---
schema_version: "secwatch.filing_event.v1"
accession: "0001494650-24-000029"
form_type: "8-K"
ticker: null
cik: "0001494650"
company_name: "OptiNose, Inc."
filed_at: "2024-03-14T23:59:59+00:00"
generated_at: "2026-06-04T19:19:02.305895+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001494650-24-000029
- form_type: 8-K
- cik: 0001494650
- company_name: OptiNose, Inc.
- filed_at: 2024-03-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 1.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1494650/000149465024000029/0001494650-24-000029-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1494650/000149465024000029/optn-20240309.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001494650-24-000029
- JSON: https://secwatch.observer/filing/0001494650-24-000029.json
- Plain text: https://secwatch.observer/filing/0001494650-24-000029.txt

## Key facts
- Material Agreements
  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
  source text: 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.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1494650/000149465024000029/0001494650-24-000029-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.