EXHIBIT 10.1
Contract Between (MTC) and (ITC) -2007
AGREEMENT
This AGREEMENT (this "Agreement") is effective this 25th day of June, 2007,
between the Infotonics Technology Center Inc., (ITC) a New York not-for-profit
Corporation and the Mediscience Technology Corporation and/or its New York
state, wholly-owned subsidiary BioScopix, Inc (MTC).
RECITALS:
A. (ITC) was organized to, inter alia, lessen the burdens of government by
conducting and sponsoring scientific research for the development of new
businesses and the development of jobs in the field of photonics and
microsystems in New York State;
B. (ITC) has been retained by the Mediscience Technology Corporation to develop
and commercialize medical diagnostic systems using tissue autofluorescence to
detect disease states;
C. (ITC) has access to medical diagnostic system designs based upon tissue
autofluorescence that were developed by third parties under contract to the
Mediscience Technology Corporation;
D. (ITC) desires to extend and improve upon said medical diagnostic system
designs with the expectation that such extensions and improvements will include
advances in optical, mechanical, electrical, software, and diagnostic aspects of
the medical diagnostic system; and
E. (MTC) desires the support of (ITC) in designing, prototyping, testing,
further development of, and supporting the commercialization of medical
diagnostic systems using tissue autofluorescence to detect disease states.
F. In the context of this agreement, the following definitions are used;
1) Development: the scope of work defined in the statement of
work in this contract.
2) Development IP: the intellectual property that results from
the Development services;
3) Background IP: the intellectual property, belonging to either
party to this agreement, developed prior to this agreement,
necessary for the successful completion of the Development
services;
NOW, THEREFORE, in consideration of the premises and mutual covenants herein
contained, the parties agree to the following:
1. Development Services. (ITC) will perform development and commercialization
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support for (MTC) as described in and pursuant to the terms of the Statement of
Work attached hereto as Exhibit A (the "Development").
2. Fee. As consideration for (ITC) exerting its good faith efforts to carry out
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the Development,(MTC) will pay (ITC) an amount not to exceed $2,000,000 for
services rendered in calendar year 2007. (ITC) will make a best efforts attempt
to secure grant awards that will be included in this $2,000,000 as appropriate.
(ITC) will invoice (MTC) according to the milestone
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schedule set forth in Exhibit B, upon completion of seminal milestones. Payments
shall be made by (MTC) within 30 days of receipt of invoice from (ITC), so long
as the seminal milestones have been successfully completed as agreed to by both
(MTC) and (ITC). As possible, (ITC) will invoice on a 2-week cycle as agreed-to
milestones are completed.
3. Period of Performance
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Development under this Agreement will be performed commencing upon the Effective
Date and will terminate upon completion of the 2007 Development plan, December
31, 2007, unless sooner terminated as provided in Article 17.
4. Technical Representatives
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(ITC)'s Technical Representative shall be Xxxxx Xxxxxx-Xxxxxx or such other
representative as (ITC) may subsequently designate in writing. (MTC)
representative shall be Xxxxx Xxxxxxxxx, or such other representative as (MTC)
may subsequently designate by board action in writing.
5. Consultation with (ITC)' Representatives
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During the period of this Agreement, (MTC)'s Representative may have reasonable
access to consult informally with (ITC)'s Technical Representative regarding the
Development both personally and by telephone. Access to work carried on at (ITC)
in the course of the Development shall be entirely under the control of (ITC)'s'
personnel; (MTC)'s representatives shall be permitted to visit the laboratories
at (ITC) as mutually agreed during usual hours of operation.
6. Technical Reports
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The (ITC) Technical Representative shall submit written reports with their
invoices on a 2-week cycle. Oral reports will be supplied from (ITC) as
necessary, to (MTC)'s Representative. Said Technical Representatives may also
make other reporting arrangements as mutually agreed to from time to time.
Within thirty (30) days after the expiration of this Agreement, the (ITC)
Technical Representative shall submit a comprehensive final report to
(MTC).describing all the work performed and the results achieved.
7. Publicity; Confidential Information
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7.1. Except as set forth below, neither (ITC) nor (MTC) will issue
any press release or make any other public announcement
concerning this Agreement and the transactions contemplated
hereby without the prior written consent of the other party,
unless such press release or announcement is required by law.
Such press releases or announcements as required by law
include those required by the SEC as submitted in full
compliance with sections 8-K 1.01 and 2.01 re; "materiality, `
as applicable and in fulfillment of SEC Section 6, 6.01
Regulation (FD) Full Disclosure, Sections 7, and 7.0, and all
applicable and presently effective Xxxxxxxx-Xxxxx disclosure
requirements under Regulation G. The form and content of any
such press release or announcement will be approved, in
writing, by both parties, provided such approval shall not be
unreasonably withheld, delayed or conditioned by either party.
7.2. If a Party ("discloser") discloses its technology or other
information to the other Party ("receiver") and identifies the
technology and such information as proprietary and/or
confidential by use of an appropriate stamp, legend or other
marking or notice ("Confidential Information"), the receiver
agrees that the rights and
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obligations of the Parties with respect to the Confidential
Information shall be governed by the terms and conditions of
the Master Confidentiality and Mutual Disclosure Agreement
between the Parties dated February 9, 2007. It is agreed by
the Parties that the disclosure of Confidential Information
shall be solely for the purposes of this Agreement and shall
not be construed as a grant of any right or license with
respect thereto except as set forth otherwise herein or in a
duly executed license agreement.
8. Intellectual Property
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8.1. Inventorship of inventions conceived during the course of
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performing research under the Project will be determined in
accordance with U.S. Patent laws and ownership would follow
inventorship.
8.2. Prior Patents. The parties hereto agree that neither party
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shall have rights in any invention made by the other before
the date of this Agreement, except for those rights provided
by law or under specific agreement. No party obtains any
rights under this Agreement to background patents held by the
other party or to related inventions or discoveries which are
not conceived or made in the performance of the Development
("Background IP"). Each Party represents that, prior to the
initiation of the Development, it has made a good-faith effort
to identify to the other Party the existence of any Background
IP possessed by the first Party that is necessary for and
essential to the implementation, use or commercialization of
the results of the Development, and that it shall promptly
identify to the other Party the existence of any such
necessary Background IP possessed by the first Party which may
subsequently come to its attention. To the extent it is able
to do so, each Party will negotiate with the other Party to
provide the other Party with rights, under reasonable terms
and conditions to be negotiated, to use Background IP where
necessary to allow the practice or commercialization of rights
acquired by such Party in the Development IP.
8.3. Reporting. The parties shall promptly report, within thirty
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(30) days, to each other any Subject Invention made.
8.4. The parties hereto agree that all rights, title and interest
to any idea, design, concept, technique, invention, discovery
or improvement, whether or not patentable, conceived and/or
reduced to practice hereunder, including but not limited to,
patent applications and resulting issued patents, including
but not limited to any continuations, continuations-in-part
(to the extent the claims are specifically directed to the
subject matter in the patent or patent application to which it
claims priority), divisionals, reissues, reexaminations, and
renewal patents, all foreign counterparts thereof, and any
registered and unregistered copyrights and mask works that are
created or discovered in the performance of the Development
and commercialization agreement (collectively "Development
IP") developed either solely by employees, consultants, or
agents of (ITC) or jointly with (MTC), its employees,
consultants or agents, shall belong to (MTC), with a
non-exclusive, royalty-free, irrevocable license to (ITC) in
other fields of use, subject to the following:
8.4.1. (ITC) Employee Inventions Not Pertaining to Medical
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and Veterinary Device Designs, Methods, and Use. The
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parties agree that (ITC) shall have the initial
option to retain title to any Subject Invention made
solely by (ITC) employees, wherein said Subject
Inventions do not pertain to medical and veterinary
diagnostic product designs, methods, and uses. (ITC)
shall promptly notify
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(MTC) upon making this election and in the event that
(ITC) retains title to said Subject Invention, (ITC)
agrees to timely file patent applications on such
Subject Inventions at its own expense and agrees to
grant to (MTC) a non-exclusive, irrevocable paid-up
license to practice such Subject Invention throughout
the world in an agreed upon field of use.
8.4.2. The party having the right to retain title and file
patent applications on a specific Subject Invention
must elect to file patent applications thereon and
advise the other party within thirty (30) days from
the date it reports the Subject Invention to the
other party. In the event that the party fails to
make such an election and so advises the other party
within thirty (30) days from the date it reports the
Subject Invention, the other party may elect to file
patent applications on such Subject Invention. If the
other party elects to file patent applications, the
party initially reporting such Subject Invention
agrees to assign its rights, title and interest in
such Subject Invention to the other party and to
cooperate with such other party in the preparation
and filing of patent applications thereon. The
assignment of the entire right, title and interest to
the other party pursuant to this paragraph shall be
subject to the retention by the party assigning title
of a non-exclusive, irrevocable, paid-up license to
practice, or have practiced, the Subject Invention
throughout the world. In the event neither of the
parties to this Agreement elect to file a patent
application on Subject Invention, either or both (if
a joint invention) may, at their sole discretion and
subject to reasonable conditions, release the right
to file to the inventors subject to the retention of
a non-exclusive irrevocable, royalty free, paid-up
license to be held by (ITC) and (MTC).
8.4.3. The party in charge of patent prosectuion shall be
responsible for making decisions regarding scope and
content of applications to be filed and prosecuted.
In the case of joint inventions, both parties are
responsible to provide all necessary and reasonable
technical detail to support patent application
preparation and prosecution. Further in the case of
joint inventions, the party filing the patent
application shall keep the other party advised as to
all developments with respect to such applications
and shall promptly supply copies of all papers
received and filed in connection with the prosecution
thereof and shall do so in sufficient time for said
other party to review, comment and to be fully
involved in the patenting process.
8.5. Should the patent owner decide at any time to cease necessary
payments on patent, copyright or mask works, applications, or
maintenance of any patent obtained pursuant to this Section,
it shall give the other parties reasonable advance notice and
shall offer to the other parties the opportunity to assume
responsibility for all of such expenses. If the other party
chooses to assume responsibility for such expenses, the owner
shall assign to the party assuming the expenses all rights to
the applicable Development IP, including, but not limited to,
the right to xxx for past infringement.
9. Right of First Refusal.
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During the term of this Agreement, (MTC) agrees to make all reasonable efforts
to utilize (ITC) for technology, development, scale-up and for future
manufacturing of medical and veterinary diagnostic systems using tissue
autofluorescence to detect disease and/or health state. Accordingly, (MTC) will
engage (ITC) to produce products or services embodying the Technology at (ITC)
fabrication facility at commercially reasonable rates and hereby grants to
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Contract Between (MTC) and (ITC) -2007
(ITC) a right of first refusal (based on price, quantity, quality, delivery
dates, and related specification or production terms) to produce any such
service or product.
10. Independent Contractors
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(ITC) and (MTC) shall be deemed independent contractors with respect to this
Agreement and nothing herein contained shall be construed as creating a joint
venture between them or as empowering either party to act as the agent of the
other party.
11. Indemnification
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(MTC) shall indemnify, defend, and hold harmless (ITC) and its present and
former officers, directors, trustees, employees, and agents, from any damages,
from any claim, loss, cost, expense, or liability of any kind, including
reasonable attorney's fees (whether incurred as the result of a third party
claim or a claim to enforce this provision), arising out of or connected with
this Agreement or the Development, including, without limitation, product
liability claims relating to commercialization of the Development. It shall be a
condition of the indemnification obligation that (ITC) promptly notify (MTC) of
any such claim and cooperate with (MTC) and its insurance carrier in the defense
of the claim. (MTC) shall consult with (ITC) for its approval (which approval
shall not be unreasonably withheld) regarding the defense of such claim and
shall submit any proposed settlement to (ITC) in advance of its approval
whenever (ITC)' interests are materially and adversely affected.
12. Warranties; Limitation of Liability
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(ITC) MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER,
INCLUDING, WITHOUT LIMITATION, THE CONDITION, ORIGINALITY, OR ACCURACY OF THE
DEVELOPMENT OR ANY DEVELOPMENT IP OR PRODUCT(S) BASED THEREON, WHETHER TANGIBLE
OR INTANGIBLE, CONCEIVED, DISCOVERED, OR DEVELOPED UNDER THIS AGREEMENT; OR THE
OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE
DEVELOPMENT OR ANY SUCH DEVELOPMENT IP OR PRODUCT. (ITC) SHALL NOT BE LIABLE FOR
ANY DIRECT, INDIRECT, CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY (MTC), ANY
LICENSEE, OR ANY OTHERS RESULTING FROM THE USE OF THE DEVELOPMENT OR ANY SUCH
DEVELOPMENT IP OR PRODUCT(S). (ITC)'s MAXIMUM LIABILITY TO (MTC) FOR ANY CAUSE
OF ACTION OR OTHER CLAIM DIRECTLY OR INDIRECTLY ARISING OUT OF THIS AGREEMENT OR
THE DEVELOPMENT IS LIMITED TO THE CASH PAYMENTS MADE TO (ITC) IN THE COURSE OF
FULFILLMENT OF THE SEMINAL DEVELOPMENT MILESTONES.
13. Notices
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Any notice or report required or permitted to be given under this Agreement
shall be deemed to have been sufficiently given for all purposes if mailed by
first class certified or registered mail to the following addresses of either
Party:
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Contract Between (MTC) and (ITC) -2007
Infotonics Technology Center Inc. Mediscience Technology Corporation.
0000 Xxxxxx Xxxxx 0000 Xxxxxxxxx Xxx
Xxxxxxxxxxx, XX 00000 Xxxxxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxxx Attention: Xxxxx Xxxxxxxxx
Phone (000) 000-0000 Phone (000) 000-0000
Fax (000) 000-0000 Fax (000) 000-0000
E-mail xxxxx.x.xxxxx@(ITC).org E-mail xxxxx@xxx.xxx
With copy to: With a copy to:
X. Xxxxxxxx Xxxxx, Legal Counsel
Xxxxxxx Xxxxxxxxxxx & Mugel, LLP
000 Xxxxxx Xxxx
Xxxxxxxxx, XX 00000-0000
E-mail xxxxxx@xxxxxxx.xxx
or to such other addresses as shall hereafter have been furnished by
written notice to the other Party.
14. Export Controls
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It is understood that (MTC) and (ITC) are subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes, and other commodities, and that their obligations
hereunder are contingent on compliance with applicable U.S. export laws and
regulations (including the Arms Export Control Act as amended, and the Export
Administration Act of 1979). The transfer of certain technical data and
commodities may require a license from the cognizant agency of the United States
Government and/or written assurances by (ITC) that (ITC) will not re-export data
or commodities to certain foreign countries without prior approval of the
cognizant government agency. While (MTC) shall cooperate in securing any license
which such agency deems necessary in connection with this Agreement, (MTC)
cannot guarantee that such licenses will be granted.
15. Force Majeure
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(ITC) shall not be responsible to (MTC) for failure to perform any of the
obligations imposed by this Agreement, provided such failure shall be occasioned
in whole or in part by fire, flood, explosion, lightning, windstorm, earthquake,
subsidence of soil, failure or destruction of machinery or equipment, or failure
of supply of materials, discontinuity in the supply of power, governmental
interference, civil commotion, riot, war, strike, labor disturbance,
transportation difficulty, labor shortage, or any cause beyond the reasonable
control of (ITC).
16. Termination
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16.1. Except as otherwise provided in Section 18 hereof, this
Agreement shall expire on completion of the Development,
December 31, 2007, unless extended or sooner terminated in
accordance with the provisions of this Section.
16.2. If either Party fails to meet any of its obligations under
this Agreement and fails to remedy the failures within thirty
(30) days after receipt of written notice thereof, the other
Party shall have the option of terminating this Agreement upon
written notice thereof, and such right to terminate shall be
such Party's sole remedy at law or in equity.
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16.3. Upon termination by one Party under Section 16.2 above,
licenses to the Development IP and Background IP previously
provided by the involuntarily terminated Party to other Party
shall continue in effect.
17. Survivorship
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The provisions of Articles 7, 8, 10, 11, 12, 14, 15, 16.3, 18(E) and 18(F) shall
survive any expiration or termination of this Agreement.
18. Miscellaneous
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A. Paragraph Headings
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The section headings are provided for convenience and are not to be used in
construing this Agreement.
B. Entire Agreement. This Agreement and the Exhibits hereto contain the entire
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agreement between the parties, superseding in all respects any and all prior
oral or written agreements or understandings, pertaining to the subject matter
hereof and transactions contemplated hereby, and can be amended or modified only
by a written instrument signed by the parties.
C. Waiver. No waiver by either party of any condition, breach, covenant,
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representation, or warranty contained in this Agreement, whether by conduct or
otherwise, in any one or more instances shall be deemed to be or construed as a
further and continuing waiver of any such condition, breach, covenant,
representation, or warranty.
D. Binding Effect; Assignment. This Agreement shall be binding upon and shall
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inure to the benefit of and be enforceable by the parties and their respective
successors and permitted assigns. This Agreement shall not be assigned by either
party without the written consent of the other, which consent shall not be
unreasonably withheld.
E. Submission to Jurisdiction. Each party hereby irrevocably submits to the
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exclusive personal jurisdiction of any New York State or federal court in
Rochester, New York, in any action or proceeding arising out of or relating to
this Agreement. All claims in respect of such action or proceeding shall be
heard and determined exclusively in such New York State or federal court. Each
party irrevocably waives, to the fullest extent it may effectively do so, the
defense of an inconvenient forum to the maintenance of such action or
proceeding.
F. Governing Law. This Agreement and the legal relations between the parties
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shall be governed by and construed in accordance with the laws of the State of
New York without regard to its conflict of laws principles.
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IN WITNESS WHEREOF, the Parties have each caused this Agreement to be signed by
its duly authorized officers, all as of the day and year first above written.
MEDISCIENCE TECHNOLOGY CORP. INFOTONICS TECHNOLOGY CENTER INC.
By: By:
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Name: Xxxxx Xxxxxxxxx Name: Xxxxx X. Xxxxx
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Title: President Title: President
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(ITC)/(MTC)
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Contract Between (MTC) and (ITC) -2007
Exhibit A
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STATEMENT OF WORK
Background: This statement of work outlines the tasks and schedule required to
deliver an autofluorescence diagnostic system for in vivo detection of
malignant, nonmalignant, and benign tissue states. The work to be done by
Infotonics is reportable to the Mediscience Technology Corporation, and to its
wholly-owned subsidiary, BioScopix, Inc. The scope of work includes the
development of the BioScopix company, located on the Infotonics Technology
Center site.
The (ITC) support comprises development leadership, IP assessment, coordination
of external contractors, coordination with the Chief Medical Consultant to
BioScopix, product map creation, product line rationalization with common
sub-systems envisioned for shared costs across product lines, and development of
grant proposals as appropriate to support some aspects of R&D associated with
one or more of the autofluorescence-based products in the product map.
The Statement of Work can be modified only in writing, with both (MTC) and (ITC)
approvals indicated by signature or initialing of revisions.
Exhibit B
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SEMINAL MILESTONES
NOTE: the seminal milestones noted here represent the entire development effort
beyond that funded via this contract. Additional monies beyond those noted in
this contract will be provided by (MTC) to the contractors and other
professionals who will support the development work
1. February 16, 2007: Autofluorescence tech assessment, competitive
positioning, potential product line roadmap. A literature review to be
conducted to assess (MTC) IP position with respect to the CD-R,
competitive positioning relative to other companies with cervical
cancer diagnostic fluorescent imaging systems, development of a
preliminary product map, identification of potential key resources in
Rochester area with CDAs in place.
2. February 28, 2007: Critical communications with potential investor
groups. Development of key investor documents and presentations. Travel
to make presentations to key investor groups within the Empire
Financial Group. Rochester-area presentations to local support groups
to provide information on BioScopix product map and critical areas of
product differentiation, as well as potential economic impact on
Rochester area if successful.
3. March 16, 2007: Fluorescence excitation and imaging feasibility.
Initial calculations of light levels due to 340nm and 440nm
autofluorescence of biological tissue due to a controlled exposure at
300nm. Preliminary paper assessment of adequate light levels to form
images using commercially available imaging sensors and optics.
Determination of most appropriate imaging sensors and components for an
imaging CD-Ratiometer. Identification of required resources in the
Rochester area. CDAs in place with key resources, initial
organizational meetings concluded. Plan developed for first breadboard
module to test light levels..
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4. June 30, 2007: Breadboard 1 build, test, and trial. Build an imaging
sensor breadboard with commercially available image sensor, control
electronics, and imaging optics. Trial the breadboarded sensor with
consultant firms to confirm adequate light levels and dynamic range. If
light levels are appropriate, continue with imaging design for a second
breadboarded imaging sensor using optimized components. If light levels
are inadequate, focus on non-imaging sensor while assessing additional
options for more sensitive imaging components and designs.
5. July 16, 2007: Updated IDE for FDA trial, identification of medical
facilities interested to participate in the trial, leadership in place
for FDA trial. Edit the IDE documents to include most likely CDR system
design, medical protocol, and proposed facilities to be included in the
pilot. In collaboration with Xx. X. Xxxxxxxx, NYU.
6. July 30, 2007: CDR sensor design, CDR system design, component
specifications. Using data from breadboard 1, deliver updated CDR
sensor head design including all optical, electronic, and mechanical
components. Upgrade CDR system design including all optical,
electronic, and mechanical components. Deliver designs, component
specifications, blue prints, and cost estimates.
7. July 30, 2007: Resubmission of IDE to FDA for approval of protocol
upgrades, CDR system design details. Submit the updated IDE documents
to the FDA for review and approval, incorporating responses to FDA
concerns raised during initial document approval in 2006. Fully specify
all protocol details, system designs, participating facilities, etc as
required to launch the trials by 4Q07.
8. TBD: Build of first CDR prototype with testing and design mods as
needed.
9. September 3, 2007: Establishment of ITC team for CPE development
10. TBD: Build of next 3 CDR prototypes with testing
11. TBD: Shipment of prototype CDRs to FDA trial sites and initiation of
FDA trial.
12. October 19, 2007: CPE preliminary engineering assessment of competitive
assembly methods and determination of preferred assembly technologies.
(ITC)/(MTC)
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