Code of ethics and Transparency

1. INTRODUCTION

Pharmaceutical companies belong to one of the most regulated industrial sectors and are required to adhere strictly to legislation and regulations, as well as to the highest applicable ethical and quality standards.
In Grupo PiSA® we adhere to the regulations applicable to this sector, however, we are also convinced that, in the field of ethics, beyond legal obligations, are the duties, convictions, and personal responsibilities of each one of us.

Grupo PiSA® was founded in 1945 by Professor Miguel Álvarez Ochoa with the collaboration of a group of eminent physicians, and since then, it has fostered in its personnel the attachment to the values of Humility, Honesty, Respect for the Person with Justice, Responsibility and Drive.

Although these values constitute an essential part of our corporate culture and are a fundamental part of the life of our company, it is necessary to formalize them and establish a common frame of reference that unifies the criteria and guides the actions and judgments of all employees who belong to Grupo PiSA®.

The Code of Ethics of Grupo PISA® is a document that contains a set of provisions that reflect the principles and values that govern internal and external operations, as well as the guidelines of conduct that are in harmony with the applicable legal regulations, sound business practices, and codes of conduct that govern the pharmaceutical industry.

This Code of Ethics incorporates the experience of our daily work, formalizes the corporate vision of our environment, and reaffirms the inalienable values that have guided the consolidation, growth, and projection of Grupo PiSA® as companies deeply committed to their country, their people, and the noble task of contributing to preserving the health and quality of life of people, as expressed in our motto:

It is expected that the guidelines of this code are complied with and disseminated by shareholders and employees, as well as by other stakeholders, and that following them is a source of pride that in turn helps to distinguish and build trust in Grupo PISA® in the eyes of society.

Finally, it is stated that this Code of Ethics is part of the Integrity Policy of Grupo PiSA® within the framework of the General Law of Administrative Responsibilities applicable in the United Mexican States, together with the Anti-Corruption Policy of Grupo PiSA®, among others. In this context, it is essential to reiterate the commitment of Grupo PiSA® to comply with the applicable legal framework and convey to its shareholders, employees, and stakeholders the importance of maintaining this commitment.

2.- OBJECTIVES AND SCOPE

The Grupo PiSA® Code of Ethics is authorized by the Ethics Committee with the following objectives:

Establish the basic criteria of ethical conduct to be met by shareholders and employees, both management and operational, customers, competitors, authorities, and society, and share the values and criteria of ethical conduct with stakeholders who seek to know or maintain a relationship with Grupo PiSA®, including its customers, suppliers, and advisors.  

3. THE COMMITMENT OF GRUPO PISA®

3.1. Fundamental commitments

Grupo PiSA® expresses its commitment to promoting a responsible pharmaceutical industry with integrity, transparency, and always being attentive to prevent any abuse, unfair practice, or act of corruption that may jeopardize compliance with the principles developed in its Code of Ethics, designed to ensure the welfare of society and the development of a responsible industry , or that may jeopardize compliance with applicable legal provisions.

In accordance with the above, at Grupo PiSA® , without limitation, we commit ourselves:

3.1.1. To comply with the laws, regulations, and legal provisions on health, labor, commercial, administrative, economic, environmental, and corruption prevention matters, as well as with the current official standards applicable to the pharmaceutical industry.

3.1.2. To develop, produce, and commercialize accessible drugs, medical devices, and healing materials, complying with the highest quality, safety, and efficacy standards, both for the domestic and export markets.

3.1.3. To inform health authorities, physicians, and, if applicable, civil society truthfully and objectively in general about the characteristics of our products, taking into account the respective scientific and technical commercial information, in accordance with the applicable legislation.

3.1.4. To make transparent our social responsibility activities and the information of Grupo PiSA® that the competent Mexican authorities request.

3.1.5. To adopt principles, policies, and codes that are in line with our Code of Ethics and that promote internationally accepted guidelines and principles of conduct.

3.1.6. To verify compliance with the law and the Code of Ethics by our collaborators and relationship or interest groups through annual reviews and audits, both internal and external.

3.1.7. To promote the adoption of the principles established in the Code of Ethics , through its internal communication and its dissemination to relationships or interest groups.

3.2. Organizational Culture of Grupo PISA®

3.2.1. About us (Mission). We are a group of responsible, reliable, ethical, and service-oriented companies committed to our collaborators and to health.

3.2.2. What do we want? (Vision) Permanence through innovation and accelerated growth in Mexico and abroad.

3.2.3. How are we going to do it? By complying with our Decalogue: 

I. Living up to the values of Grupo PiSA®.
II. With directors, managers, and supervisors responsible for communicating and developing their team.
III. With employees capable of adapting to change and growth of Grupo PiSA®.
IV. With employees committed to their personal growth and development.
V. With collaborators capable of making decisions that benefit Grupo PiSA®, analyzing situations and foreseeing risks.
VI. Working in a team with a high focus on goals and results.
VII. Innovating and manufacturing products and services of the highest quality.
VIII. Operating at the lowest cost in the industry.
IX. Continuously simplifying processes.
X. Complying with internal and external regulations.

3.3. Values of Grupo PiSA®

Within Grupo PISA® the following values are defined as inalienable for employees, managers, shareholders, and other stakeholders: 

3.3.1. Humility

How does a person who lives up to this value behave?

a. Willing to learn and teach.
b. Share accomplishments as a team.
c. It is open to the fact that he or she can improve.
d. Acknowledges his or her mistakes.
e. He or she is self-critical.
f. Accepts feedback.
g. Knows how to listen to them, regardless of their level.
h. Treats customers and suppliers with simplicity.
h. Treats others as she wants to be treated. Is not arrogant.
i. Understands that "it is not accepting everything".

3.3.2. Honesty

How does a person who lives by this value behave?

a. Always tells the truth, objectively, completely, and without justification.
b. Does not steal.
c. Chooses what is best for the company.
d. He/she does not privilege his "acquaintance friend".
e. Promotes the right person; not his/her "favorite one".
f. He or she takes care of the company’s information. Does not disclose it.
g. He or she is neither a liar nor a cheat.
h. Reports bad practices and behaviors.
i. Does not check the badges of his or her classmates.
j. Does not waste time during working hours.

3.3.3. Respect for the person with justice.

How does a person who lives by this value behave?

a. Gives fair recognition to those who work and those who do not work.
b. Knows that being demanding is not at odds with being well treated.
c. Avoids favoritism.
d. His or her manner is friendly and courteous.
e. Does not insult.
f. Considers the time of others.
g. Gives everyone what is due.

3.3.4. Responsibility

How does a person who lives by this value behave?

a. He or she is accountable for the consequences of his or her actions.
b. Complies with what he or she must do.
c. Avoids absences for unjustified causes.
d. Reports failures and inappropriate behaviors.
e. He or she takes care not to have accidents.

3.3.5. Drive

How does a person who lives by this value behave?

a. She or he has a sense of urgency.
b. Hungry to excel.
c. Wants to grow.
d. Wants to improve.
e. Is not a conformist.
f. Finds solutions.
g. Proposes ideas.
h. Sees how things are possible, not impossible.

3.4. Grupo PiSA® Social Responsibility Principles

At Grupo PISA® we are committed to acting with social responsibility for the benefit of the interests of the pharmaceutical industry as well as the health of society, and we pledge to comply with the following principles:

3.4.1. Contribute to preserving health and quality of life by manufacturing and marketing innovative products and services. In this sense, Grupo PiSA® must ensure that its health products and supplies effectively serve to preserve and improve the quality of life of people, with care for safety and quality, as well as to ensure an efficient distribution that guarantees their availability.

3.4.2. To foster the well-being of the communities where we operate by promoting responsible competitiveness through the establishment of objectives for the success of Grupo PiSA®.

3.4.3. To promote favorable working conditions for the quality of life and human and professional development of its entire community (employees, family members, shareholders, and suppliers).

3.4.4. To respect the ecological environment in every one of the operation and commercialization processes, in addition to contributing to the preservation of the environment.

3.4.5. To develop programs that respond to the needs and expectations of society and promote actions that have a positive impact on the social and economic development of the entity.

3.4.6. Identify and support social causes related to the organization’s interests, as part of its strategy.

3.4.7. To live up to schemes of participative leadership, solidarity, service, and respect for human dignity and rights.

3.4.8. To serve as an example of responsible and honest competitiveness and social commitment for the Mexican pharmaceutical industry.

3.4.9. Participate through intersectoral alliances and civil society organizations in addressing social issues of interest.

3.4.10. Take stakeholders into account in its social responsibility programs.

3.4.11. Adopt diversity and non-discrimination principles in Grupo PiSA®.

3.4.12. To act with solidarity in situations of natural disasters or health emergencies, meeting the requirements of the authority for the benefit of society.

3.4.13. To act responsibly in accordance with health regulations and this Code of Ethics in the promotional activities that comprise:

a. The conduct of sales and promotion personnel.
b. Promotional texts.
c. Distribution of medical specimens.
d. Advertising.
e. Granting of donations.
f. Sponsorships.
g. Participation in medical congresses and symposiums.

3.4.14. To favor the conditions that encourage other actors related to the sector, such as the government, distributors and suppliers, professionals, health institutions, and, where appropriate, patient organizations, to act appropriately to increase the credibility of the pharmaceutical industry within society.

4.- GENERAL GUIDELINES OF CONDUCT

All employees, shareholders, and other stakeholders, such as customers and suppliers, must:

4.1. Act under Grupo PiSA® Values, being obliged to demonstrate in all operations the highest level of professionalism, honesty, and transparency so that the company is distinguished in the business environment for its exemplary performance.

4.2. To always act responsibly in the development, production, and distribution of our products and services, taking care of the lives, health, and safety of people.

4.3. Respect the physical and moral integrity of employees (superiors, peers, and subordinates), as well as of all people, without committing harassment and without discriminating or abusing their human rights for reasons of race, nationality, gender, age, sexual preference, religious or political beliefs, or because of their social status, physical condition, and/or disability.

4.4. Abolish child labor, avoiding the violation of the right to education and the physical and moral risks to minors.

4.5. Refrain from committing fraud or stealing for any reason or situation: opportunity, pressure,, or “apparent justification”.

4.6. Refrain from any act of corruption or bribery such as gifts, bonuses, gifts, commissions, or any other tangible benefit to a person or public or private entity, national or international, that is against the law, in exchange for favoring one’s own business or having a personal benefit.

4.7. Refrain from carrying out operations in which there is any conflict of interest, which is against the law or the interests of Grupo PiSA®.

4.8. Refrain from misrepresenting information about their work, including confidential and privileged information as well as information about products or services provided. Likewise, refrain from providing Grupo PiSA® with any type of false information.

4.9. On the part of the employees, the handling of privileged and/or confidential information, including trade secrets and personal data to which they have access ("confidential information") shall be treated in the following manner:

4.9.1. Employees may not use or disclose, directly or indirectly, confidential information to which they may have access, including personal data and industrial secrets, or any other information derived therefrom to third parties, or use it for their direct or indirect benefit, even if they cease to render their services for the contracting company for any reason.

4.9.2. Employees who have access to confidential information of Grupo PiSA® companies and/or any of its customers, suppliers, subsidiaries, affiliates, divisions, or any other company or individual related to them, whether such access is accidental or intentional, direct or indirect, shall be obliged to keep it and keep it in strict secrecy and take the necessary measures to ensure that such information is kept secret.

4.9.3. In case of termination of the employment relationship, whatever its cause, the employee shall be obliged to keep under the strictest confidentiality, for at least 5 (five) years, counted from the date of such termination, all confidential information to which he/she had access or received during his/her employment relationship with the contracting company. This is because such confidential information represents Grupo PiSA® and/or its customers a competitive and economic advantage over third parties in the performance of its business activities and that its development represents a high economic cost for the same, reason why Grupo PiSA® has adopted sufficient and necessary mechanisms to preserve its confidentiality and restrict its access to third parties.

4.9.4. The products, inventions, brands and/or works that any collaborator creates, designs, develops, participates in, or implements, individually or jointly, by virtue of their position and responsibilities; are the exclusive property of the contracting company and the compensation they will receive for it is included within the salary agreed in the Individual Employment Agreement, the foregoing under the provisions of the applicable articles of the Federal Copyright Law and the Federal Labor Law.

4.9.5. Workers shall be subject to penalties, fines, and labor liability as well as civil liability with respect to the reparation of material damage and/or compensation for damages, in accordance with the provisions of the Federal Labor Law, the Industrial Property Law, the Federal Criminal Code, civil legislation, and any other applicable law or regulation, if they fail to maintain confidentiality or respect the Intellectual Property rights of Grupo PiSA® companies and/or any of its customers, suppliers, subsidiaries, affiliates, divisions, or any other company related to them.

4.10. Workers are required to notify the Ethics Committee members in the first occurrence of any act of extortion, bribery, fraud, or conflict of interest. They also have an obligation to report any plagiarism or misuse of private information, including trade secrets or personal information. Unless a responsible national authority requests otherwise, the members of the Ethics Committee shall maintain the confidentiality demanded by any person who declares, reports, or provides evidence of any act that violates this Code of Ethics or the applicable legislation.

4.11. Workers are obliged to abide by the Federal Law for the Protection of Personal Data in Possession of Individuals and its regulations. Grupo PiSA® , Laboratorios PiSA, S.A. de C.V., its subsidiaries, other businesses that they operate and/or manage in any capacity, as well as their staff, clients, and suppliers, are all required to observe this law.

5.- SPECIFIC CONDUCT GUIDELINES

5.1. With regard to associates

5.1.1. All Grupo PiSA® employees are expected to adhere to and respect the values and norms specified in this Code of Ethics and the Internal Work Regulations from the beginning of their employment relationship until the end.

5.1.2. Employees, as well as those aspiring to occupy a position in Grupo PiSA® , must report any type of relationship they have with another Grupo PiSA® employee.

5.1.3. To prevent situations in which a conflict of interest may arise, it is established that:

a. Relationships between operational, administrative, or management collaborators prohibit them from reporting to one another. Staff members’ relatives may work at Grupo PiSA® if there is no hierarchy of duties.

b. If a person has a relationship to another employee who works for Grupo PISA® in another location, they must notify the Ethics Committee. This is particularly important for employees who hold a strategic position or have access to privileged and sensitive data. The Ethics Committee will specify the course of action in these situations.

c. When there is a hierarchy between two partners, sentimental attachments are not permitted. The Ethics Committee must be notified if a sentimental relationship is maintained between parties who are under the same administration.

5.1.4. Workers who plan, sponsor, or participate in internal or external activities on behalf of Grupo PiSA® are not permitted to serve alcohol or encourage others to do so. Alcohol drinking by Grupo PiSA® personnel while doing work-related tasks is neither encouraged nor permitted.

5.1.5. The premises, machinery, equipment, computer software, furniture, tools, stationery, and office supplies owned by Grupo PiSA® may not be used by employees for any purpose other than Grupo PiSA® -related operations.

5.1.6. When it comes to ensuring that the collaborators under their supervision follow this Code of Ethics , the management collaborators are required to keep the members of the Ethics Committee informed of their choices.

5.2. With regard to customers

When Grupo PiSA® employees interact with Customers, they are required to adhere to specific criteria in addition to the general ones. These include:

5.2.1. Comply with the provisions of section 3.4.13 of this Code of Ethics.

5.2.2. In addition to the general standards, Grupo PiSA® personnel are expected to follow guidelines while interacting with customers. Taking unfair advantage of a consumer, a rival’s product, person, business, trade brand, or symbol through media advertising is one of them.

5.2.3. Clearly and honestly describe the features, purposes, benefits, and drawbacks of our goods and services.

5.2.4. In order to encourage the use of the prescription and prevent substitution by pharmacy staff, they will fight the vices that exist between the users and the means of distribution and dispensation, including the use of the medical prescription when it is against the law.

5.2.5. Any relationship, whether private or public, should be reported to the Ethics Committee. The Committee will then notify the relevant director so that appropriate steps can be made to avoid instances where a conflict of interest arises.

5.2.6. Notify their immediate supervisor of any lunches or gatherings to which Customers are invited on behalf of any Grupo PiSA® company, even if the cost is covered by them personally rather than by Grupo PiSA®.

5.2.7. Avoid taking or making personal offers of gifts, favorable terms, gratuities, travel, commissions, or any other type of remuneration that isn’t specified in an official way.

5.2.8. If, for reasons of courtesy in the business relationship and with the authorization of the area manager, it is decided to receive a gift from a customer, the following must be complied with:

a.- Presents of any kind must be reported, with the exception of promotional items like the following examples, but not limited to pens, pencils, markers, rulers, mugs, thermoses, card holders, backpacks, calendars, t-shirts, balls, key rings, caps, buttons, badge holders, notebooks, calculators, notepads, agendas, umbrellas, and more.

b. Accepting meals, refreshments, and other forms of hospitality is accepted in some business partnerships and isn't thought to have any influence on choices. Such courtesy must always be established and upheld clearly beyond the bounds of influencing actions or choices, and it must be reported to and approved beforehand by the immediate supervisor.

c. The Ethics Committee must be notified of any reward, courtesy, prize, or gift that employees receive—such as airline miles or lodging—from various events, raffles, or trips taken by and/or on behalf of any of Grupo PiSA®’ s companies. This allows the committee to determine whether the employee may use the item for personal use.

5.2.9. For customers in the public sector, strict adherence to the relevant public procurement regulations and relevant anti-corruption measures in line with the Grupo PiSA® Anti-Corruption Policy is required.

5.3. With regard to market practices and competitors.

Grupo PiSA® employees in commercial activities in the private or governmental market must adhere to the following guidelines, seeking and encouraging similar behavior by competitors:

5.3.1. Avoid unfair business tactics that reduce, harm, or obstruct free competition and free concurrence in the manufacturing, processing, distributing, and marketing of pharmaceutical products. The following actions are forbidden because they are deemed to be unfair and anti-competitive: 

a. Any action taken in concert with rivals with the intention of "stabilizing" prices or maximizing profits, such as setting prices in public bids, either directly or indirectly, including through distributors, is referred to as manipulating the pricing of goods or exchanging information to that effect.

b. The division or allocation of market segments, customers, or territories, either directly or indirectly, including using distributors, is known as allocation or distribution. One such forbidden practice is the coordination of distributors' and laboratories' bids.

c. Refusal to deal is the act of not selling products to distributors that are prepared to pay the same price and adhere to terms that are typically extended to other distributors.

d. manipulation of sales conditions, which includes varying pricing or terms of sale for purchasers in comparable situations, unless such variances are warranted for commercial

e. The restriction or conditioning of production and closing of distribution channels.

5.3.2. Refrain from agreeing with competitors to any unfair or anti-competitive practice of those mentioned in the previous guideline.

5.4. In relationWith regard to suppliers

Grupo PiSA® employees who have a relationship with suppliers of products or services, in addition to complying with the general guidelines, must:

5.4.1. Seek for and cultivate connections with suppliers who uphold this Code of Ethics and who, in addition to satisfying Grupo PiSA®’s requirements for pricing and quality of goods or services, exhibit a recognized ethical behavior.

5.4.2. Make sure that suppliers of materials and services that have a direct impact on the caliber of goods and services provided by any Grupo PiSA® companies have a quality system in place or consent to its verification.

5.4.3. Ascertain that the provider of any information, legal, advising, or consulting services that have a direct impact on the business or operational efficiency of any Grupo PiSA® company has agreed to abide by this Code of Ethics.

5.4.4. Any relationship that you may have with any supplier of supplies or services to Grupo PiSA® should be disclosed to your immediate supervisor. Please note that the supervisor will then report the information to the relevant director so that appropriate action can be taken to avoid situations where a conflict of interest arises

5.4.5. Any business relationship with suppliers, consultants, advisors, service providers, or even customers and distributors who were once employed by any of the Grupo PiSA® companies should be reported to the immediate supervisor, regardless of whether they are directly involved in Grupo PiSA® or through other related parties. In order to prevent instances where there is a conflict of interest, the corresponding director must be notified by the immediate supervisor.

5.4.6. In relation to points 5.4.4 and 5.4.5, dealings with suppliers, consultants, advisors, service providers, or even customers and distributors, must be authorized by the General Management.

5.4.7. The following must be followed if it is chosen to accept a present out of courtesy in the business connection, as part of the company objectives, and with the area manager's approval.

a. Except for promotional items like pens, pencils, markers, rulers, thermoses, backpacks, calendars, t-shirts, balls, key chains, buttons, badge holders, notebooks, calculators, notepads, agendas, umbrellas, and more—all of which are mentioned as examples but are not restricted to—all gifts received must be reported.

b. Accepting meals, refreshments, and other forms of hospitality is accepted in some business partnerships and isn't thought to have any influence on choices. Such courtesy must always be established and upheld clearly beyond the bounds of influencing actions or choices, and it must be reported to and approved beforehand by the immediate supervisor.

c. Any gift, prize, courtesy, or reward that employees receive—such as hotel stays or airline miles—from various events, raffles, or travels undertaken by Grupo PiSA® companies or their suppliers must be reported to the Ethics Committee for consideration of whether the employee may use it for personal purposes

5.5. With regard to shareholders

In addition to following this Code of Ethics and sharing it with others, shareholders are expected to handle privileged and secret information with integrity.

5.6. With regard to civil society

All Grupo PiSA® employees, in addition to complying with the general guidelines, must:

5.6.1. Act responsibly, in compliance with health regulations and this Code of Ethics, in promotional activities of our products and services to civil society in general.

5.6.2. Refrain from carrying out any external activity using Grupo PiSA®’s assets and funds for this purpose.

5.6.3. Notify the members of the Ethics Committee of any action or impact resulting from Grupo PiSA®’s operations, services, or products that could endanger the company’s viability or have an impact on civil society through the communication channels and media that Grupo PiSA® provides.

5.6.4. Refrain from attending to the print, electronic, national, and international media. This activity corresponds solely and exclusively to the General Management or the Communication and Institutional Relations Department. Requests from the media will be answered based on public information available in Grupo PISA®. In case of being contacted by any media or social network, the Communication and Institutional Relations Department or General Management must be informed.

5.7. With regard to the environment

Grupo PiSA® employees, in addition to complying with the general guidelines, must:

5.7.1. Commit to carry out actions, no matter how small, to help take care of the natural environment, such as saving energy and avoiding waste of resources.

5.7.2. To participate and contribute with knowledge in environmental forums.

5.7.3. All Grupo PiSA® companies are committed to comply with the legal provisions related to the preservation and improvement of the environment.

Grupo PiSA® is dedicated to upholding the widely recognized moral standards of sustainability, adhering to the laws pertaining to the protection and enhancement of the environment, especially with regard to the ultimate disposal of garbage and packaging, and supporting programs aimed at advancing the growth of an environmentally friendly and socially conscious sector of the economy.

6.-WORKING CONDITIONS

6.1. Free choice of employment

6.1.1. There shall be no involuntary or forced labor.

6.1.2. Workers are free to leave their jobs at any time with a reasonable notice period, and they are not obliged to leave while Grupo PiSA® is in charge of their deposits or identity documents.

6.2. Right to collective negotiations

6.2.1. All workers, without exception, will be entitled to collective bargaining rights.

6.2.2. Grupo PiSA® will approach organizational and union activities with a cooperative and tolerant attitude.

6.2.3. Employee representatives are entitled to perform union duties in the workplace without facing discrimination, including:

a. To oversee, carry out, run, and enhance programs and systems for training.

b. Make the required adjustments to labor relations, workspace layout, technology, and other aspects of the business in line with the most productive organizational and technological practices.

c. Monitor compliance with productivity agreements.

d. Resolve the objections, if any, presented by the workers when the distribution of productivity benefits.

6.3. Safe and Hygienic Conditions

Health and safety working conditions shall be optimal to prevent occupational hazards.

6.3.1. A clean and safe workplace must be created, considering any unique risks as well as current industry expertise. Necessary measures shall be taken to prevent accidents and injury to health arising out of, associated with, or occurring in the course of work by reducing, as far as reasonably practicable, the causes of hazards inherent in the working environment.

6.3.2. Workers must obtain the proper education and training to help them recognize the hazards they face, learn how to reduce those risks, and carry out their jobs safely.

6.3.3. Employees shall receive regular health and safety training.

6.3.4. Access to clean toilets and potable water shall be provided.

6.3.5. Hygienic conditions shall be provided in the facilities for employees to wash and eat.

6.4. Child employment.

6.4.1. No applicant who is less than eighteen years old may be hired.

6.5. Payment of a living wage.

6.5.1. Pay and benefits for a typical workweek must at least meet industry benchmark norms or national law minimums, whichever establishes the greatest pay and benefits.

6.5.2. Every time an employee receives their compensation, they should be given written and clear information about their working conditions and wages both before they accept employment and during the pay period in question.

6.5.3. Salary deductions for disciplinary purposes are not allowed, and no deductions not allowed by national law may be taken without the employee’s express approval. Every disciplinary action must be documented.

6.6. Payment of a living wage

Grupo PiSA® will set the duration of the working day, without exceeding the legal maximums.

6.6.1. To give employees more protection, working hours must comply with both national laws and collective bargaining agreements.

6.6.2. Except for overtime, working hours must be specified in contracts and cannot be more than 48 hours per week.

6.6.3. Working overtime must be voluntary and done responsibly, taking into account the quantity, frequency, and hours put in by each employee as well as the workforce at large. Authorized overtime will always be paid at a higher rate.

6.6.4. Working more than sixty hours in a seven-day period is not permitted unless one of the circumstances listed in 6.6.5 below comes to pass.

6.6.5. In extraordinary cases, labor hours may surpass 60 hours within a seven-day period if any of the following scenarios materialize:

  • National legislation permits.
  • When allowed by a freely negotiated collective bargaining agreement with a union that represents a sizable fraction of the workforce
  • When appropriate measures are taken to safeguard the health and safety of workers.
  • When exceptional circumstances, such as unexpected production peaks, accidents, or emergencies, can be demonstrated.

6.7. Regular work

6.7.1. The work done must, in every way, be founded on acknowledged labor connections that have been created by national law and custom.

6.7.2. Labor-only contracts, subcontracts, domestic work contracts, internship programs that do not aim to provide the employee skills or regular employment, or the excessive use of contracts with limited duration will not be acceptable ways for employers to avoid their obligations to their employees under labor or social security legislation and regulations arising from conventional labor relations.

6.8. Distinction and Discrimination

6.8.1. When hiring, training, promoting, compensating, terminating, or retiring employees, no terms may be set that imply discrimination on the basis of gender, age, disability, social status, health, religion, immigration status, opinions, sexual preferences, marital status, or any other factor that compromises human dignity.

6.9. Dignified Treatment

6.9.1. Physical abuse or punishment is prohibited.

6.9.2. It is forbidden to perform violent acts, make threats, insult, harass, sexually harass, mistreat, verbally abuse, or engage in any other type of intimidation against an employee or a member of their immediate family.

6.9.3. Every employee is entitled to the same possibilities for advancement under equal conditions as other workers or outside parties, as well as to be treated fairly, with decency, and with respect.

6.9.4. It is against the law to offer rewards, opportunities for progress, and promotions in return for financial or sexual favors.

7. -OBSERVANCE OF COMPLIANCE WITH THE CODE OF ETHICS

7.1. The members of the Ethics Committee who will handle receiving, reviewing, and addressing complaints of noncompliance with this Code of Ethics are the General Director , the Director of Human Resources , the Director of Law , and the Office Coordinator. They will also notify the other members of the Committee of any cases in which they lack sufficient justification to move forward by sending an email to linearh@pisa.com.mx. The Human Resources line administrator will forward complaints that are received by the Ethics Committee via email.

7.2. All workers are required to report any unlawful act, actual or possible conflict of interest, or violation of this code to the Ethics Committee by sending an email to linearh@pisa.com.mx as soon as they become aware of it.

7.3. You should get in touch with Human Resources if you have any questions about how to interpret, apply, or determine the scope of any provision found in this code of ethics.

7.4 Without indicating any sort of impunity for the offenders themselves, Grupo PiSA® promises that there will be no retaliation or consequence of any type against the employee who reports or informs of any infraction of this Code of Ethics.

7.5. The Ethics Committee is responsible for resolving any ambiguity in the interpretation or application of the Code of Ethics’ standards and for penalizing any instances of non-compliance. They must turn last to the Board of Directors if they lack the justification to move forward.

7.6. Violations of this Code of Ethics may lead to the imposition of disciplinary actions, which range from a warning to the termination of employment with any of

Anti-Corruption Policy

1. INTRODUCTION AND PURPOSE

Grupo PiSA, which consists of Laboratorios PiSA, S.A. de C.V. and its direct and indirect companies, is dedicated to conducting business with honesty and legality. The aforementioned indicates a commitment to prevent corruption of any type, including fraud, dishonesty, and bribery, on the part of Grupo PiSA and the Regulated Entities (as such term is defined below), in accordance with the guidelines provided in this document.

Since its founding, Grupo PiSA has insisted that all of its employees uphold the following principles: drive, responsibility, humility, honesty, and respect for the individual with justice. In this regard, Grupo PiSA released its Code of Ethics, which outlines the values and guiding principles that direct the internal and external operations of the company’s businesses and the rules of behavior that align with ethical standards and good business practices that apply to the pharmaceutical industry and related industries.
In order to ensure compliance and observance, an Ethics Committee consisting of the Chief Executive Officer, the Directors of Human Resources, Law, and Audit and Security has also been formed for this purpose.

Grupo PiSA is aware of the potential for corruption in the health and pharmaceutical industries, and it takes into account the unique effects that corruption in these fields may have on societal welfare. The risks Grupo PiSA faces in its interactions with the government are very significant. These risks pertain to its operations, oversight, and regulation as a player in the health sector, as well as potential roles as a supplier of medications to government clients. This paper lays out the internal guidelines that Obligated Entities must adhere to in order to prevent engaging in activities that are forbidden and sanctioned by law in order to combat corruption.

As a result of the aforementioned, Grupo PiSA issues this anti-corruption policy (hereinafter referred to as the “Anti-Corruption Policy”) in accordance with the provisions of article 25 of the General Law of Administrative Responsibilities of the United Mexican States (“LGRA”), which forms part of Grupo PiSA’s Integrity Policy and contains prohibitions, preventive controls, and sanctions for non-compliance.

1.2 Purpose

a. The purpose of the Anti-Corruption Policy consists of: 

I. Prevent all Covered Entities from participating in acts of corruption, whether directly or indirectly, while carrying out their duties or operations, adhering to the code of conduct outlined in this Section 4.

II. Establish controls for the prevention of acts of corruption.

III. Informing the Regulated Entities of the consequences for Grupo PiSA because of non-compliance with this Anti-Corruption Policy. 

b. The Anti-Corruption Policy’s provisions are mandatory, and failure to comply will result in disciplinary action, which may range from a reprimand to the termination of the employment relationship with Grupo PiSA without liability or the termination of the contract that gives rise to the relationship with Grupo PiSA, irrespective of any potential administrative, civil, or criminal liabilities.

c. Before taking or approving any action on behalf of Grupo PiSA that might raise a concern or question about the legality of an action or whether the action is correct or appropriate under the terms set forth in this Anti-Corruption Policy, all Covered Parties, regardless of rank or position, should seek guidance from the Ethics Committee of Grupo PiSA. Stated differently, any Covered Entity that has any questions concerning the implementation and adherence to this Anti-Corruption Policy should get in touch with Grupo PiSA’s General Counsel or the Ethics Committee.

2.- REGULATED ENTITIES

a. This Anti-Corruption Policy is binding on the following persons (the "Regulated Entities"): 

I. The shareholders, partners, or associates of Grupo PISA.

II. The principals or agents, attorneys-in-fact, commission agents, agents or managers, directors, officials, and staff of Grupo PISA, as well as anyone representing them, are all included in this. For these reasons, the agreements governing the parties' relationship may contain the sample clause found in this anti-corruption policy’s Annex A

III. Regarding actions resulting from their association with Grupo PiSA, advisors, consultants, suppliers, or subcontractors must be informed of the Anti-Corruption Policy and, if necessary, have anti-corruption clauses included in their contracts (Annex A of these Anti-Corruption Policies).

b. Grupo PiSA® business partners, also referred to as “joint ventures” or consortiums. For business partners to abide by the terms of this anti-corruption policy, Grupo PiSA® will make sure that the parties to the applicable partnership agreement explicitly state that the firm or consortium will either adopt equivalent measures or comply with the anti-corruption policy. 

c. It is not permitted for the Regulated Entities to make requests of third parties that are not legally related to Grupo PiSA®

3.- DEFINITIONS

For the purposes of this Anti-Corruption Policy, the following definitions shall apply:

a. LGRA: the General Law of Administrative Responsibilities.
b. Grupo PISA®: Laboratorios PiSA, S.A. de C.V., with the understanding that for the purposes of the Anti-Corruption Policy, this definition also includes subsidiaries or affiliates.
c. Mexico: United Mexican States.
d. Public Servant:

I. Any representative or worker of the Federal Government of Mexico or the governments of the Republic’s states, including members of the Federation's judiciary or the state governments’ judiciary branches.

II. Any individual holding any kind of employment, office, or commission in the Federal Public Administration, state or local public administration, or the Congress of the Union or state legislatures.

III. Members or staff of State Productive Enterprises and Autonomous Constitutional Bodies.

IV. Political party officials, workers or anyone acting for or on behalf of a political party or a candidate for public office.

V. Workers or individuals serving as public representatives or.

The aforementioned is stated with the understanding that the prohibitions referred to in this Anti-Corruption Policy that apply to the Regulated Entities with regard to their interactions with Public Servants also apply to Public Servants’ spouses, blood relatives, civil relatives, and other third parties with whom they have professional, labor, or business relationships, as well as to partners or businesses in which they are involved 

e. Obligated Parties: the parties indicated in Section 2 of this Anti-Corruption Policy.

4.- ANTI-CORRUPTION PROHIBITIONS

Grupo PiSA® prohibits the Obligated Entities from engaging in the activities described and detailed below: realizar las actividades que se señalan y detallan a continuación: 

 4.1 Bribery

a. Grupo PiISA® prohibits Obligated Entities from bribing Public Servants.

b. The offering, promising, or delivering of any undue benefit to public servants, directly or through third parties, in exchange for them carrying out or abstaining from an act pertaining to their functions or the functions of another public servant, or abusing their actual or perceived influence, is considered bribery to public servants. This is done with the intention of obtaining or maintaining, for Grupo PiSA®, a business opportunity, benefit, or advantage, regardless of whether the benefit or outcome is accepted or received

c. Regarding the aforementioned, regardless of whether the individual is a public servant or a member of the private sector, no Covered Subject may offer or provide any person with undue benefits in order to corruptly achieve or keep a business opportunity or advantage for Grupo PiSA®.

d. It is recognized that when acts are carried out in violation of applicable laws or regulations, or when information is misrepresented or kept secret, Grupo PiSA® is pursuing a corrupt opportunity or advantage. These actions may include, but are not limited to, the following goals: 

I. Obtain a contract with the government.
II. Influence an acquisition process.
III. To circumvent rules for the importation of products.
IV. Improperly obtain confidential information.
V. Tax evasion.
VI. Avoid the imposition of a penalty.
VII. Obtain a permit or license, or
VII. Avoid termination of a government contract.

e. Similarly, it is against the law for regulated entities to profit excessively from a contract, commercial opportunity, or other advantage that they provide Grupo PiSA®. Broadly speaking, there are a few instances of risk scenarios in the commission of acts of bribery that Grupo PiSA® may encounter during its operations. These include requests for special benefits from Public Servant to assign public contracts for the purchase of medicines, giving undue gifts or financial incentives to doctors in public hospitals so they will prescribe products to patients, or paying money to the authorities to prevent sanctions from being imposed.

 4.2. Influence peddling to induce authority

Regardless of the Public Servant's acceptance or the outcome, Grupo PiSA® forbids the Obligated Parties from using influence, economic or political power, real or imagined, over any Public Servant in order to obtain a benefit or advantage for Grupo PiSA® or for any third party, or to harm any individual or Public Servant

 4.3. Use of false information

a. Grupo PiSA® forbids the Obligated Parties from submitting fraudulent or altered documents or information, or pretending to comply with guidelines or regulations set forth in an administrative procedure pertaining to public procurement, in order to gain approval, gain an advantage, or cause harm to any individual.

b. Likewise, it is against the law to misrepresent Grupo PiSA®’s legal, financial, or administrative circumstances in private or public contractual processes or commercial talks.

 4.4. Obstruction of investigative powers

Regulated Entities are forbidden from impeding Grupo PiSA® ’s investigative powers when they possess information pertaining to an investigation into administrative misconduct or corruption and they give false information, purposefully and unjustifiably postpone the delivery of that information, or neglect to respond to the authorities' demands or decisions

 4.5. Conclusion

a. In issues of public procurement, Grupo PiSA® forbids the Obligated Parties from carrying out any acts with one or more private parties that suggest, aim, or result in gaining an unfair advantage or benefit for Grupo PiSA® in public procurement, whether at the federal, state, or local levels

b. The signing of agreements, contracts, agreements, arrangements, or combinations among competitors by the Obligated Parties with the intent to benefit Grupo PiSA® unfairly or to harm the Treasury or the assets of foreign or Mexican public bodies is deemed to constitute collusion.

c. The restriction mentioned in the previous sentence also applies to cross-border business dealings in which Grupo PiSA® is involved.

d. Since information exchanges with other participants in a public procurement procedure may involve the coordination of bids or prices, to the detriment of the contracting government entity, they may be construed as collusion under the terms mentioned above. This is because the purpose of the information exchanges is to coordinate the submitted proposals

4.6. Misuse of public resources

a. The Obligated Parties are forbidden from taking any actions that would allow Grupo PiSA® to handle, receive, administer, or have access to public resources in any way. These actions could involve misappropriation, misuse, or a departure from the intended use of the public resources, whether they be financial, human, or material.


b. Obligated Entities are also prohibited from failing to render accounts to the authorities in relation to requests made to verify the use of such resources.

4.7. Undue hiring of former Public Servants

It is forbidden for Obligated Entities to hire any individual who served as a public servant in the previous year and who possesses privileged information obtained directly from his employment, position, or commission in the public service. This information could potentially benefit Grupo PiSA® in the market or give it an advantage over its rivals

 4.8. Unlawful participation in administrative proceedings

When Grupo PiSA® , if applicable, is prohibited or disqualified from participating in federal, local, or municipal administrative procedures by law or resolution of competent authority, it is prohibited to take any action or refrain from taking any action.

5.- CONTROLS TO PREVENT ACTS OF CORRUPTION

 5.1. Facilitation Payments “bribes”

a. Payments for facilitation are not permitted. Payments made to public employees with the intention of pressuring them to complete a procedure or fulfill a regular duty quickly are known as facilitation payments. Examples of payments made in order to facilitate transactions include sums that public employees ask for in order to: 

I. Issuing a permit, license or other official document or expedite the issuance procedure.
II. Providing police protection.
III. Providing a public service.
IV. Complying with a customs procedure.
V. Allowing the transit of goods or in activities related to inspection functions by authorities. 

b. While other nations—such as the United States of America under the Foreign Corrupt Practices Act—allow for specific exclusions to be made for facilitation payments, the LGRA in Mexico does not; as a result, making such payments is forbidden and may be construed as bribery.

c. A Regulated Entity must notify the Ethics Committee and/or the Legal Director and decline to make a facilitation payment when asked by a Public Servant to fulfill regular duties or carry out a procedure.

 5.2. Cash disbursements

a. All cash payments made by Grupo PiSA®’s departments or Regulated Entities must be accurately and appropriately represented in the related accounting records. Similarly, the relevant record of documentation endorsing the associated payment must be accessible (e.g., receipts or invoices that comply with the applicable tax requirements).

b. Depending on the amount to be paid, the aforementioned does not affect compliance with other applicable accounting requirements, such as the requirement to have the relevant authorizations.

 5.3. Hospitality Expenses with Public Servants

It is forbidden for Grupo PiSA® and the Regulated Entities to reimburse public servants for hospitality costs like gifts or meals.

5.4. Training on the Anti-Corruption Policy

a. The Obligated Entities will receive training on this Anti-Corruption Policy from Grupo PiSA® once a year.
b. The Legal Department will distribute the notices inviting the Obliged Parties to attend the training sessions, informing them of the location, date, and time of the events.
c. All Covered Entities, including directors, executives, and staff members of Grupo PiSA®, are required to attend such training. During the training sessions, a roll call will be made to confirm attendance, and participants will also receive certificates of participation.
d. Upon hiring, every Grupo PiSA® employee and new hire will receive a copy of the anti-corruption policy and the training materials.

 5.5. Anti-Corruption Clauses in Contracts

Depending on the kind of legal relationship Grupo PiSA® has with the Regulated Entities, all contracts with them must include clauses that are similar to the typical anti-corruption clauses included in Annex A.

 5.6. Finance and accounting

Obligated Entities involved in finance and accounting functions shall ensure the following: 

a. All payments received or paid by Grupo PiSA® must be documented in the associated accounting records, which must be accessible for inspection by directors, hierarchical superiors, or auditors of Grupo PiSA®.
b. No transactions are listed as being “off the books”.
c. That Grupo PiSA® obtains the necessary authorizations for each payment in accordance with the amount that be paid.
d. Keep an eye on monetary or in-kind payments to make sure they aren't being used for bribery; and
e. Ensure that all paperwork and accounting records are kept for the length of time stipulated by relevant laws.

 

5.7. Charitable Donations and Political Contributions

a. Grupo PiSA® ’s charitable contributions cannot be used to cover up payments received for corrupt activities (bribes).
b. Only associations that have been granted permission by the Ethics Committee to accept tax-deductible contributions in compliance with relevant tax laws may receive donations.
c. No donations in cash are accepted.
d. Direct or indirect contributions to political parties, candidates for public office, or independent candidates are forbidden.

 5.8. Conflict of interest

a. Conflict of interest for regulated entities.
I. When a Regulated Entity’s personal interests or those of its close friends, family members, or business associates diverge from Grupo PiSA®’s, conflicts of interest may occur. Regarding this, “conflict of interest” refers to the potential influence that personal, familial, or commercial interests may have on a Regulated Entity's ability to carry out its duties.

II. Obligated Entities are required to report to the Legal Director or the Ethics Committee any circumstances that could compromise their ability to carry out their obligations, such as hiring suppliers in which they or their family members has an ownership interest. 

III. In light of the aforementioned, the Obligated Entity whose operations could be impacted by a conflict of interest case

b. Conflict of Interest for Public Servants

I. Under the LGRA, behaving in a conflict of interest while a public servant is involved is an administrative infraction. A public worker is engaging in a conflict of interest under the aforementioned law if he or she interferes in any manner during the attention, processing, or resolution of cases in which he has a conflict of interest due to their employment, position, or commission.

II. With reference to the previous, any Regulated Entity that learns of a relationship involving a Public Servant is required to notify the Ethics Committee or the Legal Director; for instance, if Public Servants are involved in a governmental process or contracting procedure and have family or business interests with any Regulated Entity

III. The Obligated Parties are required to notify Grupo PiSA® of any situations in which a relationship with a public servant could give rise to a conflict of interest, whether it be familial or commercial. The aforementioned is conditional on Grupo PiSA® adhering to the applicable legislation and making the declarations of business, personal, or family ties or relationships, as well as conflicts of interest, that are required of it in the public procurement procedures in which it participates.

 

 5.9. Compliance with the applicable legal framework for public contracting.

a. Strict adherence to the relevant legal framework is required in contracting processes that Grupo PiSA® engages in with the federal government or state governments. Giving incorrect information or dodging regulations is absolutely prohibited. A manifest of relations with the entity or public servants participating in the contract could be one of the documents that the government body in issue requests from Grupo PiSA® to conduct a procurement procedure or to award a contract by a method other than bidding. It is emphasized that providing false information to award contracts to Grupo PiSA® is prohibited. The related information sought in relation to this statement must be accurate and full.

b. In the preparation of the documents, review of the participation requirements and determination of the documentation to be submitted, as well as, in general, in the required activities, the Legal Department of Grupo PiSA® will participate, who must ensure compliance with the applicable legal framework and with the bases for participation in the procedure in question.

c. Similarly, in the event that Grupo PiSA® is granted a government contract, it is required to strictly adhere to all applicable regulations and conditions set forth in the contract.

d. If the legal framework governing government contracts is not followed, state and federal auditing agencies may make observations, and Grupo PiSA® may take administrative or even criminal action against the violators

6.- CONSEQUENCES FOR NON-COMPLIANCE WITH THE ANTI-CORRUPTION POLICY

a. The Ethics Committee will be in charge of deciding what happens when the Regulated Entities violate the anti-corruption policy. Prior to the Ethics Committee making a judgment, each case will undergo a corresponding inquiry that will be conducted with or without the Regulated Entity’s awareness and will take into account the manifestations that the Regulated Entity may have in this regard.

b. The following are the repercussions for the Obligated Entities who violate the Anti-Corruption Policy:

 I. A censure, a temporary suspension of the employment connection, or an immediate termination of the employment relationship without liability may be enforced in the case of directors, officers, or workers.

 II. The termination of the legal relationship or contract in question may be decided in the case of representatives, principals, agents, attorneys-in-fact, commission agents, agents, or managers; advisers; consultants; suppliers; or subcontractors of Grupo PiSA®. The corresponding contracts must include provisions for the aforementioned. If it is decided to terminate the legal relationship with any of the individuals, Grupo PiSA will not be allowed to hire them again for a period of three years. If this is the case, hiring must be approved by the Ethics Committee after taking the case history into account.

c. The above consequences are without prejudice to any criminal or administrative complaints that may be filed by Grupo PiISA® or the exercise of the corresponding civil actions.

d. Non-compliance with the Anti-Corruption Policy and the LGRA may result in administrative sanctions to Grupo PiISA® (such as fines or disqualification to participate in public procurement) as well as administrative sanctions directly to the Obligated Parties involved and even imprisonment for the persons involved.

7.-AUDITS AND ANONYMOUS REPORTS

a. Audits

I. Grupo PiSA® will carry out yearly audits to ensure adherence to the anti-corruption policy. Among the things that need to be checked off the list is making sure that the relevant legal framework has been followed when it comes to public procurement or administrative processes where Grupo PiSA® is involved in order to obtain or renew permits or authorizations.
II. Internal auditors or external auditors recruited for the job may conduct such audits. The auditors’ requests for information must be complied with by Obligated Entities. Should such data be subject to confidentiality requirements, it must be brought to the attention of the Ethics Committee, which will then decide how best to give it to the auditors.

b. Anonymous complaints

I. All Obligated Entities shall collaborate to prevent the commission of acts of corruption.
II. If you have become aware of or suspect that an act of bribery may be taking place within Grupo PiISA®, you should immediately inform the Legal Department, by e-mail: jppatino@corpcab.com.mx or by telephone at +52(33) 3268-8422, who will take cognizance of the reported facts and will inform the members of the Ethics Committee of Grupo PiISA®.
III. Unless a competent authority requests otherwise, the members of the Legal Department and the Ethics Committee shall maintain the confidentiality requested by any person who discloses, reports, or offers proof of any act that violates this Policy or any applicable laws, including with regard to their identity. Despite the aforementioned, anonymous reports are possible.
IV. The members of the Ethics Committee responsible for receiving, reviewing, and addressing complaints of noncompliance with this policy will be the Directors of Human Resources and Law. They will also notify the other members of the Committee of any cases in which they lack sufficient justification to proceed.
V. Without indicating any form of impunity for the offenders themselves, Grupo PiSA® ensures that there will be no reprisal or consequence of any sort against the Obligated Subject who discloses or informs of any non-compliance with this Anti-Corruption Policy.
VI. False or baseless accusations that, for instance, are made to bring down another Regulated Entity may be dealt with in line with this Anti-Corruption Policy's paragraph 6 sanctions.

ANNEX A

STANDARD CLAUSES FOR THE PREVENTION OF ACTS OF CORRUPTION

Commitment against Corruption 

Due to the risks involved, the following provisions may be added in contracts that Grupo PiSA® enters into with suppliers, customers, or counterparties:

“COMMITMENT AGAINST CORRUPTION” 

a. The parties declare that they have acted in accordance with the principles of legality, honesty, impartiality, integrity, and other applicable principles during the contract negotiations and that they have complied with the General Law of Administrative Responsibilities' provisions as well as the best practices for preventing acts of corruption. They further agree to act in accordance with the law's provisions and the best practices in the relevant field during the contract's execution. The Parties commit to denouncing any corrupt practices that they are made aware of.
b. The Parties acknowledge and agree that during the performance of this Contract, their officers, directors, employees, natural persons acting on their behalf or representation, subsidiaries, affiliates, and, if applicable, their subcontractors or agents, shall not, directly or indirectly, offer or deliver any undue advantage, in cash or in kind, to the public servants involved in the execution or supervision of this Contract or whose functions are related to its performance, in exchange for the public servants' performing or refraining from performing an act related to their functions or those of another public servant, or abusing their actual or perceived influence, in order to obtain or maintain a benefit or a
c. The other party may end this agreement at any time if this clause is broken or if one party engages in corrupt behavior as that term is defined by applicable law.
d. The Parties affirm that, in order to guarantee adherence to the terms of this section, they have internal procedures, guidelines, or policies in place to stop acts of corruption. These measures are in line with the demands of the relevant laws and industry best practices.
e. Grupo PiSA® has made [name of supplier, customer, or counterparty] aware of its Anti-Corruption Policy in this regard, and [name of supplier, customer, or counterparty] agrees to abide by its terms as appropriate

Contracts with Employees

2. Contracts with Employees

Legal entities will be punished under the provisions of the General Law on Administrative Responsibilities, Article 24, if serious administrative misconduct is committed by individuals operating on their behalf or in their representation with the intention of benefiting the legal entity. Regarding this, the following sentence can be included to the agreements controlling interactions with directors, officials, staff members, or anybody else representing Grupo PiSA® in general: 

a. [The Officer] agrees to abstain from acting in any way that could be construed as a violation of the General Law of Administrative Responsibilities' requirements [or Grupo PiSA®’s internal anti-corruption procedures]." In order to obtain or maintain a benefit or advantage for Grupo PiSA®, [The Officer] is forbidden from giving or receiving any undue benefit, whether in cash or goods, to public employees directly or through an intermediary in exchange for those employees performing or abstaining from performing an act related to their functions or the functions of another public employee, or abusing their actual or perceived influence.

b. “If [the Officer] learns of any act of corruption or any violation of Grupo PiSA® internal policies or the applicable legal framework against corruption committed by any officer, employee, or person acting on behalf of Grupo PiSA®, he or she is required to report it within Grupo PiSA® using the reporting mechanisms set forth in this regard.

c. Regardless of whether a complaint is filed with the appropriate authorities, Grupo PiSA® shall have the right to terminate the employment relationship if [the Officer] does anything that is deemed to be a violation of the General Law of Administrative Responsibilities [or the Anti-Corruption Policy of Grupo PiSA®]. In the case that Grupo PiSA® is ordered to pay a fine or indemnity due to [the Officer's] non-compliance with the terms stated above, [the Officer] shall indemnify Grupo PiSA® and respond for the damages caused to the latter in line with this provision.

d. The Officer has been informed of Grupo PiSA®’s Anti-Corruption Policy and has committed to adhering to the responsibilities outlined in that document.”

Psychosocial Risk Prevention Policy

1. POLICY

Our top priorities at LABORATORIOS PISA, S.A. DE C.V. are the identification, analysis, and prevention of psychosocial risk factors as well as the development of a work culture in which all employees, regardless of position or rank, contribute to the creation of a positive organizational environment.

2. PURPOSE

The following document lays out the components for determining, assessing, and mitigating psychosocial risk factors in addition to fostering a positive work environment.

3. DEFINITIONS

The following terminology are defined to help make sense of the components that comprise this policy:

  • Psychosocial risk factors include those that can lead to anxiety disorders, non-organic sleep-wake disorders, extreme stress, and adaptability as a result of the nature of the job, the style of workday, and exposure to violent or extremely traumatic events at work as a result of the work done.
  • Workplace Violence: Harassment, bullying, or any mistreatment directed towards an employee that could jeopardize their integrity or health is considered violence.
  • An environment that is favorable to the organization is one in which employees feel that they belong to the company; where training is provided to ensure that tasks are performed appropriately; where duties are clearly defined for workers in the work center; where workers actively participate and communicate with one another; where workloads are appropriately distributed and regular workdays are observed in compliance with Federal Labor Laws; and where performance is evaluated and acknowledged.

4. EMPLOYER’'S RULES AND OBLIGATIONS

In order to prevent workplace violence, prevent psychosocial risk factors, and foster a positive work environment, the following guidelines are set forth, along with the following suppositions: 

  • Supervisors, coordinators, chiefs, managers, and directors are responsible for implementing and adhering to this policy in accordance with the company's decalogue, code of ethics, and principles.
  • To put policies into place that are intended to reduce workplace violence, reduce psychological risk factors, and provide a positive work environment.
  • To conduct informational, educational, and awareness-raising campaigns
  • To efficiently spread preventative strategies and policies.
  • To motivate every worker to take part in creating and carrying out this policy at work.
  • To allow employees to express their rights without hindrance based on their color, sex, gender, religion, ethnicity, age, or any other factor that could lead to discrimination; and to provide avenues for employee engagement and consultation while considering their opinions.
  • To carry out follow-up action plans to prevent and control the psychosocial risks found, as well as diagnostics for the identification and prevention of psychosocial risks and the organizational environment as described in NOM-035-STPS-2018.
  • Determine which workers experienced extreme trauma either at work or in the course of their employment, and then direct them to the business physician or the medical social security institution for treatment.

5. OBLIGATIONS OF EMPLOYEES

Similarly, with regard to the avoidance of psychosocial risk factors, the staff members of LABORATORIOS PISA, S.A. DE C.V. undertake the following obligations:

  • Respect the prevention and control methods outlined in this policy, as well as those implemented by the business to manage psychological risk factors, work together to create a positive work environment, and stop incidents of workplace violence.
  • Avoid behaviors that are detrimental to a positive work environment and violent activities in the job.
  • Take part in the assessment of the organizational environment and, if appropriate, the identification of psychological risk factors.
  • "Utilizing the designated channels, report behaviors that are incompatible with a positive workplace culture and oppose instances of violence against employees.
  • Notify the firm immediately, via the Occupational Health department, in the case that a serious traumatic event was experienced. The report needs to include the following minimum information: the report's date; the name of the employee who write it; if it’s possible, the name of the others employees involved; the date of the event(s) and a description of the event(s).
  • Take part in the company’s informational or training events.
  • Obtain the medical and psychological assessments that the company determines necessary to prevent psychosocial dangers.

6. POLICIES

In order to cultivate a positive work atmosphere, the following is established:

  • That new hires undergo medical exams in order to protect and preserve their health.
  • That interviews and psychometric testing are used to match employees with roles that best suit their skills.
  • That employees are informed of their roles and responsibilities; in addition, assessments are conducted to qualify individuals for their positions and guarantee that they possess the skills and background needed to carry out their jobs.
  • That the employees’ working hours adhere to the Federal Labor Law’s requirements.
  • That information on the company’s policies, internal labor regulations (RIT), code of ethics, job descriptions that detail duties, and manuals are promoted and distributed.
  • Because it encourages proactive involvement, open communication, and a positive organizational climate among its members.
  • Through leaders, this acknowledgment of staff performance is promoted and provided with incentives.
  • That resources, like newsletters for leaders, feedback platforms, and courses, are offered to facilitate ongoing leadership development.
  • That initiatives are implemented to support employees’ feeling of community inside the company.
  • That a respectable work environment is created by maintaining the cleanliness of common and workplaces.
  • That employees can file complaints by calling the “HR Line” hotline at 800 83 047 55 or sending an email at linearh@pisa.com.mx. The hotline’s goals are to report incidents of workplace violence and lodge complaints about practices that are detrimental to a positive work environment. It also ensures that each case is kept discreet or anonymous, per the request of the employee, and does not permit retaliation.

LABORATORIOS PISA S.A. DE C.V. is dedicated to ensuring that the regulations intended to prohibit any conduct or behavior involving workplace violence are followed, to protecting the information gathered, and to promptly processing and addressing complaints made through the designated channels.

7. VALIDITY

This policy is based on the Mexican Official Standard NOM-035-STPS-2018, is supported by the Code of Ethics, in section 6 “Working Conditions ” and is effective as of October 17, 2019.

Sanction Enforcement Policies

1. OBJECTIVE

Grupo PiSA® (“PiSA”) is dedicated to abiding by any relevant sanctions in any jurisdiction where it conducts business, including, where relevant, U.S. sanctions issued and upheld by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”). PiSA is aware that noncompliance with these Sanctions, where applicable, would not only be against the law but also potentially do serious harm to the organization’s reputation and increase the likelihood that it would be sued, both of which would result in financial lost to PiSA.

The Sanctions Compliance Policies (hereafter referred to as “The Policies”) define PiSA’s procedures for handling sanctions-related risks and specify the requirements that must be fulfilled on a daily basis by all Employees. Both General Management and the Board of Directors of PiSA have adopted “The Policies”. The PiSA General Management expects all Employees to thoroughly read “The Policies” and adhere to their guidelines.

PiSA is required to abide by the various laws and legal requirements of the many areas in which it performs its business. Local regulations that are more stringent than the standards outlined here must be followed in addition to the guidelines outlined in “The Policies”.
The meaning assigned to capitalized phrases in the Policies is as follows:

2. DEFINITIONS

The following definitions apply for the purposes of “The Policies”:

(a) Chief Compliance Officer: This term designates the Chief Compliance Officer or any delegated personnel in that role.
(b) The Customer: This term refers to any individual or legal entity, including businesses and organizations that PiSA serves directly or indirectly, as well as distributors and final consumers of PiSA’s goods.
(c) Employees: This term refers to and encompasses all full-time, part-time, temporary, and executive employees of any PiSA company, as well as all directors, officers, and executives. It also includes any individual or legal organization acting on behalf of PiSA.
(d) Foreign Sanctions Evaders: Those people or organizations listed on the Foreign Sanctions Evaders List of the Office of Foreign Assets Control (“OFAC”), comprising those sanctioned under Executive Order 13608 (“Prohibits Certain Types of PISA Group Sanctions Compliance Policies on Transactions and Suspends Entry into the United States of America of Foreign Sanctions Evaders with Respect to Iran and Syria”) for engaging in activities connected to circumventing U.S. financial and economic sanctions against Iran and Syria. circumvention of US financial and economic sanctions against Syria and Iran.
(e) OFAC: The United States Department of the Treasury’s Office of Foreign Assets Control.
(f) PiSA: Describes Laboratorios PiSA, S.A. de C.V. and all of its affiliates, regardless of
(g) Countries and/or territories classified as restricted are those that fall under a more limited set of sanctions regulations than countries classified as sanctioned. While doing business with Restricted Countries is not forbidden, it must be done very carefully and cautiously. Only after confirming that the sanctions in place for this nation do not provide a latent risk of sanctions for The Group, may The Group conduct business in a Restricted Country. Annex A contains a list of these nations as of the date these policies were prepared; however, for an accurate list, please speak with the Chief Compliance Officer.
(h) Measures: Any legislation, rule, embargo, or trade restriction, as well as any financial or economic sanctions, imposed by countries or agencies or institutions of certain countries. Santions may result in specific financial restrictios, such as asset freezes or “blocking” regimes, or more comprehensive export or import controls on goods, technology and services, such as embargoes on trade and transportation activities, or all above. Sanctions may target specific indiiduals or companies oy may be directed at industry sectors or entire countries. Sanctions that areapplicable for purposes od theses policies include tose issued by the United States od America, which are issued and eforces by OFAC. Depending on the goods, their destination or the use or destination of the goods, other countries, agencies and government agencies may have sanctions restrictions that may be legally binding on certain type of transactons.
(i) Sanctioned Countries: These are nations and/or regions that are covered by restrictions that apply to the whole nation and/or its territory. As of this writing, the following nations and territories are included in this definition: North Korea, Iran, Syria, Cuba, and the Crimea. Every time the relevant sanctions agencies release updates or create new lists of nations, the list of sanctioned countries is subject to modification. An updated copy of this list must be kept up to date by the Chief Compliance Officer.
(j) Sanctions’ Target: refers to any individual or entity, whether natural or legal, that has been:  

    a. Named as a target or is facing penalties or limitations imposed by the US or another relevant jurisdiction.
    b. Is 50% owned, either directly or indirectly, by one or more sanctioned parties
    c. One that is located, organized, or resides in a Sanctioned Country.

(k) Specially Designated Nationals (SDNs): This term refers to people or organizations that are listed as Blocked Persons and Specially Designated Nationals, as well as organizations that are 50% or more directly or indirectly controlled by one or more SDNs. U.S. citizens are generally forbidden from engaging with SDNs and are required to block their assets. Certain transactions involving SDNs, and non-U.S. individuals may put the non-U.S. individual at risk of liability.
(l) SSDD: As stated in Article 9 of these Policies, this stands for the Standard Sanctions Due Diligence Process.
(m) SSI Legal Entity: This category includes organizations that are included on the OFAC Sectoral Sanctions Identification List and organizations that are at least 50% directly or indirectly controlled by one or more SSI legal entities. One or more of the four Directives apply to SSI Entities. U.S. citizens are prohibited from participating in specific transactions involving short-term debt and stock of SSI Entities under Directives 1, 2, and 3. The export of American products, software, and technology utilized in the oil industry is restricted under Directive 4. As of this writing, the SSI list solely includes Russian Legal Entities. In certain cases, transactions involving deceptive practices between non-U.S. individuals and SSI juridical persons may subject the non-U.S. individual to liability.

(n) U.S. Persons: Refers to:

a. Citizens of the United States, including dual citizens, wherever they may be in the globe.
b. A person who, independent of their physical location, is a permanent resident of the United States, also known as a holder of a green card or work permit.
c. Any corporation formed in accordance with American law or the laws of any U.S.A. jurisdiction (including foreign affiliates).
d. Any individual or entity in the United States, regardless of nationality (including affiliates of foreign individuals residing in the country); and
e. Non-U.S. entities that are owned or controlled by individuals in the United States as a result of U.S. sanctions programs pertaining to Iran and Cuba. 

(o) Supplier: Any person or entity who sells any kind of product (including goods, services, technology, software, or information) to any Grupo PiSA company is referred to as a supplier. Products may be used for PiSA’s own use, to create other products, or for resale to customers.

3. OVERVIEW OF SANCTIONS

Employees must be aware of and able to recognize potential compliance conflicts with sanctions, as well as the “red flags” that should be raised for further investigation and resolution. All these concepts are defined in this section along with some instances that are pertinent to our industry.

To put it briefly, sanctions are legal measures that prohibit PiSA from doing business with specific individuals, nations, sectors of the economy, or with specific products. For instance, doing business with terrorists or those who violate human rights, or with the companies they control, is forbidden. In a similar vein, doing business in some nations, such Iran, North Korea, South Sudan, Syria, and South Sudan, is strictly forbidden.

Numerous sanctions are aimed at specific people or businesses (as well as other companies owned or controlled by such individuals). These include SDN-related sanctions in the United States. Sanctions that restrict parties subject to U.S. jurisdiction's ability to enter into contracts with SII entities or entities flagged as foreign sanctions evaders are also listed. While these individuals are frequently encountered worldwide, the likelihood of coming across them in Sanctioned and Restricted Countries is higher. PiSA and the persons involved run a significant danger of consequences for noncompliance, which include civil and criminal fines as well as possible jail time.

Violations of the sanctions can harm our reputation and make it more difficult for us to get financing and form other banking partnerships. Beyond these hazards, since sanctions are meant to protect ideals like human rights, combat terrorism, and stop the development of nuclear weapons, breaking them may be unethical.

The following provides guidance on when certain Sanctions might be applicable to a given transaction. Contact the Chief Compliance Officer if you have any questions about whether a certain sanction regime may apply to your transaction.
Because of the nature of PiSA’s operations, sanctions may be subject to numerous regimes. However, PiSA would be badly impacted by U.S. sanctions due to its geographic proximity and business interests with the U.S. When the underlying transaction or business is under U.S. jurisdiction, compliance with U.S. sanctions is largely required. Examples of such situations include the following:

a. When the business/transaction initiates, takes place, or concludes in the U.S.A.
b. The technology, goods, or equipment have U.S. content.
c. A U.S. natural person (including U.S. citizens, dual nationals, and permanent residents), and/or a U.S. bank, and/or any U.S. legal entity is involved.
d. Compensation is in U.S. Dollars; and/or
e. Any other relationship between the transaction and the United States of America. If U.S. extraterritorial "secondary" sanctions apply, compliance with the U.S. Sanctions is also necessary, even if the underlying transaction or enterprise is not subject to U.S. jurisdiction. Secondary sanctions usually forbid even non-U.S. citizens from transacting with SDNs or corporate entities that are 50% or more controlled by SDNs, despite the fact that the circumstances under which they may apply are different. Seek guidance from the Chief Compliance Officer if you think secondary sanctions might be applicable, or if the transaction includes an SDN or a legal entity under SDN control.

4. APPLICABILITY

All Grupo PISA organizations, divisions, and employees—including those in top management positions—are subject to these policies. All these people and businesses are required to abide by these policies. Employees who violate these policies may face disciplinary action, which may include termination.

Every employee must get a copy of these policies from the Chief Compliance Officer, or an equivalent. Workers must complete the form in Annex F to attest to their understanding of the Policies. A copy of the completed form must be sent to the Chief Compliance Officer and the Human Resources Department.

5. CHIEF COMPLIANCE OFFICER

Apart from being bound by these policies, PiSA established the role of Chief Compliance Officer, who oversees managing and carrying out PiSA’s sanctions compliance program, which includes adhering to these policies. As a member of the legal department, the Chief Compliance Officer answers directly to the general counsel of PiSA. The Chief Compliance Officer must have enough familiarity with sanctions to properly implement these policies, but they are not required to be qualified attorneys or lawyers. The Chief Compliance Officer can train to acquire this experience concurrently with their appointment.

The General Management division will appoint a temporary Chief Compliance Officer until a permanent replacement is found if the Chief Compliance Officer post remains unfilled for longer than twenty-four hours.

6. GOVERNANCE STRUCTURE

The Chief Compliance Officer of PiSA is ultimately in charge of these Policies. The following division of duties has been made in relation to sanctions in order to guarantee consistent and responsible risk management:

  • Board of Directors: Defines the overall governance governing the Sanctions compliance framework on behalf of PiSA; and
  • Chief Compliance Officer: Determines PiSA’s regulatory responsibility, and monitors PiSA’s compliance with the compliance framework.

All changes to this document must be recommended by the Chief Compliance Officer and approved by the Board of Directors.

7. AREAS OF SANCTIONS APPROACH AND EXPORT/IMPORT RISK CONTROL

There is a greater chance of sanctions non-compliance in some areas of PiSA’s business. The following describes these emphasis areas, the department owners of each, and their duties and responsibilities. The requirements for each of these focus areas are outlined in these policies: áreas de enfoque: 

a. Sanctions.;
b. Customers and Suppliers; and
c. Hiring and Recruitment.

8. POLICY STATEMENT

Workers are required to study these Policies and abide by them. The Chief Compliance Officer should be contacted with any inquiries about how these policies should be interpreted and put into practice. It is within the latter's authority to interpret the Policies. The Chief Compliance Officer will analyze any ambiguous provisions in the Policies.Employees must read and comply with these Policies. Any questions regarding the interpretation of these Policies as well as the implementation of these Policies should be directed to the Chief Compliance Officer. The latter is authorized to determine how the Policies should be interpreted. If any part of the Policies is unclear, the Chief Compliance Officer shall review that provision.
For the purpose of ensuring adherence to these policies, employees must continue to be watchful and alert. Employees should notify their immediate supervisor or the Chief Compliance Officer of any suspicions they may have had of a potential violation of PiSA’s responsibilities under these policies. Anonymous reports of potential non-compliance are welcome. Employees who report possible non-compliance with these policies or sanctions in good faith to their direct supervisor or the Chief Compliance Officer will not face retaliation.
Employees must remain vigilant and vigilant to ensure compliance with these Policies. If an Employee has a suspicion that there has been a possible breach of PiSA’s obligations under these Policies, that Employee should report the possible breach to his or her direct supervisor or to the Chief Compliance Officer. Reports of possible non-compliance may be made anonymously. No Employee shall suffer retaliatory action for reporting, in good faith, to his or her direct supervisor or the Chief Compliance Officer potential non-compliance with these Policies or Sanctions.
It is forbidden for employees to look for or do business with any individual or organization that is deemed a Sanctions Target without the Chief Compliance Officer's prior consent. For the avoidance of doubt, Sanctions Targets encompass, among other things, any natural or legal person listed on the Sector Sanctions Identification (“SSI”) List or on OFAC's list of Specially Designated Nationals (“SDNs”), as well as any legal person that is 50 percent or more controlled by one or more SDN or SSI legal persons. Please get in touch with the Chief Compliance Officer if you are unsure if a person or organization is a sanction target.
Employees are prohibited from seeking or engaging in business with any person or entity considered a Sanctions Target without the prior approval of the Chief Compliance Officer. For clarity, Sanctions Targets include, without limitation, any natural or legal person on OFAC’s list of Specially Designated Nationals (“SDNs”) or a legal person on the Sector Sanctions Identification (“SSI”) List, as well as any legal person that is 50% or more controlled by one or more SDN or SSI legal persons. If you are in doubt as to whether an individual or legal entity is a Sanctions Target, please consult with the Chief Compliance Officer.
Workers need to be on the lookout for circumstances in which any portion of a transaction occurs in a Sanctioned Country without the Chief Compliance Officer's prior approval. This covers doing business with a supplier located in a sanctioned nation, buying products from a sanctioned nation, selling products to clients located in a sanctioned nation, and shipping products via a sanctioned nation.
Employees must be alert and vigilant to avoid situations where any part of the transaction takes place, without prior authorization from the Chief Compliance Officer, in a Sanctioned Country. This includes interacting with a Supplier from a Sanctioned Country, purchasing goods from a Sanctioned Country, selling goods to a Customer in a Sanctioned Country, or transporting goods through a Sanctioned Country.
Workers must exercise caution while interacting with a Restricted Country. Compared to Sanctioned Countries, Restricted Countries are subject to a more limited set of restrictions regarding sanctions. In theory, doing business with restricted countries is not forbidden. Only after verifying that the relevant sanctions do not impact the transaction in issue or otherwise do not pose a material risk to PiSA relating to sanctions can PiSA conduct business in a Restricted Country. You must speak with the Chief Compliance Officer before to doing business with a Supplier in a Restricted Country or selling products to a Customer in a Restricted Country.
Employees should also be cautious when dealing with a Restricted Country. Restricted Countries are countries and/or territories subject to a narrower range of Sanctions restrictions than Sanctioned Countries. Business connected with Restricted Countries is not prohibited in principle. PiSA may do business in a Restricted Country only after confirming that the Sanctions applicable to that country do not affect the transaction in question, or otherwise do not pose a significant Sanctions-related risk to PiSA. Before interacting with a Supplier in a Restricted Country or before selling goods to a Customer in a Restricted Country, you must consult with the Chief Compliance Officer.
Employees are prohibited from engaging in any attempt to evade Sanctions. Employees must comply with all applicable Sanctions compliance requirements. PiSA strictly prohibits any attempt to evade applicable Sanctions and any intentional omission or concealment of information by an Employee or Supplier with respect to a Sanctions Target and/or Sanctioned Country. Employees are also prohibited from "“turning a blind eye" ” to avoid detecting sanctions evasion, e.g., intentionally omitting to investigate of a counterparty. Under no circumstances may an Employee take actions to intentionally avoid applicable Sanctions obligations or conceal detection of a transaction that violates these Policies. Employees may not advise any person on how to structure or present transactions to avoid applicable Sanctions. This includes, but is not limited to, advising any person to modify their instructions to include false or misleading details, or to change, remove or omit information from a transaction that would otherwise have been detected. Fraudulent actions, breach of trust, and misrepresentation are considered separate and independent violations of PiSA’s Code of Ethics.
PiSA expects all individuals connected to PiSA to behave themselves in a way that fully complies with the law, including any applicable sanctions, in accordance with PiSA’s Code of Ethics. In all transactions involving PiSA, suppliers must also abide by the terms of these policies and all relevant sanctions. PiSA will require its Customers and Suppliers to sign agreements on Sanctions unless the Chief Compliance Officer approves an exception. For further details on Contractual Protection against Sanctions with respect to Customers and Suppliers, please see Article 9(d).

9. ON CUSTOMER AND SUPPLIER RESEARCH

From the perspective of sanctions, customers and suppliers represent a unique area of risk. As a result, in order to maintain PiSA's compliance with all relevant sanctions, Employees must exercise utmost caution when interacting with Customers and Suppliers. PiSA has created a procedure, which is explained in the paragraphs that follow, to guarantee that all Suppliers and Customers are appropriately involved and that PiSA does not incur needless risk in terms of sanctions. No Customer or Supplier may be dealt with unless the Chief Compliance Officer approves an exemption. The procedure outlined below must be followed. 

a. Sanctions Due Diligence Standard Process 

The Standard Sanction Process (“SSDD”) must be performed on all Customers and Suppliers, prior to providing any services or goods. The SSDD involves: 

  1. Investigation of the individuals or legal entities involved, through the process described in the following paragraphs.
  2. Document where the goods or services come from or where they will be delivered; and,
  3. If possible, obtain adequate contractual protection, with respect to Sanctions, from the counterparty. 

The following information/aspects must be looked into by PiSA in compliance with the SSDD procedure, both before engaging any customer or supplier and during any transactions with them, as well as at least once a year after they have been approached: 

  • Full names of the individuals or legal entities involved (written exactly as they appear on the official identification document (e.g., passport or business license).
  • Full names of the owners of 25% or more of the counterparty, and full names of the owners of 25% or more of the counterparty's parent company, if any; and,
  • All parties involved in the business relationship (which includes, if possible, the ultimate beneficial owner, authorized account signatories, principals, etc.).

The research must be done using a research database previously approved by the Chief Compliance Officer, such as World Check or similar research services provided, for example, by Dow Jones. The parameters of all searches must be set to return “close matches” of parties with names or addresses similar to that of the party being investigated. For reference, the complete SDN and SSI lists can be searched using the Consolidated Sanctions List provided by OFAC, which, at the time of this writing can be accessed at the following link: https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/consolidated.aspx. However, keep in mind that the Consolidated Sanctions List does not identify owners who are known to be subject to sanctions or other areas of potential risk (including criminal sanctions and politically exposed persons), as most screening databases would. Therefore, you should not rely solely on the Consolidated Sanctions List without the prior approval of the Chief Compliance Officer. Appendix B provides a list of the information and documents PiSA should request from its Customers and Suppliers to facilitate the investigation. Documentation of all investigations must be retained for a minimum period of 5 years.

PiSA should follow the steps below, depending on the results of the SSDD: 

  • No Matches or Concerns. If the results of the investigation do not indicate that there are no matches, nor do they produce additional concerns, PiSA may proceed with the engagement, subject to the inclusion of appropriate contractual protection, as discussed below.
  • The Customer or Supplier is a Sanctions Target or is Controlled by a Sanctions Target. If a customer or Supplier has been identified as a Sanctions Target, or is 50% or more controlled by one or more Sanctions Targets, then the transaction must be suspended, unless approved by the Chief Compliance Officer. If the SSDD suggests a potential match with a Sanctions Target, the Chief Compliance Officer must be informed, and additional investigation and due diligence must be conducted before the transaction can proceed. If the match is confirmed and the Chief Compliance Officer determines that the transaction, if carried out, would be in breach of Sanctions, PiSA must not interact with that Customer or Supplier. If the match is confirmed for a customer or Supplier with which PiSA has a current business relationship and the Chief Compliance Officer determines that any subsequent transaction would violate any of the Sanctions, PiSA must terminate that relationship.
  • The Customer or Supplier has a Nexus with a Restricted Country or Sanctioned Country. If the results of the SSDD reveal a link to a Restricted Country, the Customer or Supplier should not contract with the Customer or Supplier until all intermediaries and beneficial owners of the Customer or Supplier are investigated to ensure that the Customer or Supplier is not 50% or more controlled by a sanctioned party, and therefore subject to sanctions. In this case, in the case of closely held (specifically, non-public) corporations, the full legal name, known aliases, and addresses of all direct or indirect owners, whether natural or legal persons, of the Customer or Supplier should be requested so that they can be investigated. For all publicly traded companies, the names, aliases, and addresses of all shareholders who have a 5% percent or more interest in the company should be requested so that they can be investigated.

The transaction may proceed if it is found that the Customer or Supplier is not 50 percent or more controlled by a sanctioned party and the Chief Compliance Officer receives the documentation showing this. The transaction will be stopped and referred to the Chief Compliance Officer for additional evaluation if neither the Customer nor the Supplier can furnish additional information about its intermediate or ultimate controllers.

If the results of the SSDD reveal a link to a Sanctioned Country, do not contract with the Customer or Supplier unless

a. Increased due diligence is carried out, and (b) the Chief Compliance Officer's written consent is acquired. If PiSA has a present business engagement with a Sanctioned Country and a Customer or Supplier relationship is formed, the relationship must end, unless (a) additional due diligence is carried out and,
b. Written approval is obtained from the Chief Compliance Officer.

In addition to natural persons, entities such as partnerships or other forms of organizations may also be persons falling under the scope of this restriction. Individuals who are “indirectly involved” in a counterparty can include its directors and officials, as well as its direct or indirect owners, controllers, and officers.

Normally, PiSA will not conduct business with a Supplier or Customer that maintains ties to a Sanctioned Nation. A link to a Sanctioned Country may, nevertheless, occasionally allow the transaction to proceed. Making such a decision is the Chief Compliance Officer's job. Relationships, for instance, may be established with citizens of sanctioned nations who live permanently abroad; however, this is only possible if the individual's residence outside the sanctioned nation has been verified, no new sanctions risk or concern has been found, and the Chief Compliance Officer has given his or her approval.

  • The Customer or Supplier or the transaction raises additional sanctions concerns. Even if the proposed transaction or business relationship does not appear to have links to a Sanctions Target, Sanctioned Country or Restricted Country, you should refer the matter in question to the Chief Compliance Officer for an Enhanced Due Diligence Process if you have cause to suspect that the transaction or business relationship directly or indirectly involves a Sanctions Target or Sanctioned Country, or if you have other concerns (e.g., that the transaction may involve restricted assets, or you suspect that the Customer or Supplier may have provided false information, etc.) for consideration, or if you suspect that the transaction or business relationship may involve a Sanctions Target or Sanctioned Country, or if you suspect that the Customer or Supplier may have provided false information, etc.) for consideration, you should refer the matter in question to the Chief Compliance Officer for an Enhanced Due Diligence Process, that the transaction may involve restricted goods, or you suspect that the Customer or Supplier may have provided false information, etc.) for your consideration, a non-exhaustive list of examples of “red flags” is provided in Annex C.

b. Enhanced Due Diligence Process

The Chief Compliance Officer will set the parameters for the Enhanced Due Diligence Process, which may change based on the particular instance. The Enhanced Due Diligence Process aims to collect and evaluate more data so that the Chief Compliance Officer (or outside counsel, if required) can assess the likelihood of a sanction violation should the transaction move forward. Researching publicly available material (such as the supplier's or customer's website, news articles, corporate filings, reports, etc.) may be one of the methods used in the Enhanced Due Diligence Process. Other methods may include obtaining reports from corporate filing databases, such as D&B Hoovers, reviewing counterparty owners' more detailed information, running background checks, or interviewing the supplier or customer.

In addition to the above, the Chief Compliance Officer also maintains a questionnaire that can be customized based on the level of risk that the Customer or Supplier represents. The Customer or Supplier is given the questionnaire to complete.

A copy of this questionnaire can be found in Appendix D, however the most recent form can be obtained by contacting the Chief Compliance Officer. Every completed questionnaire must be kept on file at PiSA in duplicate.

The Chief Compliance Officer will decide whether to interact with the Customer or Supplier when the Enhanced Due Diligence Process is completed to their satisfaction. All Enhanced Due Diligence Process records are to be kept on file for a minimum of five years.

c. Monitoring

After approaching a Customer or Supplier and/or at the beginning of a transaction or business relationship, the PiSA department in charge of the Customer or Supplier relationship must periodically (at least once a year) review the transaction/business relationship in order to verify that the circumstances of the applicable Sanctions have not materially changed. This review should apply to all active Customer and Supplier relationships maintained by PiSA. This periodic review shall include a subsequent review of relevant lists and databases. Any material changes must be reported in a timely manner to the Chief Compliance Officer.

d. Contractual Protections 

Unless the Chief Compliance Officer approves an exception, you must obtain adequate contractual protection against the risks of applicable Customer or Supplier counterparty sanctions (“Contractual Sanctions Protection”) as a result of the due diligence completed on proposed transactions or business relationships.

The Chief Compliance Officer has approved standard contractual provisions, which, if approved by the counterparty, constitute adequate Contractual Protection Against Sanctions. These provisions can be found in Annex E. Because the necessary protection may vary from situation to situation, and even small changes to the terms of the Contractual Sanctions Protection may diminish PiSA’s protection against the applicable Sanctions risks, you should consult with the Chief Compliance Officer before agreeing to modify the standard Contractual Sanctions Protection.
Some counterparties may claim that the Contractual Sanctions Protection is unreasonable (for example, where there is a potential conflict of laws or where the counterparty is located, a company is subject to oversight by another regulatory body (such as companies listed on the New York Stock Exchange regulated by the U.S. Securities and Exchange Commission). In these situations, you should consult with the Chief Compliance Officer to determine whether the Contractual Sanctions Protection requirements are appropriate. Notwithstanding the above, you should consider it a “red flag” if a counterparty is unwilling to grant Contractual Sanctions Protection, which means being more alert and vigilant when doing due diligence.

10. RECRUITMENT AND HIRING

It is not appropriate to extend employment offers to those who are governed by relevant sanctions. Before making an offer of employment, a suitable investigation using the SSDD procedure and, if required, an Enhanced Due Diligence Process, should be carried out to make sure that no offers of employment are given to anyone who are subject to sanctions.

11. CHANGE OF CIRCUMSTANCES

Workers need to be ready for the potential that these policies' obligations aren't being followed because of altered conditions. This presumption could be revised, for instance:

  • There are new sanctions that forbid or have additional effects on a certain transaction or connection.
  • new diligence information is supplied, for example, in reference to an ongoing transaction or relationship that raises questions regarding compliance with sanctions; and/or,
  • These Policies are modified.

You must notify the Chief Compliance Officer of any change in circumstances as soon as you learn about it if it has an impact on a current or previous transaction or business relationship.

12. TRAINING AND AWARENESS

Employees must finish any further required periodic training about the risks and requirements of the Sanctions, in addition to the orientation program for new hires. There must be periodic training at least once a year. The Chief Compliance Officer oversees setting up the training. The Chief Compliance Officer or a certified outside consultant may conduct the training.

For a minimum of five years, the Chief Compliance Officer is required to maintain records of attendance and the material covered at each training session.

It is optional for the Chief Compliance Officer to ask Workers to certify that they are aware of the Policies and/or are complying with them.

13. INCIDENT MANAGEMENT

  • Employee Reporting and Investigation: Failure to comply with the Sanctions may result in a criminal offense. Employees must immediately report to their direct supervisor, manager, or the Chief Compliance Officer any breach of these Policies, as well as any known or suspected breach. Employees may anonymously report suspected non-compliance with these Policies. Reports are confidential to the extent permitted by law. Anonymous reports may be made electronically by establishing an anonymous email account through free commercial providers (such as Google, Yahoo, etc.) by sending an email to the Chief Compliance Officer. The Chief Compliance Officer must also establish a locked, physical box where anonymous written reports can be deposited. Employees who make anonymous reports should be sure to provide sufficient detail (including the Employees involved, a description of the transaction or incident, the date(s) on which it occurred, and any supporting documents that can be provided without revealing the identity of the reporting Employee) so that the incident can be investigated without the need to follow up with the person who made the report. Employees who report, in good faith, suspected or actual breaches of these Policies will be protected from retaliation regardless of whether their suspicions prove to be true. Failure to report an incident of Sanctions non-compliance, true or suspected, is a separate violation of these Policies and may lead to disciplinary sanctions, including termination of the Employee’'s employment relationship. PiSA will manage and report Sanctions non-compliance in accordance with applicable laws and regulations. This includes seeking advice from the Chief Compliance Officer as to whether it is necessary to report the incident to the respective authorities.
  • Disciplinary action, civil and criminal penalties: Any breach of these Policies by an Employee may result in disciplinary action by PiSA, including termination of the Employee’s employment relationship, or termination of the service agreement. Any breach of these Policies by a Supplier or Customer may result in termination of the relationship with that Customer or Supplier. As a citizen or visa holder of a particular country, Employees may be subject to the laws of their home countries, as well as those of the country in which they are working, and the penalties of some sanctions may have extraterritorial application. In addition, the mere presence of an Employee in a country may subject him or her to the laws of that country. Failure to comply with Sanctions may lead to civil or criminal penalties. Civil penalty sanctions are normally assessed under a "strict liability" standard, which means that the intent of the person who has breached the sanction is not relevant. Thus, even "innocent mistakes" can lead to civil liability. Both individuals and corporations are subject to civil liability to the same extent. Under most sanctions programs, for example, each sanctions violation carries a penalty of more than $300,000.00 U.S. dollars; systematic noncompliance resulting in multiple noncompliance can quickly escalate to fines of millions of U.S. dollars, or more. For example, historically, the top 5 enforcement actions have all been against non-U.S. companies, and all have exceeded $1 billion U.S. dollars, with the largest fine being close to $9 billion. Sanctions can also result in criminal liability for willful failure to comply with sanctions. "Intentional" noncompliance with U.S. sanctions, for example, carries fines of $1 million per violation, and for individuals, up to 20 years in prison. Proceeds from the activity that caused the violation may also be forfeited by the U.S. government.

Every Employee bears the responsibility of comprehending and abiding by the Sanctions responsibilities that are relevant to them either as citizens of that nation or as a result of their presence in that country.

14. RECORDS RETENTION

Electronic or paper documents pertaining to adherence to these policies must be kept for a minimum of five years. A duplicate of every document pertaining to compliance needs to be provided to the Chief Compliance Officer and kept on file by the relevant PiSA department.

15. AUDITS

PiSA will periodically audit the company’s compliance with these Policies, and with the sanctions program in general. These audits may be conducted internally or with the assistance of outside counsel. The purpose of these audits includes evaluating the effectiveness of these Policies and their implementation, as well as reassessing PiSA’s areas of risk in relation to Sanctions. All employees must cooperate fully in any audit, whether conducted by PiSA or through outside consultants. Cooperating includes responding fully and honestly to all questions and concerns and providing all requested documentation and information in a timely manner. PiSA is not obligated to give you prior notice if it will conduct an audit.

16. ACKNOWLEDGMENT

After receiving these policies, each employee is required to complete the acknowledgement form found in Annex F. Two copies of the completed form must be delivered: one to the Chief Compliance Officer and the other to Human Resources, where it will be retained in the employee’s personnel file.

United Nations Supplier Code of Conduct

PiSA Farmacéutica has included the United Nations Supplier Code of Conduct into its operational framework as of March 2022, reiterating its dedication to adhering to the most stringent global ethical and regulatory standards.

United Nations Charter: The values enshrined in United Nations Charter, namely respect for fundamental human rights, social justice and human dignity, and respect for the equal rights of men and women, are the general values to which suppliers of United Nations goods and services must adhere.

Global Compact: The Global Compact is an international corporate citizenship and voluntary membership network that was created to support the participation of the private sector and other social actors to promote responsible corporate citizenship and universal social and environmental principles to address the challenges of globalization. The United Nations strongly encourages all suppliers to actively participate in the Global Compact. To that end, this Code of Conduct recognizes the importance of the ten principles of the United Nations Global Compact and is seen as an important way of incorporating the principles of the Compact into the Organization’s operations. The Code of Conduct reflects the issues included in the Compact in the areas of human rights, labor, environment, and anti-corruption and should be interpreted in accordance with the Global Compact. Suppliers wishing to support the Global Compact and learn more about the ten principles can consult the Compact's website (www.unglobalcompact.org).

International Labor Conventions and Recommendations: International Labor Standards (i.e., Conventions and Recommendations) established by the United Nations tripartite specialized agency, the International Labor Organization (ILO), have served as the basis for much of this Code of Conduct. The United Nations expects all suppliers who provide products or services to the United Nations to adhere, in addition to the values of the United Nations Charter, to the principles relating to International Labor Standards summarized in paragraphs 4 to 92.

Scope of Application: The provisions of this Code of Conduct reflect the expectations of the United Nations with respect to all suppliers registered as such with the Organization or with whom the Organization has a business relationship. These principles shall apply to suppliers and their employees, as well as to parent, subsidiary or affiliated entities and subcontractors. In addition, suppliers shall make this Code of Conduct known to their employees, parent, subsidiary or affiliated entities and subcontractors in the local language and in a manner that is understandable to all. In order to register as a supplier to the United Nations or to maintain a business relationship with the Organization, a supplier must read this Code of Conduct and recognize that it contains the minimum standards with which suppliers to the United Nations must comply. It should also be noted that certain provisions of this Code of Conduct will be binding on suppliers if they are awarded a contract by the United Nations in accordance with the terms and conditions of the contract. Failure to comply with certain provisions may also preclude suppliers from being eligible to be awarded contracts in accordance with the solicitation documents of one or more organizations of the United Nations system. Prospective suppliers are invited to review the specific procurement terms and conditions and procurement policies of the organization(s) of the United Nations system organization(s) with which they wish to do business to verify whether they are or will be eligible in the future.

Continuous improvement: The provisions of this Code of Conduct set out the minimum standards to be met by suppliers to the United Nations. The United Nations expects its suppliers to strive to go beyond international and industry best practices. Furthermore, suppliers to the Organization should encourage and work with their own suppliers and subcontractors to strive to adhere to the principles of this Code of Conduct. Furthermore, the United Nations recognizes that compliance with some of the standards contained in this Code of Conduct is a dynamic rather than a static process and encourages its suppliers to improve their workplace conditions continuously and consistently.

Management, monitoring and evaluation: The United Nations expects its suppliers at a minimum to have established clear targets for meeting the standards set out in this Code of Conduct. In addition, suppliers are required to establish and maintain appropriate management systems in relation to the content of this Code of Conduct, as well as to review, monitor and actively modify their management processes and business operations to conform to the principles enshrined in this Code of Conduct. Suppliers participating in the Global Compact are strongly encouraged to implement the principles of the Compact and to report progress to stakeholders on an annual basis.

Work

Freedom of association and collective bargaining: The United Nations expects its suppliers to recognize that workers may freely exercise, without distinction, the right to organize, promote and defend their interests and bargain collectively, and to protect such workers against any discriminatory action or other form of discrimination related to the exercise of the right to unionize, engage in trade union activities and bargain collectively.
Forced or compulsory labor: The United Nations expects its suppliers to prohibit all forms of forced or compulsory labor.
Child Labor: The United Nations expects its suppliers not to employ (a) boys or girls under the age of 14, under the minimum age for employment permitted by the laws of the country or countries in which all or part of the contract is performed, whichever is higher, or under the age at which compulsory schooling ends in that country or those countries, whichever is higher; nor (b) persons under the age of 18 for work which, by its nature or the circumstances in which it is performed, is likely to be harmful to the health, safety or moral well-being of such persons.
Discrimination: The United Nations expects its suppliers to ensure equality of opportunity and treatment in respect of employment and occupation without discrimination on any ground such as race, color, sex, religion, political opinion, national or social origin or any other ground which may be recognized under the laws of the country or countries in which all or part of the contract is performed Suppliers to the United Nations are to take all appropriate measures to ensure that neither they nor parent entities, subsidiaries, affiliates and subcontractors do not engage in gender discrimination or other discriminatory employment practices, including, but not limited to, recruitment, promotion, training, compensation and benefits.
Wages, working hours and other conditions of work: The UN expects its suppliers to ensure that wages are paid in legal tender, at regular intervals of not more than one month, in full and directly to the workers concerned. Suppliers are required to maintain adequate records of such payments. Deductions from wages are permitted only under the conditions and to the extent stipulated by applicable law, regulation or collective agreement and suppliers must inform workers of such deductions at the time of each payment. Wages, hours, and other working conditions set by suppliers must not be less favorable than the best locally prevailing conditions (i.e., those contained in (i) collective agreements covering a significant proportion of employers and workers; (ii) arbitration awards; or (iii) applicable laws or regulations) for work of the same nature performed in the relevant occupation or sector in the area where the work is performed.
Health and Safety: The United Nations expects its suppliers to ensure that, so far as is reasonably practicable (a) workplaces, machinery, equipment and processes under their control are safe and without risk to health; (b) chemical, physical and biological substances and agents under their control do not present risks to health when appropriate protective measures are taken; and (c) where necessary, appropriate protective clothing and equipment are provided in order to prevent, so far as is reasonably practicable, the risk of accidents or adverse health effects.
Human Rights: The United Nations expects its suppliers to promote and respect the protection of internationally proclaimed human rights and to ensure that they are not complicit in human rights abuses.
Harassment and Rude or Inhumane Treatment: The UN expects its suppliers to create and maintain an environment in which all employees are treated with dignity and respect. In addition, suppliers, as well as their parents, subsidiaries, affiliates, and subcontractors, if any, shall not resort to, or permit their employees or other persons with whom they have contracted to resort to or engage in, threats of violence, verbal harassment or assault, psychological harassment or abuse, sexual exploitation, or sexual abuse. Sexual exploitation and sexual abuse are a violation of universally recognized international legal standards and principles and have long been considered by the United Nations as unacceptable behavior and strictly prohibited conduct. Prior
to entering a contractual arrangement with the United Nations, suppliers are informed of the standards of conduct relating to the prohibition of sexual exploitation and abuse with which the Organization expects them to comply. These standards include, but are not limited to, the following:
1) The prohibition of all sexual activity with persons under the age of 18, regardless of the legal age of majority or age of consent; 2) the prohibition of sexual intercourse in exchange for money, employment, goods, services, or other things of value; and 3) the prohibition of any sexual activity involving the exploitation or degradation of any person. Suppliers to the United Nations shall take all necessary measures to prohibit their employees or other persons engaged by them from engaging in sexual exploitation or abuse. The UN also expects its suppliers to create and maintain an environment that prevents sexual exploitation and abuse. United Nations contracts will contain provisions on the obligation of suppliers to take such measures as may be necessary to prevent sexual exploitation and abuse. Failure by a supplier to take measures to prevent acts of sexual exploitation or abuse, to investigate reported acts of sexual exploitation or abuse, or to take corrective action when such acts occur, would be sufficient grounds for termination of any contractual arrangement with the United Nations. Nor will any harsh or inhumane treatment, coercion or corporal punishment, or the threat to treat anyone in such a manner, be tolerated.

Mines: The United Nations expects its suppliers not to sell or manufacture anti-personnel mines or any of the components used in their manufacture.

Environment

Environmental aspects: The United Nations expects its suppliers to have an effective environmental policy and to comply with existing environmental protection legislation and regulations. To the extent possible, suppliers should adopt a precautionary approach to environmental issues, undertake initiatives to promote increased environmental responsibility and encourage the dissemination of environmentally friendly technologies that establish good practices throughout their life cycle.

Hazardous chemicals and materials: Substances and other materials that represent a hazard when released into the environment shall be identified and managed for safe handling, transfer, storage, recycling or reuse and disposal.

Wastewater and solid waste: Wastewater and solid waste generated by industrial operations and processes and sanitation facilities should be monitored and properly treated prior to discharge or disposal.

Atmospheric emissions: Volatile organic chemicals, aerosols, corrosives, particulate matter, ozone depleting chemicals and combustion by-products generated by the operations and emitted into the atmosphere must be described and adequately controlled and treated prior to release into the atmosphere.

Minimum waste, maximum recycling: Waste and waste of all kinds, including water and energy, shall be reduced, or eliminated, either at source or through practices such as modifying production and maintenance processes and facility processes or substituting, conserving, recycling, and reusing materials.

Ethical conduct

Corruption: The United Nations expects its suppliers to adhere to the highest standards of ethical and moral conduct, to respect local laws and to refrain from engaging in any corrupt practices, including extortion, fraud, and bribery.

Conflict of Interest: Suppliers to the United Nations shall disclose to the Organization any situation that may represent a conflict of interest and whether any of the Organization’s staff members or professionals engaged by the Organization have any interest of any kind in the supplier's business activities or any type of financial relationship with the supplier.

Gifts and Entertainment: The United Nations has a "zero tolerance" policy and does not accept gifts or offers of entertainment. They will not accept invitations to sporting or cultural events, offers of vacations or any type of recreational travel, offers of transportation or invitations to luncheons or dinners. The United Nations expects that its suppliers will not offer benefits such as free goods or services, offers of employment or purchasing opportunities to staff members of the Organization to influence the staff member's business dealings with the Organization in their favor.

Restrictions on former staff members: Employment restrictions apply to active and former United Nations staff members who participated in the procurement process if they had a prior professional relationship with the vendors. United Nations suppliers are expected to refrain from offering employment to any such individuals for a period of one year from the date of separation from service.