Product Description

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. 

Agenda & Materials

• 2:00 - 2:10 pm

  Welcome and Introduction

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  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

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  • 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

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  • 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

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  • 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

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  • 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

MCLE on demand programs are delivered completely online, underscoring their convenience and appeal. There are no published print materials. All written materials are available electronically only through a link included on the on demand program page.

Chair

Faculty