| Item 1.01 | Entry into a Material Definitive Agreement. |
Research Collaboration and License Agreement
On October 19, 2022, Hookipa Biotech GmbH (“HOOKIPA GmbH”),
a wholly-owned subsidiary of HOOKIPA Pharma Inc. (together with HOOKIPA GmbH, the “Company”), F. Hoffmann-La Roche Ltd (“Roche
Basel”) and Hoffmann-La Roche Inc. (“Roche US”, and together with Roche Basel, “Roche”) entered into a Research
Collaboration and License Agreement (the “Collaboration Agreement”). The Collaboration Agreement was entered into to (i) grant
Roche an exclusive license to research, develop, manufacture and commercialize the Company’s pre-clinical HB-700 cancer program
(“HB-700 Program”), an arenaviral immunotherapeutic for KRAS-mutated cancers, and (ii) grant Roche an exclusive option right
to exclusively license for research, development manufacturing and commercialization, a second, novel arenaviral immunotherapeutic program
targeting undisclosed cancer antigens (collectively “UCAs”), which the parties will determine and align upon the specific
UCAs and combinations thereof to be included in such program (“UCA Program”, and each of the HB-700 Program and UCA Program,
a “Program”).
Governance
The development of the programs governed by
the Collaboration Agreement is overseen by a six-member joint research committee (“JRC”), comprised of three representatives
from each of the Company and Roche. The JRC will oversee the activities carried out pursuant to the Collaboration Agreement.
Development and Commercialization of
HB-700 Program
Under the Collaboration Agreement, the Company is responsible for pre-clinical
research, development, manufacturing and supply activities and early clinical development for the HB-700 Program pursuant to the “HB-700
Collaboration Plan” (as defined in the Collaboration Agreement). In addition to the upfront payment, Roche shall pay event-based
milestone payments related to achievement of manufacturing and Investigational New Drug (“IND”)-related events for the HB-700
Program. The clinical trial costs through Phase 1b will be shared equally between the Company and Roche.
Based on the data and a final report of the Phase 1b clinical trial
to be delivered by the Company, Roche may elect to progress the development of the HB-700 Program and assume responsibility and cost for
all further research, development, manufacturing, supply and commercialization activities of the HB-700 Programs.
Roche also has the option to elect to progress the development of the
HB-700 Program prior to the completion of the Phase 1b trial.
Option Right to License UCA Program
Under the Collaboration Agreement, the Company is responsible to perform
research activities relating to the selection of a UCA Program. The Company will deliver a specified package of preclinical data and results
with respect to the UCA Program. Roche may exercise an exclusive option to license the UCA Program and to extend the collaboration of
the parties in relation to the UCA Program through the completion of a first in human trial (the “Option”). Roche shall pay
event-based milestone payments related to the achievement of manufacturing and IND-related events for the UCA Program. If the Option is
not exercised by Roche, the Collaboration Agreement shall be deemed terminated with respect to the UCA Program.
Financial Terms
Under the terms of the Collaboration
Agreement, the Company is entitled to a non-refundable upfront payment of $25 million and an additional $15 million payment if the
Option for the UCA Program is exercised. The Company is also eligible for event-based milestone payments of up to an aggregate of
$335 million during the research and development phase of the HB-700 Program for up to four oncology
indications and up to an aggregate of $250 million in payments related to the achievement of sales-based milestones. For the
additional UCA Program, subject to Option-exercise, the Company is eligible for up to an aggregate of $173 million in event-based
milestone payments during research and development for up to four oncology indications as well as up to an aggregate of $160 million
in sales-based milestones. Upon commercialization, the Company is eligible to receive tiered royalties of a high single-digit to
mid-teens percentage on the worldwide net sales of HB-700 and, subject to Option exercise, the UCA Program. The royalty payments are
subject to reduction under specified conditions set forth in the Collaboration Agreement. In aggregate, the Company is eligible to
receive up to approximately $930 million in potential future success-based milestone payment in addition to the $25 million in
upfront cash and tiered royalties.
Either party may terminate
for the uncured breach of the other party and upon the other party filing for bankruptcy, reorganization, liquidation, or receivership
proceedings. On a program-by-program basis, at any time after the expiration or termination of the collaboration term for such program,
Roche may terminate the Collaboration Agreement with respect to such program or on a product-by-product or a country-by-country basis
upon prior written notice. If the Collaboration Agreement is not otherwise terminated prior to the expiration of the last to expire royalty
term, upon such expiration the license granted to Roche will continue in effect, but will be fully paid-up, royalty free, perpetual, and
irrevocable.
The foregoing is only
a summary of the terms of the Collaboration Agreement and the transactions contemplated thereby, does not purport to be a complete description
of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the Collaboration Agreement,
a copy of which is filed as Exhibit 10.1 hereto and incorporated by reference herein.