CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTION.
EXHIBIT 10.16
THE XXXXX XXXXXXX UNIVERSITY
BIONUMERIK PHARMACEUTICALS, INC.
JOINT COLLABORATION, LICENSING, AND CLINICAL TRIALS AGREEMENT
THIS AGREEMENT (the "Agreement") is made as of February 9, 2005 (the
"Effective Date") by and between The Xxxxx Xxxxxxx University, organized and
existing under the laws of the State of Maryland with a principal place of
business at 000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 (the
"University") and BioNumerik Pharmaceuticals, Inc., a Texas corporation with its
principal place of business at Suite 1250, 0000 Xxxxxxxxx Xxxxx, Xxx Xxxxxxx,
Xxxxx 00000 (the "Company").
RECITALS
WHEREAS the Company wishes to obtain the opportunity to discuss new
technical developments with a view to potential licenses of certain inventions
discovered and/or developed at the Xxxxxx Xxxxxx Comprehensive Cancer Center at
Xxxxx Xxxxxxx (the "Center");
WHEREAS the Center believes that the Company is skillful in the
commercialization of pharmaceutical compounds and seeks to benefit economically
from the Company's efforts;
WHEREAS the Center desires to conduct certain clinical trials for the
Company on an agreed basis;
WHEREAS in consideration of such basis, the Company is willing to give the
Center certain first option rights on any clinical trials to be conducted by the
Company; and
WHEREAS in consideration for these collaborations, the Company will pay to
the Center [**] with the execution and delivery of this Agreement and an
additional [**] on each of the next [**] anniversaries thereof.
NOW, THEREFORE, the Parties agree as follows:
PART I
TECHNICAL COLLABORATION
1.1 General. This Agreement anticipates a five-year collaboration between
the University and the Company (the "Collaboration") providing for the further
development by the Company of compounds invented by members of the faculty of
the Center (collectively, the "Center Faculty") for the treatment of solid
tumors and hematologic malignancies and the potential applications of such
compounds ("Oncology Drugs").
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.2 Term. The Collaboration will take place during the period commencing
on the Effective Date and continuing for five years thereafter, provided that
the Collaboration and this Agreement may be earlier terminated by either the
University or the Company by providing written notice to the other party at
least 90 days prior to the anniversary date of the Effective Date (the "Next
Anniversary Date") that next follows the date on which such notice of
termination is provided.
In the event of such a notice of termination, this Agreement and all
rights and obligations of the University and the Company hereunder shall
terminate effective as of the Next Anniversary Date, provided that the rights
and obligations under Sections 1.3, 1.4, 1.6, 1.9, 1.10, and 1.11 of this
Agreement shall survive any such termination and continue in effect in
accordance with their terms. In addition, in the event of such an early
termination pursuant to this Section 1.2, the Company shall have no further
obligation to make payments that would otherwise be due under Part III, Section
3.1 of this Agreement with respect to anniversaries of the Effective Date of
this Agreement that occur after the date such notice of termination is provided
in accordance with this Section 1.2.
1.3 Company's Option.
(a) The University hereby grants to the Company a first option to a
worldwide, royalty bearing, exclusive license to inventions of the Center
Faculty that are made in the course of performing research funded by this
Agreement, subject to the rights of any additional sponsors including U.S.
Government rights under 35 U.S.C. Sections 200-212. Inventions discovered
through research funded by the Company are hereinafter referred to as
"University Inventions". Within 90 days after any termination of this Agreement,
the University will provide the Company with an Invention Notice of any
University Inventions with respect to which the Company has not been previously
notified.
(b) The University hereby grants to the Company a first option to a
worldwide, royalty bearing, exclusive license to selected Oncology Drugs
invented by Center Faculty without the Company's financial support and which are
unencumbered by the licensing rights of commercial third parties. Inventions
discovered without the Company's financial support are hereinafter referred to
as "Selected Inventions."
(c) The Company shall have sixty (60) days from the date of receipt of an
Invention Notice (defined in Section 1.6) to request that the parties enter
license negotiations. In the event that the Company and the University determine
to enter into a license negotiation with respect to a University Invention or
Selected Invention, the University and the Company will begin such negotiations
using the general license form attached hereto as Exhibit A but further
negotiation between the parties will be unrestricted. The Office of Technology
Licensing of the University's School of Medicine will represent the University
in such negotiations.
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1.4 Ownership of Collaboration Results. All inventions and discoveries
shall be owned by the party making the invention or discovery. Any inventions
deemed to be jointly made by the Company and the University shall be owned
jointly by the Company and the University and subject to their respective
license. Record title to patents and patent applications for University
Inventions and/or Selected Inventions shall be held by the University. Record
title to patents and patent applications for inventions made jointly by the
University and the Company shall be joint and subject to their respective
license.
1.5 Other Collaborations. Each of the University and the Company shall be
free to conduct other research, whether under the sponsorship of or in
collaboration with, the federal government or other third parties, or otherwise,
provided that the terms and conditions of any such research, sponsorships, or
collaborations shall not conflict with the terms of this Agreement.
1.6 Notice. The Center Faculty will promptly notify the Office of
Technology Licensing of the University's School of Medicine (the "Licensing
Office") in writing of any University Invention or Selected Invention (the
"Invention Notice"). The Invention Notice will include a detailed written
description of such invention. When a University Invention is not encumbered by
the licensing rights of commercial third parties, the Licensing Office shall
notify the director of the Center, who will promptly submit the Invention Notice
to the Company. In the case of a Selected Invention, the Licensing Office and
the director of the Center will review the Selected Invention and jointly
determine whether the Company is a logical licensee, who is as capable of
developing and commercializing the Selected Invention as other potential
licensees. If the Licensing Office and the director of the Center agree that the
Company is the logical licensee, the director of the Center will promptly submit
the Invention Notice to the Company.
1.7 Educational Advancement. The University does not guarantee that any
patentable or non-patentable Oncology Drugs will result from the Collaboration.
The Company understands that the University's primary mission is educational and
that the Collaboration is intended to forward that mission.
1.8 Consultation. The Company will make available its chief-executive
officer, Xxxxxxxxx X. Xxxxxxxx, M.D. ("Xx. Xxxxxxxx"), to xxxxxx on-site, one
day per year, with the Center, the Center Faculty, and the Center's
investigators and researchers concerning Oncology Drugs developed by the Center
Faculty. Xx. Xxxxxxxx'x consultations will be without charge to the University.
1.9 Confidentiality. During the period this Agreement is in effect and for
a period of three (3) years thereafter, the University and the Company agree to
keep in confidence and to use solely as contemplated in this Agreement all
information received from the other party under this Agreement or obtained
pursuant to or in connection with the Collaboration. All reasonable efforts will
be used to avoid disclosure to any third party of any information supplied or
developed under this Agreement, unless the prior written consent of the other
party is obtained. The preceding confidentiality requirements will not extend to
any information which (a) is or becomes public knowledge, after the time it
becomes public; (b) the receiving party can show by written or other tangible
evidence was in its possession at the time of disclosure hereunder and
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which the receiving party without breach of any obligation is free to disclose
to others; (c) was received by the receiving party from a third party who did
not acquire it, directly or indirectly, from the disclosing party under any
obligation of confidentiality and which the third party is free to disclose to
others; (d) is required to be disclosed by a court of law or by the regulations
of a federal agency, subject to the earliest practical notification by the party
obligated to make such disclosure so as to enable the other party to obtain such
protective orders as may be available; or (e) is independently developed by the
receiving party and which the receiving party can show by written or other
tangible evidence was so independently developed.
1.10 Publication. Notwithstanding the foregoing, and except for
information supplied by the Company and not otherwise known to the University,
the University may publish in scientific journals research results arising from
activities funded by the Company, from University Inventions, and from Selected
Inventions for which the Company is given notice pursuant to Section 1.6, in
accordance with the following procedures:
(a) the University will submit the proposed manuscript to the
Company at least thirty (30) days prior to submission for publication; and
(b) within thirty (30) days of the receipt of such manuscript, the
Company will advise the University whether the Company has determined that the
manuscript contains patentable subject matter relating to a University Invention
and whether the Company wishes that a patent application be filed.
If the Company notifies the University that the manuscript includes no
confidential information and/or that the Company does not wish patent action to
be taken, or if the Company does not so notify the University within the thirty
(30) day period, the University will be free to publish. If the Company wishes
patent action to be taken, it will notify the University of its decision and
patent protection will be sought pursuant to Section 1.11. Neither the
University nor any of its employees will submit the manuscript for publication
or disclose its contents to third parties until patent applications have been
filed. The patent application(s) will be filed within ninety (90) days of the
University's receipt of the Company's notice requesting that the University seek
patent protection. After the earlier of ninety (90) days or the filing of a
patent application, the University will be free to submit and publish the
manuscript. However, no publication of any compounds, structures or other
information which is confidential information of BioNumerik will be made by the
University without the prior written consent of the Company, which consent will
not be unreasonably withheld.
1.11 Patents. Except as provided in Section 1.10, the Company may for a
period of sixty (60) days after the Company's receipt of the Invention Notice
elect to seek patent protection for any University Invention or Selected
Invention with respect to which it negotiates a license. In the event the
Company determines to seek patent protection, the Company will inform the
University in writing of its election. The University will then cause to be
prepared, filed, prosecuted, and maintained at the Company's expense patent
applications and/or patents resulting therefrom, provided, however, that in the
event that the Company and the University are unable to negotiate a license for
such invention, the Company's liability for any additional patent
-4-
expenses shall cease upon the University's receipt of the Company's written
notification that it no longer wishes to continue negotiations, and the
University will, upon licensing the invention to a commercial third party,
reimburse the Company for all patent expenses which the Company incurred. Such
patent preparation, filing, prosecution, and maintenance will be performed
through outside patent counsel selected by the University and approved by the
Company, which approval will not be unreasonably withheld. In the event the
Company determines not to seek patent protection as provided herein, the
University will be free to seek such protection at the University's expense.
PART II
CLINICAL TRIAL AGREEMENT
2.1 Clinical Trials. The Company hereby grants to the Center a first
option to negotiate to conduct evaluative clinical trials of Oncology Drugs
developed or invented by the Company (the "Trials"). The first option granted
herein will expire thirty (30) days after the University's receipt of a written
notice identifying the Oncology Drug developed or invented by the Company and
containing an initial draft of the proposed investigational new drug application
("IND") to be filed with the Food and Drug Administration. In the event the
University and the Company are unable to agree upon the material terms of a
clinical trials agreement within such thirty (30) day period, the University's
rights herein shall terminate with respect to that Oncology Drug. In addition,
nothing herein shall prevent the Company from conducting negotiations with other
potential clinical trial sites concurrently with its negotiations with the
University. In connection with any agreement entered with respect to the Trials,
the Company agrees to reimburse the University's direct and indirect costs,
provided, however, that the University agrees that total indirect costs for such
Trials will not exceed [**] of total direct costs, and the costs and terms of
such Trials will otherwise be in accordance with and no less favorable to the
Company than clinical trial agreements Center may have with other sponsors.
PART III
PERIODIC PAYMENTS
3.1 Upon the execution and delivery of this Agreement by the University,
the Company will pay to the Center [**]. Upon each of the next [**] succeeding
anniversaries of the Effective Date of this Agreement, the Company will pay to
the Center an additional [**]. In addition, the Center and the Company will
discuss in good faith and determine a reasonable portion of the above-referenced
annual amount paid to the Center that will be allocated to fund a fellowship or
other research agreed upon by the Company and the Center.
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
-5-
PART IV
MISCELLANEOUS
4.1 University Name. The Company will not use the name, likeness, or logo
of the Xxxxx Xxxxxxx University; its Schools, Divisions, Departments, or
Centers; The Xxxxx Xxxxxxx Hospital and Health System; or Xxxxx Xxxxxxx'
faculty, employees, students, or trustees in any of the Company's fund-raising
documents, publications, advertisements, or marketing and promotional materials
without the prior written consent of the University. The University shall have
three business days from the date of receipt of the Company's request for
written consent to review such request.
4.2 Breach/Default. Upon breach or default of any of the terms and
conditions of this Agreement, the non-defaulting party will deliver a written
notice of such default to the defaulting party (the "Default Notice"). If the
default is not cured within sixty (60) days after the defaulting party's receipt
of the Default Notice, the non-defaulting party may terminate this Agreement
upon written notice provided by the non-defaulting party to the defaulting
party.
4.3 Assignment. This Agreement may not be assigned or transferred by any
party without the prior written consent of the parties, provided, however, that
the Company may assign or transfer its rights and obligations under this
Agreement to a successor to all or substantially all of its assets or business,
whether by sale, merger, operation of law, or otherwise, and the Company shall
provide written notice to the University of any such assignment.
4.4 Independent Contractor. For the purposes of this Agreement and all
services to be provided hereunder, the parties will be and will be deemed to be
independent contractors and not agents or employees of the other party. Neither
party will have authority to make any statement, representation, or commitment
of any kind, or to take any action which will be binding on the other party,
except as may be expressly provided for herein or authorized in writing.
4.5 Waiver and Amendment. The terms of this Agreement may be waived or
amended only with the written consent of the parties.
4.6 Entire Agreement. This Agreement constitutes the full and entire
understanding and agreement between the parties with regard to the subjects
hereof, and no party shall be liable or bound to any other party in any manner
by warranties, representations, or covenants except as specifically set forth
herein. In addition to this Agreement, the existing Collaboration Agreement,
dated as of November 19, 2001, between the Company and the University regarding
the area of DNA methylation, the Master Clinical Trial Research Agreement, first
dated as of March 9, 1995, between the University and the Company, and the
related protocol, confidentiality and other agreements between the University
and the Company, shall each remain and continue in full force and effect after
the date hereof in accordance with their terms.
-6-
4.7 Notices. Any notice required by this Agreement shall be effective upon
deposit in the U.S. mail when given by prepaid, first class, certified mail,
return receipt requested, addressed to:
If to the University: Xxxxxxx X. Xxxx
Associate Xxxx for Research Administration
The Xxxxx Xxxxxxx University School of Medicine
000 X Xxxxxxxx Xxxxxx, XXX 000
Xxxxxxxxx, Xxxxxxxx 00000
with a copy to: Xxxxxx X. Xxxxxxx, M.D.
Professor and Director
Xxxxxx Xxxxxx Comprehensive Cancer Center at Xxxxx Xxxxxxx
000 X Xxxxxxxx, Xxxxxxxx 0000
Xxxxxxxxx, Xxxxxxxx 00000-0000
If to the Company: Xxxxxxxxx X. Xxxxxxxx, M.D.
Chairman and Chief Executive Officer
BioNumerik Pharmaceuticals, Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 0000
Xxx Xxxxxxx, Xxxxx 00000
4.8 Governing Law. This Agreement shall be governed in all respects by and
construed in accordance with the laws of the State of Maryland as applied to
agreements among Maryland residents to be performed entirely in Maryland.
4.9 Headings. The headings of the several sections of this Agreement are
intended for convenience of reference only and are not intended to be a part of
or to affect the meaning or interpretation of this Agreement.
4.10 Severability. If any provision of this Agreement shall be found by a
court to be void, invalid, or unenforceable, the validity, legality, and
enforceability of the remaining provisions shall not be in any way affected or
impaired thereby.
4.11 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but each of which together shall constitute
one and the same instrument.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first above written.
THE XXXXX XXXXXXX UNIVERSITY BIONUMERIK PHARMACEUTICALS, INC.
By: /s/ XXXXXXX X. XXXX By: /s/ XXXXXXXXX X. XXXXXXXX
------------------------------ -------------------------------------
Name: Xxxxxxx X. Xxxx Name: Xxxxxxxxx X. Xxxxxxxx, M.D.
Title: Associate Xxxx Title: Chairman & Chief Executive Officer
Date: 3-8-05 Date: 2-28-05
------------ -------------
The undersigned have read this Agreement and agree to its terms:
/s/ XXXXXX X. XXXXXXX
___________________________________
Xxxxxx X. Xxxxxxx, M.D.
/s/ XXXXXXX XXXXXX
___________________________________
Xxxxxxx Xxxxxx, M.D.
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