Life Sciences

Emerging, middle-market and established companies alike require sophisticated legal representation that is cost-effective and capable of responding to the rapidly changing demands of regulators and customers. As counsel to domestic and global life sciences companies at every stage of development, the Life Sciences industry group at McGuireWoods offers clients a single, coordinated team of lawyers with deep, varied experience. Our clients recognize that they are treated as firm clients and not as those of a single practitioner or office location.

We counsel clients in all major areas of law affecting life sciences businesses and at every step in the product lifecycle. We provide guidance on corporate transactions and matters involving company structure and formation, financing, facilities acquisition and leasing, and vendor contracts. We have extensive experience in healthcare and life sciences-related regulatory requirements, including compliance audits and policies, FDA notification and approvals, development of pricing programs, and reimbursement and third-party payor processes.

Regulatory policies walk hand in hand with legislative mandates. In conjunction with our full-service public affairs subsidiary, McGuireWoods Consulting, we provide strategic communications and government relations guidance that helps businesses and industry coalitions shape pending legislation and respond to state and federal initiatives.

When disputes or law enforcement investigations arise, we provide aggressive defense against allegations of theft, product liability and mass torts. We represent clients facing government inquiries and administrative actions involving a broad range of issues, from securities disclosures and financial accounting rules to data privacy, antitrust and other compliance requirements. We also investigate and vigorously pursue counterfeiters, gray marketers and abusers of supply chain systems.

As life sciences businesses grow and transform, capital sourcing and other forms of financing become an important concern. We represent clients in negotiations with private equity investors, commercial banks and other financial institutions. Similarly, our depth of experience in public offerings and middle-market mergers and acquisitions adds value to growth and technology companies when exploring liquidity events.

While life sciences businesses share many of the same concerns as companies in other industries, these issues must be addressed in the context of this highly regulated sector of the economy. Our multidisciplinary team of lawyers provides broad-spectrum, coordinated counsel on all major areas of law affecting clients’ operations and strategy. These core areas of service include labor and employment, intellectual property, state and local taxation, and international trade. Our experience in these and other areas of law enables us to provide prompt, effective counsel in the dynamic life sciences marketplace.

CONTACTS

Timothy H. Kratz Partner T: +1 404 443 5730
Kathleen H. Dooley Partner T: +1 704 343 2347
Raj Natarajan Partner T: +1 704 343 2330

BLOG

FDA Life

Results 1-20 of 101
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RESULTS DEPEND ON A VARIETY OF FACTORS UNIQUE TO EACH CASE. PRIOR RESULTS DO NOT GUARANTEE OR PREDICT A SIMILAR OUTCOME.

Representative Matter

Medical device and pharmaceutical manufacturers

Representation of medical device and pharmaceutical manufacturers in outsourced manufacturing arrangements.
Representative Matter

Various life sciences clients

Counsel clients regarding Medicare and Medicaid Anti-Kickback issues, Medicare coverage and payment issues, and HIPAA issues raised by the storage, receipt or transmission of patient health information.
Representative Matter

Pharmaceutical and medical device contract manufacturers

Regularly represent pharmaceutical and medical device contract manufacturers in negotiation of outsourced manufacturing agreements for medical devices, pharmaceuticals and biotech products.
Representative Matter

Former general counsel of large pharmaceutical services and products company

Represent former general counsel of large publicly traded provider of pharmaceutical services and products in False Claims Act, and related criminal investigation involving allegations of illegal purchasing arrangement with manufacturer of pharmaceuticals.
Representative Matter

Generics pharmaceutical company

Defended generics pharmaceutical company against patent infringement claims asserted in lawsuits filed in the U.S. District Court for the Northern Districts of Illinois and the Northern District of West Virginia by the manufacturer of the brand name treatment for seizure disorders utilizing the active ingredient divalproex.
Representative Matter

World-class academic and health care system

Represent world-class academic and health care system in multi-plaintiff litigation arising from allegations that falsified genomic research was allowed to proceed to clinical trials with the enrollment and treatment of cancer patients.
Representative Matter

Investment in a manufacturer and distributor of laboratory equipment

Representation of a F.N.B. Capital Partners in connection with its investment in a manufacturer and distributor of laboratory equipment.
Representative Matter

Mezzanine fund

Represented a provider of mezzanine capital in its mezzanine investment in a lab company, which the lab company used to help fund an acquisition.  
Representative Matter

One of the world's leading suppliers to the life science industries

Represented one of the world's leading suppliers to the life science industries, based in Switzerland, in the acquisition by tender offer of an NYSE-traded chemicals company for $1.2 billion.
Representative Matter

Indiana-based bank owned SBIC Fund

Representation of an Indiana-based bank owned SBIC Fund on a bridge financing in a developer of drugs for ovarian and lung tumors.
Representative Matter

Leading generic and specialty pharmaceutical company

After a three week jury trial, obtained a unanimous defense verdict for one of the world's leading generic and specialty pharmaceutical companies.
Representative Matter

Leading generic and specialty pharmaceutical company

Representation of a pharmaceutical manufacturer in a wrongful death case, obtaining a defense verdict after an hour of deliberation.
Representative Matter

Major life sciences organization

Advising on UK data protection requirements in relation to medical research and patient records for drug trials, working as part of a team of European lawyers to provide coordinated advice to a major life sciences organisation.
Representative Matter

Fortune 500 pharmaceutical company

Represented a Fortune 500 pharmaceutical company in negotiating Microsoft's Business Agreement, Enterprise Agreement, Service Agreement and Select Agreement.  
Representative Matter

Administrative agent and lead arranger

Represented the administrative agent and lead arranger in connection with a $47 million senior secured credit facility for a leveraged buyout of a suture products distributor.
Representative Matter

Administrative agent and lead arranger

Represented the administrative agent and lead arranger in connection with a $1 billion senior secured credit facility for a designer and manufacturer of orthopedic implants.
Representative Matter

Administrative agent and lead arranger

Represented the administrative agent and lead arranger in connection with a $55 million senior credit facility for a manufacturer of reagents and other pharmaceutical research products.
Representative Matter

Administrative agent and lead arranger

Represented the administrative agent and lead arranger in connection with the provision of a $110 million senior secured syndicated credit facility for a specialty pharmaceutical company.
Representative Matter

Administrative agent and lead arranger

Represented the administrative agent and lead arranger in connection with a $95 million senior secured credit facility for a surgical equipment manufacturer.
Representative Matter

Administrative agent and lead arranger

Represented the administrative agent and lead arranger in connection with $600 million senior secured credit facilities for a national physician practice management company.
Results 1-20 of 101
Results 1-25 of 92
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Brad Alexander Brad L. Alexander
Sr. VP and Director, Georgia Gov. Relations McGuireWoods Consulting LLC
100 Peachtree Street, N.W.
Suite 2200
Atlanta, GA 30303-1931

T: +1 404 443 5811
F: +1 404 443 5682
vCard
Ashley Allen Ashley K. Allen
Counsel
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1918
F: +1 804 775 1061
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Mark E Anderson Mark E. Anderson
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 919 755 6678
F: +1 919 755 6581
vCard
Brian D Barger Brian D. Barger
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2072
F: +1 704 343 2300
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George J Barry III George J. Barry III
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5734
F: +1 404 443 5753
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Evan Bayh Evan Bayh
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 828 2825
F: +1 202 828 3331
vCard
Scott Becker Scott Becker
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 6016
F: +1 312 920 6135
vCard
Kenneth D Bell Kenneth D. Bell
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 373 4620
F: +1 704 373 8836
vCard
Samuel C Bernstein Samuel C. Bernstein
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8222
F: +1 312 698 4571
vCard
William J Boddy William J. Boddy
Associate - Solicitor Advocate
11 Pilgrim Street
London EC4V 6RN
United Kingdom

T: +44 20 7632 1625
F: +44 20 7632 1638
vCard
Ginny Boland Ginny Boland
VP, MWCAdvocacy McGuireWoods Consulting LLC
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1907
F: +1 804 775 1061
vCard
Ryan Bonistalli Ryan E. Bonistalli
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1014
F: +1 804 698 2036
vCard
Alex J Brackett Alex J. Brackett
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 4749
F: +1 804 698 2089
vCard
Caitlin Bradley Caitlin O. Bradley
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1126
F: +1 804 698 2031
vCard
Bryan C Brantley Bryan C. Brantley
Partner
EQT Plaza
625 Liberty Avenue
23rd Floor
Pittsburgh, PA 15222-3142

T: +1 412 667 7983
F: +1 412 667 7971
vCard
William Bushman William G. Bushman
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

T: +1 804 775 1806
F: +1 804 775 1061
vCard
Holly Carnell Holly Carnell
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 3687
F: +1 312 698 4504
vCard
Charles D. Case
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

T: +1 919 755 6698
F: +1 919 775 6675
vCard
Jeffrey J Chapman Jeffrey J. Chapman
Partner
1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 212 548 7060
F: +1 212 715 6277
vCard
Geoffrey C Cockrell Geoffrey C. Cockrell
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8272
F: +1 312 698 4572
vCard
J. D Costa J. D. Costa
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2236
F: +1 704 353 6192
vCard
Dave Dargatis David G. Dargatis
Senior Counsel
1750 Tysons Boulevard
Suite 1800
Tysons, VA 22102-4215

T: +1 703 712 5080
F: +1 703 712 5050
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Patrick A De Ridder Patrick A. De Ridder
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

11 Pilgrim Street
London EC4V 6RN
United Kingdom

T: +1 804 775 4369
F: +1 804 698 2221
vCard

T:+44 20 7632 1716
F: +44 20 7632 1638

Kathleen H Dooley Kathleen H. Dooley
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2347
F: +1 704 444 8755
vCard
William E. Doyle Jr.
Partner - Not Admitted in NC; Practice Limited to Federal Law Matters
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 919 755 6690
F: +1 919 755 6602
vCard
Results 1-20 of 39
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Event

8th Annual Pharmaceutical and Medical Device Conference

November 10, 2016
Chicago, IL
Speaking Engagement

2016 Danish Biotech Conference

April 12-13, 2016
New York, NY
Event

7th Annual Medical Device and Life Sciences Conference

November 19, 2015
Chicago, IL
Event

6th Annual Medical Device and Life Sciences Conference

November 18, 2014
Chicago, IL
Speaking Engagement

Europe v. U.S. Food, Drug, Device & Tobacco Regulation & Policy

November 14, 2014
Brussels
Speaking Engagement

AdvaMed 2014: The MedTech Conference

October 7, 2014
Chicago, IL
Speaking Engagement

Legal and Regulatory Summit on Generic Drugs

July 24-25, 2014
New York, NY
Event

Healthcare Litigation Conference

May 29, 2014
Richmond, VA
Event

Healthcare Litigation Conference

April 8, 2014
Chicago, IL
Event

Healthcare Litigation Conference

April 8, 2014
Chicago, IL
Event

Corporate Integrity Agreements

January 31, 2013
Complimentary Webinar
Results 1-20 of 39
Results 1-20 of 173
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Legal Alert

To BREXIT or Not to BREXIT? That is the Question.

But What are the Consequences?

June 21, 2016
Legal Alert

Patent Settlement Update for Pharmaceutical Cases in Europe

FDA Life
January 12, 2016
Legal Alert

FDA Finalizes First Two Rules Under FSMA

September 14, 2015
Results 1-20 of 173