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I. Introduction

Karalex Pharma, LLC ("Karalex Pharma") is committed to legal and ethical conduct in all of our business activities. This commitment is central to our Company's core values and critical to how we achieve our business goals.

This Code of Conduct (the "Code") is designed to promote, foster and sustain a culture of compliance with all applicable laws, as well as our internal corporate policies and procedures. All employees, officers, directors, agents, contractors and consultants ("Personnel") are expected to read, understand and comply with the policies set forth in the Code.

It is your individual responsibility to abide by this Code of Conduct. In the case of employees, failure to do so may result in disciplinary action, up to and including termination of employment, as well as civil or criminal penalties.

No manager or supervisor has the authority to instruct you to disobey this Code, the law, or any company policy or procedure. Therefore, failure to comply with this Code, the law or any company policy will not be excused on the basis that a manager or supervisor has authorized it.

The Code cannot, and is not intended to, cover every applicable law or provide answers to all questions that might arise. When in doubt, Personnel must seek guidance from the Compliance Officer on the appropriate course of conduct.

II. Legal Compliance & Waivers
  1. Legal Compliance : Obeying the law is the foundation of this Code. Karalex Pharma expects all Personnel to comply with all applicable state and federal laws. These include, but are not limited to, the Federal Anti-kickback Statute, Federal False Claims Act, Prescription Drug Marketing Act, Food and Drug Administration Modernization Act, Federal Food, Drug, and Cosmetic Act, Food and Drug Administration regulations, and Federal healthcare program requirements. Karalex Pharma is committed to market, sell, promote, research, and advertise products in accordance with all applicable laws.
  2. Healthcare Fraud and Abuse & False Claims Laws : Karalex Pharma's products may be reimbursed under federal and state health care programs, including Medicare, Medicaid, Department of Veterans' Affairs and state pharmaceutical assistance programs. Federal and state laws designed to prevent fraud and abuse under these programs prohibit pharmaceutical companies from offering valuable items or services to customers or potential customers to induce them to buy, prescribe or recommend the Company's products. The prevention of fraud and abuse is sometimes referred to as the "anti-kickback statute". Exceptions may apply (e.g. discounts may be appropriate if certain requirements are met). Other law prohibits the submission of false information to state or federal government reimbursement programs, or causing, assisting or encouraging the Company's customers to submit false claims for payment to these programs. Violations of the fraud and abuse laws may result in severe penalties against the responsible employees and the Company, including jail sentences, large fines and exclusion of Karalex Pharma products from reimbursement under federal and state programs. Karalex Pharma is committed to conducting the sales and marketing of its products in compliance with these laws.
  3. Waivers : Compliance with applicable laws may not be waived. In rare circumstances, other provisions of the Code may be waived upon approval from the Board of Managers.
III. Reporting Suspected Violations, Investigations & Reports
  1. Reporting Violations : Anyone suspecting or with knowledge of any violation of law, this Code, or internal corporate policies and procedures ("suspected violation") must immediately report it. Reports may be made "in person" to the Compliance Officer by calling (201)-529-0402, or by e-mailing Karalex Pharma at compliance@karalexpharma.com . If someone asks you to do something that you think might violate the Code, you must report it, even if you refused to take the requested action.
  2. Confidentiality : All investigations, as well as the identity of the person making the report ("reporter"), will be kept confidential to the extent practicable. Personnel reporting suspected violations through the Compliance and Ethics Helpline or by e-mail are not required to identify themselves. For reports that are not anonymous, the reporter may be asked to provide additional information during the investigation. (When the reporter's identity is not known, an investigation could be hindered due to an inability to obtain additional information from the reporter during the investigation.) Nonetheless, Karalex Pharma commits to careful review of all reports, whether anonymous or not.
  3. Policy of Non-Retaliation : Employees, officers or directors who in good faith report suspected violations will not be subject to retaliation or an adverse employment action for having reported suspected wrongdoing. If an employee, officer or director is found to have retaliated in violation of this provision, that employee may be subject to discipline, up to and including termination.
  4. Investigation : Karalex Pharma will investigate all reports of suspected violations promptly. Employees, officers and directors must cooperate with any investigation of a suspected violation and answer all inquiries truthfully. Withholding information or attempting to mislead or misdirect an investigation are grounds for disciplinary action, up to and including termination.
  5. Reports : Karalex Pharma will prepare a report that includes a detailed description of the suspected violation. Additionally, if applicable, the report will include suggested actions, remedial measures, disciplinary measures and a plan of action to prevent future violations. Reports of violations may be made to regulatory or other government authorities where appropriate.
  6. Discipline for Violations : Employees, officers and directors who commit violations of this Code, the law, or internal corporate policies and procedures, may be subject to discipline, up to and including termination. If an individual that reports a violation is directly involved in the violation, the fact that he or she reported the violation will be given appropriate consideration in any resulting disciplinary action. Failure to report wrongdoing of which an individual has knowledge may, in itself, be a basis for disciplinary action, up to and including termination. Violators of state or federal laws may also be personally subject to criminal and civil fines, and incarceration.

IV. Employee Conduct, Evaluation & Protections

  1. Respect : Karalex Pharma expects employees, officers and directors to treat each other with respect, fairness, and trust.
  2. Training : Employees, officers and directors will receive education and training regarding applicable laws, the Code, and other corporate policies and procedures that are relevant to their job responsibilities.
  3. Alcohol and Drug Free Workplace : Karalex Pharma is committed to an alcohol and drug free workplace and all employees, officers and directors must conduct themselves in accordance with this commitment.
  4. Computer Use : The integrity and security of Karalex Pharma's computer and other electronic systems is critical to our success. Computer systems are restricted to Karalex Pharma's business purposes, but may be used for brief, incidental uses for personal reasons. Computer systems may not be used for any purpose that violates the law, the Code, or internal corporate policies and procedures.
  5. Employee Evaluation : Each employee's performance will be evaluated on a regular basis. Each employee's promotion of and adherence to the Code will be a factor in that employee's evaluation.
  6. Non-discrimination : Karalex Pharma is committed to ensuring a fair and non-discriminatory workplace and ensuring equal opportunity for all employees. Karalex Pharma aims to provide a work environment where all employees and applicants for employment are treated with respect and dignity and without regard to political orientation, race, religion, age, gender, sexual orientation, marital or veteran status, or disability or any other characteristic protected under the law. Karalex Pharma prohibits discrimination or harassment of any kind based on any such characteristics.
  7. Sexual Harassment : Sexual harassment is prohibited. Any person who believes he/she has been personally harassed or is aware of any possible harassment must report it immediately to the Director of Human Resources or the Compliance Officer.
  8. Prohibited Gifts : While business relationships are encouraged Karalex Pharma prohibits you, or someone from your immediate family, from receiving gifts, services, perks, entertainment, or other items of more than token or nominal monetary value, from Karalex Pharma customers, contractors, or suppliers. Employees may accept such nominal gifts provided that it is legal to accept, and is not intended nor appears to be perceived as improperly influencing our business decisions.
  9. At Will Employment : UNLESS OTHERWISE EXPRESSLY SPECIFIED IN WRITING, ALL EMPLOYMENT WITH KARALEX IS ON AN AT-WILL BASIS. AT WILL EMPLOYMENT MEANS THAT ALL EMPLOYMENT WITH KARALEX IS TERMINABLE WITH OR WITHOUT CAUSE, AND IS TERMINABLE WITHOUT PRIOR NOTICE. NOTHING IN THE CODE OR KARALEX'S POLICIES SHALL BE CONSTRUED TO CONVEY ANY ADDITIONAL RIGHTS TO ANY PERSON, NOR TO IMPOSE ON KARALEX ANY CONTRACTUAL OBLIGATIONS OF ANY KIND.

V. Interactions with Government

  1. Government Interactions : Personnel must provide truthful information during all communications and interactions with state or federal government entities. The Compliance Officer must be notified of all non-routine government inquiries and reports.
  2. Gifts or Payments to Government Officials & Unions : Under Federal law, no offer, promise or gift of any value to an employee, agent or official of the government is permissible to influence the employee, agent or official in his or her area of responsibility. Federal law also prohibits giving gifts to any union official or employee to influence his or her decisions. Many states and foreign companies have similar laws prohibiting such gifts. Karalex Pharma prohibits gifts or making offers or promises of value to any union officer or union employee, or to any federal, state, local or foreign government employee, agent or official, for the purpose of influencing such person in his or her area of responsibility.

V. Corporate Property

  1. Unauthorized Use of Corporate Funds and Assets : Karalex Pharma employees, officers and directors are strictly forbidden from using any Company assets or property for an unlawful or improper purpose.
  2. No Kickbacks : Karalex Pharma will not condone any form of corruption, including the receipt or payment of bribery, kickbacks or similar unlawful payments, in any form. Unauthorized discounts, rebates, concessions, commissions or incentives, such as to obtain or retain business, are prohibited.
  3. Accurate Books and Records : The books and records of Karalex Pharma must be accurate and complete to properly document the transactions of the Company. No false or misleading entries shall be made in Karalex Pharma's books and records for any reason and no employee shall engage in any activity that results in such prohibited acts. No undisclosed or unrecorded fund or asset of the Company shall be established for any purpose. No payment on behalf of the Company shall be approved or made with the intention or understanding that any part of such payment is to be used for a purpose other than that described by the documents or entries supporting the payment.
  4. Protection of Company Assets : Karalex Pharma's property, including technical knowledge, proprietary information, trade secrets, patents, trademarks and copyrights must be protected by all Personnel. Company assets shall not be used for personal gain.
  5. Political Activity : Karalex Pharma encourages employees, officers and directors to vote and be active in the political process. Unless specifically authorized by Karalex Pharma, employees, officers and directors are prohibited from using company time, funds, property or facilities for political purposes. Federal law generally prohibits a company from making contributions, directly or indirectly, in connection with a federal election. Most states have similar laws that prohibit contributions in connection with state elections. There shall be no solicitation of political contributions of Karalex Pharma employees, officers and directors during business hours.
  6. Record Retention : Karalex Pharma is committed to a record retention program to ensure that records are maintained, stored, and when appropriate, destroyed in accordance with Karalex Pharma's needs and in compliance with applicable laws.
  7. Corporate Opportunities : Employees, directors and officers owe a duty to Karalex Pharma to advance Karalex Pharma's business objectives when the opportunity to do so arises. In connection with this duty, Karalex Pharma's employees and directors (1) may not take for themselves, directly or indirectly, any business opportunity that would interest or likely interest Karalex Pharma, or that is discovered through the use of corporate property, information or position, unless Karalex Pharma has already been offered the opportunity and turned it down; (2) may not use Karalex Pharma assets (including without limitation equipment, funds, facilities, know-how or personnel) or their position with Karalex Pharma for personal gain; and (3) may not knowingly compete with Karalex Pharma in acquiring or selling any asset or property (whether tangible or intangible) or otherwise interfere in Karalex Pharma's business affairs to the direct or indirect benefit of the employee or director.
  8. Confidential Information : It is the responsibility of all Personnel to maintain the confidentiality of the Company's nonpublic information, as well as nonpublic information of outside parties, such as suppliers, customers, and business partners, that may be received during the course of employment with the Company. The commitment to maintain the confidentiality of nonpublic information continues in force at all times during and after employment with the Company (whether such termination is voluntary or involuntary).

V. Business Conduct

  1. Fair Dealing : Karalex Pharma is committed to conducting its business affairs in a fair, ethical and legal manner.
  2. Conflicts of Interest : Conflicts of interest are prohibited. Employees, officers and directors must avoid any outside activities, financial interests or relationships that may present a conflict of interest or create an appearance of a conflict. All Personnel have a duty to further the Company's objectives and to work on behalf of Karalex Pharma's best interests. Some common examples that may constitute conflicts of interest are (1) involvement in any outside activity that significantly decreases an employee's impartiality or productivity or affects the employee's judgment; (2) having a material financial interest in an outside business, such as a competitor, supplier or customer, that has significant dealings with Karalex Pharma without approval of Karalex Pharma's Chief Executive Officer; or (3) providing services or advice to any business or other institution that competes with or has significant dealings with Karalex Pharma. Karalex Pharma employees, directors and officers must disclose if an immediate family member holds a position that is likely to cause a conflict between the best interests of Karalex Pharma and another business or institution.
  3. Purchasing Practices : Karalex Pharma purchases goods and services solely on the basis of value, price, and quality. Personal or family interests must not influence business dealings with suppliers or other third parties.
  4. Environmental Compliance : Karalex Pharma recognizes that its business has an impact on the environment. Karalex Pharma is dedicated to working towards sustainable development, responsible use of raw materials and natural resources, and a manufacturing process designed to prevent our manufacturing activities from having a harmful effect on the environment.
  5. Safety : All Personnel are expected to contribute to a safe working environment at Karalex Pharma's facilities.
  6. Privacy : Privacy regulations (the "Privacy Regulations") established under the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and state laws protect patient privacy. Karalex Pharma is committed to complying with all applicable privacy regulations. Employees are to respect the privacy of patients and the patient's relationship with the healthcare provider at all times.
  7. Human Rights : Karalex Pharma is committed to protecting and complying with internationally acknowledged human rights.
  8. Forced or Child Labor : Karalex Pharma does not condone forced labor and Karalex Pharma specifically prohibits child labor.
  9. Antitrust : Karalex Pharma understands that the public interest is best served by vigorous competition and will suffer from illegal agreements or collusion among competitors. Compliance with applicable competition and antitrust laws within in the United States and other countries in which the Company does business is essential to Karalex Pharma. Antitrust laws are complex and difficult to interpret. Although not exhaustive, the following list provides a general guide to antitrust compliance.

•  No employee, officer or director shall discuss with or provide information to any competitor about pricing or related matters, whether such information concerns the Company or Karalex Pharma's suppliers, distributors, wholesalers or customers.

•  No employee, officer or director shall agree with a customer on resale price; imply that such resale price is a condition of sale, contract renewal, or advertising allowance; or discuss with or imply to a customer that Karalex Pharma will attempt to influence the pricing of another customer or competitor.

•  No employee, officer or director shall engage in group boycotts or allocate or divide customers, territories or production with a competitor.

•  No employee, officer or director shall publish advertising or promotional claims that are not fair, balanced and accurate or which are not supported by appropriate studies or data.

•  No employee, officer or director shall engage in any predatory pricing or discriminate in prices or terms of sale, for like goods, between competing customers to the injury or damage of the disfavored customers, or induce a seller to so discriminate in favor of the Company, as purchaser.

VI. Amendments & Waivers

Karalex Pharma may amend this Code of Conduct at any time without prior notice. The Compliance Officer will review and incorporate changes to this Code of Conduct when necessary. The Compliance Officer and the President of Karalex Pharma will approve any amendments to this Code. Upon approval of the amendments, employees will be notified and will be required to sign a new certification form upon receipt of the amendments or amended version of the Code.

A copy of this document Karalex Pharma's declaration of compliance can be obtained by calling (201) 529-0402.

Karalex Pharma, L.L.C.
Code of Conduct Declaration of Compliance

To the best of its knowledge, information and belief, Karalex Pharma, LLC hereby declares that it is in compliance, in all material respects, with its Comprehensive Compliance Program and the requirements of California Health and Safety Code §§ 119400-119402. A copy of this document can be obtained by calling 1-201-529-0402.

       
 
   

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100 Overlook Center, 2nd Floor, Princeton, NJ 08540 All Rights Reserved
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