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29-09-2020 (Live Online)

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Live Online: Drafting & Negotiating Commercial Contracts in Pharma

29 Sept- 2 Oct 2020 | 4-Day Live Online | 1:30 pm – 5:00 pm (SGT)

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Early Bird Rate: Register & Pay by 7 August 2020
Register 2 Delegates & the 3rd attends FREE!

overview

About The Course

Designed for legal and commercial managers working closely with various pharmaceutical agreements, this masterclass offers important touchpoints on contract law, the complex regulatory systems, as well as practical considerations in negotiating & drafting commercial contracts.

Through examining practical legal aspects & real-world case studies ranging from competition law, CRO contracting to licensing, co-promotion & distribution agreements, you will gain advanced understanding on interpreting key contractual clauses and effective negotiation skills.

 

Key Learning Outcomes

  • Commercial law for pharmaceutical industry: competition law, antitrust, antibribery among others
  • Drafting & negotiating key commercial contracts: Licensing, collaborative research, drug co-promotion, co-marketing & distribution
  • Key issues in clinical trials, clinical manufacturing and impacts on agreements
  • Development in regulatory compliance, the implications on contractual rights & obligations
  • Exercise clinical contract budget negotiation – Fair market value, mechanisms & processes
  • Intellectual property rights enforcement and infringement issues
  • Commercial dispute, violation, infringement pharma industry and legal cases

pricing

Packages Price
Live Online LearningSGD $2876SGD $2716Early BirdEarly Bird

Early Bird Rate: Register & Pay by 7 August 2020

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate of 2-day main conference package only.
For Group Registrations, email register@informa.com or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organization registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.
  • View payment terms and bank transfer details, click here »

Course Directors

Linda Hsu (PhD)
Founder
Astracrux Clinical Trials and Consulting Inc

Linda has Doctor of Philosophy and Law degrees. She provides multinational clinical trial legal consulting services and managing contract negotiations.

  • Over ten years’ experience in biotech and the CRO industry.
  • Served as the APAC regional head the Site Contract Lead team at a one of the world’s largest CROs, delivering 1,000+ clinical site agreements annually
  • Admitted as a Lawyer of the Supreme Court of Victoria Australia and a Barrister and Solicitor of the High Court of New Zealand
  • D., University of Canterbury; LL.B., University of Canterbury (New Zealand)
  • Specialized on Clinical Trial Agreements (CTA), Master Service Agreements, Vendor agreements and other contracts in relation to clinical trials for more than 50 pharmaceutical companies and CRO worldwide

 

 

Sebastian Handorf
Senior Legal Consultant
Compliance & Data Privacy

 

 

  • Business-oriented attorney with over 8 years’ experience and a master’s degree in Laws and Information.
  • Provides legal and contract management consulting services.
  • Acted as Americas regional head, leading site contract management team for the region.
  • Developed and implemented contracting strategy to adjust +700 clinical agreements to comply with GDPR regulation.
  • Specialized in rendering contract management and legal services in EU and Americas related to FCPA; Data Privacy; GDPR; Compliance; Risk-Assessment and Intellectual Property.

Live Online Learning

Stay Home. Skill Up!

The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.

To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.

Benefits of Live Online Learning

Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.

  • Classroom Experience: Progress with fellow participants as you would in an on-site class
  • Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
  • Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
  • Module-based approach to effectively manage your time and revisions
  • Earn your Digital Certification and broadcast your achievements to your peers
  • Onboarding: Available for all attendees
  • Proven and secure training platform

 

Click here to know more >

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Eligibility:
Attend and participate in the 2 full days of training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

Agenda

Contract Law for Pharmaceutical Industry 

  • Introduction to industry related agreements. What makes the industry unique from a contractual stand point
  • Competition law: merger, collaboration & distribution
  • Anti-bribery/anti-corruption
  • An introduction to regulatory law
  • Sample clauses
  • Anti-monopoly
  • Export controls in pharma/biotech
  • Drug price transparency

 

Interpretation And Principles Of Key Pharma Commercial Contractual Clauses

Introduction to Key Pharmaceutical Commercial Agreements

  • Clinical trial agreements / CRO agreements
  • Licensing agreements / co-licensing
  • Co-promotion, co-marketing and distribution agreements (covered by guest speaker)
    • Contingencies and termination
    • Reduced & exclusive distribution agreements
    • Scope of rights and responsibilities, restrictions, minimum purchase requirements, territory
  • Collaboration and R&D agreements (covered by guest speaker)

 

Intellectual property and licensing

  • Key commercial terms, including:
    • Governance and dispute resolution
    • Performance obligations
    • Termination rights
  • Boilerplate clauses:
    • Law and Jurisdiction
    • Infringement and enforcement
    • No challenge clauses
  • Structure of Pharma/Biotech IP contracts
  • Supplementary protection certificates
  • Lucinda Osborne,The in/out licensing deals in ASEAN
  • Joint ownership issues
  • Third party rights
  • Valuation of licensing deals
  • Forms of IP Licenses
  • Structure of Pharma/Biotech IP contracts
  • Commercial considerations
    • Territory, Loans, Field of use, upfront payments, royalty rates, development cost sharing, profit sharing, sales-based milestones, co-promotion rights, lead party

 

Clinical Trial-related Agreements

  • Introduction to types of contracts for Clinical Research Industry: Definitions, frame, context.
  • CRO Agreements / Sponsor Agreements
  • Clinical Agreements: Definitions, frame, context.
  • Boilerplate clauses and contracting structure
  • Confidential information and Publication
  • Sponsor /CRO obligations
  • Monitoring and reporting
  • Commercial considerations
  • Applicable law
  • Case study: Clinical agreement negotiations in China and/or across ASEAN

 

Exercise: Clinical Trial Budgets – Development, Compliance & Negotiation

  • Introduction to clinical trial budgets
  • Regulation / Applicable Law / Best practices. GCP guidelines
  • Structure of Clinical Budgets
  • Compliance in clinical budgets: concept of improper payments
  • Risk mitigation and mitigation strategies
  • Development of clinical budgets

 

Regulatory Frameworks and Key Obligations On Commercial Contracts

  • GCP
  • CMP
  • Applicable Law
  • International instruments and declarations

 

Workshop: Negotiation Processes and Skills

How are big Pharmas and CROs structuring globally. The negotiation in the Start-up Phase. Budget development & negotiations

  • Clinical Contract and Budget negotiation mechanisms and processes
  • Negotiation strategies
  • Technical and commercial skills

 

Key Considerations on Contractual Governance during Covid-19

  • Mitigation and pre-emptive strategies to overcome COVID Era
  • Risk analysis and key considerations

 

Negotiating a Balanced License

  • Establishing intended outcomes
    • Performance obligations
    • Financial terms
    • Dispute resolutions
  • Relative bargaining positions
  • Identifying points of conflict and points of agreement
  • Win-win vs positional negotiation
  • Seven strategies of effective negotiations
  • Specific issues relating to negotiating an IP licence

 

Commercial Disputes in Pharma

  • Arbitration
    • Co-marketing/co-promotion performance
    • Use of IP under licensing agreements
    • Royalty payment claims
  • Governance and dispute resolution

when & where

29 Sep - 02 Oct 2020

4-Day Live Online
1:30 pm – 5:00 pm (SGT)

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

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