OPPORTUNA LEGAL

The Takeovers Panel: Understanding Costs Orders in Corporate Control Disputes ========================================================================== The Takeovers Panel serves as the primary forum for resolving disputes that arise from takeover and control transactions in Australia. It provides an efficient and commercially focused mechanism for addressing issues of corporate control. One of the Panel’s key functions is remedial. In limited circumstances, and only when th

Australia’s Research and Development (R&D) Tax Incentive is one of the most generous programs of its kind globally and plays a significant role in making Australia an attractive destination for clinical research .  Administered jointly by AusIndustry (part of the Department of Industry, Science and Resources) and the Australian Taxation Office  (ATO), the R&D Tax Incentive Australia  provides a tax offset on eligible R&D expenditure. It often delivers substantial cash refund

The Therapeutic Goods Administration (TGA) has formally adopted the ICH E6(R3) guideline for Good Clinical Practice (GCP): Principles and Annex 1, effective 13 January 2026. A 12-month transition period until 13 January 2027 allows sponsors to comply with either the previous guideline or ICH E6(R3), providing flexibility during implementation. ICH E6(R3) introduces a modern, risk-proportionate framework designed to accommodate contemporary trial designs, including decentralis

Background: What the TGA Has Finalised The Therapeutic Goods Administration (TGA) has finalised its Australian-specific annotations to the International Council for Harmonisation (ICH) E6(R3) guideline for Good Clinical Practice (GCP) following a public consultation process. The outcomes of the public consultation were finalised on 16 December 2025, delivering a clear and practical framework for clinical trials conducted in Australia. The consultation received 51 submissions

Changes were recently announced to Australia’s new ACCC  mandatory notification regime, including introducing new notification thresholds, filing triggers, and exemptions. These changes were foreshadowed on 15 October 2025 when the Government announced  its intention to make amendments to the merger regime, including refined notification thresholds, expanded exemptions for low-risk activities such as ordinary course land acquisitions, and other practical adjustments, before t

1 January 2026 marks the commencement of Australia's new mandatory and suspensory merger control regime. From 1 January 2026, acquisitions that meet the specified monetary thresholds must be notified to the Australian Competition and Consumer Commission (ACCC) , with clearance required before completion. This introduces statutory review periods that will significantly extend timelines for many transactions. Transactions requiring rapid execution—such as opportunistic opportun

Australia’s stable economy, transparent regulatory environment, and strategic location in the Asia-Pacific continue to attract overseas companies seeking to register a foreign company in Australia or expand operations. For many international businesses, the most efficient way to commence trading without creating a new local entity is to register as a foreign company (commonly known as a branch) with the Australian Securities and Investments Commission ( ASIC ). At Opportuna L

AUSTRAC has released a statement of regulatory expectations to support businesses to implement the changes under the AML/CTF reforms. The...

Legal Responsibilities in Corporate Governance Directors of companies have significant legal responsibilities.  Specific duties apply to...

The Australian Transaction Reports and Analysis Centre’s (AUSTRAC) second public consultation on the new AML/CTF Rules is now open for...