| Item 1.01. | Entry into a Material Definitive Agreement |
On December 20, 2019, Fulcrum Therapeutics, Inc. (the “Company”) entered into a collaboration and license agreement (the “Agreement”) with Acceleron Pharma Inc. (“Acceleron”) pursuant to which the Company granted Acceleron an exclusive worldwide license under certain intellectual property rights to make, have made, use, sell, have sold, import, export, distribute and have distributed, market, have marketed, promote, have promoted, or otherwise exploit molecules and products directed against or expressing certain biological targets identified by the Company for the treatment, prophylaxis, or diagnosis of a targeted indication within the pulmonary disease space (the “Indication”).
Pursuant to a mutually agreed research plan, the Company will perform assay screening and related research activities to identify and validate potential gene targets for further research, development, manufacture and commercialization by Acceleron. Upon completion of the research activities, the Company will deliver a data package to Acceleron with respect to the gene targets identified by the Company in the conduct of the research activities for the treatment, prophylaxis, or diagnosis of the Indication. Within a designated period of receipt of the data package, Acceleron will have the right to designate a specified number of the biological targets identified by the Company for Acceleron’s research, development, manufacture and commercialization of products or molecules directed to such targets for the treatment, prophylaxis, or diagnosis of any disease (the “Targets”). If Acceleron does not designate any Targets during the designated period, then the Agreement will automatically terminate. If Acceleron designates one or more Targets, then Acceleron will be obligated to use commercially reasonable efforts to seek regulatory approval for one product directed to a Target in certain specified countries. Upon receipt of regulatory approval for any product directed to a Target, Acceleron must use commercially reasonable efforts to commercialize such product in certain specified countries.
While the Company is performing the research activities pursuant to the research plan and for a specified period thereafter, the Company may not research, develop, manufacture, commercialize, use, or otherwise exploit any compound or product for the treatment, prophylaxis, or diagnosis of the Indication other than for Acceleron. While the Company is performing the research activities pursuant to the research plan and for a specified period thereafter, other than for Acceleron, the Company may not research, develop, manufacture, commercialize, use, or otherwise exploit any compound or product for the treatment, prophylaxis, or diagnosis of the Indication that is directed against certain specified biological targets identified by the Company in the performance of the research activities.
Acceleron may also request that the Company perform medicinal chemistry services related to the generation and optimization of molecules directed against or expressing biological targets for the treatment, prophylaxis, or diagnosis of the Indication beyond the scope of the research plan. If the Company agrees to provide such medicinal chemistry services, the Company and Acceleron will negotiate to determine the scope, timeline and budget for such medicinal chemistry services.
Under the Agreement, Acceleron will make a $10.0 million upfront payment to the Company within fifteen days of signing the Agreement. The Company will be entitled to research milestone payments of up to $18.5 million in the aggregate upon achievement of specified research milestones. Additionally, the Company will be entitled to development milestone payments of up to $135.0 million in the aggregate upon the first achievement of specified clinical and regulatory milestones by a product directed to a Target, and up to $67.5 million in the aggregate upon the second achievement of specified clinical and regulatory milestones by a product directed to a Target. The Company will also be entitled to sales milestone payments of up to $145.0 million in the aggregate upon the achievement ofone-time aggregate annual worldwide net sales milestones for the first product directed to a Target to achieve such milestones, and up to $72.5 million in the aggregate upon the achievement ofone-time aggregate annual worldwide net sales milestones for the second product directed to a Target to achieve such milestones. Acceleron will also pay the Company tiered royalties ranging from a mid single-digit percentage to a low double-digit percentage based on Acceleron’s, and any of its affiliates’ and sublicensees’, annual worldwide net sales of products directed to any Target. The royalties are payable on aproduct-by-product basis during a specified royalty term, and may be reduced in specified circumstances.
The Agreement continues on acountry-by-country andTarget-by-Target basis until the last to expire royalty term for a product directed to such Target, at which time the Agreement expires with respect to such Target in such country. Either party has the right to terminate the Agreement if the other party has materially breached in the performance of its obligations under the Agreement and such breach has not been cured within the applicable cure period. Acceleron also has the right to terminate the Agreement for convenience in its entirety or on aTarget-by-Target andmolecule-by-molecule basis with respect to any molecule directed against a Target.
The foregoing description of the terms of the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy of which the Company intends to file with the Securities and Exchange Commission (the “SEC”) as an exhibit to the Company’s Annual Report on Form10-K for the year ending December 31, 2019.
