合规计划概述
1. Leadership and Structure
公司合规的负责人对Spark的合规计划的发展和监督有责任。Spark致力于确保公司合规的负责人有能力在必要时行使独立判断和实现组织内的变化。在此能力中，公司合规性可能会直接向首席执行官报告事项，并向董事会向合规计划行动提供记录的遵守报告。
2. Written Standards
Spark在建立企业政策方面致力于解决有关医疗保健欺诈和虐待的特定风险潜力领域的适当资源。公司的公司政策反映了美国制药研究和制造商（Phrma Code）发表的“与医疗专业人士互动互动”规定的原则。所有员工都预计将遵守这些标准。
年度支出限制
根据加州卫生和安全规范119402所要求的，Spark还建立了最高年度总额1美元的礼品，促销材料或向加州医疗保健专业人士提供的促销材料或活动。这一美元限额代表了支出概念，而不是目标或平均值，通常预计每次卫生保健专业人员所花费的金额将大大少于这一最高金额。
与加州法律一致，这一年度美元限额不包括用于对患者的免费分发的医疗或医疗保健专业人员的药物样品，持续医学教育论坛的财政支持，健康教育奖学金的财政支持，以及在公平的付款保健专业人员提供的合法专业服务的市场价值。
3.教育和培训
我们致力于教育和培训公司合规政策，并及时遍及我们的指示和指导。新人员作为其初始培训的一部分接收培训，并至少每年收到合规性培训。我们定期审查和更新培训方案，并以持续的方式确定其他培训领域。
4. Internal Lines of Communication
Dialogue is encouraged between management and employees. In addition, all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know to whom to turn for a meaningful response and be able to do so without concern of retribution. To that end, we have implemented policies regarding confidentiality and prohibition of retaliation, as well as established a Compliance Hotline so that issues may be reported anonymously. This Hotline is available 24 hours a day, 7 days a week. Corporate Compliance staff are accountable for ensuring appropriate review and follow-up with respect to issues raised via the Compliance Hotline or through other means.
5. Auditing and Monitoring
公司遵守的职责是制定审计和监测Spark的合规计划的计划。这些审计旨在识别潜在或现有的风险领域，并采取纠正措施，以防止发生或复发不合规。
6.响应潜在的违规行为和纠正措施程序
The objective of our Compliance Program is to ensure that the consequences of violating the law or Company policy are clearly understood and that appropriate, consistent disciplinary action is enforced. However, the U.S. Department of Health and Human Services in 2003 (HHS-OIG) recognizes that even an effective Compliance Program may not prevent all violations. As such, our Compliance Program requires Spark to respond promptly to potential violations of law or Company policy. When deemed necessary, the Head of Corporate Compliance, or a designee, will conduct an investigation into potentially non-compliant activity to determine whether a violation has occurred. Corrective measures take into account the findings of reviews of non-compliance, assessing whether enhancements should be made to our policies, practices, training, or internal controls, and taking action to prevent future violations.
宣言
加利福尼亚州合规声明
火花is committed to complying with all applicable laws, regulations and industry standards. The Company has developed a Comprehensive Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General, U.S. Department of Health and Human Services in 2003 (HHS-OIG Guidance) which includes policies consistent with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code). Our Compliance Program includes numerous policies and procedures and is continually assessed and evaluated to ensure consistency with additional laws and guidance. It is designed to prevent, detect and remediate violations of law, regulations and Company policies, as well as to promote an ethical culture that will, among other things, guide our interactions with healthcare professionals and healthcare entities. In the event that Spark becomes aware of any potential or actual violations of policy or law, an investigation will be triggered and, if necessary, followed by appropriate remedial or corrective actions in accordance our Compliance Program.
基于诚信了解加州健康与安全守则第119400款和119402款的要求，Spark特此声明，据知识，其全面的合规计划解决了加州法定要求，以包含解决HHS的政策-oig指导和phrma守则以及对健康专业人士的礼物和激励的限制。在上述情况下，在此，Spark也宣布，截至7月1日，所有重大尊重，符合其截至2020年7月1日的全面合规计划。
Copies of this declaration and the Compliance Program Overview may be obtained by calling 1-855-SPARKTX / 1-855-772-7589.
加州供应链透明度披露
Spark致力于确保我们的供应链反映了Spark的价值观和尊重人权和环境。Spark的与供应商的关系基于合法公正的实践。我们希望供应商遵守要求他们公平对待工人的法律，提供安全健康的工作环境，保护环境质量。在这项政策的促进方面，SIST通过合同遵守其供应商来遵守所有适用的法律法规，包括与他们正在开展业务的国家或国家的奴隶制和人口贩运者。
Code of Conduct and Business Ethics
Spark的董事会采用了Spark的行为和商业道德准则，并适用于所有Spark的员工，包括官员，董事和承包商。我们的代码是对Spark的合规性原则的阐述，并且期望我们的员工遵守完整性和高标准的道德行为。该守则代表本公司开展业务时建立对行为标准的预期，并呈现符合适用法律和公司政策的框架。
反贿赂和腐败
所有国家都被认为是非法的，火花开展业务。除了暴露于严重制裁的火花，任何员工，官员，董事或代表参与此类行为的公司行事也可以面临大量罚款和/或监禁。
火花’s employees are advised not to offer or accept money, gifts or anything else of value as a bribe or inducement to make, or as a reward for making (or not making) any decision that favors Spark’s interests or to otherwise seek to gain an unfair business advantage or enhanced product sales. This includes providing benefits to government officials (including those in local and national governments and those serving public interests) and other organizations, healthcare professionals, patients, suppliers, charities or advocacy groups. Spark’s employees are expected to report potentially corrupt behavior.
报告一个Concern
火花is committed to conducting business in an ethical and compliant manner. If standards are not met or an issue is identified, we have established procedures for reporting and handling concerns.
How to Raise a Concern
Spark提供许多渠道用于发表讲话，提出问题并提高顾虑。
These channels include:
- 管理
- 人力资源
- 公司合规性
- 法律部门
此外，Spark有一个由外部第三方管理的机密热线http://compliance.www.cqxywhcm.com（1-844-826-8149）在那里通过电话或在线任何人都有疑虑违规行为的任何时间进行报告。
Anonymity and Confidentiality
在当地法律允许的情况下，机密热线可用于匿名报告已知或疑似问题或提出问题。您的报告只会与那些需要知道该问题或调查此事的人共享。如果您能够确定自己，Spark将使每一项合理的努力在进行公平和彻底的调查时保持身份保密。在某些情况下，法律可能需要透露您的身份。
火花Therapeutics Non-Retaliation Policy
No form of retaliation or intimidation against an individual who makes a good-faith report of a suspected violation will be tolerated by Spark. Employees who engage in retaliation or intimidation will be subject to disciplinary actions as stated in our Code of Conduct and Business Ethics.
