Legal Research Center of Medicine and Health Industry

The Legal Research Institute of Medicine and Health Industry of China Commercial Law Firm is intended to grasp the trend of leading edge legal development in the medicine and health industry, create an open and shared industrial legal service and value-added service platform, carry out research and service work on corporate compliance, capital operation and investment and financing services, policy research, international market expansion, and resource connection of medicine and health industry, and devote to serving the medicine and health industry throughout China. The scope of service includes but is not limited to the following.

I. Legal services for cross-border license in/out authorized transactions
1. Providing consultation for designing transaction architecture at the request of clients (traditional single agreement cooperation mode/equity cooperation mode/integrated mode of agreement cooperation and equity cooperation);
2.Providing legal service in both Chinese and English in the whole process of drafting, modifying and signing of documents from CDA/NDA, Term Sheet to License Agreement;
3. Providing patent and professional legal due diligence services;
4. Providing patent protection service during the licensing period;
5. Providing the service around the period compensation system for pharmaceutical patents;
6. Providing consultation on international market supervision and market access and corresponding legal services;
7. Providing full-course follow-up and legal and advisory services during the authorization period.

II. Legal service for overseas investment and M&A of pharmaceutical enterprises
1. Acting as lead legal advisor to conduct legal due diligence in cooperation with the law firm in the country where the target of the M&A is located, and issue relevant legal opinions;
2. Drafting and modifying relevant legal documents and agreements on overseas investment and M&A, and assisting the enterprise in closing the transaction;
3. Coordinating overseas valuation organizations in the field of medicine to provide valuation consulting services;
4. Cooperating with overseas investment banks and other banks to provide services related to overseas investment and M&A;
5. Coordinating the foreign investment declaration, including but not limited to national security examination or foreign investment examination;
6. Formulating the anti-monopoly review and overseas investment compliance path for overseas investment and M&A for the company, managing the pressure from the Foreign Investment Risk Assessment Modernization Act (FIRRMA) of the United States and the EU Foreign Investment Review Regulations on the overseas investment and M&A of Chinese pharmaceutical enterprises;
7. Coordinating all the anti-monopoly declarations reviewed by competition law enforcement agencies as a whole, including but not limited to: judging which jurisdictions to make declarations in, and coordinating overseas law firms to complete the anti-monopoly declarations according to the different declaring threshold of each jurisdiction, the different standards of substantive review, and the different review schedule and according to whether the declaration is compulsory or voluntary;
8. Cooperating in formulating the public relations strategies of the government affairs of the host country/the country where the target of the M&A is located in connection with overseas investment or M&A, and assisting the local public relations agencies or large law firms in executing such strategies;
9. Investigation of the investment environment in the country of investment;
10. Participating in all stages of overseas investment on behalf of the enterprises and providing legal service;
11. Providing legal service for international tendering and trade in technology and services;
12. Providing Chinese ODI filing service;
13. Providing overseas financing channel arrangements including overseas bond issuance and bank/syndicated M&A loans when the overseas investment or M&A needs the support of a large amount of funds.

III. Legal service for medical device enterprises, medical institutions, institutions combining medical treatment and endowment and health administrative departments
1. Providing answers to consultation, legal opinions or suggestions on the legal problems encountered in the management and operation of medical institutions, medical device companies, institutions combining medical treatment and endowment and health administrative departments;
2. Providing special legal service for medical quality and safety management in medical institutions, and assisting in formulating and revising various medical documents and templates of informed consent forms;
3. Standardizing the procedures and relevant systems of medical institutions' diagnosis and treatment activities, assisting medical institutions in overall management and control of medical risks, including providing legal advice on medical institutions' practice according to existing laws and regulations, assisting medical institutions in formulating regulations on risk assessment of new business and new technology, and in formulating regulations on personnel and operation grading management;
4. Assisting medical institutions in establish a complete internal audit system;
5. Assisting medical institutions in standardizing all kinds of government bidding and procurement activities to ensure legal compliance of bidding process and results;
6. Providing legal training for medical institutions, pharmaceutical companies, medical device companies, institutions combining medical treatment and endowment and health administrative departments;
7. Assisting medical institutions, pharmaceutical companies, medical device companies and institutions combining medical treatment and endowment in drafting, reviewing and modifying legal instruments including agreements, contracts, project proposals, feasibility reports and official documents in management, operation and technical cooperation;
8. The Medical Institution Ethics Committee manages special legal services, participates in various medical ethics reviews for medical institutions, and puts forward ethics review opinions from the legal perspective;
9. Providing comprehensive legal support for human resources management of medical institutions, pharmaceutical companies, medical device companies and institutions combining medical treatment and endowment, cooperating with HR department to establish and operate internal mediation organization for labor and personnel disputes, and providing legal opinions for internal hearing;
10. Providing legal opinions on cases of medical disputes, participating in negotiation between doctors and patients, and mediation of medical disputes; acting as an agent for mediation, appraisal and litigation of medical dispute cases;
11. Applying for all kinds of relevant appraisals and drafting the statement materials of appraisal hearing on behalf of clients, such as medical malpractice appraisal, medical injury appraisal, disability grade appraisal, supplementary appraisal, re-appraisal and other judicial appraisals;
12. Attending the hearings of the above-mentioned appraisals on behalf of clients, making statements and proposing professional opinions on the facts of medical faults, the causal relationship between the medical fault and the consequence of injuries and the force of cause (degree of participation);
13. Presenting in the autopsy scene for whole-process witness and supervision on behalf of the client;
14. Acting as an agent for criminal charges and proceedings of the crimes of illegal medical practice or medical malpractice;
15. Acting as an agent for legal service of health administration;
16. Providing legal service for management of pharmaceutical intellectual properties, product circulation and others for pharmaceutical enterprises.

IV. Legal service for cell enterprises
1. Carrying out risk assessment on various businesses of the companies, such as cell storage, preparation and transfusion, providing consultation, legal advice and risk prevention and control scheme, and assisting in improving business operation and management mode.
2. Providing services such as the drafting, formulation and review of contracts and documents for the establishment of laboratories (laboratory design, construction, decoration, equipment procurement, etc.), and purchase and entrusted purchase of medical devices, test reagents, reagent consumables, and medicines, and assessing the risks in the process of contract performance and relief to propose preventive measures.
3. Assisting in the establishment of cooperation with the medical team, clinical trial investigators, CROs, insurance companies and cell preparation plants, and the completion of joint filing with hospitals, and assisting in passing the review by the Ethics Committee. Identifying the legal risks existing in the process of clinical drug application, and providing professional interpretation and professional and practical legal opinions and suggestions in accordance with the latest policies and regulations issued by the relevant state departments in the field of biological medicine.
4. Assisting companies in establishing and improving the emergency response mechanism, making legal risk assessment and prediction, and proposing suggestions and assisting in handling legal issues with respect to the series of problems or emergencies such as personal injury of products, administrative inspection/punishment of Health Commission, criminal offense, group incidents and information leakage of living donors occurring during the production and operation of the companies.
5. Providing special training lectures on laws and regulations such as criminal law risks of cell business, basic points of ethics review, cell storage, cell preparation, cell transfusion, placental tissue donation, and transformation of scientific and technological achievements.

V. Legal service for the establishment and financing of overseas industrial funds or M&A funds of pharmaceutical enterprises
1. Designing the overseas fund architecture and coordinating its implementation after considering international taxation, GP incentive mechanism and investor financing strategies and other related factors;
2. Providing consulting opinions for the private placement memorandum (PPM) established by the fund;
3. Coordinating the lawyers of the countries where GP or LPF is located to prepare all legal documents related to the establishment of the fund, including but not limited to: NDAs, Articles of Association of the GP, LPA, TS, Information Memorandum, Subscription Agreement, Management Agreement and Investment Advisory
Agreement (if applicable), Carried Interest Partnership or Assignment Agreement, Advisory Agreement(s), Leavers and Joiners Rules, Co-investment Agreement, legal opinions;
4. Coordinating overseas fund financing and coordinating first closing and the subsequent closings as planned;
5. Opening the overseas fund supervision account, GP account and fund main account.

Director: Bai Yongquan

Vice Director: Chen Wuhai, Huang Maoku

Secretary General: Huang Peiyu

Bai Yongquan: baiyongquan@huashang.cn

Huang Maoku: hmklawyer@163.com

Chen Wuhai: 13823704245@139.com

Huang Peiyu: huangpeiyu0127@163.com