Potential approaches to initiating contact with a company are:

(1) Directly contact the company, perhaps through a former colleague or company scientist you may have met at a conference;

(2) For small companies, if you are comfortable doing so, directly contact senior leadership (for example, the CEO or VP of Research); or

(3) Contact personnel at UCSF responsible for forming alliances with industry.

Regardless of the approach used, aspects of initiating a alliance require involvement of the University (e.g., confidentiality agreements to protect intellectual property, etc.); therefore, please confer with those individuals at UCSF whose responsibility it is to support academic/industry alliances to help you evaluate opportunities, make decisions, and structure collaborations.

To help you understand what types of information you should share (confidential versus non-confidential), please confer with those individuals at UCSF whose responsibility it is to support academic/industry alliances to help you evaluate the opportunity, make decisions, and structure collaborations. Ultimately, you will want to assess the proposed science or technology opportunity, whether it aligns well with your own research efforts, and whether an alliance would be beneficial to you and to your potential industry partner. It is also worthwhile to consult your colleagues to determine if they have worked with this company or used similar technology, or have other advice.

- A contract is an agreement between two or more parties in which an offer of something of value is made and that offer is accepted. A contract defines all of the terms, conditions, expectations, and deliverables that govern any contemplated relationship between the parties. By defining the terms, conditions, expectations, and deliverables a contract protects the interests of all of the parties to the contract. Examples of contracts commonly executed by the University include—but are not limited to—Clinical Trial Agreements, Sponsored Research Agreements, Collaboration Agreements, Material Transfer Agreements, and Clinical Service Agreements. To alter the terms, conditions, expectations, or deliverables of a contract, an Amendment to the contract is negotiated and executed by all of the parties to the contract. Any change made to a contract in the absence of an Amendment is null and void.

- A subcontract is an agreement used by a party to arrange for a third party to perform some or all of the first party's obligations under a primary contract. For example, a pharmaceutical company may contract with the University for the University to serve as the coordinating site for a multi-center clinical trial. The contract between the company and the University is called the Primary or Prime Contract. Contracts between the University and other entities recruited by the University to participate in the multi-center study are called sub-contracts.

- A grant is a giving of funds for a specific purpose. The grantor may be entitled to receive some deliverables such as a detailed technical report of research results or a report of expenditures, and may require that unexpended funds be returned at the end of the grant period. See UCOP policy entitled Review of Gifts/Grants for Research (July 8, 1980) for more guidance on distinguishing "gifts" from "grants."

- A gift is an agreement through which a party gives unrestricted funds to the university without imposing any contractual requirements and the award is irrevocable. See UCOP policy entitled Review of Gifts/Grants for Research (July 8, 1980) for more guidance on distinguishing "gifts" from "grants."

- A gift-in-kind is a contribution of equipment, supplies, or other property provided to one or more researchers in lieu of money by one or more companies generally for use in an industry sponsored research project.

- A sponsored research agreement is a contract between a private industry organization and the Regents of the University of California on behalf of UCSF for a research project that is directed by one or more UCSF investigators. Sponsored research agreements specify the research to be completed, deliverables to be provided by industry organization and the University, and the rights that the parties have to intellectual property and data that are generated in the performance of the project. Sponsored research agreements are negotiated by the Industry Contracts Group in the Office of Innovation, Technology & Alliances.

- A collaborative research agreement is a contract between organizations that wish to work together but generally do not want to exchange funding. Collaboration agreements are not considered sponsored research, per se, but govern the exchange of equipment, data and inventions. A funded collaboration agreement is sponsored research as the sponsor provides funding and other resources for the collaboration.

- A clinical trial agreement is a contract between two or more parties that defines all of the terms, conditions, expectations, and deliverables associated with one or more University researchers conducting an industry-authored or investigator-initiated clinical trial when that clinical trial is funded by one or more companies. For a study to be classified as a clinical trial by UCSF for purposes of calculating indirect costs, it must conform to the following definition: the controlled, clinical testing of Investigational New Drugs (INDs) or Investigational Devices (IDEs) using either a sponsor- or investigator-developed protocol under a FDA Phase I, II, III, or IV drug study, a FDA-regulated medical device study, or the controlled, clinical testing of a protocol performed under the sponsorship of an approved national cooperative consortium for clinical trial services; or ancillary studies at UCSF that support an FDA-approved clinical trial being performed at an outside agency, or under a clinical trial sponsored under the direction of an approved national cooperative consortium. Please note that UCSF's definition of a clinical trial is different from other UC campuses and NIH.

- A material transfer agreement (MTA) is a contract between two parties that defines all of the terms, conditions, expectations, and deliverables associated with the receipt and use of materials by one or more University researchers from a party (company, non-profit, university, institute, government, individual, etc.) external to the University.

- A fellowship is a form of grant through which funds are granted (commonly by a university, foundation, government agency, or company) for advanced study or training.

- For more details, please see the Office of Research.

Between a contract, grant, and gift, a contract is the most restrictive form of agreement and a gift is the least restrictive.

• A contract is an agreement between two or more parties that defines all of the terms, conditions, expectations, and deliverables for the activity defined in the contract.
• A grant is a form of an agreement that defines the general expectations related to whatever was proposed in the grant; however, as compared to a contract, there are no contractual obligations to deliver under a grant.

From the time the sponsor and University investigator decide upon the scope of work and the budget for a proposed project, and all required paperwork (COI, IACUC, CHR, OSR, etc.) is completed, the time required to negotiate and execute a sponsored research or clinical trial agreement is approximately 30-90 days, assuming the sponsor responds in a timely matter and that there are no changes in the scope of the work during the negotiation period.

Required Paperwork

Depending on the type of contract involved, you should contact either your department, school, the Office of Innovation, Technology & Alliances and/or the Research Development Office.

In those cases where the research relationship will entail transferring materials either from the company to your lab or vice versa you need to contact the following office(s) depending on the specifics:

a) Industry Contracts Group (ICG) of the Office of Innovation, Technology & Alliances for all incoming materials,

b) Technology Management Group (TMG) for all outgoing materials except for outgoing human clinical specimens. Human specimens are handled by the ICG regardless of whether they are coming into or going from the University.

The principal investigator (PI) is ultimately responsible for all activities under a sponsored agreement. Examples of post-award activities are: reconciling ledgers, approving invoices, getting approvals for compliance issues.

A sponsored research agreement can be transferred from UCSF to another institution. This takes the approval of the department chair or ORU (Organized Research Unit) director. The award to UCSF must be terminated and the new agreement executed between the sponsor and the new institution. All the results and any discoveries made for the work done at UCSF remains the property of the Regents of the University of California.

Material created at UCSF is the property of the Regents of the University of California. If you want to take research materials that you created at UCSF with you to your new employer, contact the Office of Innovation, Technology & Alliances (ITA) Technology Management Group to negotiate a materials transfer agreement (MTA) with your new institution. For materials that are human clinical specimens, contact ITA's Industry Contracts Group (ICG).

A discretionary account is an unrestricted fund at UCSF that is valuable because it can be used to pay for expenses that fall outside of those typically allowed by federal grants (e.g., business-related entertainment expenses, membership dues, etc.). These accounts can be part of a start-up package, gifts from various donors, or they can be derived from unused portions of fixed priced (only) industry-sponsored agreements.

The University places great importance on the ability to fund one's own research, so all independent funding is important. Historically, not all funding has been considered equally during consideration for academic advancement. Grants from federal agencies like the National Institute of Health (NIH) tend to be given greater weight than industry-sponsored research agreements, due primarily to the peer-review involved in evaluating a grant proposal. Moreover, the R01 is considered in many quarters to be THE important grant to legitimize an independent researcher's career. This being said, obtaining funding from industry sources will increase your ability to pay salaries and conduct research that will still be important in developing your career. Industry funding could support research that ultimately helps qualify you for an R01 award.

Due to the award of NIH funding for the CTSI, there are increasing discussions about faculty hiring and advancement and the need for a broader view of the value of translational and industry-sponsored research.

The Industry-University Cooperative Research Program (IUCRP) and UC Discovery Grants may provide matching funding.

Yes it can, but you can and should include this issue in your written agreement with the sponsor; see below.

These should be part of the negotiation. The investigator is not necessarily at the mercy of the company for setting benchmarks and should weigh in on what is considered reasonable progress.

Once the science has been decided, the sponsored research agreement and the way in which it is negotiated are very important with respect to the risk that you take entering into the alliance. It is very important to work closely with your ITA Industry Contracts Group negotiator to work out possible scenarios such as early termination, change of research direction, etc. that may unexpectedly affect your ability to pay salaries.

UC policy states that you cannot agree to a contract unless you are able to publish within 30-60 days of the work being completed. There are provisions about the company being able to look at the manuscript (or other forms of public disclosure, such as talks, poster sessions, etc.) and file patents prior to public disclosure, but they cannot prohibit you from publishing. The UCSF contract negotiators have fixed parameters in negotiating publication rights and should make sure that your contract does not contain improper restrictions. You should, however, pay attention to the terms in your contract and ask about any restrictions that you see. Regarding intellectual property rights, the company will get certain rights to the intellectual property and materials you develop, but there are limits to these rights that are carefully negotiated along with the rest of the research agreement.

Conflicts of interest in partnering with a company can be complicated, and include a wide array of financial concerns. Industry-related conflicts of interest can be different from those you have encountered in other situations. Please click on the questions below to learn more.

Contact the Office of Sponsored Research (OSR) Industry Contracts Division (ICD) to discuss.

Contact the Office of Innovation, Technology & Alliances (ITA) Industry Contracts Group (ICG) to discuss. More useful information can be found at the ITA's Technology Management Group website and you should consult this office as well with regard to intellectual property issues.

Contact the Office of Innovation, Technology & Alliances (ITA) Technology Management Group to discuss.

No, this is not wise. You may feel that you want to minimize the amount of funding that you request to increase the chances that the company will agree, but companies know how expensive research can be, and should understand as long as you write a good budget justification. The most important thing to avoid is to request and receive funding that ends up not completely covering your costs. Then you are stuck: your contract says you will do a certain amount of research and receive a certain amount of money, and any extra costs will have to come from your other accounts (unless you can convince the company to increase the research budget, which is not all that uncommon if you have compelling reasons). Still, paying for this company’s research with federal funds can land you in a heap of trouble, and paying from another industry-sponsored fund raises potential problems with intellectual property concerns. Also, you may wish to impress the company with how well-suited your lab is to do the proposed research, by assuming that no experiment will need to be repeated, but that is bound to backfire. Some animals die of natural causes or get sick and need to be removed from an experiment. Some experiments fail for coincidental or unknown reasons, and sometimes biology just doesn’t behave as you planned that it would, so conditions need to be varied and experiments repeated. Your budget should take a reasonable amount of this uncertainty into account, so by all mean, pad the budget accordingly—and be sure to tell the company exactly what you are doing in the budget justification so that there will be no false impression that you are just trying to get more money. And don’t forget to factor in reasonable percent effort for salaries, future salary/fringe increases, service contracts and maintenance of project-related equipment, and an appropriate portion of the general cost of running your lab. If you end up with extra funds at the end, there’s a good chance you’ll need them for publication costs that come later.

As knowledge and technology advance, performing clinical and translational research involves an increasingly complex regulatory environment. CTSI Regulatory Knowledge and Support Consulting is available to help researchers understand and meet the many regulatory and compliance requirements in the pre-award and post-award process.

YES, Please see the Office of Sponsored Research (OSR) Materials Transfer Agreement (MTA) Quick Guide. This document also includes links to the MTA questionnaire with detailed instructions for incoming and outgoing materials (e.g. human tissue samples).

UCSF clinical trial resources are listed here:

• Clinical Research Resource HUB
• CTSI Clinical Research Services
• For assistance with developing the budget or payment schedule, you should contact your research administrator or your department's Contracts & Grants Representative. To find out who your department's primary and secondary C&G Rep are, contact C&G at (415) 476-2977.
• For assistance with the industry agreement review, negotiation or approval process, you may contact your department's Industry Contracts Officer in the Office of Innovation, Technology & Alliances
• For assistance with submitting committee approval requests to the Committee on Human Research (CHR), IACUC, or any of the Technical Committees, please contact the respective office or your department's research administrator.
• For assistance with Biostatistics, research ethics and design, and more, Consultation Services can help investigators at UCSF and affiliated CTSI institutions meet these challenges successfully and produce research of the highest scientific and ethical standards
• For additional help finding research resources, Talk to a Research Navigator

The FDA offers the following internet resources for answers to questions about investigational device studies, humanitarian devices and other clinical uses of unapproved devices:

• Federal regulations (21 CFR Parts 50, 56, 812, 814, etc) and FDA Information Sheet Guidance for Institutional Review Boards (IRB), Clinical Investigators, and Sponsors
• General information regarding device regulations
• Information on off-label use of medical devices
• Significant risk guidance, including examples of SR (Sponsored Research) and NSR (Non-funded sponsored research) device studies
• Procedural guidance for IRBs requesting assistance from FDA in making the SR/NSR risk determination
• General guidance covering various IDE (Investigational Device Exemption) issues, including Early Expanded Access Policy (see Chapter III)
• Listing of all approved HDEs and HDE (Humanitarian Device Exemption) guidance documents

Contact numbers at the Center for Devices and Radiological Health with respect to IDE, HDE, compliance issues, and complaints are as follows:

• Investigational Device Exemptions/Humanitarian Device Exemption Staff: 240-276-4034. Also, contact this number to find out whether a device study needs an IDE approved by FDA.
• Division of Bioresearch Monitoring, Office of Compliance: 240-276-0125
• Office of Compliance for questions about Custom Devices: 240-276-0125

An Industry Clinical Trial Pre-Startup Fee is allowable for two types of industry contracts: clinical trials and other clinical services. The fee covers actual costs that may occur prior to the start of the contract project, and are allowable whether or not a contract is finalized during the negotiation period and applies to the following charges: All start-up effort and material costs including, but not limited to, costs for protocol review, feasibility analysis, budget preparation and negotiation, preparation and submission of human subject protocol applications, Committee on Human Research (CHR) review fee, negotiation and execution of a clinical trial or other clinical service contract, and associated Facilities and Administrative Costs. For more information, please see the Office of Innovation, Technology & Alliances policy 400-14 on Industry Sponsored Contracts.

Any research conducted at UCSF must obtain the Committee on Human Research (CHR) approval.

Any research that involves either the participation of human subjects or the use of human biological specimens, medical charts, or databases with information about humans is considered to be human subject research and requires review. All research on human subjects (including the use of bio-specimens, medical charts, and data) must be submitted to the Committee on Human Research (CHR) for review and approval prior to any contact with human subjects or any use of their specimens, records, or data. Depending on the nature of your research, you may need additional approvals.

There are three types of CHR review, with separate application formats. The type of application needed depends on the degree of risk to subjects:

• Full Committee: more than minimal risks to subjects, reviewed by one of four full CHR committees
• Expedited: no more than minimal risks, reviewed by a subcommittee of the CHR
• Exempt Certification: technically exempt from the need for CHR review, but requires submission and review of a form for certification of exempt status

Assistance and templates are available on the UCSF CHR website.

Yes, funding sources must be disclosed in the informed consent and CHR application.

A DSMP is a plan established to assure that each research study has a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of participants and the validity and integrity of the data. The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC).

1. Study Risk Assessment
2. Description of anticipated adverse events and their expected frequency
3. Describe the steps you will take to minimize the risks/discomforts to subjects
4. Description of safety monitoring
5. Describe which research results, if any, will be made available to subjects and/or to their physicians
6. Description of how AEs (adverse events) are graded
7. Plan for AE reporting
8. Describe who will perform the safety reviews: Individual versus Contracted Research Organization (CRO), or a Data and Safety Monitoring Board (DSMB).

If a Data and Safety Monitoring Board is required, please include specified description.

See the Data Safety Monitoring Protocol Library for example plans

Studies are placed on the agenda in order of receipt of a fully completed application.

There are a number of factors that affect turnaround time including type of application, quality of application, expertise of members available for review, quality of other applications at meeting and staffing levels.

The average turnaround times for the following applications are:

• Full Committee 6-8 weeks
• Expedited Review 2-6 weeks
• Exempt* 1-2 weeks

*Note: Exempt applications are reviewed in the Committee on Human Research (CHR) Office, and are not included on the Committee agenda.

A material transfer agreement (MTA) is required for transferring material from your laboratory to commercial organizations. This form must be signed by the Technology Management Group of the Office of Innovation, Technology & Alliances (ITA). See Industry UCSF Web Site for details.

A checklist for determining protocol feasibility can be found here.

Tissue Banks and Repositories: Various terms are used to designate the storage sites for human biological collections.

Repository is a term usually applied to large formal collections of specimens and/or data. Examples include
the Cooperative Human Tissue Network and the Armed Forces Repository of Specimen Samples for the Identification of Remains (AFRSSIR).

• Banks with Extracted DNA and/or RNA refer to facilities that store extracted nucleic acids. For example, the DNA Bank at UCSF isolates and stores DNA for CHR-approved studies in a monitored environment ensuring sample quality and data security.
• Tissue bank generally refers to smaller collections of specimens, which may be specific to an institution, disease, or even to specimens in a researcher's freezer. Examples include the Department of Neurological Surgery and the UCSF Comprehensive Cancer Center Tissue Core.

(IMPORTANT NOTE: "Tissue banking" also refers to tissues, cells and organs collected and processed for transplantation. Tissue banks engaged in transplantation services are subject to FDA oversight under Section 361 of the Public Health Service and 21 CFR Part 1270. The American Association of Tissue Banks is an excellent source of information regarding the regulatory standards, certification, and accreditation of tissue banks that provide materials for transplantation.)

For information about banking, please see the UCSF Guide for the Research Use of Human Biological Specimens: Collecting, Banking and Sharing Specimens (page 6 and page 23).

You must comply with multiple State and Federal guidelines, regulations, statutory restrictions, and UCSF policies. Many of the regulatory requirements and restrictions are expected to change in the near future. Faculty applying for funding for such research should review the latest information available at this site before submitting an application: http://www.research.ucsf.edu/SC/index.asp

Allow up to a couple of months for the application process (see "what is the timeline" above). Information about applying and reporting to the CHR is available here. CHR (476-1814) provides an analyst on duty who is always available to answer questions. CTSI regulatory consultants are also available to assist investigators.

A multi-center clinical trial is one that is conducted at more than one medical center or clinic.

University policy defines principal investigator (PI) status as the eligibility to submit proposals for research, training, or public service contracts or grants to extramural agencies, subject to approval of the appropriate department chair/ORU director and dean. Individuals who submit applications to the Committee on Human Research and the Committee on Animal Research must also hold PI Status.

Academic appointees in the following title groups are eligible to submit proposals for extramural support provided that the appointments are at 50% or more and they have received the approvals mentioned above: 1) Professor, Associate Professor, Assistant Professor, and Instructor; 2) Professor In Residence series; 3) Professor of Clinical X series; 4) Adjunct Professor series; 5) Clinical Professor series; 6) Professional Research series, and; 7) Librarian series.

Individuals who are not eligible for PI status by virtue of their appointments must be approved for PI status when submitting contract and grant proposals and/or applications to the Committees on Human and Animal Research. Request PI Status with the form available online at PI Status. This completed form must be submitted with the contract or grant proposal and/or with the application to the Committee on Human or Animal Research. Approval may be granted for 6 months.

Investigators who will work with human subjects must complete the UCSF Research Online Human Subjects Training before the Committee on Human Research (CHR) gives final approval. The CHR tracks this online training to document compliance with Federal training requirements. UCSF also requires completion of an online HIPAA research training module. For other clinical training and links to useful clinical services see What Research Services are Available at UCSF? in this Quick Guide.

Yes. If you are the principal investigator (PI), you must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. For more information, see Principal Investigator Eligibility.

For studies conducted under the auspices of an affiliated institution (e.g., SFVAMC, UCSF-Fresno, SFDPH) the individual listed as the PI must meet eligibility criteria defined by that institution.

Postdoctoral Fellows are now allowed to serve as PIs on CHR applications if the following two conditions are met:

• A UCSF faculty member who would otherwise qualify as a Principal Investigator is identified as the Co-PI on the application, and
• A cover letter from the Co-PI faculty member is attached to the application stating that he or she agrees to serve as faculty support and/or a mentor to the Postdoctoral Fellow.

If you are a co-principal investigator (Co-PI), you must be faculty, staff, or a student at UCSF or one of the institutions that have signed agreements designating UCSF's Committee on Human Research (CHR) as their Institutional Review Board (IRB). The Co-PI must be prepared to assume some of the responsibilities of the PI when the PI is unavailable and, thus, cannot be at an unaffiliated institution. Please see PI Eligibility.

Yes, if you are a member of any faculty and other academic employees (governed by specific Departmental and/or School rules; check your Department's compensation plan).

Yes. All academic employees (faculty, specialist series, postdocs) may consult, subject to rules of their departments. Please note that any consulting agreements must be reviewed by your Dean's office and by Risk Management Services (BARMS).

Yes. It is in the best interest of both you and your client to have a written agreement to avoid confusion, disagreement, and unpleasant surprises at a later date. Because consulting is an activity you do on your own time, the consulting agreement is personal to you and the University will not negotiate it for you. Nonetheless, is it important you do not sign a consulting agreement that puts you in conflict with your obligations to the University. To that end, both you and your client company should review UCSF Academic Affairs consulting guidelines.

Yes. Each School has its own policy, with variations by Department. For example, the School of Medicine limits outside consulting activities to 21 days (168 hours) per fiscal year unless service is provided to governmental agencies. Please contact the Dean’s Office for your School.

A consulting fee is compensation for consulting based on an official contract between the University and the consultee. It is governed by the Dean's Office compensation plan and cannot be paid directly to the consultant; it must be paid to the University and disbursed to the consultant according to departmental policy. An honorarium is a professional fee paid for services such as giving a talk or providing knowledge.

Because consulting is an activity you do on your own time, the consulting agreement is personal to you. The University will not negotiate it for you or advise you about any aspects of it other than its impact on your obligations to the University.

Because consulting is an activity you do on your own time, the consulting agreement is personal to you. The University will not negotiate it for you or advise you about any aspects of it other than its impact on your obligations to the University.

The payment goes to UCSF initially. The consultant typically has the option of having the fee added to a paycheck or to have it deposited in an account for research support. Various taxes on the level of the School may apply depending on the amount and the situation.

This is allowed if the collaborative project does not overlap with the project under consultation. However, if either project is a clinical study, this is not allowed. If no money is exchanged then one can consult and do a collaboration if their consulting does not take place on campus or overlap with the research done on campus.

If you plan to share information regarding technology you have on file with the Office of Innovation, Technology & Alliances (ITA) Technology Management Group, contact that office before disclosing this information to the company so that proper safeguards can be implemented to protect the University's IP rights in this information. If you plan to discuss any confidential information, contact the ITA's Industry Contracts Group to put a confidentiality agreement (CDA) in place.

The goal of an initial meeting is to explore and identify mutual interest, and to define next steps in the discussion toward forming a collaboration or entering into a sponsored agreement. Ultimately, the parties' ability to identify mutual interests and to demonstrate value to one another will dictate whether an ongoing relationship forms.

The intellectual property you have already developed or have conceived of developing is often critical to your ability to successfully engage an industry partner. Therefore, you will need to discuss intellectual property to some degree at some point but doing so at the wrong time or in the wrong way can destroy its value. Before sharing any information you have not already disclosed to the public, you should contact the Office of Innovation, Technology & Alliances (ITA) Technology Management Group which will develop a disclosure strategy for you and put in place any safeguards needed to maintain the value of the intellectual property.

These are legal documents signed by both parties that determine what information that is disclosed during the meeting can be discussed publicly. See below for more information.

The Industry Contracts Group of the Office of Innovation,Technology & Alliances (ITA).

The Industry Contracts Group of the Office of Innovation, Technology & Alliances (ITA) will provide you with a questionnaire that must be completed.

The Industry Contracts Group of the Office of Innovation, Technology & Alliances (ITA) is the only entity authorized to execute incoming MTAs at UCSF.

By conducting research on materials secured under a restrictive MTA you may: (i) forfeit ownership to the results of your research to the material provider; (ii) not be allowed to publish your research; (iii) inadvertently violate the terms of the MTA and be sued by the material provider; or (iv) lose all future income from any inventions created using the material. The Industry Contracts Group of the Office of Innovation, Technology & Alliances (ITA) negotiates the terms of MTAs to specifically protect the rights of faculty. MTAs are legal contracts and should be respected accordingly.

Yes, MTAs from industry are negotiated by ITA's Industry Contracts Group. MTAs from academic researchers are negotiated by the Office of Technology Management.

Contact the Office of Innovation, Technology & Alliances (ITA) Technology Management Group for all outgoing transfers except for the outgoing transfer of human clinical specimens. Outgoing human specimen transfer is handled by ITA’s Industry Contracts Group.

At a minimum, the Office of Innovation,Technology & Alliances (ITA). Technology Management Group will need to know: a) if the recipient is a for-profit or non-profit organization, b) if you are a Howard Hughes Medical Institute (HHMI) employee, c) if the material you are providing contains proprietary material(s), in whole or in part, that you obtained from an entity outside of UCSF that is not a commercial supplier.

Contact the Office of Innovation, Technology & Alliances (ITA). Technology Management Group for all outgoing transfers except for the outgoing transfer of human clinical specimens. Outgoing human specimen transfer is handled by the Industry Contracts Division of the Office of Sponsored Research.

Yes. Providing materials can trigger the "public use" patent bar which can destroy the patent rights in patentable materials if no patent application has been filed. Contact the Office of Innovation,Technology & Alliances (ITA). Technology Management Group to discuss.

Although you made a new invention, under the prevailing State labor laws, you do not own it. The technology that you created at UCSF belongs to your employer, the Regents of the University of California, and it is managed as an asset of the State of California by UCSF's Office of Innovation,Technology & Alliances (ITA) Technology Management Group. This office has authority from the Regents to make all decisions regarding UCSF intellectual property. Thus the Office is responsible for determining what to do with the invention, including what kind of intellectual property protection to seek, if any, and whether forming a company based on the technology is warranted. For more information, go to Office of Innovation, Technology & Alliances (ITA) Technology and visit such sites as: a) "IP Management Overview: Technology Transfer - A Brief Survey: Facts, Strategies & Tactics", b) "Frequently Asked Questions", c) "Working with the ITA", and d) "Laboratory Notebooks".

It is imperative that you notify the Office of Innovation,Technology & Alliances (ITA) Technology Management Group about the invention you made as soon as you have made it which means before you write the manuscript, meeting abstract or schedule a talk.

Waiting until the 11th hour in this way seriously limits the ability of the Office of Innovation, Technology & Alliances (ITA) Technology Management Group to do a proper assessment of the opportunity the invention might afford.

If the Office of Innovation, Technology & Alliances (ITA) Technology Management Group determines the invention is a suitable candidate for commercial use and/or commercial development, the Office will develop and implement the necessary marketing strategy using its own information and contacts as well as any information you can provide about potentially interested companies.

Although many University inventions may be patentable, many cannot be licensed without more work being done to establish proof-of-concept. The more value the inventor can build in the invention by advancing it, the easier it will be to license and the more attractive the license terms will be for the University and the inventor (who shares in the resulting license income). The decision to develop your invention yourself or with an industrial partner is a function of whether you have the requisite know-how and resources available to you at UCSF to advance the technology. Partnering with a company can provide access to special expertise, reagents, assays, equipment, know-how, databases, people and funding that can make a significant difference to your technology while at the same time possibly providing an immediate licensee if the partner is sufficiently interested in your technology to exercise its commercial rights provided in the research agreement.

A sponsored research agreement can be transferred from UCSF to another institution. This takes the approval of the department chair or ORU director. The award to UCSF must be terminated and the new agreement executed between the sponsor and the new institution. All the results and any discoveries made for the work done at UCSF remain the property of the Regents of the University of California.

If you want to take research materials you created at UCSF with you to your new employer, contact the Office of Innovation, Technology & Alliances (ITA) Technology Management Group to negotiate a materials transfer agreement (MTA) with your new institution. For materials that are human clinical specimens, contact ITA’s Industry Contracts Group.