Corporate Compliance

Saadia Pharmaceuticals, Inc. is committed to the maintenance of high ethical standards, both internally and in its dealings with all those with whom it is involved. This is reinforced by Saadia Pharmaceuticals’ strong belief in integrity, named as one of our Corporate Values. The following policy has been adopted in order to provide guidance to employees in several areas of work where conduct/work ethics are or might potentially be in question. All employees are required to read this policy carefully and to adhere to its principles and spirit in the daily execution of their tasks and responsibilities.

1.1 Purpose

Saadia Pharmaceuticals, Inc. (the “Company”) and its affiliates are committed to maintaining the highest ethical standards in their dealings with all parties involved in the Company’s business activities, including employees, vendors, contractors and third parties. This Code of Ethics & Business Conduct (the “Code”) has been put in place to summarize the key ethical and legal principles that everyone at the Company is required to adhere to. While this Code does not cover every issue that may arise, it is intended to promote honest and ethical conduct among all individuals employed by or associated with Saadia Pharmaceuticals.

1.2 Scope

Every employee, officer, director, consultant, and contract worker (full time or temporary) is expected to read, understand, and comply with this Code and all other applicable laws, regulations and Company policies.

This Code and the spirit of its purpose apply to all Company locations, affiliates and subsidiaries. Employees who would like to seek further information or have questions on the information contained in the Code should speak with their supervisor or Compliance Officer.

The Code is not an employment contract. It does not change the at-will status of any employee of the Company. Compliance with our Code, however, is a condition of continued employment. Accordingly, each employee must acknowledge receipt of this Code and be automatically and continuously bound by its terms.

The Code does not attempt to anticipate every ethical dilemma you may encounter. The Company is relying on you to use good judgment and common sense in all of your business dealings.

2.1 Overview

Saadia Pharmaceuticals respects diversity and the personal dignity of its employees. Company employees are expected to treat all colleagues with respect and dignity. As such, Saadia Pharmaceuticals strives to ensure that the Company’s work environment is free of discrimination and harassment.

  • Discrimination is defined as the adverse treatment of an individual based on his or her race, color, religion, gender, sexual orientation, age, gender identity, gender expression, national origin, citizenship, ancestry, marital status, disability, genetic information, veteran status, or other characteristic protected by applicable laws, rather than his or her individual merit.

Saadia Pharmaceuticals will not tolerate any form of harassment, whether physical, verbal, or visual.

  • Harassment is defined as any action that inappropriately or unreasonably creates an intimidating, hostile, uncomfortable or offensive work environment or unreasonably interferes with an individual’s ability to perform the duties or responsibilities of his or her employment.

Employees should report any type of discrimination or harassment immediately to their manager, Human Resources Department, Legal Department, Compliance Department or the Compliance Hotline.

2.4 Safety and Health

Saadia Pharmaceuticals is committed to providing a safe and healthy working environment to its employees through the adherence to applicable health and safety laws. Any employee who is aware of any conditions or practices in the workplace that pose a threat to health, safety, or the environment is responsible for reporting them to their manager, Human Resources Department, Legal Department, Compliance Department or the Compliance Hotline immediately.

3.1 Overview

The Company’s reputation for integrity and excellence requires careful adherence to all applicable laws and regulations as well as commitment to the highest standards of conduct of corporate and personal integrity. Productivity is maximized when employees act ethically, responsibly, and professionally. The Company expects all employees to conduct Company business in an ethical manner.

There may be situations where the ethical or legal course of action may be unclear. In such cases, employees are expected to seek guidance by speaking with their supervisor or the Compliance Officer.

3.2 Compliance with Laws, Regulations and Industry Codes

Company employees shall abide by applicable laws and regulations where the Company operates or otherwise conducts business. This includes, but is not limited to, laws and regulations that prohibit bribery and corruption or impose trade sanctions or protect privacy rights. Each employee must strive to fully understand which laws pertain to their area of work and what is required to be in compliance with these laws. Since the laws are numerous and complicated, this Code does not include a summary of every relevant law. Employees who have any questions or concerns about a particular law, this Code or any other Company policy, should discuss their questions or concerns with their supervisor or the Compliance Officer.

While employees are not expected to have in-depth knowledge of all applicable laws and regulations, employees should understand the underlying principles and apply them to their activities. Examples of laws and the principles that govern the Company’s business are outlined below.

Anti-Bribery and Anti-Corruption Laws: These laws prohibit bribery through the provision of anything of value to foreign government officials, and/or commercial bribery, to gain or retain business or favorable treatment and carry significant penalties for violations. The Company prohibits the payment of any bribes regardless of recipient type and prohibits facilitation payments (even if otherwise permissible by law).

Anti-Kickback Statute (“AKS”): AKS laws prohibit anyone from offering, paying, soliciting, or receiving anything of value (including a kickback, bribe, or rebate) in order to directly or indirectly, implicitly or explicitly, reward past prescribing or induce future prescribing, purchase, use or recommendation of any item or service reimbursed under a federal or state healthcare program, or to unlawfully influence regulatory, pricing, formulary or reimbursement decisions and/or gain or improve access to HCPs.

False Claims Act (“FCA”): The FCA in the US protects the federal government from false or fraudulent claims for payment. Violations of this law include providing false records or statements to obtain payment from the government or causing a third party to submit a false claim to the government. This statute has been used to prosecute pharmaceutical companies for encouraging prescribers to prescribe products for unapproved uses or for providing alleged kickbacks leading to improper reimbursement by federal healthcare programs such as Medicare and Medicaid.

Health Insurance Portability and Accountability Act (“HIPAA”): HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, addresses the security and privacy of health information, who is responsible for maintaining the security and privacy of such information, and who may access and/or use such information. Violations can lead to severe penalties including criminal and/or civil fines and/or imprisonment.

HHS-OIG Compliance Program Guidance for Pharmaceutical Manufacturers: The Office of Inspector General of the Department of Health and Human Services (“HHS-OIG”) in the US has developed guidelines for pharmaceutical manufacturers to consider when developing, implementing, or evaluating a Corporate Compliance Program. HHS-OIG also reinforced the Federal Sentencing Guidelines’ seven elements of an effective compliance program. The guidance is intended to assist with the development and implementation of internal controls and procedures that promote adherence to applicable law, regulations, and rules.

Industry Codes: The Company abides by applicable industry codes and all Company employees shall ensure that their conduct, such as interactions with HCPs, is completely appropriate and of the highest ethical standards. Examples of industry codes that the Company follows include PhRMA Code on Interactions with Healthcare Professionals and PhRMA Principles on Conduct of Clinical Trials.

Patient Protection and Affordable Care Act (“PPACA”): Under PPACA, applicable manufacturers must report certain payments or transfers of value to a US physician or teaching hospital. This law necessitates the tracking and disclosure of spend associated with healthcare professionals by the Company. In instances where state requirements and laws are more restrictive than the Company’s policies, the Company’s employees shall conduct activities in accordance with the more restrictive state requirements.

3.3 Anti-trust and Fair Competition

Anti-trust and fair competition laws are meant to prevent restraints on trade, and a competitive marketplace ensures that the greatest benefit can be realized by both consumers of healthcare products and services (i.e. patients, healthcare providers) and suppliers of those products/services. Each employee is expected to understand and comply with anti-trust and fair competition laws and not to enter into business contracts or engage in activities that violate, or give the appearance of violating these laws. Specifically, when dealing with competitors:

  • The Company will not enter into agreements or understandings which propose, or give the appearance of, limiting competition.
  • The Company will not enter into agreements or understandings which propose, or give the appearance of, sharing price, price-related terms, sales terms or other conditions.

Violations of these laws by any Company employee carry severe penalties for both the Company and the individual depending on the severity of the violation. Anti-trust and fair competition laws are complex; therefore employees must contact the Legal Department for approval of any business practice conducted on behalf of the Company that may involve an interpretation of these laws.

3.4 On-Label Promotion of Products

The Company complies with applicable laws and regulations that govern the development, manufacturing, labeling, promotion and sale of pharmaceutical products.

When patients and HCPs seek drug-related information about products, they are looking for the most accurate and complete information. Therefore, when the FDA approves a drug, it does so for certain purposes and indications only. A drug product is approved for the use stated in its label. Any other use is considered off- label. Off-label information can include information regarding disease state, dosing, patient populations, use of concomitant medications, duration of therapy, comparison to other therapies, etc. To avoid any risk of promoting an off-label use of our products, each employee is responsible for learning and understanding the on-label use of the Company’s promoted products and is prohibited from proactively communicating off-label information.

The Food & Drug Administration (“FDA”) prohibit pharmaceutical companies from marketing or promoting a drug for off-label use. However, they do not prevent HCPs from prescribing or discussing off-label information with their patients. The Company’s Medical Affairs department is permitted to respond to unsolicited requests for off-label information for a Company product. Unsolicited requests are direct, spontaneous question(s) from an HCP that is neither directly nor indirectly encouraged nor prompted by a Company employee.

3.5 Marketing of Products – Use of Approved Materials

The Company’s policy is to advertise and promote its products only through programs and materials that have been formally approved by the Company. All such programs and materials are reviewed by appropriate Company personnel to ensure compliance with applicable state and federal laws and regulations. Unauthorized alteration of product labels or literature may result in severe penalties against the responsible individual and the Company. No Company employee should modify any portion of any product labeling or literature, without prior authorization from the Legal Department and the Regulatory Affairs Department. Use of any unapproved promotional materials or advertisements is strictly prohibited. Also, materials may never be disseminated as advance notification of unapproved/ investigational product(s).

3.6 Drug Sampling

Product samples may be made available for HCPs to initiate treatment in appropriate patients but can never be provided simply to reward or encourage prescribing behaviors or for any improper purpose.

3.7 Interactions with Healthcare Professionals (“HCPs”) and

Organizations (“HCOs”)

Building strong, appropriate and ethical relationships with HCPs are an integral part of Saadia Pharmaceuticals’ business operations. The PhRMA Code provides guidance on what is acceptable during these interactions to ensure that HCPs have the most up to date and accurate information on prescription medicines. As such, all Company employees must conduct themselves in the most appropriate and compliant manner when interacting with an HCP.

The Company understands that any relationship with an HCP must be compliant with applicable healthcare fraud and abuse as well as anti-bribery and anti-corruption laws. These laws prohibit giving or offering anything of value to influence prescribing or purchasing decisions. Furthermore, laws and regulations prohibit the submission of false claims or statements to federal or state healthcare programs. To ensure compliance with regulations pertaining to interactions with HCPs and HCOs, the Company has drafted and implemented written policies and procedures that provide guidance to employees regarding appropriate interactions with these groups.

3.8 Consulting Arrangements with Healthcare Professionals

The Company may, from time to time, enter into an agreement with an HCP to provide bona fide services to the Company. These services may include assisting in the development of products or product claims, speaking at presentations or conferences, participating in advisory board meetings, providing general consulting services, training employees or conducting clinical trials or other research. Prior to entering into an agreement with an HCP, there must be a legitimate business or scientific need for the service that has been identified, demonstrated and documented. The Company bases decisions to select or retain an HCP as a consultant based on their qualifications to provide the required services, such as medical expertise, reputation, knowledge and experience regarding a particular therapeutic area.

Compensation provided to HCP consultants and reimbursement for expenses must be reasonable and reflect the fair market value (“FMV”) of the services being performed under the agreement. Compensation may not vary based on the volume or the value of the HCP’s past, present or anticipated business.

3.9 Gifts

The Company’s sales and promotional interactions with HCPs are intended to inform HCPs about Company products and provide relevant scientific and educational information to support patient care and the practice of medicine. The Company does not use gifts, meals, hospitality, entertainment, recreation, and other items or activities of value to influence HCPs to prescribe, use, purchase, recommend, or make favorable formulary recommendations concerning Saadia Pharmaceuticals’ products. Providing gifts for the personal benefit of HCPs or HCOs is not permitted. Provision of cash or cash equivalents, such as gift certificates, coupons, vouchers, tickets or similar items is also prohibited. Holidays and other special occasions (e.g., weddings, funerals or graduations) do not constitute exceptions to this policy. To the extent allowable under local law, in-kind items of educational value may be provided to HCPs

3.10 Privacy

On occasion, the Company may receive personal and private information for legitimate business purposes including, but not limited to, information concerning colleagues, job applicants, research study subjects, research investigators, patients, consultants, HCPs, vendors, and suppliers. The Company is committed to compliance with applicable legal and regulatory requirements protecting the privacy of Personal Health Information, other confidential information and safeguarding this information in a manner consistent with applicable laws. The Company respects individual privacy and adheres to applicable data privacy/data protection laws and regulations. All Company employees are expected to protect individually identifiable information as it pertains to employees, applicants, clinical trial and research study patients, and customers.

3.11 Corporate Opportunities

Employees are prohibited from (a) taking corporate opportunities that are discovered through the use of the Company’s property, information or position and using them personally; (b) using the Company’s property, information or position for personal gain; and (c) competing with the Company. Employees owe a duty to the Company to advance its legitimate interests when the opportunity to do so arises.

3.12 Fair Dealing

Each employee should endeavor to deal fairly with the Company’s shareholders, customers, suppliers, competitors and employees. No one should take unfair advantage of anyone through manipulation, concealment, abuse of privileged information, misrepresentation of material facts, or any other unfair dealing practice.

4.1 Overview

Company employees must adhere to all applicable laws and regulations. In doing so, they must steer clear of any conflicts of interest that may affect the Company’s reputation negatively. Employees must uphold Company values while conducting business within the letter and spirit of the law

4.2 Conflicts of Interest

Company employees have a responsibility to the Company, their co-workers, and themselves to avoid conflicts of interest. A conflict of interest may arise when personal interests compromise, or have the appearance of compromising, judgment. Company employees have a duty to avoid conflicts of interest whenever possible, keeping the Company’s best interest in mind at all times. Employee decisions should not be made for personal gain that conflicts with their professional or ethical obligations to the Company. Three general rules in avoiding conflicts of interest are:

  • Business activities with suppliers, customers and other individuals or entities should be conducted in a fair and objective manner
  • Do not personally profit, in kind or in cash, from Company business transactions
  • Avoid any conflict of interest with family members by not recommending or using family members’ businesses, services or products

In the event that an actual conflict of interest arises between the personal, professional or financial duties of a Company employee, the employee involved in this conflict of interest should address, disclose and handle the matter in the utmost ethical manner and in accordance with this Code, including disclosing such conflict of interest to their supervisor or the Compliance Officer.

4.3 Insider Trading

Insider trading involves the purchase or sale of securities of a reporting issuer with knowledge of a material fact or material change with respect to the reporting issuer that has not been generally disclosed. The prohibition against insider trading also applies to trading in the securities of any publicly traded company about which a Company employee, director, or agent may receive inside information during the course of his or her relationship with the Company. Employees, officers, stockholders and directors (and their families) are obligated to abide by both United States and Canadian laws and regulations prohibiting trading in the securities markets based on inside information or communicating inside information about the Company or its business partners, competitors, customers, or suppliers. Any Company employee, officer, or director who has a question regarding stock trading or the sharing of Company information with third parties should contact the Legal Department.

4.4 Competitive Intelligence

Saadia Pharmaceuticals believes in free and open competition in the marketplace. Keeping up with the competition means having the ability to produce proper business plans, which sometimes include an assessment of competitors’ products, services, or business. However, the Company respects the privacy and confidentiality of its competitor’s information and only wishes to gather such information pertaining to competitive advantages in a reasonable and ethical manner. Obtaining a competitor’s confidential, non-public information through unlawful practices is not permitted. The improper gathering of competitive information could subject the Company and the employee to criminal and civil liability. Any Company employee who has acquired a competitor’s private and confidential information unlawfully is subject to disciplinary and if necessary, legal actions and will be required to immediately destroy the confidential information that is obtained.

4.5 Confidential Information

The release of confidential information about the Company or its business or products may harm the Company. It is imperative that any confidential scientific and business information regarding the Company, as well as the Company’s trade secrets, be protected to ensure the Company’s success. It is the duty of Company employees to safeguard this confidential information. Confidential information includes, but is not limited to:

  • Unpublished financial information including, but not limited to, financial models, sales and revenue information and pre-commercial product launch information
  • Inventions, trade secrets, know-how
  • Operational and/or marketing plans, systems, techniques, information and budgets
  • Personal information including, but not limited to, compensation, wage and benefits information
  • Information pertaining to specific customer, customer information and customer requirements
  • Patient information or PHI (i.e. individually identifiable health information such as name, address, birth date, social security number, etc.)
  • Information pertaining to the Company’s relationship with existing or potential strategic partners, suppliers, distributors, consultants and any other information that is not publicly available
  • Information that might affect the Company’s competitive position

Employees must maintain the privacy of confidential information pertaining to the Company’s business at all times. Confidential information known by an employee must remain confidential both during and after employment with the Company (whether such termination is voluntary or involuntary). Any Company employee who improperly uses or discloses confidential information will be subject to disciplinary action, up to and including termination of employment without notice and legal action, even if they do not personally benefit from the disclosure. When leaving the employ of the Company, an employee must return all confidential information in any form and all copies which are, or may have been, in his or her possession.

If an employee has any doubt as to the confidentiality of specific information, he or she should discuss it with the Legal Department.

4.6 Company Assets

The Company offers employees access to a variety of the Company’s resources such as Company property, information, resources, systems and many other supplies. These resources are intended to be used by employees for Company business and the employee assumes the responsibility to protect against theft, loss, misappropriation and misuse. These resources should be used only for Company business and not for any personal use, though incidental personal use may be permitted at times.

It is important to recognize that any and all data and/or other information linked to these assets, such as email, documents and any other files, are the property of the Company. The Company reserves the right to retain and inspect this data and/or information, including any electronic communications transmitted over any Company network, with or without an employee’s or third party’s knowledge, consent or approval, in accordance with applicable law, except in each case as may be limited by applicable foreign laws.

All Company employees shall provide reasonable and appropriate care when dealing with Company’s assets, resources, and property. Any misuse of Company’s assets, resources and/or property that an employee becomes aware of should be reported to his or her supervisor, and if appropriate, the Legal Department.

4.7 Record Retention and Documentation

All employees have a duty to ensure that Company’s business information is stored in a secure manner and complete records are identified, securely stored, and disposed of in the appropriate manner. The Company must retain records for immediate use, as well as possible long-term use for litigation purposes, historical reference, contractual obligations, regulatory or legal requirements, or for other purposes as determined by the Company. When a record supersedes the necessary retention period or is simply no longer needed, it may be discarded. Should a current or potential lawsuit, audit or internal investigation be initiated, discarding of records should be suspended in accordance with the applicable legal hold. If a Company employee is unsure as to whether a document should or should not be disposed of, he or she should contact the Legal Department.

5.1 Overview

Saadia Pharmaceuticals is committed to being a good corporate citizen in the communities in which it does business. Company employees must provide an accurate and consistent message to the public when speaking of, or representing Saadia Pharmaceuticals.

5.2 Charitable Contributions

Company employees are encouraged to give back to the community through charitable contributions. While such contributions to the community can make a difference, the Company must ensure that these contributions are provided in accordance with Company policies and applicable laws and regulations. If a charitable contribution is to be made by Saadia Pharmaceuticals, it must be approved through the proper channels. Questions with regards to charitable contributions may be directed to the Compliance Officer.

5.3 Political Contributions and Activities

The Company encourages its employees to engage in political activities, such as the right to vote. However, it is imperative that all employees understand that these engagements should not be conducted on behalf of the Company or in any way that is likely to give the impression that the Company is taking a stance to support or endorse any candidate or political party. Such activities must also be done on personal time and without the involvement of any Company resources. Questions with regards to political contributions and activities may be directed to the Compliance Officer.

5.4 Media and Public Inquiries

It is extremely important that any message to the public be accurate, consistent and authorized by the appropriate person at the Company. All employees must be aware of, and adhere to Company guidelines on communicating with the public through the media, press releases, promotional materials or other means. Any requests for information from the Company by an outside party should be immediately referred to Investor Relations.

6.1 Compliance Program and Leadership

The Company has adopted policies, procedures, training programs and mechanisms to promote an atmosphere of open, honest and ethical communication throughout the Company. The Compliance Officer is primarily responsible for oversight of the Compliance Program, but each employee plays an important role in building and supporting the Compliance Program for the Company.

6.2 Reporting of Any Known or Suspected Violations

The Company is committed to ensuring compliance with Company policies and applicable laws and regulations to preserve the Company’s reputation, ensure the safety of its customers, and to continue to be successful. This is all possible because of the Company’s dedication to compliance with all applicable laws and regulations and Company policies.

If a Company employee knows of or suspects a violation of a Company policy, procedure, law or regulation or unethical conduct, he or she has a responsibility to report this. Examples of issues that require reporting include financial improprieties, accounting or audit matters, ethical violations, illegal practices, or serious violations of the Company’s Code of Business Ethics & Conduct or policies. The failure to report such a violation will itself be viewed as a violation of this Code. Appropriate channels to report a concern include your supervisor or another supervisor, the Human Resources department, the Compliance Officer, the Legal Department, or through the Company’s reporting mechanisms (e.g., the Compliance Hotline. The Company expects employees to report concerns with as much information, facts and details as possible related to the known or suspected issue so that the Company can evaluate the reports and identify and correct any problems promptly.’

6.3 Compliance Hotline

The Company has established a compliance reporting mechanism for anyone who wants to report a good faith concern related to unethical or illegal conduct or violations of this Code. Good faith means a sincere and honest belief that is not motivated by malice or the desire to defraud others for personal gain. The hotline may be used to anonymously report violations or suspected violations of the law.

6.4 Investigation and Enforcement

Reports of suspected misconduct and compliance violations made in good faith will be subject to investigation promptly and thoroughly by the appropriate persons. This information will be treated as confidential and remain anonymous unless disclosure to a third party is deemed necessary for the investigation. The Compliance Officer is responsible for determining the resources that will conduct the investigation, depending on the nature of the reported concern. Cooperation is imperative during internal investigations by each Company employee involved in such investigations.

6.5 Retaliation is Prohibited

The Company strictly prohibits intimidation or retaliation of any kind against an employee who seeks advice, raises a concern, reports known or suspected violations or unethical conduct, or provides information in an investigation, even if the good faith report is not substantiated. If an employee believes they have been subject to retaliation, or know of someone who has, notify their supervisor or the Compliance Officer.

6.6 Disciplinary Actions

This Code is provided to give Company employees the tools to understand and adhere to the laws and regulations that guide our Company and allow us to achieve the highest standards of conduct. Therefore, employees are subject to disciplinary action for authorizing or participating in an activity that results in a violation of the law, Company policies or any other standards and procedures listed.

Each situation will be evaluated and handled individually by the Company. Based on the severity of the problem and circumstances involved, the disciplinary actions will vary. If disciplinary action is warranted, subject to local law, it may range anywhere from a warning to termination of employment. In certain circumstances, an individual employee may be subject to criminal fines, imprisonment, and an official prohibition on working in the pharmaceutical industry.

6.7 Waivers and Amendments

From time to time, the Company may waive certain provisions of this Code on a case by case basis. Should a Company employee feel that he or she merits a waiver regarding this Code, he or she should contact his or her manager, who should contact the Compliance Officer directly. Any waivers of this Code require approval from the Compliance Officer. All waivers of this Code will be disclosed as required under applicable law and regulations. This Code may be amended at any time without prior notice. If necessary, amendments to the Code should be provided by the Compliance Officer. Amendments to this Code will be promptly disclosed to Company employees.

6.8 Expectations of Company Employees

Employees are expected to be a part of Company achievements. Compliance with applicable laws, regulations, Company policies and other best practices applicable to companies in our industry is critical to Company success. On an annual basis, all Company employees shall certify that he or she has read and understood the Company’s Code of Conduct, in order to demonstrate their dedication to conducting themselves in the utmost ethical and professional manner