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Section 1800 - Intellectual Property
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SECTION 1800 Intellectual Property ¶1801 Background and Introduction to Intellectual Property ¶1810 What Is Intellectual Property?
¶1811 Patents
¶1811.1 The Test of an Invention
¶1811.2 Barriers to Obtaining Patent Protection
¶1811.3 The Patent Application Process
¶1811.4 The Parts of a Patent Application
¶1811.5 Application Review
¶1811.6 Provisional Patent Applications ¶1812 Copyright
¶1813 Software
¶1814 Trademarks
¶1815 Other Intellectual Property
¶1815.1 Mask Works
¶1815.2 Biomaterials
¶1815.3 Trade Secrets ¶1820 Intellectual Property and Federal Grants: Governing Regulations
¶1821 Costs for Obtaining Patents and Copyrights ¶1822 Bayh-Dole (Patent Rights)
¶1822.1 Disclosure/Notification Requirements
¶1822.2 Interagency Edison ¶1823 Rights in Data (Copyrights)
¶1825 Biomaterials ¶1830 Protecting Government Rights in Nonfederal Agreements
¶1831 Agreements With Foundations and Other Nonprofit Organizations
¶1832 Agreements With Commercial Concerns
¶1833 Material Transfer Agreements
¶1834 Consulting Agreements ¶1840 Commercializing Intellectual Property
¶1841 Technology Assessments
¶1842 Licensing Agreements
¶1842.1 Traditional Licensing Arrangements
¶1842.2 Licensing Agreements With Equity
¶1842.3 Income Distribution ¶1843 Confidentiality Agreements ¶1850 Conflicts of Interest ¶1860 The Institution's Intellectual Property Policy
¶1861 Intellectual Property Policy
¶1861.1 Coverage
¶1861.2 Scope of Intellectual Property
¶1861.3 Use of Institutional Resources
¶1861.4 Royalty Distribution
¶1861.5 Intellectual Property Assignments
¶1861.6 Administrative Mechanics ¶1862 Employee Intellectual Property Assignments ¶1870 Useful References
Footnotes ¶1801 Background and Introduction to Intellectual Property One of the most important responsibilities for the college and university research administrator is the preservation of intellectual property rights for their faculty, their institutions, and the federal government. That focus on preserving and utilizing the intellectual property rights attached to their federally funded research has gained in intensity due to several factors:
the passage of the Bayh-Dole patent legislation in the early 1980s, which allowed institutions to retain title to inventions made with federal funding;
the use of computers and computer software to facilitate the development of new products and services as well as to further scientific discoveries; and
the availability of new materials, including ceramics, optics, and biologicals to name but a few.
The Bayh-Dole legislation gave rise to formal intellectual property and licensing offices in colleges and universities, whose primary function is the commercialization of the results of research. This emphasis has paid off for the institutions and for the economy in general. The Association of University Technology Managers reports in its AUTM U.S. Licensing Activity Survey Summary: FY2009 that the commercialization of academic research during FY 2009 resulted in 658 new commercial products, 5,328 total license and options, 596 new companies, and $53.9 billion total sponsored research expenditures. Examples of innovations from colleges and universities include the recombinant DNA technique, digital signal processing, various antibiotics and artificial joints, as well as computer processing and microprocessor developments. While not all of these innovations have been developed with federal funds, federal funds have contributed significantly to many recent discoveries and inventions. This section has been written to give the college or university research administrator an understanding of intellectual property principles and the issues relating to intellectual property and technology transfer as well as guidance in the appropriate handling of intellectual property generated as a result of federal grants.
NIH has launched the electronic Research Materials catalog (eRMa) to provide access to unpatented materials developed by government-funded investigators and streamline the licensing process. For nonprofit research organizations interested in obtaining NIH materials through a material transfer agreement, NIH also launched the Transfer Agreement Dashboard in December 2011. Both activities are the work of the NIH Office of Technology Transfer, which “manages the patenting and licensing of the wide range of inventions made by NIH and FDA scientists.”
[Return to Section Table of Contents]
¶1810 What Is Intellectual Property?
New creations, regardless of whether they are written compositions, new processes, computer software or chips, new chemical compounds, music, or even new forms of plants or animals, are all considered intellectual property. From a legal standpoint, intellectual property consists of
related proprietary matters.
At colleges and universities, the intellectual property protection and commercialization usually focus on patents and copyrights, with patents receiving the most attention.
¶1811 Patents A patent is a grant from the federal government that allows the holder of the patent to exclude others from using inventive methods or material for a certain period of time. On July 31, 1790, Samuel Hopkins was issued the first patent for a process of making potash, an ingredient used in fertilizer. The patent was signed by President George Washington.
In the United States, the term of a patent is twenty years from the date a patent application is filed. In return for the grant from the government, the patent holder must disclose the invention to the public through the publication of the patent.
Patents are legally defined as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." Examples of patentable inventions include the following:
new compounds or new uses of existing compounds;
new devices;
new life forms including plants and animals;
novel computer systems and software; and
methods of making and using genetically engineered products, including the products themselves.
The United States Patent and Trademark Office (PTO) manages and administers the patent process.
On September 16, 2011, President Obama signed the Leahy-Smith America Invents Act (AIA). It is the first major overhaul of the U.S. patent system in almost 60 years. Some of the key provisions relating to the law are discussed below. The goals of patent reform were as follows:
Encourage innovation and job creation
Support USPTO's efforts to improve patent quality and reduce backlog
Establish secure funding mechanism
Provide greater clarity around patent rights
Provide less costly, time-limited administrative alternatives to litigation
America Invents Act Website
Section 3 of the AIA amends the patent laws to
Convert the U.S. patent system from a “first to invent” system to a “first inventor to file” system; Treat U.S. patents and U.S. patent application publications as prior art as of their earliest effective filing date, regardless of whether the earliest effective filing date is based upon an application filed in the United States or in another country; Eliminate the requirement that a prior public use or sale be “in this country” to be a prior art activity; and Treat commonly owned or joint research agreement patents and patent application publications as being by the same inventive entity for purposes of novelty, as well as nonobviousness.
The change to a “first-inventor-to-file” versus a “first-to-invent” system was a major change in U.S. patent law and better aligned U.S. law with the law in much of the rest of the world (which is a “first to-file” system). This provision took effect March 16, 2013, with final regulations published February 14, 2013, as amended on March 14, 2013.
According to the USPTO, this provision provides the following:
Priority to a patent is based on the first inventor to file a patent application for a claimed invention and not the first to invent the claimed invention. An inventor has a one-year grace period within which to publically disclose an invention before filing a patent application. The scope of prior art to be applied against a claimed invention is simplified and broadened. The AIA also increases share of royalties retained by universities under the Bayh-Dole Act (see ¶1822) for federally funded inventions and repeals provisions pertaining to statutory invention registrations, effective March 16, 2013.
The USPTO is revising the rules of practice in patent cases for consistency with, and to address the examination issues raised by, the changes in section 3 of the AIA. Regulations on Examination Guidelines were also published on February 14, 2013.
The key to determining whether something is patentable is to meet the three-pronged test of an invention:
it must have utility; and
What Do These Tests Mean? Novelty is easy  the invention must be new; no one else has done this before. An invention of a new machine, for example, would be novel. A reiteration of an existing machine would probably not fulfill novelty requirements.
Utility is also easy  the invention must have some usefulness. Utility was an issue a number of years ago when the National Institutes of Health attempted to seek patent protection for a number of gene fragments it had discovered; in the patent application, they were unable to prove utility  it was obvious that the gene fragments were newly discovered, but there was no known use for them, and the patent application was denied.
Obviousness is much more difficult. Obviousness means that an invention is not obvious to one skilled in the field in which the invention is obtained. This means that an invention should not simply be an extension of what has been previously discovered, but rather, it must be something that is truly new and not anticipated. For example, if the next logical step to someone versed in the field of the invention would be to develop that invention, then it is obvious and not patentable.
¶1811.2 Barriers to Obtaining Patent Protection Protecting an invention through a patent is not always easy. Many barriers must be overcome prior to receiving a patent. The following paragraphs discuss some of the issues that arise when patent protection is sought. Important AIA Documents
First-Inventor-to-File Rules Correction (March 14, 2013) (corrections)
First-Inventor-to-File Final Rules (February 14, 2013)
First-Inventor-to-File Final Guidance (February 14, 2013)
First-Inventor-to-File FAQs
Enabling Disclosure and Foreign Patents. In the United States, there is a grace period of one year to file for patent protection once an "enabling disclosure" of the invention is made. An enabling disclosure is a written publication that describes the invention in sufficient detail that a person of ordinary skill in that area could reproduce and practice the invention without an unreasonable amount of difficulty. Under U.S. law, oral disclosures, even if they are presented with visual materials, typically are not considered "enabling publication."
However, the "enabling disclosure" creates a conflict if foreign patent protection is sought because publication immediately precludes filing of patents outside of the United States. The obvious solution to the differing disclosure times between the United States and foreign countries is to file a U.S. patent application prior to making any publication. Filing a full U.S. application provides an applicant with twelve months to file in most non-U.S. countries without losing filing rights. The PTO also instituted a provisional patent application (see ¶1811.6) that may preserve the foreign patent rights before the time-consuming full scale patent application is submitted. Because there have been some issues concerning the acceptability of provisional applications by some foreign countries. It is probably best to consult a patent attorney with respect to foreign publication rights and provisional applications.
Grant Proposals as Enabling Disclosure Academic researchers need to be aware that describing
inventions in grant proposals may be considered a form of enabling publication,
because, among other reasons, funded grant applications are subject to federal
Freedom of Information Act requests; consequently, they are available to the
public and disclosed. The case law with respect to grant proposals is somewhat
sparse, but an inventor needs to be aware of the possibility that his/her grant
proposal could be considered enabling disclosure. Marking the specific areas of
the proposal as confidential and proprietary may make a difference in whether
the grant proposal would be considered enabling disclosure.
Who is an Inventor? Determining who is an inventor is crucial to obtaining a valid patent. Inventorship is very different from academic practices of authorship. To be considered an inventor, one must have made independent inventive contributions. Under patent law, this means "the formation in the mind of the inventor of a definite and permanent idea of the complete and operative intention as it is thereafter to be applied in practice." There can be co-inventors, with the criteria for inventorship being the same for each. Persons who simply test an inventive concept or build in response to design schematics are not considered inventors because they made no independent contribution to the idea. Likewise, naming someone as an inventor as a way of recognition or reward is inappropriate because those individuals are not innovators as defined by law.
One issue that often arises at colleges and universities is the inventor status of graduate students. Here the law of inventorship must be applied as stringently as in any other case. If the graduate student truly made innovative contributions, the student must be recognized as a co-inventor.
The issue of inventorship is important because including individuals who are not inventors or excluding individuals who are inventors can cause an invalidation of a patent. Because the determination of inventorship is sometimes very difficult and can cause problems for the college or university administrator, it is probably wise to leave the legal determination of inventorship to the institution's patent counsel.
Date of the Invention. The date of the invention is a fact that the Patent Office will use to determine whether a patent should be issued on a particular invention. Detailed record keeping is crucial to the establishment of the invention's date. It also is critical in interference proceedings brought by another party who believes it may have made the invention first. Inventors should use bound notebooks with consecutively numbered pages and record the invention in as complete a description as possible. Entries should be made in ink and should be signed and dated. A person who has read and understands the material should witness these entries.
While some scientists keep their research records on computer, this practice can be problematic in establishing the various dates surrounding an invention. One solution used by scientists who prefer computerized record keeping is to print the electronic entries each week, sign and witness them, and file them for reference. Another approach to electronic entries might be a "time stamping" program that automatically dates the entry. With the advent of write-only CDs, it is possible to store records electronically without concern that these will be altered. The important thing with respect to electronic records is to have an indisputable means of time stamping in case of a patent interference action.
¶1811.3 The Patent Application Process The enabling disclosure of a patentable invention is the first step in securing a patent (see ¶1811.2). Once this disclosure is made, a patentability search is performed. This typically consists of a review of all patents issued, published foreign patent applications, and all other relevant literature. The United States Patent and Trademark Office (PTO) has a searchable database for patents and for patent applications. Important
U.S. Patent and Trademark Office Web site, www.uspto.gov, makes all the patent forms available in .pdf format. Before submitting any form to the PTO, be sure you have the most up-to-date version. With information from the patentability search, the enabling disclosure, and supplemental information from the inventor, a patent application is drafted, typically by a patent attorney. Most colleges and universities retain outside patent counsel who draft, file, and prosecute patent applications although there are some who use in-house attorneys for these actions. The PTO now has an electronic filing system (EFS) for certain types of patents and patent actions.
Once the patent application has been completed, it is filed with the PTO. The filing must include a transmittal form (e.g., Form PTO/SB/05) or letter identifying the applicant, the type of application, the title of the invention, the applications contents, and a listing of all accompanying enclosures. The filing fee also must be enclosed. Form PTO/SB/17 should be used to calculate the fee and indicate the method of payment.
Section 3 of the AIA amends the patent laws to convert the U.S. patent system from a “first to invent” system to a “first inventor to file” system; treat U.S. patents and U.S. patent application publications as prior art as of their earliest effective filing date, regardless of whether the earliest effective filing date is based upon an application filed in the United States or in another country; eliminate the requirement that a prior public use or sale be “in this country” to be a prior art activity; and treat commonly owned or joint research agreement patents and patent application publications as being by the same inventive entity for purposes of novelty, as well as nonobviousness (see ¶1811). ¶1811.4 The Parts of a Patent Application A full patent application consists of a number of parts:
the specifications, including the claims;
the inventors' oath that they have made the invention; and
documents that assign the invention to the institution.
Specifications. The first part of the application is the specifications including one or more "claims." The specifications are a written description of the invention, including how it is made and how it is best-practiced (i.e., utilized by the end user). The specifications are necessary because once a patent is granted, the owner of the patent has the right to exclude others from using an invention unless they obtain a license in return for disclosing the invention in full. The specification must be written such that a person who is ordinarily skilled in the area of the invention could reproduce it; in essence, an issued patent teaches one skilled in the area how to make the invention. According to the Patent Office instructions, the following headings should be included in the Specifications section in uppercase letters without boldface type or underlining and must be addressed in the sequence provided:
Reference to a Microfiche Appendix (if relevant)
Brief Description of the Several Views of the Drawing (if relevant)
Claims. The claims are the essential elements of the invention and describe its specific features. Claims generally range from very general to very specific, and when the U.S. Patent and Trademark Office reviews the application, the claims are the key to whether the patent is granted. In this section, any prior art also is disclosed and commented upon in light of the invention for which protection is being sought. Prior art comprises publications or any other information that is related to the specific invention; this could mean previous work by the inventor or others that led up to the invention.
Drawing. The second part of a patent application is the drawing, where necessary. For example, in an invention of a machine, specific drawings are necessary. Obviously, when an invention is a biological, drawings are not produced.
Oath by the Inventors. Another part of a patent application is the oath by the inventors that they have made the invention. The oath must be signed by all the actual inventors. The Patent Office provides forms for the oath, PTO/SB/01 and PTO/SB/02.
Assignment. Documents that assign the invention to the institution also are included in the patent application.
Once a patent application is filed, a PTO patent examiner reviews it for the three-prong patent test  utility, novelty, non-obviousness  and for the enabling disclosure (the specifications and claims). Correspondence will likely take place between the PTO patent examiner and the patent attorney about the application; these are referred to as "office actions." Typically, the first office action rejects most or all of the claims and stipulates very general reasons such as obviousness or existence of prior art. Within the allowed three-month response time, the patent attorney then replies and may adjust the claims or add additional information in order for the examiner to accept them. There can be many office actions and responses resulting in a time span ranging from a few months to several years prior to the granting of a patent. Once the patent is granted, it is published, and enforcement rights can be utilized. See http://www.uspto.gov/patft/help/images.htm for examples of patent grants.
Seeking patent protection is an expensive and time-consuming business. In the United States, it is not uncommon to spend between $30,000 to $50,000 in the course of three to five years to secure a patent. Foreign filings are even more costly  in most cases, in excess of $100,000. Annual maintenance fees just to keep patents active can be thousands of dollars. Patent Process Overview (Reprinted from the U.S. PTO) Step 1: Applicant - Has your invention already been patented? Search the Patent Full-Text and Full-Page Image Databases
Step 2: Applicant - What type of Application are you filing? Design Patent (ornamental characteristics)
Utility Patent (most common) (useful process, machine, article of manufacture, composition of matter) Step 3: Applicant - Determine Filing Strategy File Globally?
Need international protection? File in U.S.? - continue to Step 4
Step 4: Applicant - Which type of Utility Patent Application to file? Provisional or Nonprovisional Step 5: Applicant - Consider expedited examination Prioritized Examination Accelerated Examination Program First Action Interview Patent Prosecution Highway Step 6: Applicant - Who Should File? File yourself (Pro Se) Use a Registered Attorney or Agent (Recommended)
Step 7: Applicant - Prepare for electronic filing Determine application processing fees Apply for a Customer Number and Digital Certificate Step 8: Applicant - Apply for Patent using Electronic Filing System as a Registered e-Filer (Recommended) About EFS Web Step 9: USPTO - USPTO examines application Check Application Status Allowed?
Yes, go to Step 12 No, continue to Step 10
Step 10: Applicant - Applicant files replies requests for reconsideration, and appeals as necessary
Step 11: USPTO - If objections and rejection of the examiner are overcome, USPTO sends Notice of Allowance and Fee(s) due
Step 12: Applicant - Applicant pays the issue fee and the publication fee
Step 13: Applicant - Maintenance fees due 3 1/2, 7 1/2, and 11 1/2 years after patent grant Download the Utility Patent Application Guide According to the USPTO, under the AIA, prior art disclosures made publicly available one year or less before the effective filing date can be overcome by applicant showing (1) the prior art disclosure was by another who obtained the disclosed subject matter from the applicant (a deriver), or (2) the applicant or a deriver publicly disclosed the subject matter before the date of the prior art disclosure.
A prior disclosure of the invention which is publicly available more than one year before the effective filing date of an application continues to be a statutory bar. Prior public use or sale is no longer limited to the United States. For prior art purposes, U.S. patents and patent application publications are available as prior art as of any foreign priority date, provided that the subject matter being relied upon is disclosed in the foreign priority application.
Applicants can now rely on common ownership or joint research agreement provisions to overcome rejections.
¶1811.6 Provisional Patent Applications
A relatively new option in filing for patent protection is the provisional application. This method was designed as a low-cost option to provide protection for U.S. inventors in foreign countries. Once a full patent application is filed in the United States, it protects the loss of patent rights due to enabling disclosure in foreign countries for a period of one year. The provisional application does not require formal patent claims, oaths or declarations, or prior art statements. The provisional application is valid for up to one year; within that time, a formal patent application must be filed for the invention to be considered for an application for grant of patent.
In its discussion of provisional patent applications, the PTO advises applicants to make the disclosure of the invention as complete as possible, to name all inventors in the application, and not to make amendments to provisional applications. Because of the limitations inherent in the provisional application, it has not been filed often. However, when enabling disclosure, such as publication of an article in a journal, is imminent, the provisional application is certainly an "invention-saving" option for colleges and universities. ¶1812 Copyright Copyright is a protection provided to the authors of "original works of authorship." These works include literary, dramatic, musical, artistic, and certain other works, such as computer software, both published and unpublished. Under the 1976 Copyright Act, the owner of a copyright has the exclusive right to reproduce the copyrighted work, to prepare derivative works, to distribute copies of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
Unlike inventions, copyright protection is obtained the moment a work is produced. For example, once something is put down in writing, the author automatically has copyright. Only if the owner of the work wants the right to sue others for infringement does the owner need to file for formal copyright protection with the Library of Congress. The fee for filing a copyright application is nominal.
Under copyright law, the copyright is the property of the author who created the work. However, there is a concept in the law called "work-for-hire." Under the copyright law a work made for hire is defined as (1) a work produced by an employee within the scope of his or her employment, or (2) a work specifically ordered or commissioned for use. The parties must expressly agree in writing that the work shall be considered a work-for-hire. This is particularly true in the case of a non-employee, although many institutions require at least acquiescence of institutional copyright ownership at the time of employment. Because institutional assertion of ownership of copyrights is typically limited (see ¶1861, Scope), colleges and universities need to take particular care in the case of faculty.
Notice of copyright is no longer required under U.S. copyright law, but it is always a good idea to place the copyright notice on the work. According to the United States Copyright Office, visual copies should contain the following elements of notice:
the symbol © or the word "Copyright;"
Consequently, a typical copyright notice would be © 2001 XYZ University.
For works created on or after January 1, 1978, protection is for a term of the author's life plus an additional 70 years. In works-for-hire, the duration is 95 years from publication or 120 years from creation, whichever is shorter.
Like patents, when the copyright is to be held by the institution, the appropriate institutional office files for copyright protection. Unlike patents, there are specific forms used in applications for copyright. The time it takes to obtain copyright approval from the Copyright Office is much shorter than the time it takes to obtain a patent — generally a couple of months if the application is complete when submitted. ¶1813 Software Computer software may be protected either through a patent, a copyright, or both. More often than not, computer software is protected through copyright, but there are instances when a patent is more appropriate. For example, when the software is built around an algorithm, patenting is an appropriate avenue of protection. Patents provide protection from independent discovery of others, and infringement is much more difficult in the legal sense than with copyright protection.
A trademark is a word, name, symbol, or device used to indicate the source of a product and to distinguish it from the products of others. A subset of trademarks is a servicemark; the only difference is a servicemark is used to indicate a service rather than a product. Trademark rights may be used to prevent others from using similar marks. Trademarks require registration with the Patent and Trademark Office.
In most colleges and universities, trademarks generally are associated with the name or mascot of an institution; these are referred to as insignias. By trademarking the name or mascot, institutions then can market these on items such as T-shirts and coffee mugs. For example, an institution may enter into a licensing arrangement with a clothing manufacturer and receive royalties on each article sold.
In some instances, trademarks have been used to protect a particular association with a college or university invention or other intellectual property. Examples of trademarks used with patents developed at colleges and universities include the Lycos® Search Engine (Web software) and Taxol® (cancer therapy).
While patents, copyrights, and trademarks are the most common types of intellectual property, college and universities also may file for other types of intellectual property depending upon the nature of the item for which the institution seeks protection.
A mask work is defined in the Semiconductor Chip Act of 1984 as a series of related images representing a predetermined, three-dimensional pattern of metallic, insulating, or semiconducting layers of a semiconductor chip product. This is a unique type of intellectual property that can be protected through registration with the United States Copyright Office. Unlike copyright, however, an application, which consists of a completed Form MW, a filing fee, and a copy of the identifying material, must be filed to obtain protection, and that application must be filed within two years after the date on which the mask work is commercially exploited. Mask work protection extends for ten years. Registration of mask works is relatively inexpensive and similar to copyright. United States Copyright Office Publication 100, Federal Statutory Protection for Mask Works, outlines the requirements and the process to copyright mask works. ¶1815.2 Biomaterials
The product of university biological research is often the development of a new biomaterial, such as a cell line, a hybridoma, or a transgenic animal. Protection of biomaterials can be accomplished through patents, but these are generally expensive when compared with the probable use of the biomaterial as a further research tool. (See ¶1811.2 regarding failure to meet the utility test.) As a result, institutions are generally very selective on the patenting of biomaterials. Many times, the biomaterial is used to discover the commercial potential of another material or idea. Biomaterials also are used as research tools by other scientists either at other universities or colleges or in the commercial world.
¶1815.3 Trade Secrets
Even though trade secrets are a form of intellectual property, licensing probably is not a particularly viable option. Trade secrets also may seem an anathema to the open nature of a college or university environment; however, there may be instances when an institution chooses to keep "how-to" information private. For example, it may be that the discovery is unpatentable but remains commercially viable.
¶1820 Intellectual Property and Federal Grants: Governing Regulations
When intellectual property is developed under federal grants, the federal government typically retains rights to the use of that property. Under general principles, the government has the right to use the intellectual property on its own behalf and to authorize others to use the intellectual property when doing something for the government.
OMB Circular A-110 (2 CFR Part 215) The government's rights regarding patents, copyrights, and other forms of intellectual property (referred to as "intangible property") and the college's or university's responsibilities are stipulated in OMB Circular A-110 (2 CFR Part 215). Subpart A, __.2(s) of A-110 defines intellectual property as "…not limited to, trademarks, copyrights, patents, and patent applications..." Subpart C, __.36 sets forth the government rights in intangible (intellectual) property developed under federal grants as well as the grantee's rights and requirements. New Grants Management Guidance
The Office of Management and Budget (OMB) published final guidance on grants management reforms in the December 26, 2013, Federal Register. This guidance supersedes, streamlines, and consolidates requirements from OMB Circulars A-21, A-87, A-110, and A- 122 (2 CFR Parts 220, 225, 215, and 230); Circulars A-89, A-102, and A-133; and the guidance in Circular A-50 on Single Audit Act follow-up.
The guidance is codified at Title 2, part 200 of the Code of Federal Regulations. These requirements apply to new awards or new funding increments to existing awards issued “on or after” December 26, 2014. Section 200.59 defines intangible property as “property having no physical existence, such as trademarks, copyrights, patents and patent applications and property….” Section 200.315 sets forth the government rights in intangible (intellectual) property developed under federal grants as well as the grantee's rights and requirements, which are largely in keeping with the principles embodied in Circular A-110 for colleges and universities. When intellectual property is developed under federal grants, the federal government typically retains rights to the use of that property. Under this general principle, the government has the right to use the intellectual property on its own behalf and to authorize others to use the intellectual property when doing something for the government.
According to 2 CFR §200.315(a), title to intangible property “acquired under a Federal award vests upon acquisition in the non-Federal entity. The non-Federal entity must use that property for the originally-authorized purpose, and must not encumber the property without approval of the Federal awarding agency.” When no longer needed for the originally authorized purpose, disposition of the intangible property must be disposed of in keeping with the requirements surrounding use of equipment (2 CFR §200.313(e)).
¶1821 Costs for Obtaining Patents and Copyrights The Office of Management and Budget (OMB) published final guidance on grants management reforms in the December 26, 2013, Federal Register. This guidance supersedes, streamlines, and consolidates requirements from OMB Circulars A-21, A-87, A-110, and A- 122 (2 CFR Parts 220, 225, 215, and 230); Circulars A-89, A-102, and A-133; and the guidance in Circular A-50 on Single Audit Act follow-up.
The guidance is codified at Title 2, part 200 of the Code of Federal Regulations. These requirements apply to new awards or new funding increments to existing awards issued “on or after” December 26, 2014.
Section 200.448 of the guidance states that the following costs related to securing patents and copyrights are allowable: Costs of preparing disclosures, reports, and other documents required by the award and of searching the art to the extent necessary to make such disclosures; Costs of preparing documents and any other patent costs in connection with the filing and prosecution of a U.S. patent application where title or a royalty-free license is required by the federal government to be conveyed to the government; and General counseling services relating to patent and copyright matters, such as advice on patent and copyright laws, regulations, clauses, and employee intellectual property agreements.
However, these costs are unallowable: Costs of preparing disclosures, reports, and other documents and of searching the art to make disclosures not required by the award; and
Costs in connection with filing and prosecuting any foreign patent application, or any U.S. patent application, where the federal award does not require conveying title or a royalty-free license to the federal government. For a discussion of royalty and related payments, see ¶1712.
¶1822 Bayh-Dole (Patent Rights)
Rights to inventions developed under federal grants by colleges and universities are governed by regulations contained in 37 CFR Part 401, Rights to Inventions Made by Nonprofit Organizations and Small Businesses. The source of the authority for and provisions of this regulation is Pub. L. 96-517 (later amended by Pub. L. 98-620), commonly known as Bayh-Dole (named after the two senators, Senator Birch Bayh of Indiana and Senator Robert Dole of Kansas, who initially sponsored the legislation). [Note: There remain occasional references by federal agencies to OMB Circular A-124. This circular preceded the codification of the Bayh-Dole legislation in 37 CFR Part 401. OMB Circular A-124 was rescinded and is no longer the applicable regulation.]
Bayh-Dole grants nonprofit organizations, including colleges and universities, and small businesses the right to elect to retain title to inventions made in whole or in part with federal funds and to grant exclusive licenses to practice the inventions made. In return for the election rights, the nonprofit or small business must meet certain reporting requirements, federal licensing provisions, and other requirements. The provisions of 37 CFR Part 401 apply to the grants of all federal agencies, except scholarships, fellowships, training, or other "educational purposes" grants. In addition, exceptions sometimes are made for national security purposes or where the government determines that greater government rights are required. The requirements of 37 CFR Part 401 are summarized in the following paragraphs.
Bayh-Dole, as codified in 37 CFR Part 401, requires the institution to make numerous disclosures and submit numerous notifications regarding the invention to the government as it goes through the patent process.
Initial Disclosure. The clock starts running on an institution's reporting requirements when the inventor (as defined in ¶1811.3) discloses, in writing, an invention to the appropriate institutional official. Within two months of such disclosure, an institution must notify the federal funding agency that sponsored the work that an invention has been made. A copy of the disclosure or other information that conveys in more detail the basic invention must accompany the disclosure. Most institutions have developed a standard form for disclosures, such as the one in Figure 1822-1 below. Institutions also are required to notify the government of any pending publication that describes the invention. Figure 1822-1 Sample Invention Disclosure Agreement
As discussed in ¶1811.2, public disclosure has an impact on the ability to obtain patent protection. Recently, the government has made available an electronic reporting system, known as Interagency Edison, for electronic submission of disclosures as well as follow-on information requirements. See ¶1822.2 for more information about Interagency Edison.
Election of Title. Within two years of disclosure of the invention to the federal funding
agency, an institution must make an election of title to the federal government in writing. This
election confirms the institution’s acknowledgment of responsibilities under the regulations,
including the requirement for due diligence in seeking legal protection of the invention and in
licensing the technology. Due diligence, in this case, means making appropriate and timely
progression in the protection of the invention and its licensing. At the time of election of title,
the government’s confirming license (i.e., the grant to the government of its nonexclusive
rights, also should be made). Figures 1822–2 and 1822–3 are examples of a letter electing title and a confirmatory license to the government. Figure 1822-2 Sample Title Election Letter
Federal Government License. While 37 CFR Part 401 grants institutions the right to own inventions created under programs receiving federal funds, the federal government must be given a "nonexclusive, nontransferable, irrevocable paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world." In practical terms, this means that while institutions may elect title to inventions, the government also will have an interest in the invention and may use the invention royalty-free, either on its own or through a government contractor. When institutions license an invention to a company for commercialization, the license should acknowledge and include the government's rights. This is also important in sponsored research agreements between a college or university and a commercial concern (see ¶1830).
"March-in Rights." The federal government always retains the right to assert a claim against an invention or resultant patent if an institution fails in its responsibilities under the regulations. Referred to as "march-in rights," this right allows the government to require a grantee to license an invention when it believes that the grantee is not taking the appropriate steps to "achieve practical application of the invention." (See 37 CFR § 401.6.) Assertion of march-in rights by the government rarely has taken place with respect to colleges and universities.
"Greater Rights." The government also has reserved for itself the right to claim "greater rights" in any inventions made under federal funds if it determines that it is in the best interests of the government to do so. In recent years, the National Institutes of Health sometimes has claimed "greater rights" in inventions. Typically, that claim has been asserted at the time of a request for proposals and is included in the listing of proposed terms of award. These greater rights have involved only those areas where an institution is a part of a government program, such as performing clinical trials on investigational new cancer drugs. For example, if an institution is only one of a number of institutions testing a large number of compounds through a federal agreement to determine their effectiveness in curing disease, the greater rights determination would prohibit one institution from asserting patent claims on a particular compound.
Patent Filings, Prosecution, and Maintenance. When an institution elects title to an invention, it assumes the responsibility to make timely filings of patent applications, domestic or foreign, or to give the government the opportunity to file timely applications, should the institution elect not to do so.
In the case of notification to the government, 37 CFR Part 401 requires a series of notifications and actions once disclosure and title election takes place. In electing title, the grantee agrees to file the initial publication within one year after election of title or prior to any statutory bars (see ¶1811.3) that would preclude patent filing. Foreign patents must be filed in appropriate time frames; if the grantee decides not to file for foreign protection, timely notice must be given to the government so that foreign applications can be filed by the government at its own discretion. For example, if an institution decides not to file a foreign application, the government must be notified at least thirty days prior to the deadline for filing the foreign application.
Reports of utilization of inventions or licensing efforts must be filed annually. These annual reports must include information on the status of development, the date of first commercial sale or use, gross royalties received, and any other data as specified by the government. There is no specific format given for the report. The advent and use of Interagency Edison (see ¶1822.2) have made this requirement easier to manage at colleges and universities because the information normally contained in a utilization report already is available in the Interagency Edison system.
Maintenance of existing patents is also a requirement of the regulations. If a grantee holding title to an invention opts not to continue maintenance of an invention, it must inform the government in a timely manner (30 days in advance of a required legal action, such as payment of maintenance fees). This allows the government to take over the patent if it so desires.
Other Institutional Requirements. In addition to the disclosure and notification requirements described above in this discussion, 37 CFR Part 401 requires a college or university to take certain steps on an institutional level to ensure compliance with the statute and to protect the government's rights.
Employee Patent Agreements. Section 401.14(f)(2) of the regulations expressly require that an organization's employees, other than clerical or nontechnical staff, must agree in writing to promptly disclose in writing any inventions made with federal funds and to execute any documents necessary to obtain patent protection. For more information on these employee agreements, see ¶1862. 37 CFR §401.414(k)(1) expressly forbids the assignment of patent titles to other entities or individuals without approval of the federal funding agency. The only exception is assignment to a firm whose specific mission is patent management, such as Research Corporation Technologies, Inc. (RCT is a company whose purpose is to exploit college and university technology through licensing and other arrangements.) A college or university administrator must be mindful of this requirement when accepting funding from other entities, including grants from nonprofit institutions, sponsored research agreements with commercial concerns, and materials transfer agreements from all sources.
Notification of Government Rights on Patent Applications. The following statement must be included in the specifications of any patent application or on an issued patent resulting from federal funding (37 CFR § 401.414(f)(4)):
This invention was made with government support under (identify grant number) awarded by (identify the federal agency). The government has certain rights in the invention. 37 CFR § 401.414(k)(2) states that royalties must be shared with inventors. The extent of such sharing is not specified; a discussion of royalty-sharing policies is included in ¶1861. In addition, the regulations require royalty and other income derived from federally funded inventions to be used for scientific research or education after expenses are paid and the appropriate royalty sharing with the inventor(s) has occurred. An institution should keep appropriate records that indicate the disposition of royalty and other licensing income. A particular quirk in federal regulation occurs in Section __.24 of OMB Circular A-110 where royalty income is included in the definition of program income but is then quickly exempted from program income reporting requirements.
Licensing Requirements. Certain requirements that directly affect the licensing of federally funded inventions also are specified in 37 CFR Part 401. For example, there is a requirement that reasonable efforts should be made to license these inventions to small businesses, as defined by federal law. Reasonable effort in licensing would consist of proactive efforts to market the technology to those small businesses. For example, a reasonable effort would be that of letting small businesses in the field of the invention know of its availability for licensing. In addition, there is a requirement that any products using the federally funded technology should be manufactured substantially in the United States; this means, where possible, products incorporating the technology should be made in the United States.
Education. Another requirement is that an institution must provide education and training for employees regarding the statutes and regulations governing the reporting of inventions and the filing and processing of patent applications. Institutions have used a wide variety of methods to comply with this requirement, including information seminars, development and dissemination of written materials, and, most recently, Web sites. Many institutions have issued manuals to inventors on recognizing a patentable invention and the steps that must be taken to protect it, including cautions on enabling disclosures.
Subawards. The provisions of Bayh-Dole must be included in any subrecipient agreement made to other nonprofit organizations, including colleges and universities, and small businesses. Typically, that is done either in a specific article of the agreement or as part of the flow down of general terms. An example of a specific clause is as follows:
Sample Clause Pursuant to Pub. L. 96-517, as amended by Pub. L. 98-620, title to any invention or discovery made or conceived under this Subagreement shall vest in Subawardee. Subawardee shall promptly notify Awardee in writing of any such inventions or discoveries. Subawardee hereby grants to Awardee a royalty-free nonexclusive license for internal research purposes only to any Subawardee invention or discovery. ¶1822.2 Interagency Edison
Interagency Edison (iEdison), which was developed by the National Institutes of Health, enables institutions and federal agencies to manage inventions electronically in compliance with the federal reporting requirements of the Bayh-Dole Act. In addition, Interagency Edison also includes features that streamline the institution's administrative tasks. While institutions are not required to use Interagency Edison, it is a useful tool and may save the institution a lot of time and help to ensure compliance. For example, reminders of reporting actions will be sent automatically to an institution and a variety of reports can be generated. Eighteen federal agencies that award grants and other assistance agreements to institutions of higher education participate in Interagency Edison; one notable exception is NASA.
Once a user registers and logs onto Interagency Edison, a number of features are instantly accessible. The user can enter and submit online a new invention disclosure, which fulfills the initial disclosure notification requirements of Bayh-Dole. After the disclosure is made, modifications may be made to the notification to update the information and add utilization information (such as licenses) and patent issuance and maintenance information. Several online forms also can be completed and printed out if written information is required. One of these is the license to the United States Government as required by Bayh-Dole (see ¶1822.1, Figure 1822-3).
In furtherance of the requirements of the Federal Financial Assistance Management Improvement Act of 1999 (Pub. L. 106-107) (see ¶2750), the government has indicated its intention to use Interagency Edison as its common system for summary invention reporting forms.
¶1823 Rights in Data (Copyrights)
With respect to copyright, OMB Circular A-110 stipulates that a grantee may copyright any work that is subject to copyright that was developed under a grant. It reserves for the federal awarding agency a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use the work for federal purposes and to authorize others to do so.
Research data also is discussed in A-110, Subpart C, Section __.36(c). In this section, the government reserves the right to obtain, reproduce, publish, or otherwise use the data first produced under an award and to authorize others to receive, reproduce, publish, or otherwise use such data for federal purposes.
New Grants Management Guidance
The Office of Management and Budget (OMB) published final guidance on grants management reforms in the December 26, 2013, Federal Register. This guidance supersedes, streamlines, and consolidates requirements from OMB Circulars A-21, A-87, A-110, and A- 122 (2 CFR Parts 220, 225, 215, and 230); Circulars A-89, A-102, and A-133; and the guidance in Circular A-50 on Single Audit Act follow-up. The guidance is codified at Title 2, part 200 of the Code of Federal Regulations. These requirements apply to new awards or new funding increments to existing awards issued “on or after” December 26, 2014. Section 200.315(d) sets forth the government rights in data developed under federal grants as well as the grantee's rights and requirements, which are largely in keeping with the principles embodies in Circular A-110 for colleges and universities. The guidance states that if the federal government requests research data relating to published research findings generated under a federal award that were used by the Federal government in developing an agency action that has the force and effect of law, the nonfederal entity must provide, within a reasonable time, the research data.
If the awarding agency obtains the research data solely in response to a FOIA request, the agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred by both the federal agency and the nonfederal entity. Published research findings means:
When research findings are published in a peer-reviewed scientific or technical journal; or
When a Federal agency publicly and officially cites the research findings in support of an agency action that has the force and effect of law. Research data means the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This ‘‘recorded’’ material excludes physical objects (e.g., laboratory samples).
Research data also do not include: Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and
Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study. ¶1824 Computer Software
¶1825 Biomaterials
If biomaterials developed under federal grants are patented, the rights of an institution are governed by 37 CFR Part 401. It is important to note that the NIH has issued strong guidance with respect to biomedical research materials used as research tools in academic institutions and industry. NIH Principles and Guidelines for Sharing of Biomedical Resources—Final, issued on December 23, 1999, intends to ensure access by scientists to research tools developed with NIH funding. NIH defines research tools as cell lines, monoclonal antibodies, reagents, animal models, combinatorial chemistry laboratories, clones and cloning tools, and databases and computer software to the extent that these are used as unique research tools. (See also the NIH Policy on Sharing of Model Organisms for Biomedical Research.)
The guidance addresses many issues including the following:
Institutions should avoid signing agreements that unduly limit the freedom of investigators to collaborate and publish.
Certain restrictions and brief delays in publications to permit patents to be filed may be acceptable.
These research materials are subject to Bayh-Dole.
Restrictive licensing could hinder research tools' utilization and public availability.
Institutions should not agree to unreasonable terms proposed by providing organizations.
Widespread distribution on a nonexclusive basis should be encouraged.
Exclusive licenses to distributors who will make the research tool widely available on reasonable terms are acceptable.
Unique research resources must be broadly and promptly available to the scientific research community in order to advance science.
In 2003, NIH has issued complimentary guidance on data sharing that reaffirms its support of the concept of data sharing to bring the results of research to the public. That policy and other NIH pronouncements on related issues can be found here under the heading "Resource Sharing."
It also should be noted that biomaterials, including research tools, developed under federal awards must be reported to the federal agency, even if they are either not eligible for patent protection or the institution, because of the nature of the materials, determines not to file for patent protection. That reporting is typically accomplished through iEdison (see ¶1822.2).
¶1830 Protecting Government Rights in Nonfederal Agreements
Research activities of faculty at colleges and universities are more than not intertwined; that is, the subject of one research project is related to another. Consequently, it is the responsibility of the college or university research administrator to make certain that the federal rights granted under 37 CFR Part 401 are protected in agreements with nonfederal entities. Typically, this is not a problem with subawards from other institutions of higher education as they are as concerned with preserving these rights as the receiving institution. However, problems may arise when an awardee is a subawardee of a commercial concern that may have accepted restrictive rights. Flow-down federal funds from state or local governments also are not usually a concern because Bayh-Dole will apply to these funds. The agreements that may be of concern are primarily with foundations and other nonprofit organizations and agreements with commercial concerns.
¶1831 Agreements With Foundations and Other Nonprofit
Organizations Grant agreements with foundations and other nonprofit organizations should be scrutinized for their patent requirements. Many of these organizations require, at a minimum, joint ownership or sometimes assignment of patents developed under grants from them. In all likelihood, this is directly contrary to Bayh-Dole. Either these agreements must be modified to meet federal requirements or an assessment should be conducted in conjunction with the researcher regarding the overlap between any federal funding a researcher has (or contemplates during the period of the private agreement) and the work scope of the private grant agreement. If there is no overlap and the nonprofit organization's terms are not contrary to institutional policy, then it may be possible to accept the terms as written.
Agreements with commercial concerns also may be problematic with respect to Bayh-Dole compliance. Many times these agreements will provide for ownership of any inventions developed as a result of the research project to vest in the company. If the research is in any way related to a faculty member's federal research projects, this is a direct violation of Bayh-Dole. Such a clause also may be in direct violation of the institution's patent policy (see ¶1860), particularly in state institutions where inventions are considered property of the state.
Research administrators who are negotiating the agreement do have alternatives that will give a company control of the invention without giving away title. For example, the patent clause could be written to provide the company with an exclusive option to license any inventions developed under the agreement. The resultant license could be nonexclusive or exclusive  this should be spelled out in the research agreement  with reasonable royalty rates. An example of such a clause appears below.
Sample Clause 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 terms of this Agreement and directly resulting from the performance of research hereunder, with the right to sublicense with accounting to University, subject only to the reservation of the rights of the Government of the United States of America, as set forth in 37 CFR Part 401. Sponsor shall have three (3) months from disclosure or any invention or discovery to notify University of its desire to enter into such a licensing agreement, and a licensing 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 licensing agreement, or such period of time as the parties shall mutually agree. Another pitfall in commercial agreements is a requirement for licenses to any background inventions. These are inventions that relate to the invention being licensed, and these may already be subject to terms of another agreement. Research administrators who negotiate these agreements must be particularly wary when background patents are addressed.
A Material Transfer Agreement (MTA) is a relatively new form of protection for intellectual property. MTAs govern the transfer of materials and related information from one entity to another. These agreements set forth the terms of use and obligations of the recipient when exchanging materials. Typically, these materials are cell lines, DNA, or chemical compounds. However, MTAs may be used for the transfer of any kind of physical material.
Materials coming into an institution from a commercial entity pose particular challenges for those reviewing and approving the accompanying MTAs. For example, assume the material being transferred is a new chemical compound that either has or is thought to have commercial value. The institutional investigator wishes to study the compound further as a part of a federally funded research project. However, the compound is the transferring company's proprietary data and may or may not be the subject of patent protection. Because of the potential or real commercial value of the material, the MTA may contain intellectual property terms that are onerous and sometimes unacceptable in the context for which they are being used. In addition, some MTAs require certain terms of confidentiality that may preclude publication of academic works.
Why are intellectual property and confidentiality terms a problem in MTAs? The conflict between the transferring company's interests as reflected in the MTA and the investigator's research project are clear. Typically, materials are being used at colleges and universities in conjunction with federally supported research projects. An MTA that requires any patents developed using the transferred materials to remain the property of the supplying entity causes a direct conflict with the Bayh-Dole requirement that grants the government a royalty-free license. Confidentiality provisions without the right to disseminate information infringe directly on the institution's obligation to disseminate the results of academic research. This can put the institution in a difficult position. On one hand, the institution is trying to protect the rights of its faculty investigator to pursue his/her research freely and publish the findings; on the other hand, if an agreement cannot be reached to transfer the material to the faculty investigator, there will be nothing to publish. The key for the college or university research administrator is to try to negotiate terms that will be mutually satisfactory to all parties and do not infringe on Bayh-Dole requirements.
In an effort to facilitate the exchange of research materials, the Public Health Service issued a standard Uniform Biological Materials Transfer Agreement (UBMTA) in 1995 (see Figure 1833-1 below). The UBMTA was developed specifically for the transfer of biological materials; however, there is no reason that it could not be adapted for transfer of other materials as well. The UBMTA now is used widely by academic institutions transferring materials to another academic institution; however, it has had less acceptance from commercial firms. Figure 1833-1 Uniform Biological Materials Transfer Agreement
Master Agreement Regarding Use of the Uniform Biological Material Transfer Agreement (dated March 8, 1995)
Upon execution of an Implementing Letter in the form attached, which specifies the materials to be transferred, this organization agrees to be bound by the terms of the attached Uniform Biological Material Transfer Agreement (“UBMTA”) published in the Federal Register on March 8, 1995.
Organization: _________________________________________________ Address: _____________________________________________________
Authorized Official: _____________________________________________
Please return an executed copy of this Master Agreement to: The UBMTA Project, Association of University Technology Managers (AUTM), 60 Revere Drive, Suite 500, Northbrook, IL 60062. AUTM will be maintaining signed originals and the official list of signatory organizations. I. Definitions:
1.	PROVIDER: Organization providing the ORIGINAL MATERIAL. The name and address of this party will be specified in an implementing letter. 2.	PROVIDER SCIENTIST: The name and address of this party will be specified in an implementing	letter. 3.	RECIPIENT: Organization receiving the ORIGINAL MATERIAL. The name and address of this party will be specified in an implementing letter. 4.	RECIPIENT SCIENTIST: The name and address of this party will be specified in an implementing letter. 5.	ORIGINAL MATERIAL: The description of the material being transferred will be specified in an implementing letter. 6.	MATERIAL: ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES. The MATERIAL shall not include: (a) MODIFICATIONS, or (b) other substances created by the RECIPIENT through the use of the MATERIAL which are not MODIFICATIONS, PROGENY, or UNMODIFIED DERIVATIVES. 7.	PROGENY: Unmodified descendant from the MATERIAL, such as virus from virus, cell from cell, or organism from organism. 8.	UNMODIFIED DERIVATIVES: Substances created by the RECIPIENT which constitute an unmodified functional subunit or product expressed by the ORIGINAL MATERIAL. Some examples include: subclones of unmodified cell lines, purified or fractionated subsets of the ORIGINAL MATERIAL, proteins expressed by DNA/RNA supplied by the PROVIDER, or monoclonal antibodies secreted by a hybridoma cell line. 9.	MODIFICATIONS: Substances created by the RECIPIENT which contain/incorporate the MATERIAL. 10.	COMMERCIAL PURPOSES: The sale, lease, license, or other transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. COMMERCIAL PURPOSES shall also include uses of the MATERIAL or MODIFICATIONS by any organization, including RECIPIENT, to perform contract research, to screen compound libraries, to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. However, industrially sponsored academic research shall not be considered a use of the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES per se, unless any of the above conditions of this definition are met. 11.	NONPROFIT ORGANIZATION(S): A university or other institution of higher education or an organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute. As used herein, the term also includes government agencies. II. Terms and Conditions of this Agreement:
1.	The PROVIDER retains ownership of the MATERIAL, including any MATERIAL contained or incorporated in MODIFICATIONS. 2.	The RECIPIENT retains ownership of: (a) MODIFICATIONS (except that, the PROVIDER retains ownership rights to the MATERIAL included therein), and (b) those substances created through the use of the MATERIAL or MODIFICATIONS, but which are not PROGENY, UNMODIFIED DERIVATIVES or MODIFICATIONS (i.e., do not contain the ORIGINAL MATERIAL, PROGENY, UNMODIFIED DERIVATIVES). If either 2 (a) or 2 (b) results from the collaborative efforts of the PROVIDER and the RECIPIENT, joint ownership may be negotiated. 3.	The RECIPIENT and the RECIPIENT SCIENTIST agree that the MATERIAL: (a) is to be used solely for teaching and academic research purposes; (b) will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects without the written consent of the PROVIDER; (c) is to be used only at the RECIPIENT organization and only in the RECIPIENT SCIENTIST’s laboratory under the direction of the RECIPIENT SCIENTIST or others working under his/her direct supervision; and (d) will not be transferred to anyone else within the RECIPIENT organization without the prior written consent of the PROVIDER.
4.	The RECIPIENT and the RECIPIENT SCIENTIST agree to refer to the PROVIDER any request for the MATERIAL from anyone other than those persons working under the [[Page 12774]] RECIPIENT SCIENTIST’s direct supervision. To the extent supplies are available, the PROVIDER or the PROVIDER SCIENTIST agrees to make the MATERIAL available, under a separate implementing letter to this Agreement or other agreement having terms consistent with the terms of this Agreement, to other scientists (at least those at NONPROFIT ORGANIZATION(S)) who wish to replicate the RECIPIENT SCIENTIST’s research; provided that such other scientists reimburse the PROVIDER for any costs relating to the preparation and distribution of the MATERIAL. 5. (a) The RECIPIENT and/or the RECIPIENT SCIENTIST shall have the right, without restriction, to distribute substances created by the RECIPIENT through the use of the ORIGINAL MATERIAL only if those substances are not PROGENY, UNMODIFIED DERIVATIVES, or MODIFICATIONS. (b) Under a separate implementing letter to this Agreement (or an agreement at least as protective of the PROVIDER’s rights), the RECIPIENT may distribute MODIFICATIONS to NONPROFIT ORGANIZATION(S) for research and teaching purposes only. (c) Without written consent from the PROVIDER, the RECIPIENT and/or the RECIPIENT SCIENTIST may NOT provide MODIFICATIONS for COMMERCIAL PURPOSES. It is recognized by the RECIPIENT that such COMMERCIAL PURPOSES may require a commercial license from the PROVIDER and the PROVIDER has no obligation to grant a commercial license to its ownership interest in the MATERIAL incorporated in the MODIFICATIONS. Nothing in this paragraph, however, shall prevent the RECIPIENT from granting commercial licenses under the RECIPIENT’s intellectual property rights claiming such MODIFICATIONS, or methods of their manufacture or their use.
6.	The RECIPIENT acknowledges that the MATERIAL is or may be the subject of a patent application. Except as provided in this Agreement, no express or implied licenses or other rights are provided to the RECIPIENT under any patents, patent applications, trade secrets or other proprietary rights of the PROVIDER, including any altered forms of the MATERIAL made by the PROVIDER. In particular, no express or implied licenses or other rights are provided to use the MATERIAL, MODIFICATIONS, or any related patents of the PROVIDER for COMMERCIAL PURPOSES. 7.	If the RECIPIENT desires to use or license the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES, the RECIPIENT agrees, in advance of such use, to negotiate in good faith with the PROVIDER to establish the terms of a commercial license. It is understood by the RECIPIENT that the PROVIDER shall have no obligation to grant such a license to the RECIPIENT, and may grant exclusive or non-exclusive commercial licenses to others, or sell or assign all or part of the rights in the MATERIAL to any third party(ies), subject to any pre-existing rights held by others and obligations to the Federal Government. 8.	The RECIPIENT is free to file patent application(s) claiming inventions made by the RECIPIENT through the use of the MATERIAL but agrees to notify the PROVIDER upon filing a patent application claiming MODIFICATIONS or method(s) of manufacture or use(s) of the MATERIAL. 9.	Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. The PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. 10.	Except to the extent prohibited by law, the RECIPIENT assumes all liability for damages which may arise from its use, storage or disposal of the MATERIAL. The PROVIDER will not be liable to the RECIPIENT for any loss, claim or demand made by the RECIPIENT, or made against the RECIPIENT by any other party, due to or arising from the use of the MATERIAL by the RECIPIENT, except to the extent permitted by law when caused by the gross negligence or willful misconduct of the PROVIDER. 11.	This agreement shall not be interpreted to prevent or delay publication of research findings resulting from the use of the MATERIAL or the MODIFICATIONS. The RECIPIENT SCIENTIST agrees to provide appropriate acknowledgement of the source of the MATERIAL in all publications. 12.	The RECIPIENT agrees to use the MATERIAL in compliance with all applicaple statutes and regulations, including Public Health Service and National Institutes of Health regulations and guidelines such as, for example, those relating to research involving the use of animals or recombinant DNA.
13.	This Agreement will terminate on the earliest of the following dates: (a) when the MATERIAL becomes generally available from third parties, for example, though reagent catalogs or public depositories or (b) on completion of the RECIPIENT’s current research with the MATERIAL, or (c) on thirty (30) days written notice by either party to the other, or (d) on the date specified in an implementing letter, provided that:
13.	This Agreement will terminate on the earliest of the following dates: (a) when the MATERIAL becomes generally available from third parties, for example, though reagent catalogs or public depositories or (b) on completion of the RECIPIENT’s current research with the MATERIAL, or (c) on thirty (30) days written notice by either party to the other, or (d) on the date specified in an implementing letter, provided that: (i) if termination should occur under 13(a), the RECIPIENT shall be bound to the PROVIDER by the least restrictive terms applicable to the MATERIAL obtained from the then-available resources; and (ii) if termination should occur under 13(b) or (d) above, the RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the PROVIDER, return or destroy any remaining MATERIAL. The RECIPIENT, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this agreement as they apply to MODIFICATIONS; and (iii) in the event the PROVIDER terminates this Agreement under 13(c) other than for breach of this Agreement or for cause such as an imminent health risk or patent infringement, the PROVIDER will defer the effective date of termination for a period of up to one year, upon request from the RECIPIENT, to permit completion of research in progress. Upon the effective date of termination, or if requested, the deferred effective date of termination, RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the PROVIDER, return or destroy any remaining MATERIAL. The RECIPIENT, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this agreement as they apply to MODIFICATIONS. 14.	Paragraphs 6, 9, and 10 shall survive termination. 15.	The MATERIAL is provided at no cost, or with an optional transmittal fee solely to reimburse the PROVIDER for its preparation and distribution costs. If a fee is requested by the PROVIDER, the amount will be indicated in an implementing letter.
Figure 1833-2 UBMTA Implementing Letter
The purpose of this letter is to provide a record of the biological material transfer, to memorialize the agreement between the PROVIDER SCIENTIST (identified below) and the RECIPIENT SCIENTIST (identified below) to abide by all terms and conditions of the Uniform Biological Material Transfer [[Page 12775]] Agreement (“UBMTA”) March 8, 1995, and to certify that the RECIPIENT (identified below) organization has accepted and signed an unmodified copy of the UBMTA. The RECIPIENT organization’s Authorized Official also will sign this letter if the RECIPIENT SCIENTIST is not authorized to certify on behalf of the RECIPIENT organization. The RECIPIENT SCIENTIST (and the Authorized Official of RECIPIENT, if necessary) should sign both copies of this letter and return one signed copy to the PROVIDER. The PROVIDER SCIENTIST will forward the material to the RECIPIENT SCIENTIST upon receipt of the signed copy from the RECIPIENT organization.
1.	PROVIDER: Organization providing the ORIGINAL MATERIAL: Organization:________________________________________ Address:____________________________________________ 2.	RECIPIENT: Organization receiving the ORIGINAL MATERIAL:
Organization:________________________________________ Address:____________________________________________ 3.	ORIGINAL MATERIAL (Enter description):
4. Termination date for this letter (optional):_________________
5.	Transmittal Fee to reimburse the PROVIDER for preparation and distribution costs (optional). Amount:_________________.
Signature:	________________________________ Date:_____________ RECIPIENT SCIENTIST
Signature:	________________________________ Date:_____________ RECIPIENT ORGANIZATION CERTIFICATION
Authorized Official: ______________________________
Signature:	________________________________ Date:_____________ The National Institutes of Health also encourages the use of a simple letter agreement to streamline exchanges between nonprofits (see Figure 1833-3 below). Figure 1833-3 Simple Letter Agreement for the Transfer of Materials
In response to the RECIPIENT’S request for the MATERIAL [insert description]
the PROVIDER asks that the RECIPIENT and the RECIPIENT SCIENTIST agree to the following before the RECIPIENT receives the MATERIAL:
1.	The above MATERIAL is the property of the PROVIDER and is made available as a service to the research community.
2.	THIS MATERIAL IS NOT FOR USE IN HUMAN SUBJECTS.
3.	The MATERIAL will be used for teaching or non-for-profit research purposes only.
4.	The MATERIAL will not be further distributed to others without the PROVIDER’s written consent. The RECIPIENT shall refer any request for the MATERIAL to the PROVIDER. To the extent supplies are available, the PROVIDER or the PROVIDER SCIENTIST agree to make the MATERIAL available under a separate Simple Letter Agreement to other scientists for teaching or not-for-profit research purposes only.
5.	The RECIPIENT agrees to acknowledge the source of the MATERIAL in any publications reporting use of it.
6.	Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. THE PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. Unless prohibited by law, RECIPIENT assumes all liability for claims for damages against it by third parties that may arise from the use, storage, or disposal of the MATERIAL except that, to the extent permitted by law, the PROVIDER shall be liable to the RECIPEINT when the damage is caused by the gross negligence or willful misconduct of the PROVIDER.
7.	The RECIPIENT agrees to use the MATERIAL in compliance with all applicable statutes and regulations.
8.	The MATERIAL is provided at no cost, or with an optional transmittal fee solely to reimburse the PROVIDER for its preparation and distribution costs. If a fee is requested, the amount will be indicated here: ____________ [insert fee].
Th PROVIDER, RECIPIENT, and RECIPIENT SCIENTIST must sign both copies of this letter and return one signed copy to the PROVIDER. The PROVIDER will then sent the MATERIAL.
Provider Scientist: _____________________________________________
Provider Organization: _________________________________________
Name of Authorized Official: __________________________________
Title of Authorized Official: ___________________________________
Certification of Authorized Official: This Simple Letter Agreement __has/__has not [check one] been modified. If modified, the modifications are attached.
Signature of Authorized Official / Date
RECEIPIENT INFORMATION AND AUTHORIZED SIGNATURE
Recipient Scientist: _____________________________________________
Recipient Organization: _________________________________________
Name of Authorized Official: _____________________________________
Title of Authorized Official: ______________________________________
Certification of Recipient Scientist: I have read and understand the conditions outlined in this Agreement and I agree to abide by them in the receipt and use of the MATERIAL.
Because the UBMTA does not have widespread acceptance from for-profit concerns, there is no standard template used by these firms. Each agreement typically requires negotiation. Some of the issues that arise in MTAs are the following: the definition of the materials;
restrictions regarding the institution's use of the materials in funded projects;
prepublication review;
disclosure of research results; and
the legal form of the agreement itself.
¶1834 Consulting Agreements Colleges and universities typically are not parties to individual consulting agreements between faculty members and companies or other organizations. Rather, these are personal agreements made by a faculty member within the scope of an institution's consulting policy. However, the provisions of those agreements may have an impact upon an institution's ability to comply with government rights in federal agreements. The reason is that the faculty members' areas of expertise is not only why companies are interested in having them consult but also is the subject of federal awards. As is the case with other nonfederal agreements, it is difficult at times to separate out when an idea leading to an invention was conceived; was it while the faculty member was consulting or was it when the faculty member was working on his/her grant?
For this reason, many institutions ask, but do not require, to review individual consulting arrangements and urge faculty members to craft the work scope of their consulting agreements very narrowly.
¶1840 Commercializing Intellectual Property
There are many approaches that institutions take with respect to disposition of intellectual property  in particular, inventions  created by their faculty. Simply determining whether or not an invention is patentable does not mean it is commercially viable, particularly when the costs and time associated with obtaining a patent are considered. Likewise, there are certain societal pressures that are placed on institutions with respect to intellectual property licensing that also need to be considered.
In April 2007 a group of eleven research universities and the American Association of Medical Colleges developed a white paper on the topic of technology licensing. Titled "In the Public Interest: Nine Points To Consider in Licensing University Technology," its purpose is to "foster thoughtful approaches and creative solutions to complex problems that may arise when universities license technologies in the public interest and for society's benefit." The paper suggests the following nine points as core values:
Minimize the licensing of "future improvements" to avoid reducing opportunities for other funding.
Anticipate and help to manage technology transfer-related conflicts of interest.
Enforcement action should be carefully considered because litigation is seldom the preferred option for resolving disputes.
Consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics, and agricultural technologies for the developing world.
Most institutions conduct a commercial assessment as part of their determination of whether to seek patent protection. The purpose of this assessment is to determine whether there are products that can result from the invention and the value of those products in the marketplace. An invention may have tremendous scientific value but insufficient economic potential to induce a company to expend resources to develop and market the invention. Figure 1841-1 below presents a series of questions that could be used to conduct a technology assessment.
Figure 1841-1 Assessment of Technology for Commercial Viability Part 1: The Technology
Is it more than a
concept? What is the evidence
that it can work?
What is its stage of
that it is much simpler, faster, cheaper, more accurate, or better in some way
than existing technology?
Are there 
or could there be  alternative ways to achieve similar results?
products would the technology create or impact?
Part 2: Patentability
Is the technology new, useful, and not obvious (the three patent tests)?
Has it been publicly
divulged? If so, when and how?
Would patent
infringement be detectable?
Could a patent be
Would the available
patent claims protect a developer's investment in marketing a product?
Who holds the rights
to the technology?
patents necessary to derive value from the technology?
Part 3: Economic Value
What commercial needs
are addressed by this technology?
Will it create a new
market or is it an improvement on an existing product?
current and future markets?
incorporate the technology will be needed to satisfy market demand, both now
What competes with the
proposed product?
advantages of the proposed product?
difference between the manufacturing cost and the price for which the product
Part 4: Risk Factors
Will a licensee or
other investor find this technology more attractive than other investments?
What are the legal,
regulatory, and physical barriers to market entry?
Can the technology be
scaled up or proven safe and effective in the anticipated end use?
How much financial
commitment is necessary to bring the technology to market?
Are there sources of
capital to develop technologies in this scientific area?
How much time will be
needed to bring a product to market?
[Note: The material in Figure 1841-1 is extracted, with permission, from materials prepared by Research Corporation Technologies, Inc.]
If the result of the assessment is that protection and commercialization of the intellectual property should continue, then the institution, in addition to seeking legal protection, typically will begin the search for a company (or licensee) to commercialize the technology. If the result of the assessment is negative, the institution generally will decline to move forward and, in the case of a federally funded invention, will notify the government that it will not pursue protection and will decline to elect title. At that time, it is possible for the inventor to request title from the government. ¶1842 Licensing Agreements A licensing agreement is the standard vehicle to transfer intellectual property rights to industry for the purpose of commercialization. These agreements stipulate the terms and conditions under which the commercial concern has the right to use the intellectual property being transferred.
In most cases, intellectual property rights are transferred to a commercial concern through a traditional licensing agreement; that is, in return for royalties and other payments, the company will have the right to exclusively or nonexclusively make, use, or sell (or cause others to do the same through sublicense arrangements) the intellectual property that is the subject of the agreement. (See Figure 1842-2 for an example.) Licensing agreements differ greatly and are dependent upon the intellectual property rights that are being transferred and the length and type of the agreement. The following are the typical clauses that appear in a standard licensing agreement:
scope of license consideration (e.g., royalties, other payments)
protection of federal government interests
general clauses found in most legal documents (such as legal jurisdiction, force majeure, severability)
It is important to include the requirements of Bayh-Dole, where applicable, in any licensing agreement that involves the licensing of technology developed under federal agreements. For example, the rights of the government should be recognized and there should be a substantial U.S. manufacturing clause. See 37 CFR Section 401.14 for a list of standard Bayh-Dole contract clauses and Section 404, Licensing of Government-Owned Inventions.
Figure 1842-2 Patent License Agreement
THIS Agreement is between the (institution), whose address is address, (“University”) and (name of licensee), a (state of incorporation) corporation having a principal place of business located at (licensee address) (“Licensee”).
RECITALS 1. EFFECTIVE DATE 2. DEFINITIONS 3. WARRANTY, SUPERIOR RIGHTS AND REPRESENTATIONS
4. LICENSE 5. PAYMENTS AND REPORTS
6. COMMON STOCK AND EQUITY OWNERSHIP
12. USE OF UNIVERSITY AND COMPONENT’S NAME
14. PATENTS AND INVENTIONS 15. ALTERNATE DISPUTE RESOLUTION
A. University owns certain Patent Rights and Technology Rights related to Licensed Subject Matter.
B. University desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, Inventor, University, and the public as outlined in University’s Intellectual Property Policy. C. Licensee wishes to obtain a license from University to practice Licensed Subject Matter. NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the parties agree as follows:
This Agreement is effective _____________________ (“Effective Date”).
2.1 “Affiliate” means any business entity more than 50% owned by Licensee, any business entity that owns more than 50% of Licensee, or any business entity that is more than 50% owned by a business entity that owns more than 50% of Licensee. 2.2 “Licensed Field” means ____________________.
2.3 “Licensed Product” means any product Sold by Licensee comprising Licensed Subject Matter pursuant to this Agreement.
2.4 “Licensed Subject Matter” means inventions and discoveries covered by Patent Rights or Technology Rights within Licensed Field.
2.5 “Licensed Territory” means the ____________________.
2.6 “Net Sales” means the gross revenues received by Licensee from the Sale of Licensed Products less sales and/or use taxes actually paid, import and/or export duties actually paid, outbound transportation prepaid or allowed, and amounts allowed or credited due to returns (not to exceed the original billing or invoice amount).
2.7 “Patent Rights” means University’s rights in information or discoveries covered by patents [and/or patent applications], whether domestic or foreign, and all divisions, continuations, continuations-in-part, reissues, reexaminations or extensions thereof, and any letters patent that issue thereon, which name__________________ as either sole or joint inventor (“Inventor”) and which relate to the manufacture, use or sale of ______________________. [Delete “and/or patent applications” if none at this time]
2.8 “Sale or Sold” means the transfer or disposition of a Licensed Product for value to a party other than Licensee. 2.9 “Technology Rights” means University’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, software, designs, drawings or data created by _______________ (Inventor) at University before the Effective Date relating to _____________________ which are not covered by Patent Rights but which are necessary for practicing the invention covered by Patent Rights. 3. WARRANTY: SUPERIOR-RIGHTS
3.1 Except for the rights, if any, of the Government of the United States, as set forth below, University represents and warrants its belief that (i) it is the owner of the entire right, title, and interest in and to Licensed Subject Matter, (ii) it has the sole right to grant licenses thereunder, and (iii) it has not knowingly granted licenses thereunder to any other entity that would restrict rights granted to Licensee except as stated herein.
3.3 Licensee understands and acknowledges that University, by this Agreement, makes no representation as to the operability or fitness for any use, safety, efficacy, and ability to obtain regulatory approval, patentability, and/or breadth of the Licensed Subject Matter. University, by this Agreement, also makes no representation as to whether there are any patents now held, or which will be held, by others or by University in the Licensed Field, nor does University make any representation that the inventions contained in Patent Rights do not infringe any other patents now held or that will be held by others or by University.
3.4 Licensee, by execution hereof, acknowledges, covenants and agrees that it has not been induced in any way by University or its employees to enter into this Agreement, and further warrants and represents that (i) it has conducted sufficient due diligence with respect to all items and issues pertaining to this Article 3 and all other matters pertaining to this Agreement; and (ii) Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and agrees to accept all risks inherent herein.
4.1 University hereby grants to Licensee a royalty-bearing, exclusive license under Licensed Subject Matter to manufacture, have manufactured, and/or sell Licensed Products within the Licensed Territory for use within Licensed Field. This grant is subject to the payment by Licensee to University of all consideration as provided herein, and is further subject to rights retained by University to: a. Publish the general scientific findings from research related to Licensed Subject Matter subject to the terms of Section 13, Confidential Information; and
b. Use Licensed Subject Matter for research, teaching and other educationally-related purposes. 4.2 Licensee may extend the license granted herein to any Affiliate if the Affiliate consents to be bound by this Agreement to the same extent as Licensee.
4.3 Licensee may grant sublicenses consistent with this Agreement if Licensee is responsible for the operations of its sublicensees relevant to this Agreement as if the operations were carried out by Licensee, including the payment of royalties whether or not paid to Licensee by a sublicensee. Licensee must deliver to University a true and correct copy of each sublicense granted by Licensee, and any modification or termination thereof, within 30 days after execution, modification, or termination. When this Agreement is terminated, all existing sublicenses granted by Licensee must be assigned to University.
5.1 In consideration of rights granted by University to Licensee under this Agreement, Licensee will pay University the following: a. A non-refundable license documentation fee in the amount of $___________, due and payable when this Agreement is executed by Licensee; b. An annual license reissue fee in the amount of $______________, due and payable on each anniversary of the Effective Date beginning on the first anniversary;
d. A minimum yearly royalty of $_________ beginning 1 year after approval of the first Sale or offer for Sale of a Licensed Product by the Food and Drug Administration or a comparable foreign regulatory authority. 5.2 In consideration of rights granted by University to Licensee under this Agreement, Licensee further agrees to pay University the following after the execution of a sublicense hereunder: a. Within 30 days after the execution of the sublicense, a sublicense fee of ___% of any up-front cash payment made to Licensee in consideration of the sublicense, excluding funds paid to Licensee for research and development purposes, or $_______________ , whichever is more; b. Within 30 days after the execution of the sublicense, a sublicense fee constituting a cash payment equal to 10% of any non-cash consideration received by Licensee from a sublicensee, such consideration to include, without limitation, equity in other companies or equity investments in Licensee. The value of an equity investment will be calculated as the average market value of the class of stock involved for 5 consecutive days preceding the execution of the sublicense agreement. In cases where the sublicense agreement calls for payment to Licensee of a premium over the market value, University will also share 10% of the premium paid to Licensee; and c. One half of the gross revenue royalty payments received on Net Sales of Licensed Products received by Licensee from any sublicensee. 5.3 During the Term of this Agreement and for 1 year thereafter, Licensee agrees to keep complete and accurate records of its and its sublicensees’ Sales and Net Sales of Licensed Products under the license granted in this Agreement in sufficient detail to enable the royalties payable hereunder to be determined. Licensee agrees to permit University or its representatives, at University’s expense, to periodically examine its books, ledgers, and records during regular business hours for the purpose of and to the extent necessary to verify any report required under this Agreement. If the amounts due to University are determined to have been underpaid, Licensee will pay the cost of the examination and accrued interest at the highest allowable rate.
5.4 Within 30 days after March 31, June 30, September 30, and December 31, beginning immediately after the Effective Date, Licensee must deliver to University a true and accurate written report, even if no payments are due University, giving the particulars of the business conducted by Licensee and its sublicensee(s), if any exist, during the preceding 3 calendar months under this Agreement as are pertinent to calculating payments hereunder. This report will include at least: a. the quantities of Licensed Subject Matter that it has produced; b. the total Sales; c. the calculation of royalties thereon; and d. the total royalties computed and due University. Simultaneously with the delivery of each report, Licensee must pay to University the amount, if any, due for the period of each report. 5.5 On or before each anniversary of the Effective Date, irrespective of having a first Sale or offer for Sale, Licensee must deliver to University a written progress report as to Licensee’s (and any sublicensee’s) efforts and accomplishments during the preceding year in diligently commercializing Licensed Subject Matter in the Licensed Territory and Licensee’s (and, if applicable, sublicensee’s) commercialization plans for the upcoming year.
5.6 All amounts payable here by Licensee must be paid in United States funds without deductions for taxes, assessments, fees, or charges of any kind. Checks must be payable to [University name and address].
5.7 Licensee must reimburse University for all its out-of-pocket expenses thus far incurred in filing, prosecuting, enforcing and maintaining exclusively licensed Patent Rights and must pay all future expenses so long as and in the countries its license remains exclusive.
6. COMMON STOCK: EQUITY OWNERSHIP [NOTE: We advise you to contact an outside counsel with expertise in corporate and securities law before completing this article.] 6.1 In consideration of the rights granted to Licensee by University in this Agreement, Licensee will, upon execution of this Agreement, issue University _________ fully paid, non-assessable shares of its common stock (equaling ___ % of all shares of its common stock), at $________ par value. 6.2 University will name directors to serve on the University of directors of Licensee in proportion to the number of shares held by University relative to the total number of issued shares, however University will always have at least one seat on Licensee’s University.
6.3 In addition, Licensee hereby grants University a 1 year option, exercisable in its sole discretion, to purchase up to an additional ________ shares of its common stock at a fixed purchase price of $____ per share upon the same general terms and conditions as are applicable to the other purchasers of the stock. University may exercise its option to purchase all or part of the optioned shares, by providing Licensee 60 days written notice, specifying the number of shares it wants to purchase and the proposed date of purchase.
7.2 Any time after 2 years from the Effective Date, University and University have the right to terminate the exclusivity of this license in any national political jurisdiction in the Licensed Territory if Licensee, within 90 days after receiving written notice from University of intended termination of exclusivity, fails to provide written evidence satisfactory to University that Licensee or its sublicensees has commercialized or is actively attempting to commercialize a licensed invention in such jurisdiction(s). 7.3 Any time after 3 years from the Effective Date, University and University have the right to terminate this license in any national political jurisdiction in the Licensed Territory if Licensee, within 90 days after receiving written notice from University of intended termination, fails to provide written evidence satisfactory to University that Licensee or its sublicensees has commercialized or is actively attempting to commercialize a licensed invention in such jurisdiction(s). 7.4 The following definitions apply to Article 7: (i) “Commercialize” means having Sales of Licensed Products in such jurisdiction; and (ii) “Active attempts to commercialize” means having Sales of Licensed Products or an effective, ongoing and active research, development, manufacturing, marketing or sales program as appropriate, directed toward obtaining regulatory approval, production or Sales of Licensed Products in any jurisdiction, and plans acceptable to University, in its sole discretion, to commercialize licensed inventions in the jurisdiction(s) that University intends to terminate.
7.5 This Agreement will earlier terminate: a. automatically if Licensee becomes bankrupt or insolvent and/or if the business of Licensee is placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Licensee or otherwise; or
b. upon 30 days written notice from University if Licensee breaches or defaults on its obligation to make payments (if any are due) or reports, in accordance with the terms of Article 5, unless, before the end of the 30 day period, Licensee has cured the default or breach and so notifies University, stating the manner of the cure; or
c. upon 90 days written notice if Licensee breaches or defaults on any other obligation under this Agreement, unless, before the end of the 30 day period, Licensee has cured the default or breach and so notifies University, stating the manner of the cure; or d. at any time by mutual written agreement between Licensee, University and University, upon 180 days written notice to all parties and subject to any terms herein which survive termination; or
e. under the provisions of Paragraphs 7.2 and 7.3 if invoked. 7.6 If this Agreement is terminated for any cause: a. nothing herein will be construed to release either party of any obligation matured prior to the effective date of the termination; b. after the effective date of the termination, Licensee may sell all Licensed Products and parts therefore it has on hand at the date of termination, if it pays earned royalties thereon according to the terms of Article 5; and c. Licensee will be bound by the provisions of Articles 11 (Indemnification), 12 (Use of University and Component’s Name), and 13 (Confidential Information) of this Agreement. 8. INFRINGEMENT BY THIRD PARTIES
8.1 Licensee, at its expense, must enforce any patent exclusively licensed hereunder against infringement by third parties and it is entitled to retain recovery from such enforcement. Licensee must pay University a royalty on any monetary recovery if the monetary recovery is for damages or a reasonable royalty in lieu thereof. If Licensee does not file suit against a substantial infringer of a patent within 6 months of knowledge thereof, then University may enforce any patent licensed hereunder on behalf of itself and Licensee, University retaining all recoveries from such enforcement and/or reducing the license granted hereunder to non-exclusive.
8.2 In any infringement suit or dispute, the parties agree to cooperate fully with each other. At the request and expense of the party bringing suit, the other party will permit access to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours. 9. ASSIGNMENT
Except in connection with the sale of substantially all of Licensee’s assets to a third party, this Agreement may not be assigned by Licensee without the prior written consent of University, which will not be unreasonably withheld. 10. PATENT MARKING
Licensee agrees to hold harmless and indemnify University, its Regents, officers, employees and agents from and against any claims, demands, or causes of action whatsoever, including without limitation those arising on account of any injury or death of persons or damage to property caused by, or arising out of, or resulting from, the exercise or practice of the license granted hereunder by Licensee, its Affiliates or their officers, employees, agents or representatives.
12. USE OF UNIVERSITY’S NAME
Licensee may not use the name of University without express written consent.
13.1 University and Licensee each agree that all information contained in documents marked “confidential” and forwarded to one by the other (i) be received in strict confidence, (ii) be used only for the purposes of this Agreement, and (iii) not be disclosed by the recipient party, its agents or employees without the prior written consent of the other party, except to the extent that the recipient party can establish competent written proof that such information: a. was in the public domain at the time of disclosure;
b. later became part of the public domain through no act or omission of the recipient party, it’s employees, agents, successors or assigns; c. was lawfully disclosed to the recipient party by a third party having the right to disclose it; d. was already known by the recipient party at the time of disclosure;
e. was independently developed by the recipient; or f. is required by law or regulation to be disclosed. 13.2 Each party’s obligation of confidence hereunder shall be fulfilled by using at least the same degree of care with the other party’s confidential information as it uses to protect its own confidential information. This obligation shall exist while this Agreement is in force and for a period of 3 years thereafter.
13.3 University will submit its manuscript for any proposed publication of research related to Licensed Subject Matter to Licensee at least 30 days before publication, and Licensee shall have the right to review and comment upon the publication in order to protect Licensee’s confidential information. Upon Licensee’s request, publication will be delayed up to 60 additional days to enable Licensee to secure adequate intellectual property protection of Licensee’s property that would be affected by the publication. 14. PATENTS AND INVENTIONS
14.1 If after consultation with Licensee, both parties agree that a patent application should be filed for Licensed Subject Matter, University will prepare and file the appropriate patent applications, and Licensee will pay the cost of searching, preparing, filing, prosecuting and maintaining same. If Licensee notifies University that it does not intend to pay the cost of an application, or if Licensee does not respond or make an effort to agree with University on the disposition of rights in the subject invention, then University may file an application at its own expense and Licensee will have no rights to the invention. University will provide Licensee a copy of any patent application for which Licensee has paid the cost of filing, as well as copies of any documents received or filed with the respective patent office during the prosecution thereof.
15.1 Any dispute or controversy arising out of or relating to this Agreement, its construction, or its actual or alleged breach will be decided by mediation. If the mediation does not result in a resolution of such dispute or controversy, it will be finally decided by an appropriate method of alternate dispute resolution, including without limitation, arbitration, conducted in the city of __________, state in accordance with the Commercial Dispute Resolution Procedures http://www.adr.org/rules/commercial_rules.html] of the American Arbitration Association. The arbitration panel will include members knowledgeable in the evaluation of _________ technology. Judgment upon the award rendered may be entered in the highest court or forum having jurisdiction, state or federal. The provisions of this Article 15 will not apply to decisions on the validity of patent claims or to any dispute or controversy as to which any treaty or law prohibits such arbitration. The decision of the arbitration must be sanctioned by a court of law having jurisdiction to be binding upon and enforceable by the parties.
16.2 Any notice required by this Agreement must be given by prepaid, first class, certified mail, return receipt requested, addressed in the case of University to:
[name and address] or in the case of Licensee to:
16.4 This Agreement will be construed and enforced in accordance with the laws of the United States of America and of the State of ______.
16.5 Failure of University to enforce a right under this Agreement will not act as a waiver of that right or the ability to later assert that right relative to the particular situation involved.
16.7 If any part of this Agreement is for any reason found to be unenforceable, all other parts nevertheless remain enforceable. IN WITNESS WHEREOF, parties hereto have caused their duly authorized representatives to execute this Agreement.
UNIVERSITY NAME By_______________________________
Date:_______________ (LICENSEE) _______________________
Date:_______________ 1842.2 Licensing Agreements with Equity Licensing agreements with equity have one large difference from traditional licensing agreements discussed in ¶1842.1  the acquisition by the institution of equity interests in the company that licenses the intellectual property. The rise of start-up companies with little available cash to devote to a licensing arrangement is the primary reason that equity interests are included in licensing agreements. Instead of taking up-front cash payments or even running royalties, an institution will negotiate for a part of the company by taking an equity interest.
One issue that arises as a result of equity arrangements is the disposition of the equity received. This is handled in various ways by institutions, the most common being the transfer of the management of the equity to the institution's investment office. Decisions regarding disposition of the equity then are made directly by the investment office. Typically, the equity is held in conformance with legal requirements and is sold at the first opportunity to do so. At that point, the proceeds are disposed of in accordance with the institution's royalty distribution formulas. ¶1842.3 Income Distribution The distribution of income derived from licensing patents, copyrights, and other proprietary works generally is subject to a formula developed by the institution and typically is not addressed in any licensing agreement. (The Bayh-Dole requirements applicable to inventions made with federal funds only require an income distribution; they do not stipulate a formula or amount.) However, in the case of inventions or other works in which there is more than one creator, a wise institution secures a written agreement regarding the split of royalty income from the inventors or creators prior to entering into any licensing agreement. While the general rule is that the inventor/creator's share of any licensing income is split equally among the individuals involved, there may be exceptions. For example, a student who is involved as an inventor in an initial patent may not have made an inventive contribution to a follow-on patent, both of which may be the subject of a licensing agreement. In these cases, the institution probably should develop a distribution formula.
One way of handling multiple inventions is to assign shares. For example, if there are two inventions, one under the name of Professor X and Student Y and another under the name of Professor X and Student Z, the share formula might be computed as four. Any royalty income distribution, then, would allocate two shares to Professor X, one share to Student Y, and one share to Student Z.
The issue of equity as payment becomes an interesting factor when licensing is being done with an inventor (faculty) start-up company. The question that arises is whether income distribution should be made to a faculty inventor when he or she presumably already has benefited through the start-up company. Some institutions continue to use their distribution formula because of the Bayh-Dole requirement that income must be shared with the inventor(s); others do not provide additional payment to the faculty inventor.
¶1843 Confidentiality Agreements
Commercial firms that wish to disclose certain materials or information to a college or university scientist often seek confidentiality agreements. While it is optimal that these agreements be executed between the company and the researchers alone, more often than not the commercial concern will insist upon the college or university being a party to the agreement as well. Inclusion in such an agreement often is troublesome for an institution because it has no real control over the material being exchanged; in fact, it is likely that the administrators of an institution will not even know when the material was exchanged or know about the materials themselves. However, most institutions are willing to enter into these agreements, if necessary, trusting that the researcher will abide by its terms and conditions.
Confidentiality agreements should include these three provisions:
Material exchanged should be marked as confidential. If it is not possible to mark materials as confidential or proprietary or if materials also are accompanied by verbal confidential information, an institution should require that a follow-on in writing be done within a short time period (usually less than 30 days) indicating which materials are considered to be confidential.
There should be a period of confidentiality. Most institutions begin negotiating with a three-year period from receipt of the material. Some will go as far out as five-to-seven years. In this case, shorter is better; after all, institutions of higher education generally are not places that have a lot of security policies concerning confidential materials.
There should be a set of exceptions built into the confidentiality agreement. The following five exceptions are traditionally excepted from the confidentiality obligation:
material that is already in the recipient party's possession at the time of disclosure;
material that is or later becomes part of the public domain through no fault of the recipient party;
material that is received from a third party having no obligations of confidentiality to the disclosing party;
material that is independently developed by the recipient party; and
material that is required by law or regulation to be disclosed.
For state-supported colleges or universities, the last exception is most important in light of the fact that most of these institutions are subject to state freedom of information laws.
¶1850 Conflicts of Interest Conflicts of interest, whether real or potential, often arise in intellectual property matters, particularly when licensing agreements are contemplated with companies in which the faculty member has an interest. For example, how are licensing and other matters handled when the inventor already owns a share of the company to which the invention is being licensed? It is important that the institution have a policy that requires disclosure of real or potential conflicts of interest and addresses the resolution, if possible, of such conflicts. Because institutions that have funding from either the National Institutes of Health or the National Science Foundation already are required to have such policies (see ¶755), conflicts of interest that arise in licensing matters generally are handled under that policy framework. The following should be taken into consideration when looking at conflict-of-interest matters:
The institution should ascertain whether the company has the resources and ability to commercialize the technology in a timely manner.
The faculty member should acknowledge his or her relationships with the company in any publications or presentations that utilize data generated from research that is funded by the company.
The faculty member's consulting efforts with the company should be distinct from any sponsored research supported by the company.
While the faculty member has likely signed confidentiality agreements with the company, he or she is the only person bound by this confidentiality. Students, post-docs, or others who work on company-funded work should be free to publish their data in a timely manner without the constraints of the faculty member's confidentiality agreements.
Intellectual property associated with any inventions that are developed from the faculty member's consulting efforts with the company should be handled through the institution's technology licensing office.
The faculty member should be made aware that any changes in his or her research program that affects his or her company relationships should be reported to the appropriate university official charged with handling conflict-of-interest issues.
For a full discussion of conflict of interest and research, including institutional conflict of interest, see ¶2840. [Return to Section Table of Contents]
¶1860 The Institution's Intellectual Property Policy
All institutions should have a specific policy governing intellectual property. The policy should addresses any intellectual property developed in the course of employment and assert the institution's policies with respect to ownership and disposition of intellectual property. Tip
On June 6, 2011, the U.S. Supreme Court ruled in Stanford v. Roche that the university could not use the Bayh-Dole Act alone to claim ownership of inventions by one of its faculty. As a result, universities might want to re-examine and possibly tighten policies and agreements governing assignment of inventions and other intellectual property by faculty employees. Examining agreements for the specificity of the assignment might be a good place to start. ¶1861 Intellectual Property Policy
The major elements of an institutional intellectual property policy, which are discussed below, include coverage, scope, institutional resources, royalty distribution, assignment, and
administration. Most intellectual property policies will refer to other institutional policies, such as consulting and conflict of interest. It is important that the intellectual property policy not stand alone because intellectual property naturally has relevance to other academic policies.
Does the policy cover only faculty and staff or are students also included? While there are arguments that can be made that a policy should only cover faculty and staff, the federal patent rules require any student employed on a federally sponsored agreement to be covered under the institutional policy.
The policy also should address works created by administrative staff in the course of their institutional responsibilities. Most policies consider these "works-for-hire" and, as such, these automatically become the property of the college or university.
In the past, intellectual property policies would only govern inventions. With the rise of copyrightable materials, many institutions have expanded the scope of their policies or even developed separate policies concerning copyrights. Including copyrightable materials in a policy presents its own particular set of issues particularly with respect to traditional academic publishing, such as articles and books or course materials. Most institutions exempt these items from their policies.
The development of online course materials and distance learning also has presented a particular set of issues for institutions that are only beginning to be addressed in institutional policies. Because institutions continue to follow their existing policies with respect to copyright in scholarly works created by faculty members, they also tend to acknowledge that faculty members own the copyright to electronically published materials created on their own initiative. This typically includes traditional class materials.
However, when electronic materials are specifically commissioned by the college or university (i.e., a faculty member is being paid  either through their normal compensation or in addition to their normal compensation  most institutions maintain that these are works-for-hire and, therefore, are the property of the institution. Consequently, many institutions are taking title to electronic materials developed expressly for distance learning courses.
Any intellectual property policy should include a discussion of the definition and use of institutional resources. By addressing use of institutional resources in the policy, the institution anticipates and solves issues that may arise at the time of invention disclosure, such as when and how the invention was developed. Most institutions exclude use of a desktop computer from use of institutional resources; however, use of laboratories and scientific instrumentation on more than an incidental basis is use of institutional resources. A policy could make the following exceptions to significant use of institutional resources:
The inventor used a minimal amount of institutional unrestricted funds.
The intellectual property has been developed outside the research area covered by a sponsored project.
A minimum amount of time and insignificant institutional resources have been used. Use of office, library, machine shop facilities and traditional desktop personal computers are examples of facilities and equipment that are not considered significant.
An important part of any intellectual property policy is the distribution of any royalty or other income. As discussed in ¶1842.3, there are almost as many formulas for distribution as there are institutions. However, most institutions recover out-of-pocket costs prior to any royalty distribution, the distribute any remaining proceeds to the inventor or author and to any number of other entities, including departments, deans, and the institution itself. For example, a royalty distribution may look like this:
After out-of-pocket patenting expenses, royalties and income shall be distributed 40% to the inventor(s), 20% to the department(s) of the inventor(s), 20% to the school of the inventor(s), and 20% retained centrally by the institution. Some institutions use a different formula depending on the amount of income. For example, 50 percent of any net royalty income may be distributed to the inventor up to a certain amount; after that milestone is reached, a sliding scale may be implemented. Figure 1861-1 below is an example of a sliding scale.
Figure 1861-1 Sliding Scale Royalty
30% inventor's department
inventor's school or college
35% inventor's department
Another sometimes-sensitive area in royalty distribution is distribution of royalties to administrative staff who may have developed intellectual property in the course of their institutional responsibilities. Typically, these works are included as "works for hire" and are not subject to any royalty distribution.
Equity Income. The policy also should address equity income. For example, it may be that in lieu of royalties, the college or university may take an equity position in a company. It may also be that the equity is split at the time of licensing so that the faculty member has control immediately; other institutions keep the equity whole until such time as a licensing agreement allows its sale. At that time, the institutions sell their holdings and subject the proceeds to the predetermined royalty distribution formula. In most cases, equity is taken in licensing agreements with private companies, and there are federal securities rules regarding timing of equity sales after the company goes public.
Intellectual property policies should address the need for employee assignment agreements. Not only is this a requirement of Bayh-Dole, but it also is necessary as a means of written acknowledgment and acceptance of the intellectual property policy by the faculty or staff member. Further information about assignment agreements is found at ¶1862.
¶1861.6 Administrative Mechanics
Any intellectual property policy should address specifics about the administration of the policy, including the following:
the person(s) who will receive disclosures, reports, and notices;
what the institution will do with the intellectual property;
the rights of the inventor or creator;
the person with ultimate responsibility for administering the policy; and
¶1862 Employee Intellectual Property Assignments As part of an institution's intellectual property policy, employees, including students, generally are required to sign patent assignment agreements. These agreements typically require an employee to acknowledge and accept the institution's intellectual property policy, make specific reference to federal and other requirements, and acknowledge an institution's royalty-sharing policy. There is no set format for these assignment agreements; however, Figure 1862-1 provides one example of such an agreement.
Because assignment agreements are necessary to comply with federal patent regulations, it is important that an institution ensure that all appropriate personnel have executed the agreement.
Many institutions require that the assignment be made at the time of employment, perhaps at the same time a faculty or staff member signs up for benefits. Acquiring student signatures is often more difficult, and many institutions transfer the responsibility for student assignment agreements to the student's department. Figure 1862-1 Sample Employee Assignment Agreement
I understand that in the course of my activities at the <institution name> I may participate in a research program sponsored through agreements with government agencies, corporations, foundations, or others outside the University. I also understand that these agreements usually require that the <institution name> protect the sponsor’s rights to intellectual property that may result from such a research program.
If I receive any support from the University or other sponsoring agency through affiliation with a sponsor program, whether as salary or sharing in equipment use, expendable materials, or other support, I agree that I will:
1.	Disclose promptly to the <office name at institution> full information concerning inventions or discoveries I may make in the course of any such sponsored research or training program;
2.	Assign to the <institution name> or its designee all of my right, title, or interest to such inventions, discoveries, patent applications, or patents; and
3.	Upon request of the <institution name> execute any documents and do everything necessary and proper to secure the issue of letters patent, United States or foreign.
I understand that the <institution name>’s policies may provide for sharing of any income arising from inventions, discoveries, or patents that I assign to the <institution name> under this Agreement. I also understand that such sharing and other policies and practices that are outlined in <institution name>’s research policy manual which may change from time to time, I agree to abide to by the terms in effect at the time of the disclosure of an invention.
I understand that from time to time the <institution name>’s intellectual property policy and practices are periodically reviewed for needed changes, such as those resulting from government regulations. I agree to keep informed of any changes in the intellectual property policy through revisions of the research policy manual or other announcements.
Signature PRINT NAME AND DEPARTMENT:
Date Return completed form to:	<name and campus address>
Frequency of Agreements. One question that has arisen in the past is whether the acknowledgment of the institution's intellectual property policy is sufficient or whether a specific written assignment agreement is required. It is the general consensus of the legal community that separate assignment agreements (executed on a onetime basis to cover inventions made while employed by a specific institution) are necessary to comply with the provisions of Bayh-Dole. [Return to Section Table of Contents]
¶1870 Useful References There are a number of references that a college or university administrator may wish to consult for additional information on intellectual property development, protection, regulation, and licensing matters. The following is a listing of various Web sites that contain reference materials that may be useful. Web Site
on Governmental Relations (COGR)
guides/tutorials on intellectual property, including technology transfers, as
it affects colleges and universities
of University Technology Managers (AUTM)
college and university policies, sample agreements
site for invention reporting
www.iedison.gov
of American Universities (AAU)
legislation and commentary on intellectual property issues
site for USPTO--publications, forms, patent search capability, fees
site for Copyright Office--information, search capabilities, publications,
legislation, forms, etc.
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