Item 1.01 Entry into a Material Definitive Agreement.
License and Supply Agreement
On January 6, 2023, Rani Therapeutics, LLC, an operating subsidiary of Rani
Therapeutics Holdings, Inc. ("Rani"), and Celltrion, Inc. ("Celltrion") entered
into a License and Supply Agreement (the "License Agreement"). Under the License
Agreement, Celltrion grants Rani an exclusive, worldwide, royalty-free license
to certain intellectual property to make, use, sell, offer for sale, import and
otherwise exploit an orally-administered therapeutic product using Rani's oral
delivery technology and Celltrion's ustekinumab biosimilar ("Product") and to
use certain information to support the manufacture, development and
commercialization of Product. Celltrion will provide, and Rani will purchase,
supply of ustekinumab biosimilar at supply prices set forth in the License
Agreement. In accordance with the License Agreement, Rani will obtain
ustekiunmab biosimilar exclusively from Celltrion for the manufacture,
development and commercialization of Product, except that Rani has the right to
obtain supply from alternative sources under certain circumstances where
Celltrion experiences supply disruption.
Rani has sole right to manufacture, develop and commercialize Product worldwide,
subject to an exclusive right of first negotiation ("ROFN") granted to
Celltrion. Following delivery from Rani to Celltrion of a data package
consisting of topline safety information, pharmacokinetic results and device
performance, and the raw data related to topline results from a phase 1 clinical
trial of Product that meets its primary endpoints ("Data Package"), Celltrion
will have thirty (30) days to exercise its ROFN. If Celltrion timely exercises
the ROFN, then Celltrion will have an exclusive period of ninety (90) days to
negotiate in good faith a definitive agreement with Rani for rights to
clinically develop and commercialize Product in territories selected by
Celltrion. In the event Celltrion does not timely exercise the ROFN or Celltrion
notifies Rani that it does not intend to exercise the ROFN or, after timely
exercising the ROFN, notifies Rani that Celltrion withdraws its exercise of the
ROFN, or the parties fail to enter into a definitive agreement for the
development and commercialization of Product within the exclusive negotiation
period, then the ROFN will terminate and Rani will have no further obligations
under the License Agreement related to a ROFN. The License Agreement allocates
rights between the parties with respect to inventions generated in performance
of the License Agreement for the manufacture, development and commercialization
of Product. Rani will own all data related to the research, development,
manufacture, regulatory activities and commercialization of Product conducted by
Rani hereunder.
The License Agreement contains customary representations, warranties and
covenants, and mutual indemnification provisions. Under the License Agreement,
Rani has a right to terminate for convenience subject to certain notice periods,
and subject to certain conditions if terminated prior to completion of a phase 1
trial. Celltrion has a right to terminate if Rani does not achieve certain
development milestones, and each party has certain rights to terminate for
material breach or safety concerns regarding the ustekinumab biosimilar or
Product.
The description of the License Agreement contained herein does not purport to be
complete and is qualified in its entirety by reference to the complete text of
the License Agreement, a copy of which will be filed as an exhibit to the
Company's Annual Report on Form 10-K for the year ended December 31, 2022.
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