CODE OF CONDUCT
FOR EMPLOYEES, PARTNER COMPANIES, AND SUBCONTRACTORS
THINKEEN GLOBAL, GRAND BAY PLAZA EXECUTIVE 2665 SOUTH BAYSHORE DRIVE,!MIAMI USA
THINKEEN GLOBAL
WWW.THINKEEN.COM
page 01
Background
ThinKeen® Management Team,
Employees, national and
international Partner
Companies, Associates and
Subcontractors pledge.....
page 02
General Consulting Standards
ThinKeen® will serve its clients
with integrity, competence,
independence, objectivity, and
professionalism.
page 04
Interactions with Health
Institutions & Professionals.
Ethical relationships with
healthcare professionals are
critical to our mission of helping
our clients in developing and
successfully marketing .......
ThinKeen® Management Team,
Employees, national and interna-
tional Partner Companies, Associ-
ates and Subcontractors pledge in
writing to this Code Ethics. Their
adherence to the Code signifies vol-
untary assumption of self-
discipline.
ThinKeen® requires adherence to
this Code of Ethics as a condition
of affiliation, employment and col-
laboration. The standards of con-
duct set forth in this Code provide
basic principles in the ethical prac-
tice of management consulting in
the health care industry.
The purpose of this Code is to help
ThinKeen® Affiliates maintain their
professionalism and adhere to high
ethical standards in the conduct of
providing services to clients and in
their dealings with their colleagues, health professionals, patients, pa-
tients associations and the general public.
For the general consulting activities ThinKeen® embraces the key ele-
ments of other existing codes like the one proposed by the US Institute
of Management Consultants. For the interactions with health institutions
and health professional ThinKeen® embraces the key elements of the
Code of Interactions of The Pharmaceutical Research and Manufactur-
ers of America (PhRMA).
BACKGROUND
1
Background Code of Conduct
ThinKeen® Management
Team, Employees, national
and international Partner
Companies, Associates and
Subcontractors pledge in
writing to this Code Ethics.
ThinKeen Global. Miami, Florida USA - thinkeen.com
GENERAL
CONSULTING
STANDARDS
For all Consulting
Activities
A base for all our
consulting activities
independently by the
industry we serve.
Consulting Code of Conduct
Integrity
ThinKeen® will serve its clients
with integrity, competence, in-
dependence, objectivity, and
professionalism.
Promise
ThinKeen® will mutually estab-
lish with its clients realistic ex-
pectations of the benefits and
results of its services.
Acceptance
ThinKeen® will only accept as-
signments for which it possess
the requisite experience and
competence to perform. Moreo-
ver it will only assign staff or
engage colleagues with the
knowledge and expertise
needed to serve its clients ef-
fectively.
Objectives
Before accepting any engage-
ment, ThinKeen® will ensure
that it has worked with its cli-
ents to establish a mutual un-
derstanding of the objectives,
scope, work plan, and fee ar-
rangements.
Confidentiality
ThinKeen® will treat appropri-
ately all confidential client infor-
mation that is not public knowl-
edge, take reasonable steps to
prevent it from access by unau-
thorized people, and will not
take advantage of proprietary
or privileged information, either
for autonomous use, or for an-
other client, without the client's
permission.
Conflicts
ThinKeen® will avoid conflicts
of interest or the appearance
of such and will immediately
disclose to the client circumstances or interests that ThinKeen® believes
may influence its judgment or objectivity.
Withdrawal
ThinKeen® will offer to withdraw from a consulting assignment when it
believes its objectivity or integrity may be impaired.
Client Employees
ThinKeen® will refrain from inviting an employee of an active or inactive
client to consider alternative employment opportunities without prior dis-
cussion with the client.
Fiscal Integrity
ThinKeen® will agree in advance with a client on the basis for fees and
expenses and will charge fees that are reasonable and commensurate
with the services delivered and the responsibility accepted. ThinKeen®
will not accept commissions, remuneration, or other benefits from a third
party in connection with the recommendations to a client without that cli-
ent's prior knowledge and consent, and it will disclose in advance any fi-
nancial interests in goods or services that form part of such recommenda-
tions.
3
General Consulting Standards
Code of Conduct
ThinKeen® will serve its
clients with integrity,
competence, independence,
objectivity, and
professionalism.
ThinKeen Global. Miami, Florida USA - thinkeen.com
INTERACTIONS
WITH HEALTH
INSTITUTIONS &
PROFESSIONALS
For Consulting in the
Life Science Industry
On our interactions with
health care professionals
that relate to the
marketing of our Clients
products.
Interactions with Health Institutions & Professionals Code of Conduct
General Considerations
Ethical relationships with health-
care professionals are critical to our
mission of helping our clients in de-
veloping and successfully market-
ing new medicines and medical de-
vices. This document focuses on
our interactions with health care
professionals that relate to the mar-
keting of our Clients products. Ap-
propriate marketing of life-science
products ensures that patients
have access to the products they
need and that the products are
used correctly for maximum patient
benefit.
In interacting with the medical com-
munity, we are committed to follow-
ing the highest ethical standards as
well as all legal requirements. We
are also concerned that our interac-
tions with healthcare professionals
not be perceived as inappropriate
by patients or the public at large.
This Code is to reinforce our inten-
tion that our interactions with health-
care professionals are professional
exchanges designed to benefit pa-
tients and to enhance the practice
of medicine. The Code is based on
the principle that a healthcare pro-
fessional’s care of patients should
be based, and should be perceived
as being based, solely on each pa-
tient’s medical needs and the
healthcare professional’s medical
knowledge and experience.
Therefore, ThinKeen® adopted this
updated and enhanced code on re-
lationships with health care profes-
sionals.
Preamble
ThinKeen® represents research-
based pharmaceutical, medical de-
vices and biotechnology compa-
nies. Our Clients develop and mar-
ket new medicines and devices to
enable patients to live longer and
healthier lives.
Ethical relationships with health-
care professionals are critical to
our mission of helping patients by
developing and marketing new
treatments. This document focuses
on our interactions with healthcare
professionals that relate to the mar-
keting of our Client products. Ap-
propriate marketing of medicines
ensures that patients have access
to the products they need and that
the products are used correctly for
maximum patient benefit. Our rela-
tionships with healthcare profes-
sionals are critical to achieving
these goals because they enable
us to:
• inform healthcare professionals
about the benefits and risks of our
clients products to help advance
appropriate patient use,
• provide scientific and educa-
tional information,
• support medical research and
education, and
• obtain feedback and advice
about our clients products through
consultation with medical experts.
In interacting with the medical com-
munity, we are committed to follow-
ing the highest ethical standards
as well as all legal requirements.
We are also concerned that our in-
5
Interactions with Health Institutions & Professionals
Ethical relationships with
healthcare professionals are
critical to our mission of
helping our clients in
developing and successfully
marketing new medicines
ThinKeen Global. Miami, Florida USA - thinkeen.com
teractions with healthcare profes-
sionals not be perceived as inap-
propriate by patients or the public
at large. This Code is to reinforce
our intention that our interactions
with healthcare professionals are
professional exchanges designed
to benefit patients and to en-
hance the practice of medicine.
The Code is based on the princi-
ple that a healthcare profes-
sional’s care of patients should
be based, and should be per-
ceived as being based, solely on
each patient’s medical needs and
the healthcare professional’s
medical knowledge and experi-
ence.
Basis of Interactions
Our relationships with healthcare
professionals are regulated by
multiple entities and are intended
to benefit patients and to en-
hance the practice of medicine.
Interactions should be focused
on informing healthcare profes-
sionals about products, providing
scientific and educational informa-
tion, and gathering their profes-
sional feedback. ThinKeen®
should make best efforts to en-
sure that promotional materials pro-
vided to health care professionals
by or on behalf of a client company
should: (a) be accurate and not mis-
leading; (b) make claims about a
product only when properly sub-
stantiated; (c) reflect the balance
between risks and benefits; and (d)
be consistent with all other Food
and Drug Administration (FDA) re-
quirements governing such commu-
nications.
Informational Presentations by
ThinKeen® Representatives and
Accompanying Meals
Informational presentations and dis-
cussions by ThinKeen® representa-
tives speaking on behalf of a client
- provide healthcare providers with
valuable scientific and clinical infor-
mation about therapies that may
lead to improved patient care. In
order to provide important scientific
information and to respect health-
care professionals’ abilities to man-
age their schedules and provide
patient care, ThinKeen® represen-
tatives may take the opportunity to
present information during health-
care professionals’ working day, in-
cluding mealtimes. In connection
with such presentations or discus-
sions, it is appropriate for occa-
sional meals to be offered as a busi-
ness courtesy to the healthcare pro-
fessionals as well as members of
their staff attending presentations,
so long as the presentations pro-
vide scientific or educational value
and the meals (a) are modest as
judged by local standards; (b) are
not part of an entertainment or rec-
reational event; and (c) are pro-
vided in a manner conducive to in-
formational communication. Any
such meals offered in connection
with informational presentations
made by field ThinKeen® contrac-
tors, representatives or their imme-
diate managers should also be lim-
ited to in-office, meeting room facili-
ties or in-hospital settings. Inclu-
sion of a healthcare professional’s
spouse or other guest in a meal ac-
companying an informational pres-
entation made by or on behalf of a
is not appropriate. Offering “take-
out” meals or meals to be eaten
without a ThinKeen® representa-
tive being present (such as “dine &
dash” programs) is not appropriate.
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Interactions with Health Institutions & Professionals
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Prohibition on Entertainment
and Recreation
ThinKeen® interactions with health-
care professionals are profes-
sional in nature and are intended
to facilitate the exchange of medi-
cal or scientific information that will
benefit patient care. To ensure the
appropriate focus on education
and informational exchange and to
avoid the appearance of impropri-
ety, companies should not provide
any entertainment or recreational
items, such as tickets to the thea-
ter or sporting events, sporting
equipment, or leisure or vacation
trips, to any healthcare profes-
sional who is not a salaried em-
ployee of ThinKeen®. Such enter-
tainment or recreational benefits
should not be offered, regardless
of (1) the value of the items; (2)
whether ThinKeen® engages the
healthcare professional as a
speaker or consultant, or (3)
whether the entertainment or rec-
reation is secondary to an educa-
tional purpose. Modest, occasional
meals are permitted as long as
they are offered in the appropriate
circumstances and venues as de-
scribed in relevant sections of this
Code.
ThinKeen® support of Client
Company for Third-Party Educa-
tional or Professional Meetings
Third-party scientific and educa-
tional conferences or professional
meetings can contribute to the im-
provement of patient care, and
therefore, financial support from
ThinKeen® Clients under authori-
zation of its Clients is appropriate.
A conference or meeting is any ac-
tivity, held at an appropriate loca-
tion, where (a) the gathering is pri-
marily dedicated, in both time and
effort, to promoting objective scien-
tific and educational activities and
discourse (one or more educational
presentation(s) should be the high-
light of the gathering), and (b) the
main incentive for bringing at-
tendees together is to further their
knowledge on the topic(s) being pre-
sented. Since the giving of any sub-
sidy directly to a healthcare profes-
sional by Support may be viewed
as an inappropriate cash gift, any
financial support should be given to
the conference’s sponsor, which, in
turn, can use the money to reduce
the overall conference registration
fee for all attendees. When
ThinKeen® or its Clients underwrite
medical conferences or meetings
other than their own, responsibility
for and control over the selection of
content, faculty, educational meth-
ods, materials, and venue belongs
to the organizers of the confer-
ences or meetings in accordance
with their guidelines. Financial sup-
port should not be offered for the
costs of travel, lodging, or other per-
sonal expenses of non-faculty
healthcare professionals attending
third-party scientific or educational
conferences or professional meet-
ings, either directly to the individu-
als attending the conference or indi-
rectly to the conference’s sponsor
(except as set out in Section 4.7 be-
low). Similarly, funding should not
be offered to compensate for the
time spent by healthcare profession-
als attending the conference or
meeting.
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Interactions with Health Institutions & Professionals
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Clinical Consultants
Consulting arrangements with
healthcare professionals allow
ThinKeen® and its Clients to ob-
tain information or advice from
medical experts on such topics
as the marketplace, products,
therapeutic areas and the needs
of patients. ThinKeen® and its
Clients use this advice to inform
their efforts to ensure that the de-
vices and medicines they pro-
duce and market are meeting the
needs of patients. Decisions re-
garding the selection or retention
of healthcare professionals as
consultants should be made
based on defined criteria such as
general medical expertise and
reputation, or knowledge and ex-
perience regarding a particular
therapeutic area. ThinKeen®
must continue to ensure that con-
sultant arrangements are neither
inducements nor rewards for pre-
scribing or recommending a par-
ticular medicine, device or
course of treatment. It is appropri-
ate for health care consultants
who provide advisory services to
be offered reasonable compensa-
tion for those services and reim-
bursement for reasonable travel,
lodging, and meal expenses in-
curred as part of providing those
services. Any compensation or
reimbursement made in conjunc-
tion with a consulting arrange-
ment should be reasonable and
based on fair market value. To-
ken consulting or advisory ar-
rangements should not be used
to justify compensating health-
care professionals for their time
or their travel, lodging, and other
out-of-pocket expenses. The fol-
lowing factors support the existence
of a bona fide consulting arrange-
ment (not all factors may be rele-
vant to any particular arrangement):
• a written contract specifies the na-
ture of the consulting services to be
provided and the basis for payment
of those services; • a legitimate
need for the consulting services
has been clearly identified in ad-
vance of requesting the services
and entering into arrangements
with the prospective consultants; •
the criteria for selecting consultants
are directly related to the identified
purpose and the persons responsi-
ble for selecting the consultants
have the expertise necessary to
evaluate whether the particular
healthcare professionals meet
those criteria; • the number of
healthcare professionals retained is
not greater than the number rea-
sonably necessary to achieve the
identified purpose; • ThinKeen®
maintains records concerning and
makes appropriate use of the serv-
ices provided by consultants; • the
venue and circumstances of any
meeting with consultants are condu-
cive to the consulting services and
activities related to the services are
the primary focus of the meeting;
specifically, resorts are not appropri-
ate venues. While modest meals or
receptions may be appropriate dur-
ing sponsored meetings with health-
care professional commercial con-
sultants, ThinKeen® should not pro-
vide recreational or entertainment
events in conjunction with these
meetings. It is not appropriate to
pay honoraria or travel or lodging
expenses to non-faculty and non-
consultant healthcare professional
attendees at ThinKeen® - managed
meetings, including attendees who
participate in interactive sessions.
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Interactions with Health Institutions & Professionals
ThinKeen Global. Miami, Florida USA - thinkeen.com
Speaker Programs and
Speaker Training Meetings
Healthcare professionals partici-
pate in ThinKeen® - managed
speaker programs in order to
help educate and inform other
healthcare professionals about
the benefits, risks and appropri-
ate uses of Clients therapies
and medicines. Any healthcare
professional engaged by
ThinKeen® to participate in
such external promotional pro-
grams on behalf of the
ThinKeen® Clients will be
deemed a speaker for purposes
of this Code, and the require-
ments of Section 4.7 apply to
ThinKeen® interactions with that
healthcare professional in his or
her capacity as a speaker.
ThinKeen® decisions regarding
the selection or retention of
health care professionals as
speakers should be made
based on defined criteria such
as general medical expertise
and reputation, knowledge and
experience regarding a particu-
lar therapeutic area, and communi-
cations skills. ThinKeen® should
continue to ensure that speaking
arrangements are neither induce-
ments nor rewards for prescribing
a particular medicine or course of
treatment. Speaker training is an
essential activity because the FDA
holds ThinKeen® Clients account-
able for the presentations of their
speakers. It is appropriate for
healthcare professionals who par-
ticipate in programs intended to
train speakers for company-
sponsored speaker programs to be
offered reasonable compensation
for their time, considering the value
of the type of services provided,
and to be offered reimbursement
for reasonable travel, lodging, and
meal expenses. Such compensa-
tion and reimbursement should
only be offered when (1) the partici-
pants receive extensive training on
the company’s drug products or
other specific topic to be presented
and on compliance with FDA regu-
latory requirements for communica-
tions; (2) this training will result in
the participants providing a valu-
able service to ThinKeen® Clients;
and (3) the participants meet the
general criteria for bona fide con-
sulting arrangements (as dis-
cussed in Section 6 above).
Speaker training sessions should
be held in venues that are appropri-
ate and conducive to informational
communication and training about
medical information; specifically,
resorts are not appropriate venues.
Any compensation or reimburse-
ment made to a healthcare profes-
sional in conjunction with a speak-
ing arrangement should be reason-
able and based on fair market
value. ThinKeen® should make
best effort to ensure that its Client
cap the total amount of annual com-
pensation it will pay to an individual
health care professional in connec-
tion with all speaking arrange-
ments. Speaker programs may in-
clude modest meals offered to at-
tendees and should occur in a
venue and manner conducive to
informational communication.
While speaker programs offer im-
portant educational opportunities to
healthcare professionals, they are
distinct from CME programs, and
ThinKeen®, its Clients and speak-
ers should be clear about this dis-
tinction. For example, speakers
and their materials should clearly
identify ThinKeen® Client that is
ultimately sponsoring the presenta-
tion, the fact that the speaker is pre-
senting on behalf of that specific
company, and that the speaker is
presenting information that is con-
sistent with FDA guidelines. Be-
yond providing all speakers with
appropriate training, ThinKeen®
should support its Clients in periodi-
cally monitor speaker programs for
compliance with FDA regulatory re-
quirements for communications on
behalf of the Client company about
its medicines and therapies.
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Interactions with Health Institutions & Professionals
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Healthcare Professionals
Who Are Members of
Committees That Set For-
mularies or Develop Clini-
cal Practice Guidelines
Healthcare professionals
who are members of com-
mittees that set formularies
of covered medicines or
develop clinical practice
guidelines that may influ-
ence the prescribing of
medicines and therapies
often have significant expe-
rience in their fields. That
experience can be of great
benefit to ThinKeen® Cli-
ents and - ultimately - to
patients if these individuals
choose to serve as speak-
ers or commercial consult-
ants for ThinKeen® and its
Clients. To avoid even the
appearance of impropriety,
ThinKeen® should require
any healthcare profes-
sional who is a member of
a committee that sets for-
mularies or that develops
clinical guidelines and also
serves as a speaker or
commercial consultant for
the Client company to dis-
close to the committee the
existence and nature of his
or her relationship with the
Client company. This disclo-
sure requirement should
extend for at least two
years beyond the termina-
tion of any speaker or con-
sultant arrangement. Upon
disclosure, healthcare pro-
fessionals who serve as
speakers or consultants for
ThinKeen® and its Clients
should be required to fol-
low the procedures set
forth by the committee of which they
are a member, which may include re-
cusing themselves from decisions relat-
ing to the medicine for which they
have provided speaking or consulting
services.
Scholarships and Educational
Funds
Financial assistance for scholarships
or other educational funds to permit
medical students, residents, fellows,
and other healthcare professionals in
training to attend carefully selected
educational conferences may be of-
fered so long as the selection of indi-
viduals who will receive the funds is
made by the academic or training insti-
tution. “Carefully selected educational
conferences” are generally defined as
the major educational, scientific, or
policy-making meetings of national, re-
gional, or specialty medical associa-
tions.
Prohibition of Non-Educational and
Practice-Related Items
Providing items for healthcare profes-
sionals’ use that do not advance dis-
ease or treatment education — even if
they are practice-related items of mini-
mal value (such as pens, notepads,
mugs and similar “reminder” items with
Client company or product logos) —
may foster misperceptions that
ThinKeen® interactions with health-
care professionals are not based on
informing them about medical and sci-
entific issues. Such non-educational
items should not be offered to health-
care professionals or members of their
staff, even if they are accompanied by
patient or physician educational materi-
als. 12 Items intended for the personal
benefit of healthcare professionals
(such as floral arrangements, artwork,
music CDs or tickets to a sporting
event) likewise should not be offered.
Payments in cash or cash equivalents
(such as gift certificates) should not be
offered to healthcare professionals ei-
ther directly or indirectly, except as
compensation for bona fide services
as described in Sections 4.6 and 4.7. It
is appropriate to provide product sam-
ples for patient use in accordance with
the Prescription Drug Marketing Act.
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Interactions with Health Institutions & Professionals
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Educational Items
It is appropriate for
ThinKeen® , where permit-
ted by law, to offer items
designed primarily for the
education of patients or
healthcare professionals if
the items are not of sub-
stantial value ($100 or
less) and do not have
value to healthcare profes-
sionals outside of his or
her professional responsi-
bilities. For example, an
anatomical model for use
in an examination room is
intended for the education
of the patients and is there-
fore appropriate, whereas
a DVD or CD player may
have independent value to
a healthcare professional
outside of his or her profes-
sional responsibilities,
even if it could also be
used to provide education
to patients, and therefore is
not appropriate. Items de-
signed primarily for the edu-
cation of patients or health-
care professionals should
not be offered on more
than an occasional basis,
even if each individual item
is appropriate.
Prescriber Data
ThinKeen® Clients often use non-
patient identified prescriber data to fa-
cilitate the efficient flow of information
to healthcare professionals. Such pre-
scriber data, which does not identify
individual patients, may serve many
purposes, including enabling
ThinKeen® Clients to: (a) impart impor-
tant safety and risk information to pre-
scribers of a particular drug; (b) con-
duct research; (c) comply with FDA
mandated risk management plans that
require drug companies to identify and
interact with physicians who prescribe
certain drugs; (d) track adverse events
of marketed prescriptions drugs; and
(e) focus marketing activities on those
healthcare professionals who would
most likely benefit from information
about a particular drug. When
ThinKeen® supports Companies that
choose to use non-patient identified
prescriber data to facilitate communica-
tions with healthcare professionals
ThinKeen® should use and encourage
its Clients to use of this data responsi-
bly. For example, ThinKeen® and its
Clients should (a) respect the confiden-
tial nature of prescriber data; (b) de-
velop policies regarding the use of the
data; (c) educate employees and
agents about those policies; (d) main-
tain an internal contact person to han-
dle inquiries regarding the use of the
data; and (e) identify appropriate disci-
plinary actions for misuse of this data.
In addition, ThinKeen® should respect
and abide by the wishes of any health-
care professional who asks that his or
her prescriber data not be made avail-
able to ThinKeen® or Client company
representatives. ThinKeen® may dem-
onstrate this respect by following the
rules of voluntary programs that facili-
tate prescribers’ ability to make this
choice.
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Independence and Decision Mak-
ing
No grants, scholarships, subsidies,
support, consulting contracts, or edu-
cational or practice related items
should be provided or offered to a
healthcare professional in exchange
for prescribing products or therapies
or for a commitment to continue pre-
scribing them. Nothing should be of-
fered or provided in a manner or on
conditions that would interfere with
the independence of a healthcare
professional’s prescribing practices.
Information and Conduct of
ThinKeen® Representa-
tives
While representing its Cli-
ents, ThinKeen® represen-
tatives (both direct employ-
ees and contractors) might
play an important role in de-
livering accurate, up-to-
date information to health-
care professionals about
the approved indications,
benefits and risks of sev-
eral therapies. These repre-
sentatives often serve as
the primary point of contact
between the companies
who research, develop,
manufacture and market
life-saving and life-
enhancing medicines and
the healthcare profession-
als who prescribe them. As
such, ThinKeen® direct
and subcontracted repre-
sentatives must act with the
highest degree of profes-
sionalism and integrity.
ThinKeen® should ensure
that these representatives
who are employed by or act-
ing on behalf of ThinKeen®
and its Clients and who
visit healthcare professionals receive documented information about the
applicable laws, regulations and industry codes of practice, including
this Code, that govern the representatives’ interactions with healthcare
professionals. ThinKeen® should make best efforts to monitor their rep-
resentatives to ensure that they comply with relevant company policies
and standards of conduct. ThinKeen® should take appropriate action
when representatives fail to comply.
Adherence to Code
All ThinKeen® employees, Partner Companies and subcontractors
should adopt procedures to assure adherence to this Code and must
confirm this commitment by endorsing this code in writing.
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Interactions with Health Institutions & Professionals
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