EXHIBIT 10.1
RESEARCH COLLABORATION AGREEMENT BETWEEN
THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK
AND B TWELVE LTD.
AGREEMENT made this 19 day of August 1999 by and between THE RESEARCH
FOUNDATION OF STATE UNIVERSITY OF NEW YORK, a non-profit, educational
corporation organized and existing under the laws of the State of New York, with
its principal offices located at Xxxxx Xxxxxxxxxx Xxxxx, Xxxxxx, Xxx Xxxx
(mailing address: Xxxx Xxxxxx Xxx 0, Xxxxxx Xxx Xxxx 00000-0000), hereinafter
referred to as the "FOUNDATION", acting on behalf of the State University of New
York Health Science Center at Brooklyn, hereinafter referred to as "UNIVERSITY,"
and B TWELVE LTD., a corporation organized and existing under the laws of the
Province of Ontario, with its principal office located at Suite 3303, 130
Adelaide Street West, Toronto, Ontario, Canada, M5H 3P5, hereinafter referred to
as "COLLABORATOR".
WHEREAS, COLLABORATOR is engaged in the development of Vitamin
B12-related agents that have potential utilization in patient care and
treatment; and
WHEREAS, UNIVERSITY has existing antibodies to human transcobalamin II
which inhibit the uptake of Vitamin B12 as described in Exhibit A (hereinafter
referred to as the "Antibodies"), as well as research facilities and situations
that would allow investigation and study of other Vitamin B12-related agents as
described in Exhibit B (hereinafter referred to as the "Research Plan"); a copy
of both Exhibits A and B are attached hereto and incorporated in their entirety
herein by reference; and
WHEREAS, both COLLABORATOR and UNIVERSITY consider it desirable to
evaluate the Antibodies and perform the Research Plan;
NOW, THEREFORE, in consideration of the promises and mutual covenants
contained herein, COLLABORATOR and UNIVERSITY agree as follows:
I. Evaluation of the Antibodies
1. Providing Antibodies/Option to License
a. UNIVERSITY agrees to provide the Antibodies to COLLABORATOR for
the purpose of evaluation of potential therapeutic utility. UNIVERSITY further
agrees to provide COLLABORATOR any required or necessary technical support
and/or know-how for evaluation of the same by COLLABORATOR during the period of
this Research Collaboration Agreement.
Page 1 of 9
b. UNIVERSITY hereby grants COLLABORATOR an option to negotiate and
acquire an exclusive, world-wide. royalty bearing license to the Antibodies
(including patent applications. patents and copyrights thereon) following
COLLABORATOR evaluation of the same. DIVERSITY hereby warrants that it has the
exclusive right to license the Antibodies subject only to any residual rights of
the United States government pursuant to 35 U.S.C. 200 et. seq. COLLABORATOR
shall have six (6) months from the date of receipt of the Antibodies (and any
required or necessary technical support and/or know-how for evaluation of same)
to exercise this option by giving written notice to UNIVERSITY of the same.
COLLABORATOR agrees to comply with U.S. Government regulations concerning
inventions sponsored by the U.S. Government.
c. If COLLABORATOR elects to exercise its option to negotiate and
acquire such a license in the time and manner provided in Article I.1.b. herein
above, COLLABORATOR and UNIVERSITY agree to enter into good faith negotiations
regarding the terms and conditions of said license, and further agree to
negotiate license fee rates and other payments that are fair and reasonable to
both parties. If UNIVERSITY and COLLABORATOR fail to enter into an agreement
during that period of time [the license option period], COLLABORATOR shall have
a right of first refusal to any terms generally more favorable offered by
UNIVERSITY to a third party for a period of one (1) year thereafter.
d. In the event that the parties fail to reach an agreement
regarding the terms and conditions of said license as provided in Article I.1.c.
herein above, six (6) months after COLLABORATOR notification to UNIVERSITY of
COLLABORATOR exercise of said option pursuant to Article I.1.b. herein above,
UNIVERSITY shall have the right to enter into a license agreement concerning the
Antibodies with a third party.
II. Collaborative Research
1. Research Team The Parties agree to establish a joint research and
development team (hereinafter referred to as the "Team") comprising at least the
Principal Investigators designated pursuant to Article II.3.3. herein to conduct
and monitor the research in accordance with the Research Plan. Although members
of the Team shall be considered as having been delegated to the Team, they shall
continue to remain employed by their respective employers under their respective
terms of employment.
2. Review of `Work Periodic conferences shall be held by the Team to
review work progress.
3. Principal Investigators Research work under this Agreement will be
performed by the UNIVERSITY Laboratory identified in the Research Plan and the
UNIVERSITY Principal Investigator(s) designated in the Research Plan will be
responsible for the scientific and technical conduct of this project on behalf
of the
Page 2 of 9
UNIVERSITY. Also designated in the Research Plan is the COLLABORATOR Principal
Investigator who will be responsible for the scientific and technical conduct of
this project on behalf of the COLLABORATOR.
4. Research Plan Change The Research Plan may be modified by mutual
written consent of the Principle Investigators. Substantial changes in the scope
of the Research Plan will be treated as amendments under Article 111.18.
III. Performance of the Research
1. Engagement COLLABORATOR agrees to engage the services of UNIVERSITY
as an independent contractor to perform the Research. The Research will be under
the supervision of Xx. Xxxxxx X. Xxxxxxx, Associate Professor of Medicine
(Research), Department of Medicine, and Xx. Xxxxxxx X. Xxxxxxxxxx, Professor of
Medicine, Department of Medicine (hereinafter referred to as "Principal
Investigators"), at UNIVERSITY, with the assistance of appropriate associates
and colleagues at UNIVERSITY as may be required. No other persons may be
substituted for the Principal Investigators without COLLABORATOR's written
approval. COLLABORATOR may exercise the Termination provisions of Article
III.16. herein below if satisfactory substitutes are not identified.
2. Research UNIVERSITY agrees as an independent contractor to conduct
the Research. Such Research was originally approved by UNIVERSITY in accordance
with UNIVERSITY policy and may be subsequently amended only in accordance with
UNIVERSITY policy and the written agreement of UNIVERSITY and COLLABORATOR as
provided for in Article III.18. herein below. UNIVERSITY will apply its best
efforts to complete the Research, and will follow commonly accepted professional
standards.
3. Invention and Patents
a. For all purposes herein, "Invention" shall mean discovery,
concept or idea whether or not patentable or copyrightable, which (i)- arises
out of work performed pursuant to the obligations of this Agreement; (ii) is
conceived and/or reduced to practice during the term of the Agreement as defined
in Article III.15. herein below; and (iii) includes but is not limited to
processes, methods, software, formulae, techniques, compositions of matter,
devices, and improvements thereof and know-how relating, thereto. An Invention
made, using UNIVERSITY facilities, solely by one or both of the Principal
Investigators and/or other UNIVERSITY personnel as identified in Article III.1.
herein above or agents of UNIVERSITY shall be the sole property of UNIVERSITY.
An invention made jointly by employees or agents of UNIVERSITY, using,
UNIVERSITY's facilities, and COLLABORATOR, using COLLABORATOR's facilities,
shall be jointly owned by UNIVERSITY and COLLABORATOR. An Invention made solely
by employees or agents of COLLABORATOR, using COLLABORATOR's facilities, shall
Page 3 of 9
be the sole property of COLLABORATOR and are not subject to the terms and
conditions of this Agreement.
b. In the event that an Invention is made. either solely by
employees or agents of UNIVERSITY. using UNIVERSITY facilities. or jointly by
employees or agents of UNIVERSITY and COLLABORATOR. using UNIVERSITY or
COLLABORATOR facilities, UNIVERSITY and COLLABORATOR agree to give notice of
such Invention to each other within three (3) months of the identification of
such Invention. Within six (6) months of notice of Invention, UNIVERSITY and
COLLABORATOR will thereupon exert their best reasonable efforts in cooperation
with each other to investigate, evaluate and determine to the mutual
satisfaction of both parties, the disposition of rights to the Invention,
including whether. by whom. and where any patent applications are to be filed.
c. If, after consultation with COLLABORATOR, it is agreed by the
parties that a patent application should be filed, UNIVERSITY will prepare and
file appropriate United States and foreign patent applications on an Invention
made under this Agreement, and COLLABORATOR, will pay the cost of preparing,
filing and maintenance thereof. If COLLABORATOR notifies UNIVERSITY that it does
not intend to pay the costs of an application, then UNIVERSITY may file such
application at its own expense, and COLLABORATOR shall have no rights to such
Invention except those provided in Article III.3.d. herein below. UNIVERSITY
will provide COLLABORATOR a copy of any patent application filed on an Invention
made under this Agreement, as well as copies of any documents received or filed
during prosecution thereof. COLLABORATOR agrees to maintain any such application
and documents in confidence until it is published by UNIVERSITY or by the
respective patent office.
d. UNIVERSITY hereby grants COLLABORATOR a royalty free license,
during the period of this Research Collaborative Agreement, to use an Invention
made under this Agreement within COLLABORATOR's own organization for research
purposes only, including subsidiaries if 50% or more owned by COLLABORATOR.
e. In addition, UNIVERSITY hereby grants COLLABORATOR an option to
negotiate and acquire an exclusive, world-wide, royalty-bearing license to the
Invention (as well as patent applications, patents, and copyrights thereon),
provided that COLLABORATOR shall pay all costs and expenses associated with
patent and copyright filing, prosecution, issuance, and maintenance thereof.
COLLABORATOR shall have six (6) months from the date of notice of Invention from
UNIVERSITY pursuant to Article III.3.b. herein above. to Live written notice to
UNIVERSITY exercising said option. UNIVERSITY may, at its discretion, grant
further extensions to this option period. If UNIVERSITY and COLLABORATOR fail to
enter into an agreement during that period of time [the license option period],
COLLABORATOR shall have a right of first refusal to any terms generally more
favorable offered by UNIVERSITY to a third party for a period of one (1) year
thereafter.
Page 4 of 9
f. In the event that COLLABORATOR elects to exercise its option to
negotiate and acquire such a license in the time and manner provided in Article
II1.3.e. herein above. the parties agree to enter into good faith negotiations
regarding the terms and conditions of said license and further agree to
negotiate to license fee rates and other payments that are fair and reasonable
to both parties.
g. In the event that the parties fail to reach an agreement
regarding the terms and conditions of said license, six (6) months after
COLLABORATOR's notification to L:\IVERSITY of COLLABORATOR's exercise of said
option pursuant to Article III.3.e herein above unless the option period has
been extended by UNIVERSITY at its discretion, UNIVERSITY shall have the right
to enter into a license agreement concerning the same Invention with a third
party.
4. Confidentialitv: Because UNIVERSITY and COLLABORATOR will be
cooperating with each other in this Research, and because each may reveal to the
other in the course of this Research certain confidential information,
UNIVERSITY and COLLABORATOR agree to use best efforts to hold in confidence any
confidential information which (a) is obtained from the other during, the course
of this work and (b) is related thereto and (c) is marked as "CONFIDENTIAL", and
each party will use best efforts not disclose the same to any third party
without the express written consent of the other party to this Agreement. This
requirement shall remain in force for a period of five (5) years following
completion of work under this Agreement. Nothing in this paragraph shall in any
way restrict the rights of either UNIVERSITY or COLLABORATOR to use, disclose or
otherwise deal with any information which:
a. Can be demonstrated to have been in public domain as of the
effective date of this Agreement or comes into the public domain through the
term of this Agreement through no act of the recipient; or
b. Can be demonstrated to have been known to the recipient prior to
the execution of this Agreement; or
c. Can be demonstrated to have been rightfully received by the
recipient after disclosure under this Agreement from a third party who did not
require the recipient to hold it in confidence or limit its use and who did not
acquire it, directly or indirectly, under obligation of confidentiality to the
disclosing party.
5. Publication Rights. Notwithstanding the provisions of Article IIIA.
of this Agreement, UNIVERSITY may publish scientific papers relating to the
Research performed under this Agreement. In the event that UNIVERSITY wishes to
publish, UNIVERSITY shall notify COLLABORATOR of its desire to publish at least
sixty (60) days in advance of publication and shall furnish to COLLABORATOR a
written description of the subject matter of the publication in order to permit
COLLABORATOR to review and comment thereon. In order to fully protect the rights
of UNIVERSITY and COLLABORATOR, any contemplated publication containing details
of the Research, whether or not patentable may be withheld at COLLABORATOR's
request until a patent
Page 5 of 9
application is filed or other appropriate steps to protect commercial value have
been completed.
6. Publicitv. UNIVERSITY acknowledges COLLABORATOR's intention to
distribute periodically informational releases and announcements to the news
media regarding the progress of the Research. COLLABORATOR shall not release
such materials containing the name of UNIVERSITY or any of its employees without
prior written approval by an authorized representative of UNIVERSITY, and said
approval shall not be unreasonably withheld. Should UNIVERSITY reject the news
release, UNIVERSITY and COLLABORATOR agree to discuss the reasons for
UNIVERSITY's rejection, and every effort shall be made to develop an appropriate
informational news release within the bounds of accepted academic practices.
COLLABORATOR reserves the same right in the event that UNIVERSITY desires to
distribute a news release concerning the Research.
7. Responsibility. The parties agrees to assume individual
responsibility for the actions and omissions of their respective employees,
agents and assigns in conjunction with the Research.
8. Independent Contractor. While UNIVERSITY and COLLABORATOR will
Cooperate in the Research performed under this Agreement, COLLABORATOR will not
have the right to control the activities of UNIVERSITY in performing the
services provided herein, and UNIVERSITY shall perform services hereunder only
as an independent contractor, and nothing herein contained shall be construed to
be inconsistent with this relationship or status. Under no circumstances shall
UNIVERSITY be considered to be an employee or went of COLLABORATOR. This
Agreement shall not constitute, create or on any way be interpreted as a joint
venture, partnership or formal business organization of any kind.
9. Title to Equipment. UNIVERSITY shall retain title to all equipment
purchased and/or fabricated by it with funds provided by COLLABORATOR under this
Agreement.
10. Survivorship. The provisions of Article I and III.3., 4., 6. and
13. shall survive any expiration or termination of this Agreement.
11. Reports and Meetings. Written project reports summarizing the
Research shall be provided to COLLABORATOR by UNIVERSITY every three (3) months,
and a final report shall be submitted by UNIVERSITY within sixty (60) days of
the conclusion of the term of this Agreement as identified in Article 111. 15.
herein below. During the term of this Agreement, representatives of UNIVERSITY
will meet with representatives of COLLABORATOR at times and places mutually
agreed upon to discuss the progress and results of the Research, as well as
future work to be conducted.
12. Assignment. This Agreement may not be assigned by either party
without the prior written consent of the other party; provided, however, that
Page 6 of 9
COLLABORATOR may assign this Agreement to any purchaser or transferee of all or
substantially all of COLLABORATOR's business upon prior written notice to
UNIVERSITY.
13. Indemnification. UNIVERSITY shall. to the extent authorized under
the Constitution and the laws of the State of New York, indemnify and hold
harmless COLLABORATOR from liability resulting from the negligent acts or
omissions of UNIVERSITY, its agents or employees pertaining to the activities to
be carried out pursuant to the obligations of this Agreement: provided, however,
that UNIVERSITY shall not hold COLLABORATOR harmless from claims arising out of
the negligence of COLLABORATOR. its officers, agents or any person or entity not
subject to UNIVERSITY's supervision or control.
COLLABORATOR shall indemnify and hold harmless UNIVERSITY, their
regents, officers, agents and employees from any liability or loss resulting
from judgments or claims against them arising out of the activities to be
carried out pursuant to the obligations of this Agreement or the use by
COLLABORATOR of the results of the Research, provided, however, that the
following is excluded from COLLABORATOR's obligation to indemnify and hold
harmless:
a. The negligent failure of UNIVERSITY to comply with any
applicable governmental requirements; or
b. The negligence of willful malfeasance by a regent, officer,
agent or employee of UNIVERSITY.
14. Award.
a. SPONSOR agrees to pay UNIVERSITY an amount not to exceed one
hundred and twenty four thousand and eight hundred and sixty two dollars and
00/1000 ($124,862), for expenses and other related costs incurred in conjunction
with the Research. This amount, as shown by approximate category of expense in
Exhibit C (for information purposes only), shall be payable according to the
following schedule:
Payment Date Research Period Payment Amount
------------ --------------- --------------
1. Aug. 1, 1999 1. Aug. 1 - Oct. 31, 1999 1. $31.215.50
2. Nov. 1, 1999 2. Nov. 1 -Jan. 31, 2000 2. 531,215.50
3. Feb. 1, 2000 3. Feb. 1 - Apr 30, 2000 3. 531,215.50
4. May 1, 2000 4. May 1-July 31, 2000 4. S31,215.50
b. At the end of the Basic term specified in Article 111. 15. below
(i.e., Research Period 4.) UNIVERSITY shall refund to COLLABORATOR any
difference between the amount paid by COLLABORATOR and the amount incurred in
conjunction with the Research during the Basic term. Any difference remaining
after the Basic term
Pace 7 of 9
may. at COLLABORATOR's option, be applied to COLLABORATOR's payments due during
future terms.
15. Basic Term. This Agreement shall become effective as of the date
written above and. unless earlier terminated as hereinafter provided. shall
continue in force for one (1) year, from August 1,1999 through July 31, 2000.
16. Default and Termination. In the event that either party to this
Agreement shall be in default of any of its material obligations hereunder and
shall fail to remedy such default within thirty (30) days after receipt of
written notice thereof, the party not in default shall have the option of
terminating this Agreement by giving written notice thereof. notwithstanding
anything to the contrary contained in this Agreement. Termination of this
Agreement shall not affect the rights and obligations of the parties that
accrued prior to the effective date of termination. COLLABORATOR shall pay
UNIVERSITY for all reasonable expenses incurred or committed to be expended as
of the effective termination date, subject of the maximum amount as specified in
Article III.14. herein above, and any payments made in excess of this amount
shall be promptly refunded to COLLABORATOR.
17. Entire Agreement. The parties acknowledge that this Agreement and
attached Exhibits A, B and C represent the sole and entire Agreement between the
parties hereto ' pertaining to the Research and that such supersedes all prior
Agreements, understandings, negotiations and discussions between the parties
regarding same, whether oral or written. There are no warranties,
representations or other Agreements between the parties in connection with the
subject matter hereof except as specifically set forth herein. No supplement,
amendment, alteration, modification, waiver or termination of this Agreement
shall be binding unless executed in writing by the parties hereto.
18. Reform of Agreement. If any provision of this Agreement is, becomes
or is deemed invalid, illegal or unenforceable in any United States
jurisdiction, such provision shall be deemed amended to conform to applicable
laws so as to the valid and enforceable; or if it cannot be so amended without
materially altering the intention of the parties, it shall be stricken, and the
remainder of this Agreement shall remain in full force and effect. '
19. Notices. Any notices, statements, payments, or reports required by
this Agreement shall be considered given if sent by United States Certified Mail
postage prepaid and addressed as follows:
If to UNIVERSITY:
The Research Foundation of State University of New York
Office of Sponsored Program Services
Xxxx Xxxxxx Xxx 0
Xxxxxx, Xxx Xxxx
00000-0000
Page 8 of 9
If to COLLABORATOR:
President
B Twelve Ltd.
Xxxxx 0000, 000 Xxxxxxxx Xxxxxx xXxxx
Xxxxxxx, Xxxxxxx
X0X 0X0
20. Governing Law. This Agreement shall be governed and interpreted in
accordance with the substantive laws of the State of New York and with
applicable laws of the United States of America.
IN WITNESS WHEREOF, UNIVERSITY and COLLABORATOR entered into this
Agreement effective as of the date first herein above written.
COLLABORATOR: UNIVERSITY:
/s/ Xxx Xxxxxx /s/ Xxxxxx X. Xxxxxx
---------------------------- -------------------------------
Signature Signature
Xx. Xxx Xxxxxx Xxxxxx X. Xxxxxx
--------------------------------- ------------------------------------
Name Name
President and CEO Senior Associate Attorney
--------------------------------- ------------------------------------
Title Title
Attachments:
Exhibit A
Exhibit B
Exhibit C
Page 9 of 9
EXHIBIT A
Receptor blocking antibodies (monoclonal Type I)
This mAb blocks the binding, of TCII - CbI to the cell surface receptor (TCR).
1. R2-2 (ATCC HB 11939)
2. R3-11 (ATCC HB 11938)
3. R4-7 (ATCC HB 11940)
Cobalamin blocking antibodies (monoclonal Type II)
This mAb blocks the binding CbI to TCII.
1. 1-6b1
2. 1-9b1
3. 3-9b1
4. 2-bbl
5. 5-18bl
Binding (Does not affect receptor or Cbl binding) (monoclonal Type III)
This mAb binds XX XX at a site distant to the Cbl binding or receptor binding
region of TCII.
1. 1-12b
2. Q 1-2b
3. Q 2-2b
4. 3. 5b
EXHIBIT B
Receptor - Transcobalamin II as a target for inducing auoptosis and for
delivery of therapeutic compounds to cells
A research proposal submitted to: B Twelve Ltd, Toronto, Canada
Co-Principal Investigators: Xxxxxx X. Xxxxxxx, Ph.X.
Xxxxxxx X. Xxxxxxxxxx, M.D.
Introduction:
Background.
Research Objectives:
1. TCII receptor (TCR)
2. Generation of monoclonal antibodies (mAb) to TCR
3. Evaluation of monoclonal antibodies to human TCII for cross-species
reactivity
4. Cobalamin analogues
