Brochure Available Now - IP Due Diligence Summit

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a C5 Group CompanyBusiness Information in a Global Context

ACIAmerican Conference InstituteBusiness Information in a Global Context

In this unique, interactive forum, preeminent IP practitioners, in-house counsel, and industry leaders will discuss best practices and tips for completing a thorough, cost-effective due diligence analysis in today’s evolving life sciences climate. Our stellar faculty will help you:

� ASSESS scope, validity, and enforceability in light of the current patent rules and regulations

� APPLY recent case law, legislation, and influence of post-grant proceedings into your due diligence practices

� EXPLORE the patent landscape by conducting effective freedom to operate analyses

� UNCOVER potential ownership and inventorship inconsistencies

� PROTECT attorney-client privilege while avoiding contamination during the review

American Conference Institute’s Summit on

IP Due DiligenceComprehensive and Practical Tips for Pharmaceutical, Biotechnology, and Medical Device Professionals

Mock fact pattern will lay the foundation for this innovative, interactive two-day conference

Gain Key Insights from Industry Leaders from

Biogen Inc.

Blaze Bioscience, Inc.

BŌNWRx Ltd.

Dr. Reddy’s Laboratories Ltd.

Eisai Inc.

Heliae Development LLC

Immunogen Inc.

Ipsen Bioscience Inc.

Jounce Therapeutics

Merck & Co. Inc.

Microvention, Inc.

Novartis Pharmaceuticals Corp.

Shire Pharmaceuticals

Teva Pharmaceuticals

VBI Vaccines Inc.

November 2–3, 2017 | Hyatt at the Bellevue | Philadelphia, PA

Distinguished Co-Chairs:

Adda GogorisPartnerHueschen & Sage PLLC(Kalamazoo, MI)

Tom IrvingPartnerFinnegan, Henderson, Farabow, Garrett & Dunner LLP(Washington, DC)

Jennifer Zarutskie Sieczkiewicz, Ph.D.Associate General Counsel, CorporateBiogen Inc.(Cambridge, MA)


EARN CLE/ETHICSCREDITS

Sponsored by:

http://AmericanConference.com/IPDueDiligence


Join the Conversation @ACI_Pharma #IPDUEDILIGENCE ACI: Pharmaceuticals/Biotech/Life Sciences

SPEAKING FACULTY

With more than 300 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world.

As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation.

For more information about this program or our global portfolio of events, please contact:

Wendy TylerDirector of Sales, American Conference InstituteTel: 212-352-3220 [email protected]

Global Sponsorship Opportunities

Continuing Legal Education Credits


Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

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

ACI certifies that this activity has been approved for CLE credit by the State Bar of California.

You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4–8 weeks after a conference is held.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.AmericanConference.com/CLE

ACI is proud to introduce this one-of-a-kind, interactive forum where top diligence experts discuss best practices and strategies on how to successfully execute a proper due diligence analysis, both for your own portfolio, and for potential targets.

Over the past few years, with many blockbuster drug patents expiring, R&D pipelines drying up, and the evolving challenges for patenting life-sciences inventions, many have coined the current landscape

as “anti-patent.” As a result, there has been a steady increase in companies looking to collaborate and close deals to protect their assets, maintain market share, and maximize the life of their patent portfolios.

In response to the challenging patent landscape surrounding the pharmaceutical, biotechnology, and medical device industries, ACI has pioneered a conference tailored specifically to professionals involved with intellectual property due diligence for life sciences inventions. Our Life Sciences IP Due Diligence Summit is a unique gathering place for key stakeholders to learn the best strategies and tips to map out and conduct a successful and cost-effective due diligence analysis.

You don’t want to miss out on the opportunity to participate in our interactive mock fact pattern, which will flow through the 2-day event as we address the common due diligence challenges keeping you up at night. Whether you are on the acquiring or target side, our stellar faculty will provide you with specific strategies you can immediately incorporate into your practice.

To further enhance your learning and networking experience, join our in-depth post-conference workshop: Best Practices for Managing the Entire Due Diligence Process from Both Perspectives

Register today by calling 888-224-2480 or by visiting www.AmericanConference.com/IPDueDiligence.

I hope you can join us in November.

Best,

Julie KurzrokLegal Analyst & Conference Director

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SPEAKING FACULTYAndrew AllenDirector, Legal Counsel-Intellectual PropertyDr. Reddy’s Laboratories Ltd. (Princeton, NJ)

Erin J.D. AustinAttorneyFitzpatrick Cella Harper & Scinto (New York, NY)

Matthew BlischakVice-President and General Counsel, Global Specialty IP LitigationTeva Pharmaceuticals (Horsham, PA)

Ralph W. CarmichaelChairman & Chief Executive OfficerBŌNWRx Ltd. (Lansing, MI)

Jeremy CubertPartnerVLP Law Group LLP (Gaithersburg, MD)

Catherine EckenswillerLegal Counsel – Intellectual Property & AgreementsVBI Vaccines Inc. (Ottawa, CA)

Jeffrey EllisonPartnerClark & Elbing (Boston, MA)

Margo Furman, Ph.D.IP Counsel, R&D and New ProductsShire Pharmaceuticals (Lexington, MA)

Adda GogorisPartnerHueschen & Sage PLLC (Kalamazoo, MI)

Drew Holmes, Ph.D.Patent Attorney, I&D, NS & Ophthalmology PatentsNovartis Pharmaceuticals Corp. (East Hanover, NJ)

Tom IrvingPartnerFinnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Jennifer K. Johnson, J.D.Head of Legal & Intellectual PropertyBlaze Bioscience, Inc. (Seattle, WA)

Joseph Kenny, Ph.D., J.D.Vice President, Intellectual PropertyImmunogen Inc. (Waltham, MA)

Amy Gallup KlannCounselLeason Ellis LLP (White Plains, NY)

Janice KlunderVice President - Intellectual Property Endocrinology Research & Development PeptidesIpsen Bioscience Inc. (Cambridge, MA)

Forrester LiddleDirector of Intellectual PropertyJounce Therapeutics (Cambridge, MA)

Jane M. Love, Ph.D.Partner, IP LitigationGibson, Dunn & Crutcher LLP (New York, NY)

Donna MeuthAssociate General Counsel- Intellectual PropertyEisai Inc. (Andover, MA)

Mercedes K. Meyer, Ph.D., J.D.PartnerDrinker Biddle & Reath LLP (Washington, DC)

Douglas PortnowPartnerWilson Sonsini Goodrich & Rosati (Palo Alto, CA)

Barbara A. Ruskin, Ph.D., J.D.Legal Counsel, Life Sciences Intellectual Property SpecialistBA Ruskin Law LLC (New York, NY)

Jennifer Zarutskie Sieczkiewicz, Ph.D.Associate General Counsel, CorporateBiogen Inc. (Cambridge, MA)

Len SmithChief Business OfficerHeliae Development LLC (Gilbert, AZ)

N. Nicole StakleffPartnerPepper Hamilton LLP (Pittsburgh, PA)

Paul S. Tully, Ph.D.PartnerMcDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

Letitia WalkerLegal Director - PatentsMerck & Co., Inc. (Rahway, NJ)

Ha Kung WongPartnerFitzpatrick Cella Harper & Scinto (New York, NY)

Richard YoonDirector of IPMicrovention, Inc. (Tustin, CA)

��

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For over 30 years, C5 Group has provided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.




Conference Day 1Thursday, November 2, 2017

7:00

Registration and Continental Breakfast

8:00

Co-Chairs’ Opening Remarks and Laying Out Hypothetical Deal ScenarioAdda GogorisPartnerHueschen & Sage PLLC (Kalamazoo, MI)

Tom IrvingPartnerFinnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)


In this welcome session, our co-chairs will summarize the facts of the hypothetical deal scenario that will lay the groundwork for the main conference. The interactive sessions of the main conference will track the facts provided in the mock diligence scenario, and with the aid of the provided background paperwork, our speakers will examine the various aspects of due diligence both from the acquirer (“suitor”) and the target points of view. The co-chairs will encourage questions and comments during the sessions to bolster the learning environment.

8:30

Preparing the Due-Diligence Checklist and Forming your TeamMargo Furman, Ph.D.IP Counsel, R&D and New ProductsShire Pharmaceuticals (Lexington, MA)


Ha Kung WongPartnerFitzpatrick Cella Harper & Scinto (New York, NY)

For this session, we will divide the audience into small groups and each group will design a diligence team and prepare a checklist based on the provided fact pattern. One representative from each group will present the team’s checklist, and our panel of diligence experts will discuss the most important aspects of creating a cost-effective, practical roadmap as well as determining and selecting the best/most effective team members. Due diligence investigations are essentially open-ended, but need to produce a specific output — an assessment of the risks the business will have to manage in this transaction should it complete the deal.

10:00

Grab Some Coffee and Business Cards

��Conference Day 1�Conference Day 1Thursday, November 2, 2017�Thursday, November 2, 2017

10:15

Analyzing the Current Patent Landscape: AIA, Post-Grant Proceedings, Evolving Jurisprudence, and the Effects on Patent StrengthMatthew BlischakVice-President and General Counsel, Global Specialty IP LitigationTeva Pharmaceuticals (Horsham, PA)

Adda GogorisPartnerHueschen & Sage PLLC (Kalamazoo, MI)

Donna MeuthAssociate General Counsel - Intellectual PropertyEisai Inc. (Andover, MA)

• Verifying proper choice-of-law employed during prosecution of post-AIA claims, particularly in the case of “mixed applications” governed by AIA transition provisions 3(n)(1) and 3(n)(2)

• Ensuring proper declarations were filed in view of pre- and post-AIA requirements

• Balancing the pros and cons of initiating an IPR vs. PGR. vs. obtaining an invalidity opinion » Evaluating the lower burden for PTAB proceedings and the

relationship with parallel district court/Federal Circuit proceedings• Eyeing the challenges underlying patent term extension• Investigating induced infringement post Halo• Diving into divided infringement and method claims• Evaluating patent eligibility issues for bioproduct claims

11:15

Uncovering Red Flags in Ownership and InventorshipJeremy CubertPartnerVLP Law Group LLP (Gaithersburg, MD)

Catherine EckenswillerLegal Counsel - Intellectual Property & AgreementsVBI Vaccines Inc. (Ottawa, CA)

Len SmithChief Business OfficerHeliae Development LLC (Gilbert, AZ)

• Establishing chain of title and present patent owner » Sovereign immunity issues in AIA proceedings involving

university inventors and university rights » Identifying proper inventorship

� Reviewing how target acquired the IP and possible additional interests

» Verifying all assignments have been properly and timely executed and recorded � Attempting to correct missing assignments � Unique issues with university-related assignments � Date of assignment, number of inventors, and right

to claim priority under EPO law. UK national law, and other international jurisdictions

• Assessing potential third party rights » Performing a title search to uncover potential liens » Existence of sublicenses to unrelated parties » Reviewing all collaborative agreements, license agreements,

supply and distribution agreements and any other agreements as well as private grants affecting the target’s IP rights

» Assessing whether government funding has been involved and appropriately disclosed

» Missing inventors: assignees or licensees may not infringe

12:15

Luncheon



1:30

Diving into the Patent Portfolio: Examining the Scope, Patentability, Validity, and EnforceabilityAndrew AllenDirector, Legal Counsel-Intellectual PropertyDr. Reddy’s Laboratories Ltd. (Princeton, NJ)

Jeffrey EllisonPartnerClark & Elbing (Boston, MA)

Forrester LiddleDirector of Intellectual PropertyJounce Therapeutics (Cambridge, MA)

• Evaluating patent strength in light of recent jurisprudence » Analyzing ability to withstand judicial and technical challenges » Keeping up with the evolving § 101 standard » Effect of obvious-type double patenting on patent term post-Gilead

• Considering depth and breadth of patent coverage » Ensuring the patent covers the commercialized product » Confirming the broadness of the claims satisfy the desired scope » Reviewing specification for available options to expand claim scope » Making sure the worldwide portfolio meets your needs and no

key jurisdictions are missing• Reviewing Orange Book listings, eligibility, and potential

regulatory roadblocks• Determining eligibility for patent term extension• Ensuring the patent/application is consistent with the information

in the invention disclosure » Determining if any missing information has been publicly disclosed

or sold• Pondering pending legislation re: exclusivity for NCE, orphan drugs,

biologics, and antibiotics (GAIN Act exclusivity)• Confirming the granted or patentable pending claims actually cover

the commercial embodiment to be developed and sold• Eyeing enforceability

» Reviewing pending or concluded litigation involving the patent » Potential exclusivity challenges and timing of exclusivity challenges » Evidence of possible inequitable conduct » Spotting possibility of divided infringement

2:30

Focusing on Freedom to Operate: Analyzing the MarketN. Nicole StakleffPartnerPepper Hamilton LLP (Pittsburgh, PA)

Letitia WalkerLegal Director - PatentsMerck & Co., Inc. (Rahway, NJ)

Richard YoonDirector of IPMicrovention, Inc. (Tustin, CA)

• Sizing up the competition: locating the relevant players in the space » Examining potential third-party blocking patents

� Weighing the risk of infringement and potential injunction � Collecting proper search terms and identifying search forums

for an extensive infringement analysis• If there is no commercialized product

» Utilizing figures in the patent representing the commercialized product

» Ability to obtain a product sample to perform FTO analysis• Investigating whether infringement searches and analyses were

already conducted and whether written opinions were obtained• Examining license/assignment agreements, settlement agreements,

employment and consulting agreements, and active litigations

3:30

Afternoon Networking Break

3:45

Deals Gone Wild: Real-Life Horror Stories of IP Due Diligence MisstepsErin J.D. AustinAttorneyFitzpatrick Cella Harper & Scinto (New York, NY)

Jennifer K. Johnson, J.D.Head of Legal & Intellectual PropertyBlaze Bioscience, Inc. (Seattle, WA)

In this interactive panel, our expert faculty will discuss real-life examples of deals that failed miserably as a result of IP due diligence or where a lack of thorough due diligence prevented the deal from going through, or worse, ending up in debilitating litigation. The discussion will focus on what happened during the due diligence process, during the life of the deal, what ended up killing the deal, and how these issues can be avoided. Our panelists will also discuss current litigations resulting from failed due diligences.

5:00

Conference Adjourns to Day 2

Conference Day TwoFriday, November 3, 2017

8:00

Continental Breakfast

8:45

Co-Chairs’ Opening Remarks and Recap of Day One

9:00

Show Me the Money: Strategies to Overcome Valuation ChallengesRalph W. CarmichaelChairman & Chief Executive OfficerBŌNWRx Ltd. (Lansing, MI)

Janice KlunderVice President - Intellectual Property Endocrinology Research & Development PeptidesIpsen Bioscience Inc. (Cambridge, MA)

Paul S. Tully, Ph.D.PartnerMcDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

• Aligning with business team on business reason for the deal and where they are placing the value » Effectively summarizing the IP risks while considering the broad,

overall goal » Comparing methods for early vs. late-stage transactions » Working with inside business teams vs. outside personnel

��Conference Day Two�Conference Day TwoFriday, November 3, 2017�Friday, November 3, 2017



HOTEL INFORMATION

Hotel: Hyatt at the BellevueAddress: 200 South Broad St., Philadelphia, PA 19102Telephone: (888) 233-1234Online: AmericanConference.com/IPDueDiligence/Venue

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate. Please contact the hotel directly and mention “ACI’s IP Due Diligence” conference to receive this rate. Alternatively, delegates can book online via the link above.

SAVE ON YOUR STAY!

• Impact of the Affordable Care Act and the current state of drug pricing• Best practices for working with VCs• Reviewing regulatory and exclusivity risks

» Analyzing evolving case law, political dynamics, healthcare legislation• Possible deductions to the proposed value

» Questionable ownership » Patent not covering commercial product » Infringement dangers from marketing product » Other diminishments of patent strength such as possibility

of inequitable conduct• Pushing forward despite a negative diligence

» Addressing and shifting risk in the agreement » Representations and warranties » Evaluating if the product or company is of value without the IP

� Determining if you can recoup investment selling the product as is

10:15

Grab Some Coffee and Business Cards

10:30

Pursuing Trade Secret Protection in the Current Anti-Patent ClimateJoseph Kenny, Ph.D., J.D.Vice President, Intellectual PropertyImmunogen Inc. (Waltham, MA)

Mercedes K. Meyer, Ph.D., J.D.PartnerDrinker Biddle & Reath LLP (Washington, DC)

• Ensuring company has a robust, up-to-date trade secret procedure » Keeping internal procedures on a need-to-know basis

� Compartmentalizing your portfolio so no single person has access to everything

• Checking if ownership issues impact trade secret protection » Does company have a consulting agreement with the inventor » Is the invention already licensed to a competitor of the

potential partner• Minimizing risk of trade secret misappropriation

» Keeping proper employment agreements and maintaining assignment records

• Impact of Defense Trade Secrets Act

11:30

Attorney-Client Privilege, Contamination, and Ethical ChallengesDrew Holmes, Ph.D.Patent Attorney, I&D, NS & Ophthalmology PatentsNovartis Pharmaceuticals Corp. (East Hanover, NJ)

Jane M. Love, Ph.D.Partner, IP LitigationGibson, Dunn & Crutcher LLP (New York, NY)

Barbara A. Ruskin, Ph.D., J.D.Legal Counsel, Life Sciences Intellectual Property SpecialistBA Ruskin Law LLC (New York, NY)

• Avoiding conflicts when evaluating confidential information » Considering outside counsel to limit exposure

� Avoiding temptation to use confidential diligence information in litigation

» Compartmentalizing the process so no single actor has access to all information

» Reviewing and updating internal employment agreements » Unique challenges arising with international parties » Utilizing common interest agreements

• Obtaining invalidity and non-infringement positions » Discussing these opinions with the other side » Privilege issues and common or identical legal interest agreements » Drafting opinions internally or farming out

• Dealing with tough ethical decisions while working with less-sophisticated parties » Considering disclosure of negative information

• Setting up e-rooms for confidential data storage » Controlling access to the e-room and how data can be downloaded

and use » Deciding features of e-room

� User permissions - Restrictions on downloading/forwarding material

� Access points » Ensuring ability to permanently delete data immediately

when finished• Using a neutral third-party evaluator to retain both sides’ privilege

12:30

Networking Luncheon for Workshop Participants


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Payment PolicyPayment must be received in full by the program date to ensure admittance. All discounts will be applied to the Program Only fee (excluding add-ons), cannot be combined with any other offer, and must be paid in full at time of order. Group discounts available to 3 or more individuals employed by the same organization, who register at the same time.

Terms and Conditions

Registration Type Register & Pay by September 15, 2017

Register & Pay after September 15, 2017

Conference and Workshop $2695 $2895

Conference Only $2095 $2295

All program participants will receive an online link to access the conference materials as part of their registration fee.

Startup and non-profit rates available. Contact customer service for more information Special DiscountACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

Delegate Substitutions and CancellationsYou must notify us by email at least 48 hrs in advance of the conference if you wish to send a substitute participant. If you are unable to find a substitute, please notify us in writing no later than 10 days prior to the conference date. All cancellations received will be subject to a cancellation fee of $350. Delegates opting to receive a credit voucher will receive a credit for the full amount paid, redeemable against any other American Conference Institute conference in the next 12 months.

No credits or refunds will be given for cancellations received within 10 days of the conference start date. Delegates may not “share” a pass between multiple attendees without prior authorization. No liability is assumed by American Conference Institute for changes in program date, content, speakers or venue. American Conference Institute reserves the right to cancel any conference it deems necessary and will, in such event, make a full refund of any registration fee, but will not be responsible for airfare, hotel or other costs incurred by registrants.

Registration Information 657L18-PHIConference Code

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3 - 4 10% Conference Discount

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Post-Conference WorkshopFriday, November 3, 2017

2:00–5:00 pm (Registration begins at 1:30 pm)

Best Practices for Managing the Entire Due Diligence Process from Both Sides’ PerspectivesAmy Gallup KlannCounselLeason Ellis LLP (White Plains, NY)

Douglas PortnowPartnerWilson Sonsini Goodrich & Rosati (Palo Alto, CA)

This intimate and interactive workshop will cover the ins and outs of the challenges faced by both acquirers and targets. For the target company, the most challenging issues are being noticed by suitable acquirers, and getting their “IP house” in order. Being on top of your IP portfolio is crucial to putting the acquirer at ease, making them more likely to consummate the deal.

For the acquirer, it is all about doing a thorough, cost and time-effective analysis of the target’s portfolio without leaving any crucial stones unturned. However, the biggest challenge can be how to perform the diligence economically when a wrong decision at this stage can end up costing billions of dollars down the road.

This Master Class will provide practical and detailed guidance for both sides on how to plan for and complete an effective due diligence review. Get answers to all of the questions keeping you up at night:

• Reviewing and understanding the entire patent portfolio » Deciding what claims are valuable to whom

and why » Performing objective review of portfolio

to prepare for acquirer’s questions while considering how closely to guard privilege issues

» When issues arise, what to do, identify them up front vs. wait until the potential buyer asks? Timing of identification

• Evaluating what the other side is looking for, drafting a plan to get there

• Determining how to spend limited resources while maximizing value

• Forming your FTO position

• Inspecting the target’s house and identifying red flags » Determining who has the information you want

and how to obtain it efficiently. How to ask? When to ask? If you don’t get it, then what do you do?

• Benefits of using in-house vs. outside counsel for the IP review

• Evaluating risks posed and whether they are deal-killers or can be addressed through reduction in valuation

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Mock fact pattern will lay the foundation for this innovative, interactive two-day conference

REGISTRATION CODE

Attention MailroomIf undeliverable to addressee, please forward to: In-House Counsel, Patent Counsel, Chief IP Attorney, VP Intellectual Property

Update your Contact InformationIf you would like us to change any of your details, please email [email protected] And reference the conference code on the brochure.

American Conference Institute45 West 25th Street, 11th FloorNew York, NY 10010

B00-657-657L18.E


Gain Key Insights from Industry Leaders fromBiogen Inc.

Blaze Bioscience, Inc.

BŌNWRx Ltd.

Dr. Reddy’s Laboratories Ltd.

Eisai Inc.

Heliae Development LLC

Immunogen Inc.

Ipsen Bioscience Inc.

Jounce Therapeutics

Merck & Co. Inc.

Microvention, Inc.

Novartis Pharmaceuticals Corp.

Shire Pharmaceuticals

Teva Pharmaceuticals

VBI Vaccines Inc.

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