Summary
Alnylam Pharmaceuticals, Inc. (ALNY) announced a material definitive agreement with Agilent Technologies, Inc. (Agilent) for the commercial supply of patisiran drug substance. This Manufacturing Services Agreement, effective March 28, 2018, solidifies Agilent's role in providing a specified percentage of the active pharmaceutical ingredients required for patisiran, a key product for Alnylam. The agreement includes provisions for rolling forecasts, firm orders, and Agilent's commitment to reserving sufficient manufacturing capacity, which is crucial for ensuring commercial supply continuity and meeting anticipated demand.
Key Highlights
- 1Alnylam Pharmaceuticals entered into a Manufacturing Services Agreement with Agilent Technologies for the commercial supply of patisiran drug substance.
- 2The agreement covers the manufacture and supply of a specified percentage of patisiran's active pharmaceutical ingredients for commercial sale.
- 3Alnylam will provide quarterly forecasts, with a portion converted into binding firm orders, ensuring demand fulfillment.
- 4Agilent is obligated to reserve adequate manufacturing capacity, including labor, materials, and equipment, to meet committed supply levels.
- 5The agreement has an initial term of five years with provisions for automatic two-year renewals.
- 6Termination clauses are included, allowing Alnylam to exit the agreement under specific conditions, including the product not being commercially viable.
- 7The agreement incorporates standard provisions for Good Manufacturing Practices, regulatory cooperation, indemnification, confidentiality, and dispute resolution.
Frequently Asked Questions
The agreement's primary purpose is to establish Agilent Technologies as a commercial supplier of patisiran drug substance, ensuring Alnylam Pharmaceuticals has a dedicated partner for the manufacturing of its active pharmaceutical ingredients needed for commercial sales of patisiran.
Alnylam is obligated to provide rolling quarterly forecasts for patisiran, a portion of which will become binding firm orders. The company must also make an initial payment for raw materials and resource reservation, and pay for batches upon acceptance.
The agreement has an initial term of five years and is subject to automatic renewal for subsequent two-year periods, unless terminated by either party.
Alnylam can terminate the agreement with 60 days' notice if Agilent is unable to perform services as agreed, fails to maintain material licenses, or materially breaches obligations (subject to cure rights). Additionally, Alnylam can terminate with 30 days' notice if it determines patisiran is not commercially viable.