RAYMOND E. STAUFFER

*F Sentinel Court

Chatham, New Jersey 07928

973-***-****

Email: ad2ybn@r.postjobfree.com

ADMISSIONS

Member of the New York Bar

Registered Patent Attorney (U.S. Patent and Trademark Office)

Member of the Federal Bar (U.S. Court of Appeals for the Federal Circuit, S.D.N.Y., and E.D.N.Y.)

EDUCATION

BROOKLYN LAW SCHOOL, Brooklyn, N.Y.

Juris Doctor, June 1997

Honors: Brooklyn Law School Moot Court Honor Society Member

1996 Best Brief Award Judge Conrad B. Duberstein Bankruptcy Moot Court Competition

Activities: Student Law Clerk to Hon. Albert M. Rosenblatt, N.Y. Appellate Division, Second Dept.

Student Law Clerk to Hon. Conrad B. Duberstein, U.S. Bankruptcy Court, E.D.N.Y.

STATE UNIVERSITY OF NEW YORK, COLLEGE AT OLD WESTBURY, Old Westbury, N.Y.

Bachelor of Science in Chemistry, December 1993

Honors: Dean’s List

Certificate and Academic Excellence Award in French

Activities: Student Representative to Committee to Select College’s Vice President

Tutored Chemistry in College’s tutorial program

PROFESSIONAL EXPERIENCE

Mega Aid Pharmacy, Inc., Brooklyn, N.Y. March 2019 - April 2019

General Counsel and Director of Compliance

As General Counsel for multi-location compounding pharmacy and reporting directly to Chief Operating Officer, hold primary responsibility for all legal, regulatory, and risk management matters. Duties include drafting, reviewing, explicating, negotiating, approving, archiving, and administrating all contracts and proposals, including Pharmacy Provider Enrollment Agreements and Amendments and Addenda thereto, Non-Disclosure Agreements, Corrective and Preventative Action Agreements, 340B Pharmacy Agreements, Business Associate Agreements, Corrective Action Plans, Settlement Agreements, Employment Agreements, Commercial Leases, and Corporate Event Liability Waivers; ensuring operational compliance with all federal, state, and city laws, regulations, and codes, including the federal Food, Drug, and Cosmetic Act, the HIPAA and HITECH statutes, and state pharmacy and business laws, and with all relevant Network Provider Manuals and Agreements; maintaining, amending, and updating all necessary insurance coverages, pharmacy and business licenses, corporate filings, accrediting entity certifications, and payer, PSAO, PBM, and HMO credentialing requirements; coordinating pharmacy compliance audits by payers and / or their consultants and challenging findings of same to minimize disbursement clawbacks; providing strategic advice to management on litigation, human resources, contract, and business expansion issues, and on compliance with pharmacy and healthcare industries-related laws including each of the Stark Law, the Anti-Kickback Statute, the Criminal Healthcare Fraud Statute, the False Claims Act, and the Safe Harbor provisions relating to same; managing and directing outside counsel and consultants; interfacing and negotiating with opposing counsel; resolving disputes with payers regarding unajudicated claims and network exclusions; and producing medical records pursuant to HIPAA-compliant requests from patients’ attorneys.

City Drugs Specialty Pharmacy, New York, N.Y. January 2018 - March 2018

General Counsel

As General Counsel for a regional specialty pharmacy licensed and operating in seven states, provided legal advice to executive management team on all matters that affected the Company; negotiated, drafted, and reviewed all proposed contracts and clinical research and development related agreements; managed pharmacy state licensing requirements and renewals; ensured that Company was in compliance with all current business practice laws, including but not limited to the HIPAA and HITECH statutes and regulations; completed and filed state Medicaid provider applications for business expansion opportunities, reviewed and approved all marketing materials; worked with Compliance and Risk Management to respond to payer and pharmaceutical RFPs; raised statutory challenges to Health Plan / PBM actions seeking to collusively exclude the Company from provider networks; litigated as necessary on behalf of the Company; and managed outside litigation counsel and outside consultants.

Cravath, Swaine & Moore LLP, New York, N.Y. July 2017 - August 2017

Contract Attorney

In Biosimilar Price Competition and Innovation Act patent infringement action, brought by plaintiffs AbbVie Inc. and AbbVie Biotechnology Ltd., against clients Amgen Inc. and Amgen Manufacturing Ltd., in response to clients’ submission to FDA of a license application for Amjevita® (adalimumab-atto) as a biosimilar to plaintiffs’ Humira® (adalimumab) reference product for treating multiple inflammatory diseases, reviewed plaintiffs’ discovery request responses for documents relating patent invalidity and unenforceability, using the DocuMatrix (DMXTM ) e-discovery platform.

Windels, Marx, Lane & Mittendorf, Madison, N.J. May 2016 – February 2017

Staff Attorney

In breach of contract action, brought by client license administrator MPEG LA, L.L.C. against defendants Toshiba Corporation and its subsidiary Toshiba America Information Systems, Inc., for unreported and unpaid royalties due under patent portfolio licenses covering the Moving Picture Experts Group (“MPEG-2”)(video data compression and transport) and the Advanced Television Systems Committee (“ATSC”)(terrestrial digital television broadcasting) International Standards, drafted memoranda; reviewed and coded client documents for each of responsiveness, privilege, confidentiality, and sensitivity, and adversary documents for key litigation issues; and prepared privileged document log; using the Relativity® e-discovery platform. In patent infringement action, brought by client Mobile Media Ideas LLC against defendant Samsung Electronics Co., Ltd., for defendant’s importation of Mobile Phones, PC Netbooks, Chrome Books, and Tablets, reviewed patent claims and Samsung User Guides and Specification Sheets and prepared Infringement Contentions relating to same.

Kirkland & Ellis, New York, N.Y. January 2016 – April 2016

Quality Control Contract Attorney

In response to discovery requests from Federal and State authorities relating to litigations and investigations engendered by client Volkswagen’s diesel emissions cheating scandal, reviewed and coded client documents for each of Quality Control, Quality Assurance, and Statistical Quality Assurance with respect to each of responsiveness, privilege, confidentiality, and significance; using the Relativity® e-discovery platform.

Fish & Richardson, New York, N.Y. November 2014 – October 2015

Contract Attorney

In discovery phases of multiple patent infringement and declaratory judgment actions relating to client Gilead Sciences, Inc.’s Sovaldi® (sofosbuvir) and Harvoni® (sofosbuvir & ledipasvir) products, against Abbott Laboratories, Inc. (AbbVie, Inc.), Merck & Co., Inc., and Idenix Pharmaceuticals, Inc., reviewed and coded client documents for each of responsiveness, privilege, confidentiality, and sensitivity, and adversary documents for key patent-related issues; and prepared privileged document log; using the Relativity® e-discovery platform.

Quinn, Emanuel, Urquhart & Sullivan, LLP, New York, N.Y. January 2014 - July 2014

Contract Attorney

In Securities Act of 1933-based litigation brought by client American International Group, Inc. against Bank of America Corporation and its Merrill Lynch & Co., Inc. and Countrywide Financial Corporation subsidiaries in relation to defendants’ fraudulent underwriting, sponsorship, and sale of residential mortgage-backed securities (RMBS), reviewed and coded documents for each of responsiveness, privilege, confidentiality, and sensitivity, using the Relativity® and DocuMatrix (DMXTM ) e-discovery platforms; prepared privileged document log; and reviewed and summarized deposition transcripts.

Carella, Byrne, Cecchi, Olstein, Brody & Agnello, P.C., Roseland, N.J. February 2002 - October 2011

Associate

As a Registered Patent Attorney working directly with General Counsels, IP Directors, and Inventors, from large and small entity corporate clients in the pharmaceutical, chemical, and biotechnology industries, practice was directed to Patent Drafting and Prosecution; Litigation; Opinion Drafting as relates to Infringement, Validity, and Freedom-to-Operate / Freedom-to-Use inquiries; Licensing; Due Diligence analyses; and Counseling on all issues concerning Public Exploitation of Proprietary Patents including product labeling and FDA Orange Book listing, and Competitor Patent / Application Avoidance and Challenge including Interference and Reexamination Proceedings, Protests, and use of the Process Patents Amendments Acts. In addition to managing all aspects of clients’ U.S.-prosecuted patent estates, practice was further directed to advising, assisting, and supervising foreign patent counsels in counterpart prosecutions of National Phases of International Applications filed under the Patent Cooperation Treaty and National Applications filed under the Paris Convention, consistent with controlling foreign law and WIPO’s Manual of Industrial Property Conventions. Pharmaceutical patent estates included products and methods for treating each of coughs and colds; bacterial, fungal, and viral infections; cancer; diabetes; gastrointestinal disorders; and neonatal hyperbilirubinemia; and components for improving oral dosage form production and vaccine efficacy. Chemical patent estates included polyphosphazene polymers useful in fuel-cells and oxo- / thio- acid esters of phosphorus useful for stimulating methane production in subterranean coal seams. Held primary responsibility for all patent needs relating to each of the RYNA - 12®, RYNA - 12 S®, RYNA-12X®, RYNA-C®, RYNATUSS®, RYNATAN®, SINA-12X®, TUSSI-12®, TUSSI-12D®, TUSSI-ORGANIDIN®, ORGANIDIN®, COVANGESIC®, ASTELIN®, OPTIVAR®, SOMA®, FELBATOL®, TAUROLIN®, MOXATAG®, CLARAMOX®, KEFLEX®, NASULIN®, ONYCHOFITEX®, and STANATE® pharmaceutical products; and to each of the PULSYS®, CPE-215®, ADJUMER®, MICROMER®, and PYRADERM® drug delivery platforms.

Fitzpatrick, Cella, Harper & Scinto, New York, N.Y. July 1998 - January 2002

Contract Attorney

In Hatch-Waxman Act patent infringement suits brought by client Warner-Lambert, Co. against multiple generic ANDA filers relating to client’s Neurontin® (gabapentin) product: second chaired depositions; assisted at trials; conducted legal research; prepared pleadings, memoranda of law, and supporting declarations, compliant with local rules; drafted correspondence; prepared privileged document collections and log; and responded to discovery requests. Additionally, in breach of contract / trade secret arbitration concerning the sublicensing of client Iogen Corporation’s enzyme technology by defendant Amoco Corporation’s fuel-ethanol advancement program to third party: conducted legal research; prepared pleadings and memoranda of law; and assisted at depositions, preliminary conferences, arbitration hearings, and federal court confirmation proceedings.

Skadden, Arps, Slate, Meagher & Flom LLP, New York, N.Y. January 1998 - May 1998

Contract Attorney

In Products Liability Dept. defending client Interneuron Pharmaceuticals, Inc. in nationwide Fen-Phen (dexfenfluramine / phentermine) litigations: analyzed and coded incoming pleadings for entry into Case Management System; drafted answers to complaints; and prepared discovery requests and responses.

Phoenix Laboratories International Ltd., Hicksville, N.Y. May 1994 - September 1994

Analytical Chemist

Analyzed the purities of batches of aspirin, acetaminophen, amino acids, vitamins, and pharmaceutical excipients according to U.S. Pharmacopoeia / National Formulary (USP / NF) monographs. Methods of analysis included HPLC; IR, UV / Vis, and AA Spectroscopies; Specific Rotation; Gravimetric Analysis; Nitrogen Content by Kjeldahl Condensation; Assay Titrations; and Wet Chemistry Identifications.

HONORS

Litigator of the Week, The American Lawyer, September 3, 2010, in consideration of Stauffer v. Brooks Brothers, Inc., 619 F.3d 1321 (Fed. Cir. 2010), a landmark patent law decision defining the Constitutional standing of relator plaintiffs to bring qui tam actions under the false marking provisions of the patent statute (35 U.S.C. §292) and strengthening the United States’ right to intervene in such suits. [The precedent is purportedly abrogated by the subsequent enactment of the Leahy-Smith America Invents Act. See Pub. L. No. 112-29, §16(b)].

PROFESSIONAL AFFILIATIONS

Member of the American Intellectual Property Law Association (Voting Member, Committees on: Chemical Practice; Interference; and Licensing and Management of IP Assets)

Member of the Association of the Bar of the City of New York

Member of the American Chemical Society (Member, Section on: Chemistry and the Law)

Member of the New Jersey Intellectual Property Law Association

Member of the American Small Craft (Sailing) Association

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