Exhibit 10.46
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THIS AGREEMENT is made as of July 1, 2006 by and between ▇▇▇▇ Israel
Deaconess Medical Center, Inc., a Massachusetts nonprofit corporation, having
its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇,
("Institution"), andDNAPrint genomics, Inc. a for-profit corporation having its
principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
("Collaborator").
WHEREAS, Collaborator desires that Institution perform certain research
work hereinafter defined and is willing to provide funds to support such
research as well as access to proprietary research materials;
WHEREAS, Collaborator desires to obtain reports of the results of such
research and negotiate for licensing rights to Institution's inventions
developed during the course of such research;
WHEREAS, the Institution, through its principal investigator(s) as defined
below, has the expertise to conduct the research; and
WHEREAS, Institution, in order to ▇▇▇▇▇▇ the development of scientific and
medical knowledge to advance the state of patient care and to advance the
training and education of physicians, scientists and other medical professionals
associated with the Institution, is willing to perform such research and to
enter negotiations to grant to Collaborator licensing rights to such inventions
in return for access to proprietary research materials and compensation
hereinafter defined subject to the terms of this agreement and all applicable
rights of the Federal Government.
NOW, THEREFORE, in consideration of the premises and mutual covenants
herein contained, Institution and Collaborator agree as follows:
1. DEFINITIONS
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As used in this Agreement, the following terms shall have the meanings
indicated:
1.1 "Research Program" shall mean the research set forth in Exhibit A,
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attached hereto and made a part hereof.
1.2 "Invention" shall mean any inventions or discoveries, whether
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patentable or not, which are conceived or first actually reduced to practice in
performance of the Research Program.
1.3 "Patents" shall mean those United States and foreign patents and patent
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applications including any continuation, continuation-in-part, division,
reissue, or renewal thereof, and the patents that may be issued thereon,
relating to any Research Program Invention.
1.4 Other Defined Terms. Each of the following terms shall have the
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meanings ascribed to them in section set forth opposite such term:
"Agreement" Preamble
"Confidentiality" Section 4
"Federal Patent Policy" Section 8.6
"Institution" Preamble
"Principal Investigator" Section 2.2
"Collaborator" Preamble
"Institution Invention" Section 7.1
"Collaborator Invention" Section 7.1
"Joint Invention" Section 7.1
2. RESEARCH PROGRAM
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2.1 Research Efforts. Institution shall use reasonable efforts to conduct
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the Research Program, to the extent funded by Collaborator set forth in Exhibit
A.
2.2 Principal Investigator. The Research Program shall be under the
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direction ofDr. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, Director, Laboratory of Cell and Molecular
Biology, Division of Hematology and Oncology, ▇▇▇▇ Israel Deaconess Medical
Center (the "Principal Investigator").
2.3 Collaborator's Representative. Collaborator's designated
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representative for consultation and communications with Institution and the
Principal Investigator shall be ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ and/or ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ or
such other person as Collaborator may from time to time designate in writing to
Institution and the Principal Investigator in accordance with the notification
provisions of Section 13.3. During the period of this Agreement, Collaborator's
designated representative may consult informally with Institution's
representatives, both in person and by telephone, regarding the Research
Program. Access to work carried on in Institution's laboratories in the course
of the Research Program shall be for the benefit of the parties hereto, under
the control of Institution's personnel, and shall be available to Collaborator
on a reasonable basis.
2.4 Reporting. The Institution shall provide Collaborator with periodic
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reports describing the process made on the Research Program.
2.5 Institutional Purposes: Use of Facilities: No Guarantee of Results.
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Collaborator acknowledges that the primary mission of the Institution is health
care, education and the advancement of knowledge and consequently the Research
Program shall be performed in a manner best suited to carry out that mission.
Specifically, the Principal Investigator shall determine the manner of
performance of the Research Program and Institution does not guarantee specific
results of the Research Program. Institution shall furnish the facilities
(including space and laboratory equipment) necessary to carry out its
obligations under Section 2.1 only to the extent funds are provided by
Collaborator.
2.6 Notification of Investigator Relationship. Collaborator shall notify
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Institution of any agreements it proposes to enter into with all Institution's
employees or staff who are participating in the Research Program, and shall,
upon request, provide copies of such agreements to Institution for its prior
review and approval, such approval not to be unreasonably withheld or delayed.
2.7 Amendments to Research Program. If either party desires to amend or
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expand the Research Program set forth in Exhibit A of this Agreement by adding
new research projects, the parties shall, upon reasonable notice of the proposed
modification by the party desiring the change, confer in good faith to determine
the desirability of amending the Research Program. Any such amendment shall not
be effective unless agreed in writing by the signatories of this Agreement or
their authorized representatives.
3. COMPENSATION
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3.1 Research Support. In consideration of Institution conducting the
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Research Program, Collaborator shall pay Institution the amounts set forth on
Exhibit B, attached hereto and made a part of hereof. During the term of this
Agreement payments shall be made in advance as set forth in detail in Exhibit B.
The first payment shall be due and payable upon the date of this Agreement. All
payments should be made to the attention of:
Director of Research Finance
▇▇▇▇ Israel Deaconess Medical Center
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇.
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Payments should reference DNAP/Sytkowski Research Collaboration Agreement.
The tax identity of the Institution is ▇▇-▇▇▇▇▇▇▇.
3.2 Use of Funds. Institution shall monitor expenditures, in accordance
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with its institutional policies, to ensure that the funds provided by
Collaborator are spent in accordance with this Agreement and approved budgets.
However, Institution shall have the right to reallocate funds between cost
categories as deemed necessary by Institution and the Principal Investigator, so
long as such reallocation does not affect the material goals of the Research
Program.
3.3 Ownership of Equipment. Upon termination or expiration of this
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Agreement, Institution shall retain title to all equipment purchased or
fabricated by Institution with funds provided by Collaborator.
4. CONFIDENTIAL INFORMATION
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4.1 Confidential Information. "Confidential Information" means confidential
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scientific, business or financial information disclosed by either party provided
that such information:
4.1.1 is not publicly known or available from other sources that are
not under a confidentiality obligation to the source of the information;
4.1.2 has not been made available by its owners to others without a
confidentiality obligation;
4.1.3 is not already known by or available to the receiving party
without a confidentiality obligation;
4.1.4 is not independently developed by the receiving party;
4.1.5 does not relate to potential hazards or cautionary warnings
associated with the performance of the Research Program under the Agreement;
4.1.6 is not required to be disclosed by law or regulation.
4.2 Either party's use of any Confidential Information which may be
supplied by the other party in the course of the Research Program shall be
subject to the following:
4.2.1 Each party retains the right to refuse to accept any information
which it does not consider to be essential to the completion of the research
Program.
4.2.2 Where a party is in receipt of Confidential Information, it
agrees to use the same degree of care, but no less than a reasonable degree of
care, as the receiving party would use to protect its own Confidential
Information to prevent the unauthorized use, dissemination, or publication of
the Confidential Information, without the express written permission of the
providing party.
4.2.3 The receiving party's obligation to hold Confidential Information
in confidence expires three (3) years after the termination or expiration of
this Agreement or the completion of the Research Program, whichever occurs
first.
5. USE OF NAME
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5.1 Use of Name. No press release, advertising, sales literature or
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other written statements or oral statements to the public in connection with or
alluding to work performed under this Agreement or the relationship between the
parties created by it, having or containing any reference to Institution, its
parent corporation or any of its affiliates, including Harvard, the Principal
Investigator, or Collaborator, shall be made by any party without the prior
written approval of the other party, which approval shall not be denied
unreasonably. Institution, however, shall have the right to acknowledge
Collaborator's support of the investigations under this Agreement in scientific
publications and other scientific communications upon written notification of
such acknowledgement to Collaborator.
6. PUBLICATION
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6.1 Publications. Notwithstanding Section 4, Institution and the
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Principal Investigators shall have the right to publish or otherwise publicly
disclose information gained during the course of this Agreement. In order to
avoid possible loss of patent rights as a result of public disclosure of
patentable information or unauthorized public disclosure of Confidential
Information, Institution shall submit any materials relating to a planned
written publication or other disclosure for review at least thirty (30) days
prior to the date of the planned written publication or other disclosure.
Collaborator shall notify Institution within twenty (20) days of receipt of such
materials whether it is desirable to file patent applications on any inventions
contained in the materials. Written publication or other disclosure may be
deferred at the request of Collaborator, to permit the filing of any desired
patent applications; provided, however, that said deferral shall in no event
exceed sixty (60) days from the date of receipt by Collaborator of the
materials.
7. INTELLECTUAL PROPERTY RIGHTS
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7.1 Ownership of Inventions. Inventions conceived or reduced to
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practice solely by Institution, or its employees, shall be owned by Institution
and shall be known as "Institution Inventions." Inventions conceived or reduced
to practice solely by Collaborator, or its employees, or agents, shall be owned
by Collaborator and shall be known as "Collaborator Inventions." Inventions
conceived or reduced to practice by at least one employee, agent or member of
medical staff of each of Institution and Collaborator shall be jointly owned by
Institution and Collaborator and shall be known as "Joint Inventions."
7.2 Patent Prosecution and Expenses. Institution shall promptly
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disclose to Collaborator any Inventions conceived or reduced to practice in the
course of or as a result of the work done hereunder, or as a result of
information or materials supplied hereunder. Collaborator shall be responsible
for preparing, filing, prosecuting and maintaining appropriate United States and
foreign patent applications of Collaborator Inventions and Joint Inventions.
Collaborator shall consult with Institution regarding the preparation, filing,
prosecution, and maintenance of all such patent applications including
applications that relate to Collaborator Inventions, and shall furnish to
Institution copies of documents relevant to any such preparation, filing,
prosecution or maintenance of such applications prior to filing so that
Institution may review inventorship decisions and any other matters relevant to
the applications. Institution shall be responsible for preparing, filing,
prosecuting and maintaining appropriate United States and foreign patent
applications of all Institution Inventions. Collaborator shall reimburse
Institution for all expenses related to preparation, filing, prosecution or
maintenance of all such Institution applications, to which Collaborator has been
granted an Option pursuant to Article 8 below. If Collaborator notifies
Institution that it does not wish to file and pay the costs of an application to
any Institution Invention or Joint Invention, Institution may file such
application at its expense and the Collaborator shall have no further rights to
Institution's interest in that patent application.
8.GRANT OF RIGHTS
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8.1 Option for Invention Rights. Institution grants to Collaborator a
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first option to negotiate an exclusive royalty-bearing license to make, have
made, use, lease, sell and to practice any Institution Invention or Institution
rights to any Joint Invention. From the date Collaborator receives notice from
Institution, in accordance with Section 13.3 that an Invention has been
disclosed by an Institution employee, agent, or member of its medical staff to
the Institution's Technology Ventures Office, Collaborator shall have ninety
(90) days to notify Institution in writing of its intent to exercise the option
referenced in this Section 8.1.
8.2 Exercise of Option. Collaborator shall have one hundred and twenty
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(120) days from the time it notifies Institution of its intent to exercise its
option to enter into a mutually acceptable license agreement with Institution,
which Collaborator and Institution shall negotiate in good faith, and which will
include reasonable field restrictions, due diligence and performance benchmarks,
milestone payments, and royalty and sublicensing terms. Upon execution of this
license agreement, the option referred to in Section 8.1 shall be deemed to be
exercised. Royalty rates will be determined based on the relative contributions
of the parties to the Research Invention, and will be consistent with reasonable
business practices.
8.3 Effect of Failure to Exercise. In the event that Collaborator does
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not notify Institution of its intent to exercise its option to license an
Institution Invention or Joint Invention within ninety (90) days, or if the
parties do not execute a license agreement to the Institution Invention or Joint
Invention within one hundred and twenty (120) days from the date of
Collaborator's written notice of intent to exercise, Institution shall be free
to offer a license to a third party for the Institution Invention or Joint
Invention on terms no more favorable to the prospective licensee, than the terms
last offered to Collaborator.
8.4 Retained Rights. Institution shall have the right to use free of
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cost without limitation, all Inventions whether or not licensed to Collaborator
hereunder, for education and research purposes.
8.5 Joint Inventions Not Exclusively Licensed. In the event that the
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Collaborator does not obtain an exclusive commercialization license to the
Institution's rights in Joint Inventions described in Section 7.1, then each
party shall have the right to use the Joint Invention and to license its use to
others. The parties may agree to a joint licensing approach for such Joint
Inventions.
8.6 Rights Subject to Federal Patent Policy. To the extent that any
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Research Invention has been partially funded by the Federal Government, the
assignment of title or the granting of any license above is subject to federal
law set forth in 35 U.S.C. 200 et. seq., as amended, and the regulations
promulgated thereunder, as amended, or any successor statutes of regulations
(the "Federal Patent Policy"). Any right granted in this Agreement greater than
that permitted under the Federal Patent Policy shall be modified as may be
required to conform to the provisions of the Federal Patent Policy.
8.7 Discussion with Colleagues. In accordance with Section 4 relating
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to Confidential Information, Institution's investigators shall be free to
discuss the research being performed under this Agreement with internal
scientific colleagues, so long as the recipients of any Confidential Information
are bound by the non-disclosure provisions of Section 4.
9. INDEMNIFICATION AND INSURANCE
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9.1 Indemnification
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9.1.1 Collaborator shall indemnify, defend and hold harmless
Institution and its trustees, officers, medical and professional staff,
employees, and agents and their respective successors, heirs and assigns (the
"Indemnitees"), against any liability, damage, loss, or expense (including
reasonable attorneys' fees and expenses of litigation) incurred by or imposed
upon the Indemnities or any one of them in connection with any claims, suits,
actions, demands, or judgments arising out of any theory of product liability
(including but not limited to, or strict liability) concerning any products,
process or service made, used or sold pursuant to any rights granted under this
Agreement.
9.1.2 Collaborator's indemnification under 9.1.1 shall not apply to any
liability, damage, loss, or expense to the extent that it is attributable to the
negligent activities, reckless misconduct or intentional misconduct of the
Indemnities.
9.1.3 Collaborator agrees, at its own expense, to provide attorneys
reasonably acceptable to Institution to defend against any actions brought or
filed against any party indemnified hereunder with respect to the subject of
indemnity contained herein, whether or not such actions are rightfully brought.
9.1.4 Any Licensing Agreement entered into by the Parties pursuant to
Section 8 of this Agreement shall include indemnification and insurance
provisions that are consistent with the requirements of the Risk Management
Foundation of the Harvard Medical Center.
9.1.5 Collaborator shall maintain such commercial general liability
insurance beyond the expiration or termination of this Agreement during (i) the
period that any product, process, or service, is being commercially distributed
or sold (other than for the purpose of obtaining regulatory approvals) by
Collaborator or by a licensee, affiliate or agent of Collaborator and (ii) a
reasonable period after the period referred to in (i) above which in no event
shall be less than fifteen (15) years.
10. REPRESENTATIONS AND WARRANTIES
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10.1 NO WARRANTIES. EXCEPT AS SPECIFICALLY PROVIDED IN THIS SECTION,
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THE PARTIES MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER,
INCLUDING THE CONDITIONS OF THE RESEARCH OF ANY INVENTION OR PRODUCT, WHETHER
TANGIBLE OR INTANGIBLE, MADE OR DEVELOPED UNDER THIS AGREEMENT, OR THE
OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH
OR ANY INVENTION OR PRODUCT.
11. TERM AND TERMINATION
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11.1 Term. This Agreement shall remain in effect for twelve (12)
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months, unless sooner terminated in accordance with the provisions of this
Agreement.
11.2 Termination Without Cause. Neither party may unilaterally
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terminate this Agreement without cause. However, the Institute and Collaborator
may terminate this Agreement, or any portions thereof, at any time by mutual
written consent. In such event, the parties shall specify in such writing, the
disposition of all property and/or Research Program Inventions arising from or
performed under this Agreement.
11.3 Termination with Cause. In the event that either party shall be
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in default of any material obligation under this Agreement and shall fail to
remedy such default to the satisfaction of the non defaulting party within
thirty (30) days after receipt of written notice thereof from the non defaulting
party, the party not in default shall have the option of terminating this
Agreement by giving written notice thereof in accordance with Section 13.3.
11.4 Effects of Termination. Termination of this Agreement shall not
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affect the obligations of the parties accrued prior to termination.
11.5 Survival. The provisional of articles 4, 5, 6, 7, 8, 9, 10 and
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11, shall survive any expiration or termination of this Agreement.
12. DISPUTE RESOLUTION
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12.1 Any controversy, claim or other dispute arising out of this
Agreement or relating to the subject matter hereof shall be first referred to
the Chief Academic Officer for the Institution and the Chief Executive Officer
for Collaborator, or his or her designee, for resolution. Thereafter if the
parties are unable to resolve the dispute, the dispute shall be decided by
arbitration in accordance with arbitration rules under the laws of the State of
Massachusetts. Collaborator shall select three (3) arbitrators from a list of
certified arbitrators in the metropolitan Boston area. The Institution shall
select one (1) arbitrator from the three (3) selected by Collaborator, and the
arbitrator selected by the Institution shall be designated the arbitrator for
the dispute. The arbitrator shall adopt arbitration rules and schedules
customary and applicable to the type of dispute under consideration. This
agreement to arbitrate shall be specifically enforceable under the prevailing
arbitration law. The award rendered by the arbitrator shall be final and
binding on all parties, and judgment may be entered thereon in any court having
jurisdiction thereof. The arbitration shall be held in the Boston,
Massachusetts metropolitan area. Each party shall bear its own attorneys' fees
and costs, and the arbitrator's fee shall be shared and paid equally between the
parties.
13. GENERAL
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13.1 Binding Effect: Assignment. This Agreement shall be binding upon
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and shall inure to the benefit of the parties hereto and their respective
transferees, successors and assigns, except that neither party shall have the
right to assign this Agreement or its right and obligations hereunder, without
the prior written consent of the other party thereto.
13.2 Entire Agreement. This Agreement constitutes the entire and only
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agreement between the parties relating to the Research Program, and all prior
negotiations, representations, agreements and understandings are superseded
hereby. No agreements amending, altering or supplementing the terms hereof may
be made except by means of a written document signed by the duly authorized
representatives of the parties.
13.3 Notices. Any notice or communication required or permitted to be
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given hereunder shall be in writing and, except as otherwise expressly provided
in this agreement, shall be deemed given and effective (i) when delivered
personally, by telex or telecopier or (ii) when received if sent by overnight
express or mailed by certified, registered or regular mail, postage prepaid,
addressed to a party at its address set forth below (or to such other address as
such party may designate by written notice in accordance with the provisions of
this Section 13.3), said notice being deemed given as of the date of mailing:
To Institution:
▇▇▇▇ ▇▇▇▇▇▇
Chief, Business Ventures
Technology Ventures Office , E/FN-2
▇▇▇▇ Israel Deaconess Medical Center
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇.
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Copy to Principal Investigator:
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, MD
Laboratory for Cell and Molecular Biology
Division of Hematology and Oncology
▇▇▇▇ Israel Deaconess Medical Center
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇. W/BL 548
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Copy to Legal Counsel:
Office of General Counsel
▇▇▇▇ Israel Deaconess Medical Center
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
To Collaborator:
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, M.B.A., CEO
DNAPrint genomics, Inc.
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Copy to Legal Counsel:
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, Esq.
▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇, P.A.
▇▇▇▇ ▇▇▇ ▇▇ ▇▇▇ ▇▇▇▇., ▇▇▇. ▇▇▇
▇▇▇▇▇, ▇▇ ▇▇▇▇▇
13.4 Applicable Law. This Agreement shall be construed and enforced in
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accordance with the laws of The Commonwealth of Massachusetts without regard to
any choice or conflict or laws, rule or principle that would rest in the
application of the laws of any other jurisdiction.
13.5 Heading. Headings included herein are for convenience only, and
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shall not be used to construe this Agreement.
13.6 Relationship of Parties. For the purposes of this Agreement and
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all services to be provided hereunder, each party shall be, and shall be deemed
to be, an independent contractor and not any agent or employee of the other
party. Neither party shall have authority to make any statements,
representations or commitments of any kind, or to take any action which shall be
binding on the other parties, except as may be explicitly provided for herein or
authorized in writing.
13.7 Severability. If any provision of this Agreement shall be found
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by a court of competent jurisdiction to be void, invalid or unenforceable, the
same shall either be reformed to comply with applicable law or stricken if not
so conformable, so as not to affect validity or enforceability of this
Agreement.
13.8 Waivers. No delay or omission on the part of either party to
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enforce or exercise any right under this Agreement shall operate as a waiver of
that right or any other right hereunder, or the ability to later assert that
right relative to the particular situation involved or to terminate this
Agreement arising out of any subsequent default or breach.
13.9 Counterparts. This Agreement may be executed in any number of
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counterparts, each of which shall constitute an original document, but all of
which shall constitute the same agreement.
13.10 Official Version. The official version of this document will be
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in the English language.
13.11 Force Majeure. Neither party shall be liable for any
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unforeseeable event beyond its reasonable control not caused by the fault or
negligence of such party, which causes such party to be unable to perform its
obligations under this Agreement and which it has been unable to overcome by the
exercise of due diligence. In the event of the occurrence of such a force
majeure event, the party unable to perform shall promptly notify the other party
pursuant to Section 13.3. It shall further use its best efforts to resume
performance as quickly as possible and shall suspended performance only for such
period of time as is necessary as a result of the force majeure event.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the date first written above.
▇▇▇▇ ISRAEL DEACONESS DNAPRINT GENOMICS
MEDICAL CENTER
BY: /s/▇▇▇▇ ▇▇▇▇▇▇ BY: /s/▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
--------------- ------------------
NAME: ▇▇▇▇ ▇▇▇▇▇▇ NAME: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
TITLE: CHIEF, BUSINESS VENTURES TITLE: PRESIDENT
I, ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, named as Principal Investigator in this Agreement,
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acknowledge that I have read this Agreement in its entirety and that I shall use
reasonable professional efforts to fulfill my individual obligations and
responsibilities as set forth herein.
By: /s/▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, MD
-----------------------------
Name: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇, MD
Title: Director, Laboratory for Cell and Molecular Biology
EXHIBIT A
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PROPOSED WORK PLAN FOR SYTKOWSKI LABORATORY
SUPPORTED BY DNAPRINT GENOMICS, INC. 2006-2007
24 APRIL 2006
The studies outlined below will require more than one year to complete. However,
each study can be emphasized depending upon priorities agreed upon by DNAP and
▇▇. ▇▇▇▇▇▇▇▇▇. A more detailed description of each study can be provided. A one
year budget, consistent with the increased effort compared to the past year, is
also outlined.
STUDIES SUPPORTING EPO DIMER DEVELOPMENT AND PRODUCT DIFFERENTIATION COMPARING
EPO DIMER, CONVENTIONAL EPO AND DARBEPOETIN (ARANESPTM)
- Quantify parameters of binding to the Epo receptor (EpoR).
o On and off rate constants; equilibrium dissociation constant
o Receptor internalization and recycling to cell surface
o Hill coefficient
- Quantify intracellular signal strength and duration for growth and
differentiation
- Gene expression studies: compare qualitative and quantitative differences.
- Compare results for hematopoietic cell EpoR with EpoR on other cells,
e.g., endothelial cells, neuronal cells.
- Complete development of anti-Epo antibody assays required by FDA
- Interact with CRO personnel including transfer of and training in analytic
techniques.
- Carry out in vitro bioassays of samples provided by CRO. The assay is
calibrated against the World Health Organization International Reference
Preparation of human erythropoietin.
- Carry out in vivo bioassays of samples provided by CRO
RESEARCH AND DEVELOPMENT OF NEW PHARMACEUTICAL AGENTS BASED UPON LICENSED
TECHNOLOGY
- Explore polyethylene glycol derivatization (PEGylation) of Epo dimer
o Test alternative chemistries
o Vary stoichiometry
o Preliminary PK and PD
- Begin development of R103A mutant for tissue protection (neuro- and
cardioprotection)
o Prepare stably expressing CHO cell line
o Develop in vitro assays to test tissue protective effects
o Validate R103A as a tissue protective agent in vivo
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EXHIBIT B
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BUDGET AND PAYMENT SCHEDULE
ONE YEAR BUDGET
EFFECTIVE DATE: 1-Jul-06-30-Jun-07
PERSONNEL
ROLE SALARY FRINGE TOTAL
-------------------------- -------- ------- --------
$11,040
To Be Named Senior research associate $ 48,000 $ 59,040 23% fringe
----------- -------------------------- -------- -------- ----------
97,000
Molecular/Cell Biologist $26,190 $123,190 27% fringe
-------------------------- ------- -------- ----------
$13,800 $ 73,800
Biochemist $ 60,000 23% fringe
-------------------------- -------- ----------
Research Assistant $ 35,000 $ 8,050 $ 43,050 23% fringe
-------------------------- -------- ------- -------- ----------
Total salary & Fringe $240,000 $59,080 $299,080
-------------------------- -------- ------- --------
$ 50,000
Supplies/other
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Total direct costs: $349,080
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Total Indirect costs: 70% $244,356
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Total Costs: $593,436
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Payment Schedule:
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One-half of the total amount ($296,718 USD) will become due and payable to BIDMC
upon execution of this Agreement. Twenty-five percent of the total amount
($148,359 USD) will be due six months after execution of this Agreement. The
remaining twenty-five percent ($148,359 USD) will be due 10 days after
completion of this Agreement.