6th Annual Summit on Life Sciences IP Due Diligence - DS

2023 Chairs: TASHICA WILLIAMS AMIRGHOLIZADEH, PH.D.

Senior Associate General Counsel, IP, IP Alliance and Due Diligence (IPADD) Team Lead, Gilead Sciences, Inc.

6th Annual Summit on

Life Sciences IP Due Diligence

HILARY LIBKA

Chief IP Counsel Associate General Counsel Memorial Sloan Kettering Cancer Center

November 28–29, 2023 | the Westin Copley Place, Boston, MA A Life Sciences Due Diligence Industry Think Tank for Assessing, Valuing, and Commercializing IP Assets

GAIN INSIGHTS FROM KEY INDUSTRY STAKEHOLDERS AT:

ą Two Exclusive Roundtables: Investors and Business Leaders Tell-All ą Spotlight on the Impact of the Inflation Reduction Act on IP Due Diligence Analyses and Valuation ą Tailoring the Due Diligence to the Deal to Balance Comprehensiveness with Cost ą Navigating the Key Life Sciences IP Updates Shaping the Landscape of U.S.–EU Deals ą Exploring the Regulatory Aspect of IP Due Diligence and Fine-Tuning your Loss of Exclusivity Analysis ą Conducting IP Due Diligence in Connection with Distressed Companies and Distressed Assets

REGISTER NOW

Vice President, IP BlueRock Therapeutics

CREDITS

2023 Conference Highlights Include:

SUPPORTING SPONSORS

MICHAEL PENN

EARN CLE/ETHICS

» Alnylam Pharmaceuticals

» Orbital Therapeutics

» Dyno Therapeutics

» ReNAgade Therapeutics

» Eisai Inc.

» SalioGen Therapeutics

» Eli Lilly & Company

» Sanofi

» Ferring Pharmaceuticals

» Servier

» Johnson & Johnson

» Viatris

» Mersana Therapeutics

» Zentalis Pharmaceuticals

ASSOCIATE SPONSORS

AmericanConference.com/IPDueDiligence • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

ACI’s 6th Annual Summit on Life Sciences IP Due Diligence returns to Boston this November, to guide you through the process of Assessing, Valuing and Commercializing IP Assets.

IP due diligence is a key priority for life science companies. In transactions where the IP is driving the deal, a meticulous and strategically timed due diligence on the IP assets is essential to preventing a disappointing or even disastrous outcome.

However, not every deal survives or dies based on the strength of patent protection. The regulatory exclusivity or the expertise of the scientists may be the factor that makes the deal valuable. IP attorneys who focus too narrowly on the IP in their IP due diligence miss a critical opportunity for holistic valuation and dealmaking. That is why this conference will proceed with a fresh focus on bridging the gap between the corporate, IP due diligence, and regulatory aspects of due diligence, while providing you with proven strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence.

Our regulatory session will explore how better alignment between regulatory functions and IP produces the best loss of exclusivity analyses. Our two exclusive roundtables, one with investors and one with business leaders, are not to be missed, as the speakers will reveal how they value IP, when the IP is or is not the bottom line, and the market opportunities that interest them.

As 2023 is heralded as the Year of The Deal, this conference will feature sessions on core IP due diligence topics like: validity and scope, ownership and inventorship, the freedom-to-operate opinion, and tailoring the IP due diligence process to the deal for the perfect balance between comprehensiveness and cost.

Moreover, given the increasingly globalized nature of the life sciences, this year’s conference will feature two sessions dedicated to European IP due diligence: the impact of the Unified Patent Court on IP valuation and deal-making; and best practices for avoiding common cross-border IP due diligence pitfalls.

While each deal is unique and fluid, with different timelines, resources, priorities and goals, our comprehensive conference guarantees that you will walk away with new strategies, an updated due diligence checklist, and insights for your particular transaction.

MEDIA PARTNERS

2 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

2023 CHAIRS Tashica Williams Amirgholizadeh, Ph.D. Senior Associate General Counsel, IP, IP Alliance and Due Diligence (IPADD) Team Lead, Gilead Sciences, Inc. Hilary Libka Chief IP Counsel, Associate General Counsel Memorial Sloan Kettering Cancer Center Michael Penn Vice President, IP BlueRock Therapeutics

GOVERNMENT Hon. Rian Kalden Presiding Judge, Court of Appeal Unified Patent Court

IN-HOUSE COUNSEL Jens Bitsch-Norhave, Ph.D. Vice President, Transactions & Innovative Partnering Johnson & Johnson Emily Gardel Associate Director, Patent Attorney Dyno Therapeutics Henry Gu SVP, Head of Intellectual Property Zentalis Pharmaceuticals

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Nicole Grimm Legal Director, IP Alnylam Pharmaceuticals Bo Han Vice President, Intellectual Property Orbital Therapeutics Jeffrey Kopacz Senior Vice-President | Head of IP & Contracts SalioGen Therapeutics Michael R. Myers, Ph.D. VP Due Diligence Eli Lilly Research Labs, Eli Lilly & Co Gabriel J. McCool, Ph.D. VP, Legal and IP ReNAgade Therapeutics Erica Norey Senior Counsel, Intellectual Property for Global Business Development & M&A Sanofi Samir Patel Associate General Counsel, Global IP Viatris Aaron Pereira Senior Director, Patents, Global IP Ferring Pharmaceuticals Adam Poulin-Kerstien Vice President, Intellectual Property Mersana Therapeutics Brian Stone Associate General Counsel, Global Legal-Regulatory Viatris

William Vickery Director of Due Diligence Servier Lindsey Wanner Associate General Counsel, IP Alliance and Due Diligence Gilead Sciences Inc.

OUTSIDE COUNSEL Lawrence Cogswell, Ph.D. Principal Hamilton, Brook, Smith & Reynolds P.C. Julia Frost-Davies Shareholder Greenberg Traurig LLP

Brenda Herschbach Jarrell, Ph.D. Partner, Chair of Life Sciences Group Choate, Hall and Stewart LLP Willem Hoyng Partner, Hoyng Rokh Monegier Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC Michael P. Kahn Partner Akin Gump Strauss Hauer & Feld LLP

Matthew S. Rizzo General Partner OrbiMed Healthcare Fund Management Daniel G. Rudoy, Ph.D Shareholder | Executive Committee Member Wolf, Greenfield & Sacks, P.C Alicia Russo Partner | Chair of IP Transactional Group Venable Fitzpatrick LLP Rebecca L. Simmons, Ph.D. Counsel McNeill Baur PLLC

Kathleen Gersh Partner Loeb & Loeb LLP

Kurt R. Karst Director Hyman, Phelps & McNamara, P.C

DeAnn F. Smith Partner | Co-Chair PTAB Proceedings Practice Group Foley Hoag LLP

Kristin Going Partner McDermott, Will & Emery LLP

Daniel Margolis Partner Allen & Overy LLP

Len S. Smith Principal Transformative Legal

Mercedes Meyer Attorney Banner Witcoff LLP

Michael Stern Of Counsel Covington & Burling LLP

Luba Greenwood, J.D. Managing Partner Dana Farber Cancer Institute Venture Fund, Binney Street Capital Lisa Hillman, Ph.D. Partner Lathrop GPM

Samantha R. Morelli Partner Kirkland & Ellis LLP

Mary Lynne Hedley, Ph.D. Venture Partner Third Rock Ventures

Kevin Noonan, Ph.D. Partner | Co-Chair Biotechnology and Pharmaceuticals Practice Group McDonell Boehnen Hulbert & Berghoff LLP

Dr. Christian Helbig Patent Attorney Hoefer & Partner Patentanwälte mbB

Caitlin E. Olwell Counsel Akin Gump Strauss Hauer & Feld LLP

AmericanConference.com/IPDueDiligence • 888 224 2480

Bob Underwood Partner Hogan Lovells LLP Ha Kung Wong Partner Venable Fitzpatrick LLP

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Please join us in Boston for ACI’s 6th Annual Summit on Life Sciences IP Due Diligence. From foundational workshops to interactive sessions analyzing recent developments, the Summit will be an enriching experience whether you are new to IP or a seasoned professional. Ask questions and gain unique insights from talented speakers representing the life sciences ecosystem, including pharmaceutical and biotech companies, start-ups, investors, non-profits, government, and private practice."

Lock-alt MAIN CONFERENCE DAY ONE Tuesday, November 28

7:30am

Hilary J. Libka, Chief IP Counsel, Associate General Counsel, Memorial Sloan Kettering Cancer Center, 2023 Chair

Registration and Breakfast » What non-IP factors are the most important?

8:30am

Opening Remarks from Co-Chairs Microphone-alt Hilary Libka, Chief IP Counsel | Associate General Counsel, Memorial Sloan Kettering

• Demystifying investor risk assessment, preferences and their target areas for investment or acquisition • What financial valuation methods do investors use?

Cancer Center

• Navigating the balance between risk mitigation and growth potential

Michael Penn, Vice President, IP, BlueRock Therapeutics

• Examining the unique challenges faced by biotech companies in securing funding

Tashica Williams Amirgholizadeh, Ph.D., Senior Associate General Counsel, IP, IP Alliance and Due Diligence (IPADD), Team Lead, Gilead Sciences, Inc. 8:45am

INVESTORS ROUNDTABLE

Navigating the Shifting Tides of Pharma and Biotech Investments: Unraveling Market Dynamics and Strategic Insights for Success Moderator: Brenda Herschbach Jarrell, Ph.D., Partner | Chair of Life Sciences Group, Choate, Hall and Stewart LLP

Microphone-alt Nithya Desikan, Operating Principal, Gurnet Point Capital Luba Greenwood, J.D., Managing Partner, Dana Farber Cancer Institute Venture Fund, Binney Street Capital Matthew S. Rizzo, General Partner, OrbiMed Healthcare Fund Management Mary Lynne Hedley, Ph.D., Venture Partner, Third Rock Ventures In this roundtable, investors will delve into the intricacies of market dynamics and the constantly evolving pharmaceutical and biotech investment climate. By delving into these nuanced topics, attendees will become equipped with a deeper understanding of market dynamics, investment climate challenges, and strategic considerations essential for successful investments in the pharmaceutical and biotech sectors.

» Uncovering strategies to enhance capital availability and attract investor interest • Appreciating how investors are considering the impact of the price control provisions on IP under Inflation Reduction Act in today’s deal-making » How are price controls and patents linked?

• Assessing the dynamics and benefits of investor involvement in different stages of company growth 9:45am

US-EU CROSS BORDER IPDD PART I

Cracking the UPC Code: Exploring the Significance of Unitary Patents and the Unified Patent Court for U.S. IP Due Diligence Strategies Microphone-alt Hon. Rian Kalden, Judge, Court of Appeal, Unified Patent Court Willem Hoyng, Professor, Hoyng Rokh Monegier, Chairman, Advisory Committee of the UPC, Member, Drafting Committee of the UPC As life sciences and technological innovations continue to transcend borders, understanding the implications of this groundbreaking forum becomes paramount for successful due diligence practices.

During this panel designed exclusively for U.S. life sciences IP due diligence practitioners, session leaders will delve into the intricacies of the Unified Patent Court (UPC) and explore its far-reaching impact on the way you conduct IP due diligence, even across the Atlantic.

• Identifying areas of significant M&A activity and emerging investment opportunities in life sciences IP » Considering strategic alliances and royalty monetization • Outlining what investors wish inventors knew before coming to the table » What do investors want to see in patents and IP strategy? » When is the strength of the patent the bottom line and when do other factors (such as regulatory exclusivity or clinical trial results) prevail?

4 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

10:30am Morning Networking Break 10:45am US-EU CROSS BORDER IPDD PART II

Navigating the Key Life Sciences IP Updates Shaping the Landscape of U.S.- EU Deals: Common Cross Border Due Diligence Pitfalls and How to Avoid Them Microphone-alt DeAnn Smith, Partner, Foley Hoag LLP Bo Han, Vice President, Intellectual Property, Orbital Therapeutics Dr. Christian Helbig, Patent Attorney, Hoefer & Partner Patentanwälte mbB It is becoming increasingly imperative to stay well-informed about new IP laws when conducting due diligence. Following the previous session on the unitary patent system, this session will explore other significant global updates before shedding light on common cross-border due diligence pitfalls and providing valuable insights on how to effectively navigate these pitfalls.

• Appreciating the unique factors for IP due diligence U.S.-EU cross border deals: » First right to prosecute; ownership and inventorship » Accounting for differing patent filing fees, and different revival options where the patent has not been maintained in good force » The territorial scope of license grants » Regulatory compliance of the relevant jurisdictions: product approvals, clinical trials, IP rights, the availability of patent term extensions, data privacy laws, export and trade provisions • Best practices for communicating with lawyers in different countries • Understanding when the GDPR applies in due diligence and how to be compliant • Analyzing the use of the SPC waiver provisions and SPC litigation and its reach outside the EU

• Understanding how price negotiation may circumvent pharmaceutical patent values » How is the value of IP impacted when drugs are not approved for Medicare/Medicaid formularies? » How does renegotiation affect the value of the drug’s patent?

• Evaluating the influence of the IRA on mergers, acquisitions, and licensing agreements » Discussing proactive measures to adapt to the IRA and optimize business strategies » Practical strategies for safeguarding IP value when your drug is selected or likely to be selected for negotiation • Interpreting the CMS guidance on the implementation of the IRA • Update on the lawsuits challenging the IRA • Exploring the balance between government control and industry innovation » Analyzing the potential consequences of price controls on patents and profits » Assessing the implications for research and development budgets and innovation » Anticipating long-term effects on portfolio strategies and early-stage companies 12:45pm Networking Lunch 2:00pm

Protecting Innovation and Unleashing Market Opportunities: Best Practices and Strategic Insights for Validity and Scope Analyses Microphone-alt Len S. Smith, Principal, Transformative Legal Adam Poulin-Kerstien, VP of IP, Mersana Therapeutics Henry Gu, SVP, Head of Intellectual Property, Zentalis Pharmaceuticals Lawrence Cogswell, Ph.D., Principal, Hamilton, Brook, Smith & Reynolds P.C.

11:45am

Patents, Price Controls and the IRA: Understanding the Impact of the Inflation Reduction Act on IP Due Diligence Analyses in the Life Sciences Industries Microphone-alt Caitlin E. Olwell, Counsel, Akin Gump Strauss Hauer & Feld LLP Ha Kung Wong, Partner, Venable LLP Jeffrey Kopacz, Senior Vice-President | Head of IP & Contracts, SalioGen Therapeutics The profound implications of the pricing controls in the Inflation Reduction Act (IRA) on pharmaceutical and biotech innovation are of such concern that a lawsuit has been filed, challenging the law’s constitutionality. As such, it is imperative that life sciences IP transactional attorneys understand the affect the IRA is having on profitability, innovation, and deal-making strategies now.

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Topics of discussion will include:

AmericanConference.com/IPDueDiligence • 888 224 2480

The validity and scope analysis in IP due diligence for life sciences transactions serves as a crucial tool to protect investments, safeguard competitive advantage, assess market opportunities, and ultimately – the results may be used to enhance deal negotiations. Conversely, an insufficient validity and scope analysis can have severe consequences because if important aspects are missed or overlooked, gaps or weaknesses in the IP could be exploited by competitors or result in legal challenges, potentially leading to financial losses, disputes, or even the loss of exclusivity.

Therefore, a comprehensive and meticulous validity and scope analysis is essential.

Topics of discussion will include: • Discovering the critical buy side/sell side considerations • Understanding when and why broad antibody claims may be valuable or not to a company and exploring where and what type of competition can be expected in the US vs international » Considering whether “blocking patents” or very broad claims should kill the deal » If the patent is likely invalid, learning how to assess litigation risk and cost Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

• Rethinking patent continuation strategies in light of Sonos Inc. v. Google LLC, 20-06754 WHA, 2023 WL 6542320 (N.D. Cal. Oct. 6, 2023) • Understanding how the scope of the IP assists in evaluating the market opportunities » Strategies for broad functional claims versus genus claims » Dealing with questionable support in the specification • Exploring how to value the portfolio of alternative claims (e.g., MPF, Jepssen) and secondary patents 3:00pm

Leveraging FTO Analyses for Strategic Deal Negotiations: Maximizing Value and Mitigating Risks in Life Sciences IP Transactions Microphone-alt Donna Meuth, Associate General Counsel IP, Eisai Inc.

• Discussing how to potentially assess and value the need for a license » How to approach negotiations 4:00pm

Afternoon Networking Break

4:15pm

The Best and Proven Strategies for Ownership and Inventorship Analyses Microphone-alt Lisa Hillman, Ph.D., Partner, Lathrop GPM Lindsey Wanner, Associate General Counsel, IP Alliance and Due Diligence, Gilead Sciences Inc.

Alicia Russo, Partner, Venable LLP

Nicole Grimm, Legal Director, IP, Alnylam Pharmaceuticals

Erica Norey, Senior Counsel, Intellectual Property for Global Business Development & M&A, Sanofi

Daniel Margolis, Partner, Allen & Overy LLP

In today's competitive landscape, conducting comprehensive freedom-to-operate (FTO) analysis is vital to identify potential patent infringement risks. However, it's equally important to go beyond mere risk assessment and leverage the results of FTO analysis to inform strategic deal negotiations. During this session, topics of discussion will include: • Exploring different types of FTO analysis » Competitor-specific, feature-specific, and comprehensive • Avoiding the pitfall of searching only the claims without due consideration for the details in the specification • The advantages and disadvantages of using patent search software • Cost-efficient strategies for conducting an FTO in a crowded space (e.g., CRISPR) • Knowing the next steps when the target gets sued close to the closing date • Formulating strategies to address potential infringement risks based on claim constructions » Assessing the risk of injunctive relief and quantifying that risk » The importance of going beyond the identification of weaknesses in the IP by proposing appropriate solutions, e.g., contacting the competitor to purchase or license the patent; designing around the competitors patent; or challenging the competitor patent in a post-grant proceeding • What impact will the PTAB reformations proposed by the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act have on the valuation of patents?

Topics of discussion include: • Ensuring that the inventors have been properly listed on the patent application or issued patent: » In the event of errors in non-provisional applications, asking whether an ADS or a continuation application is the better solution » In the event of errors in issued patents, analyzing the best approach for filing a petition to correct inventorship » Reviewing which errors cannot be corrected, and if reissue or reexamination is not available or desirable, how to quantify this risk in the deal • Appreciating foreign filing: » Considering whether the applicant of the PTC is the right owner, whether they have the right to claim priority, and any resulting prior art issues • Verifying whether the patent been maintained in good force » If the patent is not maintained in good force, what are the revival options?

• Determining ownership: have there been valid and inclusive assignments? » Going beyond the licensor and looking to consultants, strategic alliances, CROs, or other third parties for proper assignment » Patent ownership when R&D staff departs • Considering ownership and inventorship for products developed with the assistance of federal funding and the consequences of not complying with the Bayh-Doyle Act 5:15pm

hands-helping Networking Cocktail 6:15pm

Conference Adjourns

6 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

I am honored to co-chair ACI’s 6th Annual Summit on Life Sciences IP Due Diligence here in Boston, where we all have the opportunity to gain valuable insight from a great lineup of panelists well-versed in the field. As we continue to experience challenging capital markets in the pharmaceutical and biotech sectors, join us for a timely discussion related to the interplay of IP with investments, acquisitions and partnering strategies.”

Lock-alt MAIN CONFERENCE DAY TWO Wednesday, November 29

7:30am

Registration and Breakfast

8:30am

Opening Remarks from the Co-Chairs Microphone-alt Hilary Libka, Chief IP Counsel | Associate General Counsel, Memorial Sloan Kettering Cancer Center

Michael Penn, Vice President, IP, BlueRock Therapeutics Tashica Williams Amirgholizadeh, Ph.D., Senior Associate General Counsel, IP, IP Alliance and Due Diligence (IPADD), Team Lead, Gilead Sciences, Inc. 8:40am

BUSINESS LEADER’S ROUNDTABLE

Unlocking IP Valuation: Retrospective Insights from the DealMakers on Working with Outside Counsel and How to Value IP Moderator: Tashica Williams Amirgholizadeh, Ph.D., Senior Associate General Counsel, IP, IP Alliance and Due Diligence (IPADD) Gilead Sciences, Inc. 2023 Conference Chair

Microphone-alt Samir Patel, Associate General Counsel, Global IP, Viatris Jens Bitsch-Norhave, Ph.D., Vice President, Transactions & Innovative Partnering, Johnson & Johnson Michael R. Myers, Ph.D., VP Due Diligence, Eli Lilly & Company In this interactive roundtable, those responsible for greenlighting or killing the deal will share exclusive insights on the importance of IP in deal-making for the life sciences, the factors that influence deal evaluations, and effective communication strategies during negotiations. Topics of discussion will include: • Working with the company’s bottom line: which IP due diligence red flags are deal-breakers, and which are salvageable from the business perspective?

• When is a license the better option over a merger or acquisition » What considerations lead to an M&A vs. a license and/or collaboration?

• What questions outside counsel can ask towards developing an IP opinion that is tailored to the company’s goals and vision

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AmericanConference.com/IPDueDiligence • 888 224 2480

Michael Penn, Vice President, Intellectual Property, BlueRock Therapeutics 2023 Chair

• Exploring the value equation: unraveling the methodologies and considerations for valuing intellectual property assets » What type of valuation consultations or assessments are the most helpful • The key challenges and opportunities in deal-making from the business perspective specific to the life sciences IP due diligence process 9:45am

Bespoke Due Diligence: Tailoring IP Due Diligence to the Transaction to Achieve the Ideal Balance of Diligence Depth and Cost-Efficiency Microphone-alt William Vickery, Director of Due Diligence, Servier Gabriel J. McCool, Ph.D., VP, Legal and IP, ReNAgade Therapeutics Robert H. Underwood, Partner, Hogan Lovells LLP • Assessing the nuanced spectrum of life sciences IP due diligence needs for different transactions (e.g., licensing, M&A) » Identifying key risk factors that demand in-depth examination and scrutiny • Examining the relationship between the thoroughness of a life sciences IP diligence and the mitigation of risks • Employing AI-powered search and screening techniques to detect potential risks and opportunities, while carefully evaluating the cost-benefit ratio of the obtained results • Knowing the right questions to ask stakeholders to establish consensus on the appropriate level of analysis tailored to each transaction • Developing the acumen to adapt the diligence to align seamlessly with evolving timelines or objectives of the transaction » Managing expectations regarding diligence at the outset • Taking into account the concepts of privilege and trade secrecy: » Developing precise guidelines and/or contracts for information sharing and handling of documents between target and acquirer to prevent unauthorized usage or misappropriation of information obtained during the due diligence process 10:45am Morning Networking Break

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

11:00am

12:00pm

Appreciating the Finer Points of IP Due Diligence When the Transaction Involves AI, ML, or Platform Technologies

Exploring the Regulatory Aspect of Life Sciences IP Due Diligence: Examining the Implications of Recent Developments at the FDA on IP Due Dilligence

Microphone-alt Emily Gardel, Associate Director, Patent Attorney, Dyno Therapeutics Rebecca L. Simmons, Ph.D., Counsel, McNeill Baur PLLC Daniel G. Rudoy, Ph.D, Shareholder | Executive Committee Member, Wolf, Greenfield & Sacks, P.C Platform technologies and AI and machine learning (ML) hold great promise for addressing complex diseases. However, the patentability of these technologies remains uncertain, and ownership of the AI model or ML software, the data, and the end product must be carefully diligenced and their value critically negotiated. In this session, topics of discussion include: • Identifying patentability and patent strategies for AI and ML innovations

Microphone-alt Michael Stern, Of Counsel, Covington & Burling LLP Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C Brian Stone, Associate General Counsel, Global Legal-Regulatory, Viatris Topics of discussion will include: • Creating and valuing exclusivity and patent term extension forecasts as part of the IP due diligence » Knowing which questions to ask to determine which patent should ultimately receive the patent term extension • How to navigate orphan drug exclusivity post Catalyst

» Asking where patent protection is the most needed » Considering the timeline for patent approval against the rapidly evolving AI and ML landscape » Analyzing novelty in a saturated space and how to distinguish from the prior art • When does it make sense to generate your own data versus buying data » Considering data bias and strategies towards ensuring the best data set is used » Ensuring that the data is fully owned by the seller, can be used for the purpose you want the data for, and that no data privacy laws have been violated • Best practices for negotiating ownership, inventorship, and royalties » For IP generated through the project, rights to preexisting IP, and parties’ rights upon termination of the collaboration » What if the output or discovery is more lucrative than either party anticipated?

• How to correctly name the inventors when multiple people are involved in developing and running the AI model or ML

» Unpacking Jazz Pharmaceuticals lawsuit against the FDA for granting orphan drug exclusivity to Avadel’s narcolepsy drug on the basis of clinical superiority » CMS’s guidance on orphan drug exclusivity and the IRA’s price control provisions • Learning the current landscape for Orange Book listing requirements as applied to REMS or device patents » Unpacking Jazz Pharmaceuticals lawsuit against Avadel relating to the listability of REMS patents • Strategies to protect against the risk of an expedited withdrawal of approval for patents granted through an accelerated pathway • Understanding the role of FDA classifications and designations in triggering price control negotiations under the Inflation Reduction Act 1:00pm

Networking Lunch

• Considering exclusive and non exclusive licenses and assignments

I am excited to serve as a chair for ACI’s 6th Annual Summit on Life Sciences IP Due Diligence in Boston. Please join us as we hear from an impressive array of panelists providing insightful commentary concerning the state of play in the life sciences sector."

Tashica Williams Amirgholizadeh, Ph.D., Senior Associate General Counsel, IP, IP Alliance and Due Diligence (IPADD), Team Lead, Gilead Sciences, Inc., 2023 Chair

8 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

2:00pm

4:15pm

From Distress to Success: Mastering the Enhanced IP Due Diligence Needed to Safely Acquire Distressed, Yet Promising Life Sciences IP Assets

Demystifying Privilege and Confidentiality in Pre- and PostAcquisition Due Diligence: A Case Study

Microphone-alt Mercedes Meyer, Partner, Banner Witcoff LLP Julia Frost-Davies, Shareholder, Greenberg Traurig LLP Kristin Going, Partner, McDermott, Will & Emery LLP • Understanding the scope of intellectual property assets associated with the distressed company, including patents, trademarks, copyrights, trade secrets, and proprietary technology » Conducting a comprehensive inventory of all IP assets to ensure no valuable IP is overlooked during the acquisition process • Verifying the ownership of IP assets and evaluating any potential challenges or disputes regarding ownership rights » Strategies for investigating the history of IP assignments, licenses, and transfers to ensure proper documentation and compliance with relevant laws • Addressing the enhanced diligence unique to these deals: encumbrances such as liens or security interests; compliance with bankruptcy and insolvency laws; • Stressing the significance of investigating information beyond that provided by the seller: investigating the management team, company history, and geopolitical factors relevant to the transaction • Understanding the need for timely implementation of due diligence processes to accommodate short time constraints in certain deals • Highlighting the risks of undervaluing assets and the need for comprehensive due diligence to assess past performance and insolvency cases towards establishing a fair value for the deal • Considering communication challenges, sensitivities, and language barriers that may arise during the acquisition process » Considerations of disclosure of decks/communications to high levels of the organization (e.g., Executive Committee/Board Members 3:00pm

Networking Break

ETHICS

Microphone-alt Aaron Pereira, Senior Director, Patents, Global IP, Ferring Pharmaceuticals Michael P. Kahn, Partner, Akin Gump Strauss Hauer & Feld LLP Kathleen Gersh, Partner, Loeb & Loeb IP due diligence presents challenging privilege and confidentiality questions arising from the communications between buyer and seller, mainly before the deal is signed but also in the transition period after the deal is signed.

The fast-paced speed with which deals are often concluded also complicates the issue, but parties who inadvertently or erroneously waive privilege or share confidential information for the sake of enticing a buyer may face significant consequences in the future, especially if the deal ultimately falls through and non-protected communications later become discoverable. In this case study, the speakers will take you through the privilege and confidentiality perils in both pre- and post-acquisition.

• Defining attorney-client privilege, confidential information, trade secrets, the work-product doctrine, and the exception: the common interest doctrine » Contrasting cases where the common interest doctrine was or was not upheld by the court • Reviewing all types of communications (emails, memos, powerpoint slides, counsel opinions, etc) and analyzing how and when transmission of same can be considered a waiver of privilege or confidentiality • The importance of discussing and establishing clear procedures at the outset » How will confidential information be used, who will have access to it, and what will be done with the information upon completion of the due diligence?

• Considering confidentiality and non-disclosure agreements • Advising business partners regarding what they can/cannot do with the confidential information obtained • Unpacking the possibility of breaches in the transition period after the deal is signed » To whom is the duty of confidentiality owed in the transition period?

3:15pm

Anti-Trust Enforcement in the Life Sciences: Examining Impact, Trends and Best Practices for Incorporating Anti-Trust into Your IP Due Diligence Checklist Microphone-alt Kevin Noonan, Ph.D., Partner | Co-Chair Biotechnology and Pharmaceuticals Practice Group, McDonell Boehnen Hulbert & Berghoff LLP

• How to maintain confidentiality with respect to Know-How » Considerations when drafting confidentiality agreements and obligations regarding term and disclosure 5:15pm

Conference Concludes

Samantha R. Morelli, Partner, Kirkland & Ellis LLP Since 2022, the FTC and anti-trust division of the DOJ have been increasingly investigating and challenging M&A in the life sciences: the proposed Optum-Amedisys deal; Amgen-Horizon; PfizerSeagen; and Merck-Prometheus, to name a few. This session will explore the anti-trust concerns from these cases and extrapolate their impact on IP due diligence and deal-making for the future.

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AmericanConference.com/IPDueDiligence • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

VENUE: The Westin Copley Place 10 Huntington Avenue, Boston, MA 02116 Phone: (617) 262-9600

BOOK

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s Life Sciences IP Due Diligence”.

Please note that the guest room block cut-off date is November 6, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Accreditation will be sought in those jurisdictions requested by

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CREDITS

This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

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10 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

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Past Life Sciences IP Due Diligence attendees came from: • AMRI

• Futuragene

• MicroVention Inc.

• Allergan plc

• Genentech Inc

• Novartis Pharmaceuticals

• AtriCure Inc

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• Obalon Therapeutics

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• Pieris Pharmaceuticals Inc

• Biogen

• Hikma Pharmaceuticals USA Inc

• Purdue Pharma LP

• Blaze Bioscience Inc

• Immunogen Inc

• Purdue Research Foundation

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• Indivior Inc

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• Brammer Bio

• Intellia Therapeutics Inc

• Roivant Sciences Inc

• Centre for Drug Research and Development

• Ipsen Bioscience Inc

• Sarepta Therapeutics

• Cipla Limited

• Ironwood Pharmaceuticals Inc

• Shire Pharmaceuticals

• Codiak BioSciences

• Jazz Pharmaceuticals

• SmartPharm Therapeutics

• DRI Capital Inc

• Johnson-IP Strategy & Policy Consulting

• Sun Pharmaceutical Industries Ltd

• Dentsply Sirona Inc

• Jounce Therapeutics Inc

• Taro Pharmaceutical Industries

• Eisai Inc

• KSQ Therapeutics Inc

• Teva Pharmaceuticals

• Evolve BioSystems

• MEDRx

• Transformative

• Foghorn Therapeutics

• Merchant & Gould

• VBI Vaccines Inc

• Forma Therapeutics Inc

• Merck & Co

• Wave Life Sciences

And more!

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RELATED EVENTS ACI’s

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Annual Global

LIFE SCIENCES IP SUMMIT

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27 – 28 September 2023 | Munich

October 24 – 25, 2023 | Chicago, IL

28th Annual Conference on

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L I T I G AT I O N

December 5 – 6, 2023 | New York, NY

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