Exhibit 10.5
EXECUTION COPY
Collaborative Research Agreement
by and among
Xxxxx Xxxxxxx University,
Oncor, Inc.
and
OncorPharm, Inc.
EXECUTION COPY
COLLABORATIVE RESEARCH AGREEMENT
THIS AGREEMENT (this "Agreement"), effective as of the 6th day of
March, 1996 (the "EFFECTIVE DATE") by and among ONCOR, INC., a corporation of
the State of Maryland, having a place of business at 000 Xxxxx Xxxxxxx,
Xxxxxxxxxxxx, XX 00000 (herein referred to as "ONCOR"), ONCORPHARM, INC., a
corporation of the State of Delaware, having a place of business at 000 Xxxxx
Xxxxxxx, Xxxxxxxxxxxx, XX 00000 (herein referred to as "ONCORPHARM") and THE
XXXXX XXXXXXX UNIVERSITY, a corporation of the State of Maryland, having a
School of Medicine at 0000 Xxxx Xxxxxxxx Xxxxxx, Xxxxx 0-000, Xxxxxxxxx, XX
00000 (herein referred to as "XXXXXXX")
WITNESSETH THAT
WHEREAS, Xx. Xxxx Xxxxxxxxx and his colleagues in his laboratory at
XXXXXXX, have made certain discoveries and conceived of certain inventions
relating to the Trp64Arg allele of the beta-3 adrenergic receptor (the "Trp64Arg
Allele"), and possess valuable research materials, skills, know-how and
technical information in this area;
WHEREAS, ONCOR, possesses resources of a financial and technical
nature, capabilities and expertise in microbiology, organic chemistry, DNA probe
development, DNA library construction, physical and genetic mapping,
manufacturing and sales and marketing in the United States and in foreign
countries, which are valuable and necessary in developing and commercializing
diagnostic and related products;
WHEREAS, ONCORPHARM, possesses resources of a financial and
technical nature, capabilities and expertise in microbiology, organic chemistry,
gene repair and gene-based drug delivery product development, and sales and
marketing in the United States and in foreign countries which are valuable and
necessary in developing and commercializing therapeutic and related products;
WHEREAS, ONCORPHARM, ONCOR and XXXXXXX desire to engage in
collaborative research in relation to the Trp64Arg Allele, with XXXXXXX
participation being through the work of Xx. Xxxx Xxxxxxxxx and his colleagues,
on the basis of the terms and conditions set forth in this Agreement; and
WHEREAS, the parties are also entering into certain license
agreements of even date herewith, pursuant to which ONCOR and ONCORPHARM shall
have exclusive rights to develop and commercialize existing and future
inventions and technologies
-1-
EXECUTION COPY
relating to the Trp64Arg allele of the beta-3 adrenergic receptor.
NOW, THEREFORE, in consideration of the promises and mutual
covenants and obligations herein contained, the parties hereto, intending to be
legally bound, agree as follows:
ARTICLE 1. DEFINITIONS
1.1 AFFILIATE(S) shall mean (a) any company owned or controlled to the
extent of at least fifty percent (50%) of its issued and voting
capital by a party to this Agreement and any other company so owned
or controlled (directly or indirectly) by any such company or the
owner of any such company, or (b) any partnership, joint venture or
other entity directly or indirectly controlled by, controlling, or
under common control of, to the extent of fifty percent (50%) or
more of voting power (or otherwise having power to control its
general activities), a party to this Agreement, but in each case
only for so long as such ownership or control shall continue.
1.2 CONFIDENTIAL INFORMATION shall mean any information, including
RESEARCH INFORMATION, that ONCOR, ONCORPHARM or XXXXXXX considers to
be confidential and which is so marked at the time it is transmitted
to the receiving party, or, if transmitted in oral form, is
confirmed as confidential in written summary form within a
reasonable period of time. Notwithstanding a disclosing party's
claim that certain information is confidential, CONFIDENTIAL
INFORMATION shall not include:
(a) Information which the receiving party can show by
written records was in the receiving party's possession
prior to the disclosure; or
(b) Information that either now or in the future appears in
issued patents or printed publications, or otherwise
becomes part of the public knowledge or literature, not
as a result of any action or inaction of the receiving
party;
-2-
EXECUTION COPY
(c) Information that is received by the receiving party from
a third party through channels independent of the
disclosing party; or
(d) Information independently developed by the receiving
party without use of any of the CONFIDENTIAL INFORMATION
of the disclosing party.
1.3 XXXXXXX shall mean THE XXXXX XXXXXXX UNIVERSITY.
1.4 INVENTION(S) shall mean (i) the inventions described in the PATENT
APPLICATION or in any continuation, continuation-in-part, division,
reissue, reexamination, extension or any other government actions
which extend any of the subject matter of the PATENT APPLICATION or
in any corresponding foreign patent application, and (ii) any
existing or future discovery or invention first conceived or first
actually reduced to practice in connection with or relating to the
performance of the RESEARCH PROJECT. For purposes of this Agreement
the determination of "first conceived" and "first actually reduced
to practice" shall be governed by U.S. law. INVENTION(S) shall
include discoveries and inventions which are not patentable or
patented, including but not limited to trade secrets, copyright
material or other protectable intellectual property. Without
limiting the generality of the foregoing, INVENTION(S) may include
know-how procedures, technical information, any processes,
composition, device, formula, protocol, technique, design, drawing
methodology, technical and scientific expertise and biological or
chemical materials.
1.5 JOINT INVENTION(S) shall mean any INVENTION first conceived or first
actually reduced to practice jointly by an employee of ONCOR and/or
ONCORPHARM and an employee or student of XXXXXXX listed in Appendix
B hereof, in connection with the RESEARCH PROJECT.
1.6 LICENSE AGREEMENTS shall mean (i) that certain license agreement of
even date herewith between XXXXXXX and ONCOR a copy of which is
attached hereto as Appendix C and (ii) that certain license
agreement of even date herewith between XXXXXXX and ONCORPHARM a
copy of which is attached hereto as Appendix D.
1.7 ONCOR shall mean ONCOR, INC., and its AFFILIATES.
-3-
EXECUTION COPY
1.8 ONCOR INVENTION(S) shall mean any INVENTION first conceived or first
actually reduced to practice solely by an employee of ONCOR.
1.9 ONCOR LICENSE shall mean that certain license agreement of even date
herewith between XXXXXXX and ONCOR a copy of which is attached
hereto as Appendix C.
1.10 ONCORPHARM shall mean ONCORPHARM, INC., and its AFFILIATES.
1.11 ONCORPHARM INVENTION(S) shall mean any INVENTION first conceived or
first actually reduced to practice solely by an employee of
ONCORPHARM.
1.12 ONCORPHARM LICENSE shall mean that certain license agreement of even
date herewith between XXXXXXX and ONCORPHARM a copy of which is
attached hereto as Appendix D.
1.13 OPTION AGREEMENT shall mean that certain Stock Option Agreement of
even date herewith, by and between XXXXXXX and ONCORPHARM.
1.14 PATENT APPLICATION shall mean *
1.15 PRODUCT shall mean a product incorporating any INVENTION.
1.16 RESEARCH PLAN shall mean the research plan attached hereto as
Appendix A.
1.17 RESEARCH INFORMATION shall mean data, information and results that
are obtained as a result of the RESEARCH PROJECT, including
know-how, procedures, methodology, technical and scientific
expertise and biological or chemical materials, but excluding any
such items which are included in the definition of INVENTION(S).
1.18 RESEARCH PROJECT shall mean the collaborative research program
between XXXXXXX, ONCORPHARM and ONCOR described and funded in
accordance with this Agreement.
-4-
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
1.19 RESEARCH PROJECT TERM shall mean the period from the EFFECTIVE DATE
of this Agreement to the date three years thereafter, subject to any
extensions that may be agreed between the parties in accordance with
the terms hereof, and subject to any early termination in accordance
with Article 6 hereof.
1.20 STOCK PURCHASE AGREEMENT shall mean that certain Stock Purchase
Agreement of even date herewith, by and among XXXXXXX and ONCOR.
1.21 THIRD PARTY(IES) shall mean any party other than a party of this
Agreement or an AFFILIATE of one of the parties.
1.22 UNIVERSITY INVENTION(S) shall mean any INVENTION first conceived or
first actually reduced to practice solely by an employee or student
of XXXXXXX listed in Appendix B hereto. Appendix B shall be updated
from time to time to include all employees and students engaged in
research in the laboratory of Xx. Xxxx Xxxxxxxxx and those other
employees and students participating in the RESEARCH PROJECT.
ARTICLE 2. THE RESEARCH PROJECT
2.1 The parties respective obligations under this Agreement are
conditioned upon the execution of the LICENSE AGREEMENTS by XXXXXXX.
2.2 After execution of the LICENSE AGREEMENTS, ONCOR, ONCORPHARM and
XXXXXXX shall carry out the RESEARCH PROJECT in accordance with the
RESEARCH PLAN attached hereto as Appendix A, which defines the
primary responsibilities of each party. Appendix B sets forth
details of the research staff at Xx. Xxxxxxxxx'x laboratory that
shall be involved in the RESEARCH PROJECT. Appendix A and Appendix B
shall be modified in good faith by the parties from time to time to
accommodate changes in the RESEARCH PROJECT and the XXXXXXX
employees and students participating in the RESEARCH PROJECT;
provided, however, that such modifications to either Appendix A or
Appendix B shall only become effective through a written amendment
to this Agreement executed by all of the parties hereto.
2.3 ONCOR, ONCORPHARM and XXXXXXX shall allocate human resources to
their respective responsibilities to
-5-
EXECUTION COPY
conduct the RESEARCH PROJECT substantially as set forth in the
guidelines in the RESEARCH PLAN.
2.4 The parties shall use best efforts to carry out their respective
responsibilities in the RESEARCH PROJECT. While the RESEARCH PLAN
attached hereto as Appendix A is substantially controlling, it is
understood that the parties shall cooperate and render research and
clinical trials assistance to each other, including making their
respective personnel available at reasonable times, in order to
expedite carrying out the RESEARCH PROJECT efficiently and avoiding
unwarranted duplication and e,xpenditure of effort.
2.5 The principal scientists or investigators who will direct the
performance of the respective responsibilities of each party are,
unless the parties otherwise agree, for XXXXXXX: Xx. Xxxx Xxxxxxxxx;
for ONCOR: Xx. Xxxxxx Xxxxxx; and for ONCORPHARM: Xx. Xxx Xxxxxx.
All RESEARCH INFORMATION disclosed pursuant to this Agreement, and
all other communications concerning the RESEARCH PROJECT shall be
directed to said principal scientists.
2.6 XXXXXXX shall use its reasonable efforts to participate with ONCOR
and ONCORPHARM in clinical trials relating to PRODUCTS subsequent to
the RESEARCH PROJECT. The parties shall separately negotiate in good
faith the terms and conditions of such subsequent clinical trials.
The parties acknowledge the value of using XXXXXXX for such clinical
trials.
ARTICLE 3. FUNDING
3.1 a) ONCORPHARM shall fund the RESEARCH PROJECT at XXXXXXX by paying
XXXXXXX the amount of * per quarter over the RESEARCH PROJECT TERM.
b) ONCOR shall fund the RESEARCH PROJECT at XXXXXXX by paying
XXXXXXX the amount of * per quarter over the RESEARCH PROJECT
TERM.
3.2 The cash payments specified in Paragraphs 3.1 a) and b) shall be
made in quarterly installments with the first quarterly payment
being made upon execution of this Agreement and the remaining
quarterly payments being
-6-
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
made at the beginning of each quarterly period thereafter.
ARTICLE 4. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
4.1 During the term of this Agreement, the parties shall timely and
fully exchange RESEARCH INFORMATION. To facilitate such exchanges,
the parties shall agree upon mutually acceptable means of
accomplishing such end, which means shall include joint meetings at
least twice in every one (1) year period of the RESEARCH PROJECT
TERM. Such joint meetings shall be held alternately at XXXXXXX
facilities or at ONCOR or ONCORPHARM facilities, or at such other
locations as may be mutually agreed upon. About two (2) weeks prior
to each such joint meeting, the parties shall exchange written
reports concerning the RESEARCH PROJECT. All costs incurred in
undertaking all communications relating to the RESEARCH PROJECT
shall be borne by the party incurring such costs. ONCORPHARM shall
reimburse XXXXXXX for reasonable travel costs to ONCOR or ONCORPHARM
facilities or other locations selected by ONCOR or ONCORPHARM.
4.2 While the Agreement is in effect, and for five (5) years thereafter,
XXXXXXX, ONCORPHARM and ONCOR shall employ the same efforts as they
use to protect their own proprietary information to maintain as
confidential and to not reveal or disclose to THIRD PARTIES any
CONFIDENTIAL INFORMATION received under this Agreement from the
disclosing party without first obtaining the written consent of the
disclosing party, except as provided in Paragraphs 4.3, 4.5 and 4.6
of this Agreement, or except as follows: (1) subject to any license
agreement as may be required for purposes of investigating,
manufacturing and marketing PRODUCTS, (2) as required for securing
essential or desirable authorizations, privileges or rights from
governmental agencies, (3) as required to be disclosed to a
governmental agency, (4) as is necessary to file or prosecute patent
applications, (5) as is necessary to carry out any litigation
concerning PRODUCTS, or (6) as is necessary to comply with current
"The Xxxxx Xxxxxxx University Guidelines and Policies for Technology
Transfer," or as amended in the future consistently for all
licensees in a manner not materially adverse to ONCOR or ONCORPHARM.
The parties shall take reasonable measures to assure that no
unauthorized use or
-7-
EXECUTION COPY
disclosure is made by others to whom access to such information is
granted.
4.3 Nothing herein shall be construed as preventing ONCOR or ONCORPHARM
from disclosing any information received from XXXXXXX to an
AFFILIATE or to a sublicensee, provided such AFFILIATE or
sublicensee has undertaken a similar obligation of confidentiality
with respect to the CONFIDENTIAL INFORMATION.
4.4 XXXXXXX hereby agrees that no RESEARCH INFORMATION shall be
disclosed or delivered to any third party without ONCOR's and
ONCORPHARM's prior written consent, which consent shall not be
unreasonably withheld for non-profit purposes. In the event that
ONCOR and ONCORPHARM consent to a disclosure or delivery of RESEARCH
INFORMATION to a third party, such transfer of the RESEARCH
INFORMATION shall be governed by such protective measures as ONCOR
and ONCORPHARM deem necessary to protect the respective rights,
title and interests of XXXXXXX, ONCOR and ONCORPHARM, which may
include, but are not limited to, confidentiality obligations being
imposed on the third party and the execution of a Material Transfer
Agreement. Notwithstanding the foregoing, XXXXXXX may provide
biological or chemical materials which it develops internally and
does not receive in whole or in part from either ONCOR or
ONCORPHARM, to third parties for not-for-profit activities provided
that in each case a Material Transfer Agreement substantially in the
same form as the one attached hereto as Appendix E is executed by
XXXXXXX and the third party. In the event that XXXXXXX desires to
use a substantially different form of Material Transfer Agreement or
desires to provide biological or chemical materials to a third party
for for-profit activities, or desires to provide biological or
chemical materials that it has received from ONCOR or ONCORPHARM to
a third party for any purpose, XXXXXXX shall require the prior
written consent of ONCOR and ONCORPHARM. In the event such consent
is forthcoming, XXXXXXX shall use such form of Material Transfer
Agreement as shall be agreed upon by all of the parties to this
Agreement and the third party receiving the biological or chemical
materials.
4.5 No publication, public announcement, press release or other
disclosure for publicity or promotional purposes shall be made,
either directly or indirectly, by any party to this Agreement,
except as may be legally
-8-
EXECUTION COPY
required, without first obtaining the written approval of the other
parties and agreement upon the nature and text of such announcement
or disclosure. All academic publications shall also be subject to
the provisions of Section 4.6 hereof. It is the intention of the
parties to mutually approve as soon as practicable release of
information regarding the relationship of the parties under this
Agreement. The party desiring to make any such public announcement
or other disclosure (including disclosure in documents relating to
the raising of capital financing and filings with the Securities and
Exchange Commission) shall use its best efforts to inform the other
parties of the proposed announcement or disclosure in sufficient
time prior to public release, and shall use its best efforts to
provide the other parties with a written copy thereof, in order to
allow such other parties to comment upon such announcement or
disclosure. This restriction does not apply to the dissemination of
information that has previously been approved and released in
writing by the parties in accordance with this paragraph.
4.6 Xx. Xxx Xxxxxx, principal scientist at ONCORPHARM, Xx. Xxxxxx
Xxxxxx, principal scientist at ONCOR, and Xx. Xxxx Xxxxxxxxx,
principal scientist at XXXXXXX and any employees or students of
ONCORPHARM, ONCOR or XXXXXXX participating in the RESEARCH PROJECT
may publish, in writing or orally, any manuscript or abstract
containing their RESEARCH INFORMATION or CONFIDENTIAL INFORMATION
provided that they first submit such proposed publication to each of
ONCORPHARM, ONCOR and XXXXXXX to determine the need to delay
submission of the proposed publication for filing of appropriate
patent applications. Neither ONCORPHARM, ONCOR nor XXXXXXX nor their
principal scientists nor any other employees or students
participating in the RESEARCH PROJECT shall submit for written or
oral publication any manuscript, abstract or the like which includes
RESEARCH INFORMATION or CONFIDENTIAL INFORMATION generated or
provided by one or more of the other parties without first obtaining
the prior written consent of the other parties, which consent shall
not be unreasonably withheld. Such consent shall be provided within
thirty (30) days of receipt of the proposed publication unless it is
necessary to delay publication for filing of appropriate patent
applications. If the submitting party has not received a response
from at least one of the parties reviewing the proposed publication
within thirty (30) days of
-9-
EXECUTION COPY
receipt, the submitting party may proceed with making the written or
oral publication. Delay for filing of patent applications shall not
exceed one hundred twenty (120) days from receipt of the proposed
publication.
ARTICLE 5. INVENTIONS AND PATENTS
5.1 a) Each party shall have and retain sole and exclusive title to all
INVENTIONS and RESEARCH INFORMATION which are made, conceived,
reduced to practice or generated solely by its employees or agents
arising in the course of or as a result of the RESEARCH PROJECT.
ONCOR and XXXXXXX shall own a fifty percent (50%) undivided interest
in all INVENTIONS and RESEARCH INFORMATION arising in the course of
or as a result of the RESEARCH PROJECT which are made, conceived,
reduced to practice or generated jointly by their employees or
agents. ONCORPHARM and XXXXXXX shall own a fifty percent (50%)
undivided interest in all INVENTIONS and RESEARCH INFORMATION
arising in the course of or as a result of the RESEARCH PROJECT
which are made, conceived, reduced to practice or generated jointly
by their employees or agents. In the event that an INVENTION or
RESEARCH INFORMATION is made, conceived, reduced to practice or
generated in the course of or as a result of the RESEARCH PROJECT by
employees or agents of each of ONCOR, ONCORPHARM and XXXXXXX, then
each party shall own a one-third undivided interest in such
INVENTION or RESEARCH INFORMATION.
b) All INVENTIONS and RESEARCH INFORMATION reduced to practice or
generated in the course of or as a result of the RESEARCH PROJECT
shall be subject to the licenses granted by and the other terms and
conditions of the LICENSE AGREEMENTS.
c) XXXXXXX shall have a fully paid-up non-exclusive license to
RESEARCH INFORMATION owned solely by ONCOR or ONCORPHARM or jointly
with XXXXXXX for noncommercial academic research purposes only.
5.2 ONCOR shall have the sole right, at its own expense, prepare, file,
prosecute and maintain patent applications and patents relating to
INVENTIONS in which ONCOR is the sole inventor and in which input
will be provided by XXXXXXX, if so requested by ONCOR. ONCORPHARM
shall have the sole right, at its own expense, to prepare, file,
prosecute and maintain patent applications and patents relating to
INVENTIONS to
-10-
EXECUTION COPY
in which ONCORPHARM is the sole inventor and in which input will be
provided by XXXXXXX, if so requested by ONCORPHARM. For JOINT
INVENTIONS, XXXXXXX will assist ONCORPHARM in the preparation of the
patent applications and patent filings but ONCORPHARM will have the
primary responsibility for completing the patent applications and
the patent filings, at ONCORPHARM'S expense. For UNIVERSITY
INVENTIONS, XXXXXXX will draft the initial patent applications with
ONCORPHARM'S input. XXXXXXX will have the responsibility for
completing patent applications and perfecting the patent filings for
UNIVERSITY INVENTIONS, with ONCORPHARM'S continued participation and
with ONCORPHARM bearing the reasonable expenses thereof. Such
reasonable expenses may include reasonable patent attorney fees and
all filing and maintenance fees. However, ONCORPHARM shall not be
obligated to pay XXXXXXX for any time spent by XXXXXXX employees or
students in relation to preparing, filing, maintaining or
prosecuting patents and patent applications.
5.3 For UNIVERSITY INVENTIONS and countries where XXXXXXX elects not to
prepare and file patent applications, XXXXXXX shall notify
ONCORPHARM and ONCORPHARM may file patent applications at
ONCORPHARM'S expense.
5.4 If subsequent to filing a patent application on a UNIVERSITY
INVENTION or JOINT INVENTION, ONCORPHARM elects not to prosecute or
maintain such patent application or ensuing patent or fund such
prosecution, filing or maintenance by XXXXXXX, ONCORPHARM shall give
XXXXXXX notice thereof within a reasonable period prior to allowing
such patent application or patent to lapse or become abandoned or
unenforceable and XXXXXXX may continue prosecution or maintenance of
such patent application or patent at its expense and its exclusive
benefit. In such an event ONCORPHARM shall no longer be licensed
under such patent application or patent. If subsequent to filing of
a U.S. patent application, ONCORPHARM chooses not to file in foreign
countries, ONCORPHARM shall inform XXXXXXX within eight (8) months
of the U.S. filing date and shall permit XXXXXXX to effect such
foreign filings at its expense. In such an event ONCORPHARM shall
not be licensed under any foreign filings effected by XXXXXXX at
XXXXXXX' expense.
-11-
EXECUTION COPY
5.5 XXXXXXX shall, at its own expense, provide reasonable and prompt
assistance to ONCORPHARM to facilitate filing of all patent
applications covering JOINT INVENTIONS and shall obtain agreements
from its employees and students to execute all documents deemed
necessary or desirable therefor.
5.6 Since XXXXXXX may use U.S. government funding to help perform work
related to the RESEARCH, the license to UNIVERSITY INVENTIONS and
XXXXXXX' interest in JOINT INVENTIONS pursuant to Paragraph 5.1 may
be subject to non-exclusive license and other rights granted to the
U.S. government under such funding agreements for use for
governmental purposes or march-in rights. Should XXXXXXX utilize
biological material during the RESEARCH PROJECT obtained from a
THIRD PARTY, ONCOR's and ONCORPHARM's rights pursuant to Paragraph
5.1 are subject to rights due such THIRD PARTY under a material
transfer agreement, provided that XXXXXXX shall first try to obtain
such material from ONCOR and ONCORPHARM and failing that, obtain
ONCOR's and ONCORPHARM's prior written consent prior to entering
into any such material transfer agreement which should adversely
affect ONCOR's and ONCORPHARM's rights under Paragraph 5.1 or the
LICENSE AGREEMENTS, which consent of ONCOR and ONCORPHARM shall not
be unreasonably withheld. If employees or students of XXXXXXX other
than those listed in Appendix B become co-inventors of any
UNIVERSITY ONCORPHARM INVENTIONS or any JOINT INVENTIONS, XXXXXXX
shall use its reasonable efforts to include in the licenses granted
under the LICENSE AGREEMENTS the interests of such co-inventors,
subject to conflicting rights of THIRD PARTIES.
ARTICLE 6. TERM AND TERMINATION
6.1 Unless terminated as described below, the term of this Agreement
shall extend for three (3) years from the EFFECTIVE DATE of this
Agreement. The parties shall have the mutual option to extend the
term for one (1) year periods upon written amendment executed at
least sixty (60) days before the end of the current term.
6.2 If a party fails or neglects to perform covenants or provisions of
this Agreement and if such default is material to this Agreement
taken as a whole (an "Event of Default"), and not corrected within
sixty (60) days after receiving written notice from one of the
parties
-12-
EXECUTION COPY
with respect to such Event of Default, the party giving the notice
shall have the right to terminate this Agreement at any time by
giving a further written notice thereof to the other parties.
6.3 If Xx. Xxxxxxxxx leaves XXXXXXX during the term of this Agreement,
and is not replaced within sixty (60) days thereafter with a
principal scientist or investigator acceptable to ONCOR and
ONCORPHARM in their sole discretion, ONCOR and ONCORPHARM shall each
have the right to terminate this Agreement by written notice to
XXXXXXX (a "Scientist Notice").
6.4 If a party believes that the intended objectives of the RESEARCH
PROJECT are not being achieved because of lack of due performance by
one of the other parties (hereafter referred to as "Lack of
Diligence"), such party may, in writing, demand adequate assurance
of such due performance. If the party receiving such demand does not
provide such assurance in all material respects within sixty (60)
days after receiving such demand, the demanding party shall have the
right to terminate this Agreement at any time by giving written
notice thereof to the other parties.
6.5 If (i) any party believes that the results of the RESEARCH PROJECT
do not provide sufficient support for, or indicate a failure of, the
hypothesis set forth in the RESEARCH PLAN, or (ii) if the results of
the RESEARCH PROJECT demonstrate that the Trp64Arg Allele has an
insignificant effect or no effect in relation to obesity and/or
diabetes, or (iii) if the parties cannot agree on the future
direction or scope of the RESEARCH PROJECT, then any party may
terminate this Agreement in writing upon ninety (90) days' notice (a
"Research Direction Notice"). The parties agree to negotiate in good
faith during the ninety (90) day notice period as to whether the
RESEARCH PROJECT should be continued, and if it is, as to a mutually
satisfactory definition for the future direction and funding of the
RESEARCH PROJECT. If agreement over the continuation of the RESEARCH
PROJECT cannot be reached, this Agreement shall terminate at the end
of the ninety (90) day period. However, such termination will not
affect ONCOR's and ONCORPHARM's obligations to reimburse XXXXXXX
pursuant to Section 7.4 hereof.
6.6 If either or both of the LICENSE AGREEMENTS are terminated for any
reason whatsoever, then this
-13-
EXECUTION COPY
Agreement shall also terminate, subject to ONCOR's and ONCORPHARM's
respective options specified in Section 7.2 hereof.
ARTICLE 7. RIGHTS AND DUTIES UPON TERMINATION
7.1 In the event that ONCOR either commits an Event of Default, or
demonstrates a Lack of Diligence or issues a Scientist Notice or a
Research Direction Notice, and fails to cure the Event of Default or
Lack of Diligence or to withdraw the Scientist Notice or the
Research Direction Notice within the applicable time periods
provided by Article 6, ONCORPHARM shall have the right to undertake
ONCOR's obligations under this Agreement. In the event that
ONCORPHARM either commits an Event of Default, or demonstrates a
Lack of Diligence or issues a Scientist Notice or a Research
Direction Notice, and fails to cure the Event of Default or Lack of
Diligence or to withdraw the Scientist Notice or the Research
Direction Notice within the applicable time periods provided by
Article 6, ONCOR shall have the right to undertake ONCORPHARM's
obligations under this Agreement. In each case the party exercising
its option under this Section 7.1, shall give XXXXXXX written notice
of its election to undertake the obligations of the other party
within thirty (30) days of receiving written notice from XXXXXXX of
the failure of ONCOR or ONCORPHARM, as the case may be, within the
applicable time limits, to cure the Event of Default or Lack of
Diligence or to withdraw the Scientist Notice or the Research
Direction Notice.
7.2 In the event that the ONCOR LICENSE terminates for any reason and
the ONCORPHARM LICENSE remains effective, ONCORPHARM shall have the
right and option, but not obligation, to either (i) undertake
ONCOR's obligations under this Agreement, or (ii) undertake ONCOR's
obligations under this Agreement and the ONCOR LICENSE. In the event
that the ONCORPHARM LICENSE terminates for any reason and the ONCOR
LICENSE remains effective, ONCOR shall have the right and option,
but not the obligation, to either (i) undertake ONCORPHARM's
obligations under this Agreement, or (ii) undertake ONCORPHARM's
obligations under this Agreement and the ONCORPHARM LICENSE. In each
case the party exercising its option under this Section 7.2, shall
give XXXXXXX written notice of its election to undertake the
obligations of the other party within thirty (30) days
-14-
EXECUTION COPY
of receiving written notice of the termination of the ONCOR LICENSE
or ONCORPHARM LICENSE as the case may be.
7.3 Upon termination of this Agreement as a whole or in respect of one
party, each party shall be entitled, without limitation to other
remedies it may possess, to immediate return (to the extent
technically feasible) of all biological or chemical materials
included within RESEARCH INFORMATION furnished by it to the other
parties or to demand the destruction of such materials in the hands
of or subject to the control of the other parties.
7.4 Upon termination of this Agreement as a whole or in respect of one
party, XXXXXXX shall have the right to retain any sums already paid
by ONCOR and ONCORPHARM hereunder, except as otherwise specified. In
addition, in the event that (i) this Agreement is terminated by
either ONCOR or ONCORPHARM and the options set forth in Sections 7.1
and 7.2 are not exercised, or (ii) this Agreement is terminated
after an exercise of the options set forth in Section 7.1 or Section
7.2, ONCORPHARM shall continue to be responsible for and shall pay
to XXXXXXX the funding commitment under Paragraph 3.1 hereof for a
further period of six months from the date of termination (i.e.
ONCORPHARM shall make payments to XXXXXXX over the six months
following such a termination, which in the aggregate shall total
$124,438).
7.5 The obligations described in Paragraphs 4.2, 4.3, and 7.4, Article 5
and Article 9 shall continue to apply to any terminated party and
shall survive any expiration or termination of this Agreement as a
whole.
ARTICLE 8. WARRANTIES AND REPRESENTATIONS
8.1 Each party on whose behalf this Agreement is executed warrants that
it has the authorization to enter into this Agreement.
8.2 Each party warrants that, to the best of its knowledge and belief as
of the date of this Agreement, it has the right to use and dispose
of all RESEARCH INFORMATION, including biological and chemical
materials, as provided by this Agreement. XXXXXXX warrants that, to
the best of its knowledge and belief as of the date of this
Agreement, it has the right to grant the licenses
-15-
EXECUTION COPY
under the LICENSE AGREEMENTS and has not granted licenses or rights
in the PATENT RIGHTS (as defined in the LICENSE AGREEMENTS) that
would restrict the rights granted thereunder.
8.3 Except for the restrictions contemplated by Section 5.6 of this
Agreement, each party represents that, to the best of its knowledge,
each has the right to disclose or transfer to the other the RESEARCH
INFORMATION known to it as at the EFFECTIVE DATE of this Agreement,
as it pertains to these projects.
ARTICLE 9. INDEMNIFICATION
9.1 Each party shall indemnify the other parties and hold them harmless
from any suits, costs, charges or settlements thereof which may
result from its own negligent or wrongful actions during its
performance under this Agreement.
9.2 Each party agrees to indemnify and hold the other parties harmless
against any and all liability or loss suffered as a result of
negligence committed by its employees while conducting the RESEARCH
PROJECT under this Agreement, regardless in whose facilities such
employees are located. Each party shall promptly notify the other
parties of any hazard relating to the subject matter of the RESEARCH
PROJECT of which each is aware or subsequently becomes aware.
9.3 All of the above indemnification responsibilities in Paragraphs 9.1
and 9.2 shall survive the termination of this Agreement.
ARTICLE 10. RELATIONSHIP OF THE PARTIES
10.1 Nothing in this Agreement is intended or shall be deemed to
constitute a partnership, agency, employer-employee or joint venture
relationship between the parties. All activities by the parties
hereunder shall be provided as independent contractors. Neither
party shall incur any debts or make any commitments for the other
except to the extent, if at all, specifically provided herein.
-16-
EXECUTION COPY
ARTICLE 11. FORCE MAJEURE
11.1 If the performance of any part of this Agreement by a party is
prevented, restricted, interfered with or delayed by reason of any
cause beyond the reasonable control of the party liable to perform,
unless conclusive evidence to the contrary is provided, the party so
affected shall use its best efforts to avoid or remove such causes
of non-performance and shall continue performance with the utmost
dispatch whenever such causes are removed. When such circumstances
arise, the parties shall discuss what, if any, modification of the
terms of this Agreement may be required in order to arrive at an
equitable solution.
ARTICLE 12. GOVERNING LAW
12.1 This Agreement shall be deemed to have been made in the State of
Maryland and its form, execution, validity, construction and effect
shall be determined in accordance with the laws of the State of
Maryland.
ARTICLE 13. SEPARABILITY
13.1 In the event any portion of this Agreement shall be held illegal,
void or ineffective, the remaining portions hereof shall remain in
full force and effect, as long as it does not materially alter the
purpose and performance of this Agreement.
13.2 If any of the terms or provisions of this Agreement are in conflict
with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may
conflict therewith and shall be deemed to be modified to conform
with such statute or rule of law. In the event that the terms and
conditions of this Agreement are materially altered as a result of
this paragraph, the parties will renegotiate the terms and
conditions of this Agreement to resolve any inequities.
ARTICLE 14. ENTIRE AGREEMENT
14.1 This Agreement, the LICENSE AGREEMENTS, the OPTION AGREEMENT and the
STOCK PURCHASE AGREEMENT, constitute the entire agreement between
the parties relating to
-17-
EXECUTION COPY
the subject matter hereof and supersedes all previous writings and
understandings. No terms or provisions of this Agreement shall be
varied or modified by any prior or subsequent statement, conduct or
act of either of the parties, except that the parties may amend this
Agreement by written instruments specifically referring to and
executed in the same manner as this Agreement.
ARTICLE is. NOTICES
15.1 All notices pertaining to this Agreement shall be in writing and
sent by certified mail, return receipt requested, or by overnight
delivery via a nationally recognized overnight delivery service, to
the parties at the following addresses or such other address as such
party shall have furnished in writing to the other parties in
accordance with this Paragraph 15.1:
FOR XXXXXXX: The Xxxxx Xxxxxxx University
School of Medicine
000 Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: Xxxxxxx X. Xxxx
FOR ONCOR: Oncor, Inc.
000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx, Xxxxxxxx 00000
Attention: Mr. Xxxxxxx Xxxxxx
FOR ONCORPHARM: Oncorpharm, Inc.
000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Xx. Xxxxxxx Xxxx
A notice shall be deemed to have been received three (3) days after
deposit with the U.S. postal service if sent by certified mail, and
on the day after deposit with the delivery service, if sent by
overnight delivery.
-18-
EXECUTION COPY
ARTICLE 16. ASSIGNMENT
16.1 This Agreement may be assigned by ONCOR and/or ONCORPHARM to their
respective AFFILIATES or as part of a sale by such party of its
entire business relating to a PRODUCT, provided that the party so
assigning remains liable for all their obligations hereunder. ONCOR
and ONCORPHARM may also assign their respective rights and benefits
under this Agreement if XXXXXXX approves the assignment in writing,
which approval shall not be unreasonably withheld. In the event of
such transfer, the transferee shall assume and be bound by the
provisions of this Agreement. It shall be deemed to be reasonable if
ONCOR or ONCORPHARM assigns to a responsible company and agrees to
remain responsible on an ongoing basis for performance by the
assignee company. XXXXXXX may not assign this Agreement or the
PATENT APPLICATION.
ARTICLE 17. FURTHER AGREEMENTS
17.1 Each party hereto shall execute such further papers or agreements as
may be necessary to effect the purposes of this Agreement and carry
out its provisions.
[Remainder of this page intentionally left blank]
-19-
EXECUTION COPY
IN WITNESS WHEREOF the parties hereto have executed this
Collaborative Research Agreement by their duly authorized officers as of the
date first above written.
ONCOR, INC. ONCORPHARM, INC.
BY: /s/ Xxxxxxx Xxxxxx BY: /s/ Xxxxxxx X. Xxxx, Xx.
----------------------------- ---------------------------
NAME: /s/ Xxxxxxx Xxxxxx NAME: Xx. Xxxxxxx X. Xxxx, Xx.
--------------------------- ---------------------------
TITLE: CEO and Chairman TITLE: President and CEO
-------------------------- ---------------------------
THE XXXXX XXXXXXX UNIVERSITY
BY: /s/ Xxxxx X. Xxxxx
-----------------------------
NAME: Xxxxx X. Xxxxx
---------------------------
TITLE: Executive Vice Xxxx
--------------------------
I have read and agreed to abide by the terms of this Agreement.
By /s/ Xxxx Xxxxxxxxx
-----------------------------
Xx. Xxxx Xxxxxxxxx
By /s/ Xxxxxx Xxxxxxx
-----------------------------
Xx. Xxxxxx Xxxxxxx
By /s/ Xxxxxx Silver
-----------------------------
Dr. Xxxxxx Silver
By /s/ Xxxxx Xxxx
-----------------------------
Xx. Xxxxx Xxxx
-20-
EXECUTION COPY
APPENDIX A
RESEARCH PLAN
*
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
APPENDIX B
RESEARCH STAFF AT XX. XXXXXXXXX'X LABORATORY
Xxxxxx Xxxxxxx, M.D.
Xxxxxx Silver, M.D.
Xxxxx Xxxxxx, M.D.
Xxxxxxx Xxxxxx, M.D.
Xxxxx Xxxxxx
Yuf eng Yang
Clinical Coordinator - to be named
Research Assistant - to be named
EXECUTION COPY
APPENDIX C
ONCOR LICENSE AGREEMENT
EXECUTION COPY
LICENSE AGREEMENT
This License Agreement (the or this "Agreement" or "License"),
effective this 6th day of March, 1996, is between The Xxxxx Xxxxxxx University,
a corporation of the State of Maryland, having a principal place of business at
0000 Xxxx Xxxxxxxx Xxxxxx, Xxxxx 0-000, Xxxxxxxxx, XX 00000 (hereinafter
referred to as "University") and Oncor, Inc., a corporation, having a principal
place of business at 000 Xxxxx Xxxxxxx, Xxxxxxxxxxxx, XX 00000 (hereinafter
"Company").
WITNESSETH:
WHEREAS, University, the Company and the Company's subsidiary,
Oncorpharm, Inc. ("Oncorpharm"), are concurrently herewith entering into that
certain Collaborative Research Agreement (the "CRA"), pursuant to which
OncorPharm and the Company will fund certain clinical investigations and other
studies by the University related to the Trp64Arg Adrenergic Receptor Allele
("Trp64Arg Allele");
WHEREAS, as a center for research and education, University is
interested in licensing PATENT RIGHTS and TECHNOLOGY RIGHTS (both hereinafter
defined) in a manner that will benefit the public by facilitating the
distribution of useful products and the utilization of new methods, but is
without capacity to commercially develop, manufacture, and distribute any such
products or methods; and
WHEREAS, PATENT RIGHTS include*
WHEREAS, University has acquired through assignment all right, title
and interest, with the exception of certain retained rights by the United States
government, in all the PATENT RIGHTS and TECHNOLOGY RIGHTS existing at the date
hereof, including but not limited to, the rights of the Inventors; and
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
WHEREAS, the University is interested in licensing any PATENT RIGHTS
and TECHNOLOGY RIGHTS that it may acquire in the future, including but not
limited to those of the Inventors, subject to any required retained rights of
the U.S. Government; and
WHEREAS, Company desires to commercially develop, manufacture, use
and distribute products and processes based on such PATENT RIGHTS and TECHNOLOGY
RIGHTS, throughout the world, for all uses except use as a prophylactic or
therapeutic.
NOW, THEREFORE, in consideration of the foregoing premises and the
following mutual covenants, and other good and valuable consideration, the
receipt of which is hereby acknowledged, and intending to be legally bound
hereby, the parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 AFFILIATED COMPANY shall mean (a) any company owned or controlled to
the extent of at least fifty percent (50%) of its issued and voting capital by a
party to this Agreement and any other company so owned or controlled (directly
or indirectly) by any such company or the owner of any such company, or (b) any
partnership, joint venture or other entity directly or indirectly controlled by,
controlling, or under common control of, to the extent of fifty percent (50%) or
more of voting power (or otherwise having power to control its general
activities), a party to this Agreement, but in each case only for so long as
such ownership or control shall continue.
1.2 EFFECTIVE DATE shall mean the effective date of this Agreement, as
first above written.
1.3 EXCLUSIVE LICENSE shall mean a license to UNIVERSITY INVENTIONS and
TECHNOLOGY RIGHTS, and a license of University's right, title and interest in
and to JOINT INVENTIONS, whereby Company's rights are sole and entire and
operate to exclude all others, subject to rights retained by the United States
government in accordance with P.L. 96-517, as amended by P.L. 98-620, and
subject to the retained right of University (i) to make, have made, provide and
use for its and The Xxxxx Xxxxxxx University Health Systems' non-profit purposes
LICENSED PRODUCTS and LICENSED PROCESSES and (ii) to use, distribute and
disclose RESEARCH INFORMATION for non-profit purposes subject to compliance with
Article 4 of the CRA.
1.4 FDA shall mean the United States Food and Drug Administration.
-2-
EXECUTION COPY
1.5 INVENTION(S) shall mean (i) the inventions described in the PATENT
APPLICATION or in any continuation, continuation-in-part, division or reissue of
the PATENT APPLICATION or in any corresponding foreign patent application, and
(ii) any existing or future discovery or invention first conceived or first
actually reduced to practice in connection with or relating to the performance
of the RESEARCH PROJECT. For purposes of this Agreement the determination of
"first conceived" and "first actually reduced to practice" shall be governed by
U.S. law. INVENTION(S) shall include discoveries and inventions which are not
patentable or patented, including but not limited to trade secrets, copyright
material or other protectable intellectual property. Without limiting the
generality of the foregoing, INVENTION(S) may include know-how procedures,
technical information, any process, composition, device, formula, protocol,
technique, design, drawing methodology, technical and scientific expertise and
biological or chemical materials.
1.6 JOINT INVENTION(S) shall mean any INVENTION first conceived or first
actually reduced to practice jointly by an employee of Company or OncorPharm and
an employee or student of University listed in Appendix B of the CRA, in
connection with the RESEARCH PROJECT.
1.7 LICENSED PROCESSES shall mean all methods which are covered by any
claim of one or more PATENT RIGHTS or based upon or derived from TECHNOLOGY
RIGHTS.
1.8 LICENSED PRODUCTS shall mean all products, the manufacture, use or
sale of which is covered by any claim of one or more PATENT RIGHTS or based upon
or derived from TECHNOLOGY RIGHTS.
1.9 LICENSOR shall mean University.
1.10 NET SALES shall mean gross sales revenues and fees actually received
by Company or AFFILIATED COMPANY from the sale of LICENSED PRODUCTS and/or
LICENSED PROCESSES less trade discounts allowed, refunds, returns and recalls,
sales, V.A.T. and/or use taxes, duties and similar governmental assessments and
transportation, packing and shipping insurance actually paid by the seller. In
the event that Company or AFFILIATED COMPANY sells a LICENSED PRODUCT in
combination with other active ingredients or components which are not LICENSED
PRODUCTS ("Other Items"), the NET SALES for purposes of royalty payments on the
combination shall be calculated as follows:
(a) If all LICENSED PRODUCTS and Other Items contained in the
combination are available separately, the NET SALES for
-3-
EXECUTION COPY
purposes of royalty payments will be calculated by multiplying the NET SALES of
the combination by the fraction A/A+B, where A is the separately available price
of all LICENSED PRODUCTS in the combination, and B is the separately available
price for all Other Items in the combination.
(b) If the combination includes Other Items which are not sold
separately (but all LICENSED PRODUCTS contained in the combination are available
separately), the NET SALES for purposes of royalty payments will be calculated
by multiplying the NET SALES of the combination by A/C, where A is as defined
above and C is the invoiced price of the combination.
(c) If the LICENSED PRODUCTS contained in the combination are not
sold separately, the NET SALES for such combination shall be one half of the NET
SALES of such combination as defined in the first sentence of this Paragraph
1.9.
The term "Other Items" does not include solvents, diluents, carriers, excipients
or the like used in formulating a product.
1.11 ONCOR FIELD shall mean all uses for LICENSED PRODUCTS and LICENSED
PROCESSES, except use as a prophylactic or therapeutic. For the avoidance of any
doubt, but in no way limiting the foregoing, ONCOR FIELD shall include use of
LICENSED PRODUCTS and LICENSED PROCESSES for all diagnostic purposes.
1.12 ONCORPHARM LICENSE shall mean that certain license agreement of even
date herewith between University and Oncorpharm, relating to use of the LICENSED
PRODUCTS and LICENSED PROCESSES for prophylactic and therapeutic uses.
1.13 PATENT APPLICATION shall mean *
1.14 PATENT RIGHTS shall mean the following (a) PATENT APPLICATION, (b)
any other existing or future U.S. patent application claiming either a
UNIVERSITY INVENTION or a JOINT INVENTION (hereinafter FUTURE APPLICATION), (c)
any invention disclosed and claimed in the PATENT APPLICATION or the FUTURE
APPLICATIONS and (d) all continuations, continuations-in-part, divisions,
reissues, reexaminations, extensions or other governmental actions which extend
any of the subject matter of the PATENT APPLICATION or the FUTURE APPLICATIONS,
and any
-4-
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
corresponding foreign patent applications that may be filed in the future at
Company's request and expense and any patents, patents of addition, or other
equivalent foreign patent rights issuing, granted or registered on the PATENT
APPLICATION or the FUTURE APPLICATIONS.
1.15 RESEARCH INFORMATION shall mean data, information and results
included within the definition of INVENTION(S) that are obtained during the term
of the CRA from the RESEARCH PROJECT, including know-how, procedures,
methodology, technical and scientific expertise and biological or chemical
materials, but excluding any such items which are included in the definition of
PATENT RIGHTS.
1.16 RESEARCH PROJECT shall mean the collaborative research program
between University, the Company and OncorPharm described and funded in
accordance with the CRA.
1.17 STOCK PURCHASE AGREEMENT shall mean that certain Stock Purchase
Agreement of even date herewith, by and among the Company and the University.
1.18 SUBLICENSE INCOME shall mean the gross amount actually received by
either the Company or an AFFILIATED COMPANY, directly or indirectly, for or on
account of sublicenses of any of the rights granted hereunder, without deduction
of any kind, but excluding the following, in relation to which no payments shall
be due to the University:
(a) Payments received by either the Company or an AFFILIATED COMPANY
for performance of research and development by either the Company or an
AFFILIATED COMPANY to the extent that such payments cover the actual cost of the
research and development work;
(b) Investments made by a sublicensee in either the Company or an
AFFILIATED COMPANY to the extent that such investments are made at current
market value, including but not limited to, any payments or other consideration
representing the current market value of shares in the Company or an AFFILIATED
COMPANY;
(c) Payments made to either the Company or an AFFILIATED COMPANY to
the extent they cover the actual costs of conducting clinical testing and other
activities in connection with obtaining regulatory approval for a LICENSED
PRODUCT or LICENSED PROCESS;
(d) Reimbursed expenses of either the Company or an AFFILIATED
COMPANY.
-5-
EXECUTION COPY
For purposes of Subparagraph (b) above, the current market value of the
investment shall determined as follows: (i) it shall be determined as at the
earlier of (a) the date when the investment is made or (b) the day prior to the
date when the investment is first publicly disclosed on the Dow Xxxxx News Wire
(the "Determination Date"); (ii) if there is no public market for the Company's
securities that are being purchased by the sublicensee, then the current market
value shall be determined by the Company's Board of Directors in good faith, and
if University disputes such determination, the current market value shall be
determined by an independent investment banker whose fees shall be shared by the
Company and the University; (iii) if there is a public market for Company's
securities that are being purchased by the sublicensee, then the current market
value shall be determined using the average of the closing bid and asked prices
of the securities in the Over-The-Counter Market Summary or the closing price
quoted on any exchange on which the securities are listed as published in The
Wall Street Journal for the ten (10) trading days prior to the Determination
Date. Notwithstanding the following, in the event the sublicensee is purchasing
the Company's securities in connection with the Company's initial public
offering of such securities, the current market value shall be determined using
the offering price of such securities to the public in the Company's initial
public offering.
1.19 TECHNOLOGY RIGHTS shall mean LICENSOR'S rights in any and all
technical information, know-how, process, procedure, composition, device,
method, formula, protocol, technique, software, design, drawing or data
developed in connection with the performance of the RESEARCH PROJECT defined
above, relating to LICENSED PRODUCTS or LICENSED PROCESSES, including but not
limited to INVENTIONS and/or RESEARCH INFORMATION which are not disclosed in a
patent application or patent, but which are necessary or useful for practicing
the rights granted under this License.
1.20 UNIVERSITY INVENTION(S) shall mean any INVENTION first conceived or
first actually reduced to practice solely by an employee or student of
University listed in Appendix B to the CRA, in connection with the RESEARCH
PROJECT, but not including JOINT INVENTIONS. Appendix B to the CRA shall be
updated from time to time to include all employees and students engaged in
research in the laboratories of Xx. Xxxx Xxxxxxxxx and/or Xx. Xxxxxx Xxxxxxx, or
any other principal investigator under the CRA, and those employees and students
participating in the RESEARCH PROJECT.
-6-
EXECUTION COPY
ARTICLE 2 - GRANTS
2.1 Subject to the terms and conditions of this Agreement, LICENSOR hereby
grants to Company an EXCLUSIVE LICENSE for the ONCOR FIELD to make, have made,
use, have used and/or sell or have sold the LICENSED PRODUCTS and to use the
LICENSED PROCESSES in the United States and worldwide under the PATENT RIGHTS
and TECHNOLOGY RIGHTS and to sublicense such rights to others under the PATENT
RIGHTS and TECHNOLOGY RIGHTS.
2.2 Company shall provide a copy of each such sublicense agreement to
University promptly after it is executed, provided that Company may delete
portions it considers confidential in a manner which permits University to
obtain the information it requires. Each sublicense shall be consistent with the
terms in this Agreement.
2.3 Except for the rights, if any, of the Government of the United States,
as set forth in Paragraph 1.3 and except for any joint ownership of Company or
Oncorpharm, University represents and warrants that to its knowledge as of the
EFFECTIVE DATE it is the owner of the entire right, title and interest in and to
PATENT RIGHTS resulting from UNIVERSITY INVENTIONS and University's entire
right, title and interest in and to PATENT RIGHTS resulting from JOINT
INVENTIONS, and that it has the sole right to grant licenses of its interests
thereunder, and that it has not granted licenses thereunder to any other entity
that would restrict rights granted hereunder except as stated herein. Except as
set forth in Schedule 2.3 attached hereto, University is not aware as of the
EFFECTIVE DATE that any additional rights or licenses are necessary for Company
to exercise its license rights (however, University has not performed nor was
required to perform, any right to use patent searches). However, the license
grant under Paragraph 2.1 may be subject to rights granted to providers of
biological materials or other limitations as specified in paragraph 5.6 of the
CRA.
ARTICLE 3 - PATENT INFRINGEMENT
3.1 Each party will notify the other promptly in writing when any
infringement by another of PATENT RIGHTS is uncovered.
3.2 (a) Company shall have the first right to enforce any patent within
PATENT RIGHTS against any infringement or alleged infringement thereof within
the ONCOR FIELD, and shall at all times keep University informed as to the
status thereof. Company may, in its sole judgement and at its own expense,
institute suit against any such infringer or alleged infringer and control and
-7-
EXECUTION COPY
defend such suit in a manner consistent with the terms and provisions hereof and
recover, for its account, any damages, awards or settlements resulting
therefrom, subject to Paragraph 3.2(b); provided, however, that no such suit
shall be settled without the consent of XXXXXXX, which consent shall not be
unreasonably withheld. This rights to xxx for infringement shall not be used in
an arbitrary or capricious manner. University shall reasonably cooperate in any
such litigation at Company's expense.
(b) Any recovery by Company under Paragraph 3.2(a), after
deduction of all reasonable costs and expenses associated with each suit or
settlement (the "Net Recovery"), shall be deemed to reflect loss of
commercial sales, and Company shall pay to University * of such Net Recovery.
If the cost and expenses exceed the recovery, then * of the excess shall be
credited against royalties or the percentage of SUBLICENSE INCOME payable by
Company to University hereunder in connection with sales in or SUBLICENSE
INCOME from the country of such legal proceedings, provided, however, that
any such credit under this Paragraph 3.2(b) shall not exceed * of the
royalties or the percentage of SUBLICENSE INCOME otherwise payable to
University with regard to sales in or SUBLICENSE INCOME from the country of
such legal proceedings in any one calendar year, with any excess credit being
carried forward to future calendar years.
3.3 If Company elects not to enforce any patent within the PATENT RIGHTS
within the ONCOR FIELD, then it shall so notify University in writing within six
(6) months of receiving notice that an infringement exists, and University may,
in its sole judgement and at its own expense, do so and control, settle, and
defend such suit in a manner consistent with the terms and provisions hereof,
and recover, for its own account, any damages, awards or settlements resulting
therefrom.
ARTICLE 4 - PAYMENTS
4.1 Reasonable costs of preparing, filing, maintaining and prosecuting
PATENT RIGHTS shall be reimbursed to University in accordance with the
provisions of Article 5 of the CRA.
4.2 Company shall pay to University, upon the execution of this
Agreement by both parties and the concurrent execution of the ONCORPHARM
LICENSE, * in accordance with the
-8-
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
terms of the STOCK PURCHASE AGREEMENT *. The Company shall also pay to
University, (i) within thirty (30) days of each anniversary of the EFFECTIVE
DATE of this Agreement, commencing on the first anniversary, *. The foregoing
payments are all non-refundable.
4.3 Company shall pay to LICENSOR, as a running royalty, for each LICENSED
PRODUCT and LICENSED PROCESS sold by Company or any AFFILIATED COMPANY of the
Company:
(a) * where the LICENSED PRODUCTS or LICENSED PROCESSES are
covered by any claim of one or more PATENT RIGHTS during the time period in
which, and in the geographic locations in which such PATENT RIGHTS are
legally enforceable for the making, using or selling of the particular
LICENSED PRODUCT or LICENSED SERVICE; or
(b) * where the LICENSED PRODUCTS or LICENSED PROCESSES are not
covered by any claim of one or more PATENT RIGHTS as specified in Paragraph
4.3(a).
Such payments shall be made quarterly as provided in Paragraph 4.5.
4.4 The Company shall pay the University, * of any SUBLICENSE INCOME
actually received by the Company or any AFFILIATED COMPANY from sublicensees
under this Agreement.
4.5 Company shall provide to University within thirty (30) days of the end
of each March, June, September and December after first commercial sale of a
LICENSED PRODUCT or LICENSED PROCESS a written report to University of the
amount of LICENSED PRODUCTS and LICENSED PROCESSES sold, the total NET SALES of
such LICENSED PRODUCTS and LICENSED PROCESSES or the SUBLICENSE INCOME received,
as applicable, and the running royalties due to University as a result of NET
SALES by Company or AFFILIATED COMPANY or the percentage and amount of
SUBLICENSE INCOME due to University, broken down by the categories specified in
Paragraphs 4.3 (a) and (b) and Paragraphs 4.4 and 1.18 above. Payment of any
such royalties or percentage of SUBLICENSE INCOME due shall accompany such
report.
-9-
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
4.6 Company shall make and retain, for a period of three (3) years
following the period of each report required by Paragraph 4.5, true and accurate
records, files and books of account containing all the data reasonably required
for the full computation and verification of sales and other information
required in Paragraph 4.5. Such books and records shall be in accordance with
generally accepted accounting principles consistently applied. Company shall
permit the inspection of such records, files and books of account by an
independent certified public accountant chosen by University and reasonably
acceptable to Company during regular business hours upon ten (10) business days'
written notice to Company, to the extent necessary to verify compliance with
this Agreement; provided such accountant shall hold any information gained as
confidential except to University as necessary to show underpayment. Such
inspection shall not be made more than once each calendar year. All costs of
such inspection and copying shall be paid by University, provided that if any
such inspection shall reveal that an error has been made in the amount equal to
ten percent (10%) or more of such payment, such costs shall be borne by Company.
4.7 All payments under this Agreement shall be made in U.S. Dollars. Only
one royalty or one payment of a percentage of SUBLICENSE INCOME shall be payable
on each unit of LICENSED PRODUCT or LICENSED PROCESS calculated at the highest
applicable rate specified in Article 4 of this Agreement irrespective of (i) the
number of patents within PATENT RIGHTS or the number of items of TECHNOLOGY
RIGHTS whose claims would be infringed but for this License Agreement.
ARTICLE 5 - PATENT RIGHTS
5.1 Each party shall have and retain sole and exclusive title to all
INVENTIONS and RESEARCH INFORMATION which are made, conceived, reduced to
practice or generated solely by its employees or agents arising in the course of
or as a result of the RESEARCH PROJECT. Each party shall own a fifty percent
(50%) undivided interest in all INVENTIONS and RESEARCH INFORMATION arising in
the course of or as a result of the RESEARCH PROJECT which are made, conceived,
reduced to practice or generated jointly by employees or agents of both parties.
Other matters relating to patents and patent applications included within PATENT
RIGHTS shall be governed by Article 5 of the CRA.
5.2 Company agrees that all packaging containing individual LICENSED
PRODUCTS sold by Company or AFFILIATED COMPANY will be marked with the number of
the applicable patent(s) licensed
- 10 -
EXECUTION COPY
hereunder in accordance with each country's patent laws, and will require its
sublicensees to do likewise.
5.3 Except as otherwise specified in this Agreement, matters relating to
confidential information shall be governed by Article 4 of the CRA. The
obligations of this Paragraph 5.3 shall also apply to AFFILIATED COMPANIES
and/or sublicensees provided such information by Company. Obligations under this
Paragraph 5.3 shall extend for a period of five (5) years after the termination
of this Agreement.
ARTICLE 6 - TERM MILESTONES AND TERMINATION
6.1 This Agreement shall expire in each country on the date of expiration
of the last to expire patent included within PATENT RIGHTS in that country or,
if no patent ultimately issues in a given country, ten (10) years after the
first commercial sale of an FDA approved LICENSED PRODUCT or LICENSED PROCESS.
Upon expiration, Company will be entitled to fully exploit PATENT RIGHTS and
TECHNOLOGY RIGHTS without restriction or payment of royalties.
6.2 Company shall use reasonable efforts to carry out the following either
itself or through an AFFILIATED COMPANY or a sublicensee of Company:
(a) identify a prototype assay utilizing a UNIVERSITY INVENTION or JOINT
INVENTION * of the EFFECTIVE DATE;
(b) beta test a prototype assay utilizing a UNIVERSITY INVENTION or JOINT
INVENTION * of the EFFECTIVE DATE;
(c) convert a prototype assay into a final assay format * of the EFFECTIVE
DATE; and
(d) effect the first lawful commercial sale of a LICENSED PRODUCT or LICENSED
PROCESS within the ONCOR FIELD * of the EFFECTIVE DATE.
6.3 If any of the performance milestones set forth in Section 6.2 hereof
have not been achieved by either Company, an AFFILIATED COMPANY, or a
sublicensee of Company within the time frame specified for such milestone, and
such failure has been due to legitimate and unexpected impediments outside of
the reasonable control of the Company, then the parties shall renegotiate in
good faith as to the milestones, deadlines for completion of milestones and
direction of the RESEARCH PROJECT,
- 11 -
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
as applicable. If the failure to achieve such milestone is for any other
reason University shall have the right to notify Company of its intention to
terminate the Company's licenses granted under Article 2 ("Warning Notice").
Upon receipt of a Warning Notice, Company shall have the option of extending
the deadline for completing the milestone (the "Extension Option") by another
six (6) months in consideration of a payment to University of *. If Company,
within ninety (90) days after receipt of the Warning Notice from University,
fails to exercise its Extension Option and fails to reach agreement with
University as to a plan to reach such performance milestone or the waiver of
such milestone, University shall have the right to terminate the Company's
licenses granted under Article 2 hereof by submitting a notice of termination
to the Company (the "Termination Notice").
6.4 University agrees that in the discretion of Company 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 Company given its strategies and
resources.
6.5 Company may terminate this Agreement at any time upon ninety (90) days
written notice to University.
6.6 Upon termination, Company, AFFILIATED COMPANY or sublicensee shall
return all information marked confidential first transferred to Company by
University. Company, AFFILIATED COMPANY or sublicensee shall maintain
confidential and not use any such information for a period of five (5) years
after termination of this Agreement.
6.7 Upon breach or default of any of the terms or conditions of this
Agreement, the defaulting party shall be given notice of such default in writing
and a period of ninety (90) days after receipt of such notice to correct the
breach or default. If (a) the default or breach (i) is material to this
Agreement, and (ii) is not corrected within said ninety (90) day period and the
defaulting party has not taken reasonable steps to cure the same, and (b) the
party not in default has fully complied with all of its obligations under this
Agreement, the party not in default shall have the right to terminate this
Agreement. For the avoidance of any doubt, the failure of Company to achieve any
of the performance milestones set forth in Section 6.2 hereof shall not be
deemed to be a breach or default entitling University to terminate in accordance
with this Section 6.7, but shall instead entitle University to exercise its
rights under Section 6.3 hereof.
- 12 -
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
6.8 Termination shall not affect either party's right to recover for
obligations accruing prior to the termination of this Agreement, including but
not limited to, unpaid royalties and reimbursement for Company approved patent
expenses. In the event that the parties mutually agree that Company may make
posttermination sales of LICENSED PRODUCTS or LICENSED PROCESSES, Company shall
continue to pay to University any royalties or percentage of SUBLICENSE INCOME
that would have been due to University under the terms of this Agreement in
respect of such post-termination sales, if such termination had not occurred.
ARTICLE 7 - MISCELLANEOUS
7.1 All notices pertaining to this Agreement shall be in writing and sent
by certified mail, return receipt requested, or by a nationally recognized
overnight delivery service, to the parties at the following addresses or such
other address as such party shall have furnished in writing to the other party
in accordance with this Paragraph 7.1:
The Xxxxx Xxxxxxx University
Office of Technology Licensing
School of Medicine
0000 X. Xxxxxxxx Xx., Xxxxx 0-000
Xxxxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxxx, Esq.
Oncor, Inc.
000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Mr. Xxxxxxx Xxxxxx
All notices sent in accordance with this Section 7.1 shall be deemed
received three (3) days after deposit with the U.S. postal service if sent by
certified mail, and on the day after deposit with the delivery service, if sent
by overnight delivery service.
7.2 All written progress reports, royalty and other payments, and any
other related correspondence shall be in writing and sent to:
- 13 -
EXECUTION COPY
The Xxxxx Xxxxxxx University
Office of Technology Licensing
School of Medicine
0000 X. Xxxxxxxx Xx., Xxxxx 0-000
Xxxxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxxx, Esq.
or such other addressee which University may designate in writing from time to
time. All checks should be made payable to The Xxxxx Xxxxxxx University.
7.3 This Agreement may be assigned by Company to an AFFILIATE COMPANY or
as part of a sale of its entire business relating to a LICENSED PRODUCT or
LICENSED PROCESS, provided Company remains liable for all obligations hereunder.
Company may also assign its rights and benefits under this Agreement if
University approves the assignment in writing, which approval shall not be
unreasonably withheld. In the event of such transfer, the transferee shall
assume and be bound by the provisions of this Agreement. It shall be deemed to
be reasonable if Company assigns to a responsible company and agrees to remain
responsible on an ongoing basis for performance by the assignee company. The
University may not assign this Agreement or any of the PATENT RIGHTS.
7.4 In the event that any one or more of the provisions of this Agreement
should for any reason be held by any court or authority having jurisdiction over
this Agreement, or over any of the parties hereto to be invalid, illegal or
unenforceable, such provision or provisions shall be reformed to approximate as
nearly as possible the intent of the parties, and if unreformable, shall be
divisible and deleted in such jurisdictions; elsewhere this Agreement shall not
be affected.
7.5 The construction, performance, and execution of this Agreement shall
be governed by the laws of the State of Maryland.
7.6 Company shall not use the name of The Xxxxx Xxxxxxx University or any
contraction thereof or the names of Drs. Xxxx Xxxxxxxxx, Xxxxxx Xxxxxxx, Xxxxxx
Silver or Xxxxx Xxxx in any advertising, promotional, or sales literature
without prior written consent from University, except as otherwise provided in
the CRA. University shall have at least seven (7) days for its review and
comment on a proposed piece of advertising, promotional or sales literature that
requires its consent pursuant to this Section 7.6.
- 14 -
EXECUTION COPY
7.7 University warrants that it has good and marketable title to the
inventions claimed under PATENT RIGHTS existing as of the EFFECTIVE DATE, with
the exception of certain retained rights of the United States government.
University does not warrant the validity of any patents or that practice under
such patents shall be free of infringement. EXCEPT AS EXPRESSLY SET FORTH IN
PARAGRAPH 2.3 AND THIS PARAGRAPH 7.7, COMPANY, AFFILIATED COMPANY AND
SUBLICENSEES AGREE THAT THE PATENT RIGHTS AND RESEARCH INFORMATION ARE PROVIDED
"AS IS", AND THAT UNIVERSITY MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO
THE PERFORMANCE OF LICENSED PRODUCT AND LICENSED PROCESSES INCLUDING THEIR
SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. UNIVERSITY DISCLAIMS ALL
WARRANTIES WITH REGARD TO PRODUCTS AND PROCESSES LICENSED UNDER THIS AGREEMENT,
INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESS OR IMPLIED, OR
MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY
OTHER PROVISION OF THIS AGREEMENT, UNIVERSITY ADDITIONALLY DISCLAIMS ALL
OBLIGATIONS AND LIABILITIES ON THE PART OF UNIVERSITY FOR DAMAGES, INCLUDING,
BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES,
ATTORNEYS' AND EXPERTS' FEES, AND COURT COSTS (EVEN IF UNIVERSITY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN
CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE PRODUCTS AND PROCESSES
LICENSED UNDER THIS AGREEMENT. COMPANY, AFFILIATED COMPANY AND SUBLICENSEES
ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT
AND PROCESS MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEES AND
AFFILIATES WHICH IS A LICENSED PRODUCT OR LICENSED PROCESS AS DEFINED IN THIS
AGREEMENT.
7.8 University, Inventors and any other inventors of LICENSED PRODUCTS and
LICENSED PROCESSES will not, under the provisions of this Agreement or
otherwise, have control over the manner in which Company or AFFILIATED COMPANY
or its sublicensees or those operating for its account or third parties who
purchase LICENSED PRODUCTS and LICENSED PROCESSES from any of the foregoing
entities, practice the INVENTIONS and/or TECHNOLOGY RIGHTS of LICENSED PRODUCTS
and LICENSED PROCESSES. Subject to Paragraph 7.9, Company shall defend and hold
University, the Inventors, and any other inventors harmless as against any
judgments, fees, expenses, or other costs arising from or incidental to any
product liability or other lawsuit, claim, demand or other action brought as a
consequence of the practice of said inventions by any of the foregoing entities,
whether or not University or said inventor, either jointly or severally, is
named as a party defendant in any such lawsuit. Practice of the inventions
covered by LICENSED PRODUCTS and LICENSED PROCESSES from Company, shall be
considered Company's practice of said inventions for purposes of this Paragraph
7.8. The obligation of
- 15 -
EXECUTION COPY
Company to defend and indemnify as set out in this Paragraph 7.8 shall survive
the termination of this Agreement.
7.9 University shall promptly notify Company in writing of any claim or
suit or threat thereof brought against University in respect of which
indemnification may be sought and, to the extent allowed by law, shall
reasonably cooperate with Company in defending or settling any such claim or
suit. No settlement of any claim, suit or threat thereof received by University
and for which University will seek indemnification, shall be made without the
prior written approval of Company. University will permit Company to defend
University against any such claim, suit or threat thereof and Company shall have
sole control over the defense, subject to University's right to select its own
counsel to review the matter for University at University's sole cost and
expense.
7.10 Commencing not later than the date of first commercial sale of a
LICENSED PRODUCT or LICENSED PROCESSES, Company shall use commercially
reasonable efforts to obtain and carry in full force and effect at a
commercially reasonable price product liability insurance against any claims,
judgments, liabilities and expenses for which it is obligated to indemnify
University under Paragraph 7.8 above, in such amounts and with such deductibles
and other limits as are determined reasonably necessary by mutual agreement of
the parties acting in good faith, in light of the availability of such insurance
and the custom at the customary time for similarly situated companies engaged in
similar business. University shall be named as an additional insured under any
such insurance policies.
7.11 This Agreement together with the STOCK PURCHASE AGREEMENT and the CRA
constitutes the entire understanding between the parties with respect to the
obligations of the parties with respect to the subject matter hereof, and
supersedes and replaces all prior agreements, understandings, writings, and
discussions between the parties relating to said subject matter.
7.12 This Agreement may be amended and any of its terms or conditions may
be waived only by a written instrument executed by the authorized officials of
the parties or, in the case of a waiver, by the party waiving compliance. The
failure of either party at any time or times to require performance of any
provision hereof shall in no manner affect its right at a later time to enforce
the same. No waiver by either party of any condition or term in any one or more
instances shall be construed as a further or continuing waiver of such condition
or term or of any other condition or term.
- 16 -
EXECUTION COPY
7.13 This Agreement shall be binding upon and inure to the benefit of and
be enforceable by the parties hereto and their respective successors and
permitted assigns.
7.14 Upon termination of this Agreement for any reason, Paragraphs 5.1,
5.3, 6.6, 6.8, 7.6, 7.7, 7.8 and 7.9 shall survive termination of this
Agreement.
IN WITNESS WHEREOF the parties hereto have executed this License
Agreement by their duly authorized officers as of the date first above written.
THE XXXXX XXXXXXX UNIVERSITY ONCOR, INC.
BY: /s/ Xxxxx X. Xxxxx BY: /s/ Xxxxxxx Xxxxxx
---------------------------- ------------------------------
TITLE: Executive Vice Xxxx TITLE: CEO and Chairman
--------------------------- ---------------------------
I have read and agree to abide with the terms of this Agreement.
By /s/ Xxxx Xxxxxxxxx
-----------------------------
Xx. Xxxx Xxxxxxxxx
By /s/ Xxxxxx Xxxxxxx
-----------------------------
Xx. Xxxxxx Xxxxxxx
By /s/ Xxxxxx Silver
-----------------------------
Dr. Xxxxxx Silver
By /s/ Xxxxx Xxxx
-----------------------------
Xx. Xxxxx Xxxx
- 17 -
EXECUTION COPY
Schedule 2.3
DNA amplification technologies may or may not be necessary for the development
and/or commercialization of certain LICENSED PRODUCTS and certain LICENSED
PROCESSES.
- 18 -
EXECUTION COPY
APPENDIX D
ONCORPHARM LICENSE AGREEMENT
EXECUTION COPY
LICENSE AGREEMENT
This License Agreement (the or this "Agreement" or "License"),
effective this 6th day of March, 1996, is between The Xxxxx Xxxxxxx University,
a corporation of the State of Maryland, having a principal place of business at
0000 Xxxx Xxxxxxxx Xxxxxx, Xxxxx 0-000, Xxxxxxxxx, XX 00000 (hereinafter
referred to as "University") and Oncorpharm, Inc., a corporation, having a
principal place of business at 000 Xxxxx Xxxxxxx, Xxxxxxxxxxxx, XX 00000
(hereinafter "Company").
WITNESSETH:
WHEREAS, University, the Company and the Company's parent, Oncor,
Inc. ("Oncor"), are concurrently herewith entering into that certain
Collaborative Research Agreement (the "CRA") pursuant to which the Company and
Oncor will fund certain clinical investigations and other studies by the
University related to the Trp64Arg Adrenergic Receptor Allele ("Trp64Arg
Allele");
WHEREAS, as a center for research and education, University is
interested in licensing PATENT RIGHTS and TECHNOLOGY RIGHTS (both hereinafter
defined) in a manner that will benefit the public by facilitating the
distribution of useful products and the utilization of new methods, but is
without capacity to commercially develop, manufacture, and distribute any such
products or methods; and
WHEREAS, PATENTS RIGHTS include*
WHEREAS, University has acquired through assignment all right, title
and interest, with the exception of certain retained rights by the United States
government, in all the PATENT RIGHTS and TECHNOLOGY RIGHTS existing at the date
hereof, including but not limited to, the rights of the Inventors; and
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
WHEREAS, the University is interested in licensing any PATENT RIGHTS
and TECHNOLOGY RIGHTS that it may acquire in the future, including but not
limited to those of the Inventors, subject to any required retained rights of
the U.S. Government; and
WHEREAS, Company desires to commercially develop, manufacture, use
and distribute products and processes based on such PATENT RIGHTS and TECHNOLOGY
RIGHTS, throughout the world, for use as a prophylactic or therapeutic.
NOW, THEREFORE, in consideration of the foregoing premises and the
following mutual covenants, and other good and valuable consideration, the
receipt of which is hereby acknowledged, and intending to be legally bound
hereby, the parties agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 AFFILIATED COMPANY shall mean (a) any company owned or controlled to
the extent of at least fifty percent (50%) of its issued and voting capital by a
party to this Agreement and any other company so owned or controlled (directly
or indirectly) by any such company or the owner of any such company, or (b) any
partnership, joint venture or other entity directly or indirectly controlled by,
controlling, or under common control of, to the extent of fifty percent (50%) or
more of voting power (or otherwise having power to control its general
activities), a party to this Agreement, but in each case only for so long as
such ownership or control shall continue.
1.2 EFFECTIVE DATE shall mean the effective date of this Agreement, as
first above written.
1.3 EXCLUSIVE LICENSE shall mean a license to UNIVERSITY INVENTIONS and
TECHNOLOGY RIGHTS, and a license of University's right, title and interest in
and to JOINT INVENTIONS, whereby Company's rights are sole and entire and
operate to exclude all others, subject to rights retained by the United States
government in accordance with P.L. 96-517, as amended by P.L. 98-620, and
subject to the retained right of University (i) to make, have made, provide and
use for its and The Xxxxx Xxxxxxx University Health Systems' non-profit purposes
LICENSED PRODUCTS and LICENSED PROCESSES and (ii) to use, distribute and
disclose RESEARCH INFORMATION for non-profit purposes subject to compliance with
Article 4 of the CRA.
1.4 INVENTION(S) shall mean (i) the inventions described in the PATENT
APPLICATION or in any continuation, continuation-in-
2
EXECUTION COPY
part, division or reissue of the PATENT APPLICATION or in any corresponding
foreign patent application, and (ii) any existing or future discovery or
invention first conceived or first actually reduced to practice in connection
with or relating to the performance of the RESEARCH PROJECT. For purposes of
this Agreement the determination of "first conceived" and "first actually
reduced to practice" shall be governed by U.S. law. INVENTION(S) shall include
discoveries and inventions which are not patentable or patented, including but
not limited to trade secrets, copyright material or other protectable
intellectual property. Without limiting the generality of the foregoing,
INVENTION(S) may include know-how procedures, technical information, any
process, composition, device, formula, protocol, technique, design, drawing
methodology, technical and scientific expertise and biological or chemical
materials.
1.5 JOINT INVENTION(S) shall mean any INVENTION first conceived or first
actually reduced to practice jointly by an employee of Company or Oncor and an
employee or student of University listed in Appendix B of the CRA, in connection
with the RESEARCH PROJECT.
1.6 LICENSED PROCESSES shall mean all methods which are covered by any
claim of one or more PATENT RIGHTS or based upon or derived from TECHNOLOGY
RIGHTS.
1.7 LICENSED PRODUCTS shall mean all products, the manufacture, use or
sale of which is covered by any claim of one or more PATENT RIGHTS or based upon
or derived from TECHNOLOGY RIGHTS.
1.8 LICENSOR shall mean University.
1.9 NET SALES shall mean gross sales revenues and fees actually received
by Company or AFFILIATED COMPANY from the sale of LICENSED PRODUCTS and/or
LICENSED PROCESSES less trade discounts allowed, refunds, returns and recalls,
sales, V.A.T. and/or use taxes, duties and similar governmental assessments and
transportation, packing and shipping insurance actually paid by the seller. In
the event that Company or AFFILIATED COMPANY sells a LICENSED PRODUCT in
combination with other active ingredients or components which are not LICENSED
PRODUCTS ("Other Items"), the NET SALES for purposes of royalty payments on the
combination shall be calculated as follows:
(a) If all LICENSED PRODUCTS and Other Items contained in the
combination are available separately, the NET SALES for purposes of royalty
payments will be calculated by multiplying the NET SALES of the combination by
the fraction A/A+B, where A
3
EXECUTION COPY
is the separately available price of all LICENSED PRODUCTS in the combination,
and B is the separately available price for all Other Items in the combination.
(b) If the combination includes Other Items which are not sold
separately (but all LICENSED PRODUCTS contained in the combination are available
separately), the NET SALES for purposes of royalty payments will be calculated
by multiplying the NET SALES of the combination by A/C, where A is as defined
above and C is the invoiced price of the combination.
(c) If the LICENSED PRODUCTS contained in the combination are not
sold separately, the NET SALES for such combination shall be one half of the NET
SALES of such combination as defined in the first sentence of this Paragraph
1.9.
The term "Other Items" does not include solvents, diluents, carriers, excipients
or the like used in formulating a product.
1.10 ONCORPHARM FIELD shall mean use of the LICENSED PRODUCTS and LICENSED
PROCESSES as prophylactics and/or therapeutics.
1.11 OPTION AGREEMENT shall mean that certain Stock Option Agreement of
even date herewith, by and between the University and Oncorpharm, Inc.
1.12 ONCOR LICENSE shall mean that certain license agreement of even date
herewith between University and Oncor, relating to use of the LICENSED PRODUCTS
and LICENSED PROCESSES for all uses except prophylactic and therapeutic uses.
1.13 PATENT APPLICATION shall mean *
1.14 PATENT RIGHTS shall mean the following (a) the PATENT APPLICATION,
(b) any other existing or future U.S. patent application claiming either a
UNIVERSITY INVENTION or a JOINT INVENTION (hereinafter FUTURE APPLICATION), (c)
any invention disclosed and claimed in the PATENT APPLICATION or the FUTURE
APPLICATIONS and (d) all continuations, continuations-in-part, divisions,
reissues, reexaminations, extensions or other government actions which extend
any of the subject matter of the PATENT APPLICATION or the FUTURE APPLICATIONS,
and any
4
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
corresponding foreign patent applications that may be filed in the future at
Company's request and expense and any patents, patents of addition, or other
equivalent foreign patent rights issuing, granted or registered on the PATENT
APPLICATION or the FUTURE APPLICATIONS.
1.15 RESEARCH INFORMATION shall mean data, information and results
included within the definition of INVENTION(S) that are obtained during the term
of the CRA from the RESEARCH PROJECT, including know-how, procedures,
methodology, technical and scientific expertise and biological or chemical
materials, but excluding any such items which are included in the definition of
PATENT RIGHTS.
1.16 RESEARCH PROJECT shall mean the collaborative research program
between University, Oncor and Company described and funded in accordance with
the CRA.
1.17 STOCK PURCHASE AGREEMENT shall mean that certain Stock Purchase
Agreement of even date herewith, by and among the Company and the University.
1.18 SUBLICENSE INCOME shall mean the gross amount actually received by
either the Company or an AFFILIATED COMPANY, directly or indirectly, for or on
account of sublicenses of any of the rights granted hereunder, without deduction
of any kind, but excluding the following, in relation to which no payments shall
be due to the University:
(a) Payments received by either the Company or an AFFILIATED COMPANY
for performance of research and development by either the Company or an
AFFILIATED COMPANY to the extent that such payments cover the actual cost of the
research and development work;
(b) Investments made by a sublicensee in either the Company or an
AFFILIATED COMPANY to the extent that such investments are made at current
market value, including but not limited to, any payments or other consideration
representing the current market value of shares in the Company or an AFFILIATED
COMPANY;
(c) Payments made to either the Company or an AFFILIATED COMPANY to
the extent that they cover the actual costs of conducting clinical testing and
other activities in connection with obtaining regulatory approval for a LICENSED
PRODUCT or LICENSED PROCESS;
(d) Reimbursed expenses of either the Company or an AFFILIATED
COMPANY.
5
EXECUTION COPY
For purposes of Subparagraph (b) above, the current market value of the
investment shall determined as follows: (i) it shall be determined as at the
earlier of (a) the date when the investment is made or (b) the day prior to the
date when the investment is first publicly disclosed on the Dow Xxxxx News Wire
(the "Determination Date") ; (ii) if there is no public market for the Company's
securities that are being purchased by the sublicensee, then the current market
value shall be determined by the Company's Board of Directors in good faith, and
if University disputes such determination, the current market value shall be
determined by an independent investment banker whose fees shall be shared by the
Company and the University; (iii) if there is a public market for Company's
securities that are being purchased by the sublicensee, then the current market
value shall be determined using the average of the closing bid and asked prices
of the securities in the Over-The-Counter Market Summary or the closing price
quoted on any exchange on which the securities are listed as published in The
Wall Street Journal for the ten (10) trading days prior to the Determination
Date. Notwithstanding the following, in the event the sublicensee is purchasing
the Company's securities in connection with the Company's initial public
offering of such securities, the current market value shall be determined using
the offering price of such securities to the public in the Company's initial
public offering.
1.19 TECHNOLOGY RIGHTS shall mean LICENSOR'S rights in any and all
technical information, know-how, process, procedure, composition, device,
method, formula, protocol, technique, software, design, drawing or data
developed in connection with the performance of the RESEARCH PROJECT defined
above, relating to LICENSED PRODUCTS or LICENSED PROCESSES, including but not
limited to INVENTIONS and/or RESEARCH INFORMATION which are not disclosed in a
patent application or patent, but which are necessary or useful for practicing
the rights granted under this License.
1.20 UNIVERSITY INVENTION(S) shall mean any INVENTION first conceived or
first actually reduced to practice solely by an employee or student of
University listed in Appendix B to the CRA, in connection with the RESEARCH
PROJECT, but not including JOINT INVENTIONS. Appendix B to the CRA shall be
updated from time to time to include all employees and students engaged in
research in the laboratories of Xx. Xxxx Xxxxxxxxx and/or Xx. Xxxxxx Xxxxxxx, or
any other principal investigator under the CRA, and those employees and students
participating in the RESEARCH PROJECT.
6
EXECUTION COPY
ARTICLE 2 - GRANTS
2.1 Subject to the terms and conditions of this Agreement, LICENSOR hereby
grants to Company an EXCLUSIVE LICENSE for the ONCORPHARM FIELD to make, have
made, use, have used and/or sell or have sold the LICENSED PRODUCTS and to use
the LICENSED PROCESSES in the United States and worldwide under the PATENT
RIGHTS and TECHNOLOGY RIGHTS and to sublicense such rights to others under the
PATENT RIGHTS and TECHNOLOGY RIGHTS.
2.2 Company shall provide a copy of each such sublicense agreement to
University promptly after it is executed, provided that Company may delete
portions it considers confidential in a manner which permits University to
obtain the information it requires. Each sublicense shall be consistent with the
terms in this Agreement.
2.3 Except for the rights, if any, of the Government of the United States,
as set forth in Paragraph 1.3 and except for any joint ownership of Company or
Oncor, University represents and warrants that to its knowledge as of the
EFFECTIVE DATE it is the owner of the entire right, title and interest in and to
PATENT RIGHTS resulting from UNIVERSITY INVENTIONS and University's entire
right, title and interest in and to PATENT RIGHTS resulting from JOINT
INVENTIONS, and that it has the sole right to grant licenses of its interests
thereunder, and that it has not granted licenses thereunder to any other entity
that would restrict rights granted hereunder except as stated herein. Except as
set forth in Schedule 2.3 attached hereto, University is not aware as of the
EFFECTIVE DATE that any additional rights or licenses are necessary for Company
to exercise its license rights (however, University has not performed nor was
required to perform, any right to use patent searches). However, the license
grant under Paragraph 2.1 hereof may be subject to rights granted to providers
of biological materials or other limitations as specified in Paragraph 5.6 of
the CRA.
ARTICLE 3 - PATENT INFRINGEMENT
3.1 Each party will notify the other promptly in writing when any
infringement by another of PATENT RIGHTS is uncovered.
3.2 (a) Company shall have the first right to enforce any patent within
PATENT RIGHTS against any infringement or alleged infringement thereof within
the ONCORPHARM FIELD, and shall at all times keep University informed as to the
status thereof. Company may, in its sole judgement and at its own expense,
institute suit against any such infringer or alleged infringer
7
EXECUTION COPY
and control and defend such suit in a manner consistent with the terms and
provisions hereof and recover, for its account, any damages, awards or
settlements resulting therefrom, subject to Paragraph 3.2 (b); provided,
however, that no such suit shall be settled without the consent of XXXXXXX,
which consent shall not be unreasonably withheld. This rights to xxx for
infringement shall not be used in an arbitrary or capricious manner. University
shall reasonably cooperate in any such litigation at Company' 5 expense.
(b) Any recovery by Company under Paragraph 3.2(a), after deduction
of all reasonable costs and expenses associated with each suit or settlement
(the "Net Recovery"), shall be deemed to reflect loss of commercial sales, and
Company shall pay to University* of such Net Recovery. If the cost and expenses
exceed the recovery, then* of the excess shall be credited against royalties or
the percentage of SUBLICENSE INCOME payable by Company to University hereunder
in connection with sales in or SUBLICENSE INCOME from the country of such
legal proceedings, provided, however, that any such credit under this
Paragraph 3.2(b) shall not * of the royalties or the percentage of SUBLICENSE
INCOME otherwise payable to University with regard to sales in or SUBLICENSE
INCOME from the country of such legal proceedings in any one calendar year,
with any excess credit being carried forward to future calendar years.
3.3 If Company elects not to enforce any patent within the PATENT RIGHTS
within the ONCORPHARM FIELD, then it shall so notify University in writing
within six (6) months of receiving notice that an infringement exists, and
University may, in its sole judgement and at its own expense, do so and control,
settle, and defend such suit in a manner consistent with the terms and
provisions hereof, and recover, for its own account, any damages, awards or
settlements resulting therefrom.
ARTICLE 4 - PAYMENTS
4.1 Reasonable costs of preparing, filing, maintaining and prosecuting
PATENT RIGHTS shall be reimbursed to the University in accordance with the
provisions of Article 5 of the CRA.
4.2 Upon the execution of this Agreement by both parties and the
concurrent execution of the ONCOR LICENSE, the Company shall issue to
University options to purchase Thirty Two Thousand Five Hundred (32,500)
shares of the Common Stock of the Company, pursuant to the terms and
conditions of the OPTION AGREEMENT. The Company shall also pay to University,
within thirty (30) days
8
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
of each anniversary of the EFFECTIVE DATE of this Agreement, commencing on the
first anniversary of the EFFECTIVE DATE, *.
4.3 Company shall also pay to LICENSOR as a running royalty, for each
LICENSED PRODUCT and LICENSED PROCESS sold by Company or any AFFILIATED COMPANY
of the Company:
(a) * where the LICENSED PRODUCTS or LICENSED PROCESSES are
covered by any claim of one or more PATENT RIGHTS during the time period in
which, and in the geographic locations in which such PATENT RIGHTS are
legally enforceable for the making, using or selling of the particular
LICENSED PRODUCT or LICENSED SERVICE; or
(b) * where the LICENSED PRODUCTS or LICENSED PROCESSES are not
covered by any claim of one or more PATENT RIGHTS as specified in Paragraph
4.3(a).
Such payments shall be made quarterly as provided in Paragraph 4.7.
4.4 The Company shall pay the University * of any SUBLICENSE INCOME
actually received by the Company or any AFFILIATED COMPANY from sublicensees
under this Agreement.
4.5 In the event that a percentage of sublicense income or royalties are
paid by the Company or any AFFILIATED COMPANY to an unaffiliated third party or
to University under a separate license agreement in respect of a LICENSED
PRODUCT or a LICENSED PROCESS ("Third Party Royalties") for which royalties are
also due to the University pursuant to Paragraph 4.3 above, then the royalties
to be paid to the University pursuant to Paragraph 4.3 above shall be reduced by
* of the aggregate amount of such Third Party Royalties, but in no event shall
the royalties due under Paragraph 4.3 be reduced by more than * in any year.
4.6 In the event that (i) a percentage of sublicense income or royalties
are paid by the Company or any AFFILIATED COMPANY to an unaffiliated third party
or to University under a separate license agreement in respect of a LICENSED
PRODUCT or a LICENSED PROCESS ("Third Party Royalties") for which a percentage
of SUBLICENSE INCOME is also due to the University pursuant to Paragraph 4.4,
and (ii) the LICENSED PRODUCT or LICENSED PROCESS causes or involves DNA repair,
then the percentage of SUBLICENSE INCOME to be paid to the University pursuant
to Paragraph 4.4 above shall be reduced by * of the aggregate amount of
9
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
such Third Party Royalties, but in no event shall the percentage of
SUBLICENSE INCOME due under Paragraph 4.4 be reduced by more than * in any
year. In all other cases any percentage of SUBLICENSE INCOME due to
University pursuant to Paragraph 4.4 above shall be unaffected by this
Paragraph.
4.7 Company shall provide to University within thirty (30) days of the end
of each March, June, September and December after first commercial sale of a
LICENSED PRODUCT or LICENSED PROCESS a written report to University of the
amount of LICENSED PRODUCTS and LICENSED PROCESSES sold, the total NET SALES of
such LICENSED PRODUCTS and LICENSED PROCESSES or the SUBLICENSE INCOME received,
as applicable, and the running royalties due to University as a result of NET
SALES by Company or AFFILIATED COMPANY or the percentage and amount of
SUBLICENSE INCOME due to University, broken down by the categories specified in
Paragraphs 4.3 (a) and (b), and Paragraphs 4.4 and 1.18 above. Payment of any
such royalties or percentage of SUBLICENSE INCOME due shall accompany such
report.
4.8 Company shall make and retain, for a period of three (3) years
following the period of each report required by Paragraph 4.7, true and accurate
records, files and books of account containing all the data reasonably required
for the full computation and verification of sales and other information
required in Paragraph 4.7. Such books and records shall be in accordance with
generally accepted accounting principles consistently applied. Company shall
permit the inspection of such records, files and books of account by an
independent certified public accountant chosen by University and reasonably
acceptable to Company during regular business hours upon ten (10) business days'
written notice to Company, to the extent necessary to verify compliance with
this Agreement; provided such accountant shall hold any information gained as
confidential except to University as necessary to show underpayment. Such
inspection shall not be made more than once each calendar year. All costs of
such inspection and copying shall be paid by University, provided that if any
such inspection shall reveal that an error has been made in the amount equal to
ten percent (10%) or more of such payment, such costs shall be borne by Company.
4.9 All payments under this Agreement shall be made in U.S. Dollars. Only
one royalty or one payment of a percentage of SUBLICENSE INCOME shall be payable
on each unit of LICENSED PRODUCT or LICENSED PROCESS, calculated at the highest
applicable rate specified in Article 4 of this Agreement irrespective of the
number of patents within PATENT RIGHTS or the number of items of
10
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
TECHNOLOGY RIGHTS whose claims would be infringed but for this License
Agreement.
ARTICLE 5 - PATENT RIGHTS
5.1 Each party shall have and retain sole and exclusive title to all
INVENTIONS and RESEARCH INFORMATION which are made, conceived, reduced to
practice or generated solely by its employees or agents arising in the course of
or as a result of the RESEARCH PROJECT. Each party shall own a fifty percent
(50%) undivided interest in all INVENTIONS and RESEARCH INFORMATION arising in
the course of or as a result of the RESEARCH PROJECT which are made, conceived,
reduced to practice or generated jointly by employees or agents of both parties.
Other matters relating to patents and patent applications included within PATENT
RIGHTS shall be governed by Article 5 of the CRA.
5.2 Company agrees that all packaging containing individual LICENSED
PRODUCTS sold by Company or AFFILIATED COMPANY will be marked with the number of
the applicable patent(s) licensed hereunder in accordance with each country's
patent laws, and will require its sublicensees to do likewise.
5.3 Except as otherwise specified in this Agreement, matters relating to
confidential information shall be governed by Article 4 of the CRA. The
obligations of this Paragraph 5.3 shall also apply to AFFILIATED COMPANIES
and/or sublicensees provided such information by Company. Obligations under this
Paragraph 5.3 shall extend for a period of five (5) years after the termination
of this Agreement.
ARTICLE 6 - TERM MILESTONES AND TERMINATION
6.1 This Agreement shall expire in each country on the date of expiration
of the last to expire patent included within PATENT RIGHTS in that country or,
if no patent ultimately issues in a given country, ten (10) years after the
first commercial sale of an FDA approved LICENSED PRODUCT or LICENSED PROCESS.
Upon expiration, Company will be entitled to fully exploit PATENT RIGHTS and
TECHNOLOGY RIGHTS without restriction or payment of royalties.
6.2 Company shall use reasonable efforts to carry out the following either
itself or through an AFFILIATED COMPANY or a sublicensee of Company:
11
EXECUTION COPY
(a) undertake small molecule drug screening for therapeutics utilizing a
UNIVERSITY INVENTION or JOINT INVENTION * of the EFFECTIVE DATE;
(b) identify at least one lead compound for use as a therapeutic utilizing a
UNIVERSITY INVENTION or JOINT INVENTION * of the EFFECTIVE DATE;
(c) commence testing of at least one compound for use as a therapeutic
utilizing a UNIVERSITY INVENTION or JOINT INVENTION in an animal model * of
the EFFECTIVE DATE;
(d) begin Phase I clinical studies for at least one compound for use as a
therapeutic utilizing a UNIVERSITY INVENTION or JOINT INVENTION * of
the EFFECTIVE DATE;
(e) design a gene repair pharmaceutical utilizing a UNIVERSITY INVENTION or
JOINT INVENTION and commence testing of such gene repair pharmaceutical in cell
cultures * of the EFFECTIVE DATE;
(f) commence testing of at least one gene repair pharmaceutical utilizing a
UNIVERSITY INVENTION or JOINT INVENTION in a suitable animal model * of the
EFFECTIVE DATE;
(g) begin clinical trials of at least one gene repair pharmaceutical utilizing a
UNIVERSITY INVENTION or JOINT INVENTION * of the EFFECTIVE DATE; and
(h) effect the first lawful commercial sale of each LICENSED PRODUCT or LICENSED
PROCESS within the ONCORPHARM FIELD in each country licensed hereunder, as soon
as commercially practicable after such LICENSED PRODUCT or LICENSED PROCESS has
been approved by all necessary regulatory bodies in such country.
6.3 If any of the performance milestones set forth in Section 6.2 hereof
have not been achieved by either Company, an AFFILIATED COMPANY, or a
sublicensee of Company within the time frame specified for such milestone, and
such failure has been due to legitimate and unexpected impediments outside of
the reasonable control of the Company, then the parties shall renegotiate in
good faith as to the milestones, deadlines for completion of milestones and
direction of the RESEARCH PROJECT, as applicable. If the failure to achieve such
milestone is for any other reason University shall have the right to notify
Company of its intention to terminate the Company's licenses granted under
Article 2 hereof ("Warning Notice"). Upon receipt of a Warning Notice, Company
shall have the option of extending the deadline for completing the milestone
(the "Extension
12
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
Option") by another six (6) months in consideration of a payment to
University of *. If Company, within ninety (90) days after receipt of the
Warning Notice from University, fails to exercise its Extension Option and
fails to reach agreement with University as to a plan to reach such
performance milestone or the waiver of such milestone, University shall have
the right to terminate the Company's licenses granted under Article 2 hereof
by submitting a notice of termination to the Company (the "Termination
Notice").
6.4 University agrees that in the discretion of Company 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 Company given its strategies and
resources.
6.5 Company may terminate this Agreement at any time upon ninety (90) days
written notice to University.
6.6 Upon termination, Company, AFFILIATED COMPANY or sublicensee shall
return all information marked confidential first transferred to Company by
University. Company, AFFILIATED COMPANY or sublicensee shall maintain
confidential and not use any such information for a period of five (5) years
after termination of this Agreement.
6.7 Upon breach or default of any of the terms or conditions of this
Agreement, the defaulting party shall be given notice of such default in writing
and a period of ninety (90) days after receipt of such notice to correct the
breach or default. If (a) the default or breach (i) is material to this
Agreement, and (ii) is not corrected within said ninety (90) day period and the
defaulting party has not taken reasonable steps to cure the same, and (b) the
party not in default has fully complied with all of its obligations under this
Agreement, the party not in default shall have the right to terminate this
Agreement. For the avoidance of any doubt, the failure of Company to achieve any
of the performance milestones set forth in Section 6.2 hereof shall not be
deemed to be a breach or default entitling University to terminate in accordance
with this Section 6.7, but shall instead entitle University to exercise its
rights under Section 6.3 hereof.
6.8 Termination shall not affect either party's right to recover for
obligations accruing prior to the termination of this Agreement, including but
not limited to, unpaid royalties and reimbursement for Company approved patent
expenses. In the event that the parties mutually agree that Company may make
post-
13
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
termination sales of LICENSED PRODUCTS or LICENSED PROCESSES, Company shall
continue to pay to University any royalties or percentage of SUBLICENSE INCOME
that would have been due to University under the terms of this Agreement in
respect of such post-termination sales, if such termination had not occurred.
ARTICLE 7 - MISCELLANEOUS
7.1 All notices pertaining to this Agreement shall be in writing and sent
by certified mail, return receipt requested, or by a nationally recognized
overnight delivery service, to the parties at the following addresses or such
other address as such party shall have furnished in writing to the other party
in accordance with this Paragraph 7.1:
The Xxxxx Xxxxxxx University
Office of Technology Licensing
School of Medicine
0000 X. Xxxxxxxx Xxxxxx, Xxxxx 0-000
Xxxxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxxx, Esq.
Oncorpharm, Inc.
000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Xx. Xxxxxxx Xxxx
All notices sent in accordance with this Section 7.1 shall be deemed
received three (3) days after deposit with the U.S. postal service if sent by
certified mail, and on the day after deposit with the delivery service, if sent
by overnight delivery service.
7.2 All written progress reports, royalty and other payments, and any
other related correspondence shall be in writing and sent to:
The Xxxxx Xxxxxxx University
Office of Technology Licensing
School of Medicine
0000 X. Xxxxxxxx Xxxxxx, Xxxxx 0-000
Xxxxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxxx, Esq.
or such other addressee which University may designate in writing from time to
time. All checks should be made payable to The Xxxxx Xxxxxxx University.
14
EXECUTION COPY
7.3 This Agreement may be assigned by Company to an AFFILIATE COMPANY or
as part of a sale of its entire business relating to a LICENSED PRODUCT or
LICENSED PROCESS, provided Company remains liable for all obligations hereunder.
Company may also assign its rights and benefits under this Agreement if
University approves the assignment in writing, which approval shall not be
unreasonably withheld. In the event of such transfer, the transferee shall
assume and be bound by the provisions of this Agreement. It shall be deemed to
be reasonable if Company assigns to a responsible company and agrees to remain
responsible on an ongoing basis for performance by the assignee company. The
University may not assign this Agreement or any of the PATENT RIGHTS.
7.4 In the event that any one or more of the provisions of this Agreement
should for any reason be held by any court or authority having jurisdiction over
this Agreement, or over any of the parties hereto to be invalid, illegal or
unenforceable, such provision or provisions shall be reformed to approximate as
nearly as possible the intent of the parties and if unreformable, shall be
divisible and deleted in such jurisdictions; elsewhere this Agreement shall not
be affected.
7.5 The construction, performance, and execution of this Agreement shall
be governed by the laws of the State of Maryland.
7.6 Company shall not use the name of The Xxxxx Xxxxxxx University or any
contraction thereof or the names of Drs. Xxxx Xxxxxxxxx, Xxxxxx Xxxxxxx, Xxxxxx
Silver or Xxxxx Xxxx in any advertising, promotional, or sales literature
without prior written consent from University, except as otherwise provided in
the CRA. University shall have at least seven (7) days for its review and
comment on a proposed piece of advertising, promotional or sales literature that
requires its consent pursuant to this Section 7.6.
7.7 University warrants that it has good and marketable title to the
inventions claimed under PATENT RIGHTS existing as of the EFFECTIVE DATE, with
the exception of certain retained rights of the United States government.
University does not warrant the validity of any patents or that practice under
such patents shall be free of infringement. EXCEPT AS EXPRESSLY SET FORTH IN
PARAGRAPH 2.3 AND THIS PARAGRAPH 7.7, COMPANY, AFFILIATED COMPANY AND
SUBLICENSEES AGREE THAT THE PATENT RIGHTS AND RESEARCH INFORMATION ARE PROVIDED
"AS IS", AND THAT UNIVERSITY MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO
THE PERFORMANCE OF LICENSED PRODUCT AND LICENSED PROCESSES INCLUDING THEIR
SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. UNIVERSITY DISCLAIMS ALL
WARRANTIES WITH REGARD TO PRODUCTS AND
15
EXECUTION COPY
PROCESSES LICENSED UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL
WARRANTIES, EXPRESS OR IMPLIED, OR MERCHANTABILITY AND FITNESS FOR ANY
PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT,
UNIVERSITY ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF
UNIVERSITY FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT,
SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS' AND EXPERTS' FEES, AND COURT
COSTS (EVEN IF UNIVERSITY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES,
FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OR
SALE OF THE PRODUCTS AND PROCESSES LICENSED UNDER THIS AGREEMENT. COMPANY,
AFFILIATED COMPANY AND SUBLICENSEES ASSUME ALL RESPONSIBILITY AND LIABILITY FOR
LOSS OR DAMAGE CAUSED BY A PRODUCT AND PROCESS MANUFACTURED, USED, OR SOLD BY
COMPANY, ITS SUBLICENSEES AND AFFILIATES WHICH IS A LICENSED PRODUCT OR LICENSED
PROCESS AS DEFINED IN THIS AGREEMENT.
7.8 University, Inventors and any other inventors of LICENSED PRODUCTS and
LICENSED PROCESSES will not, under the provisions of this Agreement or
otherwise, have control over the manner in which Company or AFFILIATED COMPANY
or its sublicensees or those operating for its account or third parties who
purchase LICENSED PRODUCTS and LICENSED PROCESSES from any of the foregoing
entities, practice the INVENTIONS and/or TECHNOLOGY RIGHTS of LICENSED PRODUCTS
and LICENSED PROCESSES. Subject to Paragraph 7.9, Company shall defend and hold
University, the Inventors, and any other inventors harmless as against any
judgments, fees, expenses, or other costs arising from or incidental to any
product liability or other lawsuit, claim, demand or other action brought as a
consequence of the practice of said inventions by any of the foregoing entities,
whether or not University or said inventor, either jointly or severally, is
named as a party defendant in any such lawsuit. Practice of the inventions
covered by LICENSED PRODUCTS and LICENSED PROCESSES from Company, shall be
considered Company's practice of said inventions for purposes of this Paragraph
7.8. The obligation of Company to defend and indemnify as set out in this
Paragraph 7.8 shall survive the termination of this Agreement.
7.9 University shall promptly notify Company in writing of any claim or
suit or threat thereof brought against University in respect of which
indemnification may be sought and, to the extent allowed by law, shall
reasonably cooperate with Company in defending or settling any such claim or
suit. No settlement of any claim, suit or threat thereof received by University
and for which University will seek indemnification, shall be made without the
prior written approval of Company. University will permit Company to defend
University against any such claim, suit or threat thereof and Company shall have
sole control over the
16
EXECUTION COPY
defense, subject to University's right to select its own counsel to review the
matter for University at University's sole cost and expense.
7.10 Commencing not later than the date of first commercial sale of a
LICENSED PRODUCT or LICENSED PROCESSES, Company shall use commercially
reasonable efforts to obtain and carry in full force and effect at a
commercially reasonable price product liability insurance against any claims,
judgments, liabilities and expenses for which it is obligated to indemnify
University under Paragraph 7.8 above, in such amounts and with such deductibles
and other limits as are determined reasonably necessary by mutual agreement of
the parties acting in good faith, in light of the availability of such insurance
and the custom at the customary time for similarly situated companies engaged in
similar business. University shall be named as an additional insured under any
such insurance policies.
7.11 This Agreement together with the STOCK PURCHASE AGREEMENT, the STOCK
OPTION AGREEMENT and the CRA constitutes the entire understanding between the
parties with respect to the obligations of the parties with respect to the
subject matter hereof, and supersedes and replaces all prior agreements,
understandings, writings, and discussions between the parties relating to said
subject matter.
7.12 This Agreement may be amended and any of its terms or conditions may
be waived only by a written instrument executed by the authorized officials of
the parties or, in the case of a waiver, by the party waiving compliance. The
failure of either party at any time or times to require performance of any
provision hereof shall in no manner affect its right at a later time to enforce
the same. No waiver by either party of any condition or term in any one or more
instances shall be construed as a further or continuing waiver of such condition
or term or of any other condition or term.
7.13 This Agreement shall be binding upon and inure to the benefit of and
be enforceable by the parties hereto and their respective successors and
permitted assigns.
7.14 Upon termination of this Agreement for any reason, Paragraphs 5.1,
5.3, 6.6, 6.8, 7.6, 7.7, 7.8 and 7.9 shall survive termination of this
Agreement.
17
EXECUTION COPY
IN WITNESS WHEREOF the parties hereto have executed this License
Agreement by their duly authorized officers as of the date first above written.
THE XXXXX XXXXXXX UNIVERSITY ONCORPHARM, INC.
BY: /s/ Xxxxx X. Xxxxx BY: /s/ Xxxxxxx X. Xxxx, Xx.
------------------------------ ------------------------------
TITLE: Executive Vice Xxxx TITLE: President and CEO
---------------------------- ---------------------------
I have read and agree to abide with the terms of this Agreement.
By /s/ Xxxx Xxxxxxxxx
-----------------------------
Xx. Xxxx Xxxxxxxxx
By /s/ Xxxxxx Xxxxxxx
-----------------------------
Xx. Xxxxxx Xxxxxxx
By /s/ Xxxxxx Silver
-----------------------------
Dr. Xxxxxx Silver
By /s/ Xxxxx Xxxx
-----------------------------
Xx. Xxxxx Xxxx
18
EXECUTION COPY
Schedule 2.3
1. Company has disclosed to University that Company already holds the
following licenses which may or may not be necessary for the development
and/or commercialization of certain LICENSED PRODUCTS and certain LICENSED
PROCESSES:
a. *
b. *
2. DNA amplification technologies may or may not be necessary for the
development and/or commercialization of certain LICENSED PRODUCTS and
certain LICENSED PROCESSES.
19
* CONFIDENTIAL TREATMENT REQUESTED
EXECUTION COPY
APPENDIX E
STANDARD MATERIAL TRANSFER AGREEMENT
FOR XXXXXXX DEVELOPED BIOLOGICAL OR CHEMICAL
MATERIALS, TO BE TRANSFERRED FOR NOT-FOR-PROFIT PURPOSES
Dear
Xxxxx Xxxxxxx University (JHU) agrees to provide you the material(s)
indicated below, which you requested from _______________________________ for
your nonclinical research studies. In order to protect JHU's ownership and
proprietary rights in the material(s) or its (their) progeny, portions, and
derivatives and modifications thereof (hereinafter "Materials"), we request that
you and an authorized official of your institution sign, date, and return this
letter agreement to us.
Material(s) identification:
Acceptance of the Material(s) by your institution confirms your agreement
to the following conditions:
1. This agreement and the resulting transfer of the Material(s)
constitute a personal, nonexclusive license to you to use the
Material(s) for nonprofit, nonclinical research purposes only. You
may only use the Materials in your institution's laboratories under
your supervision. The Material(s) will not be used in humans and
will be stored, used, and disposed of in accordance with applicable
law and regulations. The Material(s) will not be disclosed, provided
or used for any commercial purpose. This agreement is not assignable
and the Material(s) may not be transferred to another party. Except
for the foregoing license, JHU retains all right, title and interest
to the Materials, including but not limited to, all proprietary
rights.
2. Nothing in this Letter Agreement grants you (i) any rights under any
patents claiming the Material(s) or methods of their manufacture or
use or (ii) any rights to disclose, provide or use a Material(s) for
profit-making or commercial purposes. JHU shall have no obligation
to grant any license to you, and may grant exclusive or nonexclusive
licenses to others.
3. You are free to publish your work involving the Material(s). You
agree to provide JHU with a copy of any proposed publication which
contains results obtained from use of the Material(s) a reasonable
period of time before publication.
4. JHU makes no representations whatsoever as to the Material(s). They
are experimental in nature, may have hazardous properties, and are
provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. JHU
MAKES NO REPRESENTATION OR WARRANTY THAT THE USE OF THE MATERIAL(S)
WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
5. EXCEPT TO THE EXTENT PROHIBITED BY LAW, YOU AND YOUR INSTITUTION
ASSUME ALL LIABILITY FOR DAMAGES WHICH MAY
ARISE FROM YOUR OR YOUR INSTITUTION'S USE, STORAGE AND DISPOSAL OF
THE MATERIAL(S) OR ANY OTHER MATERIAL WHICH COULD NOT HAVE BEEN MADE
BUT FOR THE MATERIAL(S). JHU, ITS TRUSTEES, OFFICERS, EMPLOYEES,
AGENTS, AND ITS RESEARCH COLLABORATORS WILL NOT BE LIABLE UNDER ANY
CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY FOR ANY
DAMAGES, INCLUDING, WITHOUT LIMITATION, DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES.
6. Except to the extent prohibited by law, you and your institution
agree to defend, indemnify, and hold harmless JHU, its trustees,
officers, employees, agents and research collaborators from any
loss, claim, damage, or liability, of any kind whatsoever, which may
arise from you or your institution's use, storage, or disposal of
the Material(s) or any other material that could not have been made
but for the Material(s), except to the extent such arise due to the
gross negligence of JHU.
7. You shall not use the name of THE XXXXX XXXXXXX UNIVERSITY or THE
XXXXX XXXXXXX HEALTH SYSTEM or any of its constituent parts, such as
the Xxxxx Xxxxxxx Hospital or any contraction thereof or the name of
its employees or research collaborators, in any advertising,
promotional, sales literature or fundraising documents without prior
written consent from an officer of JHU.
8. Upon completion of your research, termination of this Agreement, or
at JHU's request at any time, you will either destroy the
Material(s) or return them to JHU.
To indicate you and your institution's agreement to these conditions, you
and an authorized official should sign and date this letter in the spaces
indicated below and return it to me. If you have any questions concerning this
agreement, you may call me at 000-000-0000.
Sincerely,
Xxxxxx X. Xxxxxxxx, Esq.
Assistant Xxxx and Director
Office of Technology Licensing
HWC:
Signature: _________________________________________
(Recipient Investigator Signature)
Name:
Title:
Date:
RECIPIENT INSTITUTION'S AUTHORIZED OFFICIAL
An Authorized Signature is that of an Institutional Official or Company Officer
specifically authorized to execute documents of this type on behalf of the
Institution.
Institution/Company: ________________________________
Signature:___________________________________________
Name:
Title:
Date:
