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 10.13
COLLABORATION AGREEMENT
Between
The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
and
BioNumerik Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT (this "Agreement") is entered into effective as of
November 19, 2001 by and between BioNumerik Pharmaceuticals, Inc., a Texas
corporation ("BioNumerik" or the "Company") and The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University, a
Maryland corporation (the "Institution"). BioNumerik and the Institution,
intending to be legally bound, agree as follows:
WHEREAS, the Institution and BioNumerik have previously established a joint
research program in which BioNumerik and the Institution are collaborating on
the discovery and development of novel therapeutic agents that modulate DNA
methylation in cancer.
WHEREAS, the Institution and BioNumerik wish to continue their joint research
program and collaboration on the discovery and development of novel therapeutic
agents that modulate DNA methylation in cancer.
NOW, THEREFORE, the parties hereto agree as follows:
1. TERM OF RESEARCH PROGRAM. Subject to the provisions for termination
hereinafter provided, the term of the research program to be conducted pursuant
to this Agreement (the "Program") shall be for a period (the "Program Term")
commencing November 19, 2001 and terminating at the close of business on
November 19, 2006.
2. PRINCIPAL INVESTIGATORS. For as long as he remains at the Institution, ▇▇.
▇▇▇▇▇▇▇ ▇▇▇▇▇▇ shall direct and act as principal investigator for the
Institution's portion of the Program. During the Program Term, ▇▇. ▇▇▇▇▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇ shall direct and act as principal investigator for the BioNumerik
portion of the Program.
3. SCOPE OF THE PROGRAM.
(a) Year One Program Objectives.
The overall Program will be aimed at the discovery and development of novel
therapeutic agents that modulate DNA methylation in cancer and possibly have
therapeutic benefit in other areas. The focus of the Program will be to
synthesize, patent and test novel chemical entities which target cancer cells
with altered DNA methylation. ▇▇. ▇▇▇▇▇▇ and ▇▇. ▇▇▇▇▇▇▇▇ shall work together to
develop and agree upon a definitive outline of the work to be conducted during
the first year of the Program. Thereafter, the Program will be conducted
pursuant to a definitive annual research plan to be agreed upon by the
Institution and BioNumerik at least 30 days before the commencement of each
future year of the Program.
It is intended that the Program research will include the following:
i) BioNumerik will endeavor to identify and synthesize molecules,
which may be patentable or unpatentable, for the purpose of identifying and
meeting molecular requirements for drug modulation of DNA methylation events.
ii) ▇▇. ▇▇▇▇▇▇ and the Institution will focus laboratory efforts and ▇▇.
▇▇▇▇▇▇'▇ personal expertise on the elucidation and clarification of key
mechanism(s) for optimal therapeutic targeting in cancer cells which involve
aberrant DNA methylation.
iii) BioNumerik will work to develop and refine robust and detailed
atomistic and chemical structural models and perform physics-based computer
simulations that describe the biological, thermodynamic, structural and
biochemical mechanisms that are the focus of the laboratory work of the
Institution under the Program and to use these models and information in the
design and synthesis of its new chemical entities as described above.
iv) The Institution will conduct in vitro testing of the new compounds
discovered and synthesized by BioNumerik for their ability to influence aberrant
DNA methylation with a view to identifying the most potent and desirable
potential therapeutic entity to advance to clinical trials in humans.
4. ADDITIONAL BIONUMERIK RESPONSIBILITIES.
(a) The work to be conducted by the Institution under this Agreement will
be funded out of the [**] amounts paid by BioNumerik to Institution pursuant to
the Joint Collaboration, Licensing, and Clinical Trials Agreement, dated as of
February 9, 2000, between BioNumerik and The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University.
(b) BioNumerik will also undertake sole responsibility for endeavoring to
obtain patent protection (including payment of future patent filing fees) on new
chemical entities which are developed under the Program and which are identified
as either joint inventions or sole inventions of BioNumerik, in the United
States and such other countries in the remainder of the world as BioNumerik may
determine. The Institution will cooperate with BioNumerik in providing such
information and assistance, and executing such documents and instruments, as may
be requested by BioNumerik from time to time in connection with prosecution of
patents relating to the joint Inventions (as hereinafter defined). The
Institution will take responsibility for obtaining U.S. and international patent
protection for all sole Institution inventions.
(c) BioNumerik will be responsible for supporting the preclinical and
clinical development of a new drug which is intended for possible human
treatment in the focus area of the Program. As described in Section 9, the
Institution will have a right of first offer to take the selected novel
therapeutic entity into clinical trials.
5. PUBLICATION RIGHTS.
▇▇. ▇▇▇▇▇▇ and the Institution shall have rights to publish the results of the
collaborative research work conducted pursuant to the Program that are
consistent with the rights normally associated with collaborative academic and
industry research, subject, in all cases, to prepublication notice sent to
BioNumerik at least 30 days in advance of publication submission and
prepublication review by BioNumerik. No publication of any compounds, structures
or other information which is Confidential Information (as defined below) of
BioNumerik will be made by the Institution or
[**] 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.
▇▇. ▇▇▇▇▇▇ without the prior written consent of BioNumerik (which consent will
not be unreasonably withheld and in any event will not be withheld longer than
90 days after receipt of a manuscript of the proposed publication). ▇▇. ▇▇▇▇▇▇,
the Institution and BioNumerik further agree to delay publication for up to 90
days when requested by BioNumerik to permit patent applications to be filed or
where otherwise requested by BioNumerik to protect business strategy or
intellectual property rights. Authorship on any specific publication resulting
from the Program will be determined jointly by ▇▇. ▇▇▇▇▇▇ and ▇▇. ▇▇▇▇▇▇▇▇.
6. CONFIDENTIALITY.
Each party to this Agreement (a "receiving party") who receives Confidential
Information (as defined below) disclosed by the other party to this Agreement (a
"disclosing party") shall not, during the term of this Agreement and for five
(5) years after termination of this Agreement, make use of or disclose, without
the prior written consent of the disclosing party, Confidential Information
disclosed by the disclosing party or any of its Affiliates. Each receiving party
further agrees that it will return to each disclosing party all written
materials in its possession embodying Confidential Information of such
disclosing party. For purposes of this Agreement, "Confidential Information"
includes intellectual property or other information obtained by a receiving
party from a disclosing party and which is marked as confidential or which the
disclosing party could reasonably be expected to desire be held in confidence,
or the disclosure of which would likely be embarrassing, detrimental or
disadvantageous to the disclosing party or its Affiliates. Confidential
Information, however, shall not include information (a) which is, at the time in
question, in the public domain through no wrongful act of the receiving party,
(b) which is later disclosed to a receiving party by one not under obligations
of confidentiality to the disclosing party, or (c) which is required by court or
governmental order, to be disclosed. Each of the Institution and ▇▇. ▇▇▇▇▇▇
recognizes and agrees that BioNumerik shall at all times during this Agreement
and after termination of this Agreement retain ownership of its patents,
copyrights, trade secrets and other proprietary information and neither ▇▇.
▇▇▇▇▇▇ nor the Institution shall have any right to use or disclose any such
patents, copyrights, trade secrets or other proprietary information unless
consented or agreed to in writing by BioNumerik. BioNumerik recognizes and
agrees that the Institution shall at all times during this Agreement and after
termination of this Agreement retain ownership of its patents, copyrights, trade
secrets and other proprietary information and BioNumerik shall not have any
right to use or disclose any such patents, copyrights, trade secrets or other
proprietary information except as provided herein or in other written agreements
with the Institution.
7. REPORTING AND RECORD KEEPING.
Written progress reports will be exchanged by the parties at least twice a year.
Interim data will be provided, reviewed and jointly discussed by the parties in
the interim. It is agreed that each party hereto and its authorized
representative(s), and regulatory authorities to the extent required by law,
may, during regular business hours, arrange in advance with the other party to:
(1) examine and inspect such other party's facilities required for performance
of the Program; and (2) inspect and copy on a confidential basis all data and
work products of such party relating to the Program. Each party shall prepare
and maintain complete and accurate written records, accounts, reports and data
of the research conducted by it under the Program.
8. INTELLECTUAL PROPERTY.
(a) Inventions. For purposes of this Agreement, " Inventions" shall mean
any invention, method or discovery, or improvements, whether patentable or not,
conceived or reduced to practice during and as a part of the research performed
pursuant to or in accordance with the Program (i) solely by ▇▇. ▇▇▇▇▇▇ and/or
the Institution's staff or employees supervised by him, or (ii) jointly by such
an individual or individuals with one or more employees of BioNumerik. All such
Inventions developed solely by ▇▇. ▇▇▇▇▇▇ and/or the Institution's staff or
employees supervised by him shall be owned by the Institution, subject to the
licensing provisions set forth in this Section 8. All jointly developed
Inventions shall be owned jointly by the Institution and BioNumerik, subject to
the licensing provisions set forth in this Section 8. All inventions and
discoveries arising out of the Program that are developed solely by BioNumerik
shall be owned solely by BioNumerik.
(b) Grant of License. The Institution will grant to BioNumerik an
exclusive, world-wide, royalty bearing license, which license (the "License
Agreement") will be in the form contained in Exhibit A hereto, for both sole and
joint rights of the Institution with respect to Inventions (including the right
to grant sublicenses). Such grant is subject to the retained right of the
Institution to make, have made, provide and use for its and The ▇▇▇▇▇ ▇▇▇▇▇▇▇
Health System's non-profit internal research purposes Inventions. Should any
federal grant money be used to develop Inventions, this grant shall also be
subject to the rights retained by the United States Government under P.L.
96-517, as amended by P.L. 98-620. The Institution will sign any amendments to
the License Agreement as may be necessary to add any Invention for inclusion in
the License Agreement after the Institution and BioNumerik have agreed upon a
royalty rate for the Invention, which royalty rate will be within the ranges
contained in Exhibit A. If no amendments have been made to the attached License
Agreement within (6) six months of the expiration of this Collaboration
Agreement, the License Agreement will terminate.
The Institution agrees to give BioNumerik notice prior to using any federal
grant money in connection with the Program. The Institution further agrees to
use reasonable measures to protect trade secrets and other intellectual property
rights that are covered by the Institution's retained right contained in this
Section 8(b).
9. RIGHT OF FIRST OFFER TO CONDUCT CLINICAL TRIALS.
BioNumerik hereby grants the Institution a first right to negotiate to
conduct evaluative clinical trials of drugs developed by BioNumerik under the
Program (the "Trials"). The right granted under this Section 9 will expire [**]
days after the Institution's receipt of a written notice identifying the drug
developed by BioNumerik under the Program and containing an initial draft of the
proposed commercial investigational new drug application ("IND") to be prepared
and filed by BioNumerik with the Food and Drug Administration. In the event the
Institution and BioNumerik are unable to agree upon the material terms of a
clinical trials agreement within an additional thirty (30) day negotiation
period, the Institution's right to conduct clinical trials as provided herein
shall terminate with respect to that drug. In connection with any agreement
entered into with respect to the Trials, BioNumerik agrees to reimburse the
Institution's direct and indirect costs, provided, however, that the Institution
agrees that total indirect costs for such trials shall not exceed [**] of total
direct costs for off-campus based studies.
[**] 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.
10. NONCOMPETITION.
The Institution represents to BioNumerik that ▇▇. ▇▇▇▇▇▇ is not and that
he will not during the term of the Program conduct research with any party other
than BioNumerik on compounds or technology that would be included within the
area of the Program. Neither ▇▇. ▇▇▇▇▇▇ nor the Institution shall use any
information, testing data or compound data relating to BioNumerik compounds in
any other research sponsored by commercial entities unless consented to by
BioNumerik in writing. In addition, the Institution recognizes and agrees that,
except as expressly provided herein or in other written agreements between
BioNumerik and the Institution, BioNumerik shall have no obligation to pay ▇▇.
▇▇▇▇▇▇ or the Institution royalties or any other payments with respect to sales
or other revenues or proceeds received by BioNumerik.
11. PROGRAM DURATION / TERMINATION.
The Program will have a term of five years commencing and ending as
provided in Section 1 of this Agreement. Notwithstanding any other provision of
this Agreement, either party hereto shall have the right at its option to
terminate the Program at any time after year one of the Program by giving 90
days prior written notice to the other party. In the event of termination of the
Program by BioNumerik or the Institution, all rights and duties arising under
the Program and Sections 1, 2, 3 and 4 of this Agreement shall cease as of the
date of such termination. All other provisions of this Agreement, including
without limitation the rights and obligations under Section 8 hereof, shall
survive and continue after any such termination in accordance with their terms.
12. CONSTRUCTION. Each party to this Agreement has had the opportunity to review
this Agreement with its legal counsel. This Agreement shall not be construed or
interpreted against any party on the basis that such party drafted or authored a
particular provision, parts of or the entirety of this Agreement.
13. ASSIGNMENT. This Agreement and the rights and obligations hereunder may not
be assigned by either party without the prior consent of the other party;
provided, however, that BioNumerik may assign this Agreement without consent to
any entity which acquires all or substantially all of its assets or business,
whether by merger or otherwise.
14. NOTICES. Any notice, consent or approval required under this Agreement shall
be in writing sent by registered or certified airmail, postage prepaid, or by
fax or telex (confirmed by such registered or certified mail) and addressed as
follows:
If to the Institution: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇
Assistant ▇▇▇▇ for Research Administration
The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University School of Medicine
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇-▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
with a copy to: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D.
The ▇▇▇▇▇ ▇▇▇▇▇▇▇ Oncology Center
▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
If to BioNumerik: ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, M.D.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
All notices shall be deemed to be effective three business days after the
date of mailing. In case any party changes its address at which notice is to be
received, written notice of such change shall be given without delay to the
other party.
15. ENTIRE AGREEMENT. This Agreement sets forth the entire agreement and
understanding among the parties hereto as to the subject matter hereof and has
priority over all documents, verbal consents or understandings made between the
parties hereto before the conclusion of this Agreement with respect to the
subject matter hereof. None of the terms of this Agreement shall be amended or
modified except in writing signed by the parties hereto. In addition, that
certain Joint Collaboration, Licensing and Clinical Trials Agreement, dated as
of February 9, 2000, between the Institution and BioNumerik; and that certain
Master Clinical Trial Research Agreement, dated as of April 3, 1995, between the
Institution and BioNumerik shall continue in full force and effect in accordance
with their terms.
16. WAIVERS. A waiver by any party of any term or condition of this Agreement in
any one instance shall not be deemed or construed to be a waiver of such term or
condition for any similar instance in the future or of any subsequent breach
hereof.
17. SEVERABILITY. Should any provision of this Agreement be held to be invalid,
unenforceable, or against public policy, the remaining provisions hereof shall
not be affected thereby. In such event, the parties hereto shall negotiate in
good faith to modify this Agreement so as to effect the original intent of the
parties as closely as possible with respect to those provisions which were held
to be invalid, unenforceable or against public policy.
18. UNIVERSITY NAME. BioNumerik shall not use the name, likeness, or logo of the
▇▇▇▇▇ ▇▇▇▇▇▇▇ University; its Schools, Divisions, Departments, or Centers; The
▇▇▇▇▇ ▇▇▇▇▇▇▇ Hospital and Health System; or ▇▇▇▇▇ ▇▇▇▇▇▇▇' faculty, employees,
students, or trustees in any advertising, promotional, or sales material,
whether oral or written, without the prior consent of the Institution or unless
otherwise required by law, provided that BioNumerik may list the name of
Institution and the existence of the Research Agreement and the License
Agreement on BioNumerik's web site and in other general informational materials.
IN WITNESS WHEREOF, the parties have executed this Agreement effective as of
November 19, 2001.
THE ▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇
------------------------------------------
▇▇▇▇▇▇▇ ▇. ▇▇▇▇
Title: Assistant ▇▇▇▇ for Research Administration
BIONUMERIK PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
------------------------------------------
▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, M.D.
Chief Executive Officer
READ AND UNDERSTOOD:
/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
-------------------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇, M.D.
EXHIBIT "A" TO
COLLABORATION AGREEMENT
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE ▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY
&
BIONUMERIK PHARMACEUTICALS, INC.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "Agreement") is entered into by and between
THE ▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY, a Maryland corporation having an address at ▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("JHU") and BioNumerik
Pharmaceuticals, Inc, a Texas corporation having an address of ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("Company"), with respect to the
following:
RECITALS
WHEREAS, as a center for research and education, JHU is interested in
licensing PATENT RIGHTS (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, a course of research to discover and develop therapeutic agents
that modulate DNA methylation in cancer, funded at least in part by Company, has
been and will be conducted by ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ and/or JHU's staff or employees
supervised by ▇▇. ▇▇▇▇▇▇ (hereinafter "JHU Inventors") in collaboration with
Company; and
WHEREAS, JHU will acquire, through assignment of rights, title and
interest, with the exception of certain retained rights by the United States
government, an interest in any Inventions made by JHU Inventors during such
course of research; and
WHEREAS, Company may desire to commercially develop, manufacture, use and
distribute such Inventions throughout the world;
NOW THEREFORE, in consideration of the premises and the mutual promises
and covenants contained in this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
parties hereto agree as follows:
ARTICLE I
DEFINITIONS
All references to particular Exhibits and Articles shall mean the Exhibits
to, and Articles of, this Agreement, unless otherwise specified. For the
purposes of this Agreement and the Exhibits hereto, the following words and
phrases shall have the following meanings:
1.1 "AFFILIATED COMPANY" as used herein in either singular or plural shall
mean any corporation, company, partnership, joint venture or other entity, which
controls, is controlled by or is under common control with Company. For purposes
of this Paragraph 1.1, control shall mean the direct or indirect ownership of a
majority of the voting shares or the direct or indirect entitlement to appoint a
majority of the directors of the other entity.
1.2 "BIOLOGICAL MATERIAL" shall mean materials in JHU's possession that
have been developed solely or jointly by JHU Inventors of PATENT RIGHTS and are
listed in Exhibit C, as amended from time to time by the parties hereto and any
functional equivalents, portions, progeny, derivatives or modifications thereof
made by Company.
1.3 "EFFECTIVE DATE" of this License Agreement shall mean the date that
Company provides written Notice of its intent to add an invention made under the
RESEARCH AGREEMENT to this License Agreement by first Amendment to this
Agreement (Exhibit D). This Notice must be given in duplicate to The ▇▇▇▇▇
▇▇▇▇▇▇▇ School of Medicine (JHUSOM) Office of Technology Licensing (OTL) and the
JHUSOM Office of Research Administration (ORA). This Notice will be binding.
1.4 "EXCLUSIVE LICENSE" shall mean a grant by JHU to Company of its entire
right and interest in the PATENT RIGHTS 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 JHU to make, have made, provide and use for its
and The ▇▇▇▇▇ ▇▇▇▇▇▇▇ Health Systems' non-profit internal research purposes
LICENSED PRODUCT and LICENSED SERVICE, including the ability, following notice
to Company, to distribute any biological material for nonprofit academic
research use to non-commercial entities as is customary in the scientific
community.
1.5 "INVENTIONS" shall mean "Inventions" as defined in the RESEARCH
AGREEMENT.
1.6 "LICENSED FIELD" shall mean all fields of potential medical and
non-medical uses for the inventions.
1.7 "LICENSED PRODUCT" as used herein in either singular or plural shall
mean any material, composition, drug, or other product, or any process or
method, the manufacture, use or sale of which would constitute, but for the
license granted to Company pursuant to this Agreement, an infringement of a
claim of PATENT RIGHTS (infringement shall include, but is not limited to,
direct, contributory, or inducement to infringe) or is, incorporates or uses a
BIOLOGICAL MATERIAL in its manufacture.
1.8 "LICENSED SERVICE" as used herein in either singular or plural shall
mean the performance on behalf of a third party of any method or the manufacture
of any product or the use of any product or composition which would constitute,
but for the license granted to Company pursuant to this Agreement, an
infringement of a claim of the PATENT RIGHTS, (infringement shall include, but
not be limited to, direct, contributory or inducement to infringe); or
incorporates or uses a BIOLOGICAL MATERIAL.
1.9 "NET SALES" shall mean gross sales revenues and fees billed by Company
or AFFILIATED COMPANY from the sale of LICENSED PRODUCT less trade discounts
allowed, refunds, rebates, returns and recalls, transportation charges, duties
and taxes (including sales taxes). In the event that Company or AFFILIATED
COMPANY sells a LICENSED PRODUCT in combination with other ingredients or
substances or as part of a kit, the NET SALES for purposes of royalty payments
shall be based on the sales revenues and fees received from the entire
combination or kit.
1.10 "NET SERVICE REVENUES" shall mean gross service revenues and fees
billed by Company or AFFILIATED COMPANY for the performance of LICENSED SERVICE
less sales and/or use taxes imposed upon and with specific reference to the
LICENSED SERVICE. In the event that Company or AFFILIATED COMPANY sells a
LICENSED SERVICE in combination with other services or substances or as part of
a kit, the NET SERVICE
REVENUES for purposes of royalty payments shall be based on the sales revenues
and fees received from the entire combination.
1.11 "PATENT RIGHTS" shall mean patents and patent applications listed on
Exhibit D hereto, as amended from time to time by mutual consent of the parties
hereto, and all continuations, divisions, and reissues based thereof, and any
corresponding foreign patent applications, and any patents or other equivalent
foreign PATENT RIGHTS issuing, granted or registered thereon. It is understood
that inventions and discoveries arising out of the Program (as defined in the
Research Agreement) that are developed solely by BioNumerik shall be owned
solely by BioNumerik and are not included in Patent Rights.
1.12 "RESEARCH AGREEMENT" shall mean the Collaboration Agreement entitled
"COLLABORATION AGREEMENT between The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University and BioNumerik
Pharmaceuticals, Inc" JHU Office of Research Administration tracking number
_________, dated as of November 19, 2001.
1.13 "SIGNATURE DATE" shall mean the date the last party to this License
Agreement has executed this License Agreement.
1.14 "SUBLICENSEE" as used herein in either singular or plural shall mean
any person or entity other than an AFFILIATED COMPANY to which Company has
granted a sublicense under this Agreement.
ARTICLE II
LICENSE GRANT
2.1 GRANT. Subject to the terms and conditions of this Agreement, JHU
hereby grants to Company an EXCLUSIVE LICENSE to make, have made, use, and sell
the LICENSED PRODUCT and to provide the LICENSED SERVICE in the United States
and worldwide under the PATENT RIGHTS in the LICENSED FIELD. Subject to the
terms and conditions of this Agreement, JHU additionally grants COMPANY the
right to make, use and sell BIOLOGICAL MATERIAL in the LICENSED FIELD.
2.2 SUBLICENSE. Company may sublicense others under this Agreement,
subject to JHU's approval, and shall provide a copy of each such sublicense
agreement to JHU promptly after it is executed. Each sublicense shall be
consistent with the terms of this Agreement. JHU will approve any sublicense
following notice from Company of the sublicense terms, provided that JHU will
not be obligated to approve an extremely unreasonable sublicense.
ARTICLE III
FEES, ROYALTIES, & PAYMENTS
3.1 INITIAL LICENSE PROCESSING FEE. Company shall pay to JHUSOM Office of
Technology Licensing within (30) days of the SIGNATURE DATE an Initial License
Processing Fee as set forth in Exhibit A. JHU will not submit an invoice for
this Initial License Processing Fee, which is nonrefundable and shall not be
credited against royalties or other fees, including, but not limited to, the
License Fee of Paragraph 3.2.
3.2 LICENSE FEE. Company shall pay to JHU within thirty (30) days of the
EFFECTIVE DATE of this Agreement a license fee as set forth in Exhibit A. JHU
will not submit an invoice for the license fee, which is nonrefundable and shall
not be credited against royalties or other fees.
3.3 MINIMUM ANNUAL ROYALTIES. Beginning with the calendar year commencing
on January 1st immediately following the first commercial sale of LICENSED
PRODUCT or LICENSED SERVICE, Company shall pay to JHU minimum annual royalties
as set forth in Exhibit A. Each such payment shall be due within forty-five (45)
days after the end of such year.
3.4 ROYALTIES. Company shall pay to JHU a running royalty within the range
set forth set forth in Exhibit A, as acceptable to both JHU and Company, for
each LICENSED PRODUCT sold, and for each LICENSED SERVICE provided, by Company
or AFFILIATED COMPANIES, based on NET SALES and NET SERVICE REVENUES for the
term of this Agreement. Such payments shall be made quarterly.
In order to insure JHU the full royalty payments contemplated hereunder,
Company agrees that in the event any LICENSED PRODUCT shall be sold to an
AFFILIATED COMPANY or SUBLICENSEE or to a corporation, firm or association with
which Company shall have any agreement, understanding or arrangement with
respect to consideration (such as, among other things, an option to purchase
stock or actual stock ownership, or an arrangement involving division of profits
or special rebates or allowances) the royalties to be paid hereunder for such
LICENSED PRODUCT shall be based upon the greater of: 1) the [**] at which the
purchaser of LICENSED PRODUCT resells such product to the end user, 2) the [**]
received from using the LICENSED PRODUCT in providing a service, 3) the [**] of
the Licensed Product, or 4) the [**] of LICENSED PRODUCT paid by the purchaser.
3.5 SUBLICENSE CONSIDERATION. Company shall pay to JHU a percentage of
consideration received from sublicensees under this Agreement as set forth in
Exhibit A. Such consideration shall include consideration of any kind received
by the Company or AFFILIATED COMPANIES from a SUBLICENSEE, such as upfront fees,
royalties or milestone fees and including any premium paid by the SUBLICENSEE
over Fair Market Value for stock of the Company or an Affiliated Company in
consideration for such sublicense. However, not included in such sublicense
consideration are amounts paid to the Company or an AFFILIATED COMPANY by the
SUBLICENSEE for product development, research work, clinical studies and
regulatory approvals performed by or for the Company or AFFILIATED COMPANIES, or
third parties on their behalf pursuant to a specific agreement including a
performance plan and commensurate budget. The term "Fair Market Value" shall
mean the average price that the stock in question is publicly trading at for
twenty (20) days prior to the announcement of its purchase by the SUBLICENSEE or
if the stock is not publicly traded, the value of such stock as determined by
the most recent private financing through a financial investor (an entity whose
sole interest in the Company or AFFILIATED COMPANY is financial) of the Company
or AFFILIATED COMPANY that issued the shares.
3.6 REIMBURSEMENT. Patent protection regarding Inventions will be obtained
as provided in Section 4(b) of the Research Agreement. Company will reimburse
JHU, within thirty (30) days of the receipt of an invoice from JHU, for all cost
associated with the preparation, filing, maintenance, and prosecution of PATENT
RIGHTS relating to sole JHU Inventions
[**] 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.
incurred by JHU on or before the EFFECTIVE DATE of this Agreement. In accordance
with Paragraph 4.1 below, Company will reimburse JHU, within thirty (30) days of
the receipt of an invoice from JHU, for all cost associated with the
preparation, filing, maintenance, and prosecution of PATENT RIGHTS relating to
sole JHU Inventions incurred by JHU subsequent to the EFFECTIVE DATE of this
Agreement.
3.7 FORM OF PAYMENT. All payments under this Agreement shall be made in
U.S. Dollars. Checks are to be made payable to "The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University".
Wire transfers may be made through:
The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University
AllFirst Bank
▇▇ ▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Transit/Routing/ABA number: ▇▇▇▇▇▇▇▇▇
Account Number: ▇▇▇▇▇▇▇▇
Reference: JHU SOM Office of Technology Licensing
(BioNumerik, Baylin Sponsored Research Agreement)
Attn: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Company shall be responsible for any and all costs associated with wire
transfers.
3.8 LATE PAYMENTS. In the event that any payment due hereunder is not made
when due, the payment shall accrue interest beginning on the tenth day following
the due date thereof, calculated at the annual rate of the sum of (a) [**] plus
(b) the prime interest rate quoted by The Wall Street Journal on the date said
payment is due, the interest being compounded on the last day of each calendar
quarter, provided however, that in no event shall said annual interest rate
exceed the maximum legal interest rate for corporations. Each such payment when
made shall be accompanied by all interest so accrued. Said interest and the
payment and acceptance thereof shall not negate or waive the right of JHU to
seek any other remedy, legal or equitable, to which it may be entitled because
of the delinquency of any payment including, but not limited to termination of
this Agreement as set forth in Paragraph 9.2.
ARTICLE IV
PATENT PROSECUTION, MAINTENANCE, & INFRINGEMENT
4.1 PROSECUTION & MAINTENANCE. JHU, at Company's reasonable expense, shall
file, prosecute and maintain all patents and patent applications specified under
PATENT RIGHTS that relate to sole JHU Inventions upon authorization of Company
and Company shall be licensed thereunder. Title to all such patents and patent
applications relating to sole JHU Inventions shall reside in JHU. JHU shall have
full and complete control over all patent matters relating to sole JHU
Inventions in connection therewith under the PATENT RIGHTS, provided however,
that JHU will consider and incorporate reasonable comments received from Company
and will provide Company with copies of any proposed filings, patent
correspondence or potential change in status a reasonable time before any action
is to be taken in order to allow Company an opportunity to comment. Company will
provide payment authorization to JHU at least one (1) month before an action is
due, provided that Company has received timely notice of such action from JHU.
Failure to provide authorization can be considered by JHU as a Company decision
not to authorize an action. In any country where Company elects not to have
[**] 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.
a patent application filed or to pay expenses associated with filing,
prosecuting, or maintaining a patent application or patent relating to sole or
joint JHU Inventions, JHU may file, prosecute, and/or maintain the patent
application or patent at its own expense and for its own exclusive benefit in
such country and Company thereafter shall not be licensed under such patent or
patent application with respect to such country.
4.2 NOTIFICATION. Each party will notify the other promptly in writing
when any infringement by another is discovered or suspected.
4.3 INFRINGEMENT. Company shall have the first right to enforce any patent
within PATENT RIGHTS against any infringement or alleged infringement thereof,
and shall at all times keep JHU informed as to the status thereof. Company may,
in its sole judgment and at its own expense, institute suit against any such
infringer or alleged infringer and control, settle, 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 4.4. This right to ▇▇▇ for infringement shall not be used in an
arbitrary or capricious manner. JHU shall reasonably cooperate in any such
litigation at Company's expense.
If Company elects not to enforce any patent within the PATENT RIGHTS, then
it shall so notify JHU in writing within ninety (90) days of receiving notice
that an infringement exists, and JHU may, in its sole judgment and at its own
expense, take steps to enforce any patent 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.
4.4 RECOVERY. Any recovery by Company under Paragraph 4.3 shall be deemed
to reflect loss of commercial sales, and Company shall pay to JHU [**] of the
recovery, after all reasonable costs and expenses associated with each suit or
settlement have been subtracted. If the cost and expenses exceed the recovery,
then [**] of the excess shall be credited against royalties payable by Company
to JHU hereunder in connection with sales in the country of such legal
proceedings, provided, however, that any such credit under this Paragraph shall
not exceed [**] of the royalties otherwise payable to JHU with regard to sales
in the country of such action in any one calendar year, with any excess credit
being carried forward to future calendar years.
ARTICLE V
OBLIGATIONS OF THE PARTIES
5.1 REPORTS. Company shall provide to JHU within thirty (30) days of the
end of each March, June, September and December after the EFFECTIVE DATE of this
Agreement, a written report to JHU of the amount of LICENSED PRODUCT sold, and
LICENSED SERVICE sold, the total NET SALES and NET SERVICE REVENUES of such
LICENSED PRODUCT and LICENSED SERVICE, and the running royalties due to JHU as a
result of NET SALES and NET SERVICE REVENUES by Company, AFFILIATED COMPANIES
and SUBLICENSEE thereof. Payment of any such royalties due shall accompany such
report. The report of sales and royalties due shall be substantially in the
format of the sales and royalty report form given in Exhibit B. Until Company,
an AFFILIATED COMPANY or a SUBLICENSEE has achieved a first commercial sale of a
LICENSED PRODUCT and received FDA market approval, a report shall be submitted
at the end of every June and December after the EFFECTIVE DATE of this
[**] 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.
Agreement and will include a written report describing Company's, AFFILIATED
COMPANIES or any SUBLICENSEE's technical efforts towards meeting its obligations
under the terms of this Agreement.
5.2 RECORDS. Company shall make and retain, for a period of three (3)
years following the period of each report required by Paragraph 5.1, 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 5.1. Such books and records shall be in
accordance with generally accepted accounting principles consistently applied.
Company shall permit, on a confidential basis, the inspection and copying of
such records, files and books of account by JHU or its agents during regular
business hours upon ten (10) business days' written notice to Company. Such
inspection shall not be made more than once each calendar year. All costs of
such inspection and copying shall be paid by JHU, provided that if any such
inspection shall reveal that an error has been made in the amount equal to five
percent (5%) or more of such payment, such costs shall be borne by Company.
Company shall include in any agreement with its AFFILIATED COMPANIES or its
SUBLICENSEE which permits such party to make, use or sell the LICENSED PRODUCT
or provide LICENSED SERVICE, a provision requiring such party to retain records
of sales of LICENSED PRODUCT and records of LICENSED SERVICE and other
information as required in Paragraph 5.1 and permit JHU to inspect such records
as required by this Paragraph.
5.3 REASONABLE EFFORTS. Within six months of each amendment of this
License Agreement to include JHU inventions or discoveries made under the
RESEARCH AGREEMENT, Company shall submit a Development Plan, reasonably
satisfactory to JHU, which outlines Company's intent and ability to develop and
commercialize the JHU inventions or discoveries. Company shall exercise
reasonable efforts, consistent with the Development Plan provided, as might be
amended from time to time, to develop and to introduce the LICENSED PRODUCT and
LICENSED SERVICE into the commercial market as soon as practicable, consistent
with sound and reasonable business practice and judgement; thereafter, until the
expiration of the Agreement, Company shall endeavor to keep LICENSED PRODUCT and
LICENSED SERVICE reasonably available to the public. Company shall also exercise
commercially reasonable efforts to develop other LICENSED PRODUCT suitable for
different indications, so that the PATENT RIGHTS can be commercialized as
broadly and as speedily as good scientific and business judgement would deem
practical.
5.4 OTHER PRODUCTS. After clinical or other evidence, provided in writing
by JHU or by another party, to Company, demonstrating the practicality of a
particular market which is not being developed or commercialized by Company,
Company shall either provide JHU with a reasonable development plan and start
development or attempt to reasonably sublicense the particular technology to a
third party. If within twelve (12) months of such notification by JHU, Company
has not initiated such development efforts or sublicensed that particular
market, JHU may terminate this license for such particular therapeutic market.
This Paragraph shall not be applicable if Company reasonably demonstrates to JHU
that commercializing such LICENSED PRODUCT or LICENSED SERVICE or granting such
a sublicense in said market would have a potentially adverse commercial effect
upon marketing or sales of the LICENSED PRODUCT developed and being sold by
Company.
5.5 PATENT ACKNOWLEDGEMENT. Company agrees that all packaging containing
individual LICENSED PRODUCT sold by Company, AFFILIATED COMPANIES and
SUBLICENSEE of Company will be marked with the number of the applicable
patent(s) licensed hereunder in accordance with each country's patent laws.
5.6 JHU, through its JHU Inventor(s), shall within thirty days of the
EFFECTIVE DATE ship Deliverables by overnight courier service to arrive at
COMPANY on a business day.
Deliverables shall be sent to:
BioNumerik Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Receiving Department
Company shall provide notice to JHU School of Medicine's Office of
Technology Licensing of receipt of Deliverables by FAX upon receipt.
ARTICLE VI
REPRESENTATIONS
6.1 REPRESENTATIONS BY JHU. JHU warrants that it has good and marketable
title to its interest in the inventions claimed under PATENT RIGHTS and
BIOLOGICAL MATERIAL with the exception of certain retained rights of the United
States government. JHU does not warrant the validity of any patents or that
practice under such patents or use of a BIOLOGICAL MATERIAL shall be free of
infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 6.1, COMPANY,
AFFILIATED COMPANIES AND SUBLICENSEE AGREE THAT THE PATENT RIGHTS AND BIOLOGICAL
MATERIAL ARE PROVIDED "AS IS", AND THAT JHU MAKES NO REPRESENTATION OR WARRANTY
WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCT AND LICENSED SERVICE
INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. JHU DISCLAIMS
ALL WARRANTIES WITH REGARD TO PRODUCT AND SERVICE LICENSED UNDER THIS AGREEMENT,
INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESS OR IMPLIED, OF
MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY
OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS
AND LIABILITIES ON THE PART OF JHU AND INVENTORS, FOR DAMAGES, INCLUDING, BUT
NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS'
AND EXPERTS' FEES, AND COURT COSTS (EVEN IF JHU 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 PRODUCT AND SERVICE LICENSED UNDER
THIS AGREEMENT. COMPANY, AFFILIATED COMPANIES AND SUBLICENSEE ASSUME ALL
RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT AND SERVICE
MANUFACTURED, USED, OR SOLD BY COMPANY, ITS SUBLICENSEE AND AFFILIATED COMPANIES
WHICH IS A LICENSED PRODUCT OR LICENSED SERVICE AS DEFINED IN THIS AGREEMENT.
6.2 RIGHT TO GRANT LICENSE. JHU represents that it has the right to grant
a license to Company in accordance with the terms and conditions of this
Agreement.
ARTICLE VII
INDEMNIFICATION
7.1 INDEMNIFICATION. JHU and the Inventors of LICENSED PRODUCT and
LICENSED SERVICE will not, under the provisions of this Agreement or otherwise,
have control over the manner in which Company or its AFFILIATED COMPANIES or its
SUBLICENSEE or those operating for its account or third parties who purchase
LICENSED PRODUCT or LICENSED SERVICE from any of the foregoing entities,
practice the inventions of LICENSED PRODUCT and LICENSED SERVICE. Company shall
defend and hold JHU, The ▇▇▇▇▇ ▇▇▇▇▇▇▇ Health Systems, their present and former
trustees, officers, Inventors of PATENT RIGHTS and BIOLOGICAL MATERIAL, agents,
faculty, employees and students 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 or use of patent rights by any of the foregoing
entities, whether or not JHU or said Inventors, either jointly or severally, is
named as a party defendant in any such lawsuit. Practice of the inventions
covered by LICENSED PRODUCT and LICENSED SERVICE, by an AFFILIATED COMPANY or an
agent or a SUBLICENSEE or a third party on behalf of or for the account of
Company or by a third party who purchases LICENSED PRODUCT and LICENSED SERVICE
from Company, shall be considered Company's practice of said inventions for
purposes of this Paragraph. The obligation of Company to defend and indemnify as
set out in this Paragraph shall survive the termination of this Agreement.
ARTICLE VIII
CONFIDENTIALITY
8.1 CONFIDENTIALITY. If necessary, the parties will exchange information,
which they consider to be confidential. The recipient of such information agrees
to accept the disclosure of said information which is marked as confidential at
the time it is sent to the recipient, and to employ all reasonable efforts to
maintain the information secret and confidential, such efforts to be no less
than the degree of care employed by the recipient to preserve and safeguard its
own confidential information. The information shall not be disclosed or revealed
to anyone except employees of the recipient who have a need to know the
information and who have entered into a secrecy agreement with the recipient
under which such employees are required to maintain confidential the proprietary
information of the recipient and such employees shall be advised by the
recipient of the confidential nature of the information and that the information
shall be treated accordingly.
The obligations of this Paragraph shall also apply to AFFILIATED COMPANIES
and/or SUBLICENSEE provided such information by Company. JHU's, Company's,
AFFILIATED COMPANIES, and SUBLICENSEES' obligations under this Paragraph shall
extend until three (3) years after the termination of this Agreement.
8.2 EXCEPTIONS. The recipient's obligations under Paragraph 8.1 shall not
extend to any part of the information:
a. that can be demonstrated to have been in the public domain or
publicly known and readily available to the trade or the
public prior to the date of the disclosure; or
b. that can be demonstrated, from written records, to have been
in the recipient's possession and not subject to an existing
obligation of secrecy to the disclosing party, or readily
available to the recipient from another source not under
obligation of secrecy to the disclosing party prior to the
disclosure; or
c. that becomes part of the public domain or publicly known by
publication or otherwise, not due to any unauthorized act by
the recipient; or
d. that is demonstrated from written records to have been
independently developed by or for the receiving party without
reference to or use of confidential information disclosed by
the disclosing party.
e. that is required to be disclosed by law, government regulation
or court order.
8.3 RIGHT TO PUBLISH. JHU may publish manuscripts, abstracts or the like
in the manner described in Section 5 of the RESEARCH AGREEMENT.
ARTICLE IX
TERM & TERMINATION
9.1 TERM. The term of this Agreement shall commence on the EFFECTIVE DATE
and shall continue, in each country, until the date of expiration of the last to
expire patent included within PATENT RIGHTS in that country, but in any event,
for a term of at least twenty (20) years after the EFFECTIVE DATE of this
Agreement in each particular country. The right to amend this Agreement expires
six (6) months after the termination of the RESEARCH AGREEMENT.
9.2 TERMINATION BY EITHER PARTY. This Agreement may be terminated by
either party, in the event that the other party (a) files or has filed against
it a petition under the Bankruptcy Act, makes an assignment for the benefit of
creditors, has a receiver appointed for it or a substantial part of its assets,
or otherwise takes advantage of any statute or law designed for relief of
debtors or (b) fails to perform or otherwise breaches any of its material
obligations hereunder, if, following the giving of notice by the terminating
party of its intent to terminate and stating the grounds therefor, the party
receiving such notice shall not have cured the failure or breach within thirty
(30) days. In no event, however, shall such notice or intention to terminate be
deemed to waive any rights to damages or any other remedy which the party giving
notice of breach may have as a consequence of such failure or breach.
9.3 TERMINATION BY COMPANY. Company may terminate this Agreement and the
license granted herein, including any amendments, for any reason, upon giving
JHU ninety (90) days written notice, provided the RESEARCH AGREEMENT is
terminated concurrently.
9.4 OBLIGATIONS AND DUTIES UPON TERMINATION. If this Agreement is
terminated, both parties shall be released from all obligations and duties
imposed or assumed hereunder to the extent so terminated, except as expressly
provided to the contrary in this Agreement. Upon termination, both parties shall
cease any further use of all confidential information disclosed to them as a
receiving party by the other party. Termination of this Agreement, for whatever
reason, shall not affect the obligation of either party to make any payments for
which it is liable prior to or upon such termination. Termination shall not
affect JHU's right to recover unpaid
royalties or fees or reimbursement for patent expenses incurred pursuant to
Paragraph 4.1 prior to termination. Upon termination Company shall submit a
final royalty report to JHU and any royalty payments and unreimbursed patent
expenses due JHU shall become immediately payable, and all BIOLOGICAL MATERIAL
that is the property of JHU shall be returned to JHU Inventors or destroyed.
Furthermore, upon termination of this Agreement, all rights in and to the
licensed technology originally held by JHU and licensed by JHU to Company
hereunder, including PATENT RIGHTS and BIOLOGICAL MATERIAL, shall revert
immediately to JHU at no cost to JHU. All inventions and discoveries arising out
of the Program (as defined in the RESEARCH AGREEMENT) that are solely or jointly
owned by Company shall continue to be solely or jointly owned by Company and
shall not be affected by any such reversion. Upon termination of this Agreement,
any SUBLICENSEE shall become a direct licensee of JHU and shall retain any
sublicense previously granted to it, provided such SUBLICENSEE complies with the
provisions of this Agreement assumed by such SUBLICENSEE. Company shall provide
written notice of such to each SUBLICENSEE with a copy of such notice provided
to JHU.
ARTICLE X
MISCELLANEOUS
10.1 USE OF NAME. Company shall not use the name of The ▇▇▇▇▇ ▇▇▇▇▇▇▇
University or The ▇▇▇▇▇ ▇▇▇▇▇▇▇ Health System or any of its constituent parts,
such as the ▇▇▇▇▇ ▇▇▇▇▇▇▇ Hospital or any contraction thereof or the name of JHU
Inventors of PATENT RIGHTS in any advertising, promotional, sales literature or
fundraising documents without prior written consent from an officer of JHU.
Company shall allow at least seven (7) business days notice of any proposed
public disclosure for JHU's review and comment or to provide written consent.
10.2 NO PARTNERSHIP. Nothing in this Agreement shall be construed to
create any agency, employment, partnership, joint venture or similar
relationship between the parties other than that of a licensor/licensee. Neither
party shall have any right or authority whatsoever to incur any liability or
obligation (express or implied) or otherwise act in any manner in the name or on
the behalf of the other, or to make any promise, warranty or representation
binding on the other.
10.3 NOTICE OF CLAIM. Each party shall give the other or its
representative immediately notice of any suit or action filed, or prompt notice
of any claim made, against them arising out of the performance of this
Agreement.
10.4 PRODUCT LIABILITY. Prior to initial human testing or first commercial
sale of any LICENSED PRODUCT or LICENSED SERVICE as the case may be in any
particular country, Company shall establish and maintain, in each country in
which Company, an AFFILIATED COMPANY or SUBLICENSEE shall test or sell LICENSED
PRODUCT and LICENSED SERVICE, product liability or other appropriate insurance
coverage appropriate to the risks involved in marketing LICENSED PRODUCT and
LICENSED SERVICE and will annually present evidence to JHU that such coverage is
being maintained. Upon JHU's request, Company will furnish JHU with a
Certificate of Insurance of each product liability insurance policy obtained.
JHU shall be listed as an additional insured in Company's said insurance
policies. If such Product Liability insurance is underwritten on a `claims made'
basis, Company agrees that any change in underwriters during the term of this
Agreement will require the purchase of `prior acts' coverage to ensure that
coverage will be continuous throughout the term of this Agreement.
10.5 NOTICE. All notices or communication required or permitted to be
given by either party hereunder shall be deemed sufficiently given if mailed by
registered mail or certified mail or sent by overnight courier, such as Federal
Express, to the other party at its respective address set forth below or to such
other address as one party shall give notice of to the other from time to time
hereunder. Mailed notices shall be deemed to be received on the third business
day following the date of mailing. Notices sent by overnight courier shall be
deemed received the following business day.
If to Company: Attn: Chief Executive Officer
BioNumerik Pharmaceuticals, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
If to JHU: Office of Technology Licensing
The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University
School of Medicine
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: Director
10.6 COMPLIANCE WITH ALL LAWS. In all activities undertaken pursuant to
this Agreement, both JHU and Company covenant and agree that each will in all
material respects comply with such Federal, state and local laws and statutes,
as may be in effect at the time of performance and all valid rules, regulations
and orders thereof regulating such activities.
10.7 SUCCESSORS AND ASSIGNS. Neither this Agreement nor any of the rights
or obligations created herein, except for the right to receive any remuneration
hereunder, may be assigned by either party, in whole or in part, without the
prior written consent of the other party, except that either party shall be free
to assign this Agreement in connection with any sale of substantially all of its
business or assets, without the consent of the other. Prompt notice of any such
assignment will be given to JHU. In addition, Company may sublicense others
under this Agreement as provided in Paragraph 2.2. This Agreement shall bind and
inure to the benefit of the successors and permitted assigns of the parties
hereto.
10.8 NO WAIVERS; SEVERABILITY. No waiver of any breach of this Agreement
shall constitute a waiver of any other breach of the same or other provision of
this Agreement, and no waiver shall be effective unless made in writing. Any
provision hereof prohibited by or unenforceable under any applicable law of any
jurisdiction shall as to such jurisdiction be deemed ineffective and deleted
herefrom without affecting any other provision of this Agreement. It is the
desire of the parties hereto that this Agreement be enforced to the maximum
extent permitted by law, and should any provision contained herein be held by
any governmental agency or court of competent jurisdiction to be void, illegal
or unenforceable, the parties shall negotiate in good faith for a substitute
term or provision which carries out the original intent of the parties as
closely as possible.
10.9 ENTIRE AGREEMENT; AMENDMENT. Company and JHU acknowledge that they
have read this entire Agreement and that this Agreement, including the attached
Exhibits (together with the Research Agreement) constitutes the entire
understanding and contract between the parties hereto and supersedes any and all
prior or contemporaneous oral or written communications with respect to the
subject matter hereof, all of which communications are merged herein. It is
expressly understood and agreed that (i) there being no expectations to the
contrary between the parties hereto, no usage of trade, verbal agreement or
another regular practice or method dealing within any industry or between the
parties hereto shall be used to modify, interpret, supplement or alter in any
manner the express terms of this Agreement; and (ii) this Agreement shall not be
modified, amended or in any way altered except by an instrument in writing
signed by both of the parties hereto.
10.10 DELAYS OR OMISSIONS. Except as expressly provided herein, no delay
or omission to exercise any right, power or remedy accruing to any party hereto,
shall impair any such right, power or remedy to such party nor shall it be
construed to be a waiver of any breach or default, or an acquiescence therein,
or in any similar breach or default be deemed a waiver of any other breach or
default theretofore or thereafter occurring. Any waiver, permit, consent or
approval of any kind or character on the part of any party of any breach or
default under this Agreement, or any waiver on the part of any party of any
provisions or conditions of this Agreement, must be in writing and shall be
effective only to the extent specifically set forth in such writing. All
remedies either under this Agreement or by law or otherwise afforded to any
party, shall be cumulative and not alternative.
10.11 FORCE MAJEURE. If either party fails to fulfill its obligations
hereunder (other than an obligation for the payment of money), when such failure
is due to an act of God, or other circumstances beyond its reasonable control,
including but not limited to fire, flood, civil commotion, riot, war (declared
and undeclared), revolution, or embargoes, then said failure shall be excused
for the duration of such event and for such a time thereafter as is reasonable
to enable the parties to resume performance under this Agreement.
10.12 FURTHER ASSURANCES. Each party shall, at any time, and from to time,
prior to or after the EFFECTIVE DATE of this Agreement, at reasonable request of
the other party, execute and deliver to the other such instruments and documents
and shall take such actions as may be required to more effectively carry out the
terms of this Agreement.
10.13 SURVIVAL. All representations, warranties, covenants and agreements
made herein and which by their express terms or by implication are to be
performed after the termination hereof, or are prospective in nature, shall
survive such termination, as the case may be. This shall include Articles VI,
VII, VIII, IX, and X.
10.14 NO THIRD PARTY BENEFICIARIES. Nothing in this Agreement shall be
construed as giving any person, firm, corporation or other entity, other than
the parties hereto and their successors and permitted assigns and sublicensees,
any right, remedy or claim under or in respect of this Agreement or any
provision hereof.
10.16 HEADINGS. Article headings are for convenient reference and not a
part of this Agreement. All Exhibits are incorporated herein by this reference.
10.17 COUNTERPARTS. This Agreement may be executed in counterparts, each
of which shall be deemed an original and all of which when taken together shall
be deemed but one instrument.
IN WITNESS WHEREOF, this Agreement shall take effect as of the EFFECTIVE
DATE when it has been executed below by the duly authorized representatives of
the parties.
THE ▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇ April 30, 2002
--------------------------------------------
Title: ▇▇▇▇▇▇▇ ▇. ▇▇▇, Ph.D., (Date)
Assistant ▇▇▇▇ and Executive Director
Licensing and Business Development
School of Medicine
COMPANY
BioNumerik Pharmaceuticals, Inc.
By: /s/ ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ April 22, 2202
--------------------------------------------
▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, M.D. (Date)
Chairman & Chief Executive Officer
EXHIBIT A. LICENSE FEE & ROYALTIES.
EXHIBIT B. SALES & ROYALTY REPORT FORM.
EXHIBIT C. BIOLOGICAL MATERIAL
EXHIBIT D. COMPANY RIGHTS TO PATENTS and PATENT/PROVISIONAL APPLICATIONS
EXHIBIT A
LICENSE FEE & ROYALTIES
1. INITIAL LICENSE PROCESSING FEE: The initial license processing fee due under
Paragraph 3.1 of the License Agreement is [**].
2. LICENSE FEE: The license fee due under Paragraph 3.2 of the License Agreement
is [**].
3. MINIMUM ANNUAL ROYALTIES: The minimum annual royalties pursuant to Paragraph
3.3 of the License Agreement are [**] and shall be credited against running
royalties due in that year. If royalties paid to JHU pursuant to Paragraph 3.4
of the License Agreement do not equal or exceed [**] in any applicable calendar
year, Company shall pay the difference to JHU within the 45 day time period
after the end of such year. In the event Company fails to pay JHU the minimum
annual royalty as required for a year, the license granted hereunder shall
become a nonexclusive license so long as Company pays JHU a minimum annual
royalty of [**] in that calendar year and thereafter.
3. ROYALTIES: The running royalty rate payable under Paragraph 3.4 will be in
the range set forth as follows:
(A) [**] of NET SALES and NET SERVICE REVENUES;
(B) [**] of NET SALES and NET SERVICE REVENUES [**]; and
(C) [**] of NET SALES and NET SERVICE REVENUES [**].
The royalty rate for each INVENTION shall be within the ranges set forth above
and shall be agreed upon in good faith by JHU and Company prior to the INVENTION
being added to EXHIBIT D. Only one royalty shall be paid on a product or service
that is covered by multiple patents or patent applications included in PATENT
RIGHTS.
In the event that (i) the patent covering a LICENSED PRODUCT or LICENSED SERVICE
has expired or been declared invalid or unenforceable during the term of this
Agreement and any generic form of Licensed Product or Licensed Service enters
the marketplace or (ii) all of the patents listed in Exhibit D have expired or
been declared invalid or unenforceable within the term of this License
Agreement, the parties shall consider a reasonable reduction in royalty rates
for the rest of the term.
4. SUBLICENSE CONSIDERATION: The percent sublicensee consideration payable under
Paragraph 3.5 will be as follows:
All sublicensee payments (including those described in Paragraph 3.5 as
consideration subject to a percentage payment to JHU but excluding those
described in Paragraph 3.5 as not included in sublicensee consideration) will be
included in NET SALES and a royalty will be paid thereon as provided in Section
3 above in the year in which such sublicensee payment is made.
[**] 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.
EXHIBIT B
QUARTERLY SALES & ROYALTY REPORT
FOR LICENSE AGREEMENT BETWEEN COMPANY AND
THE ▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY DATED
[EFFECTIVE DATE OF AGREEMENT]
FOR PERIOD OF ______________ TO ______________
TOTAL ROYALTIES DUE FOR THIS PERIOD $___________
TOTAL NET
PRODUCT *JHU SALES/SERVICES ROYALTY AMOUNT
NAME REFERENCE (AS PER DEFINITIONS) RATE DUE
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* Please provide the JHU Disclosure Number or Patent Reference
This report format is to be used to report quarterly royalty statements to
JHU. It should be placed on Company letterhead and accompany any royalty
payments due for the reporting period. This report shall be submitted even if no
sales are reported.
EXHIBIT C
BIOLOGICAL MATERIAL (SEE PARAGRAPH 1.2)
The following shall be provided to COMPANY under Paragraph 5.6. The amount(s)
specified have been agreed to by JHU and COMPANY as sufficient to allow COMPANY
to propagate the material(s), and JHU is under no obligation to provide
additional Deliverables. This Exhibit may be amended from time to time by mutual
agreement of JHU and COMPANY to incorporate newly discovered or made BIOLOGICAL
MATERIAL.
EXHIBIT D.
PATENT RIGHTS