BIOSENIC and its subsidiary Medsenic SAS, announced the signature of a binding term sheet with Phebra PTY Ltd. related to the adaptation of the License Agreement and the MDA signed in May 2021. The initial License Agreement provided a commercialization agreement of 100% net profits for Medsenic SAS mainly in Europe and 55 % net sales profit for Phebra PTY Ltd. in the rest of the world (including major markets such as the US, Canada, South America, Japan, South East Asia, China and Australia). In particular, the binding term sheet for the indication chronic Graft versus Host Disease (cGvHD) license now provides for a royalty payment of 2% on worldwide sales, which simplifies the conditions for offering sublicenses to new external partners.

In addition, under the license agreement, Phebra PTY Ltd. agrees that Medsenic SAS will have exclusive worldwide territorial rights for the use of OATO in GvHD. Regarding the MDA, Phebra PTY Ltd. agrees that the net profit allocation as stated in the initial MDA will be deleted for the sales revenues and profits generated from the sale of product, restricted to the indication cGvHD. Phebra PTY Ltd. also agrees to cover the costs of maintaining and updating the drug substance file to comply with the rules of all active territories; of controlling the compliance with various regulators on ongoing supplier approval and compliance to Good Manufacturing Practices (GMP) requirements; of updating the drug master file of OATO; of managing the Contract Manufacturing Organization (CMO) and supply chain from the active pharmaceutical ingredient to the clinical release of the product and of covering the regulatory and quality and GMP expenses.

To take into account these costs for Phebra PTY Ltd., the cost-of-goods for the Medsenic final clinical OATO product will be increased by a mark-up of 20%. In addition, Medsenic will have the right to establish an Australian entity to use the OATO patents for cGvHD indication. The Australian entity will not commercially compete with Phebra PTY Ltd., particularly in the field of APL (acute promyelocytic leukemia) cancer treatment, by having Medsenic's GvHD treatment produced in product-specific packaging.