designing deals between biotech companies and university ttos – opportunities and challenges

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OPPORTUNITIES AND CHALLENGES IN DESIGNING DEALS BETWEEN BIOTECH COMPANIES AND UNIVERSITY TTOS

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What are the key opportunities in Biotech / University TTO deals? What are the key challenges? What are the terms that make these deals work?

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Page 1: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

OPPORTUNITIES AND CHALLENGES IN DESIGNING DEALS BETWEEN BIOTECH

COMPANIES AND UNIVERSITY TTOS

Page 2: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Presenter David Tiemeier

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.

Page 3: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Presenter Edward Lanphier

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.

Page 4: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Moderator Marie Powers and Webinar Sponsor BioWorld Today

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.

Page 5: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

AGENDA

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

Page 6: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Opportunities and Challenges in Designing Deals Between Biotech Companies and

University TTOs

David C. Tiemeier, Ph.D.Senior Director

Innovation and New Ventures OfficeNorthwestern University

December 11, 2012

Page 7: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

Page 8: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

In general…

Universities—within and between—are not homogeneous organizations!

A “disclaimer”…

Page 9: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

$600Nonfederal

Federal$500

$400

$300

$200

$100

FY2007 FY2008 FY2009 FY2010 FY2011

Federal/Nonfederal Awards

NU Sponsored Research Awards (Dollars in Millions)

As federal funding stalls,

or worse declines,

how does one grow basic

and translational research?

Page 10: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

In wake of Bayh-Dole, TTOs generally focused on the front-end IP work

Disclosures

Asset Marketing and Licensing

Start-upExisting Co

IP Management

Election

Unmet Need

Discovery Concept

One of the results: a mindset that “our assets have enormous value”

Sponsored Research

Page 11: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Value must be built, early “market” input is critical

Disclosures

Asset Marketing and Licensing

Start-upExisting Co

IP Management

Election

Unmet Need

Discovery Concept

Prioritize: Science, Unmet Need, Competitive Landscape External

Networks

Build ValueSponsored Research

Page 12: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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 leveraged5) Innovation or Gap Funds, guided by external advisory

boards, fund proof-of-concept (POC) studies6) 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

Page 13: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

“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.

Page 14: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Opportunities for Prospective Biotech Partners1) Nurture personal contacts 2) Help shape discovery in areas of interest3) Sponsor research emphasizing complementary expertise4) Help identify sources and cooperate in securing gap funding5) Consider contingent gap funding, with option6) 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

Page 15: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Challenges for Prospective Biotech Partners1) “Valley of Death” separates “what I have” from “what you

want”2) Matching interests by indication and by stage3) Managing expectations during engagement 4) Agreeing on the value proposition 5) Indirect costs associated with sponsored research6) Data publication7) IP policies: data ownership, patent prosecution8) Tax and private-use issues: co-mingling private, public funds 9) Data reproducibility10) Managing expectations post agreement

Page 16: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Licensing Asset

Start-upBiotech/Pharma

Unmet Need

License directly into Biotech/Pharma or via Start-up?

Why an existing company?Sponsored research with optionMaster Agreement in placeAsset attracts interestComplementary expertise

Why start-up?Asset too early

Perceived long-term valueFeasible path to POCInventor preference

Selected Key termsPublication rightsIP reimbursementOngoing IP costs paidUpfront, milestonesRoyaltiesRetrieval rights

Strongly preferRetaining control of IPCollaborative arrangement

Selected Key termsPublication rights

EquityNo upfront

Milestones, fees delayedIP reimbursement deferred

Ongoing IP costs paidRoyalties with COC buy-out

Retrieval rightsSub-licensing rights

Page 17: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

Page 18: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Edward LanphierPresident & CEO

Sangamo BioSciences, Inc.

Opportunities and Challenges in Designing Deals Between Biotech Companies and

University TTOs

December 11, 2012

Page 19: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

1/4/2013 19

Page 20: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 20

Sangamo In-licensingScope of Discussion

• Early Platform Technology Licenses

• Mid Stage Platform Expansion

• Enabling / Delivery Technology Licenses

• Observations

Page 21: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 21

Sangamo In-licensingEarly 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.

Page 22: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingEarly 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.

04/11/2023 22

Page 23: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingEarly 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.04/11/2023 23

Page 24: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 24

Sangamo In-licensingEarly 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

Page 25: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingMid-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.04/11/2023 25

Page 26: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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.

04/11/2023 26

Page 27: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingEnabling 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

04/11/2023 27

Page 28: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

04/11/2023 28

Page 29: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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.

04/11/2023 29

Page 30: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 30

Sangamo In-licensingObservations

• 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

Page 31: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges
Page 32: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

Page 33: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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 leveraged5) Innovation or Gap Funds, guided by external advisory

boards, fund proof-of-concept (POC) studies6) 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

Page 34: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

“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.

Page 35: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Opportunities for Prospective Biotech Partners1) Nurture personal contacts 2) Help shape discovery in areas of interest3) Sponsor research emphasizing complementary expertise4) Help identify sources and cooperate in securing gap funding5) Consider contingent gap funding, with option6) 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

Page 36: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

Page 37: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Challenges for Prospective Biotech Partners1) “Valley of Death” separates “what I have” from “what you

want”2) Matching interests by indication and by stage3) Managing expectations during engagement 4) Agreeing on the value proposition 5) Indirect costs associated with sponsored research6) Data publication7) IP policies: data ownership, patent prosecution8) Tax and private-use issues: co-mingling private, public funds 9) Data reproducibility10) Managing expectations post agreement

Page 38: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

Page 39: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Licensing Asset

Start-upBiotech/Pharma

Unmet Need

License directly into Biotech/Pharma or via Start-up?

Why an existing company?Sponsored research with optionMaster Agreement in placeAsset attracts interestComplementary expertise

Why start-up?Asset too early

Perceived long-term valueFeasible path to POCInventor preference

Selected Key termsPublication rightsIP reimbursementOngoing IP costs paidUpfront, milestonesRoyaltiesRetrieval rights

Strongly preferRetaining control of IPCollaborative arrangement

Selected Key termsPublication rights

EquityNo upfront

Milestones, fees delayedIP reimbursement deferred

Ongoing IP costs paidRoyalties with COC buy-out

Retrieval rightsSub-licensing rights

Page 40: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

Page 41: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 41

Sangamo In-licensingScope of Discussion

• Early Platform Technology Licenses

• Mid Stage Platform Expansion

• Enabling / Delivery Technology Licenses

• Observations

Page 42: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 42

Sangamo In-licensingEarly 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.

Page 43: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingEarly 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.

04/11/2023 43

Page 44: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingEarly 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.04/11/2023 44

Page 45: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

04/11/2023 45

Sangamo In-licensingEarly 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

Page 46: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingMid-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.04/11/2023 46

Page 47: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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.

04/11/2023 47

Page 48: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Sangamo In-licensingEnabling 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

04/11/2023 48

Page 49: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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

04/11/2023 49

Page 50: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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.

04/11/2023 50

Page 51: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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Sangamo In-licensingObservations

• 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

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OPPORTUNITIES AND CHALLENGES IN DESIGNING DEALS BETWEEN BIOTECH

COMPANIES AND UNIVERSITY TTOS

Questions?

Page 53: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

Presenter Contact Information

David C. Tiemeier, Ph.D.Senior DirectorInnovation and New Ventures OfficeNorthwestern University1800 Sherman Ave., Suite 504 Evanston, IL 60201Phone: (847) 467-5467Email: [email protected]

Edward LanphierPresident & CEO

Sangamo BioSciences, Inc.501 Canal Blvd.

Richmond, CA 94804510-970-6007 (direct)

415-309-4412 (mobile)Email: [email protected]

Page 54: Designing Deals Between Biotech Companies and University TTOs – Opportunities and Challenges

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