Exhibit 10.20
SPONSORED RESEARCH AGREEMENT
RESEARCH AGREEMENT, effective on the date of last signature below, by
and between The University of North Carolina at Chapel Hill, having an address
at 308 Bynum Hall, Chapel Hill, North Carolina (the "University"), and Boston
Biomedica, Inc., a corporation existing under the laws of the State of
Massachusetts, and having its principal place of business at 375 West Street,
West Bridgewater, MA 02379 (the "Sponsor"),
WITNESSETH:
WHEREAS, in pursuit of its educational purposes, which include research
and training, the University undertakes scholarly research and experimental
activities in a variety of academic disciplines; and
WHEREAS, the Sponsor has funded, wishes to continue to fund, and
desires that the University undertake, a research program in accordance with
said research and training mission, which research program is described more
fully in Exhibit A, attached hereto and made a part hereof (hereinafter, the
"Research"); and
WHEREAS, in furtherance of its scholarly research and instructional
interests, the University is willing to undertake the Research upon the terms
and conditions set forth below;
NOW, THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereto agree as follows:
1. Scope of Research
During the term of this Agreement, the University shall use its best
efforts to perform the Research, as described in Exhibit A, attached
hereto and made a part hereof. Notwithstanding the foregoing, the
University makes no warranties or representations regarding its ability
to achieve, nor shall it be bound hereby to accomplish, any particular
research objective or results.
2. Personnel
The Research shall be performed by, and under the supervision and
direction of, Dr. Kuo-Hsiung Lee, who shall be designated the Principal
Investigator, together with such additional personnel as may be
assigned by the University. Sponsor shall be notified as to the
identity of the additional personnel and any personnel changes during
the course of the contract. If for any reason the Principal
Investigator is unable to continue to serve as the Principal
Investigator, and a successor acceptable to both the University and the
Sponsor is not available, this agreement may be terminated as provided
in Article 10.2.
2
3. University policies and Procedures
All Research conducted hereunder shall be performed in accordance with
established University policies and procedures, including, but not
limited to, policies and procedures applicable to research involving
human subjects, laboratory animals, and hazardous agents and materials.
4. Budget and Payment Schedules
4.1 The Sponsor agrees to pay University, direct and indirect costs, in
connection with the Research in accordance with the Budget attached
hereto as Exhibit B. This budget covers all work described in Exhibit
A, including the discovery and development of novel compounds against
HIV and one additional virus or disease selected by Sponsor. In
addition to the Research described in Exhibit A, these funds will allow
the Principal Investigator to generate approximately 10 grams of each
of four separate compounds, per year. If Sponsor wishes to generate
additional quantities or additional compounds, other resources must be
committed towards this effort. Sponsor, at its sole discretion, may
choose to expand the research scope as follows:
-----------------------------------------------------------------------
TYPE OF EXTENSION Additional Direct Costs
OF RESEARCH SCOPE -----------------------
Per Year
--------
additional disease state (max. of two) $50,000
additional bulk synthesis of compounds $5,000-$7,500 (approximate)
-----------------------------------------------------------------------
4.2 For the purposes of this Agreement, "disease state" shall mean an
individual virus or disease (e.g. HIV, HCV, breast cancer, lymphoma,
etc.) for which compounds are being designed, under the Research, to
serve as therapeutic agents.
4.3 The University and Sponsor have agreed that the indirect cost rates for
the Research shall be added to the direct costs listed above and shall
be charged incrementally per year according to the following schedule
Year1: 10% Total Direct Costs
Year 2: 17.5% Total Direct Costs
Year 3: 25% Total Direct Costs
Option Year 1: 35% Total Direct Costs
Option Year 2: Full UNC Negotiated Rate
3
Any modifications to the above shall be made only upon completion of a
written amendment to this Agreement executed by the University, the
Sponsor, and the Principal Investigator.
4.4 The University may submit to the Sponsor at any time, and the Sponsor
may at its discretion approve in writing, requests for additional
funds. However, the Sponsor is not liable for any cost in excess of the
amount specified herein, unless this Agreement is modified to indicate
such in writing by both parties. All checks shall be made payable to
The University of North Carolina at Chapel Hill, shall include
reference to the University, Principal Investigator and his department,
and shall be sent to: S. Kent Walker, 440 W. Franklin St., CB#1350,
UNC-CH, Chapel Hill, NC 27599-1350. Payments shall be made in
accordance with the following schedule: one-quarter (1/4) of the annual
budget on the date of signing of the agreement, and equal quarterly
payments thereafter for each funding year of the agreement.
5. Research Reports
The Principal Investigator shall furnish to the Sponsor during the term
of his Agreement informal written reports at least twice per year
regarding the progress of the Research. A final report setting forth
the significant research findings shall be prepared by the Principal
Investigator and submitted to the Sponsor within ninety (90) days
following the expiration of the term of this Agreement or the effective
date of early termination, as set forth in Article 10.
6. Publication
The University reserves, on behalf of the Principal Investigator and
other University employees and / or students, the right to disseminate
information, or to publish any material resulting from the Research
without need for approval by the Sponsor. However, the University shall
provide the Sponsor with a copy of any proposed publication forty-five
(45) days in advance of the proposed publication date. The Sponsor may
request, and the University shall agree to, a delay of such proposed
publication for an additional period, not to exceed forty-five (45)
days, in order to protect the potential patentability of any invention
described therein. The Sponsor, at its election, shall be entitled to
receive in any such publication an acknowledgment of its sponsorship of
the Research. It is specifically agreed that nothing contained in this
agreement will interfere with the publication or oral defense of
research theses and dissertations of graduate students.
4
7. Proprietary Information
7.1 University shall disclose any new invention under this Agreement to
Licensee:
(a) within two months after the inventor discloses it to the
University's Office of Technology Development.
(b) at least two months prior to any intended public disclosure of all
or part of the invention; and
(c) at least two weeks prior to submission for publication of any
manuscript or abstract which discloses all or part of the invention
7.2 The disclosure under Article 7.1 shall be in writing and shall be
sufficiently complete in technical detail to convey a clear
understanding, to the extent known at the time of the disclosure, of
all attributes associated with the invention, such that a patent
application with meaningful claims can be drafted. It should also
indicate the earliest expected date of public disclosure of the
invention.
7.3 The University will promptly inform Company of the submission of any
abstract or manuscript for publication and its acceptance thereof.
7.4 The invention will not be publicly disclosed for 60 days after Company
has received a description of the invention. Company shall remove any
of its Confidential Information from the proposed public disclosure or
file a patent application sufficiently covering the invention within
this two month review period. If Company wishes to further delay
publication in order to draft a thorough patent application describing
the invention it must request such a delay to University in writing,
and University's approval shall not be unreasonably withheld. In no way
shall the total delay be more than ninety (90) days from the initial
disclosure of invention to company except with the written mutual
consent of both parties.
7.5 All confidential information of either party disclosed to the other
party in connection with the Research hereunder will be treated by the
receiving party as confidential and restricted in its use to only those
uses contemplated by the terms of this Agreement. Any information which
is to be treated as confidential must be clearly marked as confidential
prior to transmittal to the other party. If such confidential
information is disclosed orally, it shall be identified as being
confidential at the time of disclosure, and shall thereafter be reduced
to writing within 30 days, marked as confidential, and transmitted to
the receiving party. The Sponsor may submit confidential information
only to the Principal Investigator, who shall be free to refuse to
accept such confidential information. The obligations of this paragraph
shall survive and continue for three (3) years after termination of
this Agreement. Specifically excluded from such confidential treatment
shall be information which:
(a) as of the date of disclosure and / or delivery, is already known to
the party receiving such information;
5
(b) is or becomes part of the public domain, through no fault of the
receiving party;
(c) is lawfully disclosed to the receiving party by a third party who
is not obligated to retain such information in confidence;
(d) is independently developed at the receiving party by someone not
privy to the confidential information, or
(e) either party is required by law to provide.
8. Results of the Research
8.1 "New Invention or Discovery" shall mean any invention or discovery
conceived or reduced to practice during and as a part of the Research
performed pursuant to this Agreement by Institution's Principal
Investigator, faculty, staff, employees, or students or jointly by such
an individual or individuals with one or more employees of the Sponsor.
New Inventions or Discoveries made solely by Institution's Principal
Investigator, faculty, staff, employees, or students shall be the sole
property of the Institution. New Inventions or Discoveries made jointly
by Institution's Principal Investigator, faculty, staff, employees, or
students with one or more employees of the Sponsor shall be owned
jointly by the Institution and the Sponsor. New Inventions or
Discoveries made solely by employees of Sponsor shall be the sole
property of Sponsor.
8.2 The University shall promptly disclose to the Sponsor in writing any
New Invention or Discovery which is subject to this Agreement. To the
extent that it has the legal right to do so, the University shall, upon
request of the Sponsor, grant the Sponsor the first Option for an
exclusive license to the University's right, title, and interest in any
such New Invention or Discovery under an Exclusive License Agreement to
be negotiated in accordance with the attached License Agreement and
under terms no less favorable to the Sponsor than those in the attached
License Agreement. Sponsor shall have six months to determine whether
to exercise this Option. If Sponsor declines to exercise its option to
any New Invention or Discovery University shall, at its own discretion,
be free to license the University's right, title, and interest in such
New Invention or Discovery to a third party, exclusively or
non-exclusively.
9. Ownership of Property
Title to any equipment purchased or manufactured in the performance of
the work funded under this agreement shall vest in the University.
6
10. Term and Termination
10.1 This Agreement shall be effective for three (3) years from the date of
last signature below, with two additional one-year option periods that
may be exercised by Sponsor by providing written notice to University
within sixty (60) days of the termination date above. Notwithstanding
the foregoing, this Agreement may be extended thereafter by mutual
agreement of the parties in writing.
10.2 Notwithstanding the foregoing, this Agreement may be terminated by
either party at any time upon sixty (60) days advance written notice to
the other party, however, the provisions of paragraphs 7, 8, 9, 12, 14,
15, and 20 shall survive such termination. Upon receipt of notice of
early termination from Sponsor, the University shall use its best
efforts promptly to limit or terminate any outstanding commitments and
to conclude the work. All costs associated with such termination shall
be reimbursable, including, without limitation, all non-reimbursed
costs and non-cancelable commitments incurred prior to the receipt of
the notice of termination, such reimbursement together with other
payments not to exceed the total estimated project cost specified in
Article 4.
11. Notices
Any notices given under this Agreement shall be in writing and shall be
deemed delivered when sent by first-class mail, postage paid, addressed
to the parties as follows (or at such other addresses as the parties
may notify each other of in writing):
The University of North Carolina at Chapel Hill:
Dr. Robert P. Lowman
Associate Vice Provost for Research
Office of Research Services
The University of North Carolina at Chapel Hill
CB#4100, 300 Bynum Hall
Chapel Hill, NC 27599-4100
Sponsor:
Richard T. Schumacher
President and CEO
Boston Biomedica, Inc.
375 West Street
West Bridgewater, MA 02379
7
12. Use of University Name
Sponsor shall not employ or use the name of the University in any
promotional materials, advertising, or in any other manner without the
prior express written permission of the University, except that Sponsor
may, during the term of this Agreement, state that it is sponsoring the
Research at the University. In no event shall the sponsoring of the
Research be considered to be an endorsement by the University of any
commercial product which may result, indirectly or directly, from the
Research.
13. Relationship of the Parties
The University, for all purposes related to this Agreement, shall be
deemed an independent contractor of the Sponsor, and nothing in this
Agreement shall be deemed to create a relationship of employment or
agency or to constitute the parties as partners or joint ventures.
14. Indemnification
14.1 The Sponsor agrees to defend, indemnify and hold harmless the
University, its employees, students and agents from and against any and
all liablility claims, lawsuits, losses, demands, damages, costs and
expenses, arising directly or indirectly out of the Research as
described in Exhibit A, or the design, manufacture, sale or use of any
embodiment or manifestation of said Research regardless of whether any
and all such liability, claims, lawsuits, losses, demands, damages,
costs and expenses arise in whole or in part from the negligence of any
of the indemnified parties. Notwithstanding the foregoing, the Sponsor
will not be responsible for any liablility, claims, lawsuits, losses,
demands, damages, costs, and expenses which arise solely from (a) the
gross negligence or intentional misconduct of University or the
Principal Investigator; and (b) actions by University or the Principal
Investigator in violation of applicable laws or regulations.
Notwithstanding any provisions herein to the contrary, and subject to
the provisions of the N.C. Tort Claims Act, G.S. 143-291 et seq., the
University shall indemnify the Sponsor for any claims for injuries to
persons or property damage which occur on the University premises or
premises under the exclusive control of the University.
14.2 The Sponsor agrees to provide a diligent defense against any and all
liability, claims, lawsuits, losses, demands, damages, costs, and
expenses, brought against the indemnified parties with respect to the
subject of the indemnity contained in Section 14.1, whether such claims
of actions are rightfully or wrongfully brought or filed.
8
14.3 The University, on behalf of its employees, students and agents wishing
collectively to be indemnified as provided in Sections 14.1 and 14.2
shall:
(a) promptly after receipt of notice of any all liability claims,
lawsuits, losses, demands, damages, costs and expenses, or after
the commencement of any action, suit or proceeding giving rise to
the right of idemnification, notify the Sponsor, in writing, of
said liability, claims, lawsuits, losses, demands, damages, costs,
and expense and send to the Sponsor a copy of all papers served on
the indemnified party; the University's failure to notify the
Sponsor will not relieve the Sponsor from any liability to the
indemnified party; and
(b) permit the Sponsor to retain counsel of its choosing to represent
the indemnified party (but in the event that the Sponsor does not
select counsel to represent the indemnified party within ten (10)
days, the indemnified party may select its own counsel, the fees
and all costs of which counsel will be borne by the Sponsor); and
(c) subject to the statutory authority of the Attorney General of the
State of North Carolina, allow the Sponsor to retain exclusive
control of any such liability, claims, lawsuits, losses, demands,
damages, costs, and expenses, including the right to make any
settlement, except that the Sponsor will not have the right to make
any settlement or take any other action which would be deemed to
confess wrongdoing by any of the indemnified parties or could
reasonably be expected to have a negative effect on the reputation
of one of the indemnified parties, without the prior written
consent of University and the indemnified party involved.
15. No Warranties
The University makes no warranties, either express or implied, as to
any matter, including, without limitation, the results of the research
or any inventions or product, tangible or intangible, conceived,
discovered or developed under this Agreement; or the merchantability or
fitness for a particular purpose of the research results of any such
invention or product. The University shall not be liable for any
direct, consequential or other damages suffered by the Sponsor or by
any Licensee or any others resulting from the use of the research
results or any such invention or product.
9
16. Force Major
The University shall not be liable for any failure to perform as
required by this Agreement, to the extent such failure to perform is
caused by any reason beyond the University's control, or by reason of
any of the following: labor disturbances or disputes of any kind,
accidents, failure of any required governmental approval, civil
disorders, acts of aggression, acts of God, energy or other
conservation measures, failure of utilities, mechanical breakdowns,
material shortage, disease, or similar occurrences.
17. Severability
In the event that a court of competent jurisdiction holds any provision
of this Agreement to be invalid, such holding shall have no effect on
the remaining provisions of this Agreement, and they shall continue in
full force and effect.
18 Entire Agreement; Amendments
This Agreement and the Exhibits hereto contain the entire agreement
between the parties. No amendments or modifications to this Agreement
shall be effective unless made in writing and signed by authorized
representatives of both parties.
19 Similar Research
Nothing in this Agreement shall be construed to limit the freedom of
the University of one of its researchers who are participants under
this Agreement, from engaging in similar research made under other
grants, contracts or agreements with parties other than the Sponsor.
20. Transfer of Sponsorship
During the course of this agreement, the Sponsor may transfer its
rights and obligations as Sponsor to a company formed by the Sponsor
and in which the Sponsor has at least 40% ownership at the time of
transfer, or another percent ownership interest agreed upon in writing
by the Parties. Sponsor will notify the University and Principal
Investigator in writing prior to any such transfer.
21. Governing Law
This Agreement shall be governed by and construed in accordance with
the law of North Carolina.
10
IN WITNESS WHEREOF, the parties hereto have executed this Agreement by
their duly authorized officers or representatives.
THE UNIVERSITY OF NORTH CAROLINA SPONSOR
AT CHAPEL HILL
By: _____________________ By:_____________________
Robert P. Lowman, Ph.D. Richard T. Schumacher
Associate Vice Provost President and CEO
Office of Research Services
Date: _____________________ Date: ___________________
Consented to by Principal Investigator:
Signature: __________________________________________
Dr. Kuo-Hsiung Lee
Kenan Professor of Medicinal Chemistry
Date: ________________________________________
11
Exhibit A
---------
The objectives of this Research shall be to (1) discover and develop novel
compounds that have improved anti-HIV activity and activity against one
additional virus or disease selected by Sponsor within the first two years of
the Agreement; (2) design and synthesize analogs of compounds already discovered
as a result of previous research paid for by Sponsor [e.g. compounds disclosed
in the US Patent Nos. 5,612,341; 5,637,589; 5,679,828; 5,726,204, and 5,847,165;
and in the US Patent Application entitled "Acylated Betulin and Dihydrobetulin
Derivatives, Preparation Thereof and Use Thereof", Inventors: K-H Lee, I-C Sun,
H-K Wang, and L.M. Cosentino]; and (3) synthesize gram-scale quantities of four
compounds per year to undergo extensive testing. During the course of this
research, the University will transfer to the Sponsor compounds synthesized
under this Research Plan for testing by Sponsor. Sponsor may, at his own cost,
have these compounds tested by contract testing organizations or collaborators.
These tests may include screening the compounds against a variety of viruses in
order to select the additional anti-viral target referred to above.
Sponsor may choose to direct research towards additional viruses and / or
disease states (maximum of two) at any point during the Research. However, such
research must be agreed upon by Sponsor and University prior to initiation of a
new research plan, and the minimum cost for such research will be in accordance
with Article 4 above. Sponsor may, at its own discretion, request additional
compounds as discussed in research objective #3 (in this Exhibit A) above,
provided that Sponsor pays all costs of the synthesis above and beyond the
agreed-upon costs herein.
12
EXHIBIT B
Year 1 Year 2 Year 3 Combined
Salary + fringes for 2 post-docs @ 30,000 60,000 60,000 60,000 180,000
Salary + fringes for 2 graduate students @ 14,834 29,668 29,668 29,668 89,004
Tuition for two graduate students 18,332 18,332 18,332 54,996
Supplies, starting materials for four target
compounds / year, miscellaneous expenses 42,000 42,000 42,000 126,000
TOTAL DIRECT COSTS 150,000 150,000 150,000 450,000
Indirect Costs (10% Yr 1, 17.5% Yr 2, 25% Yr 3 15,000 26,250 37,500 78,750
TOTAL COSTS 165,000 176,250 187,500 528,750