Item 1.01 Entry into a Material Definitive Agreement.
Amended and Restated Collaboration Agreement
On March 12, 2019, Scholar Rock, Inc., a wholly-owned subsidiary
of Scholar Rock Holding Corporation (“
we
,” “
our
,” “
us
”) and Adimab, LLC
(“
Adimab
”) entered into an amended and restated collaboration agreement (the “
Adimab Agreement
”),
which amended and restated the collaboration agreement with Adimab dated November 11, 2016 (the “
Original Adimab Agreement
”).
The Adimab Agreement, among other things, clarifies certain terms of the Original Adimab Agreement and expands our right to collaborate
with Adimab on research programs for the discovery and/or optimization of antibodies against additional biological targets of our
choice (each such research program, a “
Research Program
”). SRK-181, one of our product candidates, is subject
to the terms of the Adimab Agreement, and upon entering into the Adimab Agreement, we exercised our Development and Commercialization
Option (as defined below) to the Research Program from which SRK-181 was generated.
Under the Adimab Agreement, we selected a number of biological targets
against which Adimab used its proprietary platform technology to discover and/or optimize antibodies based upon mutually agreed
upon research plans, and we have the ability to select a specified number of additional biological targets against which Adimab
will provide additional antibody discovery and optimization services.
During the research term and evaluation term for each Research Program,
we have a non-exclusive, sublicenseable (solely to certain service providers and collaborators as specified in the Adimab Agreement),
worldwide license under Adimab’s technology with respect to the target, to perform certain research activities and to evaluate
the program antibodies to determine whether we want to exercise our option to obtain an exclusive license to exploit such antibodies.
We are required to pay Adimab at an agreed upon rate for its full-time employees during the research term while Adimab performs
research on each target under the applicable research plan.
On a Research Program-by-Research Program basis, Adimab granted
us an exclusive option to obtain a worldwide, royalty-free, fully paid-up, non-exclusive, sublicensable (through multiple tiers)
license under Adimab’s technology to research, develop, make and exploit up to a specified number of antibodies generated
under a given Research Program (each, a “
Development and Commercialization Option
”). Upon the exercise of a
Development and Commercialization Option, and payment of the applicable option fee to Adimab, Adimab will assign us the patents
that cover the antibodies selected by exercise of such Development and Commercialization Option. We will be required to use commercially
reasonable efforts to develop and commercialize a program antibody for such Research Program, subject to certain specifications.
Upon executing the Adimab Agreement, we also exercised our Development and Commercialization Option for one of the Research Programs.
Pursuant to the Adimab Agreement, we paid Adimab a one-time, non-creditable,
non-refundable technology access fee. We are also obligated to make certain technical milestone payments to Adimab on a Research
Program-by-Research Program basis. Upon exercise of a Development and Commercialization Option, we are obligated to pay to Adimab
a non-creditable, nonrefundable option exercise fee of either (i) a low seven-digit dollar amount or (ii) a mid six-digit dollar
amount, based on the antibodies in the given Research Program, plus, in either case, an amount equal to any technical milestone
payment which was not previously paid with respect to such Research Program and less, in either case, any option extension fees
paid with respect to such Research Program. On a Product (as defined in the Adimab Agreement)-by-Product basis, we will pay Adimab
upon the achievement of various clinical and regulatory milestone events with total milestone payments not to exceed mid-teen millions
in the aggregate for a given Product. We may also be subject to catch-up payments if we abandon a Product prior to reaching a milestone,
but later create a similar backup Product that achieves unmet milestones. For any Product that is commercialized, on a country-by-country
and Product-by-Product basis, we are obligated to pay to Adimab a low-to-mid single-digit percentage of annual worldwide net sales
of such Product during the applicable royalty period in each country.
The Adimab Agreement will remain in effect until the later of (a)
in the event that no Development and Commercialization Option is exercised, upon the conclusion of the last-to-expire evaluation
term; or (b) in the event that a Development and Commercialization Option is exercised, on a country-by-country and Product-by-Product
basis on the expiration of the last royalty term for a Product in the particular country. Either party may terminate the Adimab
Agreement for material breach if such breach remains uncured for a specified period of time. We may also terminate the Adimab Agreement
for any reason with prior notice to Adimab.