8-KMaterial Agreements

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jul 10, 2015)

Filed July 10, 2015For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) announced on July 10, 2015, the execution of an Amended and Restated Development and Manufacturing Services Agreement with Agilent Technologies, Inc. This updated agreement, originally established in 2007, solidifies Agilent's role in manufacturing and supplying a specified percentage of the active pharmaceutical ingredients (APIs) for certain of Alnylam's clinical development products and potentially other future products. The agreement outlines a framework for Alnylam to provide rolling forecasts, with a portion designated as firm, binding orders, ensuring Agilent reserves manufacturing capacity. Pricing for these APIs will be determined per statement of work, with fixed prices for firm orders and caps on increases for non-binding portions. This arrangement provides Alnylam with a committed manufacturing partner for its pipeline, crucial for advancing its RNAi therapeutics. The initial term is four years, with automatic two-year renewals, and includes provisions for termination under specific circumstances, change of control events, and breach of contract.

Key Highlights

  • 1Alnylam Pharmaceuticals (ALNY) amended and restated its Development and Manufacturing Services Agreement with Agilent Technologies.
  • 2Agilent will manufacture and supply a specified percentage of active pharmaceutical ingredients (APIs) for Alnylam's clinical development products.
  • 3The agreement covers current products in development and potentially future products.
  • 4Alnylam will provide rolling forecasts with firm order commitments, ensuring manufacturing capacity.
  • 5Pricing terms include fixed prices for firm orders and capped increases for forecast volumes.
  • 6The agreement has an initial term of four years, with automatic two-year renewal periods.
  • 7Termination clauses exist for reasons such as material breach, change of control of Agilent, and failure to maintain regulatory approvals.

Frequently Asked Questions

The primary purpose of the amended and restated agreement is to secure Agilent's commitment to manufacture and supply a specified percentage of Alnylam's active pharmaceutical ingredients (APIs) for its products currently in clinical development and potentially for future products. This ensures a reliable supply chain for Alnylam's pipeline.

Alnylam will provide rolling forecasts of its product needs to Agilent. A portion of these forecasts will be designated as firm, binding orders, obligating Agilent to reserve sufficient manufacturing capacity. This structure allows for flexibility while ensuring that critical supply needs are met.

Pricing for the APIs will be determined on a per-statement-of-work basis. Importantly, the price for the firm order portion of Alnylam's forecasted demand will be fixed. Increases for the non-binding portion of the forecast are subject to certain caps, and Agilent will adjust prices based on documented changes in raw material costs, also subject to a cap.

The agreement has an initial term of four years and is subject to automatic two-year renewal periods unless terminated earlier. Either party can terminate the agreement for customary reasons like material breach or bankruptcy. Alnylam also has specific termination rights related to a change of control at Agilent or Agilent's failure to maintain necessary licenses or approvals.