The life blood of many life sciences startups is their assets—employees, ideas, and innovations. A key focus for these companies is how to best protect those assets. In Japan, China, and the United States, there are underlying fundamentals in the employment law approach for startups to be aware of and effectively utilize, such as the use of confidentiality agreements; however, there are also important differences to note when doing business in each of these jurisdictions. Below, we take an illustrative look at these potential myriad of issues for emerging companies to consider.
For life sciences startups entering Japan, there are employment law tools that can help protect company assets, similar to the United States and China. There are a number of protective provisions that employers may choose to utilize, including confidentiality provisions; the right to approve any concurrent employment; prohibition against using or bringing any intellectual property belonging to others; work for hire and assignment of invention provisions; and noncompetes, nonsolicits, and nondisparagements. These can be documented in an employment agreement or in separate agreements as discussed below.
Unlike the United States, there is no concept of at-will employment (an employer’s ability to dismiss an employee for any reason or no reason at all, and without notice, as long as the reason is not discriminatory). Employers in Japan may only terminate for cause and the threshold for justifying a termination for cause is very high. Japan’s employment environment is largely employee friendly. Because of the limited ability to dismiss employees, most employee exits are the result of mutually agreed separations between the employer and the employee.
Using fixed-term agreements and including robust probationary provisions are potential solutions. Hiring directors or independent contractors rather than employees are also well-used alternatives to avoid some of these issues with employee terminations.
For startups engaging in cross-border matters, it is important not to use employment contracts from other jurisdictions where they may originally operate as some core employment concepts are different in Japan. In addition to employment-related agreements, work rules carry equal weight with agreements and often specify working hours, overtime, wage calculations, and termination provisions. There are also labor management agreements with unions or employee representatives which also govern the employee relationship. Once the terms of employment have been set, there are restrictions on negative changes in employment terms and conditions, which often require employee consent.
The recording and proper payment for hours worked by employees are closely monitored and employers have an obligation to ensure proper tracking and payment. The proper characterization and payment of overtime premiums are also heavily regulated.
In addition, Japan has stringent data privacy legislation, similar to the European Union’s General Data Protection Regulation, and employers are required to protect the personal information of employees in accordance with the Act on the Protection of Personal Information (APPI), which was significantly amended a few years ago. If an employing entity in Japan needs to transfer any employee personal information outside of the company or Japan, including to affiliates of the employing entity, there are a number of alternative approaches to complying with the APPI.
While China’s employment law regime has developed a great deal in the last 15 years, it is relatively young when compared to the United States and many other jurisdictions. That said, like many countries, China continues to grapple with newer phenomena, such as the gig economy and startup company environment.
At the start of the employment relationship, it is important to set out the core expectations and obligations of employers with respect to protecting intellectual property and how employees engage in business with the fundamentals, such as an employment contract, data export considerations, and a noncompetition agreement. Like Japan, China does not have at-will employment, and terminations for cause are challenging to sustain from an evidentiary perspective. Further, restrictions on negative changes in employment terms and conditions also require employee consent in China and may require employee consultation more broadly.
Expansive data protection laws and potential triggers for China’s new Anti-Espionage Law are important to consider. The data protection regime covers employee data, third-party personal and sensitive personal data, such as patient and clinical testing data, and “important data” or data related to national security, such as data potentially with respect to military hospitals. If a multinational company learns of some non-public and sensitive information that relates to China’s national security, sharing this data outside the China entity and particularly across borders could implicate the new Anti-Espionage Law.
Also worth noting is that, generally, healthcare professionals in China are government officials. There could be anticorruption risks that require robust policies and monitoring of conduct. Control of samples and third-party interactions with the personnel at laboratories, testing centers, and suppliers should also be key considerations.
Another issue for startups is that equity is regulated and requires filing and approval with the State Administration of Foreign Exchange (SAFE). Before a company is listed or if the equity plan is not filed and approved by SAFE, there is no effective and legally enforceable way to grant equity to Chinese nationals or employees of the China entity.
Central to the protection of assets in the United States are the effective use of three key tools:
Invention Assignment Agreements
An invention assignment agreement is a legal contract that gives an employer certain rights to inventions created by an employee or consultant during the employment or consulting relationship. These require detailed disclosure of prior and future inventions; a definition of what future inventions will belong to the employer, including details on “assignment” (legal transfer) of ownership rights; and cooperation in the patent process.
Employees or consultants can be required to sign an invention assignment agreement as a condition of employment or engagement. However, some states limit the extent to which an employer can require an employee to give up rights—for example, California, Delaware, Illinois, Kansas, Minnesota, North Carolina, and Washington have exemptions to the extent the invention did not rely on use of employer’s resources and was created during employee’s personal time.
Confidentiality Agreements
These are legally binding contracts that require parties to retain confidentiality for a defined time. Even if confidentially agreements are executed, care should be taken to protect confidential information, such as by using passwords, setting up need-to-know access, as well as the use of restricted USB drives.
Restrictive Covenant Agreements
Nonsolicits
These are a legal contract an employee or consultant signs agreeing not to solicit employees and/or customers for the benefit of a competing business for a stated period of time after the relationship ends. These may limit solicitation of employees and/or customers. To be enforceable, non-solicits must be reasonable in scope and duration and be tailored to protect legitimate business interests.
Noncompetes
These are legal contracts an employee or consultant signs agreeing not to start a competing business to work for a competitor for a stated period of time after the relationship ends. The Federal Trade Commission has proposed a rule banning noncompetes. Broadly, this rule would ban noncompetes with “workers” or any person “who works, whether paid or unpaid, for an employer”, and applies to explicit and de facto noncompetes. It requires rescission of existing noncompetes with notice to workers—the only exception being in connection with the sale of business—for noncompetes applicable to “substantial owners,” which is defined to mean those owning more than 25% of business.
What Should Employers Do?
许多生命科学初创企业的生命与血液是它们的员工、想法和创新。对于这些公司来说，如何最好地保护这些资产至关重要。在日本、中国和美国，初创企业应了解和有效利用劳动法的基本原则，例如保密协议的使用，但也要注意在不同的司法管辖区开展业务时存在的重大差异。我们将在下文简要介绍这些新兴公司需要考虑的纷繁复杂的潜在问题。
日本
与中美相似，日本的生命科学初创企业可以借助劳动法来保护公司资产。雇主可以选择使用一些保护性条款，包括保密条款；关于任何兼职的批准权利；禁止使用或带入任何属于他人的知识产权；雇佣关系中的职务作品和发明转让条款；以及禁止竞业、禁止招揽和禁止贬低条款。如下所述，这些条款可以记录在劳动合同或单独的协议中。
与美国不同的是，日本没有自由雇佣的概念（自由雇佣是指，只要非基于歧视性原因，雇主便可以因任何原因或没有理由而解雇员工，且无需提前通知）。日本的雇主只能因为正当理由而终止雇佣关系，而证明是正当理由的门槛非常高。日本的就业环境在很大程度上是以员工为中心的。由于解雇员工的能力有限，大多数员工离职是雇主和员工之间达成共识的结果。
潜在的解决方案包括使用固定期限劳动合同并包括实用的试用期条款。其他常见的替代方案是聘请董事或独立承包商而非员工，以此来避免一些与员工解雇相关的问题。
基于日本的一些核心劳动概念的差异，对于从事跨境业务的初创企业应注意不要使用原本用于其他司法管辖区的劳动合同。除了与雇佣相关的协议外，工作规章通常规定了工作时间、加班、工资计算和解除劳动条款，其与协议同等重要。另外，与工会或员工代表达成的劳动管理协议，同样也具有管理员工关系的作用。一旦确定了雇佣条款，对劳动条款和条件进行不利于员工的的变更将受到限制，通常需要获得员工同意。
对员工的工作时间的记录和适当支付报酬受到密切监督，雇主有责任确保适当追踪对员工的工时记录和工资支付。雇主对加班费的分类和支付同样受到严格监管。
此外，日本有着类似于欧盟《通用数据保护条例》有关数据隐私的严格立法，并且雇主需要根据几年前大幅修订的《个人信息保护法案》（APPI）来保护员工的个人信息。如果在日本的雇佣实体需要将任何员工个人信息转移至公司以外或日本以外的地区（包括雇佣实体的关联公司），可选择多种替代方法以遵守APPI的要求。
中国
虽然中国的劳动法近十五年来发展迅速，但与美国等国家相比仍有些距离。也就是说，与许多国家一样，中国仍在努力应对新现象，如零工经济和创业公司环境。
雇佣关系伊始，需明确雇主保护知识产权的核心期望和义务，以及员工如何基于基本原则开展业务，例如劳动合同、数据出境考虑因素和竞业限制协议。因为中国与日本一样没有自由雇佣制度，因此从提供证据证明正当解雇理由的角度来看，因故解雇员工是具有挑战性的。此外，中国对于劳动条款和条件的负面变化也需要得到员工的同意，并可能需要更广泛的员工意见。
还需要重点考虑的是广泛的数据保护法律和可能触发中国新反间谍法（英文版本）的问题。数据保护法律涵盖了员工数据，第三方个人或敏感个人数据，如患者和临床测试数据，以及军事医院数据等相关国家安全的资料。如果一家跨国公司获悉一些涉及中国国家安全的非公开和敏感信息，向中国实体以外的实体分享这些数据（尤其是涉及数据跨境时）可能涉及新《反间谍法》。
另外值得注意的是，一般来说，中国的医疗保健专业人员可能会被认定为政府工作人员。这可能存在反腐风险，需要制定严格的政策并监测其行为。因此，对实验室、检测中心和供应商的人员的样本控制和跟第三方的沟通控制，也应成为关键的考虑因素。
对于初创企业的另一个问题是他们的股权受到监管，并需要向国家外汇管理局（SAFE）进行备案和审批。在公司上市之前或者如果股权计划未经SAFE备案和批准，则没有有效和法律可执行的方式向中国公民或中国实体的员工授予股权。
美国
美国资产保护的核心是有效利用三个关键工具：
01发明转让协议
发明转让协议是一种法律合同，赋予雇主对雇员或顾问在雇佣或咨询关系中创造的发明的某些权利。这些协议要求详细披露之前和未来的发明；定义哪些未来的发明将属于雇主，包括有关所有权利“转让”（法律转让）的详细信息；以及专利申请过程中的合作。
雇员或顾问可能被要求签署一份发明转让协议，作为雇佣或聘用的条件。然而，一些州限制了雇主要求雇员放弃权利的程度——例如，加利福尼亚州、特拉华州、伊利诺伊州、堪萨斯州、明尼苏达州、北卡罗来纳州和华盛顿州均有豁免情形，即只要发明不依赖于使用雇主的资源，而是在雇员的私人时间内创造的。
02保密协议
保密协议是具有法律约束力的合同，它们要求合同的当事人在一定的时间内保守秘密。但即便签署了保密协议，雇主也应该注意保护机密信息，例如设置密码，以“按需知密”的原则设置访问权限，以及使用已经加密的 USB 驱动器。
03限制性条款协议
禁止招揽协议
禁止招揽协议是一份由雇员或顾问签署的法律合同，同意在双方关系结束后的一定时间内不为竞争企业招揽雇员和/或客户。这可能会限制对员工和/或客户的招揽。为了让协议具有执行力，禁止招揽的范围和期限必须要合理，并针对保护合法商业利益进行调整。
竞业禁止协议
竞业禁止协议也是由雇员或顾问签署的法律合同，同意在双方关系结束后的一定时间内不创办竞争性业务或为竞争对手工作。不久前，联邦贸易委员会提出了一项规则以废除这类协议。从广义上来说，此规则将禁止雇主与“工人”或“为雇主工作的任何人，无论是有薪或无薪”的禁止竞业协议，并适用于明确的和事实上的竞业禁止。它要求撤销现有的不合规竞业禁止，并通知工人，唯一的例外是竞业禁止可适用于“实质所有者”（“实质所有者在企业中拥有至少25%的所有权权益”），以此防止其出售企业。
雇主应采取之行动