Item 1.01. Entry Into a Material Definitive Agreement.
On January 6, 2018, Alnylam Pharmaceuticals, Inc. (the Company) and Genzyme Corporation (Genzyme) entered into Amendment
No. 2 (the Collaboration Amendment) to the Master Collaboration Agreement dated as of January 11, 2014 (the Original Collaboration Agreement), as amended by Amendment No. 1 to the Master Collaboration Agreement
dated July 1, 2015 (Amendment No. 1) (the Original Collaboration Agreement, together with Amendment No. 1 and including the License Terms appended to the Original Collaboration Agreement, the Master Agreement).
In connection and simultaneously with entering into the Collaboration Amendment, the Company and Genzyme also entered into the
ALN-AT3
Global License Terms with respect to
ALN-AT3
(fitusiran) and any
back-up
products (the AT3 License Terms) and an Exclusive License Agreement with respect to all TTR products, including
ALN-TTR02
(patisiran),
ALN-TTRsc02
(a subcutaneously administered investigational RNAi therapeutic in clinical development) and any
back-up
products (the Exclusive TTR License).
The Collaboration Amendment, together with the AT3
License Terms and the Exclusive TTR License, revise the terms and conditions of the Master Agreement to (i) provide the Company the exclusive right to pursue the further global development and commercialization of all TTR products, including
ALN-TTR02
(patisiran),
ALN-TTRsc02
and any
back-up
products, (ii) provide Genzyme the exclusive right to pursue the further global
development and commercialization of
ALN-AT3
(fitusiran) and any
back-up
products and (iii) terminate the previous
co-development
and
co-commercialization
rights related to ALN-TTRsc,
ALN-TTRsc02
and
ALN-AT3
(fitusiran) under the Master Agreement. Going forward, the Company will fund all development and commercialization costs for
ALN-TTR02
(patisiran) and
ALN-TTRsc02.
The Company also will fund development and commercialization costs for
ALN-AT3
(fitusiran) through the transition period, up to a specified cap, after which
Genzyme will fund all development and commercialization costs for
ALN-AT3
(fitusiran). Each party will be responsible for its costs associated with the transfer of the respective program to the other party.
In consideration for the rights granted to Genzyme under the Collaboration Amendment and the AT3 License Terms, Genzyme is required to make one milestone
payment of $50.0 million following the dosing of the first patient in the ATLAS Phase 3 program for
ALN-AT3
(fitusiran). In addition, the Company will be eligible to receive tiered royalties of fifteen to
thirty percent based on global annual net sales of
ALN-AT3
(fitusiran) and up to fifteen percent based on global annual net sales of
back-up
products, in each case by
Genzyme, its affiliates and its sublicensees. Under the Collaboration Amendment and the Exclusive TTR License, Genzyme will be eligible to receive (i) royalties up to twenty-five percent, increasing over time, based on annual net sales of
ALN-TTR02
(patisiran) in territories excluding the United States, Canada and western Europe, provided royalties on annual net sales of
ALN-TTR02
in Japan will be twenty-five
percent beginning as of the effective date of the Exclusive TTR License, (ii) tiered royalties of fifteen to thirty percent based on global annual net sales of
ALN-TTRsc02
(consistent with the royalties
due to the Company from Genzyme on
ALN-AT3
(fitusiran)), and (iii) tiered royalties of up to fifteen percent based on global annual net sales of
back-up
products,
in each case by the Company, its affiliates and its sublicensees. Except as described above, there will be no additional milestones due to either party with respect to
ALN-AT3
(fitusiran),
ALN-TTR02
(patisiran) or
ALN-TTRsc02.
Genzyme continues to have the right to
opt into the Companys other rare genetic disease programs for development and commercialization in territories outside of the United States, Canada, and Western Europe, as well as one right to a global license.
The transaction is subject to customary closing conditions and clearances, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
The foregoing description of the Collaboration Amendment, the AT3 License Terms and the Exclusive TTR License does not purport to be complete and is qualified
in its entirety by reference to the Collaboration Amendment, the AT3 License Terms and the Exclusive TTR License, copies of which the Company expects to file as exhibits to its Quarterly Report on Form
10-Q
for the quarter ended March 31, 2018.