Contract
Exhibit
10.37
*The
identity of the counterparty to this Agreement and certain other pieces of
information that could reasonably be expected to identify the counterparty to
this Agreement have been omitted pursuant to a request for confidential
treatment and have been filed separately with the U.S. Securities and Exchange
Commission.
**Quantitative
information contained in Sections IV(c) of this Agreement and in Paragraphs 1
and 9 of Exhibit A to this Agreement has been omitted pursuant to a request for
confidential treatment and has been filed separately with the U.S. Securities
and Exchange Commission.
***Paragraphs
5 and 7 of Exhibit A to this Agreement have been omitted in their entirety
pursuant to a request for confidential treatment and have been filed separately
with the U.S. Securities and Exchange Commission.
THIS AGREEMENT, made as of the
13th
day of December, 2007 (the “Effective Date”), by and between *, a Delaware corporation with
a principal place of business at * and OcuSense, Inc. (“Contractor”),
a Delaware corporation having its principal place of business at 00000 Xxxx
Xxxxx Xx, Xxxxx 000, Xxx Xxxxx, Xxxxxxxxxx 00000.
WITNESSETH:
WHEREAS, * and Contractor desire to
engage in research regarding the clinical validation of Contractor’s TearLab™
system for the measurement of osmolarity in the tear film (“TearLab™ System”);
and
WHEREAS, * and the Contractor desire to
engage in such research in accordance with the terms and conditions contained
herein.
NOW, THEREFORE, in
consideration of the mutual covenants and promises set forth herein, it is
agreed by and between *
and Contractor as follows:
SECTION
I
NATURE OF
RESEARCH
* and Contractor shall engage
in research regarding Contractor’s TearLab™ System via validation activities and
clinical studies of osmolarity in ocular tears as set forth in Exhibit A (the
“Research”). * and
Contractor agree to use their commercially reasonable efforts on and to keep
each other informed regarding the Research. * and Contractor agree that
all Research shall be performed in accordance with Good Clinical Practices and
all applicable laws and regulations. Exhibit A is incorporated into this
Agreement and made an essential part of this Agreement by this
reference.
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SECTION
II
TIME DEVOTED TO
RESEARCH
The
parties agree that the amount of time devoted by Contractor in performance of
Research will be entirely within the control of Contractor, and that the amount
of time devoted by * in
performance of the Research will be entirely within the control of *.
SECTION
III
PAYMENT
* will pay Contractor as set
forth in Exhibit A. Such payment shall be made within thirty (30) days of *’s receipt of Contractor’s
invoice.
SECTION
IV
TERM AND
TERMINATION
This
Agreement shall begin on the Effective Date and shall expire on December 31,
2009. Notwithstanding the above, the Agreement may be terminated as
follows:
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(a)
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In
the event that any material term or condition of this Agreement is
breached by either party, the non-breaching party upon thirty (30) days’
written notice to the other may terminate this Agreement. If any such
breach is corrected within the applicable notice period, this Agreement
shall continue in force.
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(b)
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* may terminate this
Agreement at any time and for any reason upon written notice to
Contractor. Upon such termination of the Agreement, * shall be entitled to
retain all beta units of the TearLab™ System and associated test cards set
forth in Paragraph 5 of Exhibit A and use such units solely for *’s internal business
purposes.
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(c)
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Contractor
may terminate the Agreement for safety reasons associated with the
Research upon written notice to *. In the event of such
termination by Contractor, *’s option set forth in
Paragraph 9 of Exhibit A shall survive the termination by thirty (30)
days. In the event of such termination by Contractor before the beginning
of the Contractor clinical studies set forth in Paragraph 1 of Exhibit A,
Contractor shall refund $** to *. In the event of such
termination by Contractor before delivery of all beta units of the
TearLab™ System and associated test cards as set forth in Paragraph 5 of
Exhibit A, Contractor shall refund to * a pro rata portion of
the $** payment
made by * for the
beta TearLab™ System and associated test cards. For the purposes of any
such refund, $**
shall be allocated to the beta TearLab™ Systems ($** per unit), and $** shall be allocated to
the associated test cards ($** per
unit).
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**Quantitative
information contained in Section IV(c) has been omitted pursuant to a request
for confidential treatment and has been filed separately with the U.S.
Securities and Exchange Commission.
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(d)
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In
the event of any termination of this Agreement other than material breach
by Contractor, all rights of * and obligations of
Contractor under Paragraphs 2, 3, 4, and 6 of Exhibit A shall
terminate.
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(e)
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In
the event of any termination of this Agreement other than material breach
by *, all rights
of Contractor and obligations of * under Paragraph 7 of
Exhibit A shall terminate.
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SECTION
V
INDEPENDENT
CONTRACTOR
In the
performance of the Research, the status of the parties, including their
respective employees and agents, shall be that of independent contractors and
not as employees or agents, or fiduciaries of the other party, and as such each
party shall have no right to make any commitments for or on behalf of the other
party. Nothing in this Agreement shall create any association, partnership, or
joint venture between the parties.
SECTION
VI
CONFIDENTIALLITY AND
DOCUMENTS
The
parties entered into a confidentiality agreement dated November 26, 2007
regarding the potential use of the TearLab™ System in * and Contractor clinical
studies of osmolarity in ocular tears (the “Confidentiality Agreement”). The
parties hereby agree that the Confidentiality Agreement shall be applicable to
the Research and this Agreement; provided, however that the permitted use by
* and Contractor as
receiving parties of the Confidential Information of the other party shall
include the use of Confidential Information of the other party to the extent
necessary for the purposes of this Agreement.
Each
party shall maintain records, in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes, which shall be complete and
accurate and shall fully and properly reflect all work done and results achieved
in the performance of the Research. Each party shall maintain such records and
all Confidential Information of the other party contained therein in confidence
in accordance with the Confidentiality Agreement. Subject to the terms and
conditions of this Agreement, all files, records, documents, and other materials
prepared by a party in connection with the Research are and shall remain the
exclusive property of such party.
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Except as
expressly provided in this Agreement, nothing contained herein shall be
construed as conferring any license or other rights by implication, estoppel or
otherwise. Without limiting the generality of the non-use restrictions set forth
in the Confidentiality Agreement, neither party shall (or cause, assist or
permit any third party to): (a) use the Confidential Information of the other
party, or any data, information or materials derived directly therefrom, to
reproduce, generate, create or produce, through reverse-engineering or
otherwise, the technology of the party or any derivatives thereof, or (b) file,
prosecute, or maintain, in any country, any patent application which directly
claims, uses, or relies for support upon the Confidential Information of the
other party, or any data, information or materials derived directly therefrom.
For sake of clarity, the exceptions to the obligations of confidentiality and
non-use assumed by the parties on page 2 of the Confidentiality Agreement are
applicable to the immediately preceding sentence.
SECTION
VII
INDEMNIFICATION
Contractor
shall indemnify, defend, and hold * harmless from and against
all third party claims and actions, and all expenses incidental to such claims
or actions, including reasonable attorney’s fees, based upon or arising out of
damage to property or injuries or death to persons or other tortious acts
directly caused or contributed to by Contractor or anyone acting under its
direction or control, or on its behalf in the course of the Research provided
Contractor’s aforesaid indemnity and hold harmless agreement shall not be
applicable to the extent any such claims or actions are based upon the
negligence or intentional malfeasance of *.
* shall indemnify, defend, and
hold Contractor harmless from and against all third party claims and actions,
and all expenses incidental to such claims or actions, including reasonable
attorney’s fees, based upon or arising out of damage to property or injuries or
death to persons or other tortious acts caused or contributed to by * or anyone acting under its
direction or control, or on its behalf in the course of the Research provided
*’s aforesaid indemnity
and hold harmless agreement shall not be applicable to the extent any such
claims or actions are based upon the negligence or intentional malfeasance of
Contractor.
SECTION
VIII
NOTICE
For the purposes of this Agreement,
notices and demands shall be deemed given when received at the following
address:
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To
*:
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*
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To
Contractor:
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OCUSENSE,
INC.
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00000
Xxxx Xxxxx Xx., Xxxxx 000
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San
Diego, California 92130
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Attention:
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Xxxx
Xxxxxx, CEO
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Either
party may change such address by giving the other party notice of such change in
the aforesaid manner, except notices of changes of address shall only be
effective upon receipt.
SECTION
IX
SEVERABILITY
The
invalidity of any such provision or provisions of this Agreement shall not
affect any other provisions of this Agreement, which shall remain in full force
and effect, nor shall the invalidity of a portion of any provision of this
Agreement affect the balance of such provision.
SECTION
X
REMEDIES
Nothing
in the Agreement shall be construed to limit the parties’ remedies at law or in
equity.
SECTION
XI
INSURANCE
Contractor
and * shall maintain at
their expense appropriate insurance or self-insurance adequate to meet their
respective obligations under Section VII hereinabove. Each party shall furnish
certificates of insurance showing compliance with the foregoing requirement upon
the other party’s written request.
SECTION
XII
FORCE
MAJEURE
Neither
party shall be responsible or liable for its failure to perform its obligations
during any period in which such performance is prevented by acts of God, fire,
flood, war, embargo, strikes, explosion, riots, or laws, rules, regulations,
instructions, or orders of any governmental authority not brought on by the
party unable to perform.
SECTION
XIII
MISCELLANEOUS
No
provisions of this Agreement may be modified, waived, or discharged unless such
modification, waiver, or discharge is agreed to in writing signed by officers of
Contractor and *. No
waiver by either party hereto at any time of any breach by the other party
hereto or of compliance with any condition or provision of this Agreement to be
performed by such other party shall be deemed a waiver of similar or dissimilar
provisions or conditions at the same or at any prior or subsequent time. No
agreement or representations, oral, or otherwise, express or implied, have been
made by either party with respect to the subject matter hereof that are not set
forth expressly in this Agreement (other than the Confidentiality Agreement.)
This Agreement shall be governed by and construed in accordance with the laws of
the State of *. This
Agreement supersedes, amends, restates and replaces any prior agreement(s)
entered into between Contractor and * relating to the subject
matter hereof, and all such prior agreement(s) are hereby canceled and
terminated and are of no further force of effect, with the exception that the
Confidentiality Agreement shall remain in effect in accordance with its terms
and shall apply to the Research and this Agreement. Except as otherwise
specifically provided herein, neither party shall assign this Agreement or any
rights hereunder without the consent of the other party, such consent to not be
unreasonably withheld, and any attempted or purported assignment without such
consent shall be void, except that either party may assign this Agreement
without the other party’s consent to any parent, affiliate, or subsidiary of
such party, or in connection with a merger, acquisition, sale of controlling
interest, or similar event. This Agreement shall otherwise bind and inure to the
benefit of the parties hereto and their respective successors and assigns.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY IN ANY
MANNER, UNDER ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT (INCLUDING
WITHOUT LIMITATION NEGLIGENCE), INDEMNITY, BREACH OF WARRANTY OR OTHER THEORY,
FOR ANY INDIRECT, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, PUNITIVE, STATUTORY OR
SPECIAL DAMAGES ARISING IN CONNECTION WITH THIS AGREEMENT, INCLUDING LOST
PROFITS AND LOSS OF DATA, REGARDLESS OF WHETHER SUCH PARTY WAS ADVISED OF OR WAS
AWARE OF THE POSSIBILITY OF SUCH DAMAGES.
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IN
WITNESS WHEREOF, this Agreement has been duly executed and delivered by the
parties as of the date first above written.
*
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By:
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*
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*
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Date:
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12-13-07
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OCUSENSE,
INC.
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By:
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“Xxxx Xxxxxx”
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Xxxx
Xxxxxx
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Chief
Executive Officer
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Date:
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12-13-07
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EXHIBIT
A
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1)
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* shall pay Contractor
$** for (a) the
support of Contractor clinical studies of osmolarity in ocular tears using
Contractor’s TearLab™ System, including without limitation the study
entitled “A Prospective Study to Establish Normative Values, Demographic
Variations, Referent Diagnostic Values, Disease Severity Correlations for
Dry Eye Disease, and Tearlab Osmometry” ($**) and (b) the items
outlined in Paragraph 5 ($**). Contractor shall
invoice * for such
payment upon execution of this
Agreement.
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**Quantitative
information contained in Paragraph 1 has been omitted pursuant to a request for
confidential treatment and has been filed separately with the U.S. Securities
and Exchange Commission.
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2)
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Contractor
agrees that *
shall be the sole third party corporate sponsor of such Contractor
clinical studies and that * shall receive
appropriate acknowledgement in the publication of such
studies.
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3)
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Contractor
agrees to provide *, under the
confidentiality terms of the Agreement, access to all data at the
completion of the supported clinical studies described in Paragraph 1
above. * shall
have the right to use such data solely for the purposes of evaluating same
in connection with consideration of a continuing business relationship
with Contractor relating to the results of the Research. * shall not make any
other use of such data without the prior written consent of
Contractor.
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4)
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* shall be the only
third party corporate institution to have access to the data described in
Paragraph 3 above prior to the publication of the data. Notwithstanding
the foregoing, *
agrees that such data can be shared with and presented by corporate
entities that do not compete with * in the field of
ophthalmology (or their Key Opinion Leaders) for the purpose of supporting
product launch of the TearLab™
System.
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***Paragraph
5 in its entirety has been omitted pursuant to a request for confidential
treatment and has been filed separately with the U.S. Securities and Exchange
Commission.
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6)
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Contractor
agrees to provide * with a limited
exclusive access to Contractor’s TearLab™ System solely as follows: Until
FDA clearance of the first 510(k) for Contractor’s TearLab™ System
osmolarity equipment, Contractor agrees that * shall be only third
party corporate entity that will have access to the beta units of the
TearLab™ System osmolarity equipment for the purpose of conducting dry eye
clinical studies for the commercial development of therapeutic compounds
indicated for the treatment of dry eye in countries where the TearLab™
System is not approved for commercial sale and use. Contractor reserves
the right to provide third parties with access to Contractor’s TearLab™
System in any manner that does not conflict with the foregoing
restriction, including without limitation (a) providing commercial units
of Contractor’s TearLab™ System to any third parties in countries where
Contractor’s TearLab™ System is approved for commercial sale and use, (b)
providing access to Contractor’s TearLab™ System to any academic or other
non-profit institutions (but not for the purpose of participating in dry
eye clinical studies of a third party for the commercial development of
therapeutic compounds indicated for the treatment of dry eye), and (c)
providing access to the beta units of the TearLab™ System to any third
party, including countries where the TearLab™ System is not approved for
commercial sale and use, for any purpose other than conducting clinical
studies for the commercial development of therapeutic compounds indicated
for the treatment of dry eye.
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***Paragraph
7 has been omitted in its entirety pursuant to a request for confidential
treatment and has been filed separately with the U.S. Securities and Exchange
Commission.
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8)
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If
* desires to
publish or make public any results of the Research or any data disclosed
by Contractor to *
under Paragraph 3 above, * shall first submit to
Contractor for comment any such proposed manuscript or public release of
information at least 45 days prior to its submission or release. No
publication or presentation shall be made unless and until all of
Contractor’s comments on the proposed publication or presentation have
been considered by * and any Contractor
Confidential Information has been removed. If requested in writing by
Contractor, *
shall withhold material from submission for publication or presentation
for an additional 90 days to allow for the filing of a patent application
or the taking of other measures to establish and preserve Contractor’s
proprietary rights. In any publication of studies described in Paragraph
7, * shall
acknowledge Contractor’s provision of the beta
units.
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9)
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During
the term of the Agreement, Contractor hereby grants * an option to enter
into a supply agreement for the purchase of up to ** commercial units of
the Contractor’s TearLab™ System and up to ** commercial units of
the associated test cards for use in * clinical studies at
prices not to exceed $** per commercial unit
of the TearLab™ System and $** per commercial unit
of the test cards. *, in its sole
discretion, shall exercise this option via written notice to the
Contractor. Upon receipt of such notice, * and Contractor shall
negotiate in good faith an appropriate supply agreement for such TearLab™
Systems and test cards with estimated quantity forecasts and other
commercially reasonable terms and
conditions.
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**Quantitative
information contained in Paragraph 9 has been omitted pursuant to a request for
confidential information and has been filed separately with the U.S. Securities
and Exchange Commission.
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