New CFIUS Pilot Program: What Life Sciences Companies and Investors Need to Know (Chinese Version)

Morrison & Foerster LLP

如许多生命科学公司和投资者所知,美国财政部(“财政部”)最近对美国外国投资委员会(“CFIUS”)公布了一项新的“试点计划”,该计划从2018年11月10日开始生效。试点计划实施了《2018年外商投资风险评估现代化法案》(“FIRRMA”)的某些规定,而FIRRMA已彻底改变了CFIUS对外商收购高科技领域美国企业以及外商对此类企业进行投资开展国家安全审查的权限。[1]

但是,公司和投资者可能尚未充分意识到的是,新的CFIUS试点计划要求对以医药和生物技术研发为重点的外国投资者,以及活跃在这些领域内的寻求向外国投资者融资的美国企业进行严查。本期新法速递讨论了针对这些新要求生命科学公司和投资者应该考虑的各种问题。

生命科学公司和投资者应注意的要点包括:

  • 有针对性的前期调查:外国投资者和向外国投资者融资的生命科学公司将需要在其融资伊始就认真评估以下问题:(1)公司的产品和技术是否依照美国某些出口制度受到管制,或者是否属于仍待定义的“新兴及基础技术”类别;(2)这些产品和技术是否用于某些美国特定行业,或者是否是为某些美国特定行业专门设计的;以及(3)拟采用的融资条款是否将交易置于CFIUS试点计划范围之内。
  • 强制性CFIUS申报要求:对属于试点计划范围内的交易,当事方必须在交割前至少提前45天向CFIUS提交简短声明(也可提交完整的CFIUS申报书)。
  • 高额违规处罚:不遵守新的强制申报要求的交易当事方可能会遭到最高可达交易价值的民事处罚。
  • 还会发生更多变化:预期将由美国商务部依照与FIRRMA一起实施的美国《2018年出口管制改革法案》(“ECRA”)确定的“新兴及基础技术”可能将更多生命科学相关技术纳入CFIUS试点计划范围之内。

何为CFIUS试点计划,以及它与生命科学公司有何关系?

财政部发布的新规定制定了从2018年11月10日开始生效的CFIUS试点计划。根据试点计划,对于生产、设计、测试、制造、制作或开发用于27个试点计划行业中一个行业的或专门为其中一个行业设计的“关键技术”的“试点计划美国企业”,CFIUS现在可以审查对该等企业进行的某些非控股投资。[2]

值得注意的是,“生物技术研发”(NAICS代码541714)属于指定的试点计划行业。根据《2017年NAICS手册》,该行业包括从事以下活动的企业:“研究使用微生物以及细胞和生物分子过程(机理)开发或改造活体材料或非活体材料”,且这种研究“可能会导致开发出新的生物技术……工艺流程,或导致形成可由不同行业复制、利用或实施的新型产品或基因改造产品原型”。

由于“生物技术研发”行业在字面上范围很广,许多美国生命科学公司可能会被视为涉及“CFIUS试点计划行业”。因此,投资者和公司将需要检查(1)公司的产品和技术是否构成“关键技术”,以及(2)融资补充条款是否将其置于CFIUS试点计划范围之内。

在生命科学行业何为“关键技术”?

根据试点计划,关键技术包括:[3]

  • 因与国家安全、核扩散及武器扩散、地区稳定或秘密监听有关的原因,依照美国《出口管理条例》(“EAR”)受到管制的项目;
  • 依照适用的联邦规定受到管制的特定药剂和毒素;以及
  • 将依照即将发布的出口管制规定确定并管制的“新兴及基础技术”等等。

生命科学公司必须将其产品分类,或向美国政府提交分类申请,以确定某项目是否依照ITAR或EAR的有关要求受到管制。对于EAR项目,公司还必须分析该项目受到管制的原因,以确定其是否须满足CFIUS试点项目的要求。

美国商务部正准备按照ECRA授权公布拟实施的涵盖“新兴及基础技术”的规定。此类技术清单很可能会包括曾作为俄罗斯、中国和伊朗境内团体近期民族国家经济间谍活动对象的生物材料、生物制药及新型疫苗和药品。因为中国政府的《中国制造2025》计划也将高性能医疗设备作为重点,此类器械也可能会被纳入即将公布的清单中。

CFIUS将可以审查哪些类型的生命科学投资?

在FIRRMA实施之前,CFIUS的审查限于可能会导致外国控制美国企业的交易。[4] FIRRMA将CFIUS的管辖权扩大为包括对涉及关键技术、关键基础设施或美国公民敏感个人数据的美国企业进行的某些非控股投资,为实施这些变更的有关规定即将公布,会明确该等管辖权。CFIUS试点计划实施了上述FIRRMA变更中与关键技术有关的部分,将CFIUS的审查权限扩大为包括“试点计划投资”,或对试点计划美国企业的非控股投资,其外国投资者拥有以下任何一项权利:

  • 获得美国企业占有的任何重大非公开技术信息(即对设计、制作、开发、测试、生产或制造关键技术必要的非公开信息,但不包括与实体业绩有关的财务信息);
  • 在美国企业董事会或同等管理机构拥有成员身份或观察员权利,或对美国企业董事会或同等管理机构任职人员的提名权;或
  • 参与(并非通过利用股份投票)美国企业与使用、开发、取得或公布关键技术有关的重大决策

生命科学公司和投资者应清楚,将来财政部的规定会实施FIRRMA变更,以规管对保存或收集美国公民敏感个人数据的美国企业的外国投资,如果该投资给予外国人董事会成员身份或观察员权利,或使其参与涉及该企业掌握的敏感个人数据的重大决策。生命科学公司可能收集或掌握的数据(包括基因组或健康数据)很可能被纳入此类规定中。其实,作为现行政策,CFIUS已经在严格审查涉及美国公民个人身份识别信息收集和储存的交易。

是否有投资基金需要额外考虑的因素?

试点计划规定向投资基金阐明了外国人作为有限合伙人(或同等身份)参与基金将会如何影响试点计划的管辖权。通常CFIUS不会仅因为外国有限合伙人在某基金的顾问理事会或顾问委员会任职,就有权审查该基金对美国企业的投资,前提是:(1)基金由非外国人的普通合伙人或同等身份的人全权管理;(2)顾问理事会或顾问委员会不负责批准投资决策或普通合伙人关于投资标的公司的决策;(3)外国人并未由于其他原因有能力控制基金;并且(4)外国人并未因在顾问理事会或顾问委员会任职而可以获得被投资公司的重大非公开技术信息。

当事方何时必须向CFIUS申报生命科学投资,以及不遵守规定会受到什么处罚?

在下列情况下,交易的当事方必须在交易交割前至少提前45天向CFIUS提交简短“声明”,或提交完整的CFIUS申报书:(1)交易会导致外国控制适用试点计划的美国企业;或(2)交易系试点计划投资(定义见上文)。与完整CFIUS申报书相比,声明不需超过5页,必须大体说明当事方以及交易。在CFIUS受理声明后满30天当天或之前,CFIUS必须作出下列举动之一:(1)要求当事方提交完整的CFIUS申报书;(2)告知当事方CFIUS无法基于声明完成审理,当事方可为获得批准自愿提交完整的CFIUS申报书;(3)对交易启动单方面审查;(4)通知当事方CFIUS已批准交易。

须满足试点计划强制报告要求的交易当事方,如果不遵守这些要求,则可能被美国政府处以最高可达交易价值的民事处罚。鉴于遭受高额处罚的可能性,公司和投资者都更需要认真考虑美国企业的产品和技术以及交易的情形,以确定交易是否在试点计划范围之内。

如果交易当事方接受全面的CFIUS审查,或如果CFIUS启动单方面审查,CFIUS可能会要求当事方采取某些国家安全风险缓解措施,以此作为CFIUS批准交易的条件。例如,此类缓解措施可能会包括:(1)限制外国投资者的治理权(如加入董事会);(2)限制外国投资者出入美国企业的设施或查询其信息的权利;(3)要求美国企业采取安全计划;以及(4)承担持续合规监控及向美国政府报告的义务。在CFIUS确定无法缓解与交易有关的国家安全风险的情况下,CFIUS可建议总统阻止交易,或撤销已经完成的交易。

CFIUS试点计划可能对外国对美国生命科学企业投资产生什么影响?

新的CFIUS规则是在外国投资(特别是中国投资)导致美国公司生命科学融资大幅增加时出现的。PitchBook表明,包括中国投资者的美国生命科学融资交易数量已从2013年前的个位数增加到了2017年的37项,乃至2018年前9个月的51项,约占最近一段时间全部生命科学创业融资交易的11%。就金额而言,在2018年前9个月,中国投资者参与的各轮融资价值超过37.5亿美元,或达所有此类交易价值的三分之一以上。

此次中国对美国生命科学公司投资的增加是由若干因素推动的,包括《中国制造2025》运动。中国中产阶级的增长也导致中国投资者更加重视开发针对中国人群的治疗方法的生命科学公司。推动近期中国投资的力量还包括中国生命科学公司估值的提高(这使美国公司估值相比较而言非常有吸引力),以及对美国仍是领先的生物技术创新来源国的认可。

这些推动因素在未来几年很可能会继续存在。据我们预计,除非美国政府再采取重大举措,否则中国投资者不会大规模撤出美国市场。更可能出现的情况是,投资者和公司会找到应对新要求的途径,而这些调整将代表谨慎的投资者将会接受并应付的“新常态”,包括在必要时向CFIUS提交声明,以及在合理的情况下提交申报书。

例如,既有美国投资者又有外国投资者的交易,可安排多次交割,以便无须满足CFIUS报告要求的投资者先于需要满足这些要求的投资者进行交割,并制定适当的应急计划,以防外国投资者无法完成交易。也可将交易安排为允许外国投资者在交割时享有消极权利,待获得CFIUS批准后再享有更多权利。当事方还可以重新考虑惯常的知情权、董事会成员身份以及董事会观察员权利,以防产生国家安全方面的顾虑,并加快CFIUS批准进程。经验丰富的法律顾问可帮助公司和投资者高效应对各项新要求,并实现融资和长期战略目标。

 


[1] 之前于2018年9月发表的新法速递讨论了FIRRMA对外国投资者及美国公司的影响。本月早些时候发表的另一份新法速递更为详细地解释了新的CFIUS试点计划。

[2] 这27个试点计划行业由北美行业分类系统(“NAICS”)代码界定,详见我们之前发表的的新法速递

[3] 关键技术还包括依照《国际武器贸易条例》(“ITAR”)受到管制的国防项目,以及依照与协助国外原子能活动及核设备和材料进出口有关的规定受到管制的核设备、材料和技术。

[4] 此背景下的“控制”包括使外国投资者有权确定、指示或决定影响美国企业的重要事宜的多数股权投资或“占支配地位的少数股权”投资。该权限通常不含只向外国投资者提供CFIUS规定列明的某些非经营性小股东保护的,不超过美国企业发行在外的有投票权证券10%的被动投资。

 

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.