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Healthcare

Healthcare

We are able to provide extensive and comprehensive healthcare legal services to our clients, including legal advice related to medical treatment, drugs, medical devices and equipment, biotechnology, clinical trials, nutrition supply, gene treatments, health food, etc. Our practice routinely advises on various healthcare-related legal issues in China including: the establishment of different types of legal entities in different business nature commonly used in the healthcare industry in China; mergers and acquisition (“M&A”) matters of healthcare enterprises; matters that involve the daily operation of healthcare enterprises; and other important matters such as financings, restructurings, initial public offerings (“IPOs”), reorganizations, intellectual property (“IP”) protection and relevant dispute settlement, etc.

 

Our Expertise

Establishment of Healthcare Legal Entities

We provide comprehensive legal services to our clients and assist them in the establishment of legal entities in different forms with regard to different areas of the healthcare sector, including hospitals, clinics, special medical service, Healthcare Product manufacturing/distribution enterprises, and research and development centers. A more detailed content of our scope of services is as follows:

 

Advising on the selection of the appropriate legal entity for the client which includes representative offices, domestic subsidiaries, branch offices, Sino-foreign joint ventures and cooperative enterprises, wholly foreign owned enterprises

 

Carrying out preliminary research, assisting the client in the selection of an optimal investment zone, obtaining for the client optimal treatment and conditions for the client’s investment which include tax incentives, healthcare resources

 

Assisting the client with communicating and interacting with the relevant governmental authorities (e.g. SFDA, NDRC, MOFCOM, AIC, MEP, etc), and preparing the required application documents for the establishment of the legal entity

 

Assisting the client in obtaining the necessary special industrial approvals (e.g. applying to SFDA to obtain a production license and an operation license for a Healthcare Product)

 

Assisting the client with other approval and registration procedures, e.g. obtaining project approval from NDRC, environmental approval from MEP, an approval letter and certificate of approval from MOFCOM (applicable to foreign-invested enterprises), a business license from AIC and other post-establishment registration/filing approvals from the relevant tax, foreign exchange, and customs authorities

 

Other legal services related to the establishment of healthcare legal entities

 

M&A in the Healthcare Industry

 

We provide a one-stop shop of legal services to clients for various kinds of M&A transactions, including horizontal M&A transactions between Healthcare Product manufacturing/distribution enterprises; vertical M&A transactions between Healthcare Product manufacturing and distribution enterprises; equity acquisition transactions among healthcare enterprises; and asset acquisition transactions of fixed assets or technologies of other enterprises.  A more detailed content of our scope of service is as follows:

 

Assisting the client to choose the ideal potential partner including the preliminarily assessment of potential partner

 

Evaluating and determining the transaction structure and capital arrangement in accordance with the development strategy and actual condition of the client, including selecting the type of M&A transaction for the client

 

Adjusting the transaction structure in accordance with the due diligence findings of the target company, the risk preferences of the client to realize the investment goal of the client

 

Conducting legal due diligence on the target company and issuing a legal due diligence report, especially in situations requiring special investigations that go beyond the scope of a regular due diligence investigation, e.g. the examination of registration documents and patent letters of the Healthcare Product, distribution model, franchise channels and regions, sales teams, product pricing, bidding procedures and documents

 

Assisting the client in negotiations, preparing transactional documents such as frame agreements, equity transfer/asset acquisition agreements, amendments of AOA, joint venture agreements, shareholders’ agreements

 

Preparing M&A filing materials and assisting the client to obtain the relevant governmental approvals necessary for the M&A transaction

 

In the event that certain Chinese antitrust filing thresholds are triggered, assisting the client to draft the antitrust filing report, communicating with the antitrust bureau of MOFCOM, submitting the antitrust filing report; assisting the client in disposing of relevant assets for the purpose of closing the M&A transaction if necessary

 

Assisting the client to change or modify certificates and licenses such as production /operation licenses for drug/medical devices/health food

 

Providing relevant legal services for an M&A transaction’s completion and post-completion integration phase

 

Services Related to the Day-to-Day Operations of Healthcare Enterprises

 

We provide legal consulting services for various kinds of legal issues that may arise during the course of a healthcare enterprise’s routine operations, including:

 

Advising on clinical trials in China by domestic and international healthcare enterprises (e.g. selection of and coordination with CRO; drafting and reviewing legal documents related to clinical trials such as contracts with CRO, non-disclosure agreements, clinical trials agreements; obtaining of relevant approval from SFDA regarding clinical trials)

 

Assisting domestic and international healthcare enterprises in completing their registration and filing of domestic and imported Healthcare Products which includes obtaining the registration certificate of the domestically-produced or imported drug, medical device, and/or health food and advising on license related issues

 

Assisting the client to complete the necessary licensing and filing procedures for the import and export of Healthcare Products and medical equipment

 

Providing guidance on product packaging, labeling, labeling compliance issues in China

 

Providing consulting advice on the commissioned manufacturing, commissioned processing, licensed manufacturing, and repackaging of Healthcare Products

 

Advising on domestic and international market developments

 

Providing legal services related to the distribution and circulation of Healthcare Products, including the drafting of standard distribution agreements

 

Providing legal services related to the promotion and advertisement of Healthcare Products in China including assessing the legality of certain promotional activities by medical representatives, advising on whether a Healthcare Product advertisement is compliant with all relevant regulations

 

Providing legal services related to the transfer and licensing of medical technology such as transfers of technology involving new medicines and the transfer of manufacturing technology related to the production of drug by medical manufacturing enterprises or research and development institutions. Such services include the drafting of transfer agreements, supplementary filings to SFDA

 

Providing consultation services related to compliance with anti-commercial bribery regulations

Providing consultation services related to labor compliance (including the drafting and reviewing of labor-related agreements such as labor contracts, training agreements, internal labor by-laws such as employee manuals and employee codes of conduct), the hiring and firing of employees, the settlement of employees in relation to M&A transactions, and labor dispute resolutions

 

Consulting on tax planning and tax issues

 

Other legal services related to the routine operation of healthcare enterprises

 

Healthcare Financing, IPO and Reorganization Services

 

Providing legal service on banking and financing, including designing a financing plan, drafting and reviewing loan agreements, guarantee agreements

 

Providing legal services related to restructuring and internal reorganizations, including public hospital (public service institutions) restructuring, non-operational medical institute restructuring, equity share capital restructuring, settlement of employees

 

Providing legal service on equity financing, including IPOs (A-share, H-share, and N-share markets) and private equity financing

 

Designing incentive plans for management and employees, including employee share incentive plan

 

Providing legal services related to the issuance of onshore and offshore corporate bonds

 

Providing re-financing services in the form of stock/bond issuances for publicly-listed healthcare companies, including the issuance of new shares, share allotments, corporate bonds

 

Providing legal services related to equity acquisitions and/or asset reorganizations, disclosures of information, and operational and other corporate governance issues of the publicly-listed healthcare company

 

Providing legal services related to bankruptcies, liquidations, and reorganizations

Intellectual Property Protection in the Healthcare Industry

Conducting IP due diligence and strategic planning, reviewing the employee invention incentive reward and remuneration system

 

Assisting healthcare enterprises to apply for and obtain IP protection through the registration and maintenance of  know-how, patents, trademarks, and copyrights related to Healthcare Products

Providing legal services related to the transfer and/or license of products, techniques, and other IP, designing reasonable IP ownership arrangements that incorporate the use of preferential policies and tax rates for cross border transactions within the context of the international IP system

 

Consulting on the protection of business secrets and know-how, including assisting healthcare enterprises to establish and consummate internal IP protection systems, drafting non-disclosure agreements, competitive restriction agreements involving management and employees

 

Providing IP audit and brand planning services, advising on the labeling of patent numbers on the product packaging and counseling on the correct usage of trademarks

 

Providing legal services related to IP litigation and related dispute resolution

 

Providing other legal services related to IP protection and management

 

Dispute Resolution for Healthcare Enterprises

 

Consulting on commercial decisions or policies which may incur litigation

 

Consulting on risks during the course of manufacturing and operations, such as the risk of violating anti-commercial bribery regulations, product liability risk

 

Representing the client in dispute resolution cases through arbitration, mediation, and litigation, assisting the client with various types of disputes and issues, including, but not limited to:

 

Disputes between hospitals and patients

 

Disputes between healthcare enterprises and consumers

 

Disputes involving medical malpractice

 

Disputes involving adverse drug reactions

 

Disputes between clinical trial investigators and tested subjects

 

Representing clients before arbitration panels and courts of law on the enforcement of arbitration awards and other legal documents