This new program offers an overview of the basic structure and key considerations in drafting, negotiating, and managing manufacturing and supply agreements. As with all commercial contracts, success in the business relationship turns on having a solid understanding of the client’s industry, product, long-term goals, sensitivities, and requirements. Identifying and navigating the elements that are most critical to the client, and the efficiency of its supply chain, are necessities for lawyers drafting and negotiating these agreements.
Course Content
2:00 - 2:10 pmWelcome and Introduction
Hannah H. England, Esq.,
Ropes & Gray LLP, Boston
Michelle B. Limaj, Esq.,
Ardelyx, Inc., Waltham
2:10 - 2:25 pm
Evolution of a Life Sciences Company Supply Chain
Development stage: Process development, validation, and IP ownership
Commercial supply: Predictability of quality, pricing, and delivery
Hannah H. England, Esq.,
Ropes & Gray LLP, Boston
Michelle B. Limaj, Esq.,
Ardelyx, Inc., Waltham
2:25 - 3:05 pm
Supply Chain for Life Sciences Companies: Strategic Perspective
Why a new product may be boxed into an inefficient supply chain
Upstream: Global supply chain considerations
Michelle B. Limaj, Esq.,
Ardelyx, Inc., Waltham
3:05 - 3:15 pm
Break
3:15 - 3:35 pm
Supply Chain for Life Sciences Companies: Downstream: Licensees
Managing against diverse product demands
Keeping the keys to the castle (API / trade secrets)
Leveraging licensees to negotiate supply arrangements
Hannah H. England, Esq.,
Ropes & Gray LLP, Boston
3:35 - 4:20 pm
Supply Chain for Life Sciences Companies: Key Commercial Supply Terms: Understanding the Deal from All Sides
What do the parties want? (Core needs, sensitivities, and strengths)
Basics: Forecasting; cancellation; INCOTERMS; warranties
High sensitivity topics: Annual minimums; product claims; indemnification
Sticking the landing: Termination; bankruptcy; assignment
Intellectual property protection
Hannah H. England, Esq.,
Ropes & Gray LLP, Boston
Michelle B. Limaj, Esq.,
Ardelyx, Inc., Waltham
Please Note
This webcast is delivered completely online, underscoring their convenience and appeal.
There are no published print materials. All written materials are available electronically only.
They are posted 24 hours prior to the program and can be accessed, downloaded, or printed from your computer.
Speakers
ChairMichelle B. Limaj, Esq.,
Ardelyx, Inc., Waltham
Faculty
Hannah H. England, Esq.,
Ropes & Gray LLP, Boston
