Yue Peng

Practice Areas

医药健康、企业合规、员工股权激励、劳动与人力资源、公司常年法律顾问、争议解决等

Pharmaceuticals and Healthcare, Corporate Compliance, Employee Equity Incentive Plans, Labor and Human Resources, Corporate Retained Legal Counsel, Dispute Resolution

Professional Memberships

拥有中国律师执业资格， 担任中关村 YingCamp跨境加速平台评审专家，人民法治·新说法栏目特邀法律顾问、全国卫生产业企业管理协会卫生法务分会理事，律新社2024年度生物医药及医疗领域领先律师。

Holds a Chinese lawyer practicing certificate; serves as a review expert for the Zhongguancun YingCamp Cross-border Acceleration Platform, a special legal advisor for the "People's Rule of Law • New Perspectives" column, a Council Member of the Health Legal Affairs Branch of the National Health Industry Enterprise Management Association, and was recognized as a Leading Lawyer in the Biotechnology, Pharmaceutical, and Healthcare sectors for 2024 by Legal News.

Experience

彭律师在医疗和生命科学领域有着丰富的经验。担任数十家企业法律顾问，为其提供公司治理、企业合规、技术交易、股权设计、数据合规、并购等法律服务，在企业合规、公司治理、反腐败体系建设、数据安全与个人信息保护等方面有丰富的实务经验，协助客户解决业务发展过程中的法律问题，包括提供咨询性法律意见或建议、协助交易谈判等，同时还协助客户从业务、知识产权、安全、风险防控等多个角度制定整体的合规体系。

Attorney Peng possesses extensive experience in the healthcare and life sciences sectors. He serves as legal counsel for dozens of enterprises, providing legal services in corporate governance, corporate compliance, technology transactions, equity structuring, data compliance, mergers and acquisitions, and more. He has substantial practical expertise in areas such as corporate compliance, corporate governance, anti-corruption system development, data security, and personal information protection. Attorney Peng assists clients in addressing legal issues that arise during business development, including providing advisory legal opinions or recommendations and supporting transaction negotiations. Additionally, he helps clients establish comprehensive compliance systems from multiple perspectives, such as business operations, intellectual property, security, and risk prevention and control.

Industry Sector Expertise

为一家国内创新药企业提供数据合规体系的搭建，包括数据合规问题的尽调、数据合规官的设置、体系搭建、公司数据分类分级管理制度、个人信息保护制度、数据跨境传输管理制度、数据安全应急响应预案等，并对全体员工进行了数据合规的培训；

为某国内知名疫苗企业销售部提供合规风险的尽调及完善，包括尽职调查、相关制度的完善、与第三方合同模板的修改以及全员培训；

就多家跨国药品企业及创新药企业在中国及境外的临床试验提供一系列的咨询服务，包括起草、谈判临床试验协议、与 CRO、SMO 及其他第三方的服务协议、知情同意书、人类遗传资源及生物安全相关法规咨询、药品供应协议、药物警戒协议等；

协助一家国内知名药企在接受国外药企尽调过程中提供合规咨询，协助完善公司内部合规制度及文件；

代表一家创新药企业与一家ADC公司平台技术许可(License-in)及共同开发与商业化交易提供咨询，包括协议的起草谈判以及所涉监管问题的咨询等；

代表一家抗体研发生物公司与一家西班牙公司就合作研发、注册与商业化提供咨询，包括协议的起草、谈判和法律咨询等；

代表一家科研机构与国内药企就肝母细胞的制备等技术许可事宜提供法律咨询，包括协议的起草、修改、谈判等法律咨询。

代表一家国内创新医疗服务运营企业就其商业合作经营业务提供咨询，包括新业务的合规路径研究、搭建以及商业合作模式涉及的反腐败和广告宣传合规事项提供咨询等。

Advised a domestic innovative pharmaceutical company on establishing a data compliance framework, including conducting due diligence on data compliance issues, setting up a Data Compliance Officer role, building the compliance system, developing company policies for data classification and grading management, personal information protection, cross-border data transfer management, and data security incident emergency response plans. Also conducted data compliance training for all employees.

Conducted due diligence and enhancement of compliance risks for the sales department of a well-known domestic vaccine manufacturer, including performing due diligence, improving relevant internal policies, revising third-party contract templates, and delivering comprehensive training to all staff.

Provided a series of consulting services to multiple multinational pharmaceutical companies and innovative drug firms regarding clinical trials in China and overseas. This included drafting and negotiating clinical trial agreements, service agreements with CROs, SMOs, and other third parties, informed consent forms, providing regulatory advice on human genetic resources and biosafety, drafting drug supply agreements, and pharmacovigilance agreements.

Assisted a renowned domestic pharmaceutical company during a due diligence process initiated by a foreign pharmaceutical company by providing compliance consultations and helping refine the company's internal compliance policies and documentation.

Advised an innovative drug company on a platform technology licensing agreement (License-in) and a co-development and commercialization transaction with an ADC company, including drafting and negotiating the agreements and providing regulatory guidance on related issues.

Represented an antibody R&D biotech company in advising on a collaboration for R&D, registration, and commercialization with a Spanish company, including drafting, negotiating, and providing legal counsel on the agreement.

Provided legal counsel to a research institution regarding technology licensing for hepatoblast preparation and other matters to a domestic pharmaceutical company, including drafting, revising, and negotiating the agreement.

Advised a domestic innovative healthcare service operator on its business cooperation and operational activities. This included researching compliant pathways for new business initiatives, assisting in their setup, and providing guidance on anti-corruption and advertising compliance matters related to the business cooperation model.