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 Sponsor’s 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 Sponsor’s sole inventions.
4.Intellectual Property Rights -- For allocating the ownership of University inventions to University, Sponsor’s 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 Sponsor’s 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.
[This provision allocates ownership of University inventions to University, but does not address Sponsor’s 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 Sponsor’s 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 non-exclusive, 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 attorney’s 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 Sponsor’s 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 University’s 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:
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 Sponsor’s development, marketing, and use of any Patent Rights or Technology Rights.
2.8 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 Sponsor’s 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 Invention’s 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, Sponsor’s 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 Invention’s 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 Sponsor’s 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, royalty-bearing 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 Sponsor’s 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 attorney’s 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 Sponsor’s 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 Institution’s 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 Institution’s 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 Institution’s 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 Sponsor’s 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 Sponsor’s 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 Sponsor’s 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 Sponsor’s; and it must be narrowly tailored to achieve Sponsor’s 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.
