External Use of Core Facilities Philip Hockberger Director of Core Facilities Office for Research

1. External Use of Core Facilities Philip Hockberger Director of Core Facilities Office for Research

2. External Use of Core Facilities – P. Hockberger • FY10 Survey of CFs on External Customers • Federal Compliance Issues • Meetings with Stakeholders • Policies and Procedures • Processing a “Service” Request • Pre-Approved “Service” Agreements • Annual Reporting of Unrelated Business Income

3. External Use of Core Facilities – P. Hockberger • FY10 Survey of CFs on External Customers 14 CFs responded “Yes” 74 For-Profit Organizations 27 Non-Profit Organizations

4. External Use of Core Facilities – P. Hockberger • Core Facilities with External Customers – FY10 DND-CAT IMSERC Instrument Shop IBNAM-Equipment Facility NUANCE Magnet & Low Temperature Facility Genomics Core Biological Imaging Facility X-Ray Diffraction Facility RHLCC Flow Cytometry Facility High Throughput Analysis Lab Materials Processing & Microfabrication Facility Human Embryonic and iPS Cell Facility Optical Microscopy & Metallography Facility

5. External Use of Core Facilities – P. Hockberger • For-Profit Organizations using CFs - FY10 (partial listing) Dow Chemical American Semiconductor DuPont ThermoFisherGlaxcoSmithKline Wrigley General Electric Metagenomix Kraft Foods Global Monsanto Cabot Microelectronics Applied Thin Films SP Industries Advanced Abrasives Arcmelt Atlas Materials Testing Baxter Healthcare Battelle Engis Corp. Fenwal Inc. Functional Coating Tech. Microlink Devices QuesTecAstera NanoInkNanosonixNanosphere SPS NanoCeramicsViamet Pharmaceuticals Immpheron Inc.

6. External Use of Core Facilities – P. Hockberger • Non-Profit Organizations using CFs - FY10 Purdue University Washington Univ. Colorado State Univ. Wayne State University Florida Atlantic Univ. Howard University University of Chicago Michigan State Univ. University of Georgia Loyola University, Chicago NorthshoreUniv. Health University of Kansas DePaul University Rosalind Franklin Univ. University of Kentucky Illinois Institute of Technology Southern Illinois Univ. University of Illinois, Urbana Lake Forest College Uni. Texas San Antonio Virginia Commonwealth Univ. DuPont Hospital for ChidrenOklahoma Health Sciences Univ. of Illinois, Chicago Univ. of Wisconsin, Milwaukee Art Institute of Chicago Univ. of Wollongong, Australia

7. External Use of Core Facilities – P. Hockberger • Federal Compliance Issues OMB Regulations A21 – Cost Principles for Educational Institutes (1998, 2004) A122 – Cost Principles for Non-Profit Organizations (2004) IRS Regulations for Tax-Exempt Organizations Unrelated Business Income (UBI) Tax

8. External Use of Core Facilities– P. Hockberger • Meetings with Stakeholders • McCormick School of Engineering • Associate Dean for Research • Corporate Relations • Weinberg School of Arts & Sciences • Associate Dean for Research • Feinberg School of Medicine • Vice Dean of Sci. Affairs • Director for Research Core Planning • Office for Research • Vice President for Research • Office for Sponsored Projects • Innovation & New Ventures Office • Office for Research Safety • Office for Risk Management • Controller’s Office • Office for Cost Studies • Office of General Counsel

9. External Use of Core Facilities – P. Hockberger • Policies and Procedures Preparing for Doing External Work * Northwestern University requiresa cost study to establish pricing for services or instrument usage by external customers. The Office of Cost Studies is Available to help you establish appropriate pricing. [Note: External pricing should be the calculated without any university subsidies and should include 60% overhead rate. Higher rates are possible if the market rate is higher or additional fees are necessary to cover non-standard administrative costs, e.g., lawyer fees. Lower rates are possible but must be approved by all internal organizations providing subsidies.] * For a non-profit or for-profit organization outside of NU

10. External Use of Core Facilities – P. Hockberger Processing a “Service” Request for an External Customer (non-research activity) Question 1:Will NU faculty, staff (including post-docs), or students be contributing intellectually to the project or data collection? Will any NU intellectual property be used in the provision of services? Will there be any NU claim to intellectual property resulting from the use of services or instruments? No (to all 3 questions) – Continue to question 2. Yes (to any question) – Please contact the Office for Sponsored Research and determine whether this work requires a research agreement, contract or grant proposal. If OSR determines it to be non-research, continue to question 2.

11. External Use of Core Facilities – P. Hockberger Processing a “Service” Request for an External Customer (non-research activity) Question 2:Is the customer’s employer a U.S. organization? No – Please contact the Office for Sponsored Research and determine whether import or export controls are involved. If approved by OSR, continue to question 3. Yes – Continue to question 3.

12. External Use of Core Facilities – P. Hockberger Processing a “Service” Request for an External Customer (non-research activity) Question 3:Will the work involve non-NU personnel working in your facility? Will the customer be bringing data and/or materials (software, chemicals, monoclonal antibodies, cell lines, transgenic animals, etc.) to campus to analyze and/or test? No (to both questions) – Continue to question 4. Yes (to either question) – Please contact the Office for Research Safety and determine whether visitors working in your facility, and/or the materials they plan to bring, need to be enrolled in ISIS. Visitors will also need to provide a Certificate of Insurance from their organization to the Office for Risk Management. Once completed, continue to question 4.

13. External Use of Core Facilities – P. Hockberger Processing a “Service” Request for an External Customer (non-research activity) Question 4:Will the customer be sending you data and/or materials (software, chemicals, monoclonal antibodies, cell lines, transgenic animals, etc.) to analyze and/or test? No – Continue to question 5. Yes – If data and/or materials are sent to you, please contact the Office for Research Safety and/or the Institutional Animal Care and Use Committee to determine whether this transfer of materials requires their approval. [Please note: external customers are not allowed to send NU any materials that are toxic, contagious, hazardous in nature or which are regulated by the FDA, EPA, or other federal agencies with the authority to control regulated substances and materials.] Once approved, continue to question 5.

14. External Use of Core Facilities – P. Hockberger Processing a “Service” Request for an External Customer (non-research activity) Question 5:Does the customer require a legal agreement from the University (even if NU does not)? No – Continue to question 6. Yes – Please discuss the Laboratory Service Agreement (on OR core facilities website: External Customers) with the customer to determine whether this will satisfy their requirements. If so, then contact the Director of Core Facilities to expedite the Agreement. After approval, continue to question 6. If this will not satisfy their requirements, please contact the Director of Core Facilities to discuss your customer’s needs.

15. External Use of Core Facilities – P. Hockberger Processing a “Service” Request for an External Customer (non-research activity) Question 6:Does the customer plan to pay with a purchase order (which typically has conditions that are not acceptable to NU including warranties, quality assurances, etc.)? No - You are now ready to perform work for the external customer. Provide the customer with a quote consisting of a Statement of Work and associated pricing schedule. Yes – Please contact the Office for Sponsored Research for approval of the purchase order. Once approved, then you are ready to perform work for the external customer.

16. External Use of Core Facilities – P. Hockberger • Pre-Approved “Service” Agreements Office for Research Website Instructions http://www.research.northwestern.edu/facilities/customers.html http://invo.northwestern.edu/agreements NUIT Website Instructions http://www.it.northwestern.edu/policies/nda.html

17. External Use of Core Facilities – P. Hockberger • Annual Reporting of Unrelated Business Income • To be included in Annual Report starting in FY12: • Name of Customer • Name of Customer’s Organization • For-Profit or Non-Profit Status of Organization • Total Income Received for Services during • previous Fiscal Year (Sept – Aug)