Lifecycle State : Effective

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BI Roxane Inc.

Local Document Type

Document Number:

046-Policy-01012

Version:

2.0

Status: Effective

Document Status History: Date : 13 Mar 2014 00:01:28 GMT -05:00 Lifecycle State : Effective

Document Title:

Drug, Alcohol, and Tobacco Free Workplace

Information Protection Classification: Internal use only

This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission.

SIGNATURES (ELECTRONICALLY OBTAINED):

Signed By : Marina,Glenn (gmarina) Decision : Approved

Decision Date : 04 Feb 2014 14:04:52 GMT -05:00 Role : BI-RI Signatory

Purpose : Drug, alcohol Meaning Of Signature : Approval

Signed By : Kochensparger,Andrea (akochens) Decision : Approved

Purpose : Drug, alcohol Meaning Of Signature : Approval Signed By : Harmon,Cindy (charmon) Decision : Approved

Signed By : Trowbridge,Elizabeth (etrowbri) Decision : Approved

Printed By: sdkvwr_046_RIC (rdgsdk01) Printed On: 14 Mar 2014 @ 6:01:26 AM GMT -05:00

046-Policy-01012 (2.0) Signature Page of 1 1

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Printed copy is for immediate use - then discard

Drug, Alcohol and Tobacco-Free Workplace Policy

INTRODUCTION AND PHILOSOPHY

A. Boehringer Ingelheim Roxane Inc./ Roxane Laboratories, Inc. (the "Company") believes its employees are its greatest asset, and is committed to providing a work environment which promotes the health, safety and well-being of all its employees. In conjunction with this commitment, the Company intends to provide a drug-free, alcohol-free and tobacco-free workplace for its employees. Substance abuse, alcohol impairment, and tobacco use can result in physical and/or psychological damage. It can jeopardize the safety of employees and the quality of work produced and is contrary to the Company's goal of promoting a safe, comfortable and effective workplace. This policy establishes the Company's rules and guidelines concerning drug, tobacco and alcohol use and/or abuse. All employees acknowledge they have read and understand this policy.

B. The Company has always had a policy of dealing strongly with drug abuse on the job; federal law makes certain specific actions mandatory for federal contractors and grantees. It is the Company's policy to comply with the Drug-Free Workplace Act, by:

C. Publishing a statement notifying employees that (a) the unlawful manufacture, distribution, dispensation, possession or use of a controlled substance in the workplace is prohibited; (b) specifying the disciplinary actions which will be taken against employees for violating that prohibition, and (c) as a condition of employment on the contract or grant, requiring each employee to abide by the terms of the statement and to notify the employer of any criminal drug statute conviction for a violation occurring in the workplace within five (5) days of conviction;

D. Giving a copy of the above statement to each employee engaged in performing the federal contract or grant;

E. Notifying the federal agency within ten (10) days after receiving actual notice from the employee or otherwise of the employee's conviction for a violation in the workplace of any criminal drug statute; F. Within thirty (30) days of receiving notice from the employee of his/her conviction, imposing disciplinary

sanctions or requiring the employee to participate satisfactorily in an approved drug abuse assistance or rehabilitation program;

G. Establishing a drug-free awareness program informing employees about (a) the dangers of drug abuse in the workplace; (b) the employer's policy of maintaining a drug-free workplace; (c) any available drug counseling, rehabilitation and employee assistance programs; and (d) the penalties that may be imposed on employees for drug abuse violations; and

H. Making a good faith effort to continue to maintain a drug-free workplace by implementing A through E above.

RESPONSIBILITIES

The Executive Director, Human Resources, will be responsible for the implementation of the Company's Drug, Alcohol and Tobacco-Free Workplace Policy.

DEFINITIONS

A. Legal use Drugs: FDA-approved prescription or over-the-counter drugs which are prescribed or manufactured for a legitimate medical purpose, and used for such purposes.

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B. Illegal Drugs: Controlled substances and drugs not legally obtainable, or drugs which may be legally obtainable but have not been legally obtained, including but not limited to crack, PCP, LSD, marijuana, cocaine, heroin, and amphetamines, as well as prescription drugs that have been prescribed to others or obtained unlawfully.

C. Company Property: any building, structure, property (including parking areas), vehicle, or piece of equipment owned, leased or operated by the Company, or any site where the business of the Company is conducted.

D. Responsible Alcohol Use: an employee's use of alcohol (a) during Company sponsored events or functions where alcohol consumption is authorized during working or nonworking hours off site or (b) by personnel while on Company business travel, which does not impair the employee's ability to work safely or effectively, does not cause disruption to other people, and does not lead to inappropriate behavior with negative impact on the employee's work or the Company's work environment. All other use is prohibited during Company business time or on Company property. Responsible Alcohol Use does not include possession, use or consumption of alcohol in the workplace or while performing job duties.

E. Positive Alcohol Screen: An alcohol level above 0.04 BAC existing in a breath specimen is considered a positive screen for alcohol. A serum alcohol level above 0.010 g/DL is considered a positive screen for alcohol. The screen is reviewed and interpreted by the Medical Review Officer (MRO).

F. Positive Drug Screen: The drug metabolite was detected at or above the cut-off concentration on both the screening and confirmatory assays in a certified laboratory. The screen is reviewed and interpreted by the MRO.

G. Contract Personnel: Any individual who is employed by a contractor, consultant, or temporary employment agency.

H. Visitors and Guests: An individual who comes to a Company site for any reason. Employees are considered visitors at a site that is not their regular work location.

I. Tobacco Products: Cigarettes, cigars, pipe, chewing tobacco, snuff.

PROHIBITED CONDUCT

Prohibited Conduct is grounds for immediate termination. All Company employees are strictly prohibited from engaging in the following conduct while on Company business or on Company property:

A. Any use of a legal drug for purposes other than, pursuant to a valid prescription, or other than the purpose for which the legal drug was prescribed or manufactured, or in a manner or purpose other than as prescribed or manufactured, including but not limited to the drugs the Company manufactures; B. Any possession, use, consumption, trade, purchase, offer to purchase, sale, offer for sale, manufacture,

formulation, distribution, dispensation, or processing of any illegal drug;

C. Any possession, use, or consumption of alcohol, except for Responsible Alcohol Use (see definitions); D. Refusing to undergo or submit to any screening required by this policy, or providing a substituted or

adulterated specimen for screening.

E. Smoking and the use of all tobacco products are prohibited on all Company property. This includes closed restrooms, lunchrooms, elevators, meeting rooms, all grounds outside and Company owned vehicles.

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The prohibitions in this policy do not apply to prescription or over-the-counter medications taken by employees in safety-sensitive positions which: (a) have been lawfully prescribed to, or obtained by, the employee; (b) are being used by the employee in accordance with the prescription’s guidelines (if applicable); and, (c) before reporting to work under the influence of such medication, the employee has inquired whether the drug manufacturer or the employee's physician warns against driving, operating machinery or performing other work-related safety-sensitive tasks. If such warnings exist, the employee taking the medication must inform his/her supervisor of such restrictions before reporting to work under the influence of such substances. When informing his/her supervisor(s) or Occupational Health of such restrictions, the employee should not identify the medication(s) being used or the reason for its use. The Company will evaluate and respond to this information on a case-by-case basis. Responses may include, among other things, temporary job reassignment or modifications, a request for additional medical documentation and consultation, and/or an instruction that the employee not work until the restriction is removed. Any employee reporting to work in a safety-sensitive position without first advising the Company about warnings accompanying lawfully prescribed or obtained medications will be subject to disciplinary action up to and including possible termination of employment. An employee's lack of knowledge concerning such warnings will not excuse a violation of this rule where an employee has failed to make the inquiries required by this rule.

DRUG AND ALCOHOL-FREE WORKPLACE POLICY

A. Screening

1. Post Offer: All candidates are required to undergo a post-offer drug test after receiving a conditional offer of employment. Screening is administered under the supervision and direction of the MRO. 2. Mandatory Random Screening: All applicable Company employees are required to undergo random

drug testing. Screening is administered under the direction of the MRO.

3. Follow-Up Screenings: Whenever an employee returns to work after drug or alcohol rehabilitation, follow-up drug and/or alcohol testing may be conducted in accordance with the recommendation of the employee’s treating substance abuse professional. These screenings will also be administered under the direction of the MRO.

4. Screening for Reasonable Suspicion/Cause: The Company reserves the right to conduct drug and alcohol testing when it suspects an employee has used or may have used drugs or alcohol in

violation of this policy. The Company may acquire reasonable suspicion from specific circumstances, objective facts or reasonable inferences drawn from such facts. Such facts and inferences may be based on, but are not limited to, any of the following:

a. Observable phenomena, such as direct observation of drug or alcohol use, possession or distribution, or the physical symptoms of being under the influence of drugs or alcohol, such as but not limited to slurred speech, dilated pupils, odor of alcohol or marijuana, changes in affect, dynamic mood swings, etc.;

b. A pattern of abnormal conduct, erratic or aberrant behavior, impairment of motor skills or speech, excessive belligerence, sleepiness, disorientation, deteriorating work performance which appears to be related to substance abuse and does not appear to be attributable to other factors;

c. The identification of an employee as the focus of a criminal investigation into unauthorized drug possession, use, or trafficking;

d. A report of alcohol or other drug use provided by a reliable and credible source

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Any employee or manager who suspects another employee may be under the influence of drugs and/or alcohol should contact Occupational Health Services immediately.

5. Post-Accident Screening: Whenever an employee causes or contributes to a work-related accident (as defined herein), the employee will be required to submit to a drug and/or alcohol test. As used in this policy, “work-related accident” means an accident: (1) which occurs while the employee is on the premises of the Company or at another work-site location, or is off-site while engaged in activities for or on behalf of the Company, or while the employee is operating a vehicle, including the employee’s, for or on behalf of the Company; and, (2) the accident results in one or more of the following: (i) a fatality; or (ii) bodily injury to any individual who, as a result of the accident, requires immediate medical treatment (excluding first aid) at or away from the scene of the accident; or (iii) property damage to Company property or to the property of a customer that is reasonably anticipated to exceed $1,000; or (iv) in the case of a vehicle accident, one or more vehicles involved in the accident incurs disabling damage as a result of the accident, requiring the vehicle(s) to be transported away from the scene by another vehicle.

B. Report of Screening Results

The Company nurse will report all positive, adulterated, or substituted drug or alcohol screens, as well as all admissions of Prohibited Conduct to the MRO, the Executive Director of Human Resources or his/her designee, and the employee’s management. Drug and alcohol screen results will be treated in a confidential manner to the extent practicable. However, due to the nature of the Company's business, positive drug screens may require an internal investigation by Security management.

C. Disciplinary Measures

1. Admissions: Employees who admit to Prohibited Conduct may be suspended without pay and may be subject to disciplinary action up to and including termination, or may be offered rehabilitation one time only. Rehabilitation requirements are outlined below.

2. Working while taking hazardous prescription drugs without reporting it to the Company as outlined above may lead to disciplinary action.

3. Positive Alcohol or Drug Screen Results a. First positive screen

i. Employees who test positive in a drug or alcohol screen for the first time may be suspended without pay and may be offered rehabilitation one time only.

Rehabilitation procedures and treatment requirements are outlined below. ii. Candidates for employment who admit to Prohibited Conduct or test positive in a

drug screen will not be considered eligible for Company employment.

b. Subsequent Positive Screen: Employees who test positive a second time or provide a substituted or adulterated specimen in a drug or alcohol screen following rehabilitation will be immediately terminated (see Termination section below).

D. Diluted Specimens

An applicant or employee with a negative dilute test result will be required to submit to an immediate re-collection with no notice. If the second test yields a negative dilute test result, it will stand as a negative. E. Substituted or Adulterated Specimens

Provision of a substituted or adulterated specimen is grounds for immediate termination and elimination of future employment consideration.

F. Insufficient Specimen Volume

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Printed copy is for immediate use - then discard 1. Employee Screenings

Employees who do not provide a urine specimen of sufficient volume for screening must continue to attempt to provide a sufficient specimen for as long as practicable during the screening process. If after three (3) hours the employee is unable to provide sufficient volume, the MRO will work with Occupational Health to determine an alternate way to test. If the employee refuses to provide a blood specimen, this will constitute a refusal to test and the employee will be terminated.

2. Candidate Screenings (post offer)

Candidates who do not provide a urine specimen of sufficient volume for screening must continue to attempt to provide a sufficient specimen for as long as practicable during the screening process. If the MRO or Company nurse determines continuation of the screening process is not practicable and the candidate still has not provided a sufficient urine specimen, the candidate will be given the opportunity to submit a blood specimen. If the candidate refuses, this will constitute a refusal to test and the candidate will not be considered for employment.

G. Termination

An employee will be immediately terminated for the following:

1. Engaging in or admitting to Prohibited Conduct, except in situations where the employee has the opportunity for rehabilitation pursuant to the Drug, Alcohol and Tobacco-Free Workplace Policy and chooses to undergo rehabilitation;

2. Testing positive for drugs or alcohol in a screening following completion of rehabilitation;

3. Providing a substituted or adulterated specimen in a drug or alcohol screening following completion of rehabilitation;

4. Refusing to submit to drug or alcohol screening or leaving the premises without the Nurse’s permission before or during screening;

5. Refusing to undergo rehabilitation or failing to keep scheduled appointments for rehabilitation following a positive drug or alcohol screen or other Prohibited Conduct, or failing to comply with the treatment plan recommended by substance abuse counselor or physician;

6. Refusing to release to the Company the results of post-accident drug or alcohol screening performed during off-site treatment (see Post-Accident Screening);

7. Refusing to release to the Company sufficient information to enable the MRO or a staff designee to determine whether an employee is sufficiently rehabilitated and able to return to work following completion of a rehabilitation program (see Rehabilitation);

8. Failing to report a criminal conviction for a drug-related crime within five (5) days of the conviction (see Drug-Related Crimes below);

9. Conviction for any felony or any drug-related crime regardless of where it occurs (See Drug-Related Crimes below).

H. Drug-Related Crimes

1. Employees who are convicted of drug-related crimes must notify the Company within five (5) days of the conviction.

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2. Managers who are notified or become aware that an employee has been convicted of a criminal drug statute violation should immediately notify the Executive Director, Human Resources. If the conviction is a criminal drug statute violation, the Executive Director, Human Resources, should then

immediately notify the government agency responsible for the contract the employee is working on. 3. Employees who have knowledge of drug diversion from the Company by a fellow employee are

obligated to immediately report such information to a supervisor. While the Company does not guarantee confidentiality, the Company shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information consistent with the requirements of law and the business needs of the Company. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area.

I. Drug Diversion Reporting and Drug Crimes Policy

The Company complies with all requirements outlined in CFR 21 - Part 1300, Title 21 - Food and Drugs. Any employee who possesses, sells, uses or diverts controlled substances is subject not only to State or Federal prosecution but also disciplinary action up to and including possible termination of employment by the Company.

Any employee who has knowledge of a coworker, contractor, or other, who possesses, sells, uses or diverts controlled substances, has an obligation to report such information to Security. Such information shall be treated as confidential as appropriate and reasonable steps will be taken to protect the confidentiality of the information and the identity of the employee furnishing information. Failure to report such violation subjects the employee (who knows of the violation) to disciplinary action up to and including possible termination of employment by the Company.

J. Rehabilitation

The Company may offer one opportunity for rehabilitation to employees who test positive for alcohol or drugs, engage in certain Prohibited Conduct, or admit to certain Prohibited Conduct. Employees who have questions about drug or alcohol abuse, or who want an appointment to discuss rehabilitation, should see the Company nurse or MRO. The Company nurse or MRO will refer such employees to a qualified substance abuse specialist. Rehabilitation procedures and treatment requirements follow.

1. Procedure

a. The Company nurse or MRO will refer the employee to the Employee Assistance program for a referral to a qualified substance abuse specialist.

b. A qualified substance abuse counselor must evaluate the employee and recommend a treatment plan within 10 working days of the Company's notification of a positive drug or alcohol screen or receipt of employee's admission of prohibited conduct.

c. The cost of rehabilitation and treatment will be the responsibility of the employee; to the extent his/her health insurance plan does not pay for these services.

d. The Company will allow the employee a leave of absence without pay for the duration of the rehabilitation program in accordance with the Company’s medical leave policies. This leave would run concurrently with Family Medical Leave (FMLA). An employee must contact the third party administrator to apply for FMLA.

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e. Upon the employee's completion of the rehabilitation program, the employee will be required to present documentation from the rehabilitation program certifying he/she participated and successfully completed the program and is able to perform his/her duties safely.

f. After consulting with the employee’s physician, the Company reserves the right to reassign an employee who has completed rehabilitation from high security risk areas which contain controlled substances to an area where the employee will not come into contact with controlled substances or other substances which relate to the employee's prohibited conduct. If no such assignment is available, the employee will be terminated.

2. Treatment Requirements: The following components are required as part of any rehabilitation program:

a. Completion of treatment plan recommended by substance abuse counselor;

b. Education about substance abuse including on and reaffirmation of the Drug, Alcohol and Tobacco-Free Workplace Policy;

c. Negative drug and/or alcohol screening results prior to return to duty;

d. Participation in any follow-up treatment or program as recommended by substance abuse counselor;

e. Participation in follow-up testing, if recommended by the substance abuse counselor; and f. Completion of any additional criteria recommended by the MRO.

K. Drug Free Awareness Program

The Drug-Free Awareness Program mandated by the Drug-Free Workplace Act is the responsibility of the Human Resources Department. Internal Company publications, employee handbooks, bulletin boards, and other forms of communication will be used to make all employees aware of the Company's policies regarding the use of drugs. The Company may occasionally require employees to attend educational classes to learn about substance abuse, and to be re-trained and to re-affirm knowledge and awareness of Company policies. L. Tobacco-free Workplace Policy

Smoking of any kind or use of tobacco products will not be allowed on or within Company property, whether the property is leased or owned. Department Managers will be responsible for ensuring compliance with this policy. It is the responsibility of management to inform all prospective employees of the Company's

commitment to a tobacco-free work environment. M. Employee Signature Required

Each employee will be provided a copy of this policy and, as a condition of employment at the Company, will be required to acknowledge they have read and understood the policy. Signature may be obtained either electronically or by hard copy.

Non-compliance with this policy may result in disciplinary action up to and including termination.

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Printed copy is for immediate use - then discard REFERENCE MATERIAL

Compliance Helpline A phone number where anyone can report possible violations of this or other policies: 1-800-958-9704.

HR Direct HR Direct is available to assist employees with inquiries regarding this and other company human resources policies. They can be reached by phone at x4200 (internally), 1-800-558-5064 (externally), or emailed at [email protected].

REVISION HISTORY

Revision Date Author Summary of Changes

2.0 2/1/2014 Cindy Harmon • Minor modifications to language • Added reference material

• Incorporated material from the Employee Handbook

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Printed copy is for immediate use - then discard EMPLOYEE ACKNOWLEDGEMENT

(Exhibit 1 to Drug, Alcohol and Tobacco-Free Workplace Policy)

I have read the Company's Drug, Alcohol and Tobacco-Free Workplace Policy in its entirety and understand its policies and procedures. I agree to abide by the Drug, Alcohol and Tobacco-Free Workplace Policy for the duration of my employment. I agree to submit to alcohol and drug screening as a condition of my employment with the Company, and to release to the Company the results of off-site screening and other medical information as required by the Company's Drug, Alcohol and Tobacco-Free Workplace Policy. I understand positive,

adulterated, and/or substituted results of alcohol or drug screening or other Prohibited Conduct may lead to termination and other discipline under the terms of the Drug, Alcohol and Tobacco- Free Workplace Policy.

Date: Printed Name:

Signature: