JOINT RESEARCH AND MATERIAL TRANSFER AGREEMENT
This Joint Research Agreement (the “Agreement”), effective as of
, 2014 (“Effective
Date”), is entered into by and between The Salk Institute for Biological Studies, San Diego, California, a
California nonprofit public benefit corporation (“SALK”),
and________________________________________________________________________, with an
address of______________________________________________________________ (hereinafter
referred to as “INSTITUTION”). Each of SALK and INSTITUTION are referred to herein as a “Party” or
collectively as the “Parties”.
WHEREAS INSTITUTION wishes to collaborate with Salk on a research project to be
performed by and under the direction of ________________________(“SALK Principal Investigator”) at
SALK and _________________________ (INSTITUTION Principal Investigator) at INSTITUTION;
WHEREAS, Principal Investigator wishes to perform such research project, in accordance with
the terms and conditions set forth in this Agreement; and
NOW THEREFORE, in consideration of the promises and mutual covenants set forth herein and
intending to be legally bound, SALK and INSTITUTION agree as follows:
1.
DEFINITIONS
A.
“Invention” shall mean any invention or discovery, whether or not patentable, that is
conceived or first actually reduced to practice by one or more employees, contractors or agents of SALK
and / or one or more employees, contractors or agents of INSTITUTION in the performance of the
Research Plan.
B.
“Background IP” shall mean inventions, discoveries, data, chemical entities and
Materials developed or controlled by either Party prior to the Effective Date or during the Term, but not
as a result of performance of the Research Plan, whether or not patentable, and that are, or could
reasonably be expected to be, relevant to practice any Invention.
C.
“Sole Invention” shall mean an Invention made by one or more inventors all of whom are
required to assign rights in the Invention to a single Party.
D.
“Joint Invention” shall mean an Invention made by more than one inventor in which at
least one inventor is required to assign rights in the Invention to INSTITUTION, and at least one inventor
is required to assign rights in the Invention to SALK.
E.
“Material” shall mean anything provided to one party by or on behalf of the other party in
connection with the Research Plan, such as, but not limited to, cells, tissues, mice, media, chemical
compounds (including without limitation any small molecule or biologic, and any intermediates,
fragments, fusions, complimentarily determining regions, metabolites, analogues, isomers, salts, esters or
formulations of any such small molecule or biologic), vectors and proteins (together with all fragments,
progeny, portion, unmodified derivatives, hybrids, antibodies or analogs thereof) that is described in
EXHIBIT A .
F.
“Research” shall mean the research conducted in accordance with the Research Plan.
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G.
“Research Plan” shall mean the research program that is described in Exhibit B
H.
“Research Results” shall mean results, information and data generated from the Parties’
work in the course of the performance of the Research Plan.
I.
“Confidential Information” shall mean any information, disclosed by or on behalf of
INSTITUTION to SALK, or by SALK to INSTITUTION, regardless of the form or manner of disclosure,
provided that such information is clearly identified as “confidential” at the time of disclosure, which
information may include without limitation memoranda, documents (including electronic files, records,
drawings, manuals and disks (including any copies, notes or memoranda made by the receiving party)),
data, oral or visual presentations, inventions, procedures, discoveries, patent applications, improvements,
knowledge, specifications, drawings, diagrams, business information or ideas described therein which are
not generally known to those in the industry to which the information pertains or other materials
transmitted or otherwise disclosed by INSTITUTION (and its employees) to Salk, or by Salk (and its
respective employees) to INSTITUTION. However, Confidential Information does not include any
information that: (i) was in the public domain at the time of disclosure, (ii) later became part of the public
domain through no act or omission of the recipient party, its employees agents, successors, or assigns,
(iii) was lawfully disclosed to the recipient by a third party having the right to disclose it, (iv) was already
known by the recipient at the time of disclosure and recipient can so demonstrate by competent written
proof or (v) is required to be disclosed to a governmental agency pursuant to such agency's rule and
regulations in order to secure regulatory approval, provided that Licensee shall first give notice to Salk of
such disclosure and shall have made a reasonable effort to maintain the confidentiality of such
information.
2.
RESEARCH
A.
Scope of Research Plan. In addition to and apart from the CDA executed December
20, 2013 between the Parties, the scope of the work to be performed under this Agreement shall be set
forth in the Research Plan attached hereto as Exhibit B or any subsequent revisions of Exhibit B mutually
agreed upon in writing by duly authorized representatives of SALK and INSTITUTION. Research
conducted by the INSITUTION is funded by the United States Federal Government (“Prime Sponsor”).
The Parties shall conduct the Research, using their own facilities and equipment, in a good scientific
manner and in compliance with state-of-the-art scientific standards and laboratory practice and applicable
legal requirements, but within the scope of the research plan and personnel commitments per the attached
Exhibit B. In the event of any conflict between this Agreement and the Research Plan, this Agreement
will control.
B.
Limited Rights to Use Materials. It is expected that pursuant to this Agreement,
Materials, per the attached Exhibit A, shall be transferred between the Parties in the manner set forth in
the Research Plan. The Party receiving the Material shall use the Material solely for the purpose of
performing the Research Plan per the attached Exhibit B. The receiving Party will not chemically or
biologically modify the Material, except as may be explicitly permitted in furtherance of the Research
Plan, unless otherwise agreed to in writing by the disclosing Party. The receiving Party will not transfer
the Material, or any part of the Material, to any third party, other than such Party’s employees who are
responsible for the performance of the Research Plan. The receiving Party will not administer the
Material, or any materials produced from the Material, to humans. EACH PARTY UNDERSTANDS
THAT THE MATERIAL IS PROVIDED SOLELY FOR CERTAIN RESEARCH USE ONLY AND
HAS NOT BEEN APPROVED FOR HUMAN USE. USE OF THE MATERIAL IN HUMANS IS
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SPECIFICALLY PROHIBITED.
Each Party acknowledges that the MATERIAL is experimental in nature and that it is provided "AS IS."
NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES WITH RESPECT TO
THE MATERIAL OR THE USE OF THE MATERIAL. EACH PARTY DISCLAIMS ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WIHTOUT LIMITATION ANY
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT.
3.
MEETINGS AND REPORTS
The Principal Investigator and researchers from SALK and INSTITUTION shall meet at
a time interval as agreed to by the Parties, in person or by teleconference, to review results arising from
the conduct of the Research Plan (“Research Results”).
4.
PUBLICATION
Review. Publication of Research Results is one of the primary missions of the Parties.
The Parties agrees that each Party shall be permitted to present at symposia, international, national and
regional meetings, and to publish the Research Results in journal articles, theses or dissertations (each, a
"Publication"); provided, however, that each Party agrees to submit to the other Party for other Party's
prior review and comment on any Publication utilizing the Research Results at least thirty (30) days prior
to the proposed date for submission of such Publication. The receiving Party may delay any Publication
for up to sixty (60) days in order to file a patent application or take such other measures as receiving Party
deems necessary to establish and preserve its proprietary rights. For avoidance of doubt, any time periods
set forth in this paragraph may be extended at any time by mutual written agreement of the Parties.
5.
INTELLECTUAL PROPERTY
A.
Background IP. All rights and title in and to any and all Background IP shall reside with
the owner thereof and, except as otherwise set forth herein, such ownership and rights thereto shall not be
affected by the Research Plan or either Party's performance of its obligations hereunder. Each Party grants
to the other Party a royalty-free, worldwide, non-exclusive license to Background Intellectual Property solely during
the Term, and to enable execution of the applicable Research Plan activities..
B.
Inventorship and Ownership. Inventorship of Inventions will be determined in
accordance with the principles of U.S. patent law and may be subject to the rights and requirements of the
United States Federal Government when support for the Research is provided by the United States
Federal Government. Salk Sole Inventions shall be owned by Salk. INSTITUTION Sole Inventions shall
be owned by INSTITUTION. Joint Inventions shall be owned jointly by the Parties.
C.
Research License.
Each Party shall have the right to use all Research Results and all
materials created or developed as a result of the performance of the Research Plan for non-commercial
internal research purposes and in compliance with Article 4 of this agreement.
D.
Prosecution and Expenses
(i)
Joint Inventions. SALK shall be responsible for prosecuting Joint Inventions.
INSTITUTION and SALK shall jointly decide, on a case by case basis, whether or not to file and where
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to file patent applications for Joint Inventions and shall jointly participate in decisions regarding filing,
prosecution and maintenance. Both Parties agree to cooperate and execute all documents that are
necessary for the filing, prosecution and maintenance of such patent applications. The Parties will enter
into an Inter-Institutional agreement that will provide for the Parties split of costs for the filing,
prosecution and maintenance of any such patent applications for Joint Inventions and the Parties share of
license revenue generated from licensing the Joint Inventions. If SALK elects not to file a patent on a
Joint Invention, continue prosecution and/or maintenance, SALK will notify INSTITUTION in writing.
INSTITUTION may then elect to file a patent application, continue prosecution and/or maintenance at its
own expense on the Joint Invention.
(ii)
SALK Sole Inventions. SALK shall be responsible for prosecuting SALK Sole
Inventions. SALK shall appoint patent counsel and control the prosecution. SALK will pay the costs for
the filing, prosecution and maintenance of such patent applications for SALK Sole Inventions that SALK
elects to file.
(iii)
INSTITUTION Sole Inventions. INSTITUTION shall be responsible for
prosecuting INSTITUTION Sole Inventions. INSTITUTION shall appoint patent counsel and control the
prosecution. INSTITUTION will pay the costs for the filing, prosecution and maintenance of such patent
applications for INSTITUTION Sole Inventions that INSTITUTION elects to file.
E.
CREATE Act. Notwithstanding anything to the contrary in this Section 6, each Party
shall have the right to invoke the Cooperative Research and Technology Enhancement Act of 2004, 35
U.S.C. 103(c)(2)-(c)(3) (the “CREATE Act”) when exercising its rights under this Section 6, without the
prior written consent of the other Party. Where a Party intends to invoke the CREATE Act, as permitted
by the preceding sentence, it shall notify the other Party and the other Party shall cooperate and
coordinate its activities with the invoking Party with respect to any submissions, filings or other activities
in support thereof. The Parties acknowledge and agree that this Agreement is a “joint research
agreement” as defined in the CREATE Act. The specification of any patent application filed pursuant to
this Agreement shall contain language required to invoke the CREATE Act as applicable.
6.
CERTIFICATIONS
A.
Mutual Certifications. Each Party certifies to the other that (a) it is a not-for-profit
institution duly organized, validly existing and in good standing under the laws of its state of
incorporation; (b) it has the right and authority to execute and deliver this Agreement and to perform its
obligations contemplated hereunder; (c) this Agreement is a legal, valid and binding agreement of the
Party and enforceable against it; (d) the execution and delivery of this Agreement will not, to each Party's
knowledge, violate any statute, regulation or any other restriction upon the Party; (e) it has secured all
requisite authorizations and approvals necessary for the execution, delivery and performance of this
Agreement; and (f) it is not subject to any restrictive obligations imposed by any third party which would
prevent or impair its ability to enter into this Agreement or fulfill its obligations hereunder, nor will it
knowingly enter into any agreement with any other party that would in any way prevent it from
performing its obligations under this Agreement.
B.
SALK Representations and Warranties. Additionally, the Office of Technology
Development of SALK represents, warrants and covenants to INSTITUTION, to the best of its
knowledge, as follows:
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(a)
(b)
neither it nor any individual employed or engaged by SALK to participate in the
Research have ever been and are not currently (i) under investigation for debarment or
debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a), as
amended, or any similar state law or regulation; (ii) excluded by the Office of Inspector
General pursuant to 42 U.S.C. § 1320a-7, et seq. or any state agency from participation in
any federal or state health care program; or (iii) otherwise disqualified or restricted by the
FDA pursuant to 21 C.F.R. 312.70 or any other regulatory authority, nor will SALK
knowingly utilize any debarred, excluded or disqualified personnel to perform the
Research hereunder;
it will notify INSTITUTION immediately in the event it becomes aware of any
investigation or proceeding for debarment, exclusion or disqualification is initiated
against SALK or any individual employed or engaged by SALK that is performing the
Research hereunder;
C.
Disclaimer of Warranties. EXCEPT AS OTHERWISE SET FORTH IN THIS
AGREEMENT, SALK'S CARRYING OUT OF THE RESEARCH HEREUNDER, AND PROVISION
OF RESULTS HEREUNDER, IS DONE "AS-IS" WITH NO WARRANTY OF ANY KIND, AND
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, SALK HEREBY DISCLAIMS ANY
AND ALL WARRANTIES EXPRESS OR IMPLIED (INCLUDING WITHOUT LIMITATION
WARRANTIES OF MERCHANTIBILITY AND FITNESS FOR A PARTICULAR PURPOSE) TO
THE MAXIMUM EXTENT PERMISSIBLE BY LAW. THE PARTIES DISCLAIM AND MAKE NO
WARRANIES OF ANY KIND, EITHER EXPRESS OR IMPLED, AS TO ANY MATTER,
INCLUDING BUT NOT LIMITED TO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE,
MERCHANTABILITY, PATENTABILITY OR THAT THE PARTIES USE OF THE RESEARCH
RESULTS WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, TRADEMARKS
OR OTHER RIGHTS OF THIRD PARTIES.
7.
LIMITATION OF LIABILITY
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT,
SPECIAL, INCIDENTAL, RELIANCE OR CONSEQUENTIAL DAMAGES OF ANY KIND,
REGARDLESS OF THE FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING
WITHOUT LIMITATION NEGLIGENCE), STRICT LIABILITY, OR OTHER LEGAL OR
EQUITABLE THEORY, EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES; PROVIDED, HOWEVER, THIS LIMITATION OF LIABILITY
SHALL NOT BE CONSTRUED TO LIMIT A PARTY'S LIABILITY WITH RESPECT TO ITS
INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 5 OR WITH RESPECT TO ANY
BREACHES OF A PARTY’S OBLIGATIONS OF CONFIDENTIALITY SET FORTH IN SECTION 9.
8.
PUBLICITY
Neither Party shall use the other Party’s name or insignia, or any adaptation of them, or the name
of the Principal Investigator or other researcher(s) of the other Party in any advertising, promotional or
sales literature, without the prior written approval of the other Party. This restriction shall not apply to:
(i) annual or other periodical reports prepared by either Party in the normal course of business; and (ii)
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any information required by law to be disclosed.
9.
CONFIDENTIALITY
A.
Each Party acknowledges that it is to be given access to the Confidential Information of
the other party only for purposes of carrying out the Research Plan. Each Party agrees that it will (a)
maintain in confidence such Confidential Information to the same extent such Party maintains its own
proprietary information; (b) not disclose such Confidential Information to any third party without prior
written consent of the other Party; and (c) not use such Confidential Information for any purpose except
those permitted by this Agreement. Each Party shall limit its disclosure of the Confidential Information
to employees within its own organization that have a legitimate need to receive such Confidential
Information in order to accomplish the Research Plan.
B.
Restricted Period. These restrictions upon disclosure and use of Confidential Information
shall continue during the Term and shall extend beyond the Term for a period of five (5) years.
10.
INDEPENDENT CONTRACTOR
Neither Party shall be or be deemed to be the employee or agent of the other. Neither Party is
authorized to act as an agent for the other for any purposes and shall not act on behalf of the other Party or
enter into any contract, warranty or representation as to any matter.
11.
NOTICES
Any notices to be given hereunder shall be sufficient if signed by the Party giving same and either
(a) mailed certified mail return receipt requested,
(b) made by overnight delivery, or
(c) faxed to other Party if the sender has evidence of successful transmission and if the
sender promptly sends the original by ordinary mail, in any event to the following
addresses:
If to INSTITUTION:
For administrative matters:
For scientific matters:
If to SALK:
Salk Institute for Biological Studies
10010 North Torrey Pines Road
La Jolla, CA 92037
Attn: Senior Director, Office of Technology Development
Facsimile: (858) 824-9262
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With a copy to:
Salk Institute for Biological Studies
10010 North Torrey Pines Road
La Jolla, CA 92037
Attn: General Counsel
Facsimile: (858) 450-0509
Notices mailed shall be deemed given on the date postmarked on the envelope. Notices sent by
overnight carrier shall be deemed given on the date received by such carrier, as indicated on the shipping
manifest or waybill. Notices sent by fax shall be deemed given on the date faxed.
12.
TERM AND TERMINATION
A.
Term. This Agreement shall be effective as of the Effective Date and shall
continue in full force and effect for one (1) year from the Effective Date unless earlier terminated
in accordance with this Section 12.
B.
Termination without Cause. Either Party may terminate this Agreement upon sixty (60)
days notice if that Party determines, in its sole discretion, that the project is no longer feasible or of
interest.
13.
ENTIRE AGREEMENT; MODIFICATION
This Agreement and Exhibits attached hereto contain the entire agreement and understanding
between the Parties with respect to the subject matter hereof, and merges all prior discussions,
representations and negotiations with respect to the subject matter of this Agreement.
14.
SURVIVORSHIP
The provisions of Articles 3, 4, 5, 7, 8, 9, 11, 14, 15, and 16 shall survive any expiration or
termination of this Agreement.
15.
SEVERABILITY; WAIVER
If any term, condition or provision of this Agreement is held to be unenforceable by a court
having proper jurisdiction for any reason, it shall, if possible, be interpreted rather than voided, in order to
achieve the intent of the parties to this Agreement to the extent possible. In any event, all other terms,
conditions and provisions of this Agreement shall be deemed valid and enforceable to the full extent of
the law. Any delay or waiver by a Party to declare a breach or seek any remedy available to it under this
Agreement or by law will not constitute a waiver as to any past or future breaches or remedies. Waiver of
one term, covenant or condition, shall not be construed as waiver of any other term, covenant or
condition.
16.
ASSIGNMENT
This Agreement is not assignable without the prior written consent of both Parties and any
attempt to do so shall be null and void.
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23.
EXPORT CONTROL
The Parties agree that, with respect to the performance of this Agreement, it shall comply
with any and all applicable United States export control laws and regulations, as well as any and all
embargoes and/or other restrictions imposed by the Treasury Department’s Office of Foreign Asset
Controls.
SIGNATURES BEGIN ON NEXT PAGE
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IN WITNESS WHEREOF, each Party has caused this Research Agreement to be duly executed
by an authorized representative as of the Effective Date.
THE SALK INSTITUTE FOR
BIOLOGICAL STUDIES, SAN DIEGO,
CALIFORNIA
INSTITUTION
BY:
BY:
___________________________
____________________________
NAME: Michelle A. Booden
NAME:
TITLE: Director, Licensing and Intellectual Property
Office of Technology Development
TITLE: ____________________________
DATE: __________________________
DATE: ____________________________
Acknowledged by:
Acknowledged by:
_________________________________
_________________________________
Name:
Name:
Title: Principal Investigator
Title: Principal Investigator
Date:
Date:
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EXHIBIT A
SALK MATERIALS
EXHIBIT B
RESEARCH PLAN
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EXHIBIT C
BACKGROUND TECHNOLOGY
Salk Background IP:
INSTITUTION Background IP:
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