Intellectual Property Rights

Sample Clauses
The Standard Non-Governmental Clinical Study Agreement does not contain a section addressing the
rights of the parties in inventions that might come from clinical trials. Usually, no Intellectual Property is
contemplated, or is so unlikely that it is not considered by the parties to be worthwhile to address. If,
however, a Sponsor does address the issue you may use any of the following paragraphs, as appropriate
considering the facts of your particular study. Always offer first those appropriate paragraphs that
preserve for the University the most rights in Intellectual Property.
1.

Intellectual Property Rights -- For allocating ownership of University inventions to University,

but does not address Sponsors inventions or joint inventions.

2.

Intellectual Property Rights -- This is Attachment B to the long form Sponsored Research
Agreement used by UT Austin, edited to make it useful as an insert or series of insertable
provisions in a different agreement. It may be further edited to remove many of the particulars, so
long as it retains the aspects that are crucial (see detailed checklist).

3.

Intellectual Property Rights -- For allocating the ownership of University inventions to

University unless such inventions are jointly created by Sponsor and University, in which case
they will be jointly owned. The provision does not address Sponsors sole inventions.

4.

Intellectual Property Rights -- For allocating the ownership of University inventions to

University, Sponsors sole inventions to Sponsor, and joint inventions to both parties.

5.

Intellectual Property Rights -- A fairly middle-of-the-road clause that may be used with almost
anyone.

6.

Intellectual Property Rights -- A statement of the default provisions of the law of inventorship
and UT System policy. This is generally what will apply if we say nothing about who owns what.

7.

Intellectual Property Rights -- For allocating to the Sponsor the ownership of its sole inventions
relating to the study drug, and allocates to us the ownership of everything else (University sole
and joint inventions with Sponsor).

8.

Intellectual Property Rights -- Includes an acknowledgement that we will not acquire any rights
in Sponsors study drug by performing the study, but allocates to University the ownership of any
University inventions developed during the study.

9.

Intellectual Property Rights -- For allocating the ownership of University sole inventions to
University, but allocating the ownership of joint inventions to both University and Sponsor as
joint owners.

10.

Clinical Trial Intellectual Property Rights -- For allocating the rights to possible inventions
arising from the activities to be carried out by the Investigator to the Sponsor irrespective of who
might be considered the inventor under law.
----------0---------[This provision allocates ownership of University inventions to University, but does not address
Sponsors inventions or joint inventions.]

1.

Intellectual Property Rights

1.1

Title to all inventions and discoveries made by University resulting from the research performed
hereunder shall reside in University; however, University agrees to grant to Sponsor an option to
negotiate an exclusive, worldwide, royalty-bearing license, to make, use or sell under any
invention or discovery made and conceived during the term of this Agreement and directly
resulting from the performance of research hereunder, with the right to sublicense with
accounting to University. Sponsor shall have three (3) months from disclosure of any invention or
discovery to notify University of its desire to enter into such a license agreement, and a license
agreement shall be negotiated in good faith within a period not to exceed six (6) months from
Sponsors notification to University of its desire to enter into a license agreement, or such period
of time as the parties shall mutually agree. In the event that Sponsor and University fail to enter
into an agreement during that period of time, then the rights to such inventions and discoveries
shall be disposed of in accordance with University policies, with no obligation to Sponsor.
Sponsor agrees to pay a reasonable royalty to be negotiated in good faith for the use of the
invention or discovery. Until such invention or discovery has been presented as set forth above,
University shall not offer rights to that invention or discovery to any third party.

1.2

In the event Sponsor elects to exercise its option as to any invention or discovery, in accordance
with the procedures detailed above, it shall be obligated to pay all patent expenses for such
invention or discovery. Sponsor shall also be obligated to pay all patent expenses for a nonexclusive, royalty-free license to any invention or discovery. This shall include but not be limited
to the cost of any prior activities investigating patentability of said invention or discovery before
exercise of the option, such as search and opinion for patentability, that may have been performed
by University pursuant to its arrival at a judgment of commercially exploitable status. It is
contemplated that, in the majority of instances, Sponsor will be asked to determine whether it will
exercise its option prior to the filing of the first patent application.
[This is Attachment B to the long form Sponsored Research Agreement used by U.T. Austin,
edited to make it useful as an insert or series of insertable provisions in a different agreement.
It may be further edited to remove many of the particulars, so long as it retains the aspects
that are crucial (see detailed checklist).]

2.

Intellectual Property Rights

2.1

The following terms shall have the indicated meanings when used in this Attachment:
a.

Invention shall mean any discovery, concept, or idea, whether or not patentable, made
by the University and/or the Principal Investigator during the Research Program and
arising directly from the performance of the Research Program, including but not limited
to processes, methods, software, tangible research products, formulas and techniques,
improvements thereto, and know-how related thereto.

b.

Patent Expenses shall mean any expenses, including attorneys fees, incurred in
searching prior art, obtaining search opinions, preparing applications, filing, prosecuting,
enforcing or maintaining a patent or patent application with respect to Patent Rights in
any country in which the patent or patent application is filed.

c.

Patent Rights shall mean any patent application or patent covering any Invention made
by the University and/or the Principal Investigator during the course of the Research
Program and arising directly from the performance of the Research Program, including
any continuation, continuations-in-part, divisional applications, substitutions, extensions
or additions thereto, and any corresponding foreign patent applications or patents based
on such applications or patents.

d.

Technology Rights shall mean University rights under state and federal laws, including
the laws of copyright, trade secret, and unfair competition, in unpatented inventions,
know-how, software, and other technology developed by the University and/or the
Principal Investigator during the Research Program and arising directly from the
performance of the Research Program.

2.2

Any Patent Rights and Technology Rights based upon Inventions made solely by University
personnel shall be the property of University. Any Patent Rights and Technology Rights based
upon Inventions made jointly shall be the joint property of University and Sponsor. Rights arise
during the Research Program if they are either conceived or reduced to practice during the
Research Program.

2.3

After consultation with Sponsor, University at its sole election may prepare and file appropriate
United States and foreign patent applications for Inventions. University will provide Sponsor, on
a confidential basis, a copy of any such application filed and any documents received or filed
during prosecution thereof and will provide Sponsor the opportunity to comment thereon. On any
application on which an employee of Sponsor is named as a co-inventor, Sponsor will cooperate
in obtaining execution of any necessary documents by its employees.

2.4

As partial consideration for Sponsors obligation to make the payments described in Article
above, University grants to Sponsor an option to negotiate a worldwide, royalty-bearing exclusive
license under Patent Rights and Technology Rights to practice any Invention and use any
technology made in the course of the Research Program. Such option shall be exercisable in the
following manner: Whenever University, in its good faith judgment, believes that it has a
commercially exploitable item within Patent Rights and Technology Rights (Item), it shall
present the Item to Sponsor on a confidential basis. Within thirty (30) days after such
presentation, Sponsor shall notify University in writing if it wishes to exercise its option for that
Item, and a license agreement shall be negotiated in good faith for a period not to exceed one
hundred twenty (120) days from the date that Sponsor exercises its option, or such period of time
as the parties shall mutually agree. In the event that Sponsor and University fail to enter into an
agreement during that period of time, then the rights to such inventions and technology shall be
disposed of in accordance with Universitys policies, with no further obligation to Sponsor. Until
any such Item, such as an invention disclosure, patent, patent application, or identifiable piece of
unpatented technology, has been presented as set forth above, University shall not offer rights to
the Item to any third party.

2.5

In the event Sponsor elects to exercise its option as to any Item, in accordance with the
procedures detailed above, it shall be obligated to pay all Patent Expenses for such Item. This
shall include but not be limited to the cost of any prior activities investigating patentability of the
Item before exercise of the option, such as search and opinion for patentability that may have
been performed by University pursuant to its arrival at a judgment of commercially exploitable
status. It is contemplated that, in the majority of instances, Sponsor will be asked to determine
whether it will exercise its option prior to the filing of the first patent application.

2.6

Sponsor may exercise its option on Patent Rights and Technology Rights by informing the
University and System as provided in Section of the identity of the Item within Patent Rights and
Technology Rights and by providing a written statement of its intention to develop the Item, or
cause the Item to be developed, for public use as soon as practicable, consistent with sound and
reasonable business practices and judgment.

2.7

Any license to Patent Rights and Technology Rights granted to Sponsor, as provided herein, shall
include at least the following terms and conditions:

2.8

a.

a reasonable and customary running royalty on net sales from licensed products;

b.

the right of Sponsor to grant sublicenses, with payment to the University of 50% of any
royalties or other proceeds received by Sponsor;

c.

a commitment by Sponsor and any sublicensee to diligently develop and commercialize

the licensed invention and technology. In the event Sponsor does not achieve its
commitment, its license shall terminate upon written notice by University;

d.

a term that does not exceed any limits imposed by law;

e.

retention by the University of the complete royalty-free right to use any Patent Rights and
Technology Rights, including any licensed Invention, technology, or software for
teaching, research, or other educational or academic purposes;

f.

reservation of the rights of the Government of the United States of America, as set forth
in Public Law 96-517, if applicable; and

g.

an indemnification by Sponsor of University, System and their Regents, officers,

employees, and agents from all liability arising from Sponsors development, marketing,
and use of any Patent Rights or Technology Rights.

Subject to confidential treatment by Sponsor of University confidential information that may be

disclosed thereunder, University grants Sponsor a fully paid-up, nonexclusive license under its
copyrights to make a reasonable number of copies for its internal needs, and to make derivative
works from any written report prepared and delivered to Sponsor in accordance with this
Agreement.
[This provision allocates the ownership of University inventions to University unless such
inventions are jointly created by Sponsor and University, in which case they will be jointly owned.
The provision does not address Sponsors sole inventions. ]

3.

Intellectual Property Rights

3.1

University agrees that the Investigator will promptly disclose to its Intellectual Property
Committee and to Sponsor any inventions, ideas, improvements, processes, devices, products,
new uses, know-how or the like, whether patentable or unpatentable, which the Investigator,
alone or jointly with others, may conceive, invent, produce, or reduce to practice during this
Study and which result from the Study (herein referred to as Inventions). It is agreed that all

Inventions and any information with respect thereto shall be subject to the confidentiality
obligations set forth in Section herein.
3.2

Any Inventions, as defined above, that originate solely with the Investigator, or any other
University agent or employee associated with this Study (jointly or severally referred to as
Inventor) shall be the property of University. If Inventor is a co-inventor with Sponsor, its
agents or employees, University and Sponsor shall jointly own the Invention. University does
hereby grant to Sponsor an exclusive option to acquire an exclusive, worldwide royalty-bearing
license to any such Invention which results from the Study. Sponsor shall indicate its intention to
exercise its option to license by notifying University in writing within forty-five (45) days of each
Inventions disclosure to Sponsor. If Sponsor decides to exercise its option, the terms shall be
negotiated in good faith within one hundred twenty (120) days of the date the option is exercised,
or until such time as the parties may mutually agree in writing.

[This provision allocates the ownership of University inventions to University, Sponsors sole inventions
to Sponsor, and joint inventions to both parties.]

4.

Intellectual Property Rights

4.1

Invention shall mean any discovery, concept, or idea, whether or not patentable, made during
the conduct of the study, and arising directly from the performance of the study, including but not
limited to processes, methods, software, tangible research products, formulas and techniques,
improvements thereto, and know-how related thereto.

4.2

Institution agrees that the Principal Investigator will promptly disclose to its Intellectual Property
Committee and to Sponsor any Inventions made by the Institution and/or the Principal
Investigator. It is agreed that all Inventions and any information with respect thereto shall be
subject to confidentiality obligations commensurate with those set forth in Section ___ herein.

4.3

Any Inventions that originate solely with the Principal Investigator, or any other Institution agent
or employee associated with this study (jointly or severally referred to as Inventor) shall be the
property of Institution. If Inventor is a co-inventor with Sponsor, its agents or employees,
Institution and Sponsor shall jointly own the Invention. Any Inventions that originate solely with
any agent or employee of Sponsor shall be the property of Sponsor. To the extent that Sponsor
pays all patent expenses for an Invention, Institution does hereby grant to Sponsor an exclusive
option to acquire an exclusive, worldwide royalty-bearing license to any Invention in which
Institution has an ownership interest. Sponsor shall indicate its intention to exercise its option to
license by notifying Institution in writing within forty-five (45) days of each Inventions
disclosure to Sponsor. If Sponsor decides to exercise its option, the terms shall be negotiated in
good faith within one hundred twenty (120) days of the date the option is exercised, or within
such time as the parties may mutually agree in writing.

4.4

If negotiations between Sponsor and the Institution terminate and the Institution thereafter
negotiates a license agreement with a third party on substantially better terms than those last
offered to Sponsor, Sponsor shall be given the first right to refuse such terms for a period of sixty
(60) days from the date of Sponsors receipt of a draft of such license agreement from Institution.

[This is a fairly middle-of-the-road clause that may be used with almost anyone.]

5.

Intellectual Property Rights

5.1

Title to all inventions and discoveries made by Institution resulting from the research performed
hereunder shall reside in Institution; title to all inventions and discoveries made by Sponsor
resulting from the research performed hereunder shall reside in Sponsor; title to all inventions and
discoveries made jointly by Institution and Sponsor resulting from the research performed
hereunder shall reside jointly in Institution and Sponsor. Inventorship shall be determined in
accordance with U.S. Patent law.

5.2

After consultation with Sponsor regarding the advisability of filing patent applications, Institution
shall file appropriate United States and foreign patent applications for wholly or jointly owned
Institution inventions. Institution will provide Sponsor, on a confidential basis, a copy of any such
application filed and any documents received or filed during prosecution thereof and will provide
Sponsor the opportunity to comment thereon. On any application on which an employee of
Sponsor is named as a co-inventor, Sponsor will cooperate in obtaining execution of any
necessary documents by its employees.

5.3

Institution agrees to grant to Sponsor an option to negotiate an exclusive, worldwide, royaltybearing license to make, use or sell under any invention or discovery owned wholly or partly by
Institution and made or conceived and reduced to practice during the term of this Agreement or
within six (6) months thereafter and directly resulting from the performance of the research
hereunder, with right to sublicense with accounting to University. Sponsor shall have three (3)
months from disclosure of any invention or discovery to notify Institution of its desire to enter
into such a license agreement, and a license agreement shall be negotiated in good faith within a
period not to exceed six (6) months from Sponsors notification to Institution of its desire to enter
into a license agreement, or such period of time as to which the parties shall mutually agree.

5.4

If Sponsor and Institution fail to enter into an agreement during that period of time, Sponsor shall
have a right of first refusal with respect to any terms generally more favorable offered by
Institution to a third party for a period of one (1) year thereafter.

5.5

In the event Sponsor elects to exercise its option to negotiate a license in accordance with the
procedures detailed above, it shall be obligated to pay all expenses, including attorneys fees,
incurred in searching prior art, obtaining search opinions, preparing applications, filing,
prosecuting, enforcing or maintaining a patent or patent application with respect to the licensed
invention in any country in which the patent or application is filed.

[This is a statement of the default provisions of the law of inventorship and UT System policy. This is
generally what will apply if we say nothing about who owns what.]

6.

Intellectual Property Rights

Ideas, know-how, data (including clinical study results), and other intellectual property generated under
this clinical study shall be the sole and exclusive property of the employer of the inventing party.
Inventorship shall be determined in accordance with U.S. Patent laws.

[This provision allocates to the Sponsor the ownership of its sole inventions relating to the study drug,
and allocates to us the ownership of everything else (University sole and joint inventions with Sponsor).]

7.

Intellectual Property Rights

The sole and exclusive right to any inventions or discoveries relating to the Drug, whether patentable or
not, made by Sponsor in the performance of work under this Agreement shall be the property of Sponsor.
All other inventions or discoveries under this Agreement shall be the property of the Institution and
handled in accordance with The University of Texas System Intellectual Property Policy. The Institution
hereby grants Sponsor an option to negotiate an exclusive, royalty-bearing license to any invention or
discovery arising out of research conducted under this Agreement and conceived and reduced to practice
during the course of this study or arising out of research conducted under this Agreement and reduced to
practice [within six (6) months] of completion of work under this Agreement. The Institution shall
promptly disclose to Sponsor in writing and marked confidential any such inventions or discoveries
arising from research conducted under this Agreement, and Sponsor shall advise the Institution in writing
within ninety (90) days of disclosure to Sponsor whether it wishes to secure a commercial license. If
Sponsor elects not to secure a license, or if Sponsor and the Institution fail to enter into a license
agreement within one hundred eighty (180) days from the date of election by Sponsor to secure such a
license, or such reasonable time period to which the parties may later agree in writing, then the rights to
such inventions and discoveries disclosed hereunder shall be disposed of in accordance with Institution
policies with no further obligation to Sponsor. In the exercise of the option right granted hereunder, the
parties shall negotiate in good faith concerning the terms and conditions of a license agreement.
[This provision includes an acknowledgement that we will not acquire any rights in Sponsors study
drug by performing the study, but allocates to University the ownership of any University inventions
developed during the study.]

8.

Intellectual Property Rights

8.1

Institution understands and acknowledges that the pharmaceutical compound known as which is
being provided to Institution for the purpose of conducting the Study is the property of Sponsor
and/or that the pharmaceutical compound may be subject to certain intellectual property rights
owned by or licensed to Sponsor. This Agreement shall not be deemed or construed to convey or
transfer any of such intellectual property rights to Institution except insofar as necessary to permit
Institution to conduct the Study which is the subject of this Agreement.

8.2

Sponsor understands and acknowledges that any new and patentable discovery, unpatentable
technology, technical know-how or other intellectual property developed solely by Institution as a
result of Institutions conduct of the Study hereunder shall be and remain the property of
Institution. Sponsor shall have an option to negotiate an exclusive, worldwide license in and to
any such intellectual property developed and owned by Institution (as well as that owned by it
jointly with the Sponsor) under reasonable terms and conditions which shall be negotiated within
one hundred and eighty (180) days following written notice to Sponsor by Institution that such
intellectual property has been developed as a result of the conduct of the Study which is the
subject of this Agreement and specifically referencing the start of the one hundred eighty (180)
day period in this Section . In the event that Sponsor and Institution fail to enter into a license
agreement during the time specified above, or during such extension of time as the parties may
mutually agree, then Institutions obligations to Sponsor under this Section shall cease.

[This provision allocates the ownership of University sole inventions to University, but allocates the
ownership of joint inventions to both University and Sponsor as joint owners. Joint ownership presents
a difficult problem regarding the rights of the joint inventors to commercialize the invention without
accounting to each other. Usually, this problem is not acknowledged straightforwardly. This provision
requires that the parties negotiate for some period of time regarding the commercialization of joint
inventions, thus at least giving us an opportunity to encourage Sponsor to take an exclusive license from
us as a way of acknowledging Institutions contribution to the invention, since our ability to
commercialize in competition with Sponsor is so limited.]

9.

Intellectual Property Rights

9.1

Any Inventions that originate solely with Institution, its agents or employees shall be the sole
property of Institution. If an Institution employee or agent is a co-inventor with Sponsor, its
agents or employees, Institution and Sponsor shall jointly own such Invention.

9.2

In the event that an Invention is made, either solely by employees or agents of Institution or
jointly by employees or agents of Institution and Sponsor, Institution and Sponsor agree to give
notice of such Invention to each other promptly after identification thereof. Within __________
(____) days of receipt of notice that an Invention has been identified, Institution and Sponsor will
thereupon exert their best reasonable efforts in cooperation with each other to investigate,
evaluate and determine to the mutual satisfaction of both parties, the disposition of rights to the
Invention, including whether, by whom, and where any patent applications are to be filed.

9.3

To the extent that Sponsor pays all costs associated with filing, prosecution, issuance, and
maintenance of patents related thereto, the Institution hereby grants to Sponsor the right to
negotiate an exclusive, royalty-bearing, world-wide license to practice any University solely
owned Inventions. Should Sponsor desire to secure such a license or to commercialize jointly
owned Inventions, Sponsor shall so advise Institution in writing, within sixty (60) days of
Sponsors receipt of full written disclosure of such Inventions. Thereafter, the parties shall
negotiate for a period of one hundred twenty (120) days from the date the Institution receives
notice of the Sponsors desire to secure a license under its option or to effect commercialization
of jointly owned Inventions. The terms of any resulting license shall be reasonable under the
circumstances and will be negotiated in good faith between the Institution and Sponsor.

9.4

If negotiations between the Sponsor and the Institution terminate and the Institution thereafter
negotiates a license agreement with a third party on substantially better terms than those last
offered to the Sponsor, Sponsor shall be given the first right to refuse such terms for a period of
sixty (60) days from the date of Sponsors receipt of a draft of such license agreement from
Institution.

[This Intellectual Property Rights clause allocates the rights to possible inventions arising from the
activities to be carried out by the Investigator to the Sponsor irrespective of who might be
considered the inventor under law. This is generally an unacceptable allocation for sponsored
research, but is justified under narrow circumstances: The study must be a clinical trial; the
protocol must be Sponsors; and it must be narrowly tailored to achieve Sponsors expected results.]
10.

Clinical Trial Intellectual Property Rights

All rights to any invention conceived and reduced to practice as a direct result of the performance of the
work conducted under this Agreement using the [study drug] in accordance with the protocol provided by
Sponsor to Institution shall belong to Sponsor. Institution agrees to assign to Sponsor, at the request of
Sponsor, the sole and exclusive ownership thereto, upon payment of costs by Sponsor, if any, incurred by
Institution in the filing, prosecution, issuance and/ or maintenance of any patent application or patent
issuing thereon. Further prosecution and costs, if any, shall thereafter be borne by Sponsor.
[The following clause gives Sponsor an option to negotiate a license in any Other Inventions that
could result from performance of Clinical Trials. Do not offer it unless Sponsor requests such license
rights. The Clinical Trial Intellectual Property Rights Clause above should be adequate to cover all
remotely conceivable inventions that could result, so this option clause is really not necessary. We
certainly do not wish to haggle over terms that are so unlikely to ever be called into play.]
All rights to inventions and discoveries arising from research conducted under this Agreement, other than
as provided for above (Other Inventions), shall belong to Institution and shall be disposed of in
accordance with Institution policy. To the extent that Sponsor pays all costs associated with filing,
prosecution, issuance and maintenance of patents related thereto, Sponsor is hereby granted the right to
negotiate an exclusive, world-wide, royalty-bearing license to any Other Inventions conceived and
reduced to practice during the course of the research project or conceived during the research project and
reduced to practice within six (6) months thereafter. Such license shall contain reasonable terms and
royalties and shall require diligent pursuit by Sponsor of the commercial development of such Other
Inventions. In the event Other Inventions are conceived but not actually reduced to practice during the
course of this project, such license agreement may further include a provision for actual reduction to
practice within a reasonable time by either Sponsor or by Institution under funding provided by Sponsor.
Institution shall promptly disclose to Sponsor on a confidential basis any Other Invention arising under
this Agreement and Sponsor shall advise Institution in writing within ninety (90) days after disclosure to
Sponsor whether it wishes to secure a commercial license to such Other Invention. If Sponsor elects not
to secure such a license, rights to such Other Invention shall be disposed of in accordance with Institution
policies, with no further obligation to Sponsor.