect not to undertake the defense or
settlement of such a claim of alleged infringement for a period of six months
from notice of such claim or suit, then LICENSEE shall have the right to
terminate this Agreement with respect to the infringing patent claims following
30 days' written notice to YALE and in accordance with the terms of Article XI
hereof.
ARTICLE X USE OF YALE'S NAME
LICENSEE shall not use the name "Yale" or "Yale University" for any
purpose without prior written consent obtained from YALE in each instance,
except for the purposes of referring to this Agreement a) in a press release
reviewed and approved by YALE after execution of this Agreement and b) required
disclosures to be made in documents supplied by LICENSEE in connection with
financings. The restrictions specified in this Article X shall not apply to the
dissemination of information that has previously been approved and released by
YALE in accordance with this Article X.
ARTICLE XI TERMINATION
11.01 YALE may terminate this Agreement if YALE has first given written
notice to LICENSEE of one of the events of default set forth below, and LICENSEE
has failed to cure such event of default within ninety (90) days of receipt of
such written notice, unless such default is of such nature that it cannot be
completely cured within ninety (90) days, in which case the LICENSEE shall have
the right to cure such default within one hundred eighty (180) days, provided
that LICENSEE commences work to cure such default within the
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ninety (90) days and thereafter proceeds with reasonable diligence and in good
faith to cure such default:
(i) fails to make, within the 90 day period set by the notice,
any payment which is due and payable pursuant to this Agreement and has been in
arrears for more than 1 month, provided that this provision shall not apply to
any amounts disputed in good faith by LICENSEE; or
(ii) commits a material breach of any other obligation of this
Agreement which is not cured (if capable of being cured) within the ninety (90)
day period set by the notice; or
(iii) becomes insolvent or, a petition in bankruptcy is filed
against LICENSEE and is consented to, acquiesced in or remains undismissed for
90 days; or makes a general assignment for the benefit of creditors, or a
receiver is appointed for LICENSEE, and LICENSEE does not return to solvency
before the expiration of said 30 day period set by the notice; or
(iv) fails to exercise due diligence in bringing the LICENSED
PRODUCTS to market in accordance with Article VIII; or
(v) fails to give notice as required by Article 8.04.
11.02 LICENSEE shall be entitled to terminate this Agreement upon ninety
(90) days advance written notice to YALE, in the event of YALE's material breach
of any of the provisions of this Agreement, which breach is not cured (if
capable of being cured) within the ninety (90) day period set by the notice, or
if the conditions of Section 9.03 apply.
11.03 LICENSEE shall be entitled to terminate this Agreement at any time
upon 90 days' advance written notice to YALE.
11.04 Upon termination of this Agreement pursuant to this Article XI and
except as otherwise expressly provided herein, all licenses granted to LICENSEE
under the terms of this Agreement and, at YALE's option, any sublicenses granted
by LICENSEE, shall terminate and LICENSEE must return to YALE all materials
containing the LICENSED TECHNOLOGY; provided, however, that LICENSEE shall have
the right for one year thereafter to dispose of all LICENSED PRODUCTS then in
its inventory, and shall pay AGGREGATE ROYALTIES thereon, in accordance with the
provisions of Article IV, as though this Agreement had not terminated.
11.05 Termination of this Agreement shall not affect any rights or
obligations accrued prior to the effective date of such termination and
specifically LICENSEE's obligation to pay all AGGREGATE ROYALTIES specified by
Article IV.
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11.06 The rights provided in this Article XI shall be in addition and
without prejudice to any other rights which the parties may have with respect to
any breach or violations of the provisions of this Agreement.
11.07 Waiver by either party of a single default or breach or of a
succession of defaults or breaches shall not deprive such party of any right to
terminate this Agreement pursuant to the terms hereof upon the occasion of any
subsequent default or breach.
ARTICLE XII NO WARRANTIES; INDEMNIFICATION; INSURANCE
12.01 YALE represents and warrants to LICENSEE that neither the
inventor, Xx. Xxxxx Xxxxxx, nor the Office of Cooperative Research have actual
knowledge that any LICENSED PATENT is invalid, or that the manufacturer, use,
sale or other disposal of the LICENSED PRODUCTS will infringe upon any patent or
other rights not vested in YALE. Except for the foregoing, YALE makes no
representations or warranties that any LICENSED PATENT is valid, or that the
manufacture, use, sale or other disposal of the LICENSED PRODUCTS does not
infringe upon any patent or other rights not vested in YALE.
12.02 Yale represents and warrants that to the best of its knowledge it
is the sole and exclusive owner of all title, right and interest in the LICENSED
TECHNOLOGY, free of any claims, restrictions or encumbrances whatsoever. YALE
DISCLAIMS ALL OTHER WARRANTIES WHATSOEVER, WITH RESPECT TO THE LICENSED PATENTS,
THE INVENTION, THE LICENSED TECHNOLOGY, AND THE LICENSED PRODUCTS, EITHER
EXPRESS OR IMPLIED, INCLUDING WARRANTIES AS TO THE MERCHANTABILITY OR FITNESS OF
THE LICENSED PRODUCTS FOR A PARTICULAR PURPOSE and LICENSEE shall make no
statements, representations or warranties whatsoever to any third parties which
are inconsistent with such disclaimer by YALE.
12.03 With the exception of infringement claims or actions covered by
ARTICLE IX, LICENSEE shall defend, indemnify and hold harmless YALE, its
fellows, officers, employees, and agents, from and against any and all claims,
demands, damages, losses and expenses of any nature (including attorney's fees),
including, but not limited to death, personal injury, illness, property damage
or products liability arising from or in connection with any of the following:
(i) the use by LICENSEE of any method or process related to the
LICENSED PATENTS; or
(ii) any use, sale or other disposition on any of the LICENSED
PRODUCTS by LICENSEE and/or other transferees or any statement, representation
or warranty of LICENSEE or other transferees with respect thereto; or
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(iii) the use of the LICENSED PRODUCTS by any person.
YALE shall reasonably cooperate with LICENSEE in defending any such claim. YALE
shall be entitled to receive information regarding the status of any such matter
and shall be entitled to retain counsel on its own behalf and at its sole
expense, in addition to counsel retained by LICENSEE to defend YALE, if YALE is
named party and if YALE is not satisfied with the defense provided by LICENSEE
for any reason.
12.04 LICENSEE shall purchase and maintain in effect or shall require
its sublicensees to purchase and maintain in effect a policy of products
liability insurance covering all claims with respect to any LICENSED PRODUCTS
manufactured or sold within the term of any license granted hereunder, which
policy shall i) be in such form and amount of coverage and written by such
company as YALE shall approve, ii) provide that such policy is primary and not
excess or contributory with regard to other insurance YALE may have, iii)
provide at least 30 days' notice to YALE of cancellation, and iv) include YALE
and YALE's directors, officers and employees, as additional named insureds.
LICENSEE shall furnish a copy of such insurance policy to YALE on or before the
date of first sale or use of any LICENSED PRODUCTS.
12.05 EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED FOR IN THIS AGREEMENT,
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INDIRECT,
INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, EVEN IF NOTIFIED BY THE OTHER
PARTY OF SUCH DAMAGES OR THE POTENTIAL THEREFOR.
ARTICLE XIII NOTICES
Any notice required by this Agreement shall be sent by Registered or
Certified U.S. Mail, or by confirmed telefacsimile transmission, telex or cable
and shall be deemed delivered if sent to the following addresses of the
respective parties or such other address as is furnished by proper notice to the
other party:
FOR YALE: FOR LICENSEE:
--------- -------------
YALE UNIVERSITY ONCORPHARM, Inc.
Director President
Office of Cooperative Research 000 Xxxxx Xxxxxxx
000 Xxxxxx Xx., Xxxxx 000 Xxxxxxxxxxxx, XX 00000
Xxx Xxxxx, XX 00000 Fax No.: (000) 000-0000
Fax No.: (000) 000-0000
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With a copy to:
---------------
Xxxxxxx, Xxxxxxx & Xxxxxxxx, LLP
0000 Xxxxxx xx xxx Xxxxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxx X. Xxxxxxxxx, Esq.
Fax No.: (000) 000-0000
ARTICLE XIV LAWS AND REGULATIONS
LICENSEE shall comply with all foreign and United States federal, state,
and local laws, regulations, rules and orders applicable to the testing,
production, transportation, packaging, labeling, export, sale and use of the
LICENSED PRODUCTS. In particular, LICENSEE shall be responsible for assuring
compliance with all U.S. export laws and regulations applicable to this license
and LICENSEE's activities hereunder.
ARTICLE XV MISCELLANEOUS
15.01 Any delays in or failure by either party in performance of any
obligations hereunder shall be excused if and to the extent caused by such
occurrences beyond such party's reasonable control, including but not limited to
such occurrences as acts of God, strikes or other labor disturbances, war, and
other causes which cannot reasonably be controlled by the party who failed to
perform.
15.02 This Agreement may not be amended except by written agreement
signed by both of the parties, and shall not be assigned by LICENSEE except upon
the advance written consent of YALE. This Agreement constitutes the entire
agreement of the parties relating to the subject matter hereof, and all prior
representations and understandings are merged into and superseded hereby.
15.03 This Agreement shall be governed by and in accordance with the
laws of the State of Connecticut except where the federal laws of the United
States are applicable and have precedence.
15.04 The provisions of the Agreement shall be deemed separable. If any
part of this Agreement is rendered void, invalid, or unenforceable, such shall
not affect the validity or enforceability of the remainder of this Agreement
unless the part or parts which are void, invalid or unenforceable shall
substantially impair the value of the entire Agreement as to either party.
15.05 This Agreement may be assigned by LICENSEE as part of its entire
business relating to a LICENSED PRODUCT, provided LICENSEE remains liable for
all obligations hereunder. LICENSEE may also assign its rights and benefits
under this Agreement if YALE approves the assignment in writing, which approval
shall not be unreasonably
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withheld. In the event of such transfer, the transferee shall assume and be
bound by the provisions of this Agreement. It shall not be deemed unreasonable
for YALE to refuse approval of an assignment on the ground that the assignee
does not have the financial or administrative resources and experience to carry
out the obligations of this Agreement or that the LICENSEE will not remain
responsible on an ongoing basis for performance by the assignee company.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate originals by their duly authorized representatives.
YALE UNIVERSITY ONCORPHARM, INC.
By: /s/ Xxxxx X. Xxxxxxxx By: /s/ Xxxxxxx Xxxxxx
------------------------ ------------------------
Xxxxxxx Xxxxxx
Its: Associate V.P. Its: President
for Finance -----------------------
-----------------------
Date: January , 1995 Date: January , 1995
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