Cipla Technologies a subsidiary of Cipla and Pulmatrix had inked a definitive agreement for the co-development and commercialisation of Pulmazole.
Pulmatrix announced that it has completed an amendment to Pulmatrix's agreement with Cipla for the development and commercialization of Pulmazole. The completion of the amendment resolves Pulmatrix's previously disclosed dispute with Cipla regarding the continued funding of the development costs for Pulmazole.
Cipla Technologies a subsidiary of Cipla and Pulmatrix had inked a definitive agreement for the co-development and commercialisation of Pulmazole.
As part of the agreement Cipla will continue to reimburse Pulmatrix for 50% of all third-party costs for the development of Pulmazole, provided Cipla will only be required to reimburse Pulmatrix for 40% of Pulmatrix dedicated personnel and consulting costs ("direct costs"). Upon the timely achievement of certain development milestones, Cipla will reimburse another 10% of Pulmatrix's "direct costs". The development milestones for Pulmatrix's planned Phase 2b clinical trial include the dosing of 25% of participants in the clinical trial by June 30, 2023, and the delivery of top-line data results to the joint steering committee for the program by June 30, 2024.
If the development milestones are not achieved within 9-months of such dates either party may terminate its obligation to fund its share of development costs. Pulmatrix also granted Cipla exclusive rights to the development and commercialization of Pulmazole in the India, Nepal, Yemen, Iran, South Africa, Sri Lanka, Myanmar and Algeria in exchange for, under certain circumstances, 2% royalties on net sales of Pulmazole.
"We are pleased to have come to this resolution which will enable the continued development of Pulmazole globally with our valued partners at Cipla," said Ted Raad, Chief Executive Officer of Pulmatrix. "After a successful Type C Meeting with the FDA, we are now ready to resume clinical activities with Pulmazole which has the potential to address the underlying cause of ABPA while avoiding the side effects of oral antifungals and prolonged steroid treatment."
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