ZOGENIX, INC. (NASDAQ:ZGNX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
On July 17, 2019, Zogenix International Limited, a wholly-owned subsidiary of Zogenix, Inc. (collectively, the “Company”), entered into a Supply Agreement (the “Agreement”) with Penn Pharmaceutical Services Limited, trading as PCI Pharma Services (“PCI Pharma”), to which PCI Pharma will be the commercial manufacturer and supplier of the Company’s product candidate FINTEPLA®. The Agreement is effective as of June 17, 2019 (the “Effective Date”).
to the Agreement, PCI Pharma will procure the raw materials (other than the active pharmaceutical ingredient) for, test, bottle and package an oral solution of FINTEPLA for a specified price per batch. The Company will provide fenfluramine, the active pharmaceutical ingredient used in FINTEPLA, to PCI Pharma free of charge for these purposes. Under the Agreement, the product will be supplied to purchase orders which the Company may deliver to PCI Pharma from time to time. to the Agreement, at a specified time prior to the anticipated receipt of the first marketing authorization by a regulatory agency to market FINTEPLA, and then each month following such receipt, the Company is required to deliver a rolling forecast of its expected commercial orders, a portion of which will be considered a binding, firm order.
The term of the Agreement is five years from the Effective Date, which term shall be automatically extended for successive two-year periods thereafter, unless terminated earlier. After the second anniversary of the Effective Date, either party may terminate the Agreement at any time without cause following a specified notice period applicable to the respective party. In addition, either party may terminate the agreement (1) upon written notice if the other party has failed to remedy a material breach of any of its representations, warranties or other obligations under the Agreement within a specified period following receipt of written notice of such breach, (2) immediately in the event of a material breach of the other party’s representations, warranties or other obligations under the Agreement and in the event that such breach is not capable of remedy and (3) in the event that the other party files for bankruptcy, reorganization, liquidation, administration or receivership proceedings, or a substantial portion of the assets of such party is assigned for the benefit of such party’s creditors. The Company may also terminate the Agreement immediately in the event PCI Pharma is unable to supply FINTEPLA at specified quantities and within certain times. PCI Pharma may also terminate the Agreement upon notice if it determines its performance of services would violate applicable law. PCI Pharma’s manufacturing services under the Agreement will also terminate automatically if FINTEPLA is withdrawn as a result of regulatory review or the Company decides to cease development activities of FINTEPLA.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending September 30, 2019. The Company intends to redact certain portions of the Agreement for confidentiality purposes.
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About ZOGENIX, INC. (NASDAQ:ZGNX)
Zogenix, Inc. is a pharmaceutical company engaged in developing and commercializing central nervous system (CNS) therapies that address specific clinical needs for people living with orphan and other CNS disorders in requirement of treatment alternatives. The Company’s areas of focus are epilepsy and schizophrenia. Its lead product candidate, ZX008, is a low-dose fenfluramine. The Company is also engaged in the development of Relday, which is a long-acting injectable formulation of risperidone indicated for the treatment of symptoms of schizophrenia and bipolar disorder in adults and teenagers 13 years of age and older. The Company is also engaged in manufacturing Sumavel DosePro (sumatriptan injection), a needle-free delivery system, which it sells to Endo Ventures Bermuda Limited and Endo Ventures Limited. Its DosePro technology is a drug delivery system designed for self-administration of a pre-filled, single dose of liquid drug, subcutaneously, without a needle.
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