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Standards of Global Business Practices




Version August 2007
August 2007
                                                        Dear Colleagues:

                                                        Together, we have accomplished enormous positive change in our Company since we
                                                        first issued our Standards of Global Business Practices in September of 2004. This
                                                        transformation has been driven by our people, aligned around a new, high-performance
                                                        way of working. At the center of our culture is operating with business integrity.

                                                        Business integrity means doing the right thing. It starts with following the letter and
                                                        spirit of the law, as well as the letter and spirit of our own policies and procedures. But it
                                                        also means following our own moral compass to do what is right, even when the rules are
                                                        not clear. It means seeking advice when there is any doubt about what is right to do.

                                                        This booklet and the other elements of Schering-Plough’s Global Compliance and Business
                                                        Practices program are designed to give colleagues the knowledge they need to do their jobs
                                                        in full compliance with the law and Company policies. All colleagues can be confident
                                                        that whenever they do the right thing, they will receive the Company’s full support.

                                                        However, this booklet and our Global Compliance and Business Practices program
                                                        are only guides. Ultimately, it is the responsibility of Schering-Plough colleagues,
                                                        individually and collectively, to do the right thing.

                                                        Please read the booklet carefully. In addition to describing a number of important
                                                        compliance laws and policies, it offers examples of some business integrity questions that
                                                        you may face. However, it is not designed to answer every possible question that might
                                                        arise. If you have questions about how the Standards apply to your responsibilities or a
                                                        specific situation, seek advice from your manager or a member of the Global Compliance
                                                        and Business Practices, Global Law or Global Human Resources departments. You can
                                                        also contact any Executive Management Team member. Our signatures represent our
Standards of Global Business Practices intranet site:
                                                        commitment to the Standards of Global Business Practices and all the elements of
http://standards.us.schp.com/
                                                        “Leading with Integrity.”

                                                        Sincerely,
Global Compliance and
                                                        Executive Management Team
Business Practices department

Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, N.J. 07033-0530

Integrity Action Line U.S.: 1-866-SPCORP-1
Integrity Action Line International:
AT&T U.S.A. Direct Service > 678-250-7535 >
8441569585 > 2309
TABLE OF CONTENTS



     INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES
2

     THE STANDARDS – IN OUR WORKPLACE
8
     Equal Treatment
9
     Discrimination/Harassment-Free Work Environment
9
     Safety, Health and Security
10
     Drug and Alcohol Abuse
12

     THE STANDARDS – IN THE MARKETPLACE
14
     Marketing Integrity
15
     U.S. Healthcare Laws
16
     Gifts and Entertainment
17
     Bribery and Corruption
18
     International Trade
20
     Competition and Antitrust Laws
21
     Competitive Intelligence
23
     Unfair Business Practices
24
     Information Privacy and Security
25
     Scientific Integrity
26
     Product Quality and Patient Safety
27
     Animal Welfare
28

     THE STANDARDS – IN OUR BUSINESS
32
     Books and Record Keeping
33
     Records Management
35
     Company Assets
36
     Company Computers and Software
36
     Confidential Information, Intellectual Property and Proprietary Information of Others
38
     Conflicts of Interest and Corporate Opportunities
41
     Trading on Inside Information
43

     THE STANDARDS – IN OUR COMMUNITIES AND THE PUBLIC
46
     Protecting the Environment
47
     Media and Public Inquiries
48
     Political Activity and Lobbying
49
     Investigations
50

54 UPHOLDING THE STANDARDS

56 RAISING CONCERNS AND SEEKING ADVICE

61 ACKNOWLEDGEMENT

63 INDEX

     The Standards do not alter the terms and conditions of your employment. Rather,
     they help each of us to know what is expected of us to make sure we always act
     with integrity.
Introduction to the Standards of
Global Business Practices
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES



                                                                          insurers. Special laws to regulate business practices, pricing and
Introduction to the Standards of                                          price reporting may be in place to protect the people who use our
                                                                          products and to assure the money that pays for them is properly
Global Business Practices                                                 spent. Promotional and pricing practices that are accepted or common
                                                                          in other industries may not be acceptable or lawful in our industry.
                                                                          The Standards demonstrate our commitment to Lead with Integrity
What are the Standards of Global Business Practices?
                                                                          in our highly regulated business.
The Standards of Global Business Practices are Schering-Plough’s
guide to Company policies and the legal requirements that govern          Why does Schering-Plough need the Standards?
how we conduct business around the world. They are the foundation
                                                                          People often feel that publication of a “business practices” code
of our commitment to business integrity. The Standards explain
                                                                          implies that employers do not trust their employees. Nothing is
many of the basic rules that apply to our businesses and the
                                                                          further from the truth here at Schering-Plough. Our colleagues
personal responsibilities each of us has to speak up if we ever
                                                                          worldwide come to work every day to do a good job in the right
see something that doesn’t seem right.
                                                                          way. The Standards are both a statement of, and guide to, our shared
                                                                          way of working with integrity and in full compliance with the law. The
The Standards are not a stand-alone document. They work together
                                                                          Standards also are designed to comply with the requirements of the
with, and support, our Vision, Mission, Values, and Leader Behaviors.
                                                                          New York Stock Exchange, where Schering-Plough stock is listed.
Business Integrity, a Leader Behavior, is the cornerstone on which the
Standards are built. Focusing on applying all the Leader Behaviors is
                                                                          Who should follow the Standards?
important to achieving compliance.
                                                                          The Standards apply to all officers, full and part-time colleagues of
                                                                          Schering-Plough, and all subsidiaries worldwide. Temporary workers,
The Standards are in some cases “values based” and in others “rules
                                                                          vendors, agents and consultants worldwide, while working for or
based, but all are designed to help assure that compliance with laws,
       ”
                                                                          representing Schering-Plough, must also adhere to the Standards
regulations and Company policy become part of our operational DNA.
                                                                          and should consult them for guidance when acting on behalf of the
The Standards are not intended to describe every detail of every law,
                                                                          Company. The Board of Directors is subject to the Schering-Plough
regulation or Company policy that may apply to you. To learn more
                                                                          Corporation Board of Directors Code of Business Conduct and Ethics,
about applicable laws, regulations or Company policies, see the
                                                                          (available at www.schering-plough.com) which is consistent with
additional resources identified throughout the Standards with the     ,
                                                                          the Standards and is in accordance with the requirements of the
ask your manager, the Global Law department, Global Human
                                                                          New York Stock Exchange.
Resources department or your local Compliance Officer. You may
also contact the Integrity Action Line which is described more fully
                                                                          Where do the Standards apply?
on page 56. A complete listing of Company policies is available to
you on the Company intranet at http://corporatepolicy.us.schp.com/.       The Standards apply globally, in every location Schering-Plough
                                                                          conducts business. However, application of the Standards may
How do the Standards relate to our role in healthcare?                    vary in different countries, due to local business practices or a
                                                                          need to comply with local laws and regulations.
We work in a unique industry – healthcare – that is regulated
differently from other industries in most countries in which we
                                                                          What laws apply to me?
do business. First, our products affect the health and safety of
people and animals. Second, medicines are bought or their cost is         The Standards establish principles for business conduct applicable
reimbursed by the government in many countries, or by third party         throughout Schering-Plough, regardless of location. The Standards are

2                                                                                                                                              3
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES



available in many languages and Schering-Plough attempts to provide        • Enforcing Company policy by monitoring colleague compliance and
examples applicable to colleagues at all locations. Where differences        implementing appropriate discipline for misconduct.
exist as the result of local customs, norms, laws or regulations, you      • Supporting colleagues who in good faith raise concerns regarding
must apply either the Standards or local requirements – whichever            potential misconduct.
sets the highest standard of behavior. Because Schering-Plough is
                                                                           Can the policies summarized in the Standards be waived?
incorporated in the United States, colleagues outside the United States
may also be subject to certain U.S. laws and regulations. If questions     Waivers of the policies summarized in the Standards are an exception
arise about what law or rule applies, you should consult your manager,     and will only be granted in special circumstances.
the Global Law department, Global Human Resources department or
your local Compliance Officer. You should also consult a colleague from    Schering-Plough will waive a policy only where:
one of these departments if you do not understand portions of the
                                                                           • Circumstances warrant granting a waiver,
Standards in the context of a local regulation or custom.
                                                                           • Such waiver would not permit illegal or unethical conduct, and
                                                                           • There are appropriate controls over the particular situation.
What are my individual responsibilities?
You are responsible for knowing and following all the laws, regulations    Waivers for colleagues will be made only with the approval of the
and Company policies that apply to your job and level of responsibility.   Senior Vice President, Global Compliance and Business Practices.
You also have the obligation to seek advice when needed, to raise          Waivers of any of the provisions of the Standards for corporate officers
concerns and to report suspected or known violations of law,               may be made only by the Business Practices Oversight Committee
regulation or Company policy. There are many more regulations and          of the Board of Directors after receiving the recommendation of the
policies that may apply to your specific position than can be covered      Senior Vice President, Global Compliance and Business Practices.
in this booklet, and it is your responsibility to take all appropriate     Waivers relating to the CEO, CFO and Controller will require approval
opportunities for training offered to you by your manager. (Depending      of the Audit Committee of the Board of Directors. Such waivers, if
on your role, examples of policies for various operations include Good     granted, will be promptly disclosed as required by law, regulation
Clinical Practices, Good Laboratory Practices, Good Manufacturing          and New York Stock Exchange rules.
Practices and Internal Controls over Financial Reporting.) If you know
or have a suspicion that something is not right, seek help or advice       How do I use The Standards?
immediately. Use the resources described in these Standards – your
                                                                           The Standards consist of:
manager, the Global Law department, Global Human Resources
                                                                           • This Introduction;
department or your local Compliance Officer. You may also call the
                                                                           • Four substantive sections that cover policies and legal requirements
Integrity Action Line to find an answer or raise a concern.
                                                                             relating to conduct in the Workplace, in the external Marketplace
                                                                             where we sell our products, in our internal Business operations, and
What are management’s responsibilities?
                                                                             in the Communities where we operate;
Managers have a responsibility to set the right example – to Lead
                                                                           • A brief but important section, Upholding the Standards, that offers
with Integrity. The obligations of each Schering-Plough manager under
                                                                             some common sense tips for applying the Standards;
these Standards include:
                                                                           • A section offering guidance in effectively Raising Concerns and
• Informing the people who work for him or her about                         Seeking Advice regarding any compliance or integrity issues that
  Company policies.                                                          arise; and,
• Ensuring that the people who report to him or her have adequate          • An Acknowledgement that we each must read and understand the
  knowledge and resources to take appropriate action.                        matters contained in this Booklet.

4                                                                                                                                               5
INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES



In the four substantive sections, key policies and legal requirements
are simply stated, and followed by a review of what “this means” to
each colleague. References are made to Company policies and other
internal resources where appropriate and are identified with the     .     The Standards – In Our Workplace
Q&As are also included to give real-world examples of many of the
topics discussed.

If you have a compliance or integrity question, use the Standards as
a guide. Begin by asking yourself the Questions to Ask listed in the
box below. Use the Table of Contents and the Index to locate the
issue about which you seek clarification or guidance. Reread the
applicable section carefully. Think about the tips offered in Upholding
the Standards. Finally, if you are still having difficulty resolving the
issue, refer to the Raising Concerns and Seeking Advice section for
further guidance. Whenever possible, the best place to start is with
your manager.


QUESTIONS TO ASK
Asking yourself these questions can help determine if a course of
action demonstrates Leading with Integrity:

• Am I following my own moral compass?
• Are my actions legal?
• Am I acting in accordance with the Standards?
• Would failing to act make the situation worse, or allow a
  “wrong” to continue?
• How would this look on the front page of a newspaper?
• What would those outside the Company – our customers, the
  people in the communities where we work, and the general
  public – think about these actions?
• Is it right?


If the answers to any of these questions raise doubts in your
mind, you should seek assistance and resolve the concern before
taking action.




6
THE STANDARDS – In Our Workplace



                                                                                                                     Q&A
                                                                     Equal Treatment
The Standards – In Our Workplace
                                                                     Schering-Plough is committed to a
                                                                     diverse workplace that is free from             Discrimination/Harassment-
                                                                     discrimination.                                 Free Work Environment
Leading with Integrity in our workplace means applying our
                                                                                                                     Q. My department is very diverse.
Leader Behaviors to build a workplace that is safe, professional     This means:                                     My manager refers to our group
and that promotes teamwork, high performance, diversity and          • Recruiting, hiring, training,                 as the United Nations and has a
trust. Hostility, harassment, unwelcome sexual advances and other      promoting and other employment                nickname for each of us based on
unprofessional conduct are wrong and undermine what we strive for.     actions will take place without regard        our national origin. Although
We especially need to listen carefully to colleagues and respect                                                     she thinks this is cute, it makes
                                                                       to a person’s race, color, religion,
what we hear. Leading with Integrity, and earning the trust of our                                                   all of us feel uncomfortable.
                                                                       gender, sexual orientation, gender
colleagues, creates a productive working environment.                                                                What should we do?
                                                                       identity, national origin, age, disability,
                                                                       marital or military status, or any other      A. Your manager should be
This means we are committed to:                                                                                      made aware that her use of
                                                                       legally protected characteristic.
• Treating all colleagues with honesty, fairness and respect.                                                        nicknames based on national
                                                                     • Offering reasonable accommodations
• Providing equal employment opportunities for all colleagues.                                                       origin is creating a negative work
                                                                       to colleagues with disabilities, as
                                                                                                                     environment. You or your group
• Promoting a positive work environment, free of harassment            necessary.
                                                                                                                     may address this issue with her if
  or other discriminatory conduct.
                                                                                                                     you are comfortable doing so but
• Promoting diversity, cooperation, teamwork, and trust.                   Equal Treatment Policy C-124.
                                                                                                                     you are not obligated to confront
• Protecting the safety and health of all colleagues.                      Your local Human Resources                her yourself. You or your group
• Maintaining a workplace free from the effects of drug or                 representative can answer your            can bring it to the attention of
  alcohol abuse.                                                           questions about how the policy            another manager or Human
                                                                           applies in the country where              Resources. You may also contact
                                                                           you work.                                 the Integrity Action Line.

                                                                     Discrimination/Harassment-Free
                                                                     Work Environment
                                                                     Schering-Plough is committed to
                                                                     providing a workplace free of unlawful
                                                                     discrimination or harassment and will not
                                                                     tolerate discrimination or harassment by
                                                                     or toward employees or non-employees
                                                                     with whom the Company has a business,
                                                                     service or professional relationship.
                                                                     Unlawful harassment does not just refer
                                                                     to sexual harassment, but to all forms of
                                                                     verbal, physical or visual behavior where
                                                                     the purpose or effect is to create



8                                                                                                                                           9
THE STANDARDS – In Our Workplace



Q&A                                                                                                                         Q&A
                                    an offensive, hostile or intimidating       excellence in safety and health
                                    environment.                                performance as an essential element
                                                                                of every activity or process and as a
Q. I am a sales representative.                                                                                             Safety, Health and Security
                                                                                shared business value that must not
                                    This means:
Every time I call on one                                                                                                    Q. I have been asked by a
                                    • Jokes, slurs and other remarks            be compromised. A safe and healthy
particular physician in my                                                                                                  colleague to perform a task
                                      that are about race, color, religion,     work environment also means a secure
territory, he comments on how                                                                                               that I believe may be unsafe.
                                      gender, sexual orientation, gender        workplace free from violence. Acts
nice I look and asks me when I                                                                                              What should I do?
                                      identity, national origin, age,           of violence, threats, threatening and
will agree to have dinner with
                                                                                                                            A. The first thing you should
                                      disability, marital or military status,   malicious behavior, intimidation or any
him. I have been able to handle
                                                                                                                            do is discuss your specific safety
                                      or any other legally protected            other form of workplace violence will
this by jokingly telling him that
                                                                                                                            concerns about the task with
it is not appropriate but he          characteristic are never appropriate      not be tolerated.
                                                                                                                            your manager. You should ask
doesn’t seem to be getting the        at Schering-Plough.
                                                                                                                            whether the specific hazards of
message. What should I do?          • Unwelcome sexual advances or              This means:                                 the task have been identified
A. The Company’s Workplace            requests for sexual favors do not         • Creating an atmosphere where              and evaluated, and what controls
Discrimination/Harassment             belong in the workplace.                    safety, health, environmental             are in place for your protection.
policy, protects colleagues         • Verbal remarks or unwanted physical         excellence and coaching among             If, after discussing your concerns
from discrimination and/or            conduct that interfere with another         colleagues on safe work practices         with your manager, you are
harassment from any source,           person’s work performance or that           are encouraged and valued.                still not comfortable with
including our customers. An                                                                                                 performing the proposed task
                                      create an intimidating, hostile, or       • Complying with all applicable laws,
occasional, general comment                                                                                                 you should contact a higher level
                                      offensive working environment have          regulations and other requirements
such as “your new outfit is nice”                                                                                           of management, the Global
                                      no place at Schering-Plough and will        designed to protect safety and health.
or “I like your new haircut” may                                                                                            Human Resources department,
                                      not be tolerated.                         • Encouraging the active participation of
be acceptable under certain                                                                                                 or your local safety professional
                                                                                  all colleagues in safety and health
circumstances. However,                                                                                                     for further advice. You may
                                    If you observe or experience any              efforts and initiatives.
repetitive comments like these                                                                                              also contact the Integrity
                                    form of harassment, report it to your       • Ensuring that each colleague is aware
and repeated requests for a date                                                                                            Action Line.
                                    manager, your local Human Resources           of the potential hazards in their work
may lead to a hostile work
environment. You can tell the       representative, or an Equal Employment        environment and is qualified to
physician that his comments         Opportunity representative within Global      perform his/her duties.
are making you uncomfortable        Staffing & Diversity. You may also          • Bringing any unsafe acts or conditions
but you are not required to         contact the Integrity Action Line.            – including threats or intimidation –
confront him. You should report
                                                                                  to the attention of a manager, a local
this to your manager, your local
                                         Workplace Discrimination/                Safety and Health Representative,
Human Resources representative
                                         Harassment Policy C-106.                 your local Human Resource
or the Integrity Action Line.
                                                                                  representative or Global Safety and
                                                                                  Environmental Affairs. You may also
                                    Safety, Health and Security
                                                                                  contact the Integrity Action Line.
                                    Schering-Plough is committed to
                                    providing a safe, healthy and secure
                                                                                     Safety, Health and Environmental
                                    workplace for colleagues, contractors
                                                                                     Management Policy C-170;
                                    and visitors. The Company regards
                                                                                     Prevention of Violence in the
                                                                                     Workplace Policy C-160.
       10                                                                                                                                        11
THE STANDARDS – In Our Workplace



Q&A                                    Drug and Alcohol Abuse
                                       Our work requires clear thinking and
                                       the ability to react quickly. Being under
Drug and Alcohol Abuse
                                                                                   The Standards – In the Marketplace
                                       the influence of alcohol or drugs, or
Q. A fellow colleague has
                                       improperly using medication, diminishes
recently been coming back from
                                       a colleague’s ability to perform and can
lunch with slurred speech. She
                                       compromise the safety and well-being
seems somewhat impaired and I
                                       of fellow colleagues and the public.
worry that she may be drinking
at lunch or using drugs. I am
fearful that if I confront her or      This means:
tell anyone, this may cause a          • Selling, purchasing, possessing or
scene. What should I do?                 using any illegal drug is prohibited.
                                       • Using legally purchased or doctor-
A. If the colleague has an
alcohol or drug problem, she             prescribed drugs is permitted, but
could be compromising her own            only if they do not negatively affect
and other colleagues’ safety, as         job performance.
well as her ability to perform on      • Reporting to work unimpaired by
the job. If you feel that sufficient
                                         alcohol and remaining sober while on
evidence exists to indicate that
                                         duty or on Company property. Alcohol
she is under the influence of
                                         may be permitted on Company
drugs or alcohol while at work,
                                         property in certain Schering-Plough
you are obligated to report it.
                                         facilities under certain limited
You can speak to your manager,
                                         circumstances. However, this is not
or your local Human Resources
                                         true of all locations or operations.
representative. You may also
                                         Check with your manager to see if
contact the Integrity Action
Line.                                    alcohol is permitted at your location.

                                       If you observe that another colleague’s
                                       performance on the job is impaired due
                                       to the use of alcohol, drugs or other
                                       substances, or that another colleague
                                       is using alcohol or illegal substances on
                                       Company property, notify a member of
                                       management, your Human Resources
                                       representative, or your local Health
                                       Services office if one exists. You may
                                       also contact the Integrity Action Line.

                                            Substance Abuse Policy C-157.


        12
THE STANDARDS – In the Marketplace



                                                                                                                    Q&A
                                                                        Marketing Integrity
The Standards – In the Marketplace
                                                                        We are committed to the truthful and
                                                                        accurate communication of scientific        Marketing Integrity
                                                                        information about our products and
Remaining competitive in the face of all the laws and regulations                                                   Q. Can I hire hard-to-see doctors
                                                                        services to healthcare professionals
that apply globally to our business may seem like a daunting                                                        for a consultant meeting so that I
                                                                        (defined as individual physicians           can ensure I have time with them
challenge. By Leading with Integrity in the Marketplace we make
                                                                        or nurses authorized to prescribe,          to promote my products?
the task manageable. Knowing the laws and regulations that apply
                                                                        physician practices, and pharmacists),
to our operations is important. But even more important is knowing                                                  A. No. Doctors may only be
                                                                        veterinarians, patients, the general
that each of us is expected to do what is right at all times. Leading                                               hired to provide necessary
                                                                        public and other customers. In              services to Schering-Plough.
with Integrity means doing what is right for Schering-Plough and our
                                                                        marketing our products, our interactions    These arrangements can never
customers.
                                                                        with these various customers will           be used in an effort to induce,
                                                                        comply with the laws of the countries       influence or reward a healthcare
This means we are committed to:
                                                                                                                    professional for using any
                                                                        where these contacts take place.
• Providing innovative products, product delivery systems and
                                                                                                                    Schering-Plough product or as
  technology solutions to our customers.
                                                                                                                    a way to build a relationship with
                                                                        This means:
• Marketing products honestly, in accordance with laws,                                                             or to gain access to the healthcare
                                                                        • Schering-Plough does not buy
  regulations and regional or local marketing codes.                                                                professional.
                                                                          business; that is, we do not offer
• Not making illegal payments to government officials, or offering
                                                                          anything of value to our customers
  or accepting questionable gifts or entertainment.                                                                 Q. A doctor told me she was
                                                                          in order to induce or retain business.
• Following foreign trade control, customs, and anti-boycott laws.                                                  interested in prescribing our
                                                                        • A healthcare professional’s service
• Competing vigorously, while complying with all laws protecting                                                    products. Then she asked me if
                                                                          may only be obtained for sound            Schering-Plough could sponsor
  competition and the integrity of the marketplace.
                                                                          business reasons, unrelated to            her to an upcoming international
• Gathering competitive intelligence legally and ethically.
                                                                          any purchases by that healthcare          Congress. Can we pay for her
• Ensuring individual privacy by keeping personal information
                                                                          professional, and only for fair           registration fees and travel-related
  confidential.
                                                                                                                    expenses?
                                                                          market price.
• Acting responsibly in our relationships with healthcare
                                                                        • Promotional messages must always          A. No. While it is appropriate
  professionals, patients, academics, collaborators, governments,
                                                                          be within label, truthful and fairly      in certain countries for Schering-
  regulatory entities, customers, suppliers and vendors.
                                                                          balanced – that is why promotional        Plough to support a healthcare
• Ensuring that all our activities including research, development,
                                                                                                                    professional in his or her medical
                                                                          materials are subject to a promotional
  manufacturing, marketing, sales and distribution of human drugs
                                                                                                                    or scientific education by sponsoring
                                                                          review process.
  (including drug samples), animal care products, and consumer
                                                                                                                    the healthcare professional to
  healthcare products meet or exceed the requirements of                                                            attend medical or scientific
                                                                             Global Marketing Policy C-100. You
  applicable laws and regulations worldwide.                                                                        programs organized by third
                                                                             should always check to see if there
• Respecting the welfare of animals.                                                                                parties, such support may not
                                                                             is a local marketing policy for your
                                                                                                                    be made on the basis of, or to
                                                                             business unit or country. Many         encourage, prescribing Schering-
                                                                             times, the laws governing our          Plough products.
                                                                             marketing interactions will vary
                                                                             from country to country.


14                                                                                                                                        15
THE STANDARDS – In the Marketplace



                                                                                                                    Q&A
                                                                         • Business gifts or meals should be
U.S. Healthcare Laws
                                                                           infrequent.
Both the United States federal government and many state
                                                                         • Gifts, meals and entertainment
governments in the United States have enacted laws to prevent,                                                      Gifts and Entertainment
                                                                           may be provided or accepted in the
detect and punish healthcare fraud and abuse. These laws include                                                    Q. I recently met with a
                                                                           normal course of business as long
the Federal Civil False Claims Act, the Federal Program Fraud Civil                                                 potential vendor to evaluate
                                                                           as they:
Remedies Act and similar state laws. Under these laws, false or                                                     their services to perform work
                                                                           • Involve persons with whom
fraudulent claims submitted to the government for payment or                                                        on a large project. I mentioned
                                                                              Schering-Plough has or may have
reimbursement of healthcare expenses are subject to the payment                                                     to them that my son was a fan of
                                                                              business;
of damages and punishable by substantial fines and penalties. The                                                   their local football team. Several
                                                                           • Are reasonable and consistent with     days later, I received tickets for an
federal False Claims Act and some state False Claims Acts also
                                                                              applicable laws and with accepted     upcoming game from this vendor,
include provisions under which individual citizens with evidence of
                                                                              ethical standards and local           in appreciation for considering
fraud against the government may file “whistleblower” suits on the
                                                                              business practices;                   their company as a candidate.
government’s behalf to recover the lost funds. If a whistleblower suit
                                                                                                                    Can I accept these tickets from
                                                                           • Are of modest value and properly
is successful, the person who filed it may receive a portion of
                                                                                                                    the vendor?
                                                                              recorded in Company records so
whatever money the government recovers. These laws also prohibit
                                                                              they could not be construed as a      A. No. Schering-Plough is
retaliation against persons who file whistleblower suits.
                                                                              bribe, payoff or kickback; and        committed to an unbiased,
                                                                                                                    objective evaluation of all of our
                                                                           • Are not in violation of the rules of
     U.S. Laws and Schering-Plough Policies Regarding Healthcare
                                                                                                                    current or potential suppliers and
                                                                              the recipient’s organization.
     Fraud and Abuse Policy, C-171.
                                                                                                                    vendors. There should not be
                                                                         • Honorariums or fees for speaking
                                                                                                                    even the slightest hint that any
                                                                           or presenting on behalf of the
Gifts and Entertainment                                                                                             contractual relationship is colored
                                                                           Company should not be accepted.
                                                                                                                    by personal gain. Personal trips
Exchanging social amenities or business gifts of a modest value
                                                                                                                    or entertainment like this are
such as small gifts, meals and entertainment is permitted as a           What is considered “modest” may vary,      inappropriate. However, user
common practice meant to create goodwill and establish trust in          depending on the country in which we       conferences or other educational
business relationships. Schering-Plough expects the use of good          are doing business. Certain exceptions     events that relate to your work
judgment and moderation when giving or receiving entertainment           to the Standards may be made in            for Schering-Plough may be
or gifts. Avoid situations that could compromise or appear to            countries where differing practices        appropriate. You should always
compromise your impartiality.                                            are customary with approval of your        consult your manager before
                                                                                                                    accepting such trips. In deciding
                                                                         management in consultation with your
This means:                                                                                                         among competing vendors, you
                                                                         local Compliance Officer. Any questions
• Business gifts or meals should never be conditioned upon, or be a                                                 must be objective and unbiased
                                                                         regarding the appropriateness of a
  reward for, purchasing, prescribing or promoting Schering-Plough’s                                                to avoid even the slightest hint of
                                                                         gift should be addressed with local
  products and services.                                                                                            favoritism. If you were to accept
                                                                         management and your local Compliance
                                                                                                                    these tickets, it could appear as
                                                                         Officer.
                                                                                                                    if your independent judgment
                                                                                                                    is affected.
                                                                         Special gift and entertainment rules
                                                                         apply to government employees.
                                                                         Schering-Plough colleagues may not


16                                                                                                                                        17
THE STANDARDS – In the Marketplace



Q&A                                                                                                                           Q&A
                                   provide money or its equivalent, gifts,       government employees. These laws
                                   meals or entertainment of any value           apply even when the payment is made
                                   to any government employee, unless            outside of the home country.                 that this money is not used as a
Q. Can I provide gifts to my
                                   specifically allowed by law. Laws                                                          bribe. You must seek the advice
customers during the holiday
                                   concerning this matter are often              In the United States there is a related      of your manager, the Global
season?
                                   complex and vary from country to              anti-bribery law, known as the anti-         Law department or your local
A. Not only do countries have
                                   country. Before offering or accepting         kickback law, that prohibits inducing        Compliance Officer before
different laws regarding what                                                                                                 entering into this arrangement.
                                   any gifts, meals or entertainment to          someone to recommend or purchase
types of gifts can be provided,
                                   or from a government official, consult        a healthcare product or service covered      Q. A regulatory official from
but our customers may also be
                                   with the Global Law department or             by a federal healthcare program. The         Thailand is visiting our New
subject to specific guidelines
                                   your local Compliance Officer.                purpose of this healthcare law is to         Jersey facilities in connection
of their employers. You should
                                                                                                                              with a new drug application.
                                                                                 eliminate the influences of money or
ensure that holiday gifts are
                                                                                                                              He wants to bring his wife and
                                        Conflict of Interest, Gifts and          things of value in the selection of such
allowed in your country and
                                                                                                                              make a stop in Los Angeles.
                                        Entertainment Policy C-112.              products or services.
by your customers’ employers,
                                                                                                                              Can we pay for this?
and determine if there is a cost
limit. You should also discuss                                                                                                A. It would be appropriate to
                                                                                 Schering-Plough colleagues must
                                   Bribery and Corruption
with your manager the                                                                                                         reimburse reasonable expenses
                                                                                 comply with these anti-bribery laws.
                                   Often in our industry, a country’s
appropriateness of providing                                                                                                  for the trip from Thailand to
                                                                                 Violations of these laws will not only
                                   government is both the regulator of
gifts to customers. At all                                                                                                    New Jersey for an official with
                                                                                 result in the loss of business but may
                                   our products and a major customer.
times, gifts must be modest,                                                                                                  legitimate reason for inspecting
                                                                                 also lead to severe criminal and civil
                                   We also retain the services of scientists
appropriate and customary                                                                                                     our facilities as long as it is
                                                                                 penalties for Schering-Plough and the
                                   and doctors for consulting and research
with local standards.                                                                                                         permitted under local law.
                                                                                 individuals involved. To put it simply,
                                   activities and many of them are                                                            However, we cannot pay the
                                                                                 bribery of any kind is illegal worldwide
Bribery and Corruption             employees of public institutions and                                                       expenses for his wife and the
                                                                                 and we will not engage in it.                stopover in Los Angeles.
                                   may be considered government
Q. I was told that I could hire
                                   employees.
a consultant to take care of
                                                                                 This means:                                  Q. We missed a deadline for
getting all the permits we need
                                                                                 • Never, either directly or through an       filing an official document and
from a foreign government.         Most countries in which we do
                                                                                                                              it has been suggested that we
                                                                                   agent or other third party, making
He requested a $40,000 retainer    business have laws that forbid making,
                                                                                                                              backdate the document to bring
                                                                                   payments or offering gifts, services
and said that he would use the     offering or promising any payment or                                                       it within the deadline. Can we
money to “help move the                                                            or anything of value to government
                                   giving anything of value (directly or                                                      do this?
process along.” Since we don’t                                                     employees, employees of public
                                   indirectly) to a government employee
really know where the money is                                                                                                A. The U.S. Foreign Corrupt
                                                                                   institutions, or persons that prescribe,
                                   when the payment or gift is intended
going, do we have to worry                                                                                                    Practices Act has a requirement
                                                                                   purchase or promote the Company’s
                                   to influence an official act or decision to
about it?                                                                                                                     for accurate recording of all
                                                                                   products that are intended to
                                   obtain or retain business or secure an                                                     transactions in the Company’s
A. Absolutely. You must know                                                       influence or even appear to be
                                   unfair business advantage. Under the                                                       books and records, which is
where that money is going and                                                      intended to influence that person’s
                                   U.S. Foreign Corrupt Practices Act,                                                        separate from the prohibition
for what purpose it is being                                                       actions with respect to the Company.
                                   foreign political parties and candidates                                                   of improper payments to
used. Moreover, the Company is
                                                                                 • Always exercising great care and
                                   as well as officers and employees of                                                       government officials.
required to take steps to ensure
                                                                                   vigilance when entering into
                                   state-owned companies are considered
                                                                                   transactions with employees of public

       18                                                                                                                                          19
THE STANDARDS – In the Marketplace



Q&A                                                                                                                       Q&A
                                     institutions or other government           or affiliated with a country subject
                                     employees in order to avoid potential      to significant U.S. trade sanctions
                                     bribery and corruption issues.             (commonly called “embargoes” in
Falsification of any Company                                                                                              to shipments to any party in any
                                   • Accurately recording in Schering-          their most extreme form) without
record, including a false                                                                                                 country. If you do not know
                                     Plough’s books and records all             obtaining prior Global Law
statement of the date of                                                                                                  the export classification of and
                                     transactions, including any gift or        department review. Contact the
signature, could be a violation                                                                                           export limitations that apply to
                                     payment to any third party.                Global Law department for the list of
of this requirement. You must                                                                                             what you have been asked to
                                                                                affected countries and the relevant
seek the advice of your manager,                                                                                          send, you must check with the
                                        Anti-Bribery and Corruption Policy      restrictions.
the Global Law department or                                                                                              Global Law department before
                                        C-147; Global Marketing Policy        • Screening our business partners
your local Compliance Officer                                                                                             any such shipments take place.
to determine how best to deal           C-100. A person is considered a         against various government-restricted
                                                                                                                          Competition and Antitrust Laws
with your filing requirement            government employee if he or            parties lists to avoid dealings with
without creating any backdated          she either receives any part of his     what we refer to as “denied parties.  ”   Q. I was at a trade show when
or otherwise false documents.                                                                                             a representative who sells an
                                        or her salary from the government     • Being aware of products, materials,
                                                                                                                          allergy product that directly
                                        (including a state-owned                and technical information that are
International Trade                                                                                                       competes with my product
                                        company), or performs a                 subject to heightened export
                                                                                                                          stopped me. He suggested I
Q. While processing an                  governmental function with or           control and of the export license
                                                                                                                          limit my sales calls to retail
order for products for Syria,           without pay. If you have questions      requirements that apply to such items.
                                                                                                                          pharmacies since he had decided
you identify a document that            whether a healthcare professional     • Not participating in or responding        to focus exclusively on hospital
requests a statement regarding
                                        or individual is considered a           to requests relating to international     pharmacies. He figures this way
dealings with Israel. What
                                        government employee, or                 boycotts in which the United States       we won’t interfere with each
should you do?
                                        whether a payment or gift is            does not participate, notably the Arab    other and we’ll both benefit. It
A. Immediately report the               appropriate or legal, seek advice       League boycott of Israel. Receipt         made sense to me. Can I agree
receipt of the document to the
                                        from the Global Law department          of any requests relating to such          to this?
Global Law department, and
                                        or your local Compliance Officer.       restrictive trade practices must not      A. No, any agreement amongst
take no action whatsoever
                                                                                be acted upon and must be reported        competitors to allocate or “carve
responsive to the document until
                                                                                to the Global Law department.
                                   International Trade                                                                    up” the market is a violation of
the Global Law department
                                                                                                                          antitrust and competition laws.
provides guidance.                 Schering-Plough does business around
                                                                                   International Trade Policy C-132.
                                   the globe and is subject to and complies
Q. You have been requested         with applicable international trade
                                                                              Competition and Antitrust Laws
to ship biologic materials for     controls (trade sanctions, restrictions
vaccine testing from your site
                                   on dealings with denied parties, export    Competition and antitrust laws protect
to a Schering-Plough affiliate
                                   controls, and antiboycott regulations)     free enterprise for the benefit of
located in another country.
                                   and customs requirements.                  customers and consumers. These laws
What should you do?
                                                                              prohibit anti-competitive agreements,
A. There are strict export
                                                                              such as price-fixing conspiracies, and
                                   This means:
controls on certain pathogens
                                   • Not engaging in any dealing              other conduct, such as predatory efforts
and toxins. These controls apply
                                     whatsoever, commercial or                to eliminate competitors. Schering-
                                     otherwise, with a party located in       Plough must comply with these laws.


       20                                                                                                                                      21
THE STANDARDS – In the Marketplace



Q&A                                                                                                                             Q&A
                                                                                  superior products, service or
                                    This means:
                                                                                  performance;
                                    • Never talking with or exchanging
                                                                                • Seek legal advice before either (i) selling
                                      information with competitors or
Q. Last week, I spoke with                                                                                                      Competitive Intelligence
                                                                                  “below cost” or (ii) creating “bundles”
                                      others to:
some competitors. One said,                                                                                                     Q. One of my colleagues
                                                                                  of Schering-Plough products selling
                                      • Fix prices – this can include setting
“Did you notice that our profit                                                                                                 recently joined Schering-Plough
                                                                                  collectively at a specific price. While
                                         minimum or maximum prices, or
margins aren’t as good as they                                                                                                  from a company that sells a
                                                                                  either of these practices may be
                                         “stabilizing” prices;
used to be?” Another said,                                                                                                      competing product. May I ask
                                                                                  appropriate, in certain circumstances
                                      • Fix terms related to price, pricing
“I wish we could do something                                                                                                   her about her former company’s
                                                                                  they could violate antitrust laws and
                                         formulas, credit terms, promotions,
about the deep discounts.”                                                                                                      confidential plans for marketing
                                                                                  should always be pre-approved; and
                                         discounts, allowances, etc.;
I nodded my head, but said                                                                                                      that product, if the information
                                                                                • Particularly in the United States, seek
nothing. Later, the companies         • Divide up markets, customers or                                                         would be helpful to Schering-
                                                                                  legal advice before charging different
that were present during the             territories;                                                                           Plough?
                                                                                  prices to customers who compete with
conversation raised their prices.     • Place output restrictions or limits                                                     A. No, you should never ask
                                                                                  each other.
Was the discussion a problem?            on production;                                                                         anyone to provide you with
What should I have done?
                                      • Rig a competitive bidding process,                                                      confidential or proprietary
                                                                                     Competition and Antitrust Policy C-110.
A. Yes, the discussion could             including arrangements to submit                                                       information about a former
be a problem. Someone might              sham bids; or                                                                          employer, even if that person
                                                                                Competitive Intelligence
conclude that everyone present        • Boycott a supplier, customer or                                                         currently works for Schering-
during the conversation,                 distributor or others in the           In our complex business environment, we         Plough.
whether they said anything or            marketplace.                           acquire a large amount of information
not, had engaged in price-fixing    • Avoid creating even the appearance        about our competitors and their products
even though there was never           of an improper agreement or under-        and services. It is permissible for
an explicit agreement. If you
                                      standing by keeping communications        colleagues and third parties working on
find yourself present during
                                      with our competitors to a minimum.        behalf of Schering-Plough to gather and
a discussion like this,
                                    • Ensuring there is always a                use competitive information. However, the
immediately break away
                                      legitimate business reason for all        information must be obtained using only
from the discussion in a
                                      communications with competitors.          legal and ethical means.
way that makes it clear you
consider this improper, and
                                    If you find yourself in a situation where
promptly call the Global                                                        This means:
                                    a competitor begins discussing these
Law department.                                                                 • Always gathering information about
                                    topics, you should leave the discussion
                                                                                  competitors from public sources such
                                    immediately making it clear to everyone
                                                                                  as Web sites, published articles, price
                                    present that you are leaving because
                                                                                  bulletins, advertisements, brochures and
                                    the conversation is inappropriate. You
                                                                                  public presentations. You may also use
                                    must report the incident to the Global
                                                                                  information obtained from conversations
                                    Law department as soon as possible.
                                                                                  with customers (unless the matters
                                                                                  being discussed are known by us to
                                    Complying with antitrust and competition
                                                                                  be confidential).
                                    laws also means that you should:
                                    • Not attempt to monopolize or
                                      dominate markets except through

        22                                                                                                                                          23
THE STANDARDS – In the Marketplace



                                                                                                                      Q&A
• Accepting competitive information only when there is a clear and       Information Privacy and Security
  reasonable belief that receipt and use of the information is lawful    Many countries where we do business
  and ethical.                                                           have privacy or data protection laws         Information Privacy and
• Not obtaining information through the use of unlawful or unethical     requiring the responsible management         Security
  means such as misrepresentation, deception, theft, spying or           of their citizens’ personally identifiable   Q. In my job, I sometimes
  bribery.                                                               information – information that can be        transfer personal information
• Not recruiting or hiring employees of competitors, customers or        used to identify, locate or contact an       about colleagues to a vendor for
  vendors for their knowledge of proprietary information of present      individual. These laws, and Schering-        processing. How do I make sure
  or former employers.                                                                                                I’m doing everything I can to
                                                                         Plough policies, require that the
• Never using proprietary information of a competitor or information                                                  protect the information?
                                                                         Company and its representatives
  belonging to a competitor marked “confidential” or something           respect the privacy of personally            A. You need to make sure that the
  similar, including information that someone has offered to sell.       identifiable information, and use            only personal information being
                                                                                                                      sent to the vendor is that which is
                                                                         reasonable and appropriate security
     Proprietary and Confidential Information Policy C-148.                                                           needed for the specific business
                                                                         safeguards to protect such information
                                                                                                                      purpose. You should also verify
                                                                         from unauthorized access, use or
Unfair Business Practices                                                                                             that the vendor uses appropriate
                                                                         disclosure. This may include, for
                                                                                                                      levels of security to protect the
Schering-Plough seeks competitive advantage through superior             example, personally identifiable
                                                                                                                      information and that there are
products, services and performance, never through unethical or illegal   information collected from our
                                                                                                                      privacy and security agreements
business practices. We compete vigorously for business, but some         colleagues, clinical trial subjects and      in place. You may also want
conduct in the name of competition may not be consistent with the        site personnel, and personal information     to consider encrypting the
law or our commitment to integrity.                                      collected through our sales and              information before you transfer it.
                                                                         marketing initiatives.                       If you have any questions about
This means:                                                                                                           any of these measures, please
• Never competing by using unfair practices such as:                     This means:                                  contact your local Data Privacy
                                                                                                                      Steward, the Office of Global
  • Making false or disparaging statements about competitors             • Respecting the privacy of personally
                                                                                                                      Privacy or the Office of Global
      or their services;                                                   identifiable information, and using
                                                                                                                      Information Technology Security.
  • Stealing or misusing competitors’ trade secrets;                       appropriate security safeguards to
  • Cutting off a competitor’s sources of supply in order to hurt          protect such information against loss,
                                                                                                                      Q. I am a sales representative.
      its business;                                                        misuse and unauthorized access,
                                                                                                                      During a sales call, a physician
  • Inducing customers to break contracts with competitors; or,            disclosure, alteration or destruction.
                                                                                                                      revealed confidential information
  • Offering or paying bribes to help our Company’s business or          • Collecting and protecting all              about a patient. Can I include that
      to hurt a competitor.                                                personally identifiable information in     information in my call notes?
• Never taking unfair advantage of any other person through                compliance with Company policy or
                                                                                                                      A. No. You should never
  manipulation, concealment, abuse of privileged information,              local law, whichever sets the highest
                                                                                                                      include personal health
  misrepresentation of material facts or any other unfair dealing          standard.                                  information or other sensitive
  or illegal business practice.                                          • Reporting any data security breaches       personal information about
• Always dealing fairly with clients, suppliers, competitors and our       immediately to the Global Services
  fellow colleagues.                                                       Help Desk, your local Data Privacy
                                                                           Steward or the Office of Global
                                                                           Privacy.

24                                                                                                                                        25
THE STANDARDS – In the Marketplace



Q&A                                                                                                                             Q&A
                                           Information Privacy & Security             properly documenting and monitoring
                                           Policy C-143; End-User nformation          these relationships.
                                           Security Policy C-134. Questions         • Not giving gifts or other items of
                                                                                                                                Product Quality and Patient
patients, physicians or their
                                           regarding your privacy obligations,        value to induce business or influence     Safety
family members in call notes.
                                           or reporting of security breaches,         outcomes.
If you have questions about                                                                                                     Q. A manufacturing supervisor
                                           should be directed to your local
what type of information should                                                                                                 has told us not to notify Quality
                                           Data Privacy Steward or the                   Clinical Research and Medical and
be collected in call notes, you                                                                                                 Assurance about a deviation from
                                           Office of Global Privacy at                   Scientific Research Programs Policy
should contact your manager,                                                                                                    the manufacturing instructions
                                           privacyoffice@spcorp.com.                     C-146; Global Medical Affairs
local Data Privacy Steward or                                                                                                   that occurred during the
                                                                                         Policy C-151.
local Compliance Officer.                                                                                                       manufacturing of a batch.
                                     Scientific Integrity                                                                       She said that “we can handle it
Scientific Integrity                                                                Product Quality and Patient Safety          internally without anyone else
                                     Schering-Plough enters into
                                                                                                                                being involved.” I think this
Q. I know a great cardiologist       relationships with doctors, hospitals,         Schering-Plough is committed to the
                                                                                                                                violates Company policy, but she
who sees 300 new patients
                                     universities and contract research             highest manufacturing standards for
                                                                                                                                is the supervisor. Should I just
per year and I want him to
                                     organizations to perform clinical trials       our products to ensure product quality      follow orders and ignore this?
participate in an upcoming
                                     and other sponsored research. It is            and patient safety, which are critical to
clinical trial. The problem is,                                                                                                 A. No. If you think that the
                                     critical that we act with objectivity          achieving our mission to earn the trust
the results of the initial study                                                                                                supervisor is giving instructions
                                     and integrity during these trials and          of doctors, patients, customers and
were somewhat negative, and                                                                                                     that are contrary to the current
                                     in our relationships with healthcare           regulatory agencies. They should
he might not participate if he                                                                                                  Good Manufacturing Practices
                                     professionals, veterinarians,                  expect no less from Schering-Plough.
knows this. Do I even have                                                                                                      (cGMP) regulations or our
                                     collaborators, patients, universities          We will meet these expectations through
to mention the results of the                                                                                                   internal policies and procedures,
initial study?                       and hospitals.                                 consistently effective execution of our     and you do not feel comfortable
                                                                                    global quality policies and standards,      talking with your supervisor
A. Yes. We have an obligation
                                                                                    which are designed to ensure
                                     This means:                                                                                directly, contact your supervisor’s
to give our investigators a clear,
                                                                                                                                manager, your facility’s Quality
                                     • Not allowing business pressures or           compliance with all applicable
complete picture of the study in
                                                                                                                                Assurance department, or the
which they are participating.          time constraints to compromise the           governmental quality and safety
                                                                                                                                Integrity Action Line.
You should give him all the            objectivity or integrity of our scientific   requirements.
information, even negative             investigations and the resulting data.
results.                             • Protecting the safety of research            This means:
                                       participants comes first.                    • Following all government requirements,
                                     • Following and maintaining good                 including good manufacturing
                                       clinical practices (“GCPs”) and good           practices, and all applicable Company
                                       laboratory practices (“GLPs”) as               quality policies and worldwide quality
                                       required by law and regulation.                standards.
                                     • Communicating objective, complete,           • Adhering to local standard operating
                                       honest and accurate information                procedures for the quality control and
                                       about research programs.                       quality assurance of raw materials,
                                     • Defining the roles, responsibilities           manufacturing processes, testing,
                                       and deliverables for investigators and         storage, handling and shipping of
                                                                                      our products.

        26                                                                                                                                            27
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schering-plough standards

  • 1. Standards of Global Business Practices Version August 2007
  • 2. August 2007 Dear Colleagues: Together, we have accomplished enormous positive change in our Company since we first issued our Standards of Global Business Practices in September of 2004. This transformation has been driven by our people, aligned around a new, high-performance way of working. At the center of our culture is operating with business integrity. Business integrity means doing the right thing. It starts with following the letter and spirit of the law, as well as the letter and spirit of our own policies and procedures. But it also means following our own moral compass to do what is right, even when the rules are not clear. It means seeking advice when there is any doubt about what is right to do. This booklet and the other elements of Schering-Plough’s Global Compliance and Business Practices program are designed to give colleagues the knowledge they need to do their jobs in full compliance with the law and Company policies. All colleagues can be confident that whenever they do the right thing, they will receive the Company’s full support. However, this booklet and our Global Compliance and Business Practices program are only guides. Ultimately, it is the responsibility of Schering-Plough colleagues, individually and collectively, to do the right thing. Please read the booklet carefully. In addition to describing a number of important compliance laws and policies, it offers examples of some business integrity questions that you may face. However, it is not designed to answer every possible question that might arise. If you have questions about how the Standards apply to your responsibilities or a specific situation, seek advice from your manager or a member of the Global Compliance and Business Practices, Global Law or Global Human Resources departments. You can also contact any Executive Management Team member. Our signatures represent our Standards of Global Business Practices intranet site: commitment to the Standards of Global Business Practices and all the elements of http://standards.us.schp.com/ “Leading with Integrity.” Sincerely, Global Compliance and Executive Management Team Business Practices department Schering-Plough Corporation 2000 Galloping Hill Road Kenilworth, N.J. 07033-0530 Integrity Action Line U.S.: 1-866-SPCORP-1 Integrity Action Line International: AT&T U.S.A. Direct Service > 678-250-7535 > 8441569585 > 2309
  • 3. TABLE OF CONTENTS INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES 2 THE STANDARDS – IN OUR WORKPLACE 8 Equal Treatment 9 Discrimination/Harassment-Free Work Environment 9 Safety, Health and Security 10 Drug and Alcohol Abuse 12 THE STANDARDS – IN THE MARKETPLACE 14 Marketing Integrity 15 U.S. Healthcare Laws 16 Gifts and Entertainment 17 Bribery and Corruption 18 International Trade 20 Competition and Antitrust Laws 21 Competitive Intelligence 23 Unfair Business Practices 24 Information Privacy and Security 25 Scientific Integrity 26 Product Quality and Patient Safety 27 Animal Welfare 28 THE STANDARDS – IN OUR BUSINESS 32 Books and Record Keeping 33 Records Management 35 Company Assets 36 Company Computers and Software 36 Confidential Information, Intellectual Property and Proprietary Information of Others 38 Conflicts of Interest and Corporate Opportunities 41 Trading on Inside Information 43 THE STANDARDS – IN OUR COMMUNITIES AND THE PUBLIC 46 Protecting the Environment 47 Media and Public Inquiries 48 Political Activity and Lobbying 49 Investigations 50 54 UPHOLDING THE STANDARDS 56 RAISING CONCERNS AND SEEKING ADVICE 61 ACKNOWLEDGEMENT 63 INDEX The Standards do not alter the terms and conditions of your employment. Rather, they help each of us to know what is expected of us to make sure we always act with integrity.
  • 4. Introduction to the Standards of Global Business Practices
  • 5. INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES insurers. Special laws to regulate business practices, pricing and Introduction to the Standards of price reporting may be in place to protect the people who use our products and to assure the money that pays for them is properly Global Business Practices spent. Promotional and pricing practices that are accepted or common in other industries may not be acceptable or lawful in our industry. The Standards demonstrate our commitment to Lead with Integrity What are the Standards of Global Business Practices? in our highly regulated business. The Standards of Global Business Practices are Schering-Plough’s guide to Company policies and the legal requirements that govern Why does Schering-Plough need the Standards? how we conduct business around the world. They are the foundation People often feel that publication of a “business practices” code of our commitment to business integrity. The Standards explain implies that employers do not trust their employees. Nothing is many of the basic rules that apply to our businesses and the further from the truth here at Schering-Plough. Our colleagues personal responsibilities each of us has to speak up if we ever worldwide come to work every day to do a good job in the right see something that doesn’t seem right. way. The Standards are both a statement of, and guide to, our shared way of working with integrity and in full compliance with the law. The The Standards are not a stand-alone document. They work together Standards also are designed to comply with the requirements of the with, and support, our Vision, Mission, Values, and Leader Behaviors. New York Stock Exchange, where Schering-Plough stock is listed. Business Integrity, a Leader Behavior, is the cornerstone on which the Standards are built. Focusing on applying all the Leader Behaviors is Who should follow the Standards? important to achieving compliance. The Standards apply to all officers, full and part-time colleagues of Schering-Plough, and all subsidiaries worldwide. Temporary workers, The Standards are in some cases “values based” and in others “rules vendors, agents and consultants worldwide, while working for or based, but all are designed to help assure that compliance with laws, ” representing Schering-Plough, must also adhere to the Standards regulations and Company policy become part of our operational DNA. and should consult them for guidance when acting on behalf of the The Standards are not intended to describe every detail of every law, Company. The Board of Directors is subject to the Schering-Plough regulation or Company policy that may apply to you. To learn more Corporation Board of Directors Code of Business Conduct and Ethics, about applicable laws, regulations or Company policies, see the (available at www.schering-plough.com) which is consistent with additional resources identified throughout the Standards with the , the Standards and is in accordance with the requirements of the ask your manager, the Global Law department, Global Human New York Stock Exchange. Resources department or your local Compliance Officer. You may also contact the Integrity Action Line which is described more fully Where do the Standards apply? on page 56. A complete listing of Company policies is available to you on the Company intranet at http://corporatepolicy.us.schp.com/. The Standards apply globally, in every location Schering-Plough conducts business. However, application of the Standards may How do the Standards relate to our role in healthcare? vary in different countries, due to local business practices or a need to comply with local laws and regulations. We work in a unique industry – healthcare – that is regulated differently from other industries in most countries in which we What laws apply to me? do business. First, our products affect the health and safety of people and animals. Second, medicines are bought or their cost is The Standards establish principles for business conduct applicable reimbursed by the government in many countries, or by third party throughout Schering-Plough, regardless of location. The Standards are 2 3
  • 6. INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES available in many languages and Schering-Plough attempts to provide • Enforcing Company policy by monitoring colleague compliance and examples applicable to colleagues at all locations. Where differences implementing appropriate discipline for misconduct. exist as the result of local customs, norms, laws or regulations, you • Supporting colleagues who in good faith raise concerns regarding must apply either the Standards or local requirements – whichever potential misconduct. sets the highest standard of behavior. Because Schering-Plough is Can the policies summarized in the Standards be waived? incorporated in the United States, colleagues outside the United States may also be subject to certain U.S. laws and regulations. If questions Waivers of the policies summarized in the Standards are an exception arise about what law or rule applies, you should consult your manager, and will only be granted in special circumstances. the Global Law department, Global Human Resources department or your local Compliance Officer. You should also consult a colleague from Schering-Plough will waive a policy only where: one of these departments if you do not understand portions of the • Circumstances warrant granting a waiver, Standards in the context of a local regulation or custom. • Such waiver would not permit illegal or unethical conduct, and • There are appropriate controls over the particular situation. What are my individual responsibilities? You are responsible for knowing and following all the laws, regulations Waivers for colleagues will be made only with the approval of the and Company policies that apply to your job and level of responsibility. Senior Vice President, Global Compliance and Business Practices. You also have the obligation to seek advice when needed, to raise Waivers of any of the provisions of the Standards for corporate officers concerns and to report suspected or known violations of law, may be made only by the Business Practices Oversight Committee regulation or Company policy. There are many more regulations and of the Board of Directors after receiving the recommendation of the policies that may apply to your specific position than can be covered Senior Vice President, Global Compliance and Business Practices. in this booklet, and it is your responsibility to take all appropriate Waivers relating to the CEO, CFO and Controller will require approval opportunities for training offered to you by your manager. (Depending of the Audit Committee of the Board of Directors. Such waivers, if on your role, examples of policies for various operations include Good granted, will be promptly disclosed as required by law, regulation Clinical Practices, Good Laboratory Practices, Good Manufacturing and New York Stock Exchange rules. Practices and Internal Controls over Financial Reporting.) If you know or have a suspicion that something is not right, seek help or advice How do I use The Standards? immediately. Use the resources described in these Standards – your The Standards consist of: manager, the Global Law department, Global Human Resources • This Introduction; department or your local Compliance Officer. You may also call the • Four substantive sections that cover policies and legal requirements Integrity Action Line to find an answer or raise a concern. relating to conduct in the Workplace, in the external Marketplace where we sell our products, in our internal Business operations, and What are management’s responsibilities? in the Communities where we operate; Managers have a responsibility to set the right example – to Lead • A brief but important section, Upholding the Standards, that offers with Integrity. The obligations of each Schering-Plough manager under some common sense tips for applying the Standards; these Standards include: • A section offering guidance in effectively Raising Concerns and • Informing the people who work for him or her about Seeking Advice regarding any compliance or integrity issues that Company policies. arise; and, • Ensuring that the people who report to him or her have adequate • An Acknowledgement that we each must read and understand the knowledge and resources to take appropriate action. matters contained in this Booklet. 4 5
  • 7. INTRODUCTION TO THE STANDARDS OF GLOBAL BUSINESS PRACTICES In the four substantive sections, key policies and legal requirements are simply stated, and followed by a review of what “this means” to each colleague. References are made to Company policies and other internal resources where appropriate and are identified with the . The Standards – In Our Workplace Q&As are also included to give real-world examples of many of the topics discussed. If you have a compliance or integrity question, use the Standards as a guide. Begin by asking yourself the Questions to Ask listed in the box below. Use the Table of Contents and the Index to locate the issue about which you seek clarification or guidance. Reread the applicable section carefully. Think about the tips offered in Upholding the Standards. Finally, if you are still having difficulty resolving the issue, refer to the Raising Concerns and Seeking Advice section for further guidance. Whenever possible, the best place to start is with your manager. QUESTIONS TO ASK Asking yourself these questions can help determine if a course of action demonstrates Leading with Integrity: • Am I following my own moral compass? • Are my actions legal? • Am I acting in accordance with the Standards? • Would failing to act make the situation worse, or allow a “wrong” to continue? • How would this look on the front page of a newspaper? • What would those outside the Company – our customers, the people in the communities where we work, and the general public – think about these actions? • Is it right? If the answers to any of these questions raise doubts in your mind, you should seek assistance and resolve the concern before taking action. 6
  • 8. THE STANDARDS – In Our Workplace Q&A Equal Treatment The Standards – In Our Workplace Schering-Plough is committed to a diverse workplace that is free from Discrimination/Harassment- discrimination. Free Work Environment Leading with Integrity in our workplace means applying our Q. My department is very diverse. Leader Behaviors to build a workplace that is safe, professional This means: My manager refers to our group and that promotes teamwork, high performance, diversity and • Recruiting, hiring, training, as the United Nations and has a trust. Hostility, harassment, unwelcome sexual advances and other promoting and other employment nickname for each of us based on unprofessional conduct are wrong and undermine what we strive for. actions will take place without regard our national origin. Although We especially need to listen carefully to colleagues and respect she thinks this is cute, it makes to a person’s race, color, religion, what we hear. Leading with Integrity, and earning the trust of our all of us feel uncomfortable. gender, sexual orientation, gender colleagues, creates a productive working environment. What should we do? identity, national origin, age, disability, marital or military status, or any other A. Your manager should be This means we are committed to: made aware that her use of legally protected characteristic. • Treating all colleagues with honesty, fairness and respect. nicknames based on national • Offering reasonable accommodations • Providing equal employment opportunities for all colleagues. origin is creating a negative work to colleagues with disabilities, as environment. You or your group • Promoting a positive work environment, free of harassment necessary. may address this issue with her if or other discriminatory conduct. you are comfortable doing so but • Promoting diversity, cooperation, teamwork, and trust. Equal Treatment Policy C-124. you are not obligated to confront • Protecting the safety and health of all colleagues. Your local Human Resources her yourself. You or your group • Maintaining a workplace free from the effects of drug or representative can answer your can bring it to the attention of alcohol abuse. questions about how the policy another manager or Human applies in the country where Resources. You may also contact you work. the Integrity Action Line. Discrimination/Harassment-Free Work Environment Schering-Plough is committed to providing a workplace free of unlawful discrimination or harassment and will not tolerate discrimination or harassment by or toward employees or non-employees with whom the Company has a business, service or professional relationship. Unlawful harassment does not just refer to sexual harassment, but to all forms of verbal, physical or visual behavior where the purpose or effect is to create 8 9
  • 9. THE STANDARDS – In Our Workplace Q&A Q&A an offensive, hostile or intimidating excellence in safety and health environment. performance as an essential element of every activity or process and as a Q. I am a sales representative. Safety, Health and Security shared business value that must not This means: Every time I call on one Q. I have been asked by a • Jokes, slurs and other remarks be compromised. A safe and healthy particular physician in my colleague to perform a task that are about race, color, religion, work environment also means a secure territory, he comments on how that I believe may be unsafe. gender, sexual orientation, gender workplace free from violence. Acts nice I look and asks me when I What should I do? identity, national origin, age, of violence, threats, threatening and will agree to have dinner with A. The first thing you should disability, marital or military status, malicious behavior, intimidation or any him. I have been able to handle do is discuss your specific safety or any other legally protected other form of workplace violence will this by jokingly telling him that concerns about the task with it is not appropriate but he characteristic are never appropriate not be tolerated. your manager. You should ask doesn’t seem to be getting the at Schering-Plough. whether the specific hazards of message. What should I do? • Unwelcome sexual advances or This means: the task have been identified A. The Company’s Workplace requests for sexual favors do not • Creating an atmosphere where and evaluated, and what controls Discrimination/Harassment belong in the workplace. safety, health, environmental are in place for your protection. policy, protects colleagues • Verbal remarks or unwanted physical excellence and coaching among If, after discussing your concerns from discrimination and/or conduct that interfere with another colleagues on safe work practices with your manager, you are harassment from any source, person’s work performance or that are encouraged and valued. still not comfortable with including our customers. An performing the proposed task create an intimidating, hostile, or • Complying with all applicable laws, occasional, general comment you should contact a higher level offensive working environment have regulations and other requirements such as “your new outfit is nice” of management, the Global no place at Schering-Plough and will designed to protect safety and health. or “I like your new haircut” may Human Resources department, not be tolerated. • Encouraging the active participation of be acceptable under certain or your local safety professional all colleagues in safety and health circumstances. However, for further advice. You may If you observe or experience any efforts and initiatives. repetitive comments like these also contact the Integrity form of harassment, report it to your • Ensuring that each colleague is aware and repeated requests for a date Action Line. manager, your local Human Resources of the potential hazards in their work may lead to a hostile work environment. You can tell the representative, or an Equal Employment environment and is qualified to physician that his comments Opportunity representative within Global perform his/her duties. are making you uncomfortable Staffing & Diversity. You may also • Bringing any unsafe acts or conditions but you are not required to contact the Integrity Action Line. – including threats or intimidation – confront him. You should report to the attention of a manager, a local this to your manager, your local Workplace Discrimination/ Safety and Health Representative, Human Resources representative Harassment Policy C-106. your local Human Resource or the Integrity Action Line. representative or Global Safety and Environmental Affairs. You may also Safety, Health and Security contact the Integrity Action Line. Schering-Plough is committed to providing a safe, healthy and secure Safety, Health and Environmental workplace for colleagues, contractors Management Policy C-170; and visitors. The Company regards Prevention of Violence in the Workplace Policy C-160. 10 11
  • 10. THE STANDARDS – In Our Workplace Q&A Drug and Alcohol Abuse Our work requires clear thinking and the ability to react quickly. Being under Drug and Alcohol Abuse The Standards – In the Marketplace the influence of alcohol or drugs, or Q. A fellow colleague has improperly using medication, diminishes recently been coming back from a colleague’s ability to perform and can lunch with slurred speech. She compromise the safety and well-being seems somewhat impaired and I of fellow colleagues and the public. worry that she may be drinking at lunch or using drugs. I am fearful that if I confront her or This means: tell anyone, this may cause a • Selling, purchasing, possessing or scene. What should I do? using any illegal drug is prohibited. • Using legally purchased or doctor- A. If the colleague has an alcohol or drug problem, she prescribed drugs is permitted, but could be compromising her own only if they do not negatively affect and other colleagues’ safety, as job performance. well as her ability to perform on • Reporting to work unimpaired by the job. If you feel that sufficient alcohol and remaining sober while on evidence exists to indicate that duty or on Company property. Alcohol she is under the influence of may be permitted on Company drugs or alcohol while at work, property in certain Schering-Plough you are obligated to report it. facilities under certain limited You can speak to your manager, circumstances. However, this is not or your local Human Resources true of all locations or operations. representative. You may also Check with your manager to see if contact the Integrity Action Line. alcohol is permitted at your location. If you observe that another colleague’s performance on the job is impaired due to the use of alcohol, drugs or other substances, or that another colleague is using alcohol or illegal substances on Company property, notify a member of management, your Human Resources representative, or your local Health Services office if one exists. You may also contact the Integrity Action Line. Substance Abuse Policy C-157. 12
  • 11. THE STANDARDS – In the Marketplace Q&A Marketing Integrity The Standards – In the Marketplace We are committed to the truthful and accurate communication of scientific Marketing Integrity information about our products and Remaining competitive in the face of all the laws and regulations Q. Can I hire hard-to-see doctors services to healthcare professionals that apply globally to our business may seem like a daunting for a consultant meeting so that I (defined as individual physicians can ensure I have time with them challenge. By Leading with Integrity in the Marketplace we make or nurses authorized to prescribe, to promote my products? the task manageable. Knowing the laws and regulations that apply physician practices, and pharmacists), to our operations is important. But even more important is knowing A. No. Doctors may only be veterinarians, patients, the general that each of us is expected to do what is right at all times. Leading hired to provide necessary public and other customers. In services to Schering-Plough. with Integrity means doing what is right for Schering-Plough and our marketing our products, our interactions These arrangements can never customers. with these various customers will be used in an effort to induce, comply with the laws of the countries influence or reward a healthcare This means we are committed to: professional for using any where these contacts take place. • Providing innovative products, product delivery systems and Schering-Plough product or as technology solutions to our customers. a way to build a relationship with This means: • Marketing products honestly, in accordance with laws, or to gain access to the healthcare • Schering-Plough does not buy regulations and regional or local marketing codes. professional. business; that is, we do not offer • Not making illegal payments to government officials, or offering anything of value to our customers or accepting questionable gifts or entertainment. Q. A doctor told me she was in order to induce or retain business. • Following foreign trade control, customs, and anti-boycott laws. interested in prescribing our • A healthcare professional’s service • Competing vigorously, while complying with all laws protecting products. Then she asked me if may only be obtained for sound Schering-Plough could sponsor competition and the integrity of the marketplace. business reasons, unrelated to her to an upcoming international • Gathering competitive intelligence legally and ethically. any purchases by that healthcare Congress. Can we pay for her • Ensuring individual privacy by keeping personal information professional, and only for fair registration fees and travel-related confidential. expenses? market price. • Acting responsibly in our relationships with healthcare • Promotional messages must always A. No. While it is appropriate professionals, patients, academics, collaborators, governments, be within label, truthful and fairly in certain countries for Schering- regulatory entities, customers, suppliers and vendors. balanced – that is why promotional Plough to support a healthcare • Ensuring that all our activities including research, development, professional in his or her medical materials are subject to a promotional manufacturing, marketing, sales and distribution of human drugs or scientific education by sponsoring review process. (including drug samples), animal care products, and consumer the healthcare professional to healthcare products meet or exceed the requirements of attend medical or scientific Global Marketing Policy C-100. You applicable laws and regulations worldwide. programs organized by third should always check to see if there • Respecting the welfare of animals. parties, such support may not is a local marketing policy for your be made on the basis of, or to business unit or country. Many encourage, prescribing Schering- times, the laws governing our Plough products. marketing interactions will vary from country to country. 14 15
  • 12. THE STANDARDS – In the Marketplace Q&A • Business gifts or meals should be U.S. Healthcare Laws infrequent. Both the United States federal government and many state • Gifts, meals and entertainment governments in the United States have enacted laws to prevent, Gifts and Entertainment may be provided or accepted in the detect and punish healthcare fraud and abuse. These laws include Q. I recently met with a normal course of business as long the Federal Civil False Claims Act, the Federal Program Fraud Civil potential vendor to evaluate as they: Remedies Act and similar state laws. Under these laws, false or their services to perform work • Involve persons with whom fraudulent claims submitted to the government for payment or on a large project. I mentioned Schering-Plough has or may have reimbursement of healthcare expenses are subject to the payment to them that my son was a fan of business; of damages and punishable by substantial fines and penalties. The their local football team. Several • Are reasonable and consistent with days later, I received tickets for an federal False Claims Act and some state False Claims Acts also applicable laws and with accepted upcoming game from this vendor, include provisions under which individual citizens with evidence of ethical standards and local in appreciation for considering fraud against the government may file “whistleblower” suits on the business practices; their company as a candidate. government’s behalf to recover the lost funds. If a whistleblower suit Can I accept these tickets from • Are of modest value and properly is successful, the person who filed it may receive a portion of the vendor? recorded in Company records so whatever money the government recovers. These laws also prohibit they could not be construed as a A. No. Schering-Plough is retaliation against persons who file whistleblower suits. bribe, payoff or kickback; and committed to an unbiased, objective evaluation of all of our • Are not in violation of the rules of U.S. Laws and Schering-Plough Policies Regarding Healthcare current or potential suppliers and the recipient’s organization. Fraud and Abuse Policy, C-171. vendors. There should not be • Honorariums or fees for speaking even the slightest hint that any or presenting on behalf of the Gifts and Entertainment contractual relationship is colored Company should not be accepted. by personal gain. Personal trips Exchanging social amenities or business gifts of a modest value or entertainment like this are such as small gifts, meals and entertainment is permitted as a What is considered “modest” may vary, inappropriate. However, user common practice meant to create goodwill and establish trust in depending on the country in which we conferences or other educational business relationships. Schering-Plough expects the use of good are doing business. Certain exceptions events that relate to your work judgment and moderation when giving or receiving entertainment to the Standards may be made in for Schering-Plough may be or gifts. Avoid situations that could compromise or appear to countries where differing practices appropriate. You should always compromise your impartiality. are customary with approval of your consult your manager before accepting such trips. In deciding management in consultation with your This means: among competing vendors, you local Compliance Officer. Any questions • Business gifts or meals should never be conditioned upon, or be a must be objective and unbiased regarding the appropriateness of a reward for, purchasing, prescribing or promoting Schering-Plough’s to avoid even the slightest hint of gift should be addressed with local products and services. favoritism. If you were to accept management and your local Compliance these tickets, it could appear as Officer. if your independent judgment is affected. Special gift and entertainment rules apply to government employees. Schering-Plough colleagues may not 16 17
  • 13. THE STANDARDS – In the Marketplace Q&A Q&A provide money or its equivalent, gifts, government employees. These laws meals or entertainment of any value apply even when the payment is made to any government employee, unless outside of the home country. that this money is not used as a Q. Can I provide gifts to my specifically allowed by law. Laws bribe. You must seek the advice customers during the holiday concerning this matter are often In the United States there is a related of your manager, the Global season? complex and vary from country to anti-bribery law, known as the anti- Law department or your local A. Not only do countries have country. Before offering or accepting kickback law, that prohibits inducing Compliance Officer before different laws regarding what entering into this arrangement. any gifts, meals or entertainment to someone to recommend or purchase types of gifts can be provided, or from a government official, consult a healthcare product or service covered Q. A regulatory official from but our customers may also be with the Global Law department or by a federal healthcare program. The Thailand is visiting our New subject to specific guidelines your local Compliance Officer. purpose of this healthcare law is to Jersey facilities in connection of their employers. You should with a new drug application. eliminate the influences of money or ensure that holiday gifts are He wants to bring his wife and Conflict of Interest, Gifts and things of value in the selection of such allowed in your country and make a stop in Los Angeles. Entertainment Policy C-112. products or services. by your customers’ employers, Can we pay for this? and determine if there is a cost limit. You should also discuss A. It would be appropriate to Schering-Plough colleagues must Bribery and Corruption with your manager the reimburse reasonable expenses comply with these anti-bribery laws. Often in our industry, a country’s appropriateness of providing for the trip from Thailand to Violations of these laws will not only government is both the regulator of gifts to customers. At all New Jersey for an official with result in the loss of business but may our products and a major customer. times, gifts must be modest, legitimate reason for inspecting also lead to severe criminal and civil We also retain the services of scientists appropriate and customary our facilities as long as it is penalties for Schering-Plough and the and doctors for consulting and research with local standards. permitted under local law. individuals involved. To put it simply, activities and many of them are However, we cannot pay the bribery of any kind is illegal worldwide Bribery and Corruption employees of public institutions and expenses for his wife and the and we will not engage in it. stopover in Los Angeles. may be considered government Q. I was told that I could hire employees. a consultant to take care of This means: Q. We missed a deadline for getting all the permits we need • Never, either directly or through an filing an official document and from a foreign government. Most countries in which we do it has been suggested that we agent or other third party, making He requested a $40,000 retainer business have laws that forbid making, backdate the document to bring payments or offering gifts, services and said that he would use the offering or promising any payment or it within the deadline. Can we money to “help move the or anything of value to government giving anything of value (directly or do this? process along.” Since we don’t employees, employees of public indirectly) to a government employee really know where the money is A. The U.S. Foreign Corrupt institutions, or persons that prescribe, when the payment or gift is intended going, do we have to worry Practices Act has a requirement purchase or promote the Company’s to influence an official act or decision to about it? for accurate recording of all products that are intended to obtain or retain business or secure an transactions in the Company’s A. Absolutely. You must know influence or even appear to be unfair business advantage. Under the books and records, which is where that money is going and intended to influence that person’s U.S. Foreign Corrupt Practices Act, separate from the prohibition for what purpose it is being actions with respect to the Company. foreign political parties and candidates of improper payments to used. Moreover, the Company is • Always exercising great care and as well as officers and employees of government officials. required to take steps to ensure vigilance when entering into state-owned companies are considered transactions with employees of public 18 19
  • 14. THE STANDARDS – In the Marketplace Q&A Q&A institutions or other government or affiliated with a country subject employees in order to avoid potential to significant U.S. trade sanctions bribery and corruption issues. (commonly called “embargoes” in Falsification of any Company to shipments to any party in any • Accurately recording in Schering- their most extreme form) without record, including a false country. If you do not know Plough’s books and records all obtaining prior Global Law statement of the date of the export classification of and transactions, including any gift or department review. Contact the signature, could be a violation export limitations that apply to payment to any third party. Global Law department for the list of of this requirement. You must what you have been asked to affected countries and the relevant seek the advice of your manager, send, you must check with the Anti-Bribery and Corruption Policy restrictions. the Global Law department or Global Law department before C-147; Global Marketing Policy • Screening our business partners your local Compliance Officer any such shipments take place. to determine how best to deal C-100. A person is considered a against various government-restricted Competition and Antitrust Laws with your filing requirement government employee if he or parties lists to avoid dealings with without creating any backdated she either receives any part of his what we refer to as “denied parties. ” Q. I was at a trade show when or otherwise false documents. a representative who sells an or her salary from the government • Being aware of products, materials, allergy product that directly (including a state-owned and technical information that are International Trade competes with my product company), or performs a subject to heightened export stopped me. He suggested I Q. While processing an governmental function with or control and of the export license limit my sales calls to retail order for products for Syria, without pay. If you have questions requirements that apply to such items. pharmacies since he had decided you identify a document that whether a healthcare professional • Not participating in or responding to focus exclusively on hospital requests a statement regarding or individual is considered a to requests relating to international pharmacies. He figures this way dealings with Israel. What government employee, or boycotts in which the United States we won’t interfere with each should you do? whether a payment or gift is does not participate, notably the Arab other and we’ll both benefit. It A. Immediately report the appropriate or legal, seek advice League boycott of Israel. Receipt made sense to me. Can I agree receipt of the document to the from the Global Law department of any requests relating to such to this? Global Law department, and or your local Compliance Officer. restrictive trade practices must not A. No, any agreement amongst take no action whatsoever be acted upon and must be reported competitors to allocate or “carve responsive to the document until to the Global Law department. International Trade up” the market is a violation of the Global Law department antitrust and competition laws. provides guidance. Schering-Plough does business around International Trade Policy C-132. the globe and is subject to and complies Q. You have been requested with applicable international trade Competition and Antitrust Laws to ship biologic materials for controls (trade sanctions, restrictions vaccine testing from your site on dealings with denied parties, export Competition and antitrust laws protect to a Schering-Plough affiliate controls, and antiboycott regulations) free enterprise for the benefit of located in another country. and customs requirements. customers and consumers. These laws What should you do? prohibit anti-competitive agreements, A. There are strict export such as price-fixing conspiracies, and This means: controls on certain pathogens • Not engaging in any dealing other conduct, such as predatory efforts and toxins. These controls apply whatsoever, commercial or to eliminate competitors. Schering- otherwise, with a party located in Plough must comply with these laws. 20 21
  • 15. THE STANDARDS – In the Marketplace Q&A Q&A superior products, service or This means: performance; • Never talking with or exchanging • Seek legal advice before either (i) selling information with competitors or Q. Last week, I spoke with Competitive Intelligence “below cost” or (ii) creating “bundles” others to: some competitors. One said, Q. One of my colleagues of Schering-Plough products selling • Fix prices – this can include setting “Did you notice that our profit recently joined Schering-Plough collectively at a specific price. While minimum or maximum prices, or margins aren’t as good as they from a company that sells a either of these practices may be “stabilizing” prices; used to be?” Another said, competing product. May I ask appropriate, in certain circumstances • Fix terms related to price, pricing “I wish we could do something her about her former company’s they could violate antitrust laws and formulas, credit terms, promotions, about the deep discounts.” confidential plans for marketing should always be pre-approved; and discounts, allowances, etc.; I nodded my head, but said that product, if the information • Particularly in the United States, seek nothing. Later, the companies • Divide up markets, customers or would be helpful to Schering- legal advice before charging different that were present during the territories; Plough? prices to customers who compete with conversation raised their prices. • Place output restrictions or limits A. No, you should never ask each other. Was the discussion a problem? on production; anyone to provide you with What should I have done? • Rig a competitive bidding process, confidential or proprietary Competition and Antitrust Policy C-110. A. Yes, the discussion could including arrangements to submit information about a former be a problem. Someone might sham bids; or employer, even if that person Competitive Intelligence conclude that everyone present • Boycott a supplier, customer or currently works for Schering- during the conversation, distributor or others in the In our complex business environment, we Plough. whether they said anything or marketplace. acquire a large amount of information not, had engaged in price-fixing • Avoid creating even the appearance about our competitors and their products even though there was never of an improper agreement or under- and services. It is permissible for an explicit agreement. If you standing by keeping communications colleagues and third parties working on find yourself present during with our competitors to a minimum. behalf of Schering-Plough to gather and a discussion like this, • Ensuring there is always a use competitive information. However, the immediately break away legitimate business reason for all information must be obtained using only from the discussion in a communications with competitors. legal and ethical means. way that makes it clear you consider this improper, and If you find yourself in a situation where promptly call the Global This means: a competitor begins discussing these Law department. • Always gathering information about topics, you should leave the discussion competitors from public sources such immediately making it clear to everyone as Web sites, published articles, price present that you are leaving because bulletins, advertisements, brochures and the conversation is inappropriate. You public presentations. You may also use must report the incident to the Global information obtained from conversations Law department as soon as possible. with customers (unless the matters being discussed are known by us to Complying with antitrust and competition be confidential). laws also means that you should: • Not attempt to monopolize or dominate markets except through 22 23
  • 16. THE STANDARDS – In the Marketplace Q&A • Accepting competitive information only when there is a clear and Information Privacy and Security reasonable belief that receipt and use of the information is lawful Many countries where we do business and ethical. have privacy or data protection laws Information Privacy and • Not obtaining information through the use of unlawful or unethical requiring the responsible management Security means such as misrepresentation, deception, theft, spying or of their citizens’ personally identifiable Q. In my job, I sometimes bribery. information – information that can be transfer personal information • Not recruiting or hiring employees of competitors, customers or used to identify, locate or contact an about colleagues to a vendor for vendors for their knowledge of proprietary information of present individual. These laws, and Schering- processing. How do I make sure or former employers. I’m doing everything I can to Plough policies, require that the • Never using proprietary information of a competitor or information protect the information? Company and its representatives belonging to a competitor marked “confidential” or something respect the privacy of personally A. You need to make sure that the similar, including information that someone has offered to sell. identifiable information, and use only personal information being sent to the vendor is that which is reasonable and appropriate security Proprietary and Confidential Information Policy C-148. needed for the specific business safeguards to protect such information purpose. You should also verify from unauthorized access, use or Unfair Business Practices that the vendor uses appropriate disclosure. This may include, for levels of security to protect the Schering-Plough seeks competitive advantage through superior example, personally identifiable information and that there are products, services and performance, never through unethical or illegal information collected from our privacy and security agreements business practices. We compete vigorously for business, but some colleagues, clinical trial subjects and in place. You may also want conduct in the name of competition may not be consistent with the site personnel, and personal information to consider encrypting the law or our commitment to integrity. collected through our sales and information before you transfer it. marketing initiatives. If you have any questions about This means: any of these measures, please • Never competing by using unfair practices such as: This means: contact your local Data Privacy Steward, the Office of Global • Making false or disparaging statements about competitors • Respecting the privacy of personally Privacy or the Office of Global or their services; identifiable information, and using Information Technology Security. • Stealing or misusing competitors’ trade secrets; appropriate security safeguards to • Cutting off a competitor’s sources of supply in order to hurt protect such information against loss, Q. I am a sales representative. its business; misuse and unauthorized access, During a sales call, a physician • Inducing customers to break contracts with competitors; or, disclosure, alteration or destruction. revealed confidential information • Offering or paying bribes to help our Company’s business or • Collecting and protecting all about a patient. Can I include that to hurt a competitor. personally identifiable information in information in my call notes? • Never taking unfair advantage of any other person through compliance with Company policy or A. No. You should never manipulation, concealment, abuse of privileged information, local law, whichever sets the highest include personal health misrepresentation of material facts or any other unfair dealing standard. information or other sensitive or illegal business practice. • Reporting any data security breaches personal information about • Always dealing fairly with clients, suppliers, competitors and our immediately to the Global Services fellow colleagues. Help Desk, your local Data Privacy Steward or the Office of Global Privacy. 24 25
  • 17. THE STANDARDS – In the Marketplace Q&A Q&A Information Privacy & Security properly documenting and monitoring Policy C-143; End-User nformation these relationships. Security Policy C-134. Questions • Not giving gifts or other items of Product Quality and Patient patients, physicians or their regarding your privacy obligations, value to induce business or influence Safety family members in call notes. or reporting of security breaches, outcomes. If you have questions about Q. A manufacturing supervisor should be directed to your local what type of information should has told us not to notify Quality Data Privacy Steward or the Clinical Research and Medical and be collected in call notes, you Assurance about a deviation from Office of Global Privacy at Scientific Research Programs Policy should contact your manager, the manufacturing instructions privacyoffice@spcorp.com. C-146; Global Medical Affairs local Data Privacy Steward or that occurred during the Policy C-151. local Compliance Officer. manufacturing of a batch. Scientific Integrity She said that “we can handle it Scientific Integrity Product Quality and Patient Safety internally without anyone else Schering-Plough enters into being involved.” I think this Q. I know a great cardiologist relationships with doctors, hospitals, Schering-Plough is committed to the violates Company policy, but she who sees 300 new patients universities and contract research highest manufacturing standards for is the supervisor. Should I just per year and I want him to organizations to perform clinical trials our products to ensure product quality follow orders and ignore this? participate in an upcoming and other sponsored research. It is and patient safety, which are critical to clinical trial. The problem is, A. No. If you think that the critical that we act with objectivity achieving our mission to earn the trust the results of the initial study supervisor is giving instructions and integrity during these trials and of doctors, patients, customers and were somewhat negative, and that are contrary to the current in our relationships with healthcare regulatory agencies. They should he might not participate if he Good Manufacturing Practices professionals, veterinarians, expect no less from Schering-Plough. knows this. Do I even have (cGMP) regulations or our collaborators, patients, universities We will meet these expectations through to mention the results of the internal policies and procedures, initial study? and hospitals. consistently effective execution of our and you do not feel comfortable global quality policies and standards, talking with your supervisor A. Yes. We have an obligation which are designed to ensure This means: directly, contact your supervisor’s to give our investigators a clear, manager, your facility’s Quality • Not allowing business pressures or compliance with all applicable complete picture of the study in Assurance department, or the which they are participating. time constraints to compromise the governmental quality and safety Integrity Action Line. You should give him all the objectivity or integrity of our scientific requirements. information, even negative investigations and the resulting data. results. • Protecting the safety of research This means: participants comes first. • Following all government requirements, • Following and maintaining good including good manufacturing clinical practices (“GCPs”) and good practices, and all applicable Company laboratory practices (“GLPs”) as quality policies and worldwide quality required by law and regulation. standards. • Communicating objective, complete, • Adhering to local standard operating honest and accurate information procedures for the quality control and about research programs. quality assurance of raw materials, • Defining the roles, responsibilities manufacturing processes, testing, and deliverables for investigators and storage, handling and shipping of our products. 26 27