1. Outsourced General Counsel
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An innovative approach of the legal function for
innovative companies involved in life sciences

2. 1 – Life sciences companies face
multiple legal challenges

3. • Innovative companies involved in life sciences have their
own expertise and development path;
• Some of them face the difficulties proper to start-up
companies, related to their creation and development;
• They face in the same time the intricacies of the
pharmaceutical and medical regulations applying to their
activities at any level;
• Life sciences industries need informed counsels.
Life sciences industries need tailored legal
services
Outsourced general counsel
Innovative approach of the
legal function
3
Life sciences companies face
various kinds of legal challenges

4. Usual management of the legal topics
4
Life sciences companies face
various kinds of legal challenges
Outsourced general counsel
Innovative approach of the
legal function

5. Life sciences companies face
various kinds of legal challenges
Life sciences industries face multiple challenges
5
As companies
Challenges: corporate law, contract
law, management of the relationship
with multiple service providers (head-
hunters, software developers,
consultants, etc), employment law,
data privacy
Opportunities: development of
distribution networks, multiple
partnerships and subsidiaries,
collection and treatment of big data,
marketing 2 and 3.0, recruitment of
new collaborators
As Life Sciences
industries
Challenges: clinical trials, marketing
authorisations, reimbursement
prices, parallel imports, generics
and biosimilars, adverse events
Opportunities: progresses of
biology and genomics, orphan
treatments and personalised
therapies, new technologies for
medical devices, booming of
biomaterials and 3D-printing
For their usual management and growth, these companies need to
have partners providing them back-office legal services.
Outsourced general counsel
Innovative approach of the
legal function

6. 2 – Life sciences companies need
informed general counsels

7. Outsourced legal counsel:
tailored legal services
Within a company, the general counsel is both a
body guard and a Swiss army knife
7
PROTECTING
PREVENTING
S W I S S AR M Y K N I F E SOLVINGCOOPERATIN
G
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G
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Profile of a general
counsel
Outsourced general counsel
Innovative approach of the
legal function

8. • The general counsel is a problem solver, cooperating with all the
departments of the company;
• The general counsel participates to the risk prevention and protects
both the company and its managers;
• The general counsel is listening to his/her colleagues; as a
consequence, he/she is curious of them, their jobs, their challenges;
• The general counsel knows how to manage information, what to keep
for himself/herself, what to share with whom within his/her environment,
how, and when;
• The general counsel is responsive.
What are the qualities of a general counsel?
Profile of a general
counsel 8
Outsourced general counsel
Innovative approach of the
legal function

9. • Life sciences companies should be assisted by legal
advisors who:
– Understand what their own expertise and development path are;
– Can take on the legal intricacies these companies are facing;
– Can put at their disposal a validated experience already acquired in
the life sciences industry;
– Can free these companies, their managers and their employees
from the burden of legal matters; and
– Allow them to focus on their core business.
• This is what Labeolegal provides to these companies,
offering them services as outsourced general counsel.
Labeolegal: tailored services for life sciences
industries
Need of dedicated services for
life sciences companies 9
Outsourced general counsel
Innovative approach of the
legal function

10. 3 – The outsourced legal counsel is a
solution to the legal challenges faced
by the life science industries

11. • These services are an innovative way to provide
legal services, for both growing and well-
established businesses;
• These services are conceived for the companies
who have the need for regular, on-going legal
support;
• These services are conceived for the companies
who do not consider to recruit a full-time in-house
lawyer. Outsourced legal counsel:
tailored legal services
What are Labeolegal outsourced
general counsel services?
11
Outsourced general counsel
Innovative approach of the
legal function

12. Who is an outsourced general counsel?
Outsourced legal counsel:
tailored legal services 12
In-house
counsel
External
lawyer
Attorney-at-law Possibly Yes Yes
Confidentiality duty by status No Yes Yes
Experience as an in-house counsel Yes Yes No
Experience in the life sciences industries Possibly Yes Possibly
Employee Yes No No
Consultant No Yes Yes
Full-time dedication to the client’s needs (i.e.
40h/week)
Yes No No
Part-time dedication to the client’s needs Possibly Yes No
Dedication to the client’s needs on a per-hour basis No Yes Yes
Work within the client’s premises Yes Yes No
Phone/email address provided by the client Yes Yes No
Daily visibility on the legal needs of the client Yes Yes No
Direct capability to anticipate the client’s legal needs Yes Yes No
Outsourced general counsel
Innovative approach of the
legal function

13. • The Labeolegal services are a perfect solution for
companies, letting them optimise their costs and
their organisations;
• Labeolegal provides them with a regular legal
service at a measured cost;
• Labeolegal provides them with all the benefits of
an in-house counsel coupled with all the flexibility
of a consultant.
Advantages for your organization
Outsourced legal counsel:
tailored legal services 13
Outsourced general counsel
Innovative approach of the
legal function

14. • The company keeps its relationship with its usual
external advisors, referring to them on the topics
where these law firms can provide their most
accurate skills and expertise;
• The company avoids referring to these law firms
for day-to-day legal services, where the expertise
of these law firms can be over-dimensioned;
• It brings an optimisation of the legal costs.
Optimised use of the external law firms
Outsourced legal counsel:
tailored legal services 14
Outsourced general counsel
Innovative approach of the
legal function

15. • The Labeolegal outsourced general counsel
solution provides all the advantages of having an
in-house lawyer, without the inconvenient of having
a full-time employee.
• Like an in-house counsel, the Labeolegal
outsourced general counsel is a key-element for
the company’s growth:
– He is a regular interlocutor of the managing team.
– He gets an intimate knowledge of the company’s legal
needs and challenges.
– He solves problems internally.
– He anticipates on the future challenges of the company.
Benefits of the outsourced general counsel
Outsourced legal counsel:
tailored legal services 15
Outsourced general counsel
Innovative approach of the
legal function

16. 4 – What Labeolegal offers you

17. Outsourced general
counsel specific services
Scope of activities of the outsourced general
counsel
17
Corporate
law
Contract
law
Employ-
ment law
Marketing
Regulato-
ry affairs
Data
privacy
Market
access/rei
mburse-
ment
Pre-
litigation
and
dispute
resolution
Outsourced general counsel
Innovative approach of the
legal function

18. Corporate law
18
Creation of
entities, in
Switzerland and
other countries
Shareholders
agreements
Legal book-
keeping
Merger &
acquisitions
Leases
Distribution
agreements
Consulting
agreements
Intra-group
agreements
Licenses
Contract law
Outsourced general
counsel specific services
Outsourced general counsel
Innovative approach of the
legal function

19. Employment law Marketing
19
Employment
agreements
Agreements
with
headhunters
Disciplinary
law
Prevention of
permanent
establishment
risk
Review of
marketing
documentation
Compliance
with medicines
regulations
Compliance
with
advertising
regulations
Prevention of
inappropriate
advertising or
branding risks
Outsourced general
counsel specific services
Outsourced general counsel
Innovative approach of the
legal function

20. Regulatory
20
Relationship with
physicians
Relationship with
patient
associations
Legal support
for clinical trials
Implementqtion
of the EFPIA
regulations
Grants and
sponsorships
Identification of
the collectible
data
Declaration and
authorisation
procedures
Data transfer
EU-CH/ROW
Safe Harbor
Implementation
of the new EU
regulation
Outsourced general
counsel specific services
Data privacy
Outsourced general counsel
Innovative approach of the
legal function

21. Market
access/reimbursem
ents
21
Assistance of the
company in its
relationship with
MoH and medicine
agencies
Assistance of the
company in its
relationship with
Welfare states and
insurance companies
Negotiations with
insurance companies
Identification of local
partners
Prevention of
conflicts
Termination
of agreements
Termination
of employees
Relationship
with damage
insurances
Interface with
external law
firms
Arbitrations,
settlements
and ADR
Pre-litigation and
dispute resolutions
Outsourced general
counsel specific services
Outsourced general counsel
Innovative approach of the
legal function

22. Full panel of services
Providing legal advice and outsourced general counsel
services, Labeolegal brings its clients with strategic
support in:
• Legal support for EU and Swiss pharmaceutical regulatory
procedures;
• Legal support for implantation in Switzerland and in the EU;
• Company officer;
• Data privacy officer;
• Drawing up of contracts and legal documents;
• IP coordination;
• EMEA coordination.
22
Dedicated services for life
sciences companies
Outsourced general counsel
Innovative approach of the
legal function

23. Labeolegal is led by Olivier Guillotin
• Olivier Guillotin is a lawyer, holding the French advocate
proficiency certificate, alumnus from and former teacher at the
Paris Institute of Political Studies (Sciences Po).
• He has practised during the last fifteen years as an advocate and
as a legal counsel. As a legal counsel, he has successfully created
and managed for seven years the European legal department of a
start-up, converted shortly into a major biotech company. He has
been a key player of its growth, monitoring the legal aspects of its
development in almost thirty countries in Europe, Russia, Turkey
and Middle East.
• He has built on this fruitful experience to develop a broad
international approach, an in-depth knowledge of the European
and various national regulations applying to the life sciences
industry, and a strategic vision of the legal function within the
global activity of a company.
• Olivier Guillotin works in French, English and Spanish.
Olivier Guillotin – Experienced
as a lawyer and as an in-house
counsel
23
Outsourced general counsel
Innovative approach of the
legal function

24. LABEOLEGAL – LIFE SCIENCES EXPERIENCE – LEGAL
EXPERTISE
LIFE SCIENCES
INDUSTRIES NEED
TAILORED
SERVICES
LIFE SCIENCES
INDUSTRIES NEED
INFORMED
ADVISORS
THE OUTSOURCED
GENERAL COUNSEL
SERVICE IS MADE FOR
THE COMPANIES WHO
NEED ON-GOING LEGAL
SUPPORT
LABEOLEGAL SUPPLIES
YOU WITH AN
OUTSOURCED
GENERAL COUNSEL
WHO IS EXPERIENCED
IN THE LIFE SCIENCES
INDUSTRY
Dedicated services for life
sciences companies 24
Outsourced general counsel
Innovative approach of the
legal function

25. CONTACTS
Avenue du Léman 19,
1005 Lausanne, Switzerland
Tel: + 41 (0) 21 558 58 70
Mob: + 41 (0) 79 102 22 20
contact@labeolegal.ch
Skype: labeolegal-og
www.labeolegal.ch
LIFE SCIENCES EXPERIENCE LEGAL EXPERTISE