On March 6, 2023, Cambodia issued requirements and procedures for merger and acquisition (M&A) filings to allow the country’s competition regulator to monitor the impact of M&A transactions on the Cambodian market. These rules are contained in Sub-decree No. 60 on the Requirements and Procedures for Business Combinations. This subdecree is the latest in a series of detailed regulations issued to develop Cambodia’s competition and antitrust law framework since the 2021 enactment of the Law on Competition, which formally established the Cambodia Competition Commission (CCC), set out the CCC’s complaint and investigation procedures, listed prohibited anticompetitive practices, and outlined applicable penalties. Sub-decree No. 60 applies to any business combination that may materially affect competition in Cambodia, regardless of where in the world it takes place. Premerger and Postmerger Notifications The parties to a business combination must notify the CCC of the proposed combination if the transaction meets certain thresholds, which will be determined by the CCC at a future date. The notification must include, among other things, key terms of the relevant agreements, incorporation documents and financial statements of the parties, and an indication of the types of goods or services provided by the parties. All documentation submitted must be in Khmer, except for names, addresses, and certain other items. The CCC will determine within seven working days whether it requires additional information or documentation. Once it has all necessary documentation, the CCC will issue a decision on the proposed business combination within 30 days—the combination may be approved outright or declared subject to a secondary review. Sub-decree No. 60 states that a proposed business combination will not be subject to secondary review if the market share of each party does not exceed 30 percent in each relevant market, among other criteria. However, the CCC reserves to right to require a secondary review if

On March 9, 2023, Myanmar’s Intellectual Property Department (IPD) informed the country’s certified trademark representatives that the Trademark Law enacted in 2019 is set be enforced on April 1, 2023. A written notification about the effective date of the Trademark Law is expected soon. [Update: The official announcement is contained in Notification No. 82/2023, which was dated March 10, 2023, and published in the government-owned daily newspaper the following day.] The Trademark Rules, which are necessary to establish procedures for collecting official fees, are expected to be issued in March 2023. Once the Trademark Rules are set up and the Trademark Law comes into force, the official fees will be announced by a separate notification, as will the start of the second phase of the “soft opening” period. This second phase is expected to commence on April 3, 2023. In this phase, mark owners can pay the official fees for trademark applications filed within the first phase of the soft opening. In the meantime, the marks recorded under Myanmar’s old system or used in the country can still be filed together with payment during the soft opening’s second phase—either in person by the mark owner or through a certified representative via the online system. This second phase will continue until Ministry of Commerce (MOC) officials announce the “grand opening” of the IPD, which they hope to achieve in 2023. The IPD officials added that applications can now be submitted together with the notarized appointment of representative form that was issued by the MOC for appointing a representative for trademark matters. Any other requests, such as those for amendment, assignment, or change of representative, still need to wait for the IPD’s grand opening. While subsequent rules and announcements are expected soon, owners of existing marks should consider refiling these marks with the IPD before

Intellectual property experts from Tilleke & Gibbins’ Hanoi office have written the Vietnam chapter of Practical Law Company’s Copyright Litigation Global Guide 2023, a high-level comparative overview of laws and regulations related to copyright law presented in an easy to read Q&A format. The Vietnam chapter, which includes changes introduced by the latest amendment of Vietnam’s Intellectual Property Law, covers the following topics and more: Sources of law and the court system Types of works that can be protected by copyright Acts that constitute copyright infringement Parties to litigation Enforcement options Procedure in civil courts To read the Vietnam chapter, please visit the Practical Law website or click on the link below.

On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent problems in the healthcare sector in Vietnam. Decree 07 took effect on the same day and amends and supplements several articles in its predecessor, Decree 98, which originally took effect on January 1, 2022. Some outstanding points of Decree 07 are summarized below. 1. Registration of Medical Devices The compulsory implementation of the ASEAN Common Submission Dossier Template (CSDT) in registration applications for medical devices will be delayed until January 1, 2024, instead of the deadline of January 1, 2023 under Decree 98. In addition, if after three rounds of amendment/supplementation as requested by the authority, the registration dossiers still have not been approved, the applicants must submit new registration dossiers. 2. Withdrawal of Registration Number Decree 98 adds one case for withdrawing the registration number of a medical device, which is when the documents in the registration dossier are concluded by the authority to be noncompliant with the provisions of law. 3. Listing Price of Medical Devices It is required for establishments manufacturing or trading medical devices to list their prices in locations stipulated under Article 17 of Decree No. 177/2013/ND-CP implementing the Law on Prices (such as at transaction or selling locations of the trading establishments) or on the online portal of the Department of Medical Equipment and Construction’s (DMEC). 4. Price Declaration It is no longer required to declare prices of all medical devices circulating on the Vietnam market. Instead, the Ministry of Health will issue and adjust the list of medical devices subject to price declaration, depending on management requirements and the actual situation, especially when there are abnormal fluctuations in prices affecting the supply of medical devices, buyers’ ability to pay, and the solvency of the

According to the Ministry of Health of Vietnam, many healthcare facilities in the country are facing a shortage of drugs, medical devices, and materials/chemicals. To address the urgent needs of medical examination and treatment in public healthcare facilities, on March 4, 2023, the government of Vietnam promulgated Resolution No. 30/NQ-CP on continuing to implement solutions to ensure the availability of drugs, medical equipment, and healthcare supplies (“Resolution 30”). Resolution 30 amends item 4 of Resolution No. 144/NQ-CP dated November 5, 2022, allowing medical examination and treatment expenses to continue to be covered by health insurance for technical services carried out with medical devices supplied by contractors after winning tenders to supply materials and chemicals. The new mechanism brings more benefit to patients by removing the previous ending date of November 5, 2023, and will be applicable until there is further guidance from the government. Resolution 30 also allows the use of medical devices that were donated or gifted by domestic and foreign entities (including those that were provided under now-expired joint ventures or cooperation contracts) regardless of whether those entities have fulfilled the procedures for ownership establishment. Technical services that are performed by such devices will be covered by health insurance. This provision will help address the shortage of medical devices used in public hospitals. The determination of bid price is also a highlight of Resolution 30, which pilots a simpler price determination procedure for the purchase of drugs and medical devices. Instead of requiring purchasers to obtain quotations from three suppliers, Resolution 30 allows them to compare prices based on the quotations actually received, even from only one or two suppliers. Alternatively, price determination can be based on the winning bid price for a similar medical device procurement package that was awarded within the last 120 days. This pilot procedure for

The newly released Licensing 2023 guide published by Lexology Getting the Deal Through features a chapter on Vietnam by four licensing specialists from Tilleke & Gibbins. The comparative guide provides companies and other interested readers with information on licensing law and practice in various jurisdictions around the world. Licensing 2023 provides detailed information on the following topics: Restrictions, laws and licensing arrangements Intellectual property issues: Paris Convention for the Protection of Industrial Property, contesting the validity of licensor’s IP rights, invalidity and expiry of IP rights, security interests, proceedings against third parties, sublicensing, jointly owned IP, first to file, scope of patent protection, trade secrets, copyright Software licensing: Perpetual licensing, legal requirements, user restrictions Royalties and payments, currency conversion, and taxes: Relevant legislation, restrictions, taxation of foreign licensors Competition law issues: Restrictions on trade, legal restrictions, and IP-related court rulings Indemnification, disclaimers, and damages: Prevalence and enforceability of indemnity provisions and contractual waivers of damages Termination: Right to terminate, impact of termination Bankruptcy: Impact of licensee or licensor bankruptcy Dispute resolution: Governing law, arbitration, enforceability, injunctive relief, contractual waivers The Vietnam chapter was authored by Linh Thi Mai Nguyen, partner and head of Tilleke & Gibbins’ trademark team in Vietnam; Son Thai Hoang, trademark executive; and Chi Lan Dang, associate, of Tilleke & Gibbins’ trademark team, along with corporate and commercial senior associate Tu Ngoc Trinh, who has extensive experience in franchising and competition law. The Vietnam chapter is available below as a PDF. Tilleke & Gibbins also contributed the Thailand chapter to Licensing 2023. To browse all jurisdictions covered by the guide, please visit the Getting the Deal Through website.

Two of Tilleke & Gibbins’ life science specialists in Bangkok have contributed the Thailand chapter to the newly issued Licensing 2023, a comprehensive guide from Lexology Getting the Deal Through to licensing in various jurisdictions around the world. The Thailand chapter covers the following topics: Laws and licensing arrangements: Unfair Contract Terms Act, Trade Competition Act, pre-contractual disclosure, registration of international licensing, implied obligations, Civil and Commercial Code, Trademark Act, Patent Act, Trade Secrets Act Intellectual property issues: Paris Convention for the Protection of Industrial Property, contesting the validity of licensor’s IP rights, invalidity and expiry of IP rights, security interests, proceedings against third parties, sublicensing, jointly owned IP, first to file, scope of patent protection, trade secrets, copyright Software licensing: Perpetual licensing, legal requirements, user restrictions Royalties and payments, currency conversion, and taxes: Relevant legislation, restrictions, taxation of foreign licensors Competition law issues: Restrictions on trade, legal restrictions, and IP-related court rulings Indemnification, disclaimers, and damages: Prevalence and enforceability of indemnity provisions and contractual waivers of damages Termination: Right to terminate, impact of termination Bankruptcy: Impact of licensee or licensor bankruptcy Dispute resolution: Governing law, arbitration, enforceability, injunctive relief, contractual waivers The full Thailand chapter is available below as a PDF. Tilleke & Gibbins also contributed the Vietnam chapter to Licensing 2023. To browse all jurisdictions covered by the guide, please visit the Getting the Deal Through website.

In Cambodia, the Ministry of Commerce takes the lead on many consumer protection matters, issuing and enforcing regulations that contribute greatly to a fairer and more transparent legal framework. The regulations protect consumers while simultaneously creating a more a level playing field for businesses. On September 2, 2022, the ministry issued a new regulation concerning household chemical products. The regulation, named Prakas No. 192 on the Requirements for the Labeling of Household Chemical Products, is another big leap forward in light of the consumer protection framework that the Cambodian government has been rapidly updating in recent years. Interesting issues in the regulation include household chemical product classification, labeling and language requirements, product storage requirements, recall requirements, and obligations for companies engaging in business activities related to household chemicals. In addition, the regulation reminds household chemicals businesses operating online of the need to obtain additional e-commerce licensing. Cambodia’s consumer protection authority, the Consumer Protection, Competition and Fraud Repression Directorate-General—commonly known as the CCF—has already started to enforce the new regulation, as the three-month transition period under the regulation has now passed. Classifying and Defining Household Chemicals The regulation classifies household chemicals into three groups based on the product’s purpose—namely detergents, pesticides, and substances for home and garden protection. There is also a separate list of household chemicals identified as “chemicals not allowed for use in food.” This list is just a reminder, as existing legislation already prohibits the use of the identified chemicals in food. The regulation defines household chemicals as finished chemical products, or chemical additives to products, that can be harmful to health and that have one of the three purposes mentioned above. The regulation further states that the products are for use in “normal life,” such as in homes, workshops, or gardens, or for other public use. The regulation lists many examples of household chemicals—including