slide kit outsourced general counsel-April 2015

Outsourced General Counsel----------

An innovative approach of the legal function for

innovative companies involved in life sciences

1 – Life sciences companies face multiple legal challenges

• 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

3Life sciences companies face

various kinds of legal challenges

Usual management of the legal topics

4

Your company

Has no legal department so

Has a legal department

which is

Understaffed and

overwhelmed so

Not to be enlarged for

costs matters so

You refer to external law

firms but

Costs and delays are

unpredictable

You refer to your auditors but

Legal advice is not the core business

of your auditors so

Your legal needs are unmet so

You may be at risk

Life sciences companies face various kinds of legal

challenges



Life sciences companies face various kinds of legal

challenges

Life sciences industries face multiple challenges

5

As companiesChallenges: 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


2 – Life sciences companies need informed general counsels

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

SWISS ARMY KN IFE SOLVINGCOOPERATING

BODY

GUARD

Profile of a general counsel



• 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



• 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



3 – The outsourced legal counsel is a solution to the

legal challenges faced by the life science industries

• 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?

11Outsourced general counsel Innovative


Who is an outsourced general counsel?


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 NoOutsourced general counsel Innovative


• 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


services13



• 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


services14



• 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


services15



4 – What Labeolegal offers you

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/reimburse-

ment

Pre-litigation

and dispute

resolution



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


services



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


services



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


services

Data privacy



Market access/reimburs

ements

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


services



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.

22Dedicated services for life

sciences companiesOutsourced general counsel Innovative


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

23Outsourced general counsel Innovative


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 INDUSTRYDedicated services for life

sciences companies 24Outsourced general counsel Innovative


CONTACTS

Avenue du Léman 19, 1005 Lausanne, Switzerland

Tel: + 41 (0) 21 558 58 70Mob: + 41 (0) 79 102 22 20

[email protected]

Skype: labeolegal-og

www.labeolegal.ch

LIFE SCIENCES EXPERIENCE LEGAL EXPERTISE

mailto:[email protected]



http://www.labeolegal.ch/

slide kit outsourced general counsel-April 2015

Documents

Transcript of slide kit outsourced general counsel-April 2015