| Item 1.01 | Entry into a Material Definitive Agreement. |
On July 21, 2023 (the “Effective Date”), Alnylam Pharmaceuticals, Inc. (the “Company”), entered into a Collaboration and License Agreement (the “Agreement”) with F. Hoffmann-La Roche Ltd. (“Roche Basel”) and Genentech, Inc. (“Genentech,” each of Roche Basel and Genentech, individually and collectively, “Roche”), pursuant to which the Company and Roche established a worldwide, strategic collaboration for the joint development of pharmaceutical products containing zilebesiran, the Company’s proprietary siRNA therapeutic targeting liver-expressed angiotensinogen or AGT01-RVR (“Licensed Products”). Under the Agreement, the Company granted to Roche (i) co-exclusive rights to develop and commercialize Licensed Products in the United States (the “Shared Territory”) and (ii) exclusive rights to develop and commercialize Licensed Products outside the United States (the “Roche Territory”).
Under the Agreement, Roche will make an upfront payment of $310 million to the Company. In addition, the Company will be eligible to receive up to $2.5 billion in contingent payments based on the achievement of specified development, regulatory and sales-based milestones.
The Company and Roche will conduct development of Licensed Products in the Shared Territory and Roche Territory in accordance with a global development plan. The Company will have primary responsibility for the day-to-day operational activities with respect to (i) those clinical trials included in the global development plan as of the Effective Date and (ii) development of Licensed Products for use in the treatment of hypertension. Subject to the foregoing, Roche will be responsible for any development activities conducted primarily to support regulatory approval of Licensed Products in the Roche Territory. Each party is required to use commercially reasonable efforts to carry out the tasks assigned to it under the global development plan.
The Company will be responsible for forty percent (40%) and Roche will be responsible for the remaining sixty percent (60%) of development costs incurred in the conduct of development activities that support regulatory approval of Licensed Products in both the Shared Territory and the Roche Territory. To the extent development activities are conducted primarily to support the regulatory approval of Licensed Products in the Shared Territory or Roche Territory, Roche will be solely responsible for all costs incurred primarily to support regulatory approval in the Roche Territory and the parties will share equally (50/50) all costs incurred primarily to support regulatory approval in the Shared Territory. Notwithstanding the foregoing, the Company will remain solely responsible for costs incurred in connection with the conduct of clinical trials for Licensed Products ongoing as of the Effective Date.
If development is successful and regulatory approval is granted by applicable regulatory authorities for a Licensed Product, the Company will hold marketing authorizations for such Licensed Product in the Shared Territory and Roche will hold marketing authorizations for such Licensed Product in the Roche Territory. Upon receipt of any such regulatory approval, as applicable, the parties must use commercially reasonable efforts to commercialize such Licensed Product in the Shared Territory and Roche must use commercially reasonable efforts to commercialize such Licensed Product in certain major market countries in the Roche Territory.
Roche will be solely responsible for costs incurred in connection with commercialization of Licensed Products in the Roche Territory and will pay the Company tiered, low double digit royalties based on net sales of Licensed Products on a Licensed Product-by-Licensed Product and country-by-country basis in the Roche Territory during the royalty term. The parties will share equally (50/50) profits and losses (including commercialization costs) of Licensed Products in the Shared Territory.
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