EXHIBIT 10.5
[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [*], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
This Agreement, effective as of date of execution by the Parties (the
"Effective Date"), is between the Montefiore Medical Center ("Institution"), a
corporation of the State of New York, and Ivivi Technologies, Inc. ("Sponsor"),
a New Jersey corporation.
RECITALS
Institution and Sponsor are entering into this Agreement because
Sponsor desires to fund the research of Xxxxx Xxxxxx Ph.D. of Institution's
Department of Neuro Surgery in certain specific areas. Sponsor desires to
support such research conducted by Institution in accordance with the terms and
conditions of this Agreement. The research program contemplated by this
Agreement is of mutual interest to Sponsor and Institution and furthers the
educational, scholarship and research objectives of Institution.
In consideration of the promises and mutual covenants contained herein, and
intending to be legally bound hereby, the parties hereto agree as follows:
1. Definitions
1.1. "Confidential Information" means any confidential or
proprietary information furnished by one party (the "Disclosing Party") to the
other party (the "Receiving Party") in connection with the performance of the
Research Project, provided that such information is specifically designated as
confidential. Such Confidential Information may include, without limitation,
trade secrets, know-how, inventions, technical data or specifications and
testing methods.
1.2. "Device" means any pulsed magnetic field device employing
Sponsor Proprietary Technology.
1.3. "Inventions" means any potentially patentable invention based
on the Research Results which is (i) conceived during the term of this Agreement
by employees of Institution or Sponsor, or both, and (ii) reduced to practice
either during the term of this Agreement or thereafter within a period of six
(6) months.
1.4. "Materials" means any tangible biological, chemical, or
physical materials. In the case of biological materials, the term "Materials"
shall also include tangible materials that are routinely produced through use of
the original materials, including, for example, any progeny derived from a cell
line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated
from isolated DNA or RNA, recombinant proteins produced through use of isolated
DNA or RNA, and recombinant proteins isolated from a cell extract or supernatant
by non-proprietary affinity purification methods.
1.5. "Other Inventions" means any potentially patentable invention
based on the Research Results which is (i) conceived during the term of this
Agreement by employees of Institution or Sponsor, or both, (ii) reduced to
practice either during the term of this Agreement or thereafter within a period
of six (6) months and (iii) not owned by Sponsor under section 5.1.
1.6. "Patent Rights" means all United States and foreign patent
applications claiming an Invention, including any divisional, continuation,
continuation-in-part (to the extent that the claims are directed to an
Invention), and foreign equivalents thereof, as well as any patents issued
thereon or reissues or reexaminations thereof.
1.7. "PMF" means pulsed magnetic field. PRF means pulsed radio
frequency, PEMF means pulsed electromagnetic field, all of which are known
collectively as PMF.
1.8. "Principal Investigator" means an employee of Institution who
has primary responsibility for the performance of the Research Project. The
Principal Investigator is identified in Section 2.1. below.
1.9. "Project Materials" means Materials that are discovered or
developed in the performance of the Research Project.
1.10. "Proprietary Materials" means any proprietary Materials other
than Project Materials that are furnished by one party (the "Supplier") to the
other party (the "Recipient") in connection with the performance of the Research
Project.
1.11. "Research Project" means the research project described on
Exhibit A ("Description of Research Project"), which Institution agrees to
perform under the terms and conditions of this Agreement.
1.12. "Research Results" means all data, test results, laboratory
notes, techniques, know-how, and any other research results that are obtained in
the performance of the Research Project. The term "Research Results" shall not
include any Project Materials, patentable inventions, copyrighted or
copyrightable works, trademarks or service marks, or other intellectual property
based on the Research Results. As a matter of policy, Institution ordinarily
will not assert trade secret protection for Research Results.
1.13. "Sponsor Proprietary Technology" means confidential
information, trade secrets, inventions and know-how in the area of pulsed
magnetic field technology held by Sponsor.
1.14. "Technical Representative" means an individual designated by
Sponsor as its principal technical representative for consultation and
communications with Institution and the Principal Investigator. The Technical
Representative is identified in Section 2.1. below.
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2. Performance of Research Project.
2.1. Principal Investigator and Technical Representative. The
Principal Investigator shall be Xxxxx Xxxxxx, Ph.D. If Xxxxx Xxxxxx ceases to
serve as Principal Investigator for any reason, Institution will promptly notify
Sponsor, and Institution and Sponsor shall use good faith efforts to identify a
mutually acceptable replacement within sixty (60) days. If a suitable
replacement Principal Investigator cannot be identified within the sixty-day
period, Sponsor shall have right to terminate this Agreement as provided in
Section 6.2. The Technical Representative shall be Xxxxxx X. Xxxxx, Ph.D.
Sponsor may change its Technical Representative upon thirty (30) days written
notice to Institution.
2.2. Performance of Research Project. Institution shall use
reasonable efforts to complete the Research Project. The Principal Investigator
shall direct the Research Project and shall control the manner of its
performance. The Technical Representative may consult informally with the
Principal Investigator, both in person and by telephone, regarding the
performance of the Research Project. The Technical Representative shall have
reasonable access to Institution facilities where the Research Project is being
conducted, but the exact time and manner of such access shall be determined by
the Principal Investigator.
2.3. Records, Materials, and Reports. The Principal Investigator
will prepare and maintain records containing all Research Results, including
laboratory notebooks maintained in accordance with customary academic practice.
During the term of this Agreement, and at the convenience of the Principal
Investigator, the Technical Representative shall have reasonable access to such
research records, and the Principal Investigator agrees to furnish Sponsor, upon
request, with reasonable amounts of any Project Materials, subject to
availability. Within ninety (90) days after the expiration or termination of
this Agreement, the Principal Investigator shall deliver to Sponsor a final
report describing all significant Research Results in reasonable detail;
provided, however, that the Principal Investigator may extend this ninety-day
deadline with the consent of Sponsor, which consent shall not be unreasonably
withheld.
3. Contributions of Sponsor.
3.1. Contributions to Research Project. Sponsor shall contribute to
the Research Project the financial support and other resources listed on Exhibit
B ("Sponsor Contributions"). Sponsor may also furnish Institution and the
Principal Investigator with certain Confidential Information and Proprietary
Materials, which shall remain the property of Sponsor. Institution and the
Principal Investigator reserve the right to refuse to accept any Confidential
Information or Proprietary Materials offered by Sponsor.
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3.2. Payments to Institution. In consideration of the performance
of the Research Project, Sponsor shall make an initial payment of 50% upon the
signing of this Agreement and quarterly payments to Institution in the amounts
listed on Exhibit B ("Sponsor Contributions"). Payments should be made in the
name of "Montefiore Hospital c/o the Department of Neuro Surgery Research Fund"
and sent to Xxxxxx X. Xxxxxxx, Ph.D., Director, The Office of Research &
Sponsored Programs, Montefiore Medical Center, 0000 Xxxxxxxxxx Xxxxxx, Xxxxx, XX
00000. If this Agreement is terminated prior to its expiration for any reason
other than a material breach by Institution (as described in Section 6.3.), then
on the effective date of such termination, Sponsor shall pay Institution the
entire amount of any uncancellable financial commitments that Institution
intended to pay through Sponsor Contributions, including without limitation (i)
salaries for appointed employees for the remainder of their term of appointment
(e.g., postdoctoral fellows) and stipends for graduate students and (ii)
Institution expenses previously incurred for equipment, travel, and associated
indirect costs. Upon the request of Sponsor made within thirty (30) days after
the expiration or termination of this Agreement, Institution shall furnish
Sponsor with a final accounting of all expenses incurred in connection with the
Research Project and all funds received from Sponsor pursuant to this Section
3.2., together with a check payable to Sponsor in the amount of any unexpended
and uncommitted funds, failing which Institution shall retain any unexpended
funds.
3.3. Use of Funds. Institution shall monitor expenditures, in
accordance with its institutional policies, to ensure that the funds provided by
Sponsor are spent in connection with the performance of the Research Project and
matters related to the project.
3.4. Ownership of Equipment. Upon termination or expiration of this
Agreement, Institution shall retain title to all equipment purchased or
fabricated by Institution with funds provided by Sponsor.
4. Confidential Information; Proprietary Materials; Publications.
4.1. Confidential Information. Any previous confidentiality
agreement concerning the Protocol and/or this Study between the parties is
hereby incorporated herein and extended by this Agreement. Sponsor, Institution
and Principal Investigator recognize that the conduct of this Study may require
the transfer of confidential or proprietary information between the parties (the
"Confidential Information"). Any such Confidential Information disclosed by a
party to another party or its employees, agents and contractors, shall be used
only in connection with the legitimate purposes of this Agreement, shall be
disclosed by the receiving party only to those who have a need to know it and
are obligated to keep same in confidence, and shall be safeguarded with
reasonable care; provided, however, that the disclosing party marks the
Confidential Information as such at the time of disclosure (or, if disclosed
verbally, such Confidential Information is reduced to writing and so marked
within a reasonable period of time thereafter).
4.1.1. Designation. Confidential Information that is
disclosed in writing shall be marked with a legend indicating its confidential
status (such as "Confidential" or "Proprietary"). Confidential Information that
is disclosed orally or visually shall be documented in a written notice prepared
by the Disclosing Party and delivered to the Receiving Party within thirty (30)
days of the date of disclosure; such notice shall summarize the Confidential
Information disclosed to the Receiving Party and reference the time and place of
disclosure.
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4.1.2. Obligations. In consideration of the disclosure of
any Confidential Information to the other, it is agreed that during the term of
this Agreement and thereafter for a period of five (5) years, the Receiving
Party shall (i) maintain all Confidential Information in strict confidence.
except that the Receiving Party may disclose or permit the disclosure of any
Confidential Information to its directors, officers, employees, consultants, and
advisors who are obligated to maintain the confidential nature of such
Confidential Information and who need to know such Confidential Information for
the performance of the Research Project; (ii) use all Confidential Information
solely for the performance of the Research Project; (iii) take precautions as
normally taken with the Receiving Party's own confidential and proprietary
information to prevent disclosure to third parties, and (iv) allow its
directors, officers, employees, consultants, and advisors to reproduce the
Confidential Information only to the extent necessary for the performance of the
Research Project, with all such reproductions being considered Confidential
Information.
4.1.3. Exceptions. The obligations of the Receiving Party
under Section 4.3 above shall not apply to the extent that the Receiving Party
can demonstrate that certain Confidential Information (i) was in the public
domain prior to the time of its disclosure under this Agreement; (ii) entered
the public domain after the time of its disclosure under this Agreement through
means other than an unauthorized disclosure resulting from an act or omission by
the Receiving Party; (iii) was independently developed or discovered by the
Receiving Party without use of the Confidential Information; (iv) is or was
disclosed to the Receiving Party at any time, whether prior to or after the time
of its disclosure under this Agreement, by a third party having no fiduciary
relationship with the Disclosing Party and having no obligation of
confidentiality with respect to such Confidential Information; or (v) is
required to be disclosed to comply with applicable laws or regulations, or with
a court or administrative order, provided that the Disclosing Party receives
reasonable prior written notice of such disclosure.
4.1.4. Ownership and Return. The Receiving Party
acknowledges that the Disclosing Party (or any third party entrusting its own
information to the Disclosing Party) claims ownership of its Confidential
Information in the possession of the Receiving Party. Upon the expiration or
termination of this Agreement, and at the request of the Disclosing Party, the
Receiving Party shall return to the Disclosing Party all originals, copies, and
summaries of documents, materials, and other tangible manifestations of
Confidential Information in the possession or control of the Receiving Party,
except that the Receiving Party may retain one copy of the Confidential
Information in the possession of its legal counsel solely for the purpose of
monitoring its obligations under this Agreement.
4.2. Research Results. All data and study results from the Study
will be promptly and fully disclosed to Sponsor and shall be owned by Sponsor.
Institution Principal Investigator or his/her designee may freely present or
publish the results of a scientific investigation involving this Study, provided
that Confidential Information of Sponsor is not disclosed without written
permission from Sponsor. Principal Investigator shall provide with a copy of the
manuscript, paper or poster within a reasonable time (at least thirty (30) days)
prior to their submission to a scientific journal or presentation at scientific
meetings and a reasonably detailed summary or abstract of any other oral or
written publication within a reasonable time prior to their submission or
presentation, in order to allow Sponsor to review said publication for comments
and to ensure that no Sponsor confidential or propriety information is
disclosed. If identified by Sponsor, Principal Investigator will delete any of
Sponsor's confidential or proprietary information that may be contained therein.
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4.3. Proprietary Materials.
4.3.1. Limited Use and Transfer. The Recipient shall use
Proprietary Materials only for the performance of the Research Project. The
Recipient shall use the Proprietary Materials only in compliance with all
applicable federal, state, and local laws and regulations. The Recipient shall
not use the Proprietary Materials in any in vivo experiments on human subjects.
The Recipient shall not transfer any Proprietary Materials to any third party
without the prior written consent of the Supplier.
4.3.2. Warranty Disclaimer. Any Proprietary Materials that
are furnished to a party pursuant to this Agreement are provided for
experimental purposes and may have hazardous properties. THE SUPPLIER MAKES NO
REPRESENTATIONS, AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, WITH RESPECT TO ANY PROPRIETARY MATERIALS. THERE ARE NO EXPRESS OR
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR
THAT THE USE OF PROPRIETARY MATERIALS WILL NOT INFRINGE ANY PATENT RIGHTS OR
OTHER PROPRIETARY RIGHTS OF A THIRD PARTY.
4.3.3. Ownership and Return. The Recipient acknowledges that
the Supplier (or any third party entrusting its Materials to the Supplier)
claims ownership of its Proprietary Materials in the possession of the
Recipient. The Recipient agrees to cause its employees to execute and deliver
any documents of assignment or conveyance to effectuate the ownership rights of
the Supplier in Proprietary Materials. Upon the expiration or termination of
this Agreement, the Recipient shall at the instruction of Supplier either
destroy or return any unused Proprietary Materials.
4.4. Publications. Institution and its employees will be free to
publicly disclose (through journals, lectures, or otherwise) the Research
Results, provided that the Principal Investigator shall have provided a copy of
the proposed disclosure to Sponsor at least sixty (60) days prior to the
submission of any written publication and at least thirty (30) days prior to any
oral public disclosure (the "Review Period") to allow Sponsor to determine
whether any Invention or its Confidential Information would be disclosed. The
parties expressly agree that research grant proposals submitted to federal,
state, or local agencies or non-profit organizations shall not be subject to
review under this Section. If Sponsor reasonably determines that the proposed
disclosure would reveal an Invention or Sponsor Confidential Information, then
Sponsor shall notify Institution and the Principal Investigator of such
determination and its basis prior to the expiration of the Review Period. With
respect to disclosure of an Invention, upon receipt of timely notice by Sponsor,
the Principal Investigator agrees to delay submission of the written publication
or presentation of the oral public disclosure until one of the following events
occurs: (i) Sponsor and Institution agree that no patentable Invention exists;
(ii) Institution or Sponsor files a patent application claiming the relevant
Invention pursuant to Article 5; (iii) Sponsor, Institution, and Principal
Investigator jointly agree upon deletions that prevent disclosure of any
Invention; or (iv) a period of sixty (60) days elapses commencing with the
effective date of notice to Institution. With respect to disclosure of Sponsor
Confidential Information, upon receipt of timely notice by Sponsor, the
Principal Investigator agrees to delete such information from any proposed
disclosure.
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5. Intellectual Property.
5.1. Inventions. Institution shall promptly disclose to Sponsor any
discovery or invention (each an "Invention") made by institution, Principal
Investigator or any other Study personnel in the performance of the Study. Title
to all Inventions and all related intellectual property rights developed that
relate to Device (or its class of equivalents), any other Sponsor product, the
Protocol or the Study shall be the sole and exclusive property of Sponsor.
Institution and Principal Investigator shall assign, and shall take appropriate
steps to ensure that all of its Study personnel are obligated to assign, to
Sponsor all rights, title and interests each may have in any such Invention and
will cooperate to effect the foregoing.
5.2. Licenses. In consideration of the contributions provided by
Sponsor, Institution and Principal Investigator grant to Sponsor or its
Affiliates a first option to obtain a worldwide royalty-bearing license to all
other Inventions not owned by Sponsor ("Other Inventions") conceived or made in
the performance of the Study. The parties shall negotiate a license agreement
for such Other Inventions developed under the Study upon reasonable commercial
terms and conditions. If a mutually acceptable license agreement for any Other
Invention is not executed and delivered by the end of one (1) year from the date
Sponsor receives written notice of such Other Invention, Sponsor's first option
concerning such Other Invention as described above shall terminate. In the event
Sponsor and Institution enter into a license agreement for any Other Invention
conceived or made in the performance of the Project, and Sponsor desires to file
a patent application for such Other Invention, Sponsor will pay the costs
associated with such filing.
5.3. Licensing Terms. Notwithstanding any provision to the
contrary, in the event the parties do not enter into a license agreement for any
particular Other Invention, then for a period of two (2) years from the date
receives written notice of such Other Invention, Institution and Principal
Investigator nevertheless agree that neither shall offer a license for such
Other Invention to any third party on terms more favorable to such third party
than were first offered to Sponsor without first making such an offer to
Sponsor.
5.4. No right or license is granted under this Agreement by any
party expressly or by implication, except those specifically set forth herein.
Nothing contained within this Agreement shall impose an obligation of
exclusivity on one party by the other. Both parties reserve the right to enter
into and participate in other activities (either alone or with a third party)
including, but not limited to, clinical trails and sponsored research studies.
5.5. Copyrightable Works. Institution or its employees shall have
sole ownership of any copyrighted or copyrightable works (including reports and
publications) that are created by Institution employees in the performance of
the Research Project. Institution and the Principal Investigator hereby grant
Sponsor an irrevocable, royalty-free, nontransferable, non-exclusive right to
copy and distribute any research reports furnished to Sponsor under this
Agreement and to prepare, copy, and distribute derivative works based on these
research reports. This section shall not be construed to provide Sponsor with
rights in published works authored by Institution or its employees for which
rights must be assigned by the authors to the publisher as a condition of
publication.
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6. Term and Termination.
6.1. Term. This Agreement shall commence on the Effective Date and
shall remain in effect for a period of 1 year, unless earlier terminated in
accordance with the provisions of this Agreement.
6.2. Loss of Principal Investigator. If the Principal Investigator
leaves Institution or otherwise terminates his involvement in the Research
Project, and if Institution and Sponsor fail to identify a mutually acceptable
substitute as provided in Section 2.1., Sponsor may terminate this Agreement
upon sixty (60) days prior written notice to Institution.
6.3. Termination for Default. In the event that either party
commits a material breach of its obligations under this Agreement and fails to
cure that breach within sixty (60) days after receiving written notice thereof,
the other party may terminate this Agreement immediately upon written notice to
the party in breach. If the alleged breach involves nonpayment of any amounts
due Institution under this Agreement, Sponsor shall have only one opportunity to
cure a material breach for which it receives notice as described above; any
subsequent material breach by Sponsor will entitle Institution to terminate this
Agreement immediately upon written notice to Sponsor, without the sixty-day cure
period.
6.4. Force Majeure. Neither party will be responsible for delays
resulting from causes beyond the reasonable control of such party, including
without limitation fire, explosion, flood, war, strike, or riot, provided that
the nonperforming party uses commercially reasonable efforts to avoid or remove
such causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever such causes are removed.
6.5. Effect of Termination. The following provisions shall survive
the expiration or termination of this Agreement: Articles 1, 4, and 7; Sections
2.3. (obligation to deliver final report), 3.2. (obligation to deliver final
accounting), 6.5., 8.2., 8.3., 8.5., 8.14., and 8.15. In addition, the
provisions of Article 5 shall survive termination of this Agreement, as
necessary to effectuate the rights of Sponsor, unless Institution has terminated
this Agreement because of a material breach by Sponsor pursuant to Section 6.3.
7. Dispute Resolution.
7.1. Procedures Mandatory. The parties agree that any dispute
arising out of or relating to this Agreement shall be resolved solely by means
of the procedures set forth in this Article, and that such procedures constitute
legally binding obligations that are an essential provision of this Agreement;
provided, however, that all procedures and deadlines specified in this Article
may be modified by written agreement of the parties. If either party fails to
observe the procedures of this Article, as modified by their written agreement,
the other party may bring an action for specific performance in any court of
competent jurisdiction.
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7.2. Dispute Resolution Procedures.
7.2.1. Negotiation. In the event of any dispute arising out
of or relating to this Agreement, the affected party shall notify the other
party, and the parties shall attempt in good faith to resolve the matter within
ten (10) days after the date such notice is received by the other party (the
"Notice Date"). Any disputes not resolved by good faith discussions shall be
referred to senior executives of each party, who shall meet at a mutually
acceptable time and location within thirty (30) days after the Notice Date and
attempt to negotiate a settlement.
7.2.2 Trial Without Jury. If the parties fail to resolve
the dispute through negotiation, each party shall have the right to pursue any
other remedies legally available to resolve the dispute, provided, however, that
the parties expressly waive any right to a jury trial in any legal proceeding
under this Section.
7.3. Preservation of Rights Pending Resolution.
7.3.1. Performance to Continue. Each party shall continue to
perform its obligations under this Agreement pending final resolution of any
dispute arising out or relating to this Agreement; provided, however, that a
party may suspend performance of its obligations during any period in which the
other party fails or refuses to perform its obligations.
7.3.2. Provisional Remedies. Although the procedures
specified in this Article are the sole and exclusive procedures for the
resolution of disputes arising out of relating to this Agreement, either party
may seek a preliminary injunction or other provisional equitable relief if, in
its reasonable judgment, such action is necessary to avoid irreparable harm to
itself or to preserve its rights under this Agreement.
7.3.3. Statute of Limitations. The parties agree that all
applicable statutes of limitation and time-based defenses (such as estoppel and
laches) shall be tolled while the procedures set forth in Subsections 7.2.(a)
and 7.2(b) are pending. The parties shall take any actions necessary to
effectuate this result.
8. Miscellaneous.
8.1. Compliance with Law and Policies. Sponsor agrees to comply
with applicable law and the policies of Institution in the area of technology
transfer and shall promptly notify Institution of any violation that Sponsor
knows or has reason to believe has occurred or is likely to occur.
8.2. Indemnification. Sponsor shall indemnify, defend, and hold
harmless Institution and its trustees, officers, faculty, students, 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 any of the Indemnitees in connection with any claims, suits, actions,
demands or judgments arising out of any theory of liability (including without
limitation actions in the form of tort, warranty, or strict liability and
regardless of whether such action has any factual basis) relating to this
Agreement or concerning any product, process, or service that is made, used, or
sold pursuant to any right or license granted under this Agreement; provided,
however, that such indemnification shall not apply to any liability, damage,
loss, or expense to the extent directly attributable to (i) the negligent
activities or intentional misconduct of the Indemnitees or (ii) the settlement
of a claim, suit, action, or demand by Indemnitees without the prior written
approval of Sponsor.
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8.3. Publicity Restrictions. Sponsor shall not use the name of
Institution or any of its trustees, officers, faculty, students, employees, or
agents, or any adaptation of such names; or any terms of this Agreement in any
promotional material or other public announcement or disclosure without the
prior written consent of Institution; such consent shall not be unreasonably
withheld. The foregoing notwithstanding, Sponsor shall have the right to
disclose such information without the consent of Institution in any prospectus,
offering memorandum, or other document or filing required by applicable
securities laws or other applicable law or regulation, provided that Sponsor
shall have given Institution at least ten (10) days prior written notice of the
proposed text for the purpose of giving Institution the opportunity to comment
on such text.
8.4 Representations and Warranties. Institution and Sponsor each
hereby represents and warrants to the other that:
8.4.1 Corporate Power. It is duly organized and validly
existing and has full corporate power and authority to enter into this Agreement
and to carry out the provisions hereof.
8.4.2 Due Authorization. It is duly authorized to execute
and deliver this Agreement and to perform its obligations hereunder.
8.4.3 Binding Agreement. This Agreement is a legal and
valid obligation binding upon the party making such representation and warranty
and enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement does not conflict with any agreement, instrument
or understanding, oral or written, to which or by which the party making such
representation and warranty may be bound, nor violate any law or regulation of
any court, governmental body or administrative or other agency having
jurisdiction over the party making such representation and warrant.
8.4.4 Intellectual Property Rights. It holds all necessary
right, title and interest in and to its respective Background Inventions and
technology to permit it to undertake the Sponsored Research Program contemplated
by this Agreement without subjecting the other party hereto to liability for
infringement of any patent, copyright or trade secret of any third party
8.5. Notice to Other Investigators. The Principal Investigator
shall furnish all investigators involved in the Research Project, including
faculty, staff, students, and post-doctoral fellows, with written notice of
their obligations under Articles 4 and 5 of this Agreement.
8.6. Research Partially Funded by Grants.
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8.6.1 Federal Government. To the extent that any Invention
has been partially funded by the federal government, this Agreement and the
grant of any rights in such Invention is subject to and governed by federal law
as set forth in 35 U.S.C. xx.xx. 201-211, and the regulations promulgated
thereunder, as amended, or any successor statutes or regulations. If any term of
this Agreement fails to conform with such laws and regulations, the relevant
term shall be deemed an invalid provision and modified by the parties pursuant
to Section 8.16.
8.6.2 Other Organizations. To the extent that any Invention
has been partially funded by a non-profit organization or state or local agency,
this Agreement and the grant of any rights in such Invention is subject to and
governed by the terms and conditions of the applicable research grant. If any
term of this Agreement fails to conform with such terms and conditions, the
relevant term shall be deemed an invalid provision and modified by the parties
pursuant to Section 8.16. At the request of Sponsor, Institution shall make
available to Sponsor the terms and conditions of any research grants that will
partially fund the Research Project.
8.7. Tax-Exempt Status. Sponsor acknowledges that Institution holds
the status of an exempt organization under the United States Internal Revenue
Code. Sponsor also acknowledges that certain facilities in which the Research
Project may be performed were financed through offerings of tax-exempt bonds. If
the Internal Revenue Service determines, or if counsel to Institution reasonably
determines, that any term of this Agreement jeopardizes the tax-exempt status of
Institution or the bonds used to finance Institution facilities, the relevant
term shall be deemed an invalid provision and modified by the parties pursuant
to Section 8.16.
8.8. Relationship of Parties. For the purposes of this Agreement,
each party is an independent contractor and not an 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 party, except as may be explicitly provided for in this
Agreement or authorized in writing by the other party.
8.9. Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, and all of which
together shall be deemed to be one and the same instrument.
8.10. Headings. All headings are for convenience only and shall not
affect the meaning of any provision of this Agreement.
8.11. Binding Effect. This Agreement shall be binding upon and inure
to the benefit of the parties and their respective permitted successors and
assigns.
8.12. Assignment. This Agreement may not be assigned by either party
without the prior written consent of the other party, except that Sponsor may
assign this Agreement to an affiliate or to a successor in connection with the
merger, consolidation, or sale of all or substantially all of its assets or that
portion of its business to which this Agreement relates.
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8.13. Amendment and Waiver. This Agreement may be amended,
supplemented, or otherwise modified only by means of a written instrument signed
by both parties. Any waiver of any rights or failure to act in a specific
instance shall relate only to such instance and shall not be construed as an
agreement to waive any rights or fail to act in any other instance, whether or
not similar.
8.14. Governing Law. This Agreement shall be governed by and
construed in accordance with the laws of the New Jersey irrespective of any
conflicts of law principles.
8.15. Notice. Any notices required or permitted under this Agreement
shall be in writing, shall specifically refer to this Agreement, and shall be
sent by hand, recognized national overnight courier, confirmed facsimile
transmission, confirmed electronic mail, or registered or certified mail,
postage prepaid, return receipt requested, to the following addresses or
facsimile numbers of the parties:
If to Institution:
Montefiore Medical Center
000 Xxxx 000xx Xxxxxx
Xxxxx, XX 00000
Attention: Xxxxxx X. Xxxxxxx, Ph.D.
Director, The Office of Research & Sponsored Programs
Tel: (000) 000-0000
(000) 000-0000
Fax: (000) 000-0000
E-Mail: xxxxxxxx@xxxxxxxxxx.xxx
If to Sponsor: Ivivi Technologies, Inc.
000-X Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Andre' XxXxxx
Invoices to: Xxxxxx X. Xxxxxx
Tel: (000) 000-0000
Fax: (000) 000-0000
E-Mail: xxxxx@xxxxxxxxxx.xxx
All notices under this Agreement shall be deemed effective upon receipt. A party
may change its contact information immediately upon written notice to the other
party in the manner provided in this Section.
-12-
8.16. Severability. In the event that any provision of this
Agreement shall be held invalid or unenforceable for any reason, such invalidity
or unenforceability shall not affect any other provision of this Agreement, and
the parties shall negotiate in good faith to modify the Agreement to preserve
(to the extent possible) their original intent. If the parties fail to reach a
modified agreement within sixty (60) days after the relevant provision is held
invalid or unenforceable, then the dispute shall be resolved in accordance with
the procedures set forth in Article 7. While the dispute is pending resolution,
this Agreement shall be construed as if such provision were deleted by agreement
of the parties.
8.17. Entire Agreement. This Agreement constitutes the entire
agreement between the parties with respect to its subject matter and supersedes
all prior agreements or understandings between the parties relating to its
subject matter.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the date first written
above.
MONTEFIORE MEDICAL CENTER IVIVI TECHNOLOGIES, INC.
By: /s/ Xxxxxx X. Xxxxxxx, Ph.D. By: /s/ Andre' Xxxxxx
------------------------------- -------------------------------
Name: Xxxxxx X. Xxxxxxx, Ph.D. Name: Andre' XxXxxx
Title: Research Director Title: Chairman
I hereby acknowledge and agree to the terms of Articles 4 and 5 and
Sections 2.2., 2.3., and 8.5. of this Agreement, and I reaffirm that I will
assign to Sponsor all of my right, title, and interest in any Inventions.
ACKNOWLEDGED AND AGREED:
/s/ Xxxxx Xxxxxx, Ph.D.
---------------------------------
Xxxxx Xxxxxx, Ph.D.
Principal Investigator
-13-
Exhibit A
Montefiore Medical Center
Research Project Summary
The following list represents the proposed projects on the applications of
pulsed magnetic fields (PMF) to be carried out in the Neuro Surgery Laboratory
at Montefiore Medical Center. The subdivisions are not listed in order of
performance. Additional projects may be added as time and resources allow.
PROPOSAL TITLE: OPTIMIZING THE EFFECTS OF PULSED MAGNETIC FIELDS ON [*]
AIM: The purpose of this project is to establish the physical characteristics of
cell culture and signal parameters of pulsed magnetic fields that maximize the
potential of [*].
RATIONALE: [*] cells that participate in wound healing. One of the mechanisms
that mediate this process is the induction of growth factors. [*] growth factors
are a [*] that are produced by [*] as well as other cell types. Of these [*],
basic [*] growth factor is the best characterized. Upon various types of
stimulation, [*] is synthesized and released by cells, which can act on the same
and other cell types via extracellular [*] receptors. This growth factor can
increase tissue growth and participate in healing. Extremely low pulsed magnetic
fields can also enhance healing, and one of the mechanisms by which this is
achieved is by inducing growth factor expression.
EXPERIMENTAL DESIGN: For the purposes of this study, we will use a [*] that can
consistently and reproducibly synthesize and release basal levels of [*].
SPECIFIC AIMS:
1) Determine effects of cell culture conditions on [*] cell cultures
2) Determine effects of various PMF parameters on [*] cell cultures
3) Determine the best combination of culture conditions and PMF parameters
to produce maximal induction of [*] cell cultures.
EXPERIMENT 1: DEMONSTRATE AND QUANTIFY [*] CELLS. [*] cells are a
well-characterized mouse [*] with known growth requirements. Cells will be
obtained from the [*]. Cells will be grown and the first passage frozen and
stored for further use and comparisons. Cultures will be split and grown to
sub-confluence. Basic [*] will be assessed using the [*] kit. Several assays
will be performed to optimize the amount of sample required to produce a signal
in the linear range of detection. [*] will be normalized to [*] or cell numbers.
EXPECTED RESULTS: Other groups have demonstrated that [*] is synthesized by
these cells. This experiment will confirm this and will optimize conditions for
the [*].
TIME REQUIRED: 1 week (**see note)
PROBLEMS/SOLUTIONS: It is possible that [*] under basal conditions will be below
the levels of detection. If this turns out to be the case, we will either, 1)
induce [*] by manipulation of culture conditions (i.e. heat shock, known to
induce [*]), or use [*] cells, a sub-clone of [*] cells that have elevated
levels of [*] (**see note).
EXPERIMENT 2: DETERMINE WHETHER CHANGING CULTURE PARAMETERS ALTERS [*]
PRODUCTION. The following parameters will be tested:
a) CELL DENSITY. Cells will be cultured at 4 densities over a ten-fold
range in the same culture vessels. Conditioned media will be collected
and [*] will be determined.
b) CELL PASSAGE. Cells from various passages (rounds of [*] and replating)
will be plated and cultured. Conditioned media will be collected and
[*] will be determined. If [*] production is a function of cell
passage, large numbers of cells will be generated from a given passage
and frozen in multiple tubes to ensure that each experiment can be
carried out using the same passage.
c) CULTURE VESSEL. Cells will be cultured in flasks or dishes of various
sizes, such as 35, 60 and 100 mm plates, and 25, 75, and 150 cm2
flasks. This experiment can be done in 2 ways; keeping the same cell
densities by using the same ratio of cells/area, or by plating the same
number of cells in each different vessel, where a density effect may
also regulate [*].
d) TIME IN CULTURE. Cells will be plated at low density and conditioned
media will be collected on specified days. It is possible that cells
grown in culture for different periods of time will synthesize more or
less [*].
EXPECTED RESULTS: These experiments will allow us to identify the conditions
that favor [*] production, and to avoid conditions where expression is already
at its maximum. Since growth factor expression can be regulated by all of these
parameters, this information will be used to design the system for testing PMF
effects. Conditions for experiment 3 will be chosen in which [*] is synthesized
at sub (e.g. half) maximal levels.
TIME REQUIRED: 4 weeks (**see note)
PROBLEMS/SOLUTIONS: This experiment was designed to identify potential sources
of variability for experiments 3 and 4. No major problems are anticipated. It is
possible that increased [*] will affect the proliferation rate and appearance of
these cells, as growth factors in general can move cultured cells to a more [*].
We will therefore observe cultures and describe the [*] throughout all
experiments.
EXPERIMENT 3: CHANGING PARAMETERS OF PMF. The instrument to apply PMF can be
used in a standard [*]. In these experiments cells will be cultured under the
conditions that produce measurable, [*]. Replicate dishes will be exposed to PMF
using various combinations of the following parameters:
[*].
Conditioned media will be collected and [*] will be quantified.
EXPECTED RESULTS: Signals that increase [*] should be identified and
optimized.
TIME REQUIRED: Several rounds of experiments may be required to
optimize the response, requiring up to 2 months (**see note).
PROBLEMS/SOLUTIONS: PMF may have no effect on [*] production in this
cell line. If this result is obtained, there are three strategies that
we can follow; 1) use other cell lines, or [*], as they are relatively
easy to adapt to culture conditions, or 2) examine other parameters of
[*], such as [*], 3) measure variables that are known to be affected by
PME, [*], etc. (**see note).
**NOTE: ESTIMATES OF TIME AND COST ARE BASED ON THE SUCCESSFUL OUTCOME OF THE
ORIGINAL PROPOSED EXPERIMENTS. ALTERNATIVE EXPERIMENTAL STRATEGIES, AS OUTLINED
FOR EACH EXPERIMENT, MAY REQUIRE ADDITIONAL TIME AND/OR EXPENSES FOR SALARIES
AND SUPPLIES. BEFORE THESE EXPERIMENTS BEGIN, THE NEED FOR SUPPLEMENTAL
FINANCING WILL BE DISCUSSED WITH THE SPONSOR.
Exhibit B
Sponsor Contributions
Montefiore Medical Center
Research Project Budget
Salary: Xxxxx Xxxxxx, Ph.D.(including fringe) $11,000
[*], Technician (including fringe) 5,500
TOTAL SALARY AND BENEFITS $16,500
Research: Cells $ 200
Supplies $ 6,700
Equipment/Software $ 1,600
TOTAL RESEARCH PROJECT EXPENSES $ 8,500
Overhead (15%) $ 3,750
-------
TOTAL SPONSOR CONTRIBUTION $28,750
The total Sponsor Contribution is to be paid according to the following
schedule:
Date of execution of the agreement $14,375.00
Two month anniversary of the execution of the agreement $ 7,187.50
Four month anniversary of the execution of the agreement $ 7,187.50
TOTAL $28,750.00
