University of California, San Francisco
Industry Contracts Division

Agreements executed by the Industry Contracts Division

The agreements executed by the Industry Contracts Division and submittal process for UCSF faculty and staff  is outlined below:

Material Transfer Agreement

Description:

A Material Transfer Agreement (MTA) is a contract between a provider and a recipient for the transfer of tangible research materials, including, but not limited to: chemicals, proteins, nucleic acids, biological samples, organisms (including laboratory animals) and human specimen and data.  An MTA defines the terms and conditions under which a provider is willing to transfer materials to a recipient and substantially reduces the possibility of future misunderstandings between the provider and recipient of materials.

While MTAs with other academic or non-profit institutions are generally negotiated and approved rapidly (usually <15 days), MTAs for materials provided by a for-profit entity require more time (usually <45 days) to negotiate and approve, since many companies propose terms and conditions which conflict with UC policies and federal funding guidelines (see Bayh-Dole Act). The most common issues that require negotiation are publication rights, the future availability of the materials, and intellectual property provisions.

Incoming MTAs govern the transfer of tangible research material from an outside organization to UCSF. The Industry Contract Division (ICD) must review and approve all incoming MTAs.

Outgoing MTAs govern the transfer of all University research materials from UCSF to an outside organization. Outgoing MTAs that concern the transfer of human materials (tissue or data) require review and approval by the ICD. All other outgoing MTAs are handled by UCSF's Office of Technology Management.

Procedures:

Please complete and submit an MTA Request Form.  The Primary Investigator should email the MTA Request Form and the documents discussed below to mta@ucsf.edu.

When filling out the MTA Request Form, you may need to submit one or more of the following documents:

Once the MTA Request Form has been confirmed by the PI, and all other applicable documents are received, the MTA will be assigned to an ICD Officer (see ICD Department Assignments) who will review the agreement to ensure that the terms are consistent with UCSF policies and federal funding guidelines.

If the MTA is acceptable, the ICD Officer will proceed with obtaining the necessary signature(s). If not, the ICD Officer will negotiate the terms of the MTA with the provider/recipient.

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Sponsored Research Agreement

Description:

UCSF uses Sponsored Research Agreements (SRAs) for research funded by industry partners. Under these agreements, the industry sponsor funds a specific project for a definite time period and in return receives certain deliverables such as research data, reports and certain rights to intellectual and tangible property. An industry sponsor may fund an SRA as either a fixed-price agreement or cost-reimbursement agreement, where any monies not used can be returned to the sponsor. The Industry Contract Division (ICD) reviews, drafts, negotiates and executes SRAs, as described above. 

Individual ICD Officers will meet with interested UCSF Principal Investigators and industry partners to discuss potential SRAs. However, for Federal, State and non-profit contracts and grants please contact the Contracts and Grants Office.

Procedures:

Please submit the following documents to your assigned ICD Officer (see ICD Department Assignments) by e-mail to industrycontracts@ucsf.edu:

  • OSR Approval Form
  • Protocol
  • Budget
  • Description of the resources, materials, equipment, etc., to be provided by each party
  • IACUC/CHR Approval Letter (if applicable)
  • Completed 700-U (original signature required)

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Collaborative Agreement

Description:

A Collaboration Agreement is used when UCSF and an industry partner determine to work together on a particular research project, and both parties agree to contribute resources. Under a typical Collaboration Agreement, the industry partner and UCSF may each contribute substantial materials, equipment, personnel, or specialized expertise to the project. UCSF investigators are encouraged to consult with the ICD officer assigned to their department (see ICD Department Assignments) for assistance in structuring the collaboration.

Procedures:

Please submit the following documents to your assigned ICD Officer (see ICD Department Assignments) by e-mail to industrycontracts@ucsf.edu:

  • OSR Approval Form
  • Protocol
  • Final Budget (if applicable)
  • Description of the resources, materials, equipment, etc., to be provided by each party
  • IACUC/CHR Approval Letter (if applicable)
  • Completed 700-U (original signature required, if applicable)
  • Completed 700-U Supplement (if CHR is required)

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Clinical Trial Agreement

Description:

To qualify for a clinical trial facilities and administrative rates, a Clinical Trial Agreement (CTA) must either:

  1. Involve the controlled, clinical testing of Investigational New Drugs (INDs) or Investigational Devices (IDEs) using either a sponsor or investigator developed protocol under FDA Phase I, II, III, or IV drug study or a FDA-regulated medical device study; or
  2. Involve the controlled, clinical testing of a protocol performed under the sponsorship of an approved national cooperative consortium for clinical trial services (please contact Contracts & Grants Office); or
  3. An ancillary study at UCSF that supports an FDA-approved clinical trial performed at an outside agency, or under a clinical trial sponsored under the direction of an approved national cooperative consortium also qualifies for the CTA rate (please contact Contracts & Grants Office); and
  4. May not include projects involving animal subjects. These should not be classified as clinical trials.

There are two types of industry funded CTA, each with its own distinct F&A rate. The first type of CTA, known as an Industry Clinical Trial Agreement, usually involves UCSF and a Sponsor. This type of CTA has an industry clinical trial rate of 26% of Total Direct Cost. On the other hand, a UCSF Coordinated Multi-Center Industry Clinical Trial Contract involves a Sponsor where the study is conducted at more than one clinical site and for which UCSF is defined as the coordinating clinical center for the study. UCSF may be on of the clinical sites for the study. This later type of CTA has a clinical trial rate of 33% of Modified Total Direct Cost. 

Procedures:

Please submit the following documents to your assigned ICD Officer (see ICD Department Assignments) by e-mail to industrycontracts@ucsf.edu:

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Confidentiality Agreement

Description:

A Confidentiality Agreement (also referred to as an "CDA", "NDA" or "Nondisclosure Agreement") protects a party's proprietary or non-public information, and is typically used when parties must disclose such information in order to evaluate a possible relationship with the other party. Generally, if the UCSF investigator expects to disclose any confidential information to the outside entity, then the Confidentiality Agreement should be set up between UCSF and the other party. However, if the UCSF investigator merely expects to receive, but not disclose, confidential information then the Confidentiality Agreement should be between the UCSF investigator and the outside entity. Please note, UCSF investigators are not authorized to sign on behalf of UCSF.

Procedures:

If UCSF is a party to the Confidentiality Agreement, then please contact your assigned ICD Officer (see ICD Department Assignments) and describe the type of information expected to be disclosed by each party, and the purpose of the disclosure(s). If the outside entity has provided a form of Confidentiality Agreement, then please forward that agreement to the appropriate ICD Officer.

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Fellowship

Description:

A Fellowship is a source of funding for either a graduate student, post-doctoral fellow, or fellow ("UCSF Recipient"). The Industry Contract Division (ICD) processes and executes ALL fellowships that are funded by an industry partner. The mechanism used to provide the funding to the UCSF Recipient will determine the F&A rate applied to the Fellowship funding. For example, a stipend paid directly by the industry partner to the UCSF Recipient will carry a different F&A rate from funding provided to UCSF and paid to the UCSF Recipient through Human Resources as salary.

Procedures:

Please Contact the ICD Officer assigned to the department for which the Fellowship will be provided (see ICD Department Assignments) and discuss the various mechanisms for which the Fellowship may be funded.

After discussing the mechanisms of the Fellowship, please submit the following documents to your assigned ICD Officer by e-mail to industrycontracts@ucsf.edu:

  • OSR Approval Form
  • Scope of Work
  • Budget
  • Completed 700-U of the fellow(s) (original signature required)

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SBIR/STTR

Description:

The Small Business Innovation Research (SBIR) program allocates 2.5 percent of a qualified federal agency's budget for domestic small business concerns to engage in Research/Research and Development (R/R&D) that has the potential for commercialization. A company qualifies as a small business concern if at the time of award for both Phase I and Phase II SBIR awards, the company meets all of the criteria established in Section III of the SBIR Parent Funding Opportunity Announcement. Similarly, the Small Business Technology Transfer Research (STTR) program allocates .30 percent of a qualified federal agency's budget for domestic small business concerns to engage in R/R&D that has the potential for commercialization. To date, the SBIR has awarded over $12 billion to various small businesses.

The SBIR and STTR programs are similar in that both programs seek to increase the participation of small businesses in Federal R&D and to increase private sector commercialization of Federal R&D. However, the two programs differ in two substantial ways. First, under the SBIR program, the Principle Investigator must have his or her primary employment with the small business concern at the time of the award and for the duration of the project, while under the STTR program, primary employment at the small business concern is unnecessary. Second, the STTR program requires research partners at universities to have a formal collaborative relationship with the small business concern.

For more detailed information concerning Small Business Research Funding Opportunities please refer to the Office of Extramural Research, National Institutes of Health website at: http://grants1.nih.gov/grants/funding/sbir.htm.

ICD will provide a Letter of Intent or a “Certification of Research Institution” page for the small business concern to support their application for funding. Once the grant is awarded, ICD will assist the small business and UCSF Investigators to establish a sub-contract award to UCSF.

Procedures:

Please submit the following documents to your assigned ICD Officer (see ICD Department Assignments) by e-mail to industrycontracts@ucsf.edu:

  • OSR Approval Form
  • Protocol
  • Final Budget
  • Description of the resources, materials, equipment, etc., to be provided by each party
  • Completed 700-U (original signature required)

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UC Discovery Grant

Description:

The Industry-University Cooperative Research Program (IUCRP) awards UC Discovery Grants in five fields of science and engineering. Founded in 1996, under the leadership of UC President Richard Atkinson, UC Discovery Grants form a 3-way partnership between UC, Industry and the State of California. As of 2008, the jointly funded investment portfolio has grown to 1,189 grants amounting to $281 million in investments. Typical grants have ranged from $50k - $2 million per year, for a maximum period of 4 years.

UC Discovery Grants are awarded on a competitive, peer reviewed basis and focused solely on the scientific and technical merit and relevance of the submitted proposals. Only individuals with Principal Investigator status at UC may submit UC Discovery Grant proposals, and these proposals should contain detailed research plans, descriptive statements of significance and relevance, and detailed budgets with point-by-point justification. A research partnership initiates when a Principal Investigator and an eligible Industry Sponsor converge to pursue a common research goal. The two parties work together to develop a research proposal and may request UC Discovery Grant funding for up to half of the proposed project. However, at least half of the direct costs and applicable indirect costs must come from the Sponsor.

The five fields of science and engineering covered under the IUCRP include:

Procedures:

Submit your UC Discovery Grant proposal(s) online at the UC Discovery Grant Webpage. Additionally, please contact and submit the following documents to your assigned ICD Officer (see ICD Department Assignments) by e-mail to industrycontracts@ucsf.edu:

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