OptiNose gets FDA nod for Hikma as second XHANCE manufacturing site; signs supply deal

OptiNose, Inc.

FDA approved Hikma as an additional manufacturing site for finished XHANCE units on March 9, 2024.
OptiNose entered a Manufacturing and Supply Agreement with Hikma with binding forecast and minimum purchase obligations.
Agreement runs through December 31, 2026, with termination rights for material breach or IP claims.
Two approved sites now: Hikma and Contract Pharmaceuticals Limited Canada.
Annual minimum purchase requirement included; failure triggers a specified fee payment.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.95

OptiNose, Inc. entered into Manufacturing and Supply Agreement with Hikma Pharmaceuticals USA, Inc. valued at Manufacturing and Supply Agreement for XHANCE units; minimum purchase obligations; term through Dece (effective 2020-12-11).

Action: entry
Agreement: supply
Counterparty: Hikma Pharmaceuticals USA, Inc.
Value: Manufacturing and Supply Agreement for XHANCE units; minimum purchase obligations; term through Dece
Effective: 2020-12-11

Exact text from the filing

OptiNose, Inc. (“Optinose”) and Hikma Pharmaceuticals USA, Inc. (“Hikma”) are parties to a Manufacturing and Supply Agreement, dated December 11, 2020 (the “Manufacturing Agreement”) pursuant to which, following FDA approval of Hikma as an alternative manufacturing site (which occurred on March 9, 2024), Hikma will manufacture and supply finished XHANCE units.

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Source: SEC EDGAR

accession 0001494650-24-000029

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