UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
Collaboration Agreement
On June 17, 2024, Rani Therapeutics, LLC, an operating subsidiary of Rani Therapeutics Holdings, Inc. (“Rani”), and ProGen Co., Ltd. (“ProGen”) entered into a Collaboration Agreement (the “Collaboration Agreement”). Under the Collaboration Agreement, Rani and ProGen will collaborate to manufacture, develop, seek regulatory approvals for and, if approved, commercialize a product (the “Product”) combining ProGen’s GLP-1/GLP-2 dual agonist compound, PG-102, and the RaniPill HC oral delivery device (the “Device”) in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans (the “Collaboration”).
In accordance with a development plan approved by both Rani and ProGen, the parties will share responsibility for the development of the Product for weight management worldwide, with Rani leading such development for preclinical activities through Phase 1 clinical trials. After initiation of the first Phase 2 clinical trial of the Product, Rani will lead development of the Product in the United States, Canada, Europe (including the United Kingdom) and Australia and ProGen will lead development in all other countries. Rani and ProGen will prioritize seeking regulatory approvals for and, if approved, commercializing the Product in the United States, the European Union, the United Kingdom, Canada, Australia, Japan and South Korea. Rani and ProGen each hold the exclusive right to commercialize and sublicense the Product in their assigned territories.
Unless otherwise determined by the Collaboration Agreement, ProGen will be solely responsible for manufacturing and supplying PG-102 for all development and commercialization of the Product worldwide, and Rani shall be solely responsible for manufacturing and supplying the Product (the Device, and incorporating PG-102 into the Device) for all development and commercialization of the Product worldwide. Development costs, as well as operating profits and losses from the commercialization of the Product, will be equally shared by Rani and ProGen.
Under the Collaboration Agreement, Rani and ProGen each granted to the other party an exclusive right and license (except with respect to the other party’s affiliates and sublicensees) to certain intellectual property to develop the Product for weight management and an exclusive right and license to seek regulatory approval for, and to use, sell, offer to sell, import and commercialize the Product in their assigned territories.
Each party has the right to opt-out of the Collaboration (“Opt-Out”) at any time upon prior written notice to the other party. Following an Opt-Out, the continuing party shall have sole right to develop, conduct regulatory activities for and commercialize the Product on a worldwide basis. The Opt-Out party shall share all development costs and operating profit (or loss) through the effective date of the Opt-Out, and all costs to complete the conduct of any clinical trials of Product that have been initiated prior to delivery of the Opt-Out notice, even if the costs are incurred or the trials are completed after the effective date of the Opt-Out. The continuing party shall pay to the Opt-Out party low single to mid-single digit royalties on net sales of the Product made after the Opt-Out date depending on when the Opt-Out occurs.
The Collaboration Agreement contains customary representations, warranties and covenants, and mutual indemnification provisions. Under the Collaboration Agreement, the parties have certain rights to terminate for material breach, insolvency or safety concerns regarding the Product.
The description of the Collaboration Agreement contained herein does not purport to be complete and is qualified in its entirety by reference to the complete text of the Collaboration Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
| Item 8.01 | Other Events. |
The Company is making available a copy of a presentation (the “Presentation”) that the Company intends to use during a conference call and webcast scheduled to be held at 5 am Pacific Time on June 24, 2024 related to the Collaboration Agreement. A copy of the Presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Exhibit Description | |
| 99.1 | Presentation dated June 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: June 24, 2024 | Rani Therapeutics Holdings, Inc. | |||||
| By: | /s/ Svai Sanford | |||||
| Svai Sanford | ||||||
| Chief Financial Officer | ||||||