Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially. INDUSTRY-UNIVERSITY COOPERATIVE RESEARCH AGREEMENT
Exhibit
10.2
Portions
of this exhibit marked [*] are omitted and are requested to be treated
confidentially.
INDUSTRY-UNIVERSITY
COOPERATIVE
RESEARCH
AGREEMENT
THIS
AGREEMENT, effective
this 16th day of March 2005, by and between The Pennsylvania State University
College of Medicine and The Xxxxxx X. Xxxxxxx Medical Center (hereinafter
referred to collectively as "University") and INNOVIVE Pharmaceuticals, Inc.,
(hereinafter referred to as "Contractor").
RECITALS:
1. |
The
research program contemplated by this agreement is of mutual interest
and
benefit to the University and Contractor, will further the multiple
missions of University (instruction, research, and public service
including patient care) in a manner consistent with its status as
a
non-profit, tax-exempt, educational University, and may derive benefits
for the Contractor, the University, and society by the advancement
of
science and human health through
discovery;
|
2. |
Contractor
has entered into a license agreement with The Penn State Research
Foundation, (hereinafter referred to as “License Agreement”, and
Contractor has agreed to provide additional funding to University
on an
annual basis to support the research efforts of Drs. Xxx X. Xxxxx,
Xxxxxxxx X. XxXxxxxxxx and Xxxx X. Xxxxx, employees of University,
as
Co-Principal Investigators or individually as Principal
Investigators;
|
3. |
Contractor
has expressed a desire to engage the University to create or further
enhance technologies through this funding that will assist in Contractor's
development and commercialization of new products and/or
processes;
|
4. |
University
and employees acknowledge that the terms and conditions as specified
in
said License Agreement will influence and determine in part the granting
of rights to intellectual property and improvements created under
this
Agreement and such granting of rights to intellectual property will
be
consistent with License Agreement, with University policy, and with
applicable laws and regulations.
|
NOW,
THEREFORE,
in
consideration of the premises and mutual covenants set forth below, the parties
hereto agree to the following:
Article 1 - |
Definitions
|
As
used
herein, the following terms shall have the following meanings:
1.1 |
"Project"/"Research"
shall mean the description of the project as described in Attachment
I
hereof, under the direction of Drs. Xxx X. Xxxxx, Xxxxxxxx X. XxXxxxxxxx
and Xxxx X. Xxxxx as Co-Principal Investigators or individually as
Principal Investigators. Said attachment shall be reviewed at least
annually by the parties and amended from time to time upon mutual
agreement of the parties.
|
1.2 |
"Contract
Period" is June 1, 2005 through May 31, 2006. The Contract Period
shall be
renewed for one year on each June 1 on which the License Agreement
is in
force.
|
1.3 |
“FIELD
OF USE”, shall be defined as stated in License
Agreement.
|
1.4 |
“PATENT
RIGHTS” shall be defined as stated in License
Agreement.
|
1.5 |
“IMPROVEMENTS”
shall be defined as stated in License
Agreement.
|
1.6 |
"New
University Intellectual Property" shall mean certain inventions and/or
discoveries, other than IMPROVEMENTS, conceived and/or reduced to
practice
by one or more employees of University in performance of this Project
and
resulting patents, divisions, continuations, or substitutions of
such
applications and all reissues thereof.
|
1.7 |
"Proprietary
Information" means any written information and data marked proprietary
or
non-written information and data disclosed which is identified at
the time
of disclosure as proprietary and is reduced to writing and transmitted
to
the other party within sixty (60) days of such non-written
disclosure.
|
Article 2 - |
Research
Work
|
2.1 |
University
shall commence the performance of Project in accordance with the
first day
of Contract Period and shall use reasonable best efforts to perform
such
Project substantially in accordance with the terms and conditions
of this
Agreement. Anything in this Agreement to the contrary notwithstanding,
Contractor and University may at any time amend Project by mutual
written
agreement.
|
2.2 |
Contractor
may at Contractor’s option and at Contractor’s expense in addition to the
Fiscal Considerations provided by Article 4, provide any trial compound
or
control compound to be used in any clinical trial undertaken as a
portion
of the Research. University agrees not to make use in a clinical
trial of
any alternative source for any trial or control compounds provided
by
Contractor unless required (i) by law, (ii) for the well being of
a human
subject, or (iii) by obligation to a third party. University shall
apprise
Contractor of any third party obligation reasonably known to University
before the start of any clinical trial sponsored herein. Contractor
shall
in good faith plan for availability of compounds to properly support
clinical trials based upon protocols to be provided in advance by
University.
|
Article 3 - |
Reports
|
The
Co-
Principal Investigators shall furnish Contractor technical report upon
completion of Project and as described in Project statement of
work.
Article 4 - |
Fiscal
Considerations
|
4.1 |
It
is agreed to and understood by the parties hereto that total costs
to
Contractor hereunder shall be [*] dollars ($[*]) per annum. Payment
for
annual costs shall be made by Contractor within 30 days of receipt
of
invoice to be provided by University not more than 30 days prior
to the
start of each annual contract period.
|
4.2 |
University
shall retain title to any equipment purchased with funds provided
by
Contractor under this Agreement.
|
Article 5 - |
Publicity
|
Neither
party will use the name of the other party, nor of any member of the other
party's employees, in any publicity, advertising, or news release without
the
prior written approval of an authorized representative of that
party.
[*]
Confidential treatment requested; certain information omitted and filed
separately with the SEC.
Page
2
Article 6 - |
Publication
|
6.1 |
It
is the purpose of this Article 6, in conjunction with Article 7 -
Confidentiality, to balance the Contractor's need to protect commercially
feasible technologies, products, processes and licensed patent rights
with
the University's responsibility to freely disseminate scientific
findings
for the advancement of knowledge, and to further the interests of
both
parties in making therapeutic materials and processes available to
the
public. University recognizes that the public dissemination of information
based upon the research performed under this agreement cannot contain
Contractor’s Proprietary Information nor should it jeopardize Contractor's
ability to commercialize intellectual property developed hereunder
or
licensed to Contractor under License Agreement. Further, University
acknowledges that commercially sensitive information related to the
design
or composition of specified products or processes is not of general
interest, while its confidentiality may be critical to the
commercialization of said products or processes. Similarly, Contractor
recognizes that the scientific results of University Research must
be
publishable and, subject to the confidentiality provisions of this
Agreement, may be publicly presented or
published.
|
6.2 |
University
acknowledges that University is bound by Paragraph 6.3 of the License
Agreement.
|
6.3 |
University
agrees not to publish or otherwise disclose Contractor’s Proprietary
Information. Contractor agrees that University, subject to review
by
Contractor, shall have the right to publish results of the Project
that
are not proprietary to the design or composition of specified products
or
processes derived from the project. Contractor shall be furnished
a copy
of any proposed publication or presentation at least 30 days before
submission of such proposed publication or presentation. During that
time,
Contractor shall have the right to review the material for Proprietary
Information provided by the Contractor and to assess the patentability
of
any invention described in the material. If both parties agree that
a
patent application should be filed, the publication or presentation
shall
be delayed an additional sixty (60) days or until a patent application
is
filed, whichever is sooner. At Contractor's request, Proprietary
Information provided by Contractor shall be
deleted.
|
Article 7 - |
Confidentiality
|
7.1 |
During
the Contract Period, the parties may be disclosing Proprietary Information
to each other. Prior
to disclosure by Contractor, Contractor shall notify the investigator
identified in Article 13 as the contact for notices as to Technical
Matters of its intent to disclose proprietary information; and University
Principal Investigator shall have the right to decline receipt of
said
information. Said Proprietary Information shall be sent only to the
Principal Investigators or Co-Principal Investigators but may be
shared
among them and, as necessary for conduct of the Research, among those
under their immediate supervision.
Each party agrees to treat Proprietary Information received from
the other
with the same degree of secrecy with which it treats its own Proprietary
Information, but not less than a reasonable amount of secrecy, and
further
agrees not to disclose without prior written consent from the disclosing
party such Proprietary Information to a third party other than the
receiving party’s consultants or agents who are bound by the same
obligation of confidentiality as the receiving party is bound pursuant
to
this agreement..
|
7.2 |
The
foregoing obligations of non-disclosure do not apply to Proprietary
Information which the recipient can demonstrate through the production
of
tangible evidence:
|
(a) |
was
known to the recipient prior to the disclosure
hereunder;
|
(b) |
was
received from a third party not under an obligation of confidence
to
recipient;
|
(c) |
is
in the public domain at the time of disclosure hereunder or subsequently
entered the public domain without the fault of the
recipient;
|
(d) |
has
been independently developed by an employee of recipient that has
not had
access directly or indirectly to such Proprietary Information, and
recipient can substantiate any claim of independent development by
written
evidence; or
|
(e) |
is
required to be disclosed by law, provided, however, the recipient
shall
give notice to the other party prior to such disclosure so that such
other
party has the opportunity to pursue equitable relief to prevent or
restrict such disclosure..
|
Page
3
7.3 |
Unless
otherwise agreed to in writing, neither party shall have any obligation
of
secrecy under this Agreement after the [*] anniversary of the conclusion
of the annual Contract Period in which the disclosure
occurs.
|
Article 8 - |
Intellectual
Property
|
8.1 |
The
purpose of Articles 8 and 9 is to balance Contractor's ability to
reasonably exploit, with due competitive advantage, the commercial
viability of technologies, products, or processes with University's
responsibility to ensure the broadest public benefit from the results
of
University Research.
University
recognizes that one of the prime reasons Contractor has entered this
Research Agreement is an effort to secure, through the creation or
enhancement of technologies, a market position with regard to its
products
or processes. At the same time, Contractor recognizes that University
has
an obligation to utilize the knowledge and technology generated by
University Research in a manner which maximizes societal benefit
and
economic development and which provides for the education of graduate
and
undergraduate students.
|
8.2 |
All
rights and title to New University Intellectual Property shall belong
to
University and shall be subject to the terms and conditions of this
Agreement.
|
8.3 |
Copyright
to copyrightable materials, including computer software, resulting
from
the Research funded under this Agreement shall vest in
University.
|
8.4 |
University
will promptly disclose to Contractor in writing any New University
Intellectual Property developed during the Research performed hereunder.
Such disclosure(s) shall be sufficiently detailed for Contractor
to assess
the commercial viability of the intellectual property and shall be
provided and maintained by Contractor in confidence pursuant to the
terms
of Article 7.
|
8.5 |
For
60 days from first disclosure of any New University Intellectual
Property
to Contractor, such time period to be extended at University’s discretion,
Contractor may direct University to file, prosecute and maintain
patent
applications on said New University Intellectual Property in the
United
States and in additional jurisdictions of Contractor’s choosing. Such
filing, prosecution and maintenance shall be done using counsel of
University’s choosing, with due consideration of Contractor’s comments.
Contractor will notify University no later than three (3) months
before
applicable bar dates, as to any additional countries in which it
wishes
University to seek patent protection, provided however, that neither
party
shall have any liability to the other if Contractor should fail to
provide
such notices on a timely basis. Contractor shall reimburse University
for
all reasonable costs associated with filing, prosecution, and maintenance
of patent applications and patents Contractor has directed University
to
file. University shall keep Contractor advised as to all developments
with
respect to application(s) and shall supply copies of all papers received
and filed in connection with the prosecution in sufficient time for
Contractor to comment. Contractor's comments shall be taken into
consideration. Contractor may at any time notify University in writing
of
its intent to cease reimbursement of costs associated with any or
all
patent applications, at which time Contractor shall remain obligated
to
reimburse University for costs incurred through the date University
receives said notice and Contractor’s rights and options and University’s
obligations with regard to the patent applications and resulting
patents
shall cease.
|
[*]
Confidential treatment requested; certain information omitted and filed
separately with the SEC.
Page
4
Grant
of
Rights
8.6 |
Contractor’s
license to IMPROVEMENTS are provided by Article 2 of the License
Agreement. Nothing in this Cooperative Research Agreement shall be
construed to restrict in any fashion Contractor’s license to IMPROVEMENTS
as provided in the License Agreement.
|
8.7 |
University
hereby grants to Contractor a royalty-free nonexclusive license for
Contractor’s non-commercial use of New University Intellectual Property
for research purposes.
|
8.8 |
Subject
to Article 2.8 of the License Agreement, University hereby grants
to
Contractor an exclusive option for a period of [*] days from disclosure
under Paragraph 8.4 to negotiate additional license to New University
Intellectual Property made in the performance of the research Project.
Said license shall be non-exclusive or exclusive (to the extent the
University is free to do so) within the Contractor's field of commercial
interest. Terms and conditions of said license, including specification
of
Contractor’s field of use, sublicensing rights, and royalties, are to be
negotiated in good faith and agreed upon between University and
Contractor. Contractor shall have upon exercise of Contractor’s option [*]
days to negotiate a license, which period can be extended by mutual
agreement. In the event the parties fail to reach a mutually acceptable
license agreement within the above specified negotiation period,
University shall be entitled to negotiate in good faith with one
or more
third parties a license under any New University Intellectual
Property.
|
8.9 |
University
reserves, and shall reserve in any license anticipated hereunder,
the
right to use New University Intellectual Property for its own research
and
educational purposes. University further reserves, and shall reserve
in
any license anticipated hereunder, the right on behalf of all nonprofit
entities to use for their own research and educational purposes only
any
research tools embodied in New University Intellectual
Property.
|
8.10 |
University
hereby grants to Contractor a royalty-free license for Contractor’s
non-commercial use of materials to which University owns copyright,
including computer software, resulting from the Research funded under
this
Agreement. University shall grant Contractor an option to license
any such
material(s) it wishes to develop for commercial purposes on reasonable
terms and conditions, including a reasonable royalty, as the parties
agree
in a subsequent writing.
|
8.11 |
Contractor
understands that University must comply with the provisions of the
Xxxx-Xxxx Act. To the extent that government's approval may be deemed
necessary to transfer license rights hereunder to Contractor, Contractor
shall provide whatever reasonable assistance is required, and will
reimburse University for all external costs associated
therewith.
|
Article 9 - |
Termination
|
9.1 |
University
may terminate this Agreement upon ninety (90) days’ prior written notice
to Contractor.
|
9.2 |
In
the event that the either party hereto shall commit any material
breach of
or default in any terms or conditions of this Agreement, and also
shall
fail to reasonably remedy such default or breach within sixty (60)
days
after receipt of written notice thereof, the non-breaching party
may, at
its option and in addition to any other remedies which it may have
at law
or in equity, terminate this Agreement by sending notice of termination
in
writing to the other party to such effect. Termination shall be effective
as of the day of the receipt of such
notice.
|
9.3 |
Termination
of this Agreement by either party for any reason shall not affect
the
rights and obligations of the parties accrued prior to the effective
date
of termination of this Agreement, including rights and obligations
of the
parties under the License Agreement, except insofar as Contractor's
breach
of contract for failure to make payments under Article 4 shall cause
Contractor to forfeit its rights under Article 9 of this Agreement.
The
rights and obligations of Article 7 of this Agreement shall survive
termination.
|
[*]
Confidential treatment requested; certain information omitted and filed
separately with the SEC.
Page
5
Article 10 - |
Independent
Contractor
|
10.1 |
In
the performance of all services hereunder, University shall be deemed
to
be and shall be an independent contractor.
|
10.2 |
Neither
party is authorized or empowered to act as agent for the other for
any
purpose and shall not on behalf of the other enter into any contract,
warranty, or representation as to any matter. Neither shall be bound
by
the acts or conduct of the other.
|
Article 11 - |
Indemnity
|
Each
party assumes all risks of personal injury, bodily injury including death,
and
property damage caused by the negligent acts or omissions of that party.
Except
as provided above, Contractor shall fully indemnify and hold harmless University
against all claims arising out of Contractor's use,
commercialization, or distribution of information, materials or products
which
result in whole or in part from the research performed pursuant to this
Agreement. Contractor will hold University harmless from any claims arising
from
third party claims that the work performed hereunder infringes third party
intellectual property rights. University has no knowledge of any such
claims.
Article 12 - |
Notices
|
Notices,
invoices, communications, and payments hereunder shall be deemed made if
given
by overnight courier or by registered or certified envelope, post prepaid,
and
addressed to the party to receive such notice, invoice or communication at
the
address given below or such other address as may hereafter be designated
by
notice in writing:
If to Contractor: | Xxxxxx Xxxxx | |
President and Chief Executive Officer | Phone: 000-000-0000 | |
000 Xxxxxxx Xxxxxx, 00xx Xxxxx | Fax: 000-000-0000 | |
Xxx Xxxx, XX 00000 | E-mail: xxxxxx@xxxxxxxxxxxxxx.xxx | |
If to University: | Xxxxxxx Xxxxxx, M.P.A. | |
Director, Office of Research Affairs | Phone: 000-000-0000 | |
The Pennsylvania State University | Fax: 000-000-0000 | |
000 Xxxxxxxxxx Xxxxx X000 | E-mail: xxx@xxx.xxx.xxx | |
Xxxxxxx, XX 00000 | ||
If Payment Matters: | Research Accounting | Phone: 000-000-0000 |
The Pennsylvania State University | Fax: 000-000-0000 | |
313 Rider Building | E-mail: Xxx-Xxxx@xxx.xxx | |
000 Xxxxx Xxxxxxxx Xxxxxx | ||
Xxxxxxxxxx Xxxx, XX 00000 | ||
If Technical Issue: | ||
PI
|
Xxx X. Xxxxx, Ph.D. | |
Title
|
Professor of Neuroscience | |
Campus
Address
|
000 Xxxxxxxxxx Xxxxx | |
Xxxx/Xxxxx/Xxx
|
Xxxxxxx, XX 00000 | |
Notice
given pursuant to this Article shall be effective as of the day of receipt
of
notice.
Page
6
Article 13 - |
Governing
Law
|
This
Agreement shall be governed and construed in accordance with laws of the
Commonwealth of Pennsylvania.
Article 14 - |
Dispute
resolution
|
Except
for the right of either party to apply to a court of competent jurisdiction
for
a temporary restraining order, a preliminary injunction, or other equitable
relief to preserve the status quo or prevent irreparable harm, any and all
claims, disputes or controversies arising under, out of, or in connection
with
this Agreement, including any dispute relating to patent validity or
infringement, which the parties shall be unable to resolve within sixty (60)
days, shall be mediated in good faith. The party raising such dispute shall
promptly advise the other party of such claim, dispute or controversy in
a
writing, which describes in reasonable detail the nature of such dispute.
By not
later than five (5) business days after the recipient has received such notice
of dispute, each party shall have selected for itself a representative who
shall
have the authority to bind such party, and shall additionally have advised
the
other party in writing of the name and title of such representative. By not
later than ten (10) business days after the date of such notice of dispute,
the
party against whom the dispute shall be raised shall select a mediation firm
in
Pennsylvania and such representatives shall schedule a date with such firm
for a
mediation hearing. The parties shall enter into good faith mediation and
shall
share the costs equally. If the representatives of the parties have not been
able to resolve the dispute within fifteen (15) business days after such
mediation hearing, the parties shall have the right to pursue any other remedies
legally available to resolve such dispute in either the Centre County Court
of
Common Pleas or in the United States District Court for the Middle District
of
Pennsylvania, to whose jurisdiction for such purposes University and Contractor
each hereby irrevocably consents and submits.
Article 15 - |
General
Provisions
|
15.1 |
Non-assignability
--
The rights and obligations of the parties under this Agreement shall
not
be assignable without written permission of the other
party.
|
15.2 |
Severability
--
If any provision hereof is held unenforceable or void, the remaining
provisions shall be enforced in accordance with their
terms.
|
15.3 |
Entire
Agreement
--
This Agreement and the License Agreement contain the entire and only
agreement between the parties respecting the subject matter hereof
and
supersedes or cancels all previous negotiations, agreements, commitments
and writings between the parties on the subject of this Agreement
and the
License Agreement. Should processing of this agreement require issuance
of
a purchase order or other contractual document, all terms and conditions
of said document are hereby deleted in entirety. This Agreement may
not be
amended in any manner except by an instrument in writing signed by
the
duly authorized representatives of each of the parties hereto. It
is
expressly agreed that if there is any inconsistency between this
Agreement
and the License Agreement, the terms of the License Agreement shall
be
controlling and supersede the terms of this
Agreement.
|
15.4 |
Export
Control Regulations
--
Contractor agrees that it shall comply with all applicable export
control
regulations of the United States of America. Contractor shall be
responsible for obtaining all information regarding such regulations
that
is necessary for Contractor to comply with such
regulations.
|
Page
7
IN
WITNESS WHEREOF,
the
parties have caused these presents to be executed in duplicate as of the
day and
year first above written.
By An Authorized Official of University | By An Authorized Official of Contractor |
/s/ Xxxxxxx X. Xxxxx | /s/ Xxxxxx Xxxxx |
Name: Xxxxxxx X. Xxxxx | Name: Xxxxxx Xxxxx |
Title: Associate Controller | Title: President and CEO |
Date: 3/16/05 | Date: 3/15/05 |
THE XXXXXX X. XXXXXXX MEDICAL CENTER | |
BY: /s/ Xxxxx X. Xxxxx | |
NAME: Xxxxx X. Xxxxx, Interim | |
TITLE: Chief Financial Officer | |
DATE: 3/16/05 | |
Page
8
ATTACHMENT
I
Project
Description
Research
relating to therapeutic use of opioid growth factor (OGF), to be defined
in a
revision of this Attachment I to be mutually determined by the parties on
or
before June 1, 2005.
Page
9