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David Tiemeier joined INVO as Senior Director in July 2012. He leads a team that is
responsible for building relationships with faculty, for helping to shape and prosecute
University intellectual property, and for commercial assessment and licensing of University
inventions into existing and start-up companies. The team looks for ways to build value in
early-stage projects and draws heavily on internal and external experts to catalyze the
translation of basic science into innovative products and services.


Mr. Tiemeier brings over twenty-five years of industry experience to INVO including
leadership positions in research and business development with Monsanto, Searle, Pharmacia
and Pfizer. After retiring from Pfizer in 2004, he work with the biotech companies NeoPharm,
Immtech, and Kalypsys before joining UChicagoTech, the University of Chicago’s Office of
Technology and Intellectual Property, as Deputy Director in 2006.


Mr. Tiemeier holds a B.S. in Chemistry from the University of Notre Dame and a Ph.D. in
Biochemistry from the University of California, Berkeley. He completed postdoctoral studies
in Molecular Genetics at the National Institutes of Health and served on the faculty of the
University of California, Irvine, Medical School for three years before joining Monsanto.
Edward Lanphier, the founder of Sangamo BioSciences, Inc., has served as
President, Chief Executive Officer and as a member of the Board of Directors
since Sangamo's inception in 1995. Mr. Lanphier has over twenty-five years of
experience in the pharmaceutical and biotechnology industry.

From June 1992 to May 1997, he held various positions at Somatix Therapy
Corporation, a gene therapy company, including Executive Vice President,
Commercial Development and Chief Financial Officer. Prior to Somatix, he
was President and Chief Executive Officer of BioGrowth, Inc., a
biotechnology company that merged with Celtrix Laboratories to form Celtrix
Pharmaceuticals, Inc. in 1991.

From 1986 to 1987, he served as Vice President of Corporate Development at
Biotherapeutics, Inc. From 1984 to 1986 Mr. Lanphier served as Vice President
of Corporate Development at Synergen Inc. Prior to Synergen, he was
employed by Eli Lilly and Company, a pharmaceutical company, in the
strategic business planning biotechnology group. He currently serves on the
board of directors of the Biotechnology Institute. Mr. Lanphier holds a B.A. in
biochemistry from Knox College.
   Marie Powers served as a contributing writer for BioWorld Today before
    joining the staff in 2011. With more than 20 years on the health care beat,
    Ms. Powers has contributed to a variety of industry publications,
    including ENT Today, Managed Care Contracting & Reimbursement Advisor,
    Orthopaedic Practice Management, Neurology Practice Management, Capitation
    Management Report, Capitation Rates & Data, Physician Profiling & Behavior
    Change Report, and Women's Health Center Management. She's also served
    as a Contributing Editor to Technology Transfer Tactics.


   BioWorld Today delivers actionable intelligence on the biotech science
    that drives the business, which funds the means to heal disease. With
    writers and editors stationed around the globe, BioWorld Today reports
    the breaking news -- and provides key perspective -- on hundreds of
    medicines in development, the companies behind those therapeutic
    candidates, the business development transactions that evolve the
    market, and the regulatory hurdles that both challenge and guard the
    process.
   What are the key opportunities in Biotech / University TTO deals?
       How to establish and nurture relationships on both sides of the table
       How to build value and de-risk emerging technologies
       How to improve the reproducibility hit rate

   What are the key challenges?
     How to develop rational start-up operational structures
     How to identify potential partners
     How to market technologies to potential partners
     How to develop internal or attract external funding to move university technologies
      across the Valley of Death
     The role of preclinical and other studies in building value for a technology


   What are the terms that make these deals work?
       Perception of value
       Exclusive vs. non-exclusive rights
       Up-front fees
       Equity
       Ongoing research funding
       Objectives/interests of inventors
       Milestones
       Royalties
Opportunities and Challenges in Designing
 Deals Between Biotech Companies and
            University TTOs

            David C. Tiemeier, Ph.D.
                 Senior Director
       Innovation and New Ventures Office
            Northwestern University

                 December 11, 2012
Academic Mission: Impact the world
• Increase knowledge through research and
  publication
• Develop leaders through education
• Deliver healthcare through clinical care and
  practice
• Mobilize people and organizations to address
  unmet needs through its convening function
• Impact, primary; income, secondary…in general
A “disclaimer”…



             In general…
 Universities—within and between—
 are not homogeneous organizations!
NU Sponsored Research Awards (Dollars in Millions)
Federal/Nonfederal Awards

  $600
                                                          Nonfederal

                                                          Federal
  $500




  $400




  $300




  $200




  $100




          FY2007      FY2008   FY2009   FY2010   FY2011
In wake of Bayh-Dole, TTOs generally focused
                 on the front-end IP work

      Discovery      Concept                  Asset Marketing
                                               and Licensing




Sponsored          Disclosures
 Research                                   Existing Co   Start-up



                     Election


                                                  Unmet Need

                  IP Management



One of the results: a mindset that “our assets have enormous value”
Value must be built, early “market” input is critical

               Prioritize: Science, Unmet Need,
                   Competitive Landscape                                External
                                                                        Networks

   Discovery         Concept                          Asset Marketing
                                                       and Licensing



Sponsored          Disclosures
 Research                            Build Value   Existing Co   Start-up



                     Election


                                                         Unmet Need

                 IP Management
Academic Approaches to “Building Value”
1) Commercialization experts embedded in departments work
   with faculty (Executives- and Entrepreneurs-in- Residence)
2) Prospective partners and external experts engaged ad hoc to
   shape specific discoveries and set the commercial trajectory
3) Team mentoring provided to budding faculty entrepreneurs
   (Chicago Innovation Mentors)
4) Corporate relation groups and Board of Trustees leveraged
5) Innovation or Gap Funds, guided by external advisory
   boards, fund proof-of-concept (POC) studies
6) Technology embedded in start-ups with business leadership
   and non-dilutive funding (SBIR, STTR)
7) Complementary skill sets leveraged in earlier-staged
   academic:corporate collaborations
“Building Value” Examples
1) Novel peptide synthesis technology developed
   • Gap funding leveraged 5x investment by collaborative partner to
     complete successful POC. In turn, this led to successive rounds of
     investment.
2) Investigator pursuing most potent of 12 hits from screen
   • A panel of three experts, including a medicinal chemist, pointed
     out its potential toxicity and redirected the faculty member to one
     of the other structures.
3) Novel molecule found to be active in mouse xenograft model
   • Gap Fund Advisory Board recommended testing in second lab.
     CRO failed to reproduce results, reshaping the direction and
     subsequent funding.
Opportunities for Prospective Biotech Partners
1)  Nurture personal contacts
2)  Help shape discovery in areas of interest
3)  Sponsor research emphasizing complementary expertise
4)  Help identify sources and cooperate in securing gap funding
5)  Consider contingent gap funding, with option
6)  Define data that is critical to direct engagement
7)  Clearly distinguish “must-haves” early in negotiations, define
    an “upside” for the academic partner
8) Get behind proposed numbers to identify term options
9) Actively manage post-agreement
10) Track academic start-ups and help shape direction
Challenges for Prospective Biotech Partners
1) “Valley of Death” separates “what I have” from “what you
    want”
2) Matching interests by indication and by stage
3) Managing expectations during engagement
4) Agreeing on the value proposition
5) Indirect costs associated with sponsored research
6) Data publication
7) IP policies: data ownership, patent prosecution
8) Tax and private-use issues: co-mingling private, public funds
9) Data reproducibility
10) Managing expectations post agreement
License directly into Biotech/Pharma or via Start-up?

Why an existing company?                                              Why start-up?
Sponsored research with option                                       Asset too early
Master Agreement in place                                 Perceived long-term value
Asset attracts interest             Licensing Asset            Feasible path to POC
Complementary expertise                                         Inventor preference

   Selected Key terms                                          Selected Key terms
   Publication rights      Biotech/Pharma      Start-up          Publication rights
   IP reimbursement                                                         Equity
   Ongoing IP costs paid                                                No upfront
   Upfront, milestones                                    Milestones, fees delayed
   Royalties                                           IP reimbursement deferred
   Retrieval rights                 Unmet Need               Ongoing IP costs paid
                                                       Royalties with COC buy-out
   Strongly prefer                                                 Retrieval rights
   Retaining control of IP                                     Sub-licensing rights
   Collaborative arrangement
Bridging the “Valley of Death” requires
that individuals on both sides build relationships
      and look to leverage complementarity

            Yes…So, what’s different?

        Growing number of institutions
    are recognizing that as the key element
   in the value proposition that drives deals
Opportunities and Challenges in Designing
  Deals Between Biotech Companies and
              University TTOs


               Edward Lanphier
               President & CEO
           Sangamo BioSciences, Inc.

               December 11, 2012
Sangamo BioSciences

• Focused on the development of a new class of human therapeutics
  that function at the DNA level
• Driven by a robust ZFP product development platform
      – Zinc finger proteins (ZFPs) can be designed to bind to any DNA
        sequence with singular specificity
      – Targeted gene regulation and gene modification
• Broad commercial applications in research reagents, transgenic
  animals, agriculture, manufacturing and human therapeutics
• Significant partnerships and strong balance sheet
• Dominant intellectual property position
1/8/2013                            19
Sangamo In-licensing
Scope of Discussion
• Early Platform Technology Licenses

• Mid Stage Platform Expansion

• Enabling / Delivery Technology Licenses

• Observations




1/8/2013                    20
Sangamo In-licensing
Early Platform Technology License
• Large Mid Atlantic University
      – Grant: Exclusive world-wide right for use with reserved right for research
      – Financials
           Upfront license fee in low 5 digits, annual license maintenance fee in low 5 digits
           Mid single digit royalty on Net Sales
           Milestones, low 6 figures PI trial, mid low 6 figures PIII, mid 6 figures for BLA
             approval, low 6 digits for ex-US approval
      – Sublicensing
           Rights to sublicense, single digit sublicensing royalty on any up fronts received
      – Intellectual Property
           Sangamo reimburses patent prosecution costs, licensor prosecutes
      – Obligations
           Obligation for commercial development, penalty payments for not meeting
             development milestones
      – Term
           Last to expire patent rights.

1/8/2013                                       21
Sangamo In-licensing
Early Platform Technology License
• Research Institute (SD-based Medical and Research Clinic)
      – Grant: Exclusive, Worldwide with right to sublicense
      – Financials
            Upfront of company common stock (in the 10s of thousands of dollars value)
            Royalties: low single digit of net sales, p% of royalty on combination products
            Minimum Royalty: 10s of thousands of dollars per year
      – Sublicensing
            Rights to sublicense, sub licensee has same royalty obligations
      – Intellectual Property
            Institute prosecutes, licensee pays pro rated portion of fees
      – Obligations
            Obligation for commercial development
      – Term
            Expires when last of royalty obligations has expired.


1/8/2013                                       22
Sangamo In-licensing
Early Platform Technology License
• Research Institute (Boston-based Major Institute of Technology)
      – Grant: Exclusive (except for retention of University research rights),Worldwide with
        right to sublicense for all fields of use for commercial use
      – Financials
           Upfront license fee: low $10s of thousands . Yearly maintenance fees - 4 digits.
           Royalties: single digit of net sales, percentage royalty on combination products
           Milestone payment of low six digits for first clinical trial
           Milestone payment of six digits for FDA approval
      – Sublicensing
           Rights to sublicense, sublicense fee of low five figures, maintenance fee of mid
             four digits
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development
      – Term
           Last to expire patent rights.
1/8/2013                                      23
Sangamo In-licensing
Early Platform Technology License & Subsequent M&A
• European Research Institute
      – Grant: Non-exclusive world-wide right for use with reserved right for research
      – Financials
           Upfront license issue fee in low 5 digits, license maintenance fee in low 5 digits
           Mid single digit royalty on Net Sales
           Milestones, low 5 figures PI trial, mid 5 figures PIII, low 6 figures for BLA
            approval, low 6 digits for ex-US approval

•   Remaining non-exclusive IP rights plus additional new IP spun out into a new commercial
    entity 3 years after initial license (Gendaq)
     – Sangamo purchased company in 2001 (asset purchase)
     – Purchase price was ~$20M in Sangamo stock
     – Sangamo has residual royalty and fee obligations on original IP grant from Research
         Institution as above




1/8/2013                                       24
Sangamo In-licensing
Mid-Stage Platform Expansion
• Mid-sized Western University
      – Grant: Exclusive Worldwide with right to sublicense for all fields of use
      – Financials
           Upfront issuance of low 5 digit shares of Sangamo stock ($10s of thousands)
           Reimbursement of 50% of past patent costs
           Royalty of single digit of net Sales, if orphan drug states, lower single digits
           Annual maintenance fee of low 5 digits
           Mid 5 digit milestone for first patent issuing, mid 5 digit milestone for start of
             PIII. Mid 5 digit milestone for BLA application.
      – Sublicensing
           Rights to sublicense, sublicense fee in low 5 figures, annual sublicense fee in low
             5 digits.
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development. Sangamo must spend low 6 digits in
             research during first 2 years.
1/8/2013                                       25
Sangamo In-licensing
Mid-Stage Platform Expansion
• Major Southern California-based Institute of Technology
      – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for
        retained right to offer co-exclusive license to unrelated third party for Research Tools
        and Diagnostics
      – Financials
           Upfront issuance of low 5 digit shares of Sangamo stock
           Reimbursement of 90% of past patent costs
      – Sublicensing
           Rights to sublicense
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development
      – Term
           Last to expire patent rights.


1/8/2013                                        26
Sangamo In-licensing
Enabling Technology License
• Government Institute of Health
      – Grant: Nonexclusive world-wide right to sublicense when also licensing Sangamo’s
        own IP with licensor’s approval (delivery technology)
      – Financials
           Upfront license issue fee in low 5 digits, minimum annual royalty of mid 4 digits
           Single digit royalty on Net Sales
           Milestones, low 5 figures PI trial, mid low 5 figures PII, High mid 5 figures for PIII,
             Low 6 digit for BLA approval, low 5 figures for annual net sales of low mid 8
             figures. Mid 5 figures for annual net of mid 8 figures.
      – Sublicensing
           Rights to sublicense, single digit sublicensing royalty on any upfronts received
      – Intellectual Property
           Sangamo reimburses patent prosecution costs, licensor prosecutes
      – Obligations
           Obligation for commercial development


1/8/2013                                         27
Sangamo In-licensing
Enabling Technology License
• Pacific Coast University
      – Grant: Exclusive US-based right to sublicense for all fields of use (delivery
        technology)
      – Financials
           Up front licensee fee of low 5 digits, annual licensee fee of low 5 digits.
           Reimbursement of 90% of past patent costs
           Royalty: low single digit on Net Sales.
           Minimum Annual Royalties of low 5 figures
           Milestones of low 5 digits for phase 2 trail, low 5 digits for first patient in pIII.
             Approval of a BLA of low 6 digits.
      – Sublicensing
           Rights to sublicense but have to give University single digit percentage of
             upfront consideration received
      – Intellectual Property
           Sangamo pays for prosecution, institute prosecutes
      – Obligations
           Obligation for commercial development
1/8/2013                                          28
Sangamo In-licensing
Enabling Technology License
• Government Institute of Health
      – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for
        retained right for research (manufacturing technology)
      – Financials
           Upfront issuance fee of low 5 digits, yearly minimum royalty in mid 4 digits
           Single digit royalty on net sales
           Reimbursement of 90% of past patent costs
           Milestones- low 5 digits on low 8 figures from P1 thru sales
      – Sublicensing
           Rights to sublicense, single digit royalty on upfront
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development
      – Term
           Last to expire patent rights.
1/8/2013                                        29
Sangamo In-licensing
Observations
• Early stage technology licenses – determination of value /
  probability of success / additional IP requirements
• Start up companies – access to capital requires exclusive licenses
• FTO / BTE / …access to capital, partnerships, M&A
• Exclusive vs. non-exclusive licenses
• Terms
• Relationship with inventors
• Patents vs. publications – authorship vs. inventorship



1/8/2013                          30
   How to establish and nurture relationships on
    both sides of the table

   How to build value and de-risk emerging
    technologies

   How to improve the reproducibility hit rate
Academic Approaches to “Building Value”
1) Commercialization experts embedded in departments work
   with faculty (Executives- and Entrepreneurs-in- Residence)
2) Prospective partners and external experts engaged ad hoc to
   shape specific discoveries and set the commercial trajectory
3) Team mentoring provided to budding faculty entrepreneurs
   (Chicago Innovation Mentors)
4) Corporate relation groups and Board of Trustees leveraged
5) Innovation or Gap Funds, guided by external advisory
   boards, fund proof-of-concept (POC) studies
6) Technology embedded in start-ups with business leadership
   and non-dilutive funding (SBIR, STTR)
7) Complementary skill sets leveraged in earlier-staged
   academic:corporate collaborations
“Building Value” Examples
1) Novel peptide synthesis technology developed
   • Gap funding leveraged 5x investment by collaborative partner to
     complete successful POC. In turn, this led to successive rounds of
     investment.
2) Investigator pursuing most potent of 12 hits from screen
   • A panel of three experts, including a medicinal chemist, pointed
     out its potential toxicity and redirected the faculty member to one
     of the other structures.
3) Novel molecule found to be active in mouse xenograft model
   • Gap Fund Advisory Board recommended testing in second lab.
     CRO failed to reproduce results, reshaping the direction and
     subsequent funding.
Opportunities for Prospective Biotech Partners
1)  Nurture personal contacts
2)  Help shape discovery in areas of interest
3)  Sponsor research emphasizing complementary expertise
4)  Help identify sources and cooperate in securing gap funding
5)  Consider contingent gap funding, with option
6)  Define data that is critical to direct engagement
7)  Clearly distinguish “must-haves” early in negotiations, define
    an “upside” for the academic partner
8) Get behind proposed numbers to identify term options
9) Actively manage post-agreement
10) Track academic start-ups and help shape direction
   How to develop rational start-up operational structures

   How to identify potential partners

   How to market technologies to potential partners

   How to develop internal or attract external funding to move
    university technologies across the Valley of Death

   The role of preclinical and other studies in building value for a
    technology
Challenges for Prospective Biotech Partners
1) “Valley of Death” separates “what I have” from “what you
    want”
2) Matching interests by indication and by stage
3) Managing expectations during engagement
4) Agreeing on the value proposition
5) Indirect costs associated with sponsored research
6) Data publication
7) IP policies: data ownership, patent prosecution
8) Tax and private-use issues: co-mingling private, public funds
9) Data reproducibility
10) Managing expectations post agreement
Bridging the “Valley of Death” requires
that individuals on both sides build relationships
      and look to leverage complementarity

            Yes…So, what’s different?

        Growing number of institutions
    are recognizing that as the key element
   in the value proposition that drives deals
License directly into Biotech/Pharma or via Start-up?

Why an existing company?                                              Why start-up?
Sponsored research with option                                       Asset too early
Master Agreement in place                                 Perceived long-term value
Asset attracts interest             Licensing Asset            Feasible path to POC
Complementary expertise                                         Inventor preference

   Selected Key terms                                          Selected Key terms
   Publication rights      Biotech/Pharma      Start-up          Publication rights
   IP reimbursement                                                         Equity
   Ongoing IP costs paid                                                No upfront
   Upfront, milestones                                    Milestones, fees delayed
   Royalties                                           IP reimbursement deferred
   Retrieval rights                 Unmet Need               Ongoing IP costs paid
                                                       Royalties with COC buy-out
   Strongly prefer                                                 Retrieval rights
   Retaining control of IP                                     Sub-licensing rights
   Collaborative arrangement
   Perception of value              Ongoing research funding

   Exclusive vs. non-exclusive      Objectives/interests of
    rights                            inventors

   Up-front fees                    Milestones

   Equity                           Royalties
Sangamo In-licensing
Scope of Discussion
• Early Platform Technology Licenses

• Mid Stage Platform Expansion

• Enabling / Delivery Technology Licenses

• Observations




1/8/2013                    41
Sangamo In-licensing
Early Platform Technology License
• Large Mid Atlantic University
      – Grant: Exclusive world-wide right for use with reserved right for research
      – Financials
           Upfront license fee in low 5 digits, annual license maintenance fee in low 5 digits
           Mid single digit royalty on Net Sales
           Milestones, low 6 figures PI trial, mid low 6 figures PIII, mid 6 figures for BLA
             approval, low 6 digits for ex-US approval
      – Sublicensing
           Rights to sublicense, single digit sublicensing royalty on any up fronts received
      – Intellectual Property
           Sangamo reimburses patent prosecution costs, licensor prosecutes
      – Obligations
           Obligation for commercial development, penalty payments for not meeting
             development milestones
      – Term
           Last to expire patent rights.

1/8/2013                                       42
Sangamo In-licensing
Early Platform Technology License
• Research Institute (SD-based Medical and Research Clinic)
      – Grant: Exclusive, Worldwide with right to sublicense
      – Financials
            Upfront of company common stock (in the 10s of thousands of dollars value)
            Royalties: low single digit of net sales, p% of royalty on combination products
            Minimum Royalty: 10s of thousands of dollars per year
      – Sublicensing
            Rights to sublicense, sub licensee has same royalty obligations
      – Intellectual Property
            Institute prosecutes, licensee pays pro rated portion of fees
      – Obligations
            Obligation for commercial development
      – Term
            Expires when last of royalty obligations has expired.


1/8/2013                                       43
Sangamo In-licensing
Early Platform Technology License
• Research Institute (Boston-based Major Institute of Technology)
      – Grant: Exclusive (except for retention of University research rights),Worldwide with
        right to sublicense for all fields of use for commercial use
      – Financials
           Upfront license fee: low $10s of thousands . Yearly maintenance fees - 4 digits.
           Royalties: single digit of net sales, percentage royalty on combination products
           Milestone payment of low six digits for first clinical trial
           Milestone payment of six digits for FDA approval
      – Sublicensing
           Rights to sublicense, sublicense fee of low five figures, maintenance fee of mid
             four digits
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development
      – Term
           Last to expire patent rights.
1/8/2013                                      44
Sangamo In-licensing
Early Platform Technology License & Subsequent M&A
• European Research Institute
      – Grant: Non-exclusive world-wide right for use with reserved right for research
      – Financials
           Upfront license issue fee in low 5 digits, license maintenance fee in low 5 digits
           Mid single digit royalty on Net Sales
           Milestones, low 5 figures PI trial, mid 5 figures PIII, low 6 figures for BLA
            approval, low 6 digits for ex-US approval

•   Remaining non-exclusive IP rights plus additional new IP spun out into a new commercial
    entity 3 years after initial license (Gendaq)
     – Sangamo purchased company in 2001 (asset purchase)
     – Purchase price was ~$20M in Sangamo stock
     – Sangamo has residual royalty and fee obligations on original IP grant from Research
         Institution as above




1/8/2013                                       45
Sangamo In-licensing
Mid-Stage Platform Expansion
• Mid-sized Western University
      – Grant: Exclusive Worldwide with right to sublicense for all fields of use
      – Financials
           Upfront issuance of low 5 digit shares of Sangamo stock ($10s of thousands)
           Reimbursement of 50% of past patent costs
           Royalty of single digit of net Sales, if orphan drug states, lower single digits
           Annual maintenance fee of low 5 digits
           Mid 5 digit milestone for first patent issuing, mid 5 digit milestone for start of
             PIII. Mid 5 digit milestone for BLA application.
      – Sublicensing
           Rights to sublicense, sublicense fee in low 5 figures, annual sublicense fee in low
             5 digits.
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development. Sangamo must spend low 6 digits in
             research during first 2 years.
1/8/2013                                       46
Sangamo In-licensing
Mid-Stage Platform Expansion
• Major Southern California-based Institute of Technology
      – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for
        retained right to offer co-exclusive license to unrelated third party for Research Tools
        and Diagnostics
      – Financials
           Upfront issuance of low 5 digit shares of Sangamo stock
           Reimbursement of 90% of past patent costs
      – Sublicensing
           Rights to sublicense
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development
      – Term
           Last to expire patent rights.


1/8/2013                                        47
Sangamo In-licensing
Enabling Technology License
• Government Institute of Health
      – Grant: Nonexclusive world-wide right to sublicense when also licensing Sangamo’s
        own IP with licensor’s approval (delivery technology)
      – Financials
           Upfront license issue fee in low 5 digits, minimum annual royalty of mid 4 digits
           Single digit royalty on Net Sales
           Milestones, low 5 figures PI trial, mid low 5 figures PII, High mid 5 figures for PIII,
             Low 6 digit for BLA approval, low 5 figures for annual net sales of low mid 8
             figures. Mid 5 figures for annual net of mid 8 figures.
      – Sublicensing
           Rights to sublicense, single digit sublicensing royalty on any upfronts received
      – Intellectual Property
           Sangamo reimburses patent prosecution costs, licensor prosecutes
      – Obligations
           Obligation for commercial development


1/8/2013                                         48
Sangamo In-licensing
Enabling Technology License
• Pacific Coast University
      – Grant: Exclusive US-based right to sublicense for all fields of use (delivery
        technology)
      – Financials
           Up front licensee fee of low 5 digits, annual licensee fee of low 5 digits.
           Reimbursement of 90% of past patent costs
           Royalty: low single digit on Net Sales.
           Minimum Annual Royalties of low 5 figures
           Milestones of low 5 digits for phase 2 trail, low 5 digits for first patient in pIII.
             Approval of a BLA of low 6 digits.
      – Sublicensing
           Rights to sublicense but have to give University single digit percentage of
             upfront consideration received
      – Intellectual Property
           Sangamo pays for prosecution, institute prosecutes
      – Obligations
           Obligation for commercial development
1/8/2013                                          49
Sangamo In-licensing
Enabling Technology License
• Government Institute of Health
      – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for
        retained right for research (manufacturing technology)
      – Financials
           Upfront issuance fee of low 5 digits, yearly minimum royalty in mid 4 digits
           Single digit royalty on net sales
           Reimbursement of 90% of past patent costs
           Milestones- low 5 digits on low 8 figures from P1 thru sales
      – Sublicensing
           Rights to sublicense, single digit royalty on upfront
      – Intellectual Property
           Sangamo prosecutes
      – Obligations
           Obligation for commercial development
      – Term
           Last to expire patent rights.
1/8/2013                                        50
Sangamo In-licensing
Observations
• Early stage technology licenses – determination of value /
  probability of success / additional IP requirements
• Start up companies – access to capital requires exclusive licenses
• FTO / BTE / …access to capital, partnerships, M&A
• Exclusive vs. non-exclusive licenses
• Terms
• Relationship with inventors
• Patents vs. publications – authorship vs. inventorship



1/8/2013                          51
Questions?
David C. Tiemeier, Ph.D.
Senior Director                                       Edward Lanphier
Innovation and New Ventures Office                     President & CEO
Northwestern University                     Sangamo BioSciences, Inc.
1800 Sherman Ave., Suite 504                            501 Canal Blvd.
Evanston, IL 60201                                 Richmond, CA 94804
Phone: (847) 467-5467                              510-970-6007 (direct)
Email: david.tiemeier@northwestern.edu            415-309-4412 (mobile)
                                         Email: lanphier@sangamo.com
Thank you for reading!

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Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

  • 1.
  • 2. David Tiemeier joined INVO as Senior Director in July 2012. He leads a team that is responsible for building relationships with faculty, for helping to shape and prosecute University intellectual property, and for commercial assessment and licensing of University inventions into existing and start-up companies. The team looks for ways to build value in early-stage projects and draws heavily on internal and external experts to catalyze the translation of basic science into innovative products and services. Mr. Tiemeier brings over twenty-five years of industry experience to INVO including leadership positions in research and business development with Monsanto, Searle, Pharmacia and Pfizer. After retiring from Pfizer in 2004, he work with the biotech companies NeoPharm, Immtech, and Kalypsys before joining UChicagoTech, the University of Chicago’s Office of Technology and Intellectual Property, as Deputy Director in 2006. Mr. Tiemeier holds a B.S. in Chemistry from the University of Notre Dame and a Ph.D. in Biochemistry from the University of California, Berkeley. He completed postdoctoral studies in Molecular Genetics at the National Institutes of Health and served on the faculty of the University of California, Irvine, Medical School for three years before joining Monsanto.
  • 3. Edward Lanphier, the founder of Sangamo BioSciences, Inc., has served as President, Chief Executive Officer and as a member of the Board of Directors since Sangamo's inception in 1995. Mr. Lanphier has over twenty-five years of experience in the pharmaceutical and biotechnology industry. From June 1992 to May 1997, he held various positions at Somatix Therapy Corporation, a gene therapy company, including Executive Vice President, Commercial Development and Chief Financial Officer. Prior to Somatix, he was President and Chief Executive Officer of BioGrowth, Inc., a biotechnology company that merged with Celtrix Laboratories to form Celtrix Pharmaceuticals, Inc. in 1991. From 1986 to 1987, he served as Vice President of Corporate Development at Biotherapeutics, Inc. From 1984 to 1986 Mr. Lanphier served as Vice President of Corporate Development at Synergen Inc. Prior to Synergen, he was employed by Eli Lilly and Company, a pharmaceutical company, in the strategic business planning biotechnology group. He currently serves on the board of directors of the Biotechnology Institute. Mr. Lanphier holds a B.A. in biochemistry from Knox College.
  • 4. Marie Powers served as a contributing writer for BioWorld Today before joining the staff in 2011. With more than 20 years on the health care beat, Ms. Powers has contributed to a variety of industry publications, including ENT Today, Managed Care Contracting & Reimbursement Advisor, Orthopaedic Practice Management, Neurology Practice Management, Capitation Management Report, Capitation Rates & Data, Physician Profiling & Behavior Change Report, and Women's Health Center Management. She's also served as a Contributing Editor to Technology Transfer Tactics.  BioWorld Today delivers actionable intelligence on the biotech science that drives the business, which funds the means to heal disease. With writers and editors stationed around the globe, BioWorld Today reports the breaking news -- and provides key perspective -- on hundreds of medicines in development, the companies behind those therapeutic candidates, the business development transactions that evolve the market, and the regulatory hurdles that both challenge and guard the process.
  • 5. What are the key opportunities in Biotech / University TTO deals?  How to establish and nurture relationships on both sides of the table  How to build value and de-risk emerging technologies  How to improve the reproducibility hit rate  What are the key challenges?  How to develop rational start-up operational structures  How to identify potential partners  How to market technologies to potential partners  How to develop internal or attract external funding to move university technologies across the Valley of Death  The role of preclinical and other studies in building value for a technology  What are the terms that make these deals work?  Perception of value  Exclusive vs. non-exclusive rights  Up-front fees  Equity  Ongoing research funding  Objectives/interests of inventors  Milestones  Royalties
  • 6. Opportunities and Challenges in Designing Deals Between Biotech Companies and University TTOs David C. Tiemeier, Ph.D. Senior Director Innovation and New Ventures Office Northwestern University December 11, 2012
  • 7. Academic Mission: Impact the world • Increase knowledge through research and publication • Develop leaders through education • Deliver healthcare through clinical care and practice • Mobilize people and organizations to address unmet needs through its convening function • Impact, primary; income, secondary…in general
  • 8. A “disclaimer”… In general… Universities—within and between— are not homogeneous organizations!
  • 9. NU Sponsored Research Awards (Dollars in Millions) Federal/Nonfederal Awards $600 Nonfederal Federal $500 $400 $300 $200 $100 FY2007 FY2008 FY2009 FY2010 FY2011
  • 10. In wake of Bayh-Dole, TTOs generally focused on the front-end IP work Discovery Concept Asset Marketing and Licensing Sponsored Disclosures Research Existing Co Start-up Election Unmet Need IP Management One of the results: a mindset that “our assets have enormous value”
  • 11. Value must be built, early “market” input is critical Prioritize: Science, Unmet Need, Competitive Landscape External Networks Discovery Concept Asset Marketing and Licensing Sponsored Disclosures Research Build Value Existing Co Start-up Election Unmet Need IP Management
  • 12. Academic Approaches to “Building Value” 1) Commercialization experts embedded in departments work with faculty (Executives- and Entrepreneurs-in- Residence) 2) Prospective partners and external experts engaged ad hoc to shape specific discoveries and set the commercial trajectory 3) Team mentoring provided to budding faculty entrepreneurs (Chicago Innovation Mentors) 4) Corporate relation groups and Board of Trustees leveraged 5) Innovation or Gap Funds, guided by external advisory boards, fund proof-of-concept (POC) studies 6) Technology embedded in start-ups with business leadership and non-dilutive funding (SBIR, STTR) 7) Complementary skill sets leveraged in earlier-staged academic:corporate collaborations
  • 13. “Building Value” Examples 1) Novel peptide synthesis technology developed • Gap funding leveraged 5x investment by collaborative partner to complete successful POC. In turn, this led to successive rounds of investment. 2) Investigator pursuing most potent of 12 hits from screen • A panel of three experts, including a medicinal chemist, pointed out its potential toxicity and redirected the faculty member to one of the other structures. 3) Novel molecule found to be active in mouse xenograft model • Gap Fund Advisory Board recommended testing in second lab. CRO failed to reproduce results, reshaping the direction and subsequent funding.
  • 14. Opportunities for Prospective Biotech Partners 1) Nurture personal contacts 2) Help shape discovery in areas of interest 3) Sponsor research emphasizing complementary expertise 4) Help identify sources and cooperate in securing gap funding 5) Consider contingent gap funding, with option 6) Define data that is critical to direct engagement 7) Clearly distinguish “must-haves” early in negotiations, define an “upside” for the academic partner 8) Get behind proposed numbers to identify term options 9) Actively manage post-agreement 10) Track academic start-ups and help shape direction
  • 15. Challenges for Prospective Biotech Partners 1) “Valley of Death” separates “what I have” from “what you want” 2) Matching interests by indication and by stage 3) Managing expectations during engagement 4) Agreeing on the value proposition 5) Indirect costs associated with sponsored research 6) Data publication 7) IP policies: data ownership, patent prosecution 8) Tax and private-use issues: co-mingling private, public funds 9) Data reproducibility 10) Managing expectations post agreement
  • 16. License directly into Biotech/Pharma or via Start-up? Why an existing company? Why start-up? Sponsored research with option Asset too early Master Agreement in place Perceived long-term value Asset attracts interest Licensing Asset Feasible path to POC Complementary expertise Inventor preference Selected Key terms Selected Key terms Publication rights Biotech/Pharma Start-up Publication rights IP reimbursement Equity Ongoing IP costs paid No upfront Upfront, milestones Milestones, fees delayed Royalties IP reimbursement deferred Retrieval rights Unmet Need Ongoing IP costs paid Royalties with COC buy-out Strongly prefer Retrieval rights Retaining control of IP Sub-licensing rights Collaborative arrangement
  • 17. Bridging the “Valley of Death” requires that individuals on both sides build relationships and look to leverage complementarity Yes…So, what’s different? Growing number of institutions are recognizing that as the key element in the value proposition that drives deals
  • 18. Opportunities and Challenges in Designing Deals Between Biotech Companies and University TTOs Edward Lanphier President & CEO Sangamo BioSciences, Inc. December 11, 2012
  • 19. Sangamo BioSciences • Focused on the development of a new class of human therapeutics that function at the DNA level • Driven by a robust ZFP product development platform – Zinc finger proteins (ZFPs) can be designed to bind to any DNA sequence with singular specificity – Targeted gene regulation and gene modification • Broad commercial applications in research reagents, transgenic animals, agriculture, manufacturing and human therapeutics • Significant partnerships and strong balance sheet • Dominant intellectual property position 1/8/2013 19
  • 20. Sangamo In-licensing Scope of Discussion • Early Platform Technology Licenses • Mid Stage Platform Expansion • Enabling / Delivery Technology Licenses • Observations 1/8/2013 20
  • 21. Sangamo In-licensing Early Platform Technology License • Large Mid Atlantic University – Grant: Exclusive world-wide right for use with reserved right for research – Financials  Upfront license fee in low 5 digits, annual license maintenance fee in low 5 digits  Mid single digit royalty on Net Sales  Milestones, low 6 figures PI trial, mid low 6 figures PIII, mid 6 figures for BLA approval, low 6 digits for ex-US approval – Sublicensing  Rights to sublicense, single digit sublicensing royalty on any up fronts received – Intellectual Property  Sangamo reimburses patent prosecution costs, licensor prosecutes – Obligations  Obligation for commercial development, penalty payments for not meeting development milestones – Term  Last to expire patent rights. 1/8/2013 21
  • 22. Sangamo In-licensing Early Platform Technology License • Research Institute (SD-based Medical and Research Clinic) – Grant: Exclusive, Worldwide with right to sublicense – Financials  Upfront of company common stock (in the 10s of thousands of dollars value)  Royalties: low single digit of net sales, p% of royalty on combination products  Minimum Royalty: 10s of thousands of dollars per year – Sublicensing  Rights to sublicense, sub licensee has same royalty obligations – Intellectual Property  Institute prosecutes, licensee pays pro rated portion of fees – Obligations  Obligation for commercial development – Term  Expires when last of royalty obligations has expired. 1/8/2013 22
  • 23. Sangamo In-licensing Early Platform Technology License • Research Institute (Boston-based Major Institute of Technology) – Grant: Exclusive (except for retention of University research rights),Worldwide with right to sublicense for all fields of use for commercial use – Financials  Upfront license fee: low $10s of thousands . Yearly maintenance fees - 4 digits.  Royalties: single digit of net sales, percentage royalty on combination products  Milestone payment of low six digits for first clinical trial  Milestone payment of six digits for FDA approval – Sublicensing  Rights to sublicense, sublicense fee of low five figures, maintenance fee of mid four digits – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development – Term  Last to expire patent rights. 1/8/2013 23
  • 24. Sangamo In-licensing Early Platform Technology License & Subsequent M&A • European Research Institute – Grant: Non-exclusive world-wide right for use with reserved right for research – Financials  Upfront license issue fee in low 5 digits, license maintenance fee in low 5 digits  Mid single digit royalty on Net Sales  Milestones, low 5 figures PI trial, mid 5 figures PIII, low 6 figures for BLA approval, low 6 digits for ex-US approval • Remaining non-exclusive IP rights plus additional new IP spun out into a new commercial entity 3 years after initial license (Gendaq) – Sangamo purchased company in 2001 (asset purchase) – Purchase price was ~$20M in Sangamo stock – Sangamo has residual royalty and fee obligations on original IP grant from Research Institution as above 1/8/2013 24
  • 25. Sangamo In-licensing Mid-Stage Platform Expansion • Mid-sized Western University – Grant: Exclusive Worldwide with right to sublicense for all fields of use – Financials  Upfront issuance of low 5 digit shares of Sangamo stock ($10s of thousands)  Reimbursement of 50% of past patent costs  Royalty of single digit of net Sales, if orphan drug states, lower single digits  Annual maintenance fee of low 5 digits  Mid 5 digit milestone for first patent issuing, mid 5 digit milestone for start of PIII. Mid 5 digit milestone for BLA application. – Sublicensing  Rights to sublicense, sublicense fee in low 5 figures, annual sublicense fee in low 5 digits. – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development. Sangamo must spend low 6 digits in research during first 2 years. 1/8/2013 25
  • 26. Sangamo In-licensing Mid-Stage Platform Expansion • Major Southern California-based Institute of Technology – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for retained right to offer co-exclusive license to unrelated third party for Research Tools and Diagnostics – Financials  Upfront issuance of low 5 digit shares of Sangamo stock  Reimbursement of 90% of past patent costs – Sublicensing  Rights to sublicense – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development – Term  Last to expire patent rights. 1/8/2013 26
  • 27. Sangamo In-licensing Enabling Technology License • Government Institute of Health – Grant: Nonexclusive world-wide right to sublicense when also licensing Sangamo’s own IP with licensor’s approval (delivery technology) – Financials  Upfront license issue fee in low 5 digits, minimum annual royalty of mid 4 digits  Single digit royalty on Net Sales  Milestones, low 5 figures PI trial, mid low 5 figures PII, High mid 5 figures for PIII, Low 6 digit for BLA approval, low 5 figures for annual net sales of low mid 8 figures. Mid 5 figures for annual net of mid 8 figures. – Sublicensing  Rights to sublicense, single digit sublicensing royalty on any upfronts received – Intellectual Property  Sangamo reimburses patent prosecution costs, licensor prosecutes – Obligations  Obligation for commercial development 1/8/2013 27
  • 28. Sangamo In-licensing Enabling Technology License • Pacific Coast University – Grant: Exclusive US-based right to sublicense for all fields of use (delivery technology) – Financials  Up front licensee fee of low 5 digits, annual licensee fee of low 5 digits.  Reimbursement of 90% of past patent costs  Royalty: low single digit on Net Sales.  Minimum Annual Royalties of low 5 figures  Milestones of low 5 digits for phase 2 trail, low 5 digits for first patient in pIII. Approval of a BLA of low 6 digits. – Sublicensing  Rights to sublicense but have to give University single digit percentage of upfront consideration received – Intellectual Property  Sangamo pays for prosecution, institute prosecutes – Obligations  Obligation for commercial development 1/8/2013 28
  • 29. Sangamo In-licensing Enabling Technology License • Government Institute of Health – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for retained right for research (manufacturing technology) – Financials  Upfront issuance fee of low 5 digits, yearly minimum royalty in mid 4 digits  Single digit royalty on net sales  Reimbursement of 90% of past patent costs  Milestones- low 5 digits on low 8 figures from P1 thru sales – Sublicensing  Rights to sublicense, single digit royalty on upfront – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development – Term  Last to expire patent rights. 1/8/2013 29
  • 30. Sangamo In-licensing Observations • Early stage technology licenses – determination of value / probability of success / additional IP requirements • Start up companies – access to capital requires exclusive licenses • FTO / BTE / …access to capital, partnerships, M&A • Exclusive vs. non-exclusive licenses • Terms • Relationship with inventors • Patents vs. publications – authorship vs. inventorship 1/8/2013 30
  • 31.
  • 32. How to establish and nurture relationships on both sides of the table  How to build value and de-risk emerging technologies  How to improve the reproducibility hit rate
  • 33. Academic Approaches to “Building Value” 1) Commercialization experts embedded in departments work with faculty (Executives- and Entrepreneurs-in- Residence) 2) Prospective partners and external experts engaged ad hoc to shape specific discoveries and set the commercial trajectory 3) Team mentoring provided to budding faculty entrepreneurs (Chicago Innovation Mentors) 4) Corporate relation groups and Board of Trustees leveraged 5) Innovation or Gap Funds, guided by external advisory boards, fund proof-of-concept (POC) studies 6) Technology embedded in start-ups with business leadership and non-dilutive funding (SBIR, STTR) 7) Complementary skill sets leveraged in earlier-staged academic:corporate collaborations
  • 34. “Building Value” Examples 1) Novel peptide synthesis technology developed • Gap funding leveraged 5x investment by collaborative partner to complete successful POC. In turn, this led to successive rounds of investment. 2) Investigator pursuing most potent of 12 hits from screen • A panel of three experts, including a medicinal chemist, pointed out its potential toxicity and redirected the faculty member to one of the other structures. 3) Novel molecule found to be active in mouse xenograft model • Gap Fund Advisory Board recommended testing in second lab. CRO failed to reproduce results, reshaping the direction and subsequent funding.
  • 35. Opportunities for Prospective Biotech Partners 1) Nurture personal contacts 2) Help shape discovery in areas of interest 3) Sponsor research emphasizing complementary expertise 4) Help identify sources and cooperate in securing gap funding 5) Consider contingent gap funding, with option 6) Define data that is critical to direct engagement 7) Clearly distinguish “must-haves” early in negotiations, define an “upside” for the academic partner 8) Get behind proposed numbers to identify term options 9) Actively manage post-agreement 10) Track academic start-ups and help shape direction
  • 36. How to develop rational start-up operational structures  How to identify potential partners  How to market technologies to potential partners  How to develop internal or attract external funding to move university technologies across the Valley of Death  The role of preclinical and other studies in building value for a technology
  • 37. Challenges for Prospective Biotech Partners 1) “Valley of Death” separates “what I have” from “what you want” 2) Matching interests by indication and by stage 3) Managing expectations during engagement 4) Agreeing on the value proposition 5) Indirect costs associated with sponsored research 6) Data publication 7) IP policies: data ownership, patent prosecution 8) Tax and private-use issues: co-mingling private, public funds 9) Data reproducibility 10) Managing expectations post agreement
  • 38. Bridging the “Valley of Death” requires that individuals on both sides build relationships and look to leverage complementarity Yes…So, what’s different? Growing number of institutions are recognizing that as the key element in the value proposition that drives deals
  • 39. License directly into Biotech/Pharma or via Start-up? Why an existing company? Why start-up? Sponsored research with option Asset too early Master Agreement in place Perceived long-term value Asset attracts interest Licensing Asset Feasible path to POC Complementary expertise Inventor preference Selected Key terms Selected Key terms Publication rights Biotech/Pharma Start-up Publication rights IP reimbursement Equity Ongoing IP costs paid No upfront Upfront, milestones Milestones, fees delayed Royalties IP reimbursement deferred Retrieval rights Unmet Need Ongoing IP costs paid Royalties with COC buy-out Strongly prefer Retrieval rights Retaining control of IP Sub-licensing rights Collaborative arrangement
  • 40. Perception of value  Ongoing research funding  Exclusive vs. non-exclusive  Objectives/interests of rights inventors  Up-front fees  Milestones  Equity  Royalties
  • 41. Sangamo In-licensing Scope of Discussion • Early Platform Technology Licenses • Mid Stage Platform Expansion • Enabling / Delivery Technology Licenses • Observations 1/8/2013 41
  • 42. Sangamo In-licensing Early Platform Technology License • Large Mid Atlantic University – Grant: Exclusive world-wide right for use with reserved right for research – Financials  Upfront license fee in low 5 digits, annual license maintenance fee in low 5 digits  Mid single digit royalty on Net Sales  Milestones, low 6 figures PI trial, mid low 6 figures PIII, mid 6 figures for BLA approval, low 6 digits for ex-US approval – Sublicensing  Rights to sublicense, single digit sublicensing royalty on any up fronts received – Intellectual Property  Sangamo reimburses patent prosecution costs, licensor prosecutes – Obligations  Obligation for commercial development, penalty payments for not meeting development milestones – Term  Last to expire patent rights. 1/8/2013 42
  • 43. Sangamo In-licensing Early Platform Technology License • Research Institute (SD-based Medical and Research Clinic) – Grant: Exclusive, Worldwide with right to sublicense – Financials  Upfront of company common stock (in the 10s of thousands of dollars value)  Royalties: low single digit of net sales, p% of royalty on combination products  Minimum Royalty: 10s of thousands of dollars per year – Sublicensing  Rights to sublicense, sub licensee has same royalty obligations – Intellectual Property  Institute prosecutes, licensee pays pro rated portion of fees – Obligations  Obligation for commercial development – Term  Expires when last of royalty obligations has expired. 1/8/2013 43
  • 44. Sangamo In-licensing Early Platform Technology License • Research Institute (Boston-based Major Institute of Technology) – Grant: Exclusive (except for retention of University research rights),Worldwide with right to sublicense for all fields of use for commercial use – Financials  Upfront license fee: low $10s of thousands . Yearly maintenance fees - 4 digits.  Royalties: single digit of net sales, percentage royalty on combination products  Milestone payment of low six digits for first clinical trial  Milestone payment of six digits for FDA approval – Sublicensing  Rights to sublicense, sublicense fee of low five figures, maintenance fee of mid four digits – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development – Term  Last to expire patent rights. 1/8/2013 44
  • 45. Sangamo In-licensing Early Platform Technology License & Subsequent M&A • European Research Institute – Grant: Non-exclusive world-wide right for use with reserved right for research – Financials  Upfront license issue fee in low 5 digits, license maintenance fee in low 5 digits  Mid single digit royalty on Net Sales  Milestones, low 5 figures PI trial, mid 5 figures PIII, low 6 figures for BLA approval, low 6 digits for ex-US approval • Remaining non-exclusive IP rights plus additional new IP spun out into a new commercial entity 3 years after initial license (Gendaq) – Sangamo purchased company in 2001 (asset purchase) – Purchase price was ~$20M in Sangamo stock – Sangamo has residual royalty and fee obligations on original IP grant from Research Institution as above 1/8/2013 45
  • 46. Sangamo In-licensing Mid-Stage Platform Expansion • Mid-sized Western University – Grant: Exclusive Worldwide with right to sublicense for all fields of use – Financials  Upfront issuance of low 5 digit shares of Sangamo stock ($10s of thousands)  Reimbursement of 50% of past patent costs  Royalty of single digit of net Sales, if orphan drug states, lower single digits  Annual maintenance fee of low 5 digits  Mid 5 digit milestone for first patent issuing, mid 5 digit milestone for start of PIII. Mid 5 digit milestone for BLA application. – Sublicensing  Rights to sublicense, sublicense fee in low 5 figures, annual sublicense fee in low 5 digits. – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development. Sangamo must spend low 6 digits in research during first 2 years. 1/8/2013 46
  • 47. Sangamo In-licensing Mid-Stage Platform Expansion • Major Southern California-based Institute of Technology – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for retained right to offer co-exclusive license to unrelated third party for Research Tools and Diagnostics – Financials  Upfront issuance of low 5 digit shares of Sangamo stock  Reimbursement of 90% of past patent costs – Sublicensing  Rights to sublicense – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development – Term  Last to expire patent rights. 1/8/2013 47
  • 48. Sangamo In-licensing Enabling Technology License • Government Institute of Health – Grant: Nonexclusive world-wide right to sublicense when also licensing Sangamo’s own IP with licensor’s approval (delivery technology) – Financials  Upfront license issue fee in low 5 digits, minimum annual royalty of mid 4 digits  Single digit royalty on Net Sales  Milestones, low 5 figures PI trial, mid low 5 figures PII, High mid 5 figures for PIII, Low 6 digit for BLA approval, low 5 figures for annual net sales of low mid 8 figures. Mid 5 figures for annual net of mid 8 figures. – Sublicensing  Rights to sublicense, single digit sublicensing royalty on any upfronts received – Intellectual Property  Sangamo reimburses patent prosecution costs, licensor prosecutes – Obligations  Obligation for commercial development 1/8/2013 48
  • 49. Sangamo In-licensing Enabling Technology License • Pacific Coast University – Grant: Exclusive US-based right to sublicense for all fields of use (delivery technology) – Financials  Up front licensee fee of low 5 digits, annual licensee fee of low 5 digits.  Reimbursement of 90% of past patent costs  Royalty: low single digit on Net Sales.  Minimum Annual Royalties of low 5 figures  Milestones of low 5 digits for phase 2 trail, low 5 digits for first patient in pIII. Approval of a BLA of low 6 digits. – Sublicensing  Rights to sublicense but have to give University single digit percentage of upfront consideration received – Intellectual Property  Sangamo pays for prosecution, institute prosecutes – Obligations  Obligation for commercial development 1/8/2013 49
  • 50. Sangamo In-licensing Enabling Technology License • Government Institute of Health – Grant: Exclusive Worldwide with right to sublicense for all fields of use except for retained right for research (manufacturing technology) – Financials  Upfront issuance fee of low 5 digits, yearly minimum royalty in mid 4 digits  Single digit royalty on net sales  Reimbursement of 90% of past patent costs  Milestones- low 5 digits on low 8 figures from P1 thru sales – Sublicensing  Rights to sublicense, single digit royalty on upfront – Intellectual Property  Sangamo prosecutes – Obligations  Obligation for commercial development – Term  Last to expire patent rights. 1/8/2013 50
  • 51. Sangamo In-licensing Observations • Early stage technology licenses – determination of value / probability of success / additional IP requirements • Start up companies – access to capital requires exclusive licenses • FTO / BTE / …access to capital, partnerships, M&A • Exclusive vs. non-exclusive licenses • Terms • Relationship with inventors • Patents vs. publications – authorship vs. inventorship 1/8/2013 51
  • 53. David C. Tiemeier, Ph.D. Senior Director Edward Lanphier Innovation and New Ventures Office President & CEO Northwestern University Sangamo BioSciences, Inc. 1800 Sherman Ave., Suite 504 501 Canal Blvd. Evanston, IL 60201 Richmond, CA 94804 Phone: (847) 467-5467 510-970-6007 (direct) Email: david.tiemeier@northwestern.edu 415-309-4412 (mobile) Email: lanphier@sangamo.com
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