Corporate Compliance and Ethical Responsibility

Carwin Pharma is dedicated to ensuring that all business operations and activities that it is involved with are conducted in accordance with the highest of ethical standards. Carwin Pharma considers its reputation within the medical community to be a valuable asset and, as such, is committed to promoting the honest and ethical behavior of all individuals employed by or associated with Carwin Pharma.

Compliance with all laws, regulations, company policies and other best practices applicable to the organization by all Carwin Pharma employees is critical to Carwin Pharma’s professional standards and corporate success. Carwin Pharma’s Compliance Program incorporates the fundamental elements addressed within the Office of the Inspector General’s (OIG) “Compliance Program Guidance for Pharmaceutical Manufacturers,” the PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code), industry standards and best practices, and includes the following:

Corporate Compliance Officer (CCO) and Compliance Committee

The CCO oversees the Compliance Program and is responsible for ensuring that all employees, directors and officers act in the utmost ethical, compliant and professional manner.

Carwin Pharma has established a Compliance Committee consisting of key stakeholders from each departmental function within Carwin Pharma. The purpose of the Compliance Committee is to assist the CCO in overseeing and providing guidance over Carwin Pharma’s Compliance Program with regard to (1) adherence to laws and regulations applicable to Carwin Pharma’s business operations and activities; (2) compliance with Carwin Pharma’s Code of Conduct and related policies and procedures by all employees, officers, and other agents and associates of Carwin Pharma; and (3) assist the CCO in ensuring the effectiveness of the Corporate Compliance Program.

Written Policies and Procedures

Carwin Pharma’s Code of Conduct guides its business practices in an ethical and compliant manner. Carwin Pharma expects all employees, executives, contractors and agents of Carwin Pharma to abide by this Code of Conduct. Carwin Pharma has also developed and implemented policies and procedures to address risk areas identified in by the OIG, the PhRMA Code and industry standards and best practices.

Training and Education

Training and education are essential to reinforcing Carwin Pharma’s compliance and ethical standards, as well as providing personnel with the resources they need to understand and effectively abide by industry legal, regulatory and Carwin Pharma’s compliance requirements. Carwin Pharma trains its personnel on all job-related policies, procedures and other guidelines as well as updates training on an as-needed basis.

Effective Lines of Communication

Carwin Pharma encourages an atmosphere of open communication that fosters dialog between management and employees regarding compliance or ethical concerns, or reporting potential instances of fraud and abuse. Carwin Pharma has policies and procedures in place to ensure employees making such reports will not be subject to retaliation or retribution.

Monitoring and Auditing

Carwin Pharma is committed to conducting ongoing internal monitoring and auditing, as these activities serve as essential components of a Corporate Compliance Program. It is the duty of Carwin Pharma to ensure that business processes and operations are as efficient and effective as possible. Carwin Pharma’s CCO is responsible for ensuring that the elements of the Compliance Program are audited and monitored on an on-going basis.

Enforcement and Discipline

Carwin Pharma develops and maintains documentation that informs all employees of Carwin Pharma’s dedication to, and enforcement of, ethics and compliance policies regarding each employee’s day to day responsibilities, and the consequences of violations of these policies. Any employee who fails to abide by Carwin Pharma’s ethics and compliance standards may be subject to appropriate disciplinary action following an investigation.

Response and Corrective Action for Detected Problems

Carwin Pharma requires a prompt response and corrective action for identified potential compliance violations when necessary and appropriate. Personnel are expected to report any compliance issues or concerns they may have through Carwin Pharma’s Compliance Hotline or other lines of reporting as necessary. All reported compliance issues will be reviewed, investigated and remediated as deemed appropriate on a case-by-case basis.

As a company dedicated to improving the lives of its patient and quality of life within the medical community, Carwin Pharma is committed to further enhancing its culture of compliance on an on-going basis to continue to prevent, detect, and resolve any activities or interactions that may not align with Carwin Pharma’s standards of compliance and business conduct.

CARWIN PHARMA’S DECLARATION OF COMPLIANCE WITH CALIFORNIA’S REQUIREMENTS

Carwin Pharma, based upon a good faith belief and understanding of legal requirements, hereby declares Carwin Pharma has adopted a Comprehensive Compliance Program compliant with the requirements of California Health and Safety Code §§119400-119402. Carwin Pharma has tailored its Comprehensive Compliance Program to its current size and business operations and continues to develop and implement changes to the Comprehensive Compliance Program as compliance and operational needs evolve. To the best of its knowledge and based on a good faith belief, Carwin Pharma is in compliance with its Comprehensive Compliance Program.

As required by California Health & Safety Code §§ 119400-119402, Carwin Pharma has established an annual dollar limit on educational items, promotional material, meals associated with educational presentations, or other items of value which Field Based Employees are permitted to provide to medical or health professionals in California. The annual limit of $2500 applies to educational or practice-related items, items of minimal value, and meals associated with informational presentations or discussions provided to medical or health professionals located or licensed in California.

COMMITMENT TO TRANSPARENCY
Carwin Pharma is focused on delivering safe and effective medicines to patients and physicians. To ensure the availability of new treatment options, the company may work and innovate with other individuals and organizations including physicians and/or teaching hospitals. Carwin Pharma is fully committed to the financial transparency of these relationships and to prevent any real or perceived conflict of interest.

Under federal law and implementing regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS) any payment or other transfer of value we make to a physician or teaching hospital is subject to collection and potential public reporting. Certain states have also enacted laws and regulations relating to transparency of interactions with healthcare professionals which often cover additional categories of healthcare professionals and are separate and in addition to the federal transparency reporting requirements. We are committed to complying with state and federal laws and regulations today and in the future.