Day 1 - Thursday, November 14, 2019

7:00
Registration & Continental Breakfast
8:00
Co-Chair’s Opening Remarks
8:15
Looking Beyond M&A Transactions: Tailoring Your Life Science IP Due Diligence Checklist to Fit the Purpose for the Review
9:30

KEYNOTE ADDRESS

The Role of IP in a Personal Scientific Quest to Prevent Prion Disease
10:45
Avoiding Missteps During the Chain of Title Review: Understanding Ownership Rules
12:00
Networking Luncheon
1:15

FREEDOM TO OPERATE

Mastering the FTO Search: Avoiding Blockades, Identifying Third Party Rights, and Evaluating the Likelihood of Infringement
2:15

VALUATION

Valuation and Intellectual Property: The Real Driving Force Behind the Deal
3:15
Networking Refreshment Break
3:45

ETHICS CREDITS

Mitigating Risk Through Improved Due Diligence: A Case Study from Both the Target and Acquirer Perspectives
4:45
Conference Adjourns to Day Two

Day 2 - Friday, November 15, 2019

7:30
Continental Breakfast
8:00
Co-Chair’s Opening Remarks and Recap of Day One
8:15
New Developments in the Courts and Congress Influencing IP Due Diligence
9:15
Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process
10:00
Morning Coffee Break
10:15

SECURING FUNDING

The Benefits of Partnering with PE Firms and Venture Capitalists
11:15

INTERNATIONAL

Mitigating International Legal Risks Presented in Life Sciences IP Due Diligence Investigations
12:00

AUDIENCE POLLING

When Faulty IP Due Diligence Kills the Deal: If I Knew Then What I Know Now
1:00
Networking Luncheon for Workshop Participants

Day 1 - Thursday, November 14, 2019

7:00
Registration & Continental Breakfast
8:00
Co-Chair’s Opening Remarks

Donna Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Cambridge, MA)

Timothy Witkowski
Global Head, Chemistry Patents
Novartis Institutes for BioMedical Research (NIBR) (Cambridge, MA)

8:15
Looking Beyond M&A Transactions: Tailoring Your Life Science IP Due Diligence Checklist to Fit the Purpose for the Review

Heather Boussios
Assistant General Counsel and Head of Intellectual Property, Legal Department
Aptevo Therapeutics (Seattle, WA)

Ryan M. Daniel
Acting Chief Patent Counsel
Fresenius Kabi USA, LLC (Lake Zurich, IL)

Philip I. Datlow
Director & Senior Counsel II, IP
Boehringer Ingelheim USA Corp. (Ridgefield, CT)

Philippe Edouard
Senior Director Intellectual Property, Legal
Takeda Pharmaceutical Company Limited (Lexington, MA)

Moderator:

Nick Boivin
Deputy General Counsel, Head of IP
FORMA Therapeutics, Inc.

This session will consider reasons and transactions other than a traditional M&A for an IP due diligence review. Our speakers will engage you in an interactive discussion on the most important aspects of creating and implementing a cost-effective, concrete checklist. They will also help you identify and select essential team members for the review process. Points of discussion will include:

  • Ensuring that the driving force behind the deal and the objectives of the diligence review are properly aligned
  • Determining the appropriate scope and depth of IP due diligence
  • Ensuring that non-patent IP is not overlooked
  • Updating the checklist based on the type of the transaction as well as the reason or impetus for the review
  • Considering when to consult with experts
  • Assigning roles and involving the supporting players
  • Implementing new methods for conducting the review process while also mitigating your risk and exposure

9:30

KEYNOTE ADDRESS

The Role of IP in a Personal Scientific Quest to Prevent Prion Disease

Sonia Vallabh
Prion Scientist
Broad Institute (Cambridge, MA)

In 2010, Sonia learned that she inherited a causal mutation of prion disease and as such launched a new therapeutic initiative to discover drugs for this condition and assemble a clinical pipeline to translate these advances into meaningful gains for patients. Sonia will tell her incredible story and talk about collaboration between academia and small pharma and how IP has played into her work and roles at the Broad and Prion Alliance.

10:45
Avoiding Missteps During the Chain of Title Review: Understanding Ownership Rules

Jeffrey N. Myers
Vice President & Assistant General Counsel
Pfizer Inc. (New York, NY)

Adam Strauss
Chief Intellectual Property Counsel
Stryker (Kalamazoo, MI)

Marina Volin
VP, Head of Legal and IP
Kintai Therapeutics, Inc. (Cambridge, MA)

Jen Sieczkiewicz Zarutskie
VP, Chief Intellectual Property Counsel
Wave Life Sciences (Cambridge, MA)

Moderator:

David J. Dykeman
Shareholder
Greenberg Traurig, LLP (Boston, MA)

Before you can consider the value of proprietary technology, you must first determine and identify who has clear title or a fully protectable interest. This session will answer your most unyielding questions concerning ownership, including:

  • Who is the true owner of the patents?
  • Have the patents been maintained in force and the patent applications in good standing?
  • Have any prior investors or creditors encumbered the IP by imposing liens?
  • Has there been a valid and inclusive assignment of patents to the licensor?

12:00
Networking Luncheon
1:15

FREEDOM TO OPERATE

Mastering the FTO Search: Avoiding Blockades, Identifying Third Party Rights, and Evaluating the Likelihood of Infringement

Olga Kay
Senior Patent Counsel
Roche (Pleasanton, CA)

Tara Rahemba
Senior Director and Patent Counsel
Alexion Pharmaceuticals, Inc. (New Haven, CT)

Melanie R. Rupert
Partner
Paul Hastings (New York, NY)

Bruce Weintraub
Senior Corporate Counsel
Pfizer Inc. (New York, NY)

Moderator:

Keisha Hylton-Rodic
Managing Principal
Hylton-Rodic Law PLLC (Washington, DC)

This session will explore common complexities in the FTO analysis and provide tips and techniques to avoid the unexpected trap. Points of discussion will include:

  • Overcoming obstacles by ensuring that the purchaser/licensee has the right to commercialize the IP at issue
  • Protecting the rights on future developments and preserving the freedom to operate
  • Analyzing filings and determining the strength of claims of infringement
  • Factors to consider when assessing risk of suit
  • Using non-patent resources to assess risk
  • Assessing the Impact of domestic vs. foreign manufacture of the commercial product on risk assessment

2:15

VALUATION

Valuation and Intellectual Property: The Real Driving Force Behind the Deal

Beth Arnold
Founder
BioPharma Patent Landscapes

Philip Green
Principal
Hoffman Alvary & Company LLC (Newton, MA)

Brian O’Reilly
Partner
DLA Piper

Valuation of life sciences IP is a and important and complex undertaking, as the value of the IP is often the real driving force behind a given transaction. The valuation process has evolved overtime and several analytical tools have been developed to assist in the valuation process. Topics to be discussed include:

  • Assessing valuation trends, the perceived value of intellectual property and the prices being paid
    • Understanding the influence of international markets relative to price
  • Incorporating a valuation calculation into your life sciences diligence review
  • Considering criteria that can impact the overall value of the deal

3:15
Networking Refreshment Break
3:45

ETHICS CREDITS

Mitigating Risk Through Improved Due Diligence: A Case Study from Both the Target and Acquirer Perspectives

Leah G. Brownlee
Of Counsel
Squire Patton Boggs (Cleveland, OH)

Patricia A. Carson
Partner
Kirkland & Ellis LLP (New York, NY)

Jennifer Gregory
Assistant General Patent Counsel, IP Transactions
Eli Lilly and Company (Indianapolis, IN)

Jen Grant Moitoso

Jennifer Grant Moitoso
Vice President, US Head of IP
Takeda

Ha Kung Wong

Ha Kung Wong
Partner
Venable | Fitzpatrick

Moderator:

Thomas Duley
Partner
Sidley Austin LLP (San Francisco, CA)

This interactive case study will walk you through a mock deal scenario from both the target and acquirer perspectives and will explore many of the challenges that arise with IP due diligence, including:

  • Product-specific challenge
  • Marketing approvals
  • Post-marketing obligations, and licensing and collaboration relationships
  • Enterprise-level roadblocks, such as compliance and supply chain considerations

4:45
Conference Adjourns to Day Two

Day 2 - Friday, November 15, 2019

7:30
Continental Breakfast
8:00
Co-Chair’s Opening Remarks and Recap of Day One
8:15
New Developments in the Courts and Congress Influencing IP Due Diligence

Tom Irving
Partner
Finnegan, Henderson, Farabow, Garret & Dunner, LLP (Washington, DC)

Hilary J. Libka
Intellectual Property Counsel
Dana-Farber Cancer Institute, Inc. (Boston, MA)

Jane M. Love
Partner
Gibson Dunn (New York, NY)

Henry H. Gu
Vice President, Chief IP Counsel
Akebia Therapeutics, Inc. (Cambridge, MA)

Moderator:

Ryan Murphey
Counsel
Ropes & Gray LLP (New York, NY)

This session will provide you with insights into how recent court decisions, and pending legislation relating to patent rights will impact life sciences pipelines and reshape future business analyses. Points of discussion during this session will include:

  • Factoring recent developments in life sciences IP case law
  • Reviewing pending patent reform legislation and adapting the due diligence analysis
  • Understanding the USPTO’s guidance on §101 and related considerations in patent applications

9:15
Understanding the Impact of New Developments at FDA on the IP Due Diligence Review Process

Kurt R. Karst
Director
Hyman, Phelps & McNamara PC (Washington, DC)

Michael K. Stern
Of Counsel
Covington & Burling LLP (Washington, DC)

This session aims to answer the following questions:

  • Which RNA therapeutics are likely to qualify for 12-year exclusivity?
  • What does Braeburn v. FDA mean for the scope of 3-year exclusivity?
  • How will FDA assess whether gene or cell therapies are the “same drug” for orphan drug purposes?

10:00
Morning Coffee Break
10:15

SECURING FUNDING

The Benefits of Partnering with PE Firms and Venture Capitalists

John Christopher LiPuma
Vice President, Investment Professional
Fortress Investment Group (New York, NY)

Angela Ni
Director of Underwriting and Data Strategies
Parabellum Capital LLC (New York, NY)

Jeffrey Wade
Executive Vice President, Corporate and Administrative Affairs and CFO
Lexicon Pharmaceuticals, Inc. (Spring, TX)

Partnering with an investment firm to secure funding is an essential and valuable tool to facilitate business expansion and accelerated growth for your life sciences organization. Two funding options to consider are private equity firms and venture capitalists. While private equity firms can deliver tactical financial backing and business alliance, venture capital funds can provide a significant capital enhancement for startups. Topics of discussion include:

  • Identifying optimal timing in a company’s lifecycle to partner with a PE fund versus a VC fund
  • Recognizing capital structure and governance considerations
  • Considering alternative or complimentary sources of funding, e.g. structured and venture lenders, royalty monetization, or intellectual property linked funding

11:15

INTERNATIONAL

Mitigating International Legal Risks Presented in Life Sciences IP Due Diligence Investigations

Sylvia Georges Evangelinos
Senior Patent Attorney
Novartis Institutes for BioMedical Research (NIBR) (Cambridge, MA)

Janet Xiao
Partner
Morrison & Foerster LLP (Palo Alto, CA)

Conducting a baseline international legal risk assessment and finding and utilizing appropriate resources for your IP due diligence examination

  • Identifying potential antitrust and CFIUS risks and adjusting your IP due diligence checklist
  • Tips for the IP due diligence team including identifying wants/needs/must-haves and deal-breakers
  • What to do if legal concerns are uncovered
  • Protecting yourself in the definitive agreements
  • Incorporating lessons from the diligence process to facilitate ultimate integration

12:00

AUDIENCE POLLING

When Faulty IP Due Diligence Kills the Deal: If I Knew Then What I Know Now

Michael A. Davitz
Partner
Leason Ellis (White Plains, NY)

Rebecca Goodman
Senior Corporate Counsel
Celgene (Summit, NJ)

Cara Z. Lowen
VP and Chief IP Counsel
Codiak BioSciences (Waltham, MA)

Moderator:

Mercedes K. Meyer
Partner
Drinker, Biddle & Reath LLP (Washington, DC)

In this interactive session, we will examine real-life examples of deals that failed as a result of ineffectual IP due diligence and call on attendees to surmise the outcome. The discussion will focus on what went wrong during the due diligence process and lifecycle of the transaction. Our panelists will identify red flags to watch for, including specific instances of uncovering:

  • Overstatement of IP rights held by the target or partner company
  • Previous out-licensing activity
  • Pending litigation risks
  • Use restrictions that would impact on the business reasons for the partnership

1:00
Networking Luncheon for Workshop Participants