Dublin, July 03, 2024 (GLOBE NEWSWIRE) -- The "Drafting Commercial Contracts for the Pharmaceutical Industry Training Course" training has been added to ResearchAndMarkets.com's offering.
In such a highly regulated industry and in these turbulent and uncertain times, understanding the key challenges of negotiating and drafting an effective and watertight contract on an international level are complex topics. They can be difficult for even the most well-equipped in-house lawyer and most often it is not the lawyer in the driving seat.
Commercial managers from all areas of the pharmaceutical industry are leading negotiations and drafting and managing key contracts on a daily basis. It is vital that both legal counsel and commercial executives not only have the key skills and tactics to create a win:win scenario but also the knowledge to ensure any agreement is within current laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes.
This programme will:
- Deliver an in-depth examination of intellectual property issues that affect pharmaceutical industry agreements
- Focus on competition regulations pertinent to pharmaceutical industry agreements
- Analyse the commercial and legal issues affecting pharmaceutical industry agreements
- Examine collaboration and licensing agreements
This unique and highly interactive two-day programme looks at all stages of the contracting process and aims to deliver applied training through a balanced blend of practical learning. The presenters will use a mixture of practical exercises and cases from the pharmaceutical industry to ensure you leave the seminar with the knowledge and skills to perfect all stages of the contracting process.
By attending this seminar, you will:
- Update your practical skills when drafting effective licensing and collaboration agreements
- Explore the current issues relating to IP including the Unitary Patent and Unified Patent Court
- Understand the key intellectual property issues affecting pharmaceutical industry agreements
- Explore the implications of SPCs for pharmaceutical industry agreements
- Learn how to draft contracts to avoid anti-trust infringement
- Familiarise yourself with the key commercial and legal issues that affect pharmaceutical industry agreements
- Gain knowledge of the key issues in clinical trial agreements, contract manufacturing agreements and co-promotion, co-marketing and distribution agreements, and material transfer agreements
- Get to grips with competition law relevant to doing deals in the pharmaceutical industry and best practice tactics to use
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Who Should Attend?
Personnel from R&D, clinical, regulatory, commercial, sales and marketing, manufacturing, distribution and purchasing functions, including:
- In-house counsel
- Commercial and contract managers
- Business development managers
- Purchasing and procurement personnel
- Heads of legal departments
- Legal advisers
- Patent, IP, trade marks or licensing counsel
Key Topics Covered
Day 1
Understanding licensing and collaboration agreements
- Precontractual documents and the role of the term sheet
- Scope of the licence
- The interplay of key commercial terms, including:
- governance and dispute resolution
- performance obligations and termination rights
- financial terms
- Boilerplate clauses, including law and jurisdiction
Workshop: Understanding licensing and collaboration agreements
The Unitary Patent and the Unified Patent Court
- Latest developments
- Implications for the pharmaceutical industry
Third-party IP rights - freedom-to-operate searches and implications for pharmaceutical industry agreements
- Evaluating your freedom to operate
- Different approaches to infringement in Europe
- Assessment of injunction risk
- Mitigating risk and pre-launch patent strategies more generally
- Strategies for obtaining freedom to operate including via licensing
- Freedom-to-operate warranties and indemnities
- Payments and royalty stacking
- Enforcement against infringers
- No-challenge clauses
- Benefits of recording your licence
Supplementary protection certificates (SPCs) - securing the full commercial potential of your product
- What are SPCs?
- What are the implications for pharmaceutical industry agreements?
- The duration of the SPC
- What does the SPC cover?
- Combination products
- Basic patents and basic follow-on SPCs
- Leveraging the full commercial value of your property
Understanding and drafting R&D agreements
- The scope and purpose of R&D agreements
- Key terms and conditions
- Limitations of experimental use defence to patent infringement
- The 'Euro Bolar' defence: Article 10(6) Directive 2001/83/EC explained
- The varying scope of the 'Euro Bolar' defence across the EU and how it has been implemented in UK law
Day 2
Medicines regulations using regulatory processes to define contractual obligations
- An introduction to regulatory law
- Brief contrast of differing regulatory regimes: medicines/ devices
- Milestones in approving medicines
- Using regulatory processes and milestones in defining contractual obligations
- Common pitfalls and hot spots
Key issues in clinical trials and related agreements
- Introduction to clinical trials
- Outline of principal EU and UK legislation
- Horizon scanning: preparing for regulatory change
- Structuring clinical trial agreements
- Engaging CROs
- Key agreement terms and obligations
- Liability, indemnities and insurance
Key issues in contract manufacturing agreements
- The importance of the GMP audit
- Issues with technology transfer
- Apportionment of risk and reward
- Secondary sources of supply
- Building a supply chain
- Other key issues
Key issues in co-promotion, co-marketing and distribution agreements
- Introduction to the agreements
- Scoping the deal
- Preparing for contingencies and termination
- Key characteristics of the distribution relationship
- Key terms - scope of rights and responsibilities, restrictions, minimum purchase requirements, territory
Key issues in material transfer agreements
- The purpose of the agreement
- The scope of the agreement
- Key terms and conditions
- Key issues to be aware of
Introduction to relevant EU competition law rules
- Article 101 TFEU and 102 TFEU: restrictive agreements and practices and abuse of dominance in pharmaceutical markets
- The December 2010 Horizontal Cooperation Guidelines
- The Jan 2011 R&D Block Exemption - strategy for early joint research
- The Technology Transfer Block Exemption - dos and don'ts for licensing in and out
- The Vertical Agreements Block Exemption and Vertical Restraints Guidelines - designing distribution models in the EU
- Specialisation Agreements Block Exemption
- Implications of Brexit
Practical workshop: Current competition law issues
- Reduced and exclusive distribution agreements
- Licensing in and out
- The new technology transfer exemption
- Quota schemes and other devices for protecting domestic needs
- Discount schemes for dominant companies
For more information about this training visit https://www.researchandmarkets.com/r/mvbqn7
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